CODE OF FEDERAL REGULATIONS
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The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further subdivided into parts covering specific regulatory areas.
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Title 17 through Title 27
Title 28 through Title 41
Title 42 through Title 50
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Title 21—
(This book contains parts 1 to 99)
Food Safety and Inspection Service, Department of Agriculture: 9 CFR chapter III.
Federal Trade Commission: See Commercial Practices, 16 CFR chapter I.
U.S. Customs Service, Department of the Treasury: See Customs Duties, 19 CFR chapter I.
Internal Revenue Service, Department of the Treasury: See Internal Revenue, 26 CFR chapter I.
Bureau of Alcohol, Tobacco, and Firearms, Department of the Treasury: See Alcohol, Tobacco Products and Firearms, 27 CFR chapter I.
For nomenclature changes to chapter I see 59 FR 14366, Mar. 28, 1994 and 66 FR 56035, Nov. 6, 2001.
15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 343, 352, 355, 360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262, 264.
(a) The provisions of regulations promulgated under the Federal Food, Drug, and Cosmetic Act with respect to the doing of any act shall be applicable also to the causing of such act to be done.
(b) The definitions and interpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act shall be applicable also to such terms when used in regulations promulgated under that act.
(c) The definition of
(a)
(b)
(a) For each part of its regulations, the Food and Drug Administration includes a centralized citation of all of the statutory provisions that provide authority for any regulation that is included in that part.
(b) The agency may rely on any one or more of the authorities that are listed for a particular part in implementing or enforcing any section in that part.
(c) All citations of authority in this chapter will list the applicable sections in the organic statute if the statute is the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or the Fair Packaging and Labeling Act. References to an act or a section thereof include references to amendments to that act or section. These citations will also list the corresponding United States Code (U.S.C.) sections. For example, a citation to section 701 of the Federal Food, Drug, and Cosmetic Act would be listed: Sec. 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371).
(d) If the organic statute is one other than those specified in paragraph (c) of this section, the citations of authority in this chapter generally will list only the applicable U.S.C. sections. For example, a citation to section 552 of the Administrative Procedure Act would be listed: 5 U.S.C. 552. The agency may, where it determines that such measures are in the interest of clarity and public understanding, list the applicable sections in the organic statute and the corresponding U.S.C. section in the same manner set out in paragraph (c) of this section. References to an act or a section thereof include references to amendments to that act or section.
(e) Where there is no U.S.C. provision, the agency will include a citation to the U.S. Statutes at Large. Citations to the U.S. Statutes at Large will refer to volume and page.
(f) The authority citations will include a citation to executive delegations (i.e., Executive Orders), if any, necessary to link the statutory authority to the agency.
The term
(a) Shipping containers or wrappings used solely for the transportation of any such commodity in bulk or in quantity to manufacturers, packers, processors, or wholesale or retail distributors;
(b) Shipping containers or outer wrappings used by retailers to ship or deliver any such commodity to retail customers if such containers and wrappings bear no printed matter pertaining to any particular commodity; or
(c) Containers subject to the provisions of the Act of August 3, 1912 (37 Stat. 250, as amended; 15 U.S.C. 231-233), the Act of March 4, 1915 (38 Stat. 1186, as amended; 15 U.S.C. 234-236), the Act of August 31, 1916 (39 Stat. 673, as amended; 15 U.S.C. 251-256), or the Act of May 21, 1928 (45 Stat. 635, as amended; 15 U.S.C. 257-257i).
(d) Containers used for tray pack displays in retail establishments.
(e) Transparent wrappers or containers which do not bear written, printed, or graphic matter obscuring the label information required by this part.
(a) Labeling of a food, drug, device, or cosmetic shall be deemed to be misleading if it fails to reveal facts that are:
(1) Material in light of other representations made or suggested by statement, word, design, device or any combination thereof; or
(2) Material with respect to consequences which may result from use of the article under: (i) The conditions prescribed in such labeling or (ii) such conditions of use as are customary or usual.
(b) Affirmative disclosure of material facts pursuant to paragraph (a) of this section may be required, among other appropriate regulatory procedures, by
(1) Regulations in this chapter promulgated pursuant to section 701(a) of the act; or
(2) Direct court enforcement action.
(c) Paragraph (a) of this section does not:
(1) Permit a statement of differences of opinion with respect to warnings (including contraindications, precautions, adverse reactions, and other information relating to possible product hazards) required in labeling for food, drugs, devices, or cosmetics under the act.
(2) Permit a statement of differences of opinion with respect to the effectiveness of a drug unless each of the opinions expressed is supported by substantial evidence of effectiveness as defined in sections 505(d) and 512(d) of the act.
Section 403(e) of the act (in this part 1, the term
The following exemptions are granted from label statements required by this part:
(a)
(2) Random food packages, as defined in § 101.105(j) of this chapter, bearing labels declaring net weight, price per pound or per specified number of pounds, and total price shall be exempt from the type size, dual declaration,
(3) Individual serving-size packages of foods containing less than
(4) Individually wrapped pieces of
(5)(i) Soft drinks packaged in bottles shall be exempt from the placement requirements for the statement of identity prescribed by § 101.3 (a) and (d) of this chapter if such statement appears conspicuously on the bottle closure. When such soft drinks are marketed in a multiunit retail package, the multiunit retail package shall be exempt from the statement of identity declaration requirements prescribed by § 101.3 of this chapter if the statement of identity on the unit container is not obscured by the multiunit retail package.
(ii) A multiunit retail package for soft drinks shall be exempt from the declaration regarding name and place of business required by § 101.5 of this chapter if the package does not obscure the declaration on unit containers or if it bears a statement that the declaration can be found on the unit containers and the declaration on the unit containers complies with § 101.5 of this chapter. The declaration required by § 101.5 of this chapter may appear on the top or side of the closure of bottled soft drinks if the statement is conspicuous and easily legible.
(iii) Soft drinks packaged in bottles which display other required label information only on the closure shall be exempt from the placement requirements for the declaration of contents prescribed by § 101.105(f) of this chapter if the required content declaration is blown, formed, or molded into the surface of the bottle in close proximity to the closure.
(iv) Where a trademark on a soft drink package also serves as, or is, a statement of identity, the use of such trademark on the package in lines not parallel to the base on which the package rests shall be exempted from the requirement of § 101.3(d) of this chapter that the statement be in lines parallel to the base so long as there is also at least one statement of identity in lines generally parallel to the base.
(v) A multiunit retail package for soft drinks in cans shall be exempt from the declaration regarding name and place of business required by § 101.5 of this chapter if the package does not obscure the declaration on unit containers or if it bears a statement that the declaration can be found on the unit containers and the declaration on the unit containers complies with § 101.5 of this chapter. The declaration required by § 101.5 of this chapter may appear on the top of soft drinks in cans if the statement is conspicuous and easily legible, provided that when the declaration is embossed, it shall appear in type size at least one-eighth inch in height, or if it is printed, the type size shall not be less than one-sixteenth inch in height. The declaration may follow the curvature of the lid of the can and shall not be removed or obscured by the tab which opens the can.
(6)(i) Ice cream, french ice cream, ice milk, fruit sherbets, water ices, quiescently frozen confections (with or without dairy ingredients), special dietary frozen desserts, and products made in semblance of the foregoing, when measured by and packaged in
(ii) The foods named in paragraph (a)(6)(i) of this section, when measured by and packaged in 1-liquid pint, 1-liquid quart, and
(iii) The foods named in paragraph (a)(6)(i) of this section, when measured by and packaged in
(7)(i) Milk, cream, light cream, coffee or table cream, whipping cream, light whipping cream, heavy or heavy whipping cream, sour or cultured sour cream, half-and-half, sour or cultured half-and-half, reconstituted or recombined milk and milk products, concentrated milk and milk products, skim or skimmed milk, vitamin D milk and milk products, fortified milk and milk products, homogenized milk, flavored milk and milk products, buttermilk, cultured buttermilk, cultured milk or cultured whole buttermilk, low-fat milk (0.5 to 2.0 percent butterfat), and acidified milk and milk products, when packaged in containers of 8- and 64-fluid-ounce capacity, are exempt from the requirements of § 101.105(b)(2) of this chapter to the extent that net contents of 8 fluid ounces and 64 fluid ounces (or 2 quarts) may be expressed as
(ii) The products listed in paragraph (a)(7)(i) of this section, when packaged in glass or plastic containers of
(iii) The products listed in paragraph (a)(7)(i) of this section, when packaged
(8) Wheat flour products, as defined by §§ 137.105, 137.155, 137.160, 137.165, 137.170, 137.175, 137.180, 137.185, 137.200, and 137.205 of this chapter, packaged:
(i) In conventional 2-, 5-, 10-, 25-, 50-, and 100-pound packages are exempt from the placement requirement of § 101.105(f) of this chapter that the declaration of net contents be located within the bottom 30 percent of the area of the principal display panel of the label; and
(ii) In conventional 2-pound packages are exempt from the dual net-contents declaration requirement of § 101.105(j) of this chapter provided the quantity of contents is expressed in pounds.
(9)(i) Twelve shell eggs packaged in a carton designed to hold 1 dozen eggs and designed to permit the division of such carton by the retail customer at the place of purchase into two portions of one-half dozen eggs each are exempt from the labeling requirements of this part with respect to each portion of such divided carton if the carton, when undivided, is in conformance with the labeling requirements of this part.
(ii) Twelve shell eggs packaged in a carton designed to hold 1 dozen eggs are exempt from the placement requirements for the declaration of contents prescribed by § 101.105(f) of this chapter if the required content declaration is otherwise placed on the principal display panel of such carton and if, in the case of such cartons designed to permit division by retail customers into two portions of one-half dozen eggs each, the required content declaration is placed on the principal display panel in such a manner that the context of the content declaration is destroyed upon division of the carton.
(10) Butter as defined in 42 Stat. 1500 (excluding whipped butter):
(i) In 8-ounce and in 1-pound packages is exempt from the requirements of § 101.105(f) of this chapter that the net contents declaration be placed within the bottom 30 percent of the area of the principal display panel;
(ii) In 1-pound packages is exempt from the requirements of § 101.105(j)(1) of this chapter that such declaration be in terms of ounces and pounds, to permit declaration of “1-pound” or “one pound”; and
(iii) In 4-ounce, 8-ounce, and 1-pound packages with continuous label copy wrapping is exempt from the requirements of §§ 101.3 and 101.105(f) of this chapter that the statement of identity and net contents declaration appear in lines generally parallel to the base on which the package rests as it is designed to be displayed, provided that such statement and declaration are not so positioned on the label as to be misleading or difficult to read as the package is customarily displayed at retail.
(11) Margarine as defined in § 166.110 of this chapter and imitations thereof in 1-pound rectangular packages, except for packages containing whipped or soft margarine or packages that contain more than four sticks, are exempt from the requirement of § 101.105(f) of this chapter that the declaration of the net quantity of contents appear within the bottom 30 percent of the principal display panel and from the requirement of § 101.105(j)(1) of this chapter that such declaration be expressed both in ounces and in pounds to permit declaration of “1-pound” or “one pound,” provided an accurate statement of net weight appears conspicuously on the principal display panel of the package.
(12) Corn flour and related products, as they are defined by §§ 137.211, 137.215, and §§ 137.230 through 137.290 of this chapter, packaged in conventional 5-, 10-, 25-, 50-, and 100-pound bags are exempt from the placement requirement of § 101.105(f) of this chapter that the declaration of net contents be located within the bottom 30 percent of the area of the principal display panel of the label.
(13)(i) Single strength and less than single strength fruit juice beverages, imitations thereof, and drinking water when packaged in glass or plastic containers of
(ii) Single strength and less than single strength fruit juice beverages, imitations thereof, and drinking water when packaged in glass, plastic, or paper (fluid milk type) containers of 1-pint, 1-quart, and
(iii) Single strength and less than single strength fruit juice beverages, imitations thereof, and drinking water when packaged in glass, plastic, or paper (fluid milk type) containers of 8- and 64-fluid-ounce capacity, are exempt from the requirements of § 101.105(b)(2) of this chapter to the extent that net contents of 8 fluid ounces and 64 fluid ounces (or 2 quarts) may be expressed as
(14) The unit containers in a multiunit or multicomponent retail food package shall be exempt from regulations of section 403 (e)(1), (g)(2), (i)(2), (k), and (q) of the act with respect to the requirements for label declaration of the name and place of business of the manufacturer, packer, or distributor; label declaration of ingredients; and nutrition information when:
(i) The multiunit or multicomponent retail food package labeling meets all the requirements of this part;
(ii) The unit containers are securely enclosed within and not intended to be separated from the retail package under conditions of retail sale; and
(iii) Each unit container is labeled with the statement “This Unit Not Labeled For Retail Sale” in type size not less than one-sixteenth of an inch in height. The word “Individual” may be used in lieu of or immediately preceding the word “Retail” in the statement.
(b)
(c)
(1) When such cosmetics are affixed to a display card labeled in conformance with all labeling requirements of this part; or
(2) When such cosmetics are sold at retail as part of a cosmetic package consisting of an inner and outer container and the inner container is not for separate retail sale and the outer container is labeled in conformance with all labeling requirements of this part.
For the purposes of regulations prescribed under section 801(a), (b), and (c) of the Federal Food, Drug, and Cosmetic Act:
(a) The term
(b) The term
When a sample of an article offered for import has been requested by the district director, the collector of customs having jurisdiction over the article shall give to the owner or consignee prompt notice of delivery of, or intention to deliver, such sample. Upon receipt of the notice, the owner or consignee shall hold such article and not distribute it until further notice from the district director or the collector of customs of the results of examination of the sample.
The Food and Drug Administration will pay for all import samples which are found to be in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act. Billing for reimbursement should be made by the owner or consignee to the Food and Drug Administration district headquarters in whose territory the shipment was offered for import. Payment for samples will not be made if the article is found to be in violation of the act, even though subsequently brought into compliance under the terms of an authorization to bring the article into compliance or rendered not a food, drug, device, or cosmetic as set forth in § 1.95.
(a) If it appears that the article may be subject to refusal of admission, the district director shall give the owner or consignee a written notice to that effect, stating the reasons therefor. The notice shall specify a place and a period of time during which the owner or consignee shall have an opportunity to introduce testimony. Upon timely request giving reasonable grounds therefor, such time and place may be changed. Such testimony shall be confined to matters relevant to the admissibility of the article, and may be introduced orally or in writing.
(b) If such owner or consignee submits or indicates his intention to submit an application for authorization to relabel or perform other action to bring the article into compliance with the act or to render it other than a food, drug, device, or cosmetic, such testimony shall include evidence in support of such application. If such application is not submitted at or prior to the hearing, the district director shall specify a time limit, reasonable in the light of the circumstances, for filing such application.
Application for authorization to relabel or perform other action to bring the article into compliance with the act or to render it other than a food, drug, device or cosmetic may be filed only by the owner or consignee, and shall:
(a) Contain detailed proposals for bringing the article into compliance with the act or rendering it other than a food, drug, device, or cosmetic.
(b) Specify the time and place where such operations will be carried out and the approximate time for their completion.
(a) When authorization contemplated by § 1.95 is granted, the district director shall notify the applicant in writing, specifying:
(1) The procedure to be followed;
(2) The disposition of the rejected articles or portions thereof;
(3) That the operations are to be carried out under the supervision of an officer of the Food and Drug Administration or the U.S. Customs Service, as the case may be;
(4) A time limit, reasonable in the light of the circumstances, for completion of the operations; and
(5) Such other conditions as are necessary to maintain adequate supervision and control over the article.
(b) Upon receipt of a written request for extension of time to complete such operations, containing reasonable grounds therefor, the district director may grant such additional time as he deems necessary.
(c) An authorization may be amended upon a showing of reasonable grounds therefor and the filing of an amended application for authorization with the district director.
(d) If ownership of an article covered by an authorization changes before the operations specified in the authorization have been completed, the original owner will be held responsible, unless the new owner has executed a bond and obtained a new authorization. Any authorization granted under this section shall supersede and nullify any previously granted authorization with respect to the article.
(a) The bonds required under section 801(b) of the act may be executed by the owner or consignee on the appropriate form of a customs single-entry or term bond, containing a condition for the redelivery of the merchandise or any part thereof upon demand of the collector of customs and containing a provision for the performance of conditions as may legally be imposed for the relabeling or other action necessary to bring the article into compliance with the act or rendering it other than a food, drug, device, or cosmetic, in such manner as is prescribed for such bond in the customs regulations in force on the date of request for authorization. The bond shall be filed with the collector of customs.
(b) The collector of customs may cancel the liability for liquidated damages incurred under the above-mentioned provisions of such a bond, if he receives an application for relief therefrom, upon the payment of a lesser amount or upon such other terms and conditions as shall be deemed appropriate under the law and in view of the circumstances, but the collector shall not act under this regulation in any case unless the district director is in full agreement with the action.
The cost of supervising the relabeling or other action in connection with an import of food, drugs, devices, or cosmetics which fails to comply with the Federal Food, Drug, and Cosmetic Act shall be paid by the owner or consignee who files an application requesting such action and executes a bond, pursuant to section 801(b) of the act, as amended. The cost of such supervision shall include, but not be restricted to, the following:
(a) Travel expenses of the supervising officer.
(b) Per diem in lieu of subsistence of the supervising officer when away from his home station, as provided by law.
(c) The charge for the services of the supervising officer, which shall include administrative support, shall be computed at a rate per hour equal to 266 percent of the hourly rate of regular pay of a grade GS-11/4 employee, except that such services performed by a customs officer and subject to the provisions of the act of February 13, 1911, as amended (sec. 5, 36 Stat. 901, as amended (19 U.S.C. 267)), shall be calculated as provided in that act.
(d) The charge for the service of the analyst, which shall include administrative and laboratory support, shall be computed at a rate per hour equal to 266 percent of the hourly rate of regular pay of a grade GS-12/4 employee. The rate per hour equal to 266 percent of the equivalent hourly rate of regular pay of the supervising officer (GS-11/4) and the analyst (GS-12/4) is computed as follows:
Ratio of equivalent gross annual number of working hours charged to Food and Drug appropriation to net number of annual working hours4,512/1,696=266 pct.
(e) The minimum charge for services of supervising officers and of analysts shall be not less than the charge for 1
(a)
(b)
(1) Records demonstrating that the product meets the foreign purchaser's specifications: The records must contain sufficient information to match the foreign purchaser's specifications to a particular export;
(2) Records demonstrating that the product does not conflict with the laws of the importing country: This may consist of either a letter from an appropriate foreign government agency, department, or other authorized body stating that the product has marketing approval from the foreign government or does not conflict with that country's laws, or a notarized certification by a responsible company official in the United States that the product does not conflict with the laws of the importing country and that includes a statement acknowledging that he or she is subject to the provisions of 18 U.S.C. 1001;
(3) Records demonstrating that the product is labeled on the outside of the shipping package that it is intended for export: This may consist of copies of any labels or labeling statements, such as “For export only,” that are placed on the shipping packages or, if the exported product does not have a shipping package or container, on shipping invoices or other documents accompanying the exported product; and
(4) Records demonstrating that the product is not sold or offered for sale in the United States: This may consist of production and shipping records for the exported product and promotional materials.
(c)
(1) Records demonstrating that the product for export is a partially processed biological product and not in a form applicable to the prevention, treatment, or cure of diseases or injuries of man;
(2) Records demonstrating that the partially processed biological product was manufactured in conformity with current good manufacturing practice requirements;
(3) Records demonstrating the distribution of the exported partially processed biological products; and
(4) Copies of all labeling that accompanies the exported partially processed biological product and other records demonstrating that the exported partially processed biological product is intended for further manufacture into a final dosage form outside the United
(d)
(i) The product's trade name;
(ii) If the product is a drug or biological product, the product's abbreviated or proper name or, if the product is a device, the type of device;
(iii) If the product is a drug or biological product, a description of the product's strength and dosage form or, if the product is a device, the product's model number; and
(iv) If the export is to a country not listed in section 802(b)(1) of the act, the country that is to receive the exported article. The notification may, but is not required to, identify countries listed in section 802(b)(1) of the act or state that the export is intended for a listed country without identifying the listed country.
(2) The notification shall be sent to the following addresses:
(i) For biological products and devices regulated by the Center for Biologics Evaluation and Research—Division of Case Management (HFM-610), Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, rm. 200N, Rockville, MD 20852-1448;
(ii) For human drug products—Division of Labeling and Nonprescription Drug Compliance (HFD-310), Center for Drug Evaluation and Research, Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855-2737;
(iii) For devices—Division of Program Operations (HFZ-305), Center for Devices and Radiological Health, Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850.
(e)
(i) The product's trade name;
(ii) If the product is a drug or biological product, the product's abbreviated or proper name or, if the product is a device, the type of device;
(iii) If the product is a drug or biological product, a description of its strength and dosage form and the product's lot or control number or, if the product is a device, the product's model number;
(iv) The consignee's name and address; and
(v) The date on which the product was exported and the quantity of product exported.
(2) These records shall be kept at the site from which the products were exported or manufactured, and be maintained for the same period of time as required for records subject to good manufacturing practice or quality systems regulations applicable to the product. The records shall be made available to FDA, upon request, during an inspection for review and copying by FDA.
15 U.S.C. 402, 409; 21 U.S.C. 321, 331, 335, 342, 343, 346a, 348, 351, 352, 355, 360b, 361, 362, 371, 372, 374; 42 U.S.C. 7671
(a) Within the meaning of the Federal Food, Drug, and Cosmetic Act an imminent hazard to the public health is considered to exist when the evidence is sufficient to show that a product or practice, posing a significant threat of danger to health, creates a public health situation (1) that should be corrected immediately to prevent injury and (2) that should not be permitted to continue while a hearing or other formal proceeding is being held. The
(b) In exercising his judgment on whether an
(a)(1) When any officer or employee of the Department collects a sample of a food, drug, or cosmetic for analysis under the act, the sample shall be designated as an official sample if records or other evidence is obtained by him or any other officer or employee of the Department indicating that the shipment or other lot of the article from which such sample was collected was introduced or delivered for introduction into interstate commerce, or was in or was received in interstate commerce, or was manufactured within a Territory. Only samples so designated by an officer or employee of the Department shall be considered to be official samples.
(2) For the purpose of determining whether or not a sample is collected for analysis, the term
(3) The owner of a food, drug, or cosmetic of which an official sample is collected is the person who owns the shipment or other lot of the article from which the sample is collected.
(b) When an officer or employee of the Department collects an official sample of a food, drug, or cosmetic for analysis under the act, he shall collect at least twice the quantity estimated by him to be sufficient for analysis, unless:
(1) The amount of the article available and reasonably accessible for sampling is less than twice the quantity so estimated, in which case he shall collect as much as is available and reasonably accessible.
(2) The cost of twice the quantity so estimated exceeds $150.
(3) The sample cannot by diligent use of practicable preservation techniques available to the Food and Drug Administration be kept in a state in which it could be readily and meaningfully analyzed in the same manner and for the same purposes as the Food and Drug Administration's analysis.
(4) The sample is collected from a shipment or other lot which is being imported or offered for import into the United States.
(5) The sample is collected from a person named on the label of the article or his agent, and such person is also the owner of the article.
(6) The sample is collected from the owner of the article, or his agent, and such article bears no label or, if it bears a label, no person is named thereon.
(c) After the Food and Drug Administration has completed such analysis of an official sample of a food, drug, or cosmetic as it determines, in the course of analysis and interpretation of analytical results, to be adequate to establish the respects, if any, in which the article is adulterated or misbranded within the meaning of the act, or otherwise subject to the prohibitions of the act, and has reserved an amount of the article it estimates to be adequate for use as exhibits in the trial of any case that may arise under the act based on the sample, a part of the sample, if any remains available, shall be provided for analysis, upon written request, by any person named on the label of the article, or the owner thereof, or the attorney or agent of such person or owner, except when:
(1) After collection, the sample or remaining part thereof has become decomposed or otherwise unfit for analysis, or
(2) The request is not made within a reasonable time before the trial of any case under the act, based on the sample to which such person or owner is a party. The person, owner, attorney, or agent who requests the part of sample shall specify the amount desired. A request from an owner shall be accompanied by a showing of ownership, and a request from an attorney or agent by a showing of authority from such person or owner to receive the part of sample. When two or more requests for parts of the same sample are received the requests shall be complied with in the order in which they were received so long as any part of the sample remains available therefor.
(d) When an official sample of food, drug, or cosmetic is the basis of a notice given under section 305 of the act, or of a case under the act, and the person to whom the notice was given, or any person who is a party to the case, has no right under paragraph (c) of this section to a part of the sample, such person or his attorney or agent may obtain a part of the sample upon request accompanied by a written waiver of right under such paragraph (c) from each person named on the label of the article and owner thereof, who has not exercised his right under such paragraph (c). The operation of this paragraph shall be subject to the exceptions, terms, and conditions prescribed in paragraph (c) of this section.
(e) The Food and Drug Administration is authorized to destroy:
(1) Any official sample when it determines that no analysis of such sample will be made;
(2) Any official sample or part thereof when it determines that no notice under section 305 of the act, and no case under the act, is or will be based on such sample;
(3) Any official sample or part thereof when the sample was the basis of a notice under section 305 of the act, and when, after opportunity for presentation of views following such notice, it determines that no other such notice, and no case under the act, is or will be based on such sample;
(4) Any official sample or part thereof when the sample was the basis of a case under the act which has gone to final judgment, and when it determines that no other such case is or will be based on such sample;
(5) Any official sample or part thereof if the article is perishable;
(6) Any official sample or part thereof when, after collection, such sample or part has become decomposed or otherwise unfit for analysis;
(7) That part of any official sample which is in excess of three times the quantity it estimates to be sufficient for analysis.
Where the method of analysis is not prescribed in a regulation, it is the policy of the Food and Drug Administration in its enforcement programs to utilize the methods of analysis of the Association of Official Analytical Chemists (AOAC) as published in the latest edition (13th Ed., 1980) of their publication “Official Methods of Analysis of the Association of Official Analytical Chemists,” and the supplements thereto (“Changes in Methods” as published in the March issues of the “Journal of the Association of Official Analytical Chemists”), which are incorporated by reference, when available and applicable. Copies are available from the Association of Official
(a) In recent years there has developed increasing use of poisonous treatments on seed for fungicidal and other purposes. Such treated seed, if consumed, presents a hazard to humans and livestock. It is not unusual for stocks of such treated food seeds to remain on hand after the planting season has passed. Despite the cautions required by the Federal Seed Act (53 Stat. 1275, as amended 72 Stat. 476, 7 U.S.C. 1551
(b) On and after December 31, 1964, the Food and Drug Administration will regard as adulterated any interstate shipment of the food seeds wheat, corn, oats, rye, barley, and sorghum bearing a poisonous treatment in excess of a recognized tolerance or treatment for which no tolerance or exemption from tolerance is recognized in regulations promulgated pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act, unless such seeds have been adequately denatured by a suitable color to prevent their subsequent inadvertent use as food for man or feed for animals.
(c) Attention is called to the labeling requirements of the Federal Hazardous Substances Act, where applicable to denatured seeds in packages suitable for household use.
(a) Investigations by the Food and Drug Administration, the National Communicable Disease Center of the U.S. Public Health Service, the Consumer and Marketing Service of the U.S. Department of Agriculture, and by various State public health agencies have revealed practices whereby food and animal feed stored or shipped in secondhand containers have been rendered dangerous to health. Such contamination has been the result of the original use of these containers for the
(b) The Commissioner concludes that such dangerous or potentially dangerous practices include, but are not limited to, the following:
(1) Some vegetable growers and packers employ used poultry crates for shipment of fresh vegetables, including cabbage and celery. Salmonella organisms are commonly present on dressed poultry and in excreta and fluid exudates from dressed birds. Thus wooden crates in which dressed poultry has been iced and packed are potential sources of Salmonella or other enteropathogenic microorganisms that may contaminate fresh vegetables which are frequently consumed without heat treatment.
(2) Some potato growers and producers of animal feeds use secondhand bags for shipment of these articles. Such bags may have originally been used for shipping or storing pesticide-treated seed or other articles bearing or containing poisonous substances. Thus these secondhand bags are potential sources of contamination of the food or animal feed stored or shipped therein.
(c) In a policy statement issued April 11, 1968, the Food and Drug Administration declared adulterated within the meaning of section 402(a) of the Federal Food, Drug, and Cosmetic Act shipments of vegetables or other edible food in used crates or containers that may render the contents injurious to health. This policy statement is extended so that the Food and Drug Administration will regard as adulterated within the meaning of section 402(a) of the act shipments of vegetables, other edible food, or animal feed in used crates, bags, or other containers that may render the contents injurious to health.
For the purpose of determining whether an article containing ammonia is subject to the Federal Caustic Poison Act, the ammonia content is to be calculated as NH
(a) As used in this section,
(b) Except as provided in paragraph (c) of this section, any food, drug, device, or cosmetic that is, consists in part of, or is contained in an aerosol product or other pressurized dispenser that releases an ODS is not an essential use of the ODS under the Clean Air Act.
(c) A food, drug, device, or cosmetic that is, consists in part of, or is contained in an aerosol product or other pressurized dispenser that releases an ODS is an essential use of the ODS under the Clean Air Act if paragraph (e) of this section specifies the use of that product as essential. For drugs, including biologics and animal drugs, and for devices, an investigational application or an approved marketing application must be in effect, as applicable.
(d) [Reserved]
(e) The use of ODSs in the following products is essential:
(1)
(i) Beclomethasone.
(ii) Dexamethasone.
(iii) Flunisolide.
(iv) Fluticasone.
(v) Triamcinolone.
(2)
(i) Albuterol.
(ii) Bitolterol.
(iii) Metaproterenol.
(iv) Pirbuterol.
(v) Epinephrine.
(3) [Reserved]
(4)
(ii) Metered-dose ergotamine tartrate drug products administered by oral inhalation for use in humans.
(iii) Anesthetic drugs for topical use on accessible mucous membranes of humans where a cannula is used for application.
(iv) Metered-dose cromolyn sodium human drugs administered by oral inhalation.
(v) Metered-dose ipratropium bromide for oral inhalation.
(vi) Metered-dose atropine sulfate aerosol human drugs administered by oral inhalation.
(vii) Metered-dose nedocromil sodium human drugs administered by oral inhalation.
(viii) Metered-dose ipratropium bromide and albuterol sulfate, in combination, administered by oral inhalation for human use.
(ix) Sterile aerosol talc administered intrapleurally by thoracoscopy for human use.
(f) Any person may file a petition under part 10 of this chapter to request that FDA initiate rulemaking to amend paragraph (e) of this section to add an essential use. FDA may initiate notice-and-comment rulemaking to add an essential use on its own initiative or in response to a petition, if granted.
(1) If the petition is to add use of a noninvestigational product, the petitioner must submit compelling evidence that:
(i) Substantial technical barriers exist to formulating the product without ODSs;
(ii) The product will provide an unavailable important public health benefit; and
(iii) Use of the product does not release cumulatively significant amounts of ODSs into the atmosphere or the release is warranted in view of the unavailable important public health benefit.
(2) If the petition is to add use of an investigational product, the petitioner must submit compelling evidence that:
(i) Substantial technical barriers exist to formulating the investigational product without ODSs;
(ii) A high probability exists that the investigational product will provide an unavailable important public health benefit; and
(iii) Use of the investigational product does not release cumulatively significant amounts of ODSs into the atmosphere or the release is warranted in view of the high probability of an unavailable important public health benefit.
(g) Any person may file a petition under part 10 of this chapter to request that FDA initiate rulemaking to amend paragraph (e) of this section to remove an essential use. FDA may initiate notice-and-comment rulemaking to remove an essential use on its own initiative or in response to a petition, if granted. If the petition is to remove an essential use from paragraph (e) of this section, the petitioner must submit compelling evidence of any one of the following criteria:
(1) The product using an ODS is no longer being marketed; or
(2) After January 1, 2005, FDA determines that the product using an ODS no longer meets the criteria in paragraph (f) of this section after consultation with a relevant advisory committee(s) and after an open public meeting; or
(3) For individual active moieties marketed as ODS products and represented by one new drug application (NDA):
(i) At least one non-ODS product with the same active moiety is marketed with the same route of administration, for the same indication, and with approximately the same level of convenience of use as the ODS product containing that active moiety;
(ii) Supplies and production capacity for the non-ODS product(s) exist or will exist at levels sufficient to meet patient need;
(iii) Adequate U.S. postmarketing use data is available for the non-ODS product(s); and
(iv) Patients who medically required the ODS product are adequately served by the non-ODS product(s) containing that active moiety and other available products; or
(4) For individual active moieties marketed as ODS products and represented by two or more NDAs:
(i) At least two non-ODS products that contain the same active moiety are being marketed with the same route of delivery, for the same indication, and with approximately the same level of convenience of use as the ODS products; and
(ii) The requirements of paragraphs (g)(3)(ii), (g)(3)(iii), and (g)(3)(iv) of this section are met.
21 U.S.C. 321, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360gg-360ss, 371(a), 379e, 381, 394; 42 U.S.C. 216, 262.
This regulation relates to agency management and organization and has two purposes. The first is to implement section 503(g) of the act, as added by section 16 of the Safe Medical Devices Act of 1990 (Pub. L. 101-629), by specifying how FDA will determine the organizational component within FDA designated to have primary jurisdiction for the premarket review and regulation of products that are comprised of any combination of a drug and a device; a device and a biological; a biological and a drug; or a drug, a device and a biological. This determination will eliminate, in most cases, the need to receive approvals from more than one FDA component for such combination products. The second purpose of this regulation is to enhance the efficiency of agency management and operations by providing procedures for determining which agency component will have primary jurisdiction for any drug, device, or biological product where such jurisdiction is unclear or in dispute. Nothing in this section prevents FDA from using any agency resources it deems necessary to ensure adequate review of the safety and effectiveness of any product, or the substantial equivalence of any device to a predicate device.
For the purpose of this part:
(a)
(b)
(c)
(d)
(e)
(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
(2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;
(3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with
(4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
This section applies to:
(a) Any combination product, or
(b) Any product where the agency component with primary jurisdiction is unclear or in dispute.
(a) To designate the agency component with primary jurisdiction for the premarket review and regulation of a combination product, the agency shall determine the primary mode of action of the product. Where the primary mode of action is that of:
(1) A drug (other than a biological product), the agency component charged with premarket review of drugs shall have primary jurisdiction;
(2) A device, the agency component charged with premarket review of devices shall have primary jurisdiction;
(3) A biological product, the agency component charged with premarket review of biological products shall have primary jurisdiction.
(b) The designation of one agency component as having primary jurisdiction for the premarket review and regulation of a combination product does not preclude consultations by that component with other agency components or, in appropriate cases, the requirement by FDA of separate applications.
(a)(1) The Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Drug Evaluation and Research have entered into agreements clarifying product jurisdictional issues. These guidance documents are on display in the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn
(2) These guidance documents describe the allocation of responsibility for categories of products or specific products. These intercenter agreements, and any amendments thereto, are nonbinding determinations designed to provide useful guidance to the public.
(3) The sponsor of a premarket application or required investigational filing for a combination or other product covered by these guidance documents may contact the designated agency component identified in the intercenter agreement before submitting an application of premarket review or to confirm coverage and to discuss the application process.
(b) For a combination product not covered by a guidance document or for a product where the agency component with primary jurisdiction is unclear or in dispute, the sponsor of an application for premarket review should follow the procedures set forth in § 3.7 to request a designation of the agency component with primary jurisdiction before submitting the application.
FDA Ombudsman (HF-7), Food and Drug Administration, rm. 14-84, 5600 Fishers Lane, Rockville, MD 20857, 301-443-1306, is the designated product jurisdiction officer.
(a) Who should file: the sponsor of:
(1) Any combination product the sponsor believes is not covered by an intercenter agreement; or
(2) Any product where the agency component with primary jurisdiction is unclear or in dispute.
(b) When to file: a sponsor should file a request for designation before filing any application for premarket review, whether an application for marketing approval or a required investigational notice. Sponsors are encouraged to file a request for designation as soon as there is sufficient information for the agency to make a determination.
(c) What to file: an original and two copies of the request for designation must be filed. The request for designation must not exceed 15 pages, including attachments, and must set forth:
(1) The identity of the sponsor, including company name and address, establishment registration number, company contact person and telephone number.
(2) A description of the product, including:
(i) Classification, name of the product and all component products, if applicable;
(ii) Common, generic, or usual name of the product and all component products;
(iii) Proprietary name of the product;
(iv) Identification of any component of the product that already has received premarket approval, is marketed as not being subject to premarket approval, or has received an investigational exemption, the identity of the sponsors, and the status of any discussions or agreements between the sponsors regarding the use of this product as a component of a new combination product.
(v) Chemical, physical, or biological composition;
(vi) Status and brief reports of the results of developmental work, including animal testing;
(vii) Description of the manufacturing processes, including the sources of all components;
(viii) Proposed use or indications;
(ix) Description of all known modes of action, the sponsor's identification of the primary mode of action, and the basis for that determination;
(x) Schedule and duration of use;
(xi) Dose and route of administration of drug or biologic;
(xii) Description of related products, including the regulatory status of those related products; and
(xiii) Any other relevant information.
(3) The sponsor's recommendation as to which agency component should have primary jurisdiction, with accompanying statement of reasons.
(d) Where to file: all communications pursuant to this subpart shall be addressed to the attention of the product jurisdiction officer. Such a request, in its mailing cover should be plainly marked “Request for Designation.”
(a) Each request for designation will be reviewed for completeness within 5 working days of receipt. Any request for designation determined to be incomplete will be returned to the applicant with a request for the missing information. The sponsor of an accepted request for designation will be notified of the filing date.
(b) Within 60 days of the filing date of a request for designation, the product jurisdiction officer will issue a letter of designation to the sponsor, with copies to the centers, specifying the agency component designated to have primary jurisdiction for the premarket review and regulation of the product at issue, and any consulting agency components. The product jurisdiction officer may request a meeting with the sponsor during the review period to discuss the request for designation. If the product jurisdiction officer has not issued a letter of designation within 60 days of the filing date of a request for designation, the sponsor's recommendation of the center with primary jurisdiction, in accordance with § 3.7(c)(3), shall become the designated agency component.
(c) Request for reconsideration by sponsor: If the sponsor disagrees with the designation, it may request the product jurisdiction officer to reconsider the decision by filing, within 15 days of receipt of the letter of designation, a written request for reconsideration not exceeding 5 pages. No new information may be included in a request for reconsideration. The product jurisdiction officer shall review and act on the request in writing within 15 days of its receipt.
(a) The letter of designation constitutes an agency determination that is subject to change only as provided in paragraph (b) of this section.
(b) The product jurisdiction officer may change the designated agency component with the written consent of the sponsor, or without its consent to protect the public health or for other compelling reasons. A sponsor shall be given 30 days written notice of any proposed nonconsensual change in designated agency component. The sponsor may request an additional 30 days to submit written objections, not to exceed 15 pages, to the proposed change, and shall be granted, upon request, a timely meeting with the product jurisdiction officer and appropriate center officials. Within 30 days of receipt of the sponsor's written objections, the product jurisdiction officer shall issue to the sponsor, with copies to appropriate center officials, a written determination setting forth a statement of reasons for the proposed change in designated agency component. A nonconsensual change in the designated agency component requires the concurrence of the Deputy Commissioner for Operations or the Deputy Commissioner for Policy.
Any filing with or review by the product jurisdiction officer stays the review clock or other established time periods for agency action for an application for marketing approval or required investigational notice during the pendency of the review by the product jurisdiction officer.
5 U.S.C. 504, 552, App. 2 605; 7 U.S.C. 138a, 2217; 15 U.S.C. 638, 1261-1282, 1451-1461, 3701-3711a; 21 U.S.C., 61-63, 141-149, 301-394, 467f, 679(b), 801-886, 1031-1309, 1401-1403; 35 U.S.C. 156; 42 U.S.C. 238, 241, 242, 242a, 242l, 242n, 242o, 243, 262, 263, 264, 265, 300u-300u-5, 300aa-1, 300ar-25-28, 300cc, 300ff, 1395y, 4332, 4831(a), 10007-10008; E.O. 11921, 41 FR 24294, 3 CFR, 1977 Comp., p. 124-131; E.O. 12591, 52 FR 13414, 3 CFR, 1988 Comp., p. 220-223.
(a) The Secretary of Health and Human Services (the Secretary) has redelegated to the Commissioner of Food and Drugs (Commissioner), with authority to redelegate (except when specifically prohibited), all authority as follows:
(1) Functions vested in the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
(2) Functions vested in the Secretary under section 301 (Research and Investigations); section 307 (International Cooperation); and section 311 (Federal-State Cooperation) of the Public Health Service Act (the PHS Act) (42 U.S.C. 241, 242l, 243), as amended, which relate to the functions of the Food and Drug Administration.
(3) Functions vested in the Secretary under section 361 of the PHS Act (42 U.S.C. 264), as amended, which relate to the law enforcement functions of the Food and Drug Administration concerning the following products and activities: Biologicals (including blood and blood products); interstate travel sanitation (except interstate transportation of etiologic agents under 42 CFR part 72); food (including milk and food service sanitation and shellfish sanitation); and drugs, devices, cosmetics, electronic products, and other items or products regulated by the Food and Drug Administration.
(4) Functions vested in the Secretary under sections 351 and 352 of part F, subpart 1 of the PHS Act (42 U.S.C. 262 and 263), as amended (Biological Products), insofar as they relate to the functions assigned to the Food and Drug Administration.
(5) Functions vested in the Secretary under section 302(a) of the PHS Act (42 U.S.C. 242(a)), as amended, which relate to the determination and reporting requirements with respect to the medicinal and scientific requirements of the United States for controlled substances.
(6) Functions vested in the Secretary under section 303 of the PHS Act (42 U.S.C. 242a), as amended, which relate to the authorization of persons engaged in research on the use and effect of drugs to protect the identity of their research subjects with respect to drugs scheduled under Public Law 91-513 for which an investigational new drug application is filed with the Food and Drug Administration and with respect to all drugs not scheduled under Public Law 91-513.
(7) Functions vested in the Secretary pertaining to section 4 of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (Public Law 91-513, 84 Stat. 1241) which relate to the determination of the safety and effectiveness of drugs or to approve new drugs to be used in the treatment of narcotic addicts.
(8) Functions vested in the Secretary pertaining to section 303(f) of the Controlled Substances Act (21 U.S.C. 823(f)), which relate to the merits of the research protocol and to the determination of the qualifications and competency of practitioners wishing to conduct research with controlled substances listed in Schedule I of the Act.
(9) Functions vested in the Secretary pertaining to provisions of the Controlled Substances Act (21 U.S.C. 801
(10) Functions vested in the Secretary under section 409(b) of the Federal Meat Inspection Act (21 U.S.C. 679(b)), which relate to the detention of any carcass, part thereof, meat, or meat product of cattle, sheep, swine, goats, or equines.
(11) Functions vested in the Secretary under section 24(b) of the Poultry Products Inspection Act (21 U.S.C. 467f(b)), which relate to the detention
(12) Functions vested in the Secretary under the Egg Products Inspection Act (21 U.S.C. 1031
(13) Functions vested in the Secretary by amendments to the foregoing statutes subsequent to Reorganization Plan No. 1 of 1953.
(14) Function of issuing all regulations of the Food and Drug Administration, except as provided in § 5.11. The reservation of authority contained in Chapter 2-000 of the Department Organization Manual shall not apply.
(15) Functions vested in the Secretary under section 1103 of Executive Order 11490, as amended by Executive Order 11921, which relate to emergency health functions as they pertain to the operations and functional responsibilities assigned to the agency. This authority shall be exercised in accordance with section 102 and pertinent sections of part 30 of Executive Order 11490 and guidelines issued by the Federal Preparedness Agency of the General Services Administration and the Office of the Secretary.
(16) Function vested in the Secretary of authorizing and approving miscellaneous and emergency expenses of enforcement activities.
(17) Functions vested in the Secretary under the Federal Advisory Committee Act, Public Law 92-463, to:
(i) Renew, recharter, amend and terminate established Federal Advisory Committees;
(ii) Authority to approve waivers to appoint committee members to established Federal Advisory Committees;
(iii) Authority to close review meetings following approval by the Office of the General Counsel based on a determination that the Advisory Committee meeting or a portion thereof may be closed to the public under the provisions of 5 U.S.C. 552b(c) and section 10(d) of the Federal Advisory Committee Act. These authorities are to be exercised in accordance with the requirements of 5 U.S.C. 552b; the Federal Advisory Committee Act (Public Law 92-463); Departmental regulations (45 CFR part 11, superseded by 41 CFR part 101-6); and any other applicable statutes and regulations. These authorities may be redelegated.
(18) Functions vested in the Secretary under the second sentence of section 310(a) and under section 310(b) (Health Conferences and Health Education Information) of the PHS Act (42 U.S.C. 242o), as amended, to call for a conference and invite as many health authorities and officials of State or local public or private agencies or organizations as deemed necessary or proper on subjects related to the functions of the Food and Drug Administration, and to issue information related to health for the use of the public and other pertinent health information for the use of persons and institutions concerned with health services when such information is related to the functions of the Food and Drug Administration.
(19) Functions vested in the Secretary under section 2701 of the PHS Act (42 U.S.C. 238), as amended, to accept offers of gifts, excluding the acceptance of gifts of real property. Only the authority to accept unconditional gifts of personal property valued at $5,000 or less may be redelegated.
(20) Functions vested in the Secretary under section 362 of the PHS Act (42 U.S.C. 265), as amended, which relate to the prohibition of the introduction of foods, drugs, devices, cosmetics, electronic products, and other items or products regulated by the Food and Drug Administration into the United States when it is determined that it is required in the interest of public health when such functions relate to the law enforcement functions of the Food and Drug Administration.
(21) Functions vested in the Secretary under section 401(a) of the Lead-Based Paint Poisoning Prevention Act, as amended by Public Law 94-317 (42 U.S.C. 4831(a)), relating to the prohibition of the application of lead-based paint to cooking, drinking, or eating utensils.
(22) Functions vested in the Secretary for the health information and health promotion program under title XVII of the PHS Act (42 U.S.C. 300u
(23) To administer a Small Business Innovation Research Program under section 9 of the Small Business Act (15 U.S.C. 638), as amended. The delegation excludes the authority to issue regulations, establish advisory councils and committees, appoint members to advisory councils and committees, and submit reports to Congress.
(24) Functions vested in the Secretary under sections 982 and 983 of the Consumer-Patient Radiation Health and Safety Act of 1981 (the Act) (42 U.S.C. 10007 and 10008), as amended. The delegation excludes the authority to issue regulations and submit reports to Congress. The authority delegated under section 983 of the Act may only be exercised as it relates to functions assigned to the Food and Drug Administration.
(25) Functions vested in the Secretary under section 156 of title 35 of the U.S. Code (35 U.S.C. 156), as amended, which allows for the extension of patent terms for human drug products, medical devices, food additives, and color additives subject to the Federal Food, Drug, and Cosmetic Act (the act). These authorities may be redelegated, except the authority to make due diligence determinations under section 156(d)(2)(B), which may not be redelegated to an Office below the Office of the Commissioner of Food and Drugs.
(26) Functions vested in the Secretary under the Stevenson-Wydler Technology Innovation Act of 1980 (15 U.S.C. 3701
(i) The authorities under section 11(c)(5)(A) and (B) of the act (15 U.S.C. 3710a(c)(5)(A) and (B)) to disapprove or require the modification of cooperative research and development agreements and licensing agreements after the agreement is presented to the Commissioner by the head of the laboratory concerned, and to transmit written explanation of such disapproval or modification to the head of the laboratory concerned, may be redelegated only to a senior official in the immediate Office of the Commissioner.
(ii) The following authorities may not be redelegated: The authority under section 11(b)(3)(D) of the Act (15 U.S.C. 3710a(b)(3)(D)) to waive a right of ownership which the Federal Government may have to an invention made under a cooperative research and development agreement; the authority under section 11(b)(3)(C) of the Act (15 U.S.C. 3710a(b)(3)(C)) to permit employees or former employees to participate in efforts to commercialize inventions they made while in the service of the United States; the authority under section 11(c)(3)(A) of the Act (15 U.S.C. 3710a(c)(3)(A)) to review employee standards of conduct for resolving potential conflicts of interest; the authority under section 13(a)(1) of the Act (15 U.S.C. 3710c(a)(1)) to retain any royalties or other income, except as provided in section 13(a)(2) of the Act (15 U.S.C. 3710c(a)(2)); and the authority under section 13(a)(1)(A)(i) of the Act (15 U.S.C. 3710c(a)(1)(A)(i)) to pay royalties or other income the agency receives on account of an invention to the inventor if the inventor was an employee of the agency at the time the invention was made.
(iii) Any authorities under paragraph (a)(26) of this section delegated by the Commissioner may not be further redelegated.
(27) Functions vested in the Secretary under sections 4702, 4703, and 4704 of the Pesticide Monitoring Improvements Act of 1988 (21 U.S.C. 1401-1403) that relate to pesticide monitoring and enforcement information, foreign pesticide information, and pesticide analytical methods. The delegation excludes the authority to submit reports to Congress.
(28) Functions vested in the Secretary under sections 2312(a)(1) and (2)(B), (b), and (c) (Use of Investigational New Drugs with Respect to Acquired Immunodeficiency Syndrome); 2314(c) (Scientific and Ethical Guidelines for Certain Treatments); and 2317(d) and (e) (Information Services) of title XXIII of the PHS Act (42 U.S.C. 300cc-12(a)(1) and (2)(B), (b) and (c), 300cc-14(c) and 300cc-17(d) and (e)), as amended, insofar as these authorities pertain to the functions assigned to the Food and Drug Administration. The delegation excludes the authority to issue regulations, submit reports to the Congress, establish advisory committees or national commissions, and appoint members to such committees or commissions.
(29) Functions vested in the Secretary under section 2672(a)(1) (A) and (B) (Provisions Relating to Blood Banks) and section 2672(a)(2) (Information and Training Programs) of the PHS Act (42 U.S.C. 300ff-72(a)(1)(A) and (B) and (a)(2)
(30) Functions vested in the Secretary under sections 1322(b) and (c) of the Food, Agriculture, Conservation, and Trade Act of 1990 (the National Laboratory Accreditation Program) (7 U.S.C. 138a), as amended hereafter, which relate to setting standards for the National Laboratory Accreditation Program and approving State agencies or private, nonprofit entities as accrediting bodies to implement certification and quality assurance programs in accordance with the requirements of this section. The delegation excludes the authority to submit reports to Congress.
(31) Functions vested in the Secretary under part C, subtitle 2 of title XXI of the PHS Act (42 U.S.C. 300aa-25
(i) Section 2125 of the PHS Act (42 U.S.C. 300aa-25)—Recording and reporting of information.
(ii) Section 2127 of the PHS Act (42 U.S.C. 300aa-27)—-Mandate for safer childhood vaccines.
(iii) Section 2128 of the PHS Act (42 U.S.C. 300aa-28)—Manufacturer recordkeeping and reporting.
(iv) Section 312 of the National Childhood Vaccine Injury Act of 1986—Related studies (42 U.S.C. 300aa-1 note).
(v) Section 313 of the National Childhood Vaccine Injury Act of 1986—Study of other vaccine risks (42 U.S.C. 300aa-1 note).
(vi) Section 314 of the National Childhood Vaccine Injury Act of 1986—Review of warnings, use instructions, and precautionary information (42 U.S.C. 300aa-1 note).
(vii) The delegation excludes the authority to issue regulations and submit reports to Congress.
(32) Functions vested in the Secretary under section 201(h)(4) of the Controlled Substances Act (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended) (21 U.S.C. 811(h)(4)) to provide responses to the Drug Enforcement Administration's temporary scheduling notices. The delegation excludes the authority to submit reports to Congress.
(33) Functions vested in the Secretary under the Safe Medical Devices Act of 1990 (Pub. L. 101-629), as amended hereafter (e.g., 21 U.S.C. 360c note, 360i note, and 360j note). The delegation excludes the authority to submit reports to Congress.
(34) Functions vested in the Secretary under section 601 of Effective Medication Guides of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 1997 (Public Law 104-180), as amended hereafter. The delegation excludes the authority to issue reports to Congress.
(35) The Secretary has redelegated to the Commissioner of Food and Drugs, or his designee, the authority to take final action on matters pertaining to section 203 of the Equal Access to Justice Act (5 U.S.C. 504), and to develop
(36) The Secretary has delegated to the Commissioner, the authority to administer and make decisions regarding the invention and patent program as they pertain to the functions of the Food and Drug Administration and to make determinations of rights in inventions and patents in which the Department has an interest. This delegation excludes the authority to submit reports to Congress and further, it excludes those authorities under the Stevenson-Wydler Technology Innovation Act of 1980, as amended by the Federal Technology Transfer Act of 1986 and the National Technology Transfer and Advancement Act of 1995, which are governed by a separate delegation (under § 5.10(a)(26)). All authorities other than the authority under 35 U.S.C. section 203 (March-In Rights) may be redelegated.
(37) Functions vested in the Secretary under title III, Section 354, of the PHS Act (42 U.S.C. 262
(38) The Deputy Assistant Secretary for Health Management Operations, Public Health Service, has redelegated to the Commissioner of Food and Drugs, with authority to redelegate, the authority to certify true copies of any books, records, or other documents on file within the Food and Drug Administration, or extracts from such; to certify that true copies are true copies of the entire file of the Administration; to certify the complete original record or to certify the nonexistence of records on file within the Administration; and to cause the Seal of the Department to be affixed to such certifications and to agreements, awards, citations, diplomas, and similar documents.
(39) The Secretary of Health and Human Services has redelegated to the Commissioner, of Food and Drugs, under 45 CFR 5b.8 regulations, appeal authority to take final action upon an individual's appeal of a refusal to correct or amend the individual's record when the appeal has been made by the individual under Privacy Act regulations (part 21 of this chapter and 45 CFR part 5b). The authority may not be redelegated.
(b) The Chief Counsel of the Food and Drug Administration has been authorized to report apparent violations to the Department of Justice for the institution of criminal proceedings, under section 305 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335), section 4 of the Federal Import Milk Act (21 U.S.C. 144), and section 9(b) of the Federal Caustic Poison Act.
(a) Notwithstanding provisions of § 5.10 or any previous delegations of authority to the contrary, the Secretary of Health and Human Services (Secretary) reserves the authority to approve regulations of the Food and Drug Administration, except regulations to which sections 556 and 557 of title 5 U.S.C. apply, which:
(1) Establish procedural rules applicable to a general class of foods, drugs, cosmetics, medical devices, or other subjects of regulation; or
(2) Present highly significant public issues involving the quality, availability, marketability, or cost of one or more foods, drugs, cosmetics, medical devices, or other subjects of regulation.
(b) Nothing in this section precludes the Secretary from approving a regulation, or being notified in advance of an action, to which sections 556 and 557 of title 5 U.S.C. apply, which meets one of the criteria in paragraph (a) of this section.
(c) This reservation of authority is intended only to improve the internal management of the Department of Health and Human Services, and it is not intended to create any right or benefit, substantive or procedural, enforceable at law by a party against the United States, the Department of Health and Human Services, the Food and Drug Administration, any agency, officer, or employee of the United States, or any person. Regulations issued by the Food and Drug Administration without the approval of the Secretary are to be conclusively viewed as falling outside the scope of this reservation of authority.
(a) Final authority of the Commissioner of Food and Drugs (Commissioner) is redelegated as set forth in these subparts. The Commissioner may continue to exercise all authority delegated in subparts B through L.
(b) The following officials are authorized to perform all of the functions of the Commissioner. These officials may not further redelegate this authority, or any part of this authority, except as elsewhere specified:
(1) Deputy Commissioner;
(2) Associate Commissioner for Regulatory Affairs;
(3) Senior Associate Commissioner;
(4) Senior Associate Commissioner for Management and Systems;
(5) Senior Associate Commissioner for Policy, Planning, and Legislation; and
(6) Deputy Commissioner for International and Constituent Relations.
(c)(1) During the absence or disability of the Commissioner or in the event of a vacancy in that position, the first official who is available in the following positions, or who has been designated by the Commissioner to act in such position, shall act as Commissioner:
(i) Deputy Commissioner;
(ii) Associate Commissioner for Regulatory Affairs; or
(iii) Senior Associate Commissioner.
(2) These officials may not further redelegate this authority. However, for a planned period of absence, the Commissioner (or someone “acting” on his/her behalf) may specify a different order of succession.
(d) Authority delegated to a position by title may be exercised by a person officially designated to serve in that position in an acting capacity or on a temporary basis, unless prohibited by a restriction in the document designating him/her as “acting” or unless not legally permissible.
(e)(1) The Senior Associate Commissioner is authorized to make determinations that advisory committee meetings are concerned with matters listed in 5 U.S.C. 552(b) and therefore may be closed to the public in accordance with § 5.10(a)(17).
(2) The Senior Associate Commissioner is authorized to perform other associated advisory committee functions (e.g., establishing technical and scientific review groups (advisory committees)); appointing and paying members; approving waivers to appoint members to established advisory committees; renewing and rechartering of established advisory committees; amending charters of established advisory committees; and terminating established advisory committees.
(3) The Senior Associate Commissioner is authorized to approve conflict of interest waivers for special Government employees serving on advisory committees in accordance with 18 U.S.C. 208(b)(3), as amended.
(4) The Senior Associate Commissioner is authorized to select temporary members to advisory committees if such voting members are serving on an advisory committee managed by another center.
(5) The Senior Associate Commissioner may not further redelegate these authorities.
(f)(1) The Senior Associate Commissioner for Policy, Planning, and Legislation (SACPPL) and the Associate Commissioner for Policy (ACP) are authorized to perform any of the functions of the Commissioner with respect to the issuance of
(2) The SACPPL and the ACP are authorized to issue responses to the following matters under part 10 of this chapter as follows and these officials may not further redelegate this authority:
(i) Requests for waiver, suspension, or modification of procedural requirements under § 10.19 of this chapter;
(ii) Citizen petitions under § 10.30 of this chapter;
(iii) Petitions for reconsideration under § 10.33 of this chapter;
(iv) Petitions for stay under § 10.35 of this chapter; or
(v) Requests for advisory opinions under § 10.85 of this chapter.
(3) With respect to any matter delegated to the SACPPL and the ACP under this paragraph, the SACPPL and the ACP are authorized to perform the function of the Commissioner under §§ 10.40, 10.45, 10.50, 10.55, 10.60, 10.65, 10.80, 10.90, and 10.95 of this chapter and of the Deputy Commissioner under § 10.206(g) and (h) of this chapter. These officials may not further redelegate this authority.
(4) The SACPPL and the ACP are authorized under the Regulatory Flexibility Act (5 U.S.C. 605(b)) to certify that a proposed or final rule, if issued, will not have a significant economic impact on a substantial number of small entities. The SACPPL and the ACP may further redelegate this authority.
(g) The following officials are authorized to perform all the functions of the officials under them in their respective offices and they may not further redelegate this authority:
(1) Senior Associate Commissioner;
(2) Deputy Commissioner for International and Constituent Relations;
(3) Senior Associate Commissioner for Management and Systems; or
(4) Senior Associate Commissioner for Policy, Planning, and Legislation.
(h)(1) The Chief Mediator and Ombudsman and the Deputy Chief Mediator and Ombudsman are authorized to act upon requests for reconsideration of any user fee decisions under section 735 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379h) made by such officers and the former Deputy User Fee Waiver Officer prior to July 1, 1999. These officials may not further redelegate this authority. (See subpart C, § 5.108 for the user fee-related redelegation to officials within the Center for Drug Evaluation and Research.)
(2) The Senior Associate Commissioner for Management and Systems and the Director, Office of Financial Management, are authorized to perform the functions of the Commissioner under section 736(d)(1)(c) of the act (21 U.S.C. 379h(d)(1)(C)), as amended, to waive or reduce prescription drug user fees in situation where he or she finds that “the fees will exceed the anticipated present and future costs.” These officials may not further redelegate this authority.
(3) The Deputy Commissioner, or in the event of a vacancy in that position, the Senior Associate Commissioner, Office of the Commissioner, is designated as the User Fee Appeals Officer. The User Fee Appeals Officer is authorized to hear and decide user fee waiver appeals. The decision of the User Fee Appeals Officer will constitute final agency action on such matters. The User Fee Appeals Officer may not further redelegate this authority.
(i) The Senior Associate Commissioner for Management and Systems is authorized to perform all of the administrative authorities (i.e., financial, personnel, facilities management, property management, etc.) of the Commissioner. These authorities may be further redelegated, except when specifically prohibited.
(j) Unless specifically noted, the persons to whom the Commissioner has delegated authority in subparts B through L of this part may not further redelegate that authority.
(a) Each Regional Food and Drug Director is authorized, during any period when normal channels of direction are disrupted between the Food and Drug Administration headquarters and his or her region to:
(1) Fully represent the Food and Drug Administration within his or her region in cooperation with the Department of Health and Human Services regional emergency plans, and
(2) Exercise the authority of the Commissioner of Food and Drugs for supervision of and direction to all Food and Drug Administration activities and use of resources within his or her region for continuity and for Federal Emergency Health Service operations.
(b) These same officials are authorized to provide in Regional Emergency Plans for the delegation of Food and Drug Administration regional authorities to heads of field activities when such activities are cut off from national and regional headquarters. These officials may not further redelegate this authority.
(a) The following officials are authorized to certify true copies of, or extracts from, any books, records, papers, or other documents on file within the Food and Drug Administration, to certify that copies are true copies of the entire file, to certify the complete original record, or to certify the nonexistence of records on file within the Food and Drug Administration, and to cause the seal of the Department to be affixed to such certifications:
(1) The Deputy Commissioner, the Senior Associate Commissioner, the Deputy Commissioner for International and Constituent Relations, the Senior Associate Commissioner for Management and Systems, and the Senior Associate Commissioner for Policy, Planning, and Legislation.
(2) The Associate and Deputy Associate Commissioners and the Chief Counsel and Deputy Chief Counsels.
(3) The Director, Office of the Executive Secretariat, Office of the Senior Associate Commissioner, Office of the Commissioner (OC).
(4) The Director, Office of Executive Operations, Office of the Senior Associate Commissioner, OC.
(5)(i) The Director and Deputy Director, Office of Enforcement, Office of Regulatory Affairs (ORA).
(ii) The Director and Deputy Director, Office of Regional Operations, ORA.
(iii) The Director and Deputy Director, Office of Resource Management (ORM), ORA.
(iv) The Director, Division of Management Operations, ORM, ORA.
(v) Team Leader, FDA History Staff, ORM, ORA.
(6)(i) The Director, Office of Human Resources and Management Services (OHRMS), Office of Management and Systems (OMS), OC.
(ii) The Director, Division of Management Programs (DMP), OHRMS, OMS, OC.
(iii) The Chief, Dockets Management Branch, DMP, OHRMS, OMS, OC.
(7) The Associate Commissioner for Public Affairs, Office of Public Affairs (OPA), Office of the Senior Associate Commissioner (OSAC), OC.
(8)(i) The Chief Information Officer, Office of Information Resources Management (OIRM), Office of Management and Systems (OMS), OC.
(ii) The Director, Freedom of Information Staff, OIRM, OMS, OC.
(9)(i) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).
(ii) The Director, Office of Management, CBER.
(iii) The Director and Deputy Directors of the Office of Compliance and Biologics Quality, CBER.
(iv) The Director and Deputy Director, Office of Communication, Training, and Manufacturer's Assistance, CBER.
(v) The Director and Branch Chiefs, Division of Case Management, Office of Compliance and Biologics Quality (OCBQ), CBER; and the Consumer Safety Officers, OCBQ, CBER.
(10)(i) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN).
(ii) The Director of Regulations and Policy, CFSAN.
(iii) The Director, Office of Management Systems, CFSAN.
(iv) The Director, Office of Cosmetics and Colors, CFSAN.
(v) The Director, Office of Plant and Dairy Foods and Beverages, CFSAN.
(vi) The Director, Office of Seafood, CFSAN.
(vii) The Director, Office of Nutritional Products, Labeling, and Dietary Supplements, CFSAN.
(viii) The Director, Office of Special Research Skills, CFSAN.
(ix) The Director, Office of Constituent Operations, CFSAN.
(x) The Director, Office of Field Programs, CFSAN.
(xi) The Director, Office of Premarket Approval, CFSAN.
(xii) The Director, Office of Scientific Analysis and Support, CFSAN.
(11)(i) The Director and Deputy Directors, Center for Devices and Radiological Health (CDRH).
(ii) The Associate Director and Deputy Associate Director for Management and Systems, CDRH.
(iii) The Director and Deputy Director, Office of Compliance, CDRH.
(iv) For medical devices assigned to their respective divisions, the Division Directors, Office of Compliance, CDRH.
(v) The Director and Deputy Director, Office of Surveillance and Biometrics (OSB), CDRH, and the Director and Deputy Director, Division of Surveillance Systems (DSS), OSB, CDRH.
(vi) The Director, Office of Systems and Management, CDRH.
(vii) Freedom of Information Officers, CDRH.
(12)(i) The Director and Deputy Director, Center for Veterinary Medicine (CVM).
(ii) The Director and Deputy Director, Office of Management and Communications, CVM.
(iii) The Director and Deputy Director, Office of Surveillance and Compliance, CVM.
(iv) The Director, Division of Compliance, Office of Surveillance and Compliance, CVM.
(13)(i) The Director and Deputy Director for Washington Operations, National Center for Toxicological Research (NCTR).
(ii) The Deputy Center Director, Office of Management (OM), NCTR, and the Associate Director, Office of Management Services, OM, NCTR.
(iii) The Deputy Center Director, Office of Research, NCTR.
(14)(i) The Director and Deputy Director, the Directors, Office of Review Management and Office of Pharmaceutical Science, the Associate Director for Regulatory Policy, and the Associate Director for Medical Policy, Center for Drug Evaluation and Research (CDER).
(ii) The Director and Deputy Director, Office of Management, CDER.
(iii) The Director and Deputy Director, Office of Compliance, CDER.
(iv) The Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, IV, and V, and the Director and Deputy Director of the Office of Biostatistics, Office of Review Management, CDER.
(v) The Directors and Deputy Directors of the Offices of Testing and Research, Generic Drugs, New Drug Chemistry, and Clinical Pharmacology and Biopharmaceutics, Office of Pharmaceutical Science, CDER.
(vi) The Director, Office of Training and Communications (OTCOM), and the Director, Division of Information Disclosure Policy, Office of Regulatory Policy, CDER.
(vii) The Directors of the Divisions of Labeling and Non-prescription Drug Compliance, Prescription Drug Compliance and Surveillance, and Manufacturing and Product Quality, Office of Compliance, CDER.
(15)(i) Regional Food and Drug Directors.
(ii) District Directors.
(iii) The Director, St. Louis Branch.
(iv) The Director, Northeast Regional Laboratory, Northeast Region.
(v) The Director, Southeast Regional Laboratory, Southeast Region.
(vi) The Director, National Forensic Chemistry Center.
(vii) The Director, Arkansas Regional Laboratory.
(viii) The Director, Winchester Engineering Analytical Center.
(b) The following officials are authorized to cause the seal of the Department to be affixed to agreements, awards, citations, diplomas, and similar documents:
(1) Deputy Commissioner; the Senior Associate Commissioner; the Deputy Commissioner for International and Constituent Relations; the Senior Associate Commissioner for Management and Systems; and the Senior Associate Commissioner for Policy, Planning, and Legislation.
(2) The Associate and Deputy Associate Commissioners and the Chief Counsel and Deputies.
(3) The Director and Deputy Directors, CBER; the Director and Deputy Director, CFSAN; the Director and Deputy Directors, CDRH; the Director and Deputy Director, CVM; the Director and Deputy Directors, CDER; and the Director, NCTR, the Deputy Director for Washington Operations, NCTR, and the Deputy Center Directors, Offices of Management and Research, respectively, NCTR.
(4) The Director, Office of Executive Operations, Office of the Senior Associate Commissioner (OSAC), OC; Director, Office of Management, CBER; Director, Office of Management, CDER;
(5) The Director, Office of Human Resources and Management Services (OHRMS), Office of Management and Systems (OMS), OC.
(c) The following officials may further redelegate the authorities under paragraphs (a) and (b) of this section the Deputy Commissioner; the Senior Associate Commissioner; the Deputy Commissioner for International and Constituent Relations; the Senior Associate Commissioner for Management and Systems; the Senior Associate Commissioner for Policy, Planning, and Legislation; the Associate and Deputy Associate Commissioners; the Chief Counsel and Deputy Chief Counsels; the Directors and Deputy Directors for CBER, CFSAN, CDRH, CVM, CDER, and NCTR; the Director, Office of Executive Operations, OSAC, OC; the Directors of the Offices of Management, CBER and CDER; the Director, Office of Management Systems, CFSAN; the Director, Office of Systems and Management, CDRH; the Director, Office of Management and Communications, CVM; the Associate Director, Office of Management Services, NCTR; the Director, Office of Resource Management, ORA; and the Director, OHRMS, OMS, OC. The other officials delegated authority by this section may not further redelegate it.
(d) The Chief, Regulations Editorial Section (RES), Regulations Policy and Management Staff (RPMS), Office of Policy, Planning, and Legislation (OPPL), OC, and his or her alternates are authorized to certify true copies of
(a) The following officials are authorized to make determinations to disclose official records and information under part 20 of this chapter, except that only the officials, listed in paragraphs (a)(2) through (a)(8) of this section, have the authority under specific sections of part 20 of this chapter.
(1)(i) Deputy Commissioner, the Senior Associate Commissioner, the Deputy Commissioner for International and Constituent Relations, the Senior Associate Commissioner for Management and Systems, the Senior Associate Commissioner for Policy, Planning, and Legislation, and the Associate and Deputy Associate Commissioners.
(ii) The Director, Office of Executive Operations, Office of the Senior Associate Commissioner, Office of the Commissioner (OC).
(iii) The Director, Office of the Executive Secretariat, Office of the Senior Associate Commissioner, OC.
(iv) The Director, Office of Human Resources and Management Services (OHRMS), Office of Management and Systems (OMS), OC; the Director, Division of Management Programs (DMP), OHRMS, OMS, OC; and the Chief, Dockets Management Branch, DMP, OHRMS, OMS, OC.
(v) Program officials at all organizational levels down to and including branch level for all Headquarters organizations.
(vi) Regional Food and Drug Directors and District Directors.
(vii) Director, Winchester Engineering and Analytical Center.
(viii) Chiefs of branches Field/District Offices and Centers.
(ix) Freedom of Information Officers and other employees engaged in Freedom of Information activities.
(x) The Director, Office of Enforcement (OE), Office of Regulatory Affairs (ORA); Deputy Director, OE, ORA; and Director, Division of Compliance Policy, OE, ORA.
(xi) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER); and the Director and Deputy Director, Office of Communication, Training, and Manufacturer's Assistance (OCTMA), CBER.
(xii) The Director and Deputy Director, the Directors, Office of Review Management and Office of Pharmaceutical Science, the Associate Director for Medical Policy, and the Associate Director for Regulatory Policy,
(xiii) The Director, Center for Devices and Radiological Health (CDRH), the Deputy Director for Regulations and Policy, and the Deputy Director for Science, CDRH.
(xiv) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN).
(xv) The Director and Deputy Director, Center for Veterinary Medicine (CVM).
(xvi) The Director, National Center for Toxicological Research (NCTR); the Deputy Center Directors, Offices of Research and Management, respectively, NCTR; and the Deputy Director for Washington Operations, NCTR.
(xvii) These officials may not further redelegate this authority.
(2) The Deputy Associate Commissioner for Regulatory Affairs (Deputy ACRA), ORA; the Director and Deputy Director, Office of Enforcement OE, ORA; and the Director, Division of Compliance Policy, OE, ORA are delegated the authority to grant requests for testimony or to authorize the giving of testimony under § 20.1 of this chapter. These officials may not further redelegate this authority.
(3) The Associate and Deputy Associate Commissioners are delegated the authority to disclose official records and information under § 20.82 of this chapter. These officials may not further redelegate this authority.
(4) The Associate and Deputy Associate Commissioners; the Director and Deputy Director, OE, ORA; and the Director, Division of Compliance Policy, OE, ORA are delegated the authority to disclose official records and information under § 20.85 of this chapter. These officials may not further redelegate this authority.
(5) The following officials are delegated the authority to disclose confidential commercial information to State government officials under § 20.88(d) of this chapter and the ACRA and the Center Directors may further redelegate this authority.
(i) The ACRA, the Deputy ACRA, ORA and the Director, OE, ORA.
(ii) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER); and the Director and Deputy Director, Office of Communication, Training, and Manufacturer's Assistance (OCTMA), CBER.
(iii) The Director and Deputy Director, CDER; the Directors, Office of Review Management and Office of Pharmaceutical Science, CDER; the Associate Director for Regulatory Policy, CDER.
(iv) The Director, CDRH, the Deputy Director for Regulations and Policy, the Deputy Director for Science, and the Director, Office of Health and Industry Programs, CDRH.
(v) The Director and Deputy Director, CFSAN.
(vi) The Director and Deputy Director, CVM.
(vii) The Director, the Deputy Center Directors, Offices of Research and Management, respectively, NCTR, and the Deputy Director for Washington Operations, NCTR.
(6) The following officials are delegated the authority to disclose nonpublic, predecisional documents to State and foreign government officials under §§ 20.88(e) and 20.89(d) of this chapter and they may not further redelegate this authority.
(i) The Associate Commissioner for Policy, Office of Policy, Planning and Legislation (OPPL); and the Director, Office of International Programs, Office of International and Constituent Relations (OICR).
(ii) For level 2 nonpublic, predecisional guidance documents, any Center Director or Deputy Director, and any Director for an OC office having program responsibilities.
(7) The Associate Commissioner for Policy, OPPL; and the Director, Office of International Programs, OICR are delegated the authority to receive nonpublic, predecisional documents from State and foreign government officials under §§ 20.88(e) and 20.89(d) of this chapter. These officials may not further redelegate this authority.
(8) The following officials are authorized to disclose confidential commercial information to foreign government officials under § 20.89(c) of this chapter; and they may not further redelegate it:
(i) The Deputy ACRA, ORA; and the Director, OE, ORA.
(ii) The Director and Deputy Directors, Center for Biologics Evaluation
(iii) The Director and Deputy Director, CDER; the Directors, Office of Review Management and Office of Pharmaceutical Science, CDER; the Associate Director for Medical Policy, CDER; the Associate Director for Regulatory Policy, CDER, and the Director, Division of Information Disclosure Policy, Office of Regulatory Policy, CDER.
(iv) The Director, CDRH, the Deputy Director for Regulations and Policy and the Deputy Director for Science, CDRH.
(v) The Director and Deputy Director, CFSAN.
(vi) The Director and Deputy Director, CVM.
(vii) The Director, the Deputy Center Directors, Offices of Research and Management, respectively, and the Deputy Director for Washington Operations, NCTR.
(b) The Chief, Information Management Team, Division of Data Management and Services, Office of Information Technology, CDER, is authorized to sign affidavits regarding the presence or absence of records of Registration of Drug Establishments. This official may not further redelegate this authority.
(c) The following officials are authorized to sign affidavits regarding the presence or absence of medical device establishment registration records and these officials may not further redelegate this authority:
(1) The Director, the Deputy Director for Regulations and Policy, and the Deputy Director for Science, CDRH.
(2) The Director and Deputy Director, Office of Compliance, CDRH.
(3) The Director and Deputy Director, Division of Program Operations, Office of Compliance, CDRH.
(4) The Chief, Information Processing and Office Automation Branch, Division of Program Operations, Office of Compliance, CDRH.
(d) The Director, Office of Resource Management, Office of Regulatory Affairs is authorized to sign affidavits regarding the presence or absence of records in the files of that office and this official may not further redelegate this authority.
(e) The Director and Deputy Directors, CBER, the Director and Deputy Director, Office of Blood Research and Review (OBRR), and the Director and Deputy Director, Division of Blood Applications, OBRR, CBER, are authorized to sign affidavits regarding the presence or absence of records of registration of blood product establishments. These officials may not further redelegate this authority.
(a) The Associate Commissioner for Regulatory Affairs is authorized to perform the functions of the Commissioner of Food and Drugs as requested by the Commissioner regarding the authority to disapprove or require modification of cooperative research and development agreements and licensing agreements and transmit written explanation of such approval or disapproval to the head of the laboratory concerned under section 11(c)(5)(A) and (B) of the Stevenson-Wydler Technology Innovation Act of 1980 (the Act) (15 U.S.C. 3710a(c)(5) (A) and (B)), as amended.
(b) The following officials are authorized to perform the functions of the Commissioner of Food and Drugs (Commissioner) requested by the Commissioner under the Act (15 U.S.C. 3701
(1) The Director, Center for Biologics Evaluation and Research.
(2) The Director, Center for Devices and Radiological Health.
(3) The Director, Center for Drug Evaluation and Research.
(4) The Director, Center for Food Safety and Applied Nutrition.
(5) The Director, Center for Veterinary Medicine.
(6) The Director, National Center for Toxicological Research.
(7) The Associate Commissioner for Regulatory Affairs.
(c) These officials may not further redelegate these authorities.
(a) The following officials are authorized under sections 301, 307, 311, 1701, 1702, 1703, and 1704 of the Public Health Service Act (the PHS Act) (42 U.S.C. 241, 242l, 243, 300u, 300u-1, 300u-2, 300u-3) to establish research, investigation, and testing programs and health information and health promotion programs, which relate to their assigned functions, and to approve grants for conducting such programs:
(1) The Director, the Deputy Director for Washington Operations, and the Deputy Center Directors, Offices of Research and Management, respectively, National Center for Toxicological Research (NCTR).
(2) The Director and Deputy Directors for Science and for Regulations and Policy, Centers for Devices and Radiological Health (CDRH).
(3) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).
(4) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN).
(5) The Director and Deputy Director, Center for Veterinary Medicine (CVM).
(6) The Director and Deputy Director, the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).
(7) The Director, Office of Orphan Products Development (OPD), Office of the Senior Associate Commissioner (OSAC), Office of the Commissioner (OC).
(b) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, are authorized to establish an electronic product radiation control program and to approve grants for conducting the program under section 532 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ii).
(c) The Senior Associate Commissioner for Management and Systems, Office of Management and Systems (OMS), OC; the Director and Deputy Director, Office of Facilities, Acquisitions, and Central Services (OFACS), OMS, OC; the Director, Division of Contracts and Procurement Management (DCPM), OFACS, OMS, OC; and the Chief Grants Management Officer and the Grants Management Officer, DCPM, OFACS, OMS, OC are authorized to sign and issue all notices of grant awards and amendments thereto and sign and issue notices of suspension and termination thereof for grants approved under the authority delegated in paragraphs (a) and (b) of this section.
(d) The Director, NCTR, is authorized under section 301 of the PHS Act (42 U.S.C. 241), as amended by Public Law 95-622, to make available to educational institutions, for biomedical and behavioral research, laboratory animals bred for research purposes of the Center that are not required to support Center research programs.
(e) The Senior Associate Commissioner for Management and Systems may further redelegate the authorities in paragraph (c) of this section. With the exception for paragraph (c) of this section, these officials may not further redelegate these authorities.
(a) Under authority of sections 207(g) and 208(f) of the PHS Act (42 U.S.C. 209(g) and 210(f)), and within the limits of an approved service fellowship plan, the following officials are authorized to designate persons to receive service fellowships, appoint service fellows, and determine specific stipend rates for individual actions within the ranges established under an approved service fellowship plan:
(1) The Deputy Commissioner; the Senior Associate Commissioner; the Deputy Commissioner for International and Constituent Relations; the Senior
(2) The Director, the Deputy Director for Washington Operations, the Deputy Center Directors for Research and Management, respectively, and the Associate Director, Office of Management Services, National Center for Toxicological Research (NCTR).
(3) The Director, the Deputy Directors for Science and for Regulations and Policy, and the Director, Office of Systems and Management, Center for Devices and Radiological Health (CDRH).
(4) The Director, the Deputy Directors, the Associate Director for Research, the Office Directors, and the Director, Office of Management, Center for Biologics Evaluation and Research (CBER).
(5) The Director, the Deputy Director, and Director, Office of Management Systems, Center for Food Safety and Applied Nutrition (CFSAN).
(6) The Director, the Deputy Director, and the Director, Office of Management and Communications, Center for Veterinary Medicine (CVM).
(7) The Director and Deputy Director, the Directors, Office of Review Management and Office of Pharmaceutical Science, and the Director and Deputy Director, Office of Management, Center for Drug Evaluation and Research (CDER).
(8) The Director, Office of Executive Operations, Office of the Senior Associate Commissioner, Office of the Commissioner and the Director, Office of Resource Management, ORA.
(9) Director, Office of Human Resources and Management Services, Office of Management and Systems, Office of the Commissioner.
(b) These officials may further redelegate this authority, with the limitation that the Director, Office of Human Resources and Management Services, OMS, OC, is delegated the authority to approve service fellowship plans and exceptions to the approved plans, and this official may not further redelegate this authority.
(a) The Deputy Commissioner is authorized to perform the due diligence determinations and informal hearings functions under section 156(d)(2)(B)(ii) of title 35 U.S.C. (35 U.S.C. 156), as amended, relative to patent term extensions.
(b) The Director, Center for Drug Evaluation and Research (CDER) and the Associate Director for Regulatory Policy, CDER, are authorized to perform the functions delegated to the Commissioner under title 35 U.S.C. 156, as amended, except for making due diligence determinations and holding of informal hearings under title 35 U.S.C. 156(d)(2)(B).
(c) The Chief Mediator and Ombudsman, Office of the Ombudsman, Office of the Senior Associate Commissioner, Office of the Commissioner, is authorized to perform the functions delegated to the Commissioner to make due diligence determinations under title 35 U.S.C. 156(d)(2)(B), as amended, except for holding of informal hearings under title 35 U.S.C. 156(d)(2)(B)(ii).
(d) These officials may not further redelegate this authority.
(a) The following officials are authorized to designate officials to hold informal hearings that relate to their assigned functions under sections 305, 404(b), and 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335, 344(b), and 381(a)); section 6 of the Fair Packaging and Labeling Act (15 U.S.C. 1455) (21 U.S.C. 145); section 9(b) of the Federal Caustic Poison Act (44 Stat. 1406; see also Public Law 86-613, section 19 formerly section 18); and section 5 of the Federal Import Milk Act. Officials so designated are delegated authority vested in the Secretary of Agriculture by 7 U.S.C. 2217 (43 Stat. 803) to administer to take from any person an oath, affirmation, affidavit, or deposition for use in any prosecution or proceeding under, or in enforcement of, any law as cited in this part:
(1) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN); and the Director of Regulations and Policy, CFSAN.
(2) The Director and Deputy Director, the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); the Associate Director for Regulatory Policy and the Associate Director for Medical Policy, CDER; the Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER; and the Director and Deputy Director, Office of Compliance, CDER.
(3) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH).
(4) The Director and Deputy Director, Center for Veterinary Medicine (CVM).
(5) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Directors and Deputy Directors, Office of Blood Research and Review, Office of Vaccines Research and Review, Office of Therapeutics Research and Review, and Office of Compliance and Biologics Quality, CBER.
(6) Regional Food and Drug Directors.
(7) District Directors.
(8) The Director, St. Louis Branch.
(b) The Director and Deputy Directors for Science and for Regulations Policy, CDRH, are authorized to hold hearings, and to designate other officials to hold informal hearings, under section 360(a) of the PHS Act.
(c) The following officials are authorized to serve as the presiding officer, and to designate other Food and Drug Administration employees to serve as the presiding officer, at a regulatory hearing and to conduct such a hearing under the provisions of part 16 of this chapter. An official can serve as the presiding officer in a particular hearing only if he or she satisfies the requirements of § 16.42(b) of this chapter with respect to the action that is the subject of the hearing. Such officials are delegated authority vested in the Secretary of Agriculture by 7 U.S.C. 2217 (43 Stat. 803) to administer or to take from any person an oath, affirmation, or deposition for use in any prosecution or proceeding under, or in enforcement of, any law as cited in this part:
(1) The Director, Office of the Ombudsman, Office of External Relations, Office of the Commissioner.
(2) The Director and Deputy Director, CFSAN.
(3) The Director and Deputy Director, Center for Drug Evaluation and Research (CDER); the Directors, Office of Review Management and Office of Pharmaceutical Science, CDER; the Associate Director for Regulatory Policy and the Associate Director for Medical Policy, CDER, the Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER; and the Director and Deputy Director, Office of Compliance, CDER.
(4) The Director and Deputy Directors for Science and for Regulations Policy, CDRH.
(5) The Director and Deputy Director, CVM.
(6) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Directors and Deputy Directors, Office of Blood Research and Review, Office of Vaccines Research and Review, Office of Therapeutics Research and Review, and Office of Compliance and Biologics Quality, CBER.
(7) Regional Food and Drug Directors.
(8) District Directors.
(9) The Director, St. Louis Branch.
(10) An Administrative Law Judge.
(11) Such other FDA official as is designated by the Commissioner by memorandum in the proceeding.
(d) These officials may not further redelegate this authority.
(a) For drugs assigned to their organizations, the following officials are authorized to grant or deny citizen petitions submitted under § 10.30 of this chapter for a stay of an effective date in § 201.59 of this chapter for compliance with certain labeling requirements for human prescription drugs:
(1)(i) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).
(ii) The Directors and Deputy Directors, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), and Office of Therapeutics Research and Review (OTRR), CBER.
(iii) The Directors and Deputy Directors of the Divisions in OBRR, OVRR, and OTRR, CBER.
(2)(i) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).
(ii) The Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(iii) The Directors and Deputy Directors of the divisions in the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(b) The following officials are authorized to grant or deny citizen petitions submitted under § 10.30 of this chapter requesting in vitro test modifications under § 331.29 of this chapter:
(1) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, CDER.
(2) The Director, Office of Drug Evaluation V, Office of Review Management, CDER.
(3) The Director and Deputy Director, Division of Over-the-Counter Drug Products, Office of Drug Evaluation V, Office of Review Management, CDER.
(c) The following officials are authorized to grant or deny citizen petitions submitted under § 10.30 of this chapter for a stay of an effective date or for an exemption from the tamper-resistant packaging and labeling requirements set forth in §§ 211.132, 700.25, or 800.12 of this chapter for certain over-the-counter human drug and cosmetic products and medical devices which relate to the assigned functions of the respective organizations:
(1) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, CDER.
(2) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN); and the Director of Regulations and Policy, CFSAN.
(3) The Director and the Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH).
(d) The following officials are authorized to grant or deny citizen petitions submitted under § 10.30 of this chapter requesting exemption from the general pregnancy-nursing warning for over-the-counter (OTC) drugs required under § 201.63 of this chapter, requesting exemption from a general overdose warning required under § 330.1(g) of this chapter, and requesting exemption from OTC drug administrative procedures under § 330.10 of this chapter:
(1) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, CDER.
(2) The Director, Office of Drug Evaluation V, Office of Review Management, CDER.
(3) The Director and Deputy Director, Division of Over-the-Counter Drug Products, Office of Drug Evaluation V, Office of Review Management, CDER.
(e)(1) The following officials are authorized to issue 180-day tentative responses to citizen petitions on food and cosmetic matters under § 10.30(e)(2)(iii) of this chapter that relate to the assigned functions of that Center:
(i) The Director and Deputy Director, CFSAN.
(ii) The Director of Regulations and Policy, CFSAN.
(iii) The Director, Office of Cosmetics and Colors, CFSAN.
(iv) The Director, Office of Nutritional Products, Labeling and Dietary Supplements, CFSAN.
(v) The Director, Office of Premarket Approval, CFSAN.
(vi) The Director, Office of Plant and Dairy Foods and Beverages, CFSAN.
(vii) The Director, Office of Seafood, CFSAN.
(viii) The Director, Office of Field Programs, CFSAN.
(2) The Director and Deputy Director, Center for Veterinary Medicine (CVM), are authorized to issue 180-day tentative responses to citizen petitions on animal food and drug matters under § 10.30(e)(2)(iii) of this chapter that relate to the assigned functions of that Center.
(3) The Director and Deputy Directors, CBER, are authorized to issue 180-day tentative responses to citizen petitions on biological product matters under § 10.30(e)(2)(iii) of this chapter that relate to the assigned functions of that Center.
(4) The Director, the Deputy Director, and the Associate Director for Regulatory Policy, CDER, are authorized to issue 180-day tentative responses to citizen petitions on drug product matters under § 10.30(e)(2)(iii) of this chapter that relate to the assigned functions of that Center.
(5) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, are authorized to issue 180-day tentative responses to citizen petitions on medical device matters under § 10.30(e)(2)(iii) of this chapter that relate to the assigned functions of that Center.
(f)(1) The Director and Deputy Directors, CBER, are authorized to grant or deny citizen petitions submitted under § 10.30 of this chapter on drug and biological product matters in program areas where they have been delegated final approval authority in the following sections of this chapter:
(i) Section 5.203
(ii) Section 5.204
(iii) Section 5.101
(iv) Section 5.103
(v) Section 5.105
(vi) Section 5.34
(2) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, CDER, are authorized to grant or deny citizen petitions submitted under § 10.30 of this chapter on drug product matters in program areas where they have been delegated final approval authority in the following sections of this chapter:
(i) Section 5.100
(ii) Section 5.101
(iii) Section 5.103
(iv) Section 5.105
(v) Section 5.34
(3) The Director and Deputy Director, Office of Generic Drugs, Office of Pharmaceutical Science, CDER, except for those drug products listed in § 314.440(b) of this chapter, are authorized to issue responses to citizen petitions submitted under § 10.30 of this chapter seeking a determination of the suitability of an abbreviated new drug application for a drug product.
(4) The Directors and Deputy Directors of OBRR, OVRR, and OTRR, CBER, for those drug products listed in § 314.440(b) of this chapter, are authorized to issue responses to citizen petitions submitted under § 10.30 of this chapter seeking a determination of the suitability of an abbreviated new drug application for a drug product.
(5) For drugs assigned to their organization, the following officials are authorized to issue responses to citizen petitions submitted under § 10.30 of this chapter from sponsors of an investigational new drug application who request approval to ship in interstate commerce, in accordance with § 2.125(j) of this chapter, an investigational new drug for human use containing a chlorofluorocarbon.
(i) The Director and Deputy Directors, CBER.
(ii) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, CDER.
(6) The Director and Deputy Director, CVM, are authorized to issue responses to citizen petitions submitted under § 10.30 of this chapter from sponsors of
(7) The Director and Deputy Director, Office of New Animal Drug Evaluation, CVM, are authorized to issue responses to citizen petitions submitted under § 10.30 of this chapter, seeking a determination of the suitability of an abbreviated new animal drug application for an animal drug product.
(8) The Director and Deputy Director, CVM, are authorized to grant or deny citizen petitions submitted under § 10.30 of this chapter concerning actions they are authorized to take under § 5.34
(g) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, and the Director, Office of Compliance, CDRH, are authorized to grant or deny citizen petitions submitted under §§ 10.30 and 821.2(b) of this chapter, requesting an exemption or variance from medical device tracking requirements in part 821 of this chapter.
(h) These officials may not further redelegate this authority.
(a) Each Center director is authorized to select members of, and consultants to, scientific and technical FDA advisory committees under that Center's management to serve temporarily as voting members on another advisory committee under that Center's management when expertise is required that is not available among current voting standing members of a committee or to comprise a quorum when, because of unforeseen circumstances, a quorum is or will be lacking. When additional voting members are added to a committee to provide needed expertise not available among current voting standing members of a committee, a quorum will be based on the total of regular and added members. Authority to select temporary voting members to advisory committees, if such voting members are serving on an advisory committee managed by another Center, has not been redelegated. This authority will continue to be exercised by the Commissioner of Food and Drugs (Commissioner) or the Senior Associate Commissioner, Office of the Commissioner.
(b) Each Center director is authorized, under 18 U.S.C. 208(b)(1), to sign conflict of interest waivers for special Government employees without substantial interest to serve as consultants to advisory committees or in any other capacity within the Centers except as advisory committee members.
(c) These officials may not further redelegate this authority.
(a) Designated officers and employees of the Food and Drug Administration who have been issued the Food and Drug Administration official credentials consisting of Form FDA-200A, Identification Record, and Form FDA-200B, Specification of General Authority, are authorized:
(1) To conduct examinations, inspections, and investigations; to collect and obtain samples; to have access to and to copy and verify records as authorized by law; to make seizures of items under section 702(e)(5) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 372 (e) (5)); and to supervise compliance operations for the enforcement of the act, the Fair Packaging and Labeling Act (15 U.S.C. 1451-1461), the Federal Caustic Poison Act (44 Stat. 140b; see also Public Law 86-613, section 19, formerly section 18), the Import Milk Act (21 U.S.C. 141-149), the Filled Milk Act (21 U.S.C. 61-64), and sections 351 and 361 of the PHS Act (42 U.S.C. 262 and 264).
(2) To administer oaths and affirmations under section 1 of the act of January 31, 1925 (Ch. 124, 43 Stat. 803); sections 12 to 15 of Reorganization Plan No. IV, effective June 30, 1940; and Reorganization Plan No. 1 of 1953, effective April 11, 1953.
(b) Any officer or employee of the Food and Drug Administration who has been designated by the Commissioner of Food and Drugs (Commissioner) to conduct examinations, investigations,
(1) As set forth under section 702(e)(1) through (e)(5) of the act (21 U.S.C. 372(e)(1)-(e)(5)):
(i) Carry firearms;
(ii) Serve and execute search warrants and arrest warrants;
(iii) Execute seizure by process issued under libel under section 304 of the act (21 U.S.C. 334);
(iv) Make arrests without warrant for an offense under the act with respect to counterfeit drugs if the offense is committed in the presence of the criminal investigator or, in the case of a felony, if the investigator has probable cause to believe that the person so arrested has committed, or is committing, such offense; and
(v) Make, prior to the institution of libel proceedings under section 304(a)(2) of the act (21 U.S.C. 334(a)(2)), seizures of drugs or containers or of equipment, punches, dies, plates, stones, labeling, or other things, if they are, or the criminal investigator has reasonable grounds to believe that they are, subject to seizure and condemnation under section 304(a)(2) of the act.
(2) Perform such other functions under the act, or any other law, as the Commissioner may prescribe.
(3) To administer oaths and affirmations under section 1 of the act of January 31, 1925 (Ch. 124, 43 Stat. 803); sections 12 to 15 of Reorganization Plan No. IV, effective June 30, 1940; and Reorganization Plan No. 1 of 1953, effective April 11, 1953.
(c) Any officer or employee of the Food and Drug Administration who has been designated by the Commissioner to provide specialized law enforcement support involving criminal investigations under the act, and other duties as assigned by the Commissioner, and issued the Food and Drug Administration Official Credential consisting of Form FDA-200E, Special Authority for Criminal Investigative Specialists, is authorized to receive information as to all matters relating to such act and regulations issued under the act.
(d) These officials may not further redelegate these authorities.
Regional Food and Drug Directors and District Directors are authorized to issue certificates of sanitation under § 1240.20 of this chapter. These officials may not further redelegate this authority.
(a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) under section 309 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 336) (the act) regarding the issuance of written notices or warnings:
(1)(i) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).
(ii) The Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER.
(2)(i) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH).
(ii) The Director and Deputy Director, Office of Compliance, CDRH.
(iii) For medical devices assigned to their respective divisions, the Division Directors, Office of Compliance, CDRH.
(iv) The Director and Deputy Director, Office of Surveillance and Biometrics (OSB), CDRH, and the Director and Deputy Director, Division of Surveillance Systems (DSS), OSB, CDRH.
(3)(i) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN).
(ii) The Director of Regulations and Policy, CFSAN.
(iii) The Director, Office of Field Programs, CFSAN.
(iv) The Director, Division of Enforcement and Programs, Office of Field Programs, CFSAN.
(4)(i) The Director and Deputy Director, Center for Veterinary Medicine (CVM).
(ii) The Director and Deputy Director, Office of Surveillance and Compliance, CVM.
(iii) The Director, Division of Compliance, Office of Surveillance and Compliance, CVM.
(5)(i) The Director, the Deputy Director, the Associate Director for Regulatory Policy, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).
(ii) The Director and Deputy Director, Office of Compliance, CDER.
(iii) The Associate Director for Medical Policy, CDER.
(iv) The Director, Division of Drug Marketing, Advertising, and Communications, Office of Medical Policy, CDER.
(6)(i) Regional Food and Drug Directors.
(ii) District Directors.
(iii) Chiefs of District Compliance Branches.
(iv) The Director, St. Louis Branch.
(v) The Director, Northeast Regional Laboratory, Northeast Region.
(vi) The Director, Southeast Regional Laboratory, Southeast Region.
(vii) The Director, Winchester Engineering and Analytical Center.
(viii) The Director, National Forensic Chemistry Center.
(ix) The Director, Arkansas Regional Laboratory.
(b) The following officials are authorized to perform all the functions of the Commissioner under section 539(d) of the act (21 U.S.C. 360pp(d)) regarding the issuance of written notices or warnings:
(1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH).
(2) The Director and Deputy Director, Office of Compliance, CDRH.
(3) For medical devices assigned to their respective divisions, the Division Directors, Office of Compliance, CDRH.
(4) The Director and Deputy Director, Office of Surveillance and Biometrics (OSB), CDRH, and the Director and Deputy Director, Division of Surveillance Systems (DSS), OSB, CDRH.
(5) Regional Food and Drug Directors; District Directors; the Director, St. Louis Branch; the Director, Northeast Regional Laboratory, Northeast Region; the Director, Southeast Regional Laboratory, Southeast Region; the Director, Winchester Engineering and Analytical Center; the Director, National Forensic Chemistry Center, and the Director, Arkansas Regional Laboratory when such functions relate to:
(i) Assemblers of diagnostic x-ray systems, as defined in § 1020.30(b) of this chapter; and
(ii) Manufacturers of sunlamp products and ultraviolet lamps intended for use in any sunlamp product as defined in § 1040.20(b) of this chapter.
(c) These officials may not further redelegate these authorities.
(a) The Director, the Deputy Director, and the Associate Director for Regulatory Policy, Center for Drug Evaluation and Research, the Director and Deputy Director, Center for Veterinary Medicine, and the Director and Deputy Directors, Center for Biologics Evaluation and Research are authorized to issue the following notices and make all findings required in relation to these notices under section 306 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 335a) which relate to the assigned functions of their organizations:
(1) Notices of opportunity for hearing on proposals for mandatory or permissive debarment.
(2) Notices ordering debarment when opportunity for a hearing has been waived.
(3) Notices ordering debarment where the person notifies the agency that the person consents to debarment under section 306(c)(2)(B) of the act (21 U.S.C. 335a(c)(2)(B)).
(4) Notices of opportunity for hearing on proposals denying an application to terminate debarment under section 306(d)(3) of the act (21 U.S.C. 335u(d)(3)).
(5) Orders denying an application to terminate debarment under section 306(d)(3) of the act (21 U.S.C. 335u(d)(3)) when opportunity for a hearing has been waived.
(b) These officials may not further redelegate these authorities.
(a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs with regard to decisions made under the Regulatory Flexibility Act (5 U.S.C. 605(b)), to certify that a proposed or final rule, if issued, will not have a significant economic impact on a substantial number of small entities:
(1) The Associate Commissioner for Regulatory Affairs.
(2) The Director, Center for Biologics Evaluation and Research.
(3) The Director, Center for Drug Evaluation and Research.
(4) The Director, Center for Devices and Radiological Health.
(5) The Director, Center for Food Safety and Applied Nutrition.
(6) The Director, Center for Veterinary Medicine.
(7) Other Food and Drug Administration Officials authorized to issue
(b) These officials may not further redelegate this authority.
The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research; and the Director, the Deputy Directors for Regulations and Policy and for Science, and the Director and Deputy Directors, Office of Device Evaluation, Center for Devices and Radiological Health, are authorized to issue notices and amendments thereto implementing section 107(c)(3) of the Drug Amendments of 1962 (Pub. L. 87-781) by announcing new or revised efficacy findings on human drugs that are or were subject to the provisions of section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355). These officials may not further redelegate this authority.
(a) The following officials, for drugs under their jurisdiction, are authorized to perform all the functions of the Commissioner of Food and Drugs on the termination of exemptions for new drugs (including those that are biological products which are subject to the licensing provisions of the Public Health Service Act) for investigational use in human beings under § 312.44 of this chapter and in animals under § 312.160 of this chapter:
(1) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).
(2) The Director, the Deputy Director, and the Directors, Office of Review Management and Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).
(3) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH).
(b) The following officials, for drugs under their jurisdiction, are authorized to terminate exemptions for new drugs for investigational use when sponsors fail to submit an annual progress report under § 312.44(b)(1)(viii) of this chapter:
(1) The Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(2) The Directors and Deputy Directors of the divisions in the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(3) The Directors and Deputy Directors, Office of Blood Research and Review (OBRR), OVRR, and Office of Therapeutics Research and Review (OTRR), CBER.
(4) The Directors and Deputy Directors of the Division of Blood Applications, OBRR, the Division of Vaccines and Related Products Applications, OVRR, and the Division of Application Review and Policy, OTRR, CBER.
(5) The Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH.
(c) The following officials, for drugs under their jurisdiction, are authorized to make the findings set forth in
(1) The Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(2) The Directors and Deputy Directors of the divisions in the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(3) The Directors and Deputy Directors, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), and Office of Therapeutics Research and Review (OTRR), CBER.
(4) The Directors and Deputy Directors of the Division of Blood Applications, OBRR, the Division of Vaccines and Related Products Applications, OVRR, and the Division of Application Review and Policy, OTRR, CBER.
(5) The Director and Deputy Directors, ODE, CDRH.
(d) These officials may not further redelegate these authorities.
(a) The following officials, for drugs under their jurisdiction, are authorized to perform all the functions of the Commissioner of Food and Drugs to approve a charge and to withdraw approval to charge for investigational drugs in a clinical trial under an investigational new drug application under § 312.7(d)(1) of this chapter:
(1) The Director, the Deputy Director, and the Directors, Office of Review Management and the Office of Pharmaceutical Science, Center for Drug Evaluation and Research.
(2) The Director and Deputy Directors, Center for Biologics Evaluation and Research.
(b) These officials may not further redelegate this authority.
(a)(1) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) with regard to approval of new drug applications and supplements thereto on drugs for human use, except for those drugs listed in § 314.440(b) of this chapter, that have been submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355):
(i) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).
(ii) The Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER, for drugs under their jurisdiction.
(2) The Director and Deputy Directors, Center for Biologics Evaluation and Research, for drugs listed in § 314.440(b) of this chapter, are authorized to perform all the functions of the Commissioner with regard to approval of new drug applications and supplements thereto on drugs for human use that have been submitted under section 505 of the act.
(b) The Directors and Deputy Directors of the divisions in the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER, for drugs under their jurisdiction, are authorized to perform all functions of the Commissioner with regard to approval of supplemental applications to approved new drug applications for drugs for human use that have been submitted under § 314.70 of this chapter and of new drug applications for drug products other than those that contain new molecular entities (new chemical entities). The applications to which this authorization applies may, in appropriate circumstances, continue to be acted upon by the officials so authorized in § 5.10(a) and paragraph (a) of this section.
(c) The following officials are authorized to perform all the functions of the Commissioner with regard to approval of abbreviated new drug applications and supplements thereto for drugs for human use and new drug applications for drugs with a 5S classification whose clinical safety and efficacy may be supported by appropriate literature citations in lieu of submission of data from original proprietary studies, or section 505(b)(2) of the act (21 U.S.C. 355(b)(2)) applications under their jurisdiction.
(1) For drugs submitted under §§ 314.50, 314.70, and 314.94 of this chapter, except for those drug products listed in § 314.440(b):
(i) The Director and Deputy Director, Office of Generic Drugs (OGD), Office of Pharmaceutical Science, CDER, except that the Director and Deputy Director, OGD are not authorized to approve new drug applications with a 5S classification if clinical studies are needed.
(ii) The Directors and Deputy Directors of the divisions in Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(2) For drug products listed in § 314.440(b) of this chapter and submitted under §§ 314.50, 314.70, and 314.94 of this chapter: The Directors and Deputy Directors, Office of Blood Research and Review, Office of Vaccines Research and Review, Office of Therapeutics Research and Review, and Office of Compliance and Biologics Quality, CBER.
(d) The following officials are authorized to perform all functions of the Commissioner with respect to approval of supplemental applications to abbreviated new drug applications, 5S applications, or section 505(b)(2) applications for drugs for human use that are described in §§ 314.70(b)(1), (b)(2)(ii) through (b)(2)(x), (c)(1), and (c)(3) of this chapter. (Authority to approve supplements that require in vivo bioavailability studies or that include in vivo bioavailability study waiver requests are not included in this paragraph.)
(1) The Director and Deputy Director, Division of Chemistry I, Office of Generic Drugs, Office of Pharmaceutical Science, CDER.
(2) The Director and Deputy Director, Division of Chemistry II, Office of Generic Drugs, Office of Pharmaceutical Science, CDER.
(3) Associate Director for Chemistry, Office of New Drug Chemistry, Office of Pharmaceutical Science, CDER.
(e) The Director, Division of Labeling and Program Support, Office of Generic Drugs, Office of Pharmaceutical Science, CDER, are authorized to perform all the functions of the Commissioner with respect to approval of supplemental applications to abbreviated new drug applications, 5S applications, or section 505(b)(2) applications for drugs for human use that are described in §§ 314.70(b)(3) and (c)(2)(i) through (c)(2)(iv) of this chapter. Authority to approve supplements that require in vivo bioavailability studies or in vivo study waiver requests is not included in this paragraph.
(f) The supervisory and team leader chemists in the Divisions of New Drug Chemistry I, II, and III, Office of New Drug Chemistry, Office of Pharmaceutical Science, CDER, are authorized to perform all functions of the Commissioner with respect to approval of supplemental applications to new drug applications for drugs for human use that are described in §§ 314(b)(1), (b)(2)(ii) through (b)(2)(x), (c)(1), and (c)(3) of this chapter. Authority to approve supplements that require in vivo bioavailability information or that require a change in the labeling of the drug, except changes that reflect only the use of a different facility or establishment, are not included in this paragraph. The supplemental applications to which this authorization applies may continue to be acted upon by the officials so authorized in § 5.10(a) and paragraphs (a) and (b) of this section.
(g) These officials may not further redelegate these authorities.
The Director, Center for Drug Evaluation and Research (CDER) and the Director, Executive Operations Staff, Office of the Center Director, CDER, are authorized to provide responses to the Drug Enforcement Administration's temporary scheduling notices under section 201(h)(4) of the Controlled Substances Act, as amended (21 U.S.C. 811(h)(4)). The delegation excludes the authority to submit reports to Congress. These officials may not further redelegate this authority.
(a) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER), are authorized to issue notices of an opportunity for a hearing on proposals to refuse approval or to withdraw approval of new drug applications and abbreviated new drug applications and supplements thereto on drugs for human use, except for those drugs listed in § 314.440(b) of this chapter, that have been submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) and subpart B of part 314 of this chapter and to issue notices refusing approval or withdrawing approval when opportunity for hearing has been waived.
(b) The Director and Deputy Directors, Center for Biologics Evaluation and Research, for those drugs listed in § 314.440(b) of this chapter, are authorized to issue notices of an opportunity for a hearing on proposals to refuse approval or to withdraw approval of new drug applications and abbreviated new drug applications and supplements thereto on drugs for human use that have been submitted under section 505 of the act and subpart B of part 314 of this chapter and to issue notices refusing approval or withdrawing approval when opportunity for hearing has been waived.
(c) These officials may not further redelegate these authorities.
(a) The following officials are authorized to perform all of the functions of the Commissioner of Food and Drugs with regard to decisions made under section 505(c)(3)(D), (j)(4)(B)(iv), and (j)(4)(D) and section 505A of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 355(c)(3)(D), (j)(4)(B)(ii) and (j)(4)(D) and 355a) concerning the date of submission or the date of effective approval of abbreviated new drug applications including supplements thereto submitted under section 505(j) of the act (21 U.S.C. 355(j)) and of new drug applications including supplements thereto submitted under section 505(b)(1) (21 U.S.C. 355(b)(1)) of the act and described under section 505(b)(2) of the act (21 U.S.C. 355(b)(2)):
(1) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).
(2) The Director and Deputy Director, Office of Generic Drugs, Office of Pharmaceutical Science, CDER.
(b) These officials may not further redelegate this authority.
(a) The following officials are authorized to extend or stay an effective date in § 201.59 of this chapter for compliance with certain labeling requirements for human prescription drugs.
(1) For drugs assigned to their organizations:
(i) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).
(ii) The Directors and Deputy Directors, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), and Office of Therapeutics Research and Review (OTRR), CBER.
(iii) The Directors and Deputy Directors of the Divisions in OBRR, OVRR, and OTRR, CBER.
(2) For drugs assigned to their organizations:
(i) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).
(ii) The Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(iii) The Directors and Deputy Directors of the divisions in the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(b) These officials may not further redelegate this authority.
The Director, Center for Drug Evaluation and Research (CDER), and the Associate Director for Regulatory Policy, CDER, are authorized to perform all the functions of the Commissioner of Food and Drugs relating to waivers or reductions of prescription drug user fees under the Prescription Drug User Fee Act of 1992, as originally enacted and as reauthorized by the Food and Drug Administration Modernization Act of 1997, except for the functions under section 736(d)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379h(d)(1)(C)) that pertain to situations where “the fees will exceed the anticipated present and future costs,” on behalf of CDER, the Center for Biologics Evaluation and Research, and any other Food and Drug Administration Center. This authority pertains to waivers requested under the public health waiver provision (21 U.S.C. 379h(d)(1)(A)); the barrier to innovation waiver provision (21 U.S.C. 379h(d)(1)(B)); the applications submitted under section 505(b)(1) and (b)(2) of the Federal Food, Drug, and Cosmetic Act waiver provision (21 U.S.C. 379h(d)(1)(D)); the small business waiver provision (21 U.S.C. 379h(d)(1)(E)); and to requests for refunds of fees if an application or supplement is withdrawn after filing (21 U.S.C. 379h(a)(1)(G)); as well as waivers, reductions, or refunds requested on any other basis except fees exceeding the cost. (See § 5.20(h)(1) for the authority to reconsider any user fee decisions made by the Chief Mediator and Ombudsman, the Deputy Chief Mediator and Ombudsman, and/or the former Deputy User Fee Waiver Officer prior to July 1, 1999.) These officials may not further redelegate this authority.
(a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs under § 505(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e)) regarding the issuance of written notices.
(1) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).
(2) The Director and Deputy Director, Office of Compliance, CDER.
(3) The Director and Deputy Director, Division of Labeling and Nonprescription Drug Compliance, Office of Compliance, CDER.
(4) The Director and Deputy Director, Division of Manufacturing and Product Quality, Office of Compliance, CDER.
(5) The Director and Deputy Director, Division of Prescription Drug Compliance and Surveillance, Office of Compliance, CDER.
(6) The Associate Director for Medical Policy, and the Director and Deputy Director, Division of Scientific Investigations, Office of Medical Policy, CDER.
(7) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), the Director and Deputy Directors, Office of Compliance and Biologics Quality (OCBQ), CBER, and the Directors, Division of Case Management, Division of Inspections and Surveillance, and Division of Manufacturing and Product Quality, OCBQ, CBER.
(8) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), and the Director and Deputy Directors of the Office of Device Evaluation, CDRH.
(9) Regional Food and Drug Directors.
(10) District Directors.
(b) These officials may not further redelegate this authority.
(a) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER) are authorized to perform the functions of the Commissioner of Food and Drugs (Commissioner) under part C, subtitle 2 of title XXI of the PHS Act (42 U.S.C. 300aa-25
(1) Section 2125 of the PHS Act (42 U.S.C. 300aa-25)-Recording and reporting of information.
(2) Section 2127 of the PHS Act (42 U.S.C. 300aa-27)-Mandate for safer childhood vaccines.
(3) Section 2128 of the PHS Act (42 U.S.C. 300aa-28)-Manufacturer recordkeeping and reporting.
(4) Section 312 of the National Childhood Vaccine Injury Act of 1986-Related studies (42 U.S.C. 300aa-1 note), except that the authority to provide for notice and opportunity for public hearing on the review of vaccines and related illnesses and conditions under sections 312(a) and (d) of the National Childhood Vaccine Injury Act of 1986 is not redelegated by the Commissioner.
(5) Section 313 of the National Childhood Vaccine Injury Act of 1986-Study of other vaccine risks (42 U.S.C. 300aa-1 note), except that the authority to provide for notice and opportunity for public hearing on the establishment of guidelines regarding the risks to children of certain vaccines under section 313(a)(1)(B) and (b) of the National Childhood Vaccine Injury Act of 1986 is not redelegated by the Commissioner.
(6) Section 314 of the National Childhood Vaccine Injury Act of 1986-Review of warnings, use instructions, and precautionary information (42 U.S.C. 300aa-1 note).
(b) These officials may not further redelegate these authorities.
(a) The following officials are authorized to perform all the functions of the Director, Center for Biologics Evaluation and Research (CBER) with regard to program authorities for their respective areas:
(1) Deputy Directors, CBER.
(2) Associate Directors, CBER.
(3) Office Directors, CBER.
(4) Division Directors, CBER.
(b) These officials may not further redelegate these authorities.
(a) The Director and Deputy Directors, Center for Biologics Evaluation and Research are authorized to issue:
(1) Notices of opportunity for a hearing on proposals to deny approval or filing of applications for biologics licenses under § 601.4(b) of this chapter.
(2) Notices of opportunity for a hearing on proposals to revoke biologics licenses under § 601.5(b) of this chapter.
(3) Notices of revocation, at the manufacturer's request, of biologics licenses under §§ 601.5(a) and 601.8 of this chapter.
(4) Notices of revocation when the manufacturer has waived the opportunity for hearing under § 601.7(a) of this chapter.
(5) Notice of biologics license suspensions under § 601.6 of this chapter.
(b) These officials may not further redelegate these authorities.
(a) The following officials are authorized to issue licenses under section 351 of the PHS Act (42 U.S.C. 262) for the propagation or manufacture and preparation of biological products as specified in the PHS Act, and to revoke such licenses at the manufacturer's request:
(1) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).
(2) Directors and Deputy Directors, Office of Blood Research and Review, Office of Vaccines Research and Review, Office of Therapeutics Research and Review, and Office of Compliance and Biologics Quality, CBER.
(b) These officials may not further redelegate this authority.
(a) The following officials are authorized to issue written notices of release for distribution of licensed biological products under subchapter F (parts 600 through 680.31) of this chapter:
(1) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).
(2) The Director and Deputy Directors, Office of Compliance and Biologics Quality (OCBQ), CBER.
(3) The Director and Deputy Director, Division of Manufacturing and Product Quality, OCBQ, CBER.
(b) These officials may not further redelegate this authority.
(a)(1) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) under sections 409 and 721 of the act (21 U.S.C. 348 and 379e) regarding the issuance of notices of filing (including notices of extension of, or reopening of, the comment period), and of voluntary withdrawal, of petitions on food additives, generally recognized as safe (GRAS) substances, and color additives that relate to the assigned functions of the respective Center:
(i) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN).
(ii) The Director of Regulations and Policy, CFSAN.
(iii) The Director, Office of Premarket Approval, CFSAN.
(iv) The Director and Deputy Director, Center for Veterinary Medicine (CVM).
(2) The Director, Deputy Director, and Director of Regulations and Policy, CFSAN are authorized to perform all the functions of the Commissioner under section 401 of the act (21 U.S.C. 341) regarding the issuance of proposed rulemaking (including notices of extension of, or reopening of, the comment period) pertaining to food standards.
(b)(1) The Director, Deputy Director, and Director of Regulations and Policy, CFSAN are authorized to perform all of the functions of the Commissioner under section 409 and 721 of the act (21 U.S.C. 348 and 379e) regarding the approval of the use of food additives under section 409(e) of the act (21 U.S.C. 348(e)) and the listing of color additives under section 721(d)(1) of the act (21 U.S.C. 379e) where the listing does not involve novel or controversial issues and does not involve any questions about the applicability of the Delaney Anti-Cancer Clause.
(2) The following officials are authorized to perform all of the functions of the Commissioner under section 401 of the act (21 U.S.C. 341) regarding the issuance of notices of temporary permits for foods varying from standards of identity under § 130.17 of this chapter:
(i) The Director and Deputy Director, CFSAN.
(ii) The Director of Regulations and Policy, CFSAN.
(iii) The Director, Office of Nutritional Products, Labeling, and Dietary Supplements, CFSAN.
(3) The Director and Deputy Director, CVM, are authorized to perform all the functions of the Commissioner regarding approvals of the use of food additives under section 409(e) of the act (21 U.S.C. 348(e)), where these approvals do not involve novel or controversial issues, including any question about the applicability of the Delaney Anti-Cancer Clause.
(c)(1) The following officials are authorized to issue 90-day letters to food additive petitioners under section 409(c)(2) of the act (21 U.S.C. 348(c)(2)) or to color additive petitions under section 721e(d)(1) (21 U.S.C. 379e(d)(1)) of the act that relate to the assigned functions of the Center:
(i) The Director and Deputy Director, CFSAN.
(ii) The Director of Regulations and Policy, CFSAN.
(iii) The Director, Office of Premarket Approval, CFSAN.
(iv) The Director, Division of Product Policy, Office of Premarket Approval, CFSAN.
(v) The Director, Division of Petition Control, Office of Premarket Approval, CFSAN.
(2) The following officials are authorized to issue 90-day letters to food additive petitioners under section 409(c)(2) of the act (21 U.S.C. 348(c)(2)) that relate to the assigned functions of the Center:
(i) The Director and Deputy Director, CVM.
(ii) The Director and Deputy Director, Office of Surveillance and Compliance, CVM.
(iii) The Director and Deputy Director, Division of Animal Feeds, Office of Surveillance and Compliance, CVM.
(d) The following officials are authorized to certify batches of color additives under section 721 of the act (21 U.S.C. 379e):
(1) The Director and Deputy Director, CFSAN.
(2) The Director of Regulations and Policy, CFSAN.
(3) The Director, Office of Cosmetics and Colors, CFSAN.
(e) The following officials are authorized to issue advance notices of proposed rulemaking pertaining to Codex Alimentarius food standards and notices terminating consideration of such standards when comments fail to support the desirability and need for proposing their adoption, under § 130.6 of this chapter:
(1) The Director and Deputy Director, CFSAN.
(2) The Director of Regulations and Policy, CFSAN.
(3) The Director, Office of Nutritional Products, Labeling, and Dietary Supplements, CFSAN.
(f) The following officials are authorized to issue notices of proposed rulemaking and issue or amend regulations affirming GRAS status of food substances under §§ 170.35 or 570.35 of this chapter where the affirmations relate to the assigned functions of the respective Center and do not involve novel or controversial issues:
(1) The Director, Deputy Director, and Director of Regulations and Policy, CFSAN.
(2) The Director and Deputy Director, CVM.
(g)(1) The following officials are authorized to perform all of the functions of the Commissioner under section 403(r)(4) of the act (21 U.S.C. 343(r)(4)) regarding the issuance of decisions to grant or deny petitions for nutrient content claims and health claims that do not present controversial issues and regarding the issuance of any notices of proposed rulemaking that result from such action:
(i) The Director and Deputy Director, CFSAN.
(ii) The Director of Regulations and Policy, CFSAN.
(2) The following officials are authorized to perform all of the functions of the Commissioner under section 403(r)(4) of the act (21 U.S.C. 343(r)(4)) regarding the issuing of letters of filing in response to petitions for nutrient content claims and health claims:
(i) The Director and Deputy Director, CFSAN.
(ii) The Director of Regulations and Policy, CFSAN.
(iii) The Director, Office of Nutritional Products, Labeling, and Dietary Supplements, CFSAN.
(h) The following officials are authorized to issue letters concerning substances determined to be below the “threshold of regulation” under § 170.39 of this chapter:
(1) The Director and Deputy Director, CFSAN.
(2) The Director of Regulations and Policy, CFSAN.
(3) The Director, Office of Premarket Approval, CFSAN.
(4) The Directors of the Divisions of Petition Control and Product Policy, Office of Premarket Approval, CFSAN.
(i) The following officials are authorized to perform all of the functions of the Commissioner under section 409(h) of the act (21 U.S.C. 348(h)), excluding the duties to set out in section 409(h)(5) of the act (21 U.S.C. 348(h)(5)), regarding premarket notification of food-contact substances:
(1) The Director and Deputy Director, CFSAN.
(2) The Director of Regulations and Policy, CFSAN.
(3) The Director, Office of Premarket Approval, CFSAN.
(j) These officials may not further redelegate these authorities.
(a) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN), the Director, Office of Field Programs, CFSAN, and the Director, Division of Enforcement and Programs, Office of Field Programs,
(b) The following officials are authorized to issue notices of confirmation of effective date of final regulations on food matters issued under section 701(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(e)):
(1) The Director and Deputy Director, CFSAN.
(2) The Director of Regulations and Policy, CFSAN.
(3) The Director, Office of Nutritional Products, Labeling, and Dietary Supplements, CFSAN.
(4) The Director, Office of Plant and Dairy Foods and Beverages, CFSAN.
(5) The Director, Office of Seafood, CFSAN.
(6) The Director, Office of Field Programs, CFSAN.
(7) The Director, Office of Premarket Approval, CFSAN.
(c) These officials may not further redelegate these authorities.
The Regional Food and Drug Directors and District Directors are authorized to perform and to designate other officials to perform all of the functions of the Commissioner of Food and Drugs under:
(a) Section 409(b) of the Federal Meat Inspection Act (21 U.S.C. 679(b)), that relates to the detention of any carcass, part thereof, meat, or meat product of cattle, sheep, swine, goats, or equines.
(b) Section 24(b) of the Poultry Products Inspection Act (21 U.S.C. 467f(b)) that relates to the detention of any poultry carcass, part thereof, or poultry product.
(c) The Egg Products Inspection Act (21 U.S.C. 1031
The Director, Deputy Director, and Director of Regulations and Policy, Center for Food Safety and Applied Nutrition, are authorized to perform all the functions of the Commissioner of Food and Drugs under sections 1322(b) and (c) of the Food, Agriculture, Conservation, and Trade Act of 1990 (the National Laboratory Accreditation Program) (7 U.S.C. 138a), as amended hereafter, which relate to setting standards for the National Laboratory Accreditation Program and approving State agencies or private, nonprofit entities as accrediting bodies to implement certification and quality assurance programs in accordance with the requirements of these sections. The delegation excludes the authority to submit reports to the Congress. These officials may not further redelegate this authority.
(a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) under § 113.10 of this chapter regarding the approval of schools giving instruction in retort operations, processing systems operations, aseptic processing and packaging system operations, and container closure inspections:
(1) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN).
(2) The Director of Regulations and Policy, CFSAN.
(3) The Director, Office of Plant and Dairy Foods and Beverages, CFSAN.
(b) These officials may not further redelegate this authority.
(a) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health; and the Director and Deputy Directors, Center for Biologics Evaluation and Research, are authorized to issue
(b) These officials may not further redelegate this authority.
(a) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health; and the Directors and Deputy Directors, Center for Biologics Evaluation and Research, are authorized to make determinations and issue
(b) These officials may not further redelegate this authority.
(a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs pertaining to detention, under section 304(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334(g)) and in accordance with § 800.55 of this chapter, of medical devices that may be adulterated or misbranded:
(1) For medical devices assigned to their respective organizations:
(i) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH).
(ii) The Director and Deputy Director, Office of Compliance, CDRH.
(iii) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).
(iv) The Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER.
(2) Regional Food and Drug Directors.
(3) District Directors.
(4) The Director, St. Louis Branch.
(b) These officials may not further redelegate this authority.
(a) The following officials, for medical devices assigned to their respective organizations, may authorize under section 513(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(a)(3)(B)) the use of valid scientific evidence (other than that prescribed by section 513(a)(3)(A) of the act) for determining the effectiveness of medical devices for the purposes of sections 513, 514, and 515 of the act (21 U.S.C. 360c, 360d, and 360e):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), and the Director and Deputy Directors, Office of Device Evaluation, CDRH.
(2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Directors and Deputy Director, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), and Office of Therapeutics Research and Review (OTRR), CBER.
(b) These officials may not further redelegate this authority.
(a) The following officials, for medical devices assigned to their respective organizations, are authorized to notify petitioners of determinations made on petitions for reclassification of medical devices that are classified in class III (premarket approval) by sections 513(f) and 520(l) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f) and 360 j(1)) and denials of petitions for reclassification of medical devices that are submitted under section 513(e) of the act (21 U.S.C. 360c(e)) (except for petitions submitted in response to
(1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH) and the Director and Deputy Directors, Office of Device Evaluation.
(2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Directors and Deputy Directors, Office of Blood Research and Review, Office of Vaccines Research and Review, and Office of Therapeutics Research and Review, CBER.
(b) These officials may not further redelegate this authority.
(a) The following officials, for devices assigned to their respective organizations, are authorized to determine the classification of a medical device in commercial distribution prior to May 28, 1976, under section 513(d) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(d)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH) and the Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH.
(2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Directors of the Office of Blood Research and Review (OBRR), the Office of Vaccines Research and Review (OVRR), and the Office of Therapeutics Research and Review (OTRR), CBER.
(b) The following officials, for devices assigned to their respective organizations, are authorized to determine the classification of a medical device first intended for commercial distribution after May 28, 1976, under section 513(f)(1)(A) of the act (21 U.S.C. 360c(f)(1)(A)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, and the Director, Deputy Directors, Division and Deputy Division Directors, Associate Division Directors, Branch Chiefs, and Chief, Premarket Notification Section, ODE, CDRH.
(2) The Director and Deputy Directors, CBER, and the Directors and Deputy Directors of the OBRR, OVRR, and OTRR, CBER.
(c) The following officials are authorized to make determinations and issue orders classifying devices under section 513(f)(2)(b):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Directors, ODE, CDRH.
(3) The Director and Deputy Directors, CBER, and the Directors and Deputy Directors of the OBRR, OVRR, and OTRR, CBER.
(d) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, and the Director and Deputy Directors, CBER, and the Directors and Deputy Directors of the OBRR, OVRR, and OTRR, CBER, are authorized to issue
(e) These officials may not further redelegate those authorities.
(a) The following officials, for medical devices assigned to their respective organizations, are authorized to notify sponsors of deficiencies in petitions for reclassification of medical devices submitted under sections 513(f) and 520(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f) and 360j(l)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), and the Director and Deputy Directors, Office of Device Evaluation, CDRH.
(2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Directors and Deputy Directors of the Office of Blood Research and Review, Office of Vaccines Research and Review, and Office of Therapeutics Research and Review, CBER.
(b) These officials may not further redelegate this authority.
(a) The following officials, for medical devices assigned to their respective organizations, are authorized to approve, disapprove, declare as complete or incomplete, or revoke product development protocols for medical devices submitted under section 515(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(f)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), the Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH, and the Division Directors, ODE, CDRH.
(2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Directors, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), and Office of Therapeutics Research and Review (OTRR), CBER.
(b)(1) The following officials, for medical devices assigned to their respective organizations, are authorized to approve, disapprove, or withdraw approval of applications for premarket approval for medical devices submitted under sections 515 and 520(l) of the act (21 U.S.C. 360e and 360j(l)):
(i) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, the Director and Deputy Directors, ODE, CDRH, and the Division Directors, ODE, CDRH.
(ii) The Director and Deputy Directors, CBER, and the Directors and Deputy Directors, OBRR, OVRR, and OTRR, CBER.
(2) For medical devices assigned to their respective division, the Division Directors, Office of Device Evaluation, CDRH, are authorized to approve, disapprove, or withdraw approval of supplemental premarket applications.
(c) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, for medical devices assigned to their organization, are authorized to issue notices to announce the approval, disapproval, or withdrawal of approval of a device, and to make publicly available a detailed summary of the information on which the decision was based, under sections 515(d), (e), and (g) and 520(h)(1) of the act (21 U.S.C. (d), (e), and (g) and 360j(h)(1)).
(d) These officials may not further redelegate these authorities.
(a) The following officials are authorized to make determinations under section 513(a)(3)(D) of the act (21 U.S.C. 360c(a)(3)(D)) concerning the type of valid scientific evidence to be submitted in a premarket approval application that will provide a reasonable assurance that a device is effective under the conditions of use proposed by such person:
(i) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(ii) The Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH.
(iii) The Director, Program Operations Staff, ODE, CDRH.
(iv) For devices assigned to their respective Divisions: the Division Directors and Deputy Division Directors, ODE, CDRH.
(b) These officials may may not further redelegate this authority.
(a) The following officials, for medical devices assigned to their respective organizations, are authorized to determine that medical devices present an unreasonable risk of substantial harm to the public health, and to order adequate notification thereof, under section 518(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(a)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), and the Director and Deputy Director, Office of Compliance, CDRH.
(2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Director, Office of Compliance and Biologics Quality, CBER.
(3) The Director, the Deputy Director, and the Directors, Office of Review Management and Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); and the Director and Deputy Director, Office of Compliance, CDER.
(b) These officials may not further redelegate this authority.
(a) The following officials, for medical devices assigned to their respective organizations, are authorized to order repair or replacement of, or refund for, medical devices under section 518(b) and (c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(b) and (c)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), and the Director and Deputy Director, Office of Compliance, CDRH.
(2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER.
(3) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); and the Director and Deputy Director, Office of Compliance, CDER.
(b) These officials may not further redelegate this authority.
(a) The following officials, for medical devices assigned to their respective organizations, are authorized to perform all of the recall functions under section 518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(e)), which have been delegated to the Commissioner of Food and Drugs:
(1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH).
(2) The Director and Deputy Director, Office of Compliance, CDRH.
(3) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); and the Director and Deputy Director, Office of Compliance, CDER.
(4) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER.
(b) These officials may not further redelegate this authority.
(a) The following officials for medical devices assigned to their respective organizations are authorized under section 515(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(e)), to determine that there is reasonable probability that continuation of the distribution of a device under an approved application would cause serious adverse health consequences or death, and upon making such a determination, to issue an order to temporarily suspend the approval of an application:
(1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH).
(2) The Director and Deputy Director, Office of Compliance, CDRH.
(3) The Director and Deputy Directors, Office of Device Evaluation, CDRH.
(4) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); the Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER; the Director and Deputy Director, Office of Generic Drugs, Office of Pharmaceutical Science, CDER; and the Director and Deputy Director, Office of Compliance, CDER.
(5) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director
(b) These officials may not further redelegate this authority.
(a) For medical devices assigned to their respective organizations, the following officials are authorized to approve, disapprove, or withdraw approval of applications for investigational device exemptions submitted under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), the Director and Deputy Directors, Office of Device Evaluation, CDRH, and the Director and Deputy Director, Office of Compliance, CDRH.
(2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Directors and Deputy Directors, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), and Office of Therapeutics Research and Review (OTRR), CBER.
(b) For medical devices assigned to their respective divisions, the Division Directors, Office of Device Evaluation, CDRH, are authorized to approve, disapprove, or withdraw approval of applications for investigational device exemptions submitted under section 520(g) of the act (21 U.S.C. 360j(y)).
(c) The following officials are authorized to enter into written agreements concerning investigational device exemption protocols under section 520(g)(7) of the act (21 U.S.C. 360j(g)(7)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH.
(3) The Director, Program Operations Staff, ODE, CDRH.
(4) The Chief, Investigational Device Exemption Section, ODE, CDRH.
(5) For medical devices assigned to their respective Divisions: The Division Directors and Deputy Division Directors, ODE, CDRH.
(6) The Director and Deputy Directors, CBER, and the Director and Deputy Directors of the OBRR, OVRR, and OTRR, CBER.
(d) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH and the Director and Deputy Directors, ODE, CDRH, the Director and Deputy Directors, CBER, and the Director and Deputy Directors of the OBRR, OVRR, and OTRR, CBER, are authorized to make decisions under section 520(g)(7) of the act (21 U.S.C. 360j(g)(7)) with respect to an agreement on an investigational plan, that a substantial scientific issue essential to determining the safety and effectiveness of the device involved has been identified.
(e) These officials may not further redelegate these authorities.
(a) For any class II or class III device (including any device that is or contains a drug or biologic), the failure of which would be reasonably likely to have serious adverse health consequences, or which is intended to be implanted in the human body for more than 1 year, or a life supporting or life sustaining device used outside a user facility, any of the following officials is authorized to require a manufacturer of such device to conduct postmarket surveillance:
(1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH).
(2) The Director and Deputy Director, Office of Surveillance and Biometrics, CDRH.
(3) The Director and Deputy Director, Division of Postmarket Surveillance, Office of Surveillance and Biometrics (OSB), and the Director, Issues Management Staff, OSB, CDRH.
(4) The Director and Deputy Directors, Office of Device Evaluation, CDRH.
(5) The Director and Deputy Director, Office of Science and Technology, CDRH.
(6) The Director and Deputy Director, Office of Health and Industry Programs, CDRH.
(7) The Director and Deputy Director, Office of Compliance, CDRH.
(8) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).
(9) The Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(10) The Director and Deputy Director, Office of Compliance, CDER.
(11) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).
(12) The Director and Deputy Director, Office of Compliance and Biologics Quality, CBER.
(13) The Directors and Deputy Directors, Office of Blood Research and Review, Office of Vaccines Research and Review, and Office of Therapeutics Research and Review, CBER.
(b) These officials may not further redelegate these authorities.
(a) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), the Director and Deputy Director, Office of Surveillance and Biometrics (OSB), CDRH, and the Director and Deputy Director, Division of Surveillance Systems (DSS), OSB, CDRH, are authorized to approve electronic reporting under § 803.14 of this chapter.
(b) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, the Director and Deputy Director, OSB, CDRH, and the Director and Deputy Director, DSS, OSB, CDRH are authorized to request the submission of additional information under § 803.15 of this chapter.
(c) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, the Director and Deputy Director, OSB, CDRH, and the Director and Deputy Director, DSS, OSB, CDRH are authorized to grant or revoke exemptions and variances from reporting requirements under § 803.19 of this chapter.
(d) These officials may not further redelegate these authorities.
(a) The following officials are authorized to issue orders under section 519(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e)) requiring manufacturers to adopt methods of tracking devices:
(1) The Director and Deputy Directors, Center for Devices and Radiological Health (CDRH).
(2) The Director and Deputy Director, Office of Compliance, CDRH.
(b) These officials may not further redelegate this authority.
(a) The following officials are authorized under section 523(a)(1) and (b)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360m(a)(1) and (b)(2)(A)) to respond to a request for accreditation and to accredit persons for the purpose of reviewing reports submitted under section 510(k) of the act (21 U.S.C. 360(k)) and making recommendations regarding the initial classification of devices:
(1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH).
(2) The Director and Deputy Director, Office of Health and Industry Programs (OHIP), CDRH.
(3) The Director and Deputy Director, Division of Small Manufacturers Assistance (DSMA), OHIP, CDRH.
(b) The following officials are authorized under section 523(a)(2)(B) and (C) of the act (21 U.S.C. 360m(a)(2)(B) and (C)) to make a determination with respect to the recommendation of an initial classification of a device; and to change the initial classification under section 513(f)(1) of the act (21 U.S.C. 360c(f)(1)) that is recommended by an accredited person to provide to such person, and the person who submitted the report under section 510(k) of the act (21 U.S.C. 360(k)) for the device, a statement explaining in detail the reasons for the change:
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH.
(3) The Division Directors and Deputy Division Directors, ODE, CDRH.
(c) The following officials are authorized under section 523(b)(2)(B) of the act (21 U.S.C. 360m(b)(2)(B)) to suspend or withdraw accreditation of any person accredited to review reports and to make recommendations under section 523 of the act (21 U.S.C. 360m):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DSMA, OHIP, CDRH.
(d) The following officials are authorized under section 523(b)(2)(C) of the act (21 U.S.C. 360m(b)(2)(c)) to implement the measures described in that section to ensure that persons accredited under section 523 of the act (21 U.S.C. 360m) will continue to meet the standards of accreditation:
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, Office of Compliance, CDRH.
(e) These officials may not further redelegate these authorities.
The Director and Deputy Director, Center for Veterinary Medicine (CVM) are authorized to issue
(a) The Director and Deputy Director, Center for Veterinary Medicine (CVM), are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) with regard to the approval of new animal drug applications, and supplements thereto, for new animal drugs submitted under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b).
(b) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs with regard to the approval of supplemental applications to approved new animal drugs submitted under section 512 of the act (21 U.S.C. 360b):
(1) The Director, the Deputy Director for Human Food Safety and Consultative Services, and the Deputy Director for Therapeutic and Production Drug Review, Office of New Animal Drug Evaluation, CVM.
(2) The Director and Deputy Director, Office of Surveillance and Compliance, CVM.
(c) The following officials are authorized to perform all the functions of the Commissioner with regard to the approval of supplemental applications to new animal drug applications that are described by § 514.8(a)(4)(iii), (iv), and (v), and (d)(3) of this chapter.
(1) The Director, Division of Manufacturing Technologies, Office of New Animal Drug Evaluation, CVM.
(2) The Director, Division of Epidemiology and Surveillance, Office of Surveillance and Compliance, CVM.
(d) The following officials are authorized to perform all the functions of the Commissioner with regard to the approval of medicated feed mill license applications for the manufacture of animal feeds containing new animal drugs under section 512(m) of the act (21 U.S.C. 360b(m), as amended by the Animal Drug Availability Act of 1996 (Public Law 104-250):
(1) The Director and Deputy Director, CVM.
(2) The Director, Division of Animal Feeds, Office of Surveillance and Compliance, CVM.
(3) The Leader, Medicated Feeds Team, Division of Animal Feeds, Office of Surveillance and Compliance, CVM.
(4) The Medicated Feeds Specialist, Medicated Feeds Team, Division of Animal Feeds, Office of Surveillance and Compliance, CVM.
(e) These officials may not further redelegate these authorities.
(a) The Director and Deputy Director, Center for Veterinary Medicine (CVM), are authorized to:
(1) Issue notices of opportunity for a hearing on proposals to refuse approval or to withdraw approval of new animal drug applications, and supplements thereto, for drugs for animal use and proposals to refuse approval or to revoke approval of medicated feed mill license applications, and supplements thereto, submitted under section 512(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(m)), as amended by the Animal Drug Availability Act of 1996 (Public Law 104-250);
(2) Issue notices refusing or withdrawing approval when opportunity for hearing has been waived; and
(3) Issue proposals and orders to revoke and amend regulations for new animal drugs for drugs for animal use and medicated feed mill licenses, corresponding to said act on such applications.
(b) The Director and Deputy Director, CVM, are authorized to issue notices of availability of Public Master Files containing data acceptable for use in applications for new animal drugs for drugs for animal use and feeds bearing or containing new animal drugs.
(c) These officials may not further redelegate these authorities.
(a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) with regard to decisions made under section 512(c)(2)(D)(iv) and (c)(2)(F) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(D)(iv) and (c)(2)(F) concerning the date of submission and the date of effective approval of abbreviated new animal drug applications including supplements thereto, submitted under section 512(b)(2) of the act (21 U.S.C. 360b(b)(2)), and of new animal drug applications including supplements thereto, submitted under section 512(b)(1) of the act (21 U.S.C. 360b(b)(1)):
(1) The Director and Deputy Director, Center for Veterinary Medicine (CVM).
(2) The Director and Deputy Director, Office of New Animal Drug Evaluation, CVM.
(b) These officials may not further redelegate this authority.
(a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) under section 512(e), (m)(4)(B)(ii), and (m)(4)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(e), (m)(4)(B)(ii), and (m)(4)(B)(iii)) regarding the issuance of written notices:
(1) The Director and Deputy Director, Center for Veterinary Medicine (CVM).
(2) The Director and Deputy Director, Office of Surveillance and Compliance, CVM.
(3) The Director, Division of Compliance, Office of Surveillance and Compliance, CVM.
(4) Regional Food and Drug Directors.
(5) District Directors.
(b) These officials may not further redelegate this authority.
(a) The following officials are authorized to perform all functions of the Commissioner of Food and Drugs with regard to the termination of new animal drugs for investigational use in animals under § 511.1 of this chapter:
(1) The Director and Deputy Director, Center for Veterinary Medicine (CVM).
(2) The Director and Deputy Director, Office of New Animal Drug Evaluation, CVM.
(b) These officials may not further redelegate this authority.
(a) The following officials are authorized to grant and withdraw variances and issue notices of availability of any approved variance or any amendment or extension thereof, from the provisions of performance standards for electronic products established in subchapter J of this chapter:
(1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH).
(2) The Director and Deputy Director, Office of Compliance, CDRH.
(b) These officials may not further redelegate this authority.
(a) The following officials are authorized to exempt from performance standards any electronic product intended for use by departments or agencies of the United States under section 534(a)(5) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360kk(a)(5)) and to exempt an electronic product or class of products from all or part of the provisions of section 538(a) of the act (21 U.S.C. 360oo(a)) under section 538(b) of the act (21 U.S.C. 360oo(b)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH).
(2) The Director and Deputy Director, Office of Compliance, CDRH.
(b) These officials may not further redelegate this authority.
(a) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), and the Director and Deputy Director, Office of Compliance, CDRH, are authorized to review and evaluate industry testing programs under section 534(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360kk(g)) and to approve or disapprove alternate methods of certification and identification and to disapprove testing programs upon which certification is based under section 534(h) of the act (21 U.S.C. 360kk(h)).
(b) These officials may not further redelegate this authority.
(a) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), and the Director and Deputy Director, Office of Compliance, CDRH, are authorized to perform all functions of the Commissioner of Food and Drugs (Commissioner), relating to notification of defects in, noncompliance of, and repair or replacement of or refund for, electronic products under section 534 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360kk) and under §§ 1003.11, 1003.22, 1003.31, 1004.2, 1004.3, 1004.4, and 1004.6 of this chapter; and Regional Food and Drug Directors, District Directors, and the Director, St. Louis Branch, are authorized to perform all such functions relating to:
(1) Assemblers of diagnostic x-ray systems, as defined in § 1020.30(b) of this chapter.
(2) Manufacturers of sunlamp products and ultraviolet lamps intended for use in any sunlamp product, as defined in § 1040.20(b) of this chapter.
(b) The Director and Deputy Director, Office of Compliance, CDRH, and the Division Directors, Office of Compliance, CDRH, are authorized to notify manufacturers of defects in, and noncompliance of, electronic products under section 535(e) of the act (21 U.S.C. 360ll(e)) and under § 1003.11(a) of this chapter; and the chiefs of District Compliance Branches are authorized to perform all such functions relating to:
(1) Assemblers of diagnostic x-ray systems, as defined in § 1020.30(b) of this chapter.
(2) Manufacturers of sunlamp products and ultraviolet lamps intended for use in any sunlamp products, as defined in § 1040.20(b) of this chapter.
(c) These officials may not further redelegate these authorities.
(a) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health, are authorized to require manufacturers to provide performance and technical data to the ultimate purchaser of electronic products under section 537(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360nn(c)).
(b) These officials may not further redelegate these authorities.
(a) The Director and Deputy Director for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), the Director and Deputy Director, Office of Compliance, CDRH, and the Division Directors, Office of Compliance, CDRH, are authorized to direct dealers and distributors of electronic products to furnish information on first purchasers of such products to the manufacturer of the product under section 537(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360nn(f)).
(b) These officials may not further redelegate these authorities.
(a) The Director and Deputy Directors, Center for Devices and Radiological Health, are authorized to accept assistance from State and Local authorities engaged in activities related to health or safety or consumer protection on a reimbursable basis or otherwise, under section 541 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360rr).
(b) These officials may not further redelegate these authorities.
The Chief Mediator and Ombudsman, Office of the Ombudsman, Office of the Senior Associate Commissioner, Office of the Commissioner, as product jurisdiction officer is authorized to make a determination under section 563 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360bbb-2) respecting the classification of a product as a drug, biological product, device, or a combination product subject to section 503(g) of the act (21 U.S.C. 353(g)), and to assign primary responsibility respecting the organizational component of the Food and Drug Administration that will regulate the product. This official may not further redelegate this authority.
(a) For a product that is or contains a biologic, a device, or a drug, the following officials in the Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, or Center for Drug Evaluation and Research who currently hold delegated premarket approval authority for biologics, devices, or drugs, respectively, are hereby delegated all the authorities necessary for premarket approval of any product that is a biologic, a device, or a drug, or any combination of two or more of these products:
(1) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER) and the Directors of the Office of Blood Research and Review, Office of Vaccines Research and Review, Office of Therapeutics Research and Review, and Office of Compliance and Biologics Quality, CBER.
(2) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), and the Director, Office of Device Evaluation, CDRH.
(3) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); and the Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(b) These officials may not further redelegate this authority.
(a) The Regional Food and Drug Directors, District Directors, and the Director, St. Louis Branch, are authorized, under section 801 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381), to perform the following functions or to designate officials to:
(1) Request from the Secretary of the Treasury samples of food, drugs (including biological products), devices, or cosmetics imported or offered for import.
(2) Determine whether such articles are in compliance with the act.
(3) Authorize relabeling or other compliance actions to bring articles into compliance under the act.
(4) Supervise such compliance actions.
(b) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH); the Director and Deputy Director, Office of Compliance, CDRH; Regional Food and Drug Directors; District Directors; and the Director, St. Louis Branch, are authorized, under section 536 of the act (21 U.S.C. 360mm), to perform the following functions or to designate officials to:
(1) Request from the Secretary of the Treasury samples of electronic products imported or offered for import to determine whether such products are in compliance with section 534 of the act (21 U.S.C. 360kk).
(2) Refuse admission of noncomplying products and notify the Secretary of the Treasury of such refusal.
(3) Supervise operations to bring noncomplying products into compliance under section 534 of the act (21 U.S.C. 360kk).
(4) Refuse or grant permission and time extensions to bring noncomplying products into compliance with section 534 of the act (21 U.S.C. 360kk) in accordance with a corrective action plan approved by the Directors, Offices of Compliance Surveillance and Biometrics, CDRH.
(c) The following officials are authorized, under section 538(b) of the act (21 U.S.C. 360oo(b)), to exempt persons from issuing a certification, as required by section 534(h) of the act (21 U.S.C. 360kk(h)) for electronic products imported into the United States for testing, evaluation, demonstrations, or training, which will not be introduced into commerce and upon completion of their function will be destroyed or exported in accord with U.S. Customs Service's regulations:
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, Office of Compliance, CDRH.
(3) Regional Food and Drug Directors.
(4) District Directors.
(5) The Director, St. Louis Branch.
(d) The Regional Food and Drug Directors, District Directors, and the Director, St. Louis Branch, are authorized to exercise all of the functions of the Commissioner of Food and Drugs (Commissioner) under section 362 of the Public Health Service Act (42 U.S.C. 265) that relate to the prohibition of the introduction of foods, drugs, devices, cosmetics, and electronic products, and other items or products regulated by the Food and Drug Administration into the United States when it is determined that it is required in the interest of public health, and such functions relate to the law enforcement functions of the Food and Drug Administration.
(e) The following officials are authorized to perform all the functions of the Commissioner pertaining to exportation of medical devices under section 801(e) of the act (21 U.S.C. 381(e)):
(1) For medical devices assigned to their respective organization:
(i) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(ii) The Director and Deputy Director, Office of Compliance, CDRH.
(iii) The Director and Deputy Director, Division of Program Operations, Office of Compliance, CDRH.
(iv) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).
(v) The Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER.
(2) Regional Food and Drug Directors.
(3) District Directors.
(4) The Director, St. Louis Branch.
(f) The following officials are authorized to perform the functions of the Commissioner for drugs under their jurisdiction, pertaining to authorizing the reimportation of prescription drugs under section 801(d)(2) of the act (21 U.S.C. 381(d)(2)) for emergency medical care:
(1) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER) and the Director, Office of Compliance and Biologics Quality, CBER.
(2) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER) and the Director and Deputy Director, Office of Compliance, CDER.
(g) These officials may not further redelegate these authorities.
(a) The following officials are authorized, under section 802(b)(2) and (b)(3) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 382(b)(2) and (b)(3)), to grant or deny petitions to export unapproved new drugs and biological products and to issue notices of receipt of such petitions for human drugs assigned to their respective organizations:
(1) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).
(2) The Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER.
(3) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).
(4) The Director and Deputy Director, Office of Compliance, CDER.
(b) The following officials are authorized, under section 802(e) of the act (21 U.S.C. 382(e)), to approve or disapprove an application to export a drug (including a biological product) to be used in the prevention or treatment of a tropical disease or another disease as described in section 802(e) for human drugs assigned to their respective organizations:
(1) The Director and Deputy Directors, CBER.
(2) The Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER.
(3) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, CDER.
(4) The Director and Deputy Director, Office of Compliance, CDER.
(c) The following officials are authorized, under section 351(h) of the Public Health Service Act (42 U.S.C. 262(h)), to approve or disapprove an application to export a partially processed biological product:
(1) The Director and Deputy Directors, CBER.
(2) The Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER.
(d) These officials may not further redelegate these authorities.
The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH) and the Director and Deputy Director, Office of Compliance, CDRH, are authorized to reject manufacturer's designation of import agents under § 1005.25(b) of this chapter. These officials may not further redelegate this authority.
(a) The Director, Office of Orphan Products Development (OPD), Office of the Senior Associate Commissioner
(1) Notices of claimed investigational exemption for a new drug or new drug applications;
(2) Notices of claimed investigational exemption for a new animal drug or new animal drug applications;
(3) Applications for biologics licenses for biological products; or
(4) Applications for an investigational device exemption or premarket approval applications for medical devices, as appropriate.
(b) The Director, OPD, OSAC, OC, is authorized:
(1) To determine whether there is reason to believe that a drug is a drug for a disease or condition that is rare in the United States under section 525(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360aa(a)) and to designate such drug as a drug for a rare disease or condition under section 526(a) of the act (21 U.S.C. 360bb(a)).
(2) To issue holders of approved applications or licenses notice and opportunity for the submission of views under section 527(b)(1) of the act (21 U.S.C. 360cc(b)(1)).
(3) To encourage sponsors of an investigational new drug for a rare disease or condition to design protocols for clinical investigations to permit the addition to the investigation of persons with the disease or condition under section 528 of the act (21 U.S.C. 360dd).
(c) The following officials are authorized to provide sponsors, under section 525(a) of the act (21 U.S.C. 360aa(a)), with recommendations for nonclinical or clinical investigations believed to be necessary for a drug for a rare disease or condition to be approved or licensed:
(1) For drugs under their jurisdiction:
(i) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).
(ii) The Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(iii) The Directors and Deputy Directors of the divisions in the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(2) For biological products under their jurisdiction:
(i) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).
(ii) The Directors and Deputy Directors, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), Office of Therapeutics Research and Review (OTRR), CBER.
(iii) The Directors and Deputy Directors of the Divisions in OBRR, OVRR, and OTRR, CBER.
(d) These officials may not further redelegate these authorities.
(a) The following officials are authorized to ensure mammography facilities obtain certificates under section 354(b) of the Public Health Service Act (the PHS Act) (42 U.S.C. 263b(b)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH).
(2) The Director and Deputy Director, Office of Health and Industry Programs (OHIP), CDRH.
(3) The Director and Deputy Director, Division of Mammography Quality and Radiation Programs (DMQRP), OHIP, CDRH.
(b) The following officials are authorized to issue, renew and extend certificates to mammography facilities under section 354(c) of the PHS Act (42 U.S.C. 263b(c)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(c) The following officials are authorized to accept an application for a certificate under section 354(d)(1) of the PHS Act (42 U.S.C. 263b(d)(1)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(d) The following officials are authorized to approve accreditation bodies to accredit mammography facilities under section 354(e)(1)(A) of the PHS Act (42 U.S.C. 263b(e)(1)(A)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(e) The following officials are authorized to ensure accreditation bodies provide satisfactory assurances of compliance under section 354(e)(1)(C) of the PHS Act (42 U.S.C. 263b(e)(1)(c)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(f) The Director, CDRH is authorized to issue regulations under which the Director may withdraw approval of accreditation bodies under section 354(e)(2)(A) of the PHS Act (42 U.S.C. 263b(e)(2)(A)).
(g) The following officials are authorized to determine the expiration date of a certificate of a facility accredited by an accreditation body after the body's approval is withdrawn, or a State's certification authority has been withdrawn, or a facility's accreditation has been revoked by an accreditation body under sections 354(e)(2)(B) and 354(e)(5) of the PHS Act (42 U.S.C. 263b(e)(2)(B) and (e)(5)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(h) The following officials are authorized to determine the applicable standards for a facility for accreditation under section 354(e)(3) of the PHS Act (42 U.S.C. 263b(e)(3)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(i) The following officials are authorized to ensure accreditation bodies make on site visits and to determine whether other measures are appropriate under section 354(e)(4) of the PHS Act (42 U.S.C. 263b(e)(4)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(j) The following officials are authorized to evaluate annually the performance of each approved accreditation body as provided by section 354(e)(6)(A) of the PHS Act (41 U.S.C. 263b(e)(6)(A)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(k) The following officials are authorized to determine the compliance of certified facilities with established standards through annual facility inspections as provided by section 354(g) of the PHS Act (42 U.S.C. 263b(g)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(l) The following officials are authorized to promote voluntary compliance with established standards instead of taking actions under section 354(i) of the PHS Act (42 U.S.C. 263b(i)) by imposing directed plans of correction and/or payment of the cost of onsite monitoring under section 354(h)(1) of the PHS Act (42 U.S.C. 263b(h)(l)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(m) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH are authorized to impose sanctions under section 354(h)(2) of the PHS Act (42 U.S.C. 263b(h)(2)).
(n) The following officials are authorized to develop and implement the procedures for determining when and how to impose sanctions as provided by section 354(h)(3) of the PHS Act (42 U.S.C. 263b(h)(3)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(o) The following officials are authorized to suspend or revoke individual facility certificates under section 354(i)(1) and (i)(2) of the PHS Act (42 U.S.C. 263b(i)(1) and (i)(2)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(p) The following officials are authorized under section 354(i)(3) of the PHS Act (42 U.S.C. 263b(i)(3)) to ensure that no person who owned or operated a facility at the time the cause of revocation occurred may, within 2 years of the revocation of the certificate, own or operate a mammography facility:
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(q) The following officials are authorized to compile and make available to physicians and the general public information determined to be useful in evaluating the performance of mammography facilities as provided by section 354(l) of the PHS Act (42 U.S.C. 263b(l):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(r) The following officials are authorized to ensure that appropriate Federal agencies are consulted in the development of standards, regulations, evaluations, procedures for compliance and oversight as provided by section 354(o) of the PHS Act (42 U.S.C. 263b(o)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(s) The following officials may authorize a State to carry out certification program requirements and implement quality standards under section 354(q)(1) and (q)(2) of the PHS Act (42 U.S.C. 263b(g)(1) and (g)(2)):
(1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(t) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH are authorized, after providing notice and opportunity for corrective action, to withdraw the approval of a State's authority to carry out certification requirements and implement quality standards under section 354(q)(4) of the PHS Act (42 U.S.C. 263b(g)(4)).
(u) These officials may not further redelegate these authorities.
The central organization of the Food and Drug Administration consists of the following:
The Office of the Chief Counsel's mailing address is 5600 Fishers Lane, rm. 6-57, Rockville, MD 20857.
(a)
(b)
(c)
21 U.S.C. 321-393; 42 U.S.C. 241, 262, 263b-263n, 264.
This part governs the practices and procedures applicable to regulatory enforcement actions initiated by the Food and Drug Administration pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
(a)
(b)
(c)
(d)
(e) [Reserved]
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(1) Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
(2) Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
(3) Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
(n)
In case of the giving of a guaranty or undertaking referred to in section 303(c)(2) or (3) of the act, each person signing such guaranty or undertaking shall be considered to have given it.
(a) A guaranty or undertaking referred to in section 303(c)(2) of the act may be:
(1) Limited to a specific shipment or other delivery of an article, in which case it may be a part of or attached to the invoice or bill of sale covering such shipment or delivery, or
(2) General and continuing, in which case, in its application to any shipment or other delivery of an article, it shall be considered to have been given at the date such article was shipped or delivered by the person who gives the guaranty or undertaking.
(b) The following are suggested forms of guaranty or undertaking under section 303(c)(2) of the act:
(1) Limited form for use on invoice or bill of sale.
(Name of person giving the guaranty or undertaking) hereby guarantees that no article listed herein is adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, or is an article which may not, under the provisions of section 404, 505, or 512 of the act, be introduced into interstate commerce.
(Signature and post-office address of person giving the guaranty or undertaking.)
(2) General and continuing form.
The article comprising each shipment or other delivery hereafter made by (name of person giving the guaranty or undertaking) to, or in the order of (name and post-office address of person to whom the guaranty or undertaking is given) is hereby guaranteed, as of the date of such shipment or delivery, to be, on such date, not adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, and not an article which may not, under the provisions of section 404, 505, or 512 of the act, be introduced into interstate commerce.
(Signature and post-office address of person giving the guaranty of undertaking.)
(c) The application of a guaranty or undertaking referred to in section 303(c)(2) of the act to any shipment or other delivery of an article shall expire when such article, after shipment or delivery by the person who gave such guaranty or undertaking, becomes adulterated or misbranded within the meaning of the act, or becomes an article which may not, under the provisions of section 404, 505, or 512 of the act, be introduced into interstate commerce.
(d) A guaranty or undertaking referred to in section 303(c)(3) of the act shall state that the shipment or other delivery of the color additive covered thereby was manufactured by a signer thereof. It may be a part of or attached to the invoice or bill of sale covering such color. If such shipment or delivery is from a foreign manufacturer, such guaranty or undertaking shall be signed by such manufacturer and by an agent of such manufacturer who resides in the United States.
(e) The following are suggested forms of guaranty or undertaking under section 303(c)(3) of the act:
(1) For domestic manufacturers:
(Name of manufacturer) hereby guarantees that all color additives listed herein were manufactured by him, and (where color additive regulations require certification) are from batches certified in accordance with the applicable regulations promulgated under the Federal Food, Drug, and Cosmetic Act.
(Signature and post-office address of manufacturer.)
(2) For foreign manufacturers:
(Name of manufacturer and agent) hereby severally guarantee that all color additives listed herein were manufactured by (name of manufacturer), and (where color additive regulations require certification) are from batches certified in accordance with the applicable regulations promulgated under the Federal Food, Drug, and Cosmetic Act.
(Signature and post-office address of manufacturer.)
(Signature and post-office address of agent.)
(f) For the purpose of a guaranty or undertaking under section 303(c)(3) of the act the manufacturer of a shipment or other delivery of a color additive is the person who packaged such color.
(g) A guaranty or undertaking, if signed by two or more persons, shall state that such persons severally guarantee the article to which it applies.
(h) No representation or suggestion that an article is guaranteed under the act shall be made in labeling.
(a) Recall is an effective method of removing or correcting consumer products that are in violation of laws administered by the Food and Drug Administration. Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective. This section and §§ 7.41 through 7.59 recognize the voluntary nature of recall by providing guidance so that responsible firms may effectively discharge their recall responsibilities. These sections also recognize that recall is an alternative to a Food and Drug Administration-initiated court action for removing or correcting violative, distributed products by setting forth specific recall procedures for the Food and Drug Administration to monitor recalls and assess the adequacy of a firm's efforts in recall.
(b) Recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the Food and Drug Administration. A request by the Food and Drug Administration that a firm recall a product is reserved for urgent situations and is to be directed to the firm that has primary responsibility for the manufacture and marketing of the product that is to be recalled.
(c) Recall is generally more appropriate and affords better protection for consumers than seizure, when many lots of product have been widely distributed. Seizure, multiple seizure, or other court action is indicated when a firm refuses to undertake a recall requested by the Food and Drug Administration, or where the agency has reason to believe that a recall would not be effective, determines that a recall is ineffective, or discovers that a violation is continuing.
(a) An evaluation of the health hazard presented by a product being recalled or considered for recall will be conducted by an ad hoc committee of Food and Drug Administration scientists and will take into account, but need not be limited to, the following factors:
(1) Whether any disease or injuries have already occurred from the use of the product.
(2) Whether any existing conditions could contribute to a clinical situation that could expose humans or animals to a health hazard. Any conclusion shall be supported as completely as
(3) Assessment of hazard to various segments of the population, e.g., children, surgical patients, pets, livestock, etc., who are expected to be exposed to the product being considered, with particular attention paid to the hazard to those individuals who may be at greatest risk.
(4) Assessment of the degree of seriousness of the health hazard to which the populations at risk would be exposed.
(5) Assessment of the likelihood of occurrence of the hazard.
(6) Assessment of the consequences (immediate or long-range) of occurrence of the hazard.
(b) On the basis of this determination, the Food and Drug Administration will assign the recall a classification, i.e., Class I, Class II, or Class III, to indicate the relative degree of health hazard of the product being recalled or considered for recall.
(a)
(i) Results of health hazard evaluation.
(ii) Ease in identifying the product.
(iii) Degree to which the product's deficiency is obvious to the consumer or user.
(iv) Degree to which the product remains unused in the market-place.
(v) Continued availability of essential products.
(2) The Food and Drug Administration will review the adequacy of a proposed recall strategy developed by a recalling firm and recommend changes as appropriate. A recalling firm should conduct the recall in accordance with an approved recall strategy but need not delay initiation of a recall pending review of its recall strategy.
(b)
(1)
(i) Consumer or user level, which may vary with product, including any intermediate wholesale or retail level; or
(ii) Retail level, including any intermediate wholesale level; or
(iii) Wholesale level.
(2)
(i) General public warning through the general news media, either national or local as appropriate, or
(ii) Public warning through specialized news media, e.g., professional or trade press, or to specific segments of the population such as physicians, hospitals, etc.
(3)
(i) Level A—100 percent of the total number of consignees to be contacted;
(ii) Level B—Some percentage of the total number of consignees to be contacted, which percentage is to be determined on a case-by-case basis, but is greater that 10 percent and less than 100 percent of the total number of consignees;
(iii) Level C—10 percent of the total number of consignees to be contacted;
(iv) Level D—2 percent of the total number of consignees to be contacted; or
(v) Level E—No effectiveness checks.
(a) The Commissioner of Food and Drugs or his designee under § 5.20 of this chapter may request a firm to initiate a recall when the following determinations have been made:
(1) That a product that has been distributed presents a risk of illness or injury or gross consumer deception.
(2) That the firm has not initiated a recall of the product.
(3) That an agency action is necessary to protect the public health and welfare.
(b) The Commissioner or his designee will notify the firm of this determination and of the need to begin immediately a recall of the product. Such notification will be by letter or telegram to a responsible official of the firm, but may be preceded by oral communication or by a visit from an authorized representative of the local Food and Drug Administration district office, with formal, written confirmation from the Commissioner or his designee afterward. The notification will specify the violation, the health hazard classification of the violative product, the recall strategy, and other appropriate instructions for conducting the recall.
(c) Upon receipt of a request to recall, the firm may be asked to provide the Food and Drug Administration any or all of the information listed in § 7.46(a). The firm, upon agreeing to the recall request, may also provide other information relevant to the agency's determination of the need for the recall or how the recall should be conducted.
(a) A firm may decide of its own volition and under any circumstances to remove or correct a distributed product. A firm that does so because it believes the product to be violative is requested to notify immediately the appropriate Food and Drug Administration district office listed in § 5.115 of this chapter. Such removal or correction will be considered a recall only if the Food and Drug Administration regards the product as involving a violation that is subject to legal action, e.g., seizure. In such cases, the firm will be asked to provide the Food and Drug Administration the following information:
(1) Identity of the product involved.
(2) Reason for the removal or correction and the date and circumstances under which the product deficiency or possible deficiency was discovered.
(3) Evaluation of the risk associated with the deficiency or possible deficiency.
(4) Total amount of such products produced and/or the timespan of the production.
(5) Total amount of such products estimated to be in distribution channels.
(6) Distribution information, including the number of direct accounts and, where necessary, the identity of the direct accounts.
(7) A copy of the firm's recall communication if any has issued, or a proposed communication if none has issued.
(8) Proposed strategy for conducting the recall.
(9) Name and telephone number of the firm official who should be contacted concerning the recall.
(b) The Food and Drug Administration will review the information submitted, advise the firm of the assigned recall classification, recommend any appropriate changes in the firm's strategy for the recall, and advise the firm that its recall will be placed in the weekly FDA Enforcement Report. Pending this review, the firm need not delay initiation of its product removal or correction.
(c) A firm may decide to recall a product when informed by the Food and Drug Administration that the agency has determined that the product in question violates the law, but the agency has not specifically requested a recall. The firm's action also is considered a firm-initiated recall and is subject to paragraphs (a) and (b) of this section.
(d) A firm that initiates a removal or correction of its product which the firm believes is a market withdrawal should consult with the appropriate Food and Drug Administration district office when the reason for the removal or correction is not obvious or clearly understood but where it is apparent, e.g., because of complaints or adverse reactions regarding the product, that the product is deficient in some respect. In such cases, the Food and Drug Administration will assist the firm in determining the exact nature of the problem.
(a)
(1) That the product in question is subject to a recall.
(2) That further distribution or use of any remaining product should cease immediately.
(3) Where appropriate, that the direct account should in turn notify its customers who received the product about the recall.
(4) Instructions regarding what to do with the product.
(b)
(c)
(i) Be brief and to the point;
(ii) Identify clearly the product, size, lot number(s), code(s) or serial number(s) and any other pertinent descriptive information to enable accurate and immediate identification of the product;
(iii) Explain concisely the reason for the recall and the hazard involved, if any;
(iv) Provide specific instructions on what should be done with respect to the recalled products; and
(v) Provide a ready means for the recipient of the communication to report to the recalling firm whether it has any of the product, e.g., by sending a postage-paid, self-addressed postcard or by allowing the recipient to place a collect call to the recalling firm.
(2) The recall communication should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message. Where necessary, followup communications should be sent to those who fail to respond to the initial recall communication.
(d)
The Food and Drug Administration will promptly make available to the public in the weekly FDA Enforcement
(a) The recalling firm is requested to submit periodic recall status reports to the appropriate Food and Drug Administration district office so that the agency may assess the progress of the recall. The frequency of such reports will be determined by the relative urgency of the recall and will be specified by the Food and Drug Administration in each recall case; generally the reporting interval will be between 2 and 4 weeks.
(b) Unless otherwise specified or inappropriate in a given recall case, the recall status report should contain the following information:
(1) Number of consignees notified of the recall, and date and method of notification.
(2) Number of consignees responding to the recall communication and quatity of products on hand at the time it was received.
(3) Number of consignees that did not respond (if needed, the identity of nonresponding consignees may be requested by the Food and Drug Administration).
(4) Number of products returned or corrected by each consignee contacted and the quantity of products accounted for.
(5) Number and results of effectiveness checks that were made.
(6) Estimated time frames for completion of the recall.
(c) Recall status reports are to be discontinued when the recall is terminated by the Food and Drug Administration.
(a) A recall will be terminated when the Food and Drug Administration determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product. Written notification that a recall is terminated will be issued by the appropriate Food and Drug Administration district office to the recalling firm.
(b) A recalling firm may request termination of its recall by submitting a written request to the appropriate Food and Drug Adminstration district office stating that the recall is effective in accordance with the criteria set forth in paragraph (a) of this section, and by accompanying the request with the most current recall status report and a description of the disposition of the recalled product.
A recall can be disruptive of a firm's operation and business, but there are several steps a prudent firm can take in advance to minimize this disruptive effect. Notwithstanding similar specific requirements for certain products in other parts of this chapter, the following is provided by the Food and Drug Administration as guidance for a firm's consideration:
(a) Prepare and maintain a current written contingency plan for use in initiating and effecting a recall in accordance with §§ 7.40 through 7.49, 7.53, and 7.55.
(b) Use sufficient coding of regulated products to make possible positive lot identification and to facilitate effective recall of all violative lots.
(c) Maintain such product distribution records as are necessary to facilitate location of products that are being recalled. Such records should be maintained for a period of time that exceeds the shelf life and expected use of the product and is at least the length of time specified in other applicable regulations concerning records retention.
(a)(1) Except as provided in paragraph (a) (2) and (3) of this section, a person against whom criminal prosecution under the Federal Food, Drug, and Cosmetic Act is contemplated by the Commissioner of Food and Drugs shall be given appropriate notice and an opportunity to present information and views to show cause why criminal prosecution should not be recommended to a United States attorney.
(2) Notice and opportunity need not be provided if the Commissioner has reason to believe that they may result in the alteration or destruction of evidence or in the prospective defendant's fleeing to avoid prosecution.
(3) Notice and opportunity need not be provided if the Commissioner contemplates recommending further investigation by the Department of Justice.
(b) If a statute enforced by the Commissioner does not contain a provision for an opportunity to present views, the Commissioner need not, but may in the Commissioner's discretion, provide notice and an opportunity to present views.
(c) If an apparent violation of the Federal Food, Drug, and Cosmetic Act also constitutes a violation of any other Federal statute(s), and the Commissioner contemplates recommending prosecution under such other statute(s) as well, the notice of opportunity to present views will include all violations.
(d) Notice of an opportunity to present views may be by letter, standard form, or other document(s) identifying the products and/or conduct alleged to violate the law. The notice shall—
(1) Be sent by registered or certified mail, telegram, telex, personal delivery, or any other appropriate mode of written communication;
(2) Specify the time and place where those named may present their views;
(3) Summarize the violations that constitute the basis of the contemplated prosecution;
(4) Describe the purpose and procedure of the presentation; and
(5) Furnish a form on which the legal status of any person named in the notice may be designated.
(e) If more than one person is named in a notice, a separate opportunity for presentation of views shall be scheduled on request. Otherwise, the time and place specified in a notice may be changed only upon a showing of reasonable grounds. A request for any change shall be addressed to the Food and Drug Administration office that issued the notice and shall be received in that office at least 3 working days before the date set in the notice.
(f) A person who has received a notice is under no legal obligation to appear or answer in any manner. A person choosing to respond may appear personally, with or without a representative, or may designate a representative to appear for him or her. Alternatively, a person may respond in writing. If a person elects not to respond on or before the time scheduled, the Commissioner will, without further notice, decide whether to recommend criminal prosecution to a United States attorney on the basis of the information available.
(g) If a respondent chooses to appear solely by designated representative, that representative shall present a signed statement of authorization. If a representative appears for more than one respondent, the representative shall submit independent documentation of authority to act for each respondent. If a representative appears without written authorization, the opportunity to present views with respect to that respondent may be provided at that time only if the authenticity of the representative's authority is first
(a) The presentation of views shall be heard by a designated Food and Drug Administration employee. Other Food and Drug Administration employees may be present.
(b) A presentation of views shall not be open to the public. The agency employee designated to receive views will permit participation of other persons only if they appear with the respondent or the respondent's designated representative, and at the request of, and on behalf of, the respondent.
(c) A respondent may present any information of any kind bearing on the Commissioner's determination to recommend prosecution. Information may include statements of persons appearing on the respondent's behalf, letters, documents, laboratory analyses, if applicable, or other relevant information or arguments. The opportunity to present views shall be informal. The rules of evidence shall not apply. Any information given by a respondent, including statements by the respondent, shall become part of the agency's records concerning the matter and may be used for any official purpose. The Food and Drug Administration is under no obligation to present evidence or witnesses.
(d) If the respondent holds a “guaranty or undertaking” as described in section 303(c) of the act (21 U.S.C. 333(c)) that is applicable to the notice, that document, or a verified copy of it, may be presented by the respondent.
(e) A respondent may have an oral presentation recorded and transcribed at his or her expense, in which case a copy of the transcription shall be furnished to the Food and Drug Administration office from which the notice issued. The employee designated to receive views may order a presentation of views recorded and transcribed at agency expense, in which case a copy of such transcription shall be provided to each respondent.
(f) If an oral presentation is not recorded and transcribed, the agency employee designated to receive views shall dictate a written summary of the presentation. A copy of the summary shall be provided to each respondent.
(g) A respondent may comment on the summary or may supplement any response by additional written or documentary evidence. Any comment or addition shall be furnished to the Food and Drug Administration office where the respondent's views were presented. If materials are submitted within 10 calendar days after receipt of the copy of the summary or transcription of the presentation, as applicable, they will be considered before a final decision as to whether or not to recommend prosecution. Any materials received after the supplemental response period generally will be considered only if the final agency decision has not yet been made.
(h)(1) When consideration of a criminal prosecution recommendation involving the same violations is closed by the Commissioner with respect to all persons named in the notice, the Commissioner will so notify each person in writing.
(2) When it is determined that a person named in a notice will not be included in the Commissioner's recommendation for criminal prosecution, the Commissioner will so notify that person, if and when the Commissioner concludes that notification will not prejudice the prosecution of any other person.
(3) When a United States attorney informs the agency that no persons recommended will be prosecuted, the Commissioner will so notify each person in writing, unless the United States attorney has already done so.
(4) When a United States attorney informs the agency of intent to prosecute some, but not all, persons who had been provided an opportunity to present views and were subsequently named in the Commissioner's recommendation for criminal prosecution, the Commissioner, after being advised by the United States attorney that the notification will not prejudice the prosecution of any other person, will so notify those persons eliminated from further consideration, unless the
(a) Records related to a section 305 opportunity for presentation of views constitute investigatory records for law enforcement purposes and may include inter- and intra-agency memorandums.
(1) Notwithstanding the rule established in § 20.21 of this chapter, no record related to a section 305 presentation is available for public disclosure until consideration of criminal prosecution has been closed in accordance with paragraph (b) of this section, except as provided in § 20.82 of this chapter. Only very rarely and only under circumstances that demonstrate a compelling public interest will the Commissioner exercise, in accordance with § 20.82 of this chapter, the authorized discretion to disclose records related to a section 305 presentation before the consideration of criminal prosecution is closed.
(2) After consideration of criminal prosecution is closed, the records are available for public disclosure in response to a request under the Freedom of Information Act, except to the extent that the exemptions from disclosure in subpart D of part 20 of this chapter are applicable. No statements obtained through promises of confidentiality shall be available for public disclosure.
(b) Consideration of criminal prosecution based on a particular section 305 notice of opportunity for presentation of views shall be deemed to be closed within the meaning of this section and § 7.85 when a final decision has been made not to recommend criminal prosecution to a United States attorney based on charges set forth in the notice and considered at the presentation, or when such a recommendation has been finally refused by the United States attorney, or when criminal prosecution has been instituted and the matter and all related appeals have been concluded, or when the statute of limitations has run.
(c) Before disclosure of any record specifically reflecting consideration of a possible recommendation for criminal prosecution of any individual, all names and other information that would identify an individual whose prosecution was considered but not recommended, or who was not prosecuted, shall be deleted, unless the Commissioner concludes that there is a compelling public interest in the disclosure of the names.
(d) Names and other information that would identify a Food and Drug Administration employee shall be deleted from records related to a section 305 presentation of views before public disclosure only under § 20.32 of this chapter.
5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.
(a) Part 10 governs practices and procedures for petitions, hearings, and other administrative proceedings and activities conducted by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and other laws that the Commissioner of Food and Drugs administers under § 5.10.
(b) If a requirement in another part of title 21 differs from a requirement in this part, the requirements of this part apply to the extent that they do not conflict with the other requirements.
(c) References in this part and parts 12, 13, 14, 15, and 16 to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
(d) References in this part and parts 12, 13, 14, 15, and 16 to
(a) The following definitions apply in this part and parts 12, 13, 14, 15, 16, and 19:
(b) A term that is defined in section 201 of the Federal Food, Drug, and Cosmetic Act or part 1 has the same definition in this part.
(c) Words in the singular form include the plural, words in the masculine form include the feminine, and vice versa.
(d) Whenever a reference is made in this part to a person in FDA, e.g., the director of a center, the reference includes all persons to whom that person
To encourage public participation in all agency activities, the Commissioner will prepare for public distribution summaries of FDA administrative practices and procedures in readily understandable terms.
The Commissioner or a presiding officer may, either voluntarily or at the request of a participant, waive, suspend, or modify any provision in parts 12 through 16 applicable to the conduct of a public hearing by announcement at the hearing or by notice in advance of the hearing if no participant will be prejudiced, the ends of justice will thereby be served, and the action is in accordance with law.
(a) A submission to the Dockets Management Branch of a petition, comment, objection, notice, compilation of information, or any other document is to be filed in four copies except as otherwise specifically provided in a relevant
(b) A submission is to be signed by the person making it, or by an attorney or other authorized representative of that person. Submissions by trade associations are also subject to the requirements of § 10.105(b).
(c) Information referred to or relied upon in a submission is to be included in full and may not be incorporated by reference, unless previously submitted in the same proceeding.
(1) A copy of an article or other reference or source cited must be included, except where the reference or source is:
(i) A reported Federal court case;
(ii) A Federal law or regulation;
(iii) An FDA document that is routinely publicly available; or
(iv) A recognized medical or scientific textbook that is readily available to the agency.
(2) If a part of the material submitted is in a foreign language, it must be accompanied by an English translation verified to be complete and accurate, together with the name, address, and a brief statement of the qualifications of the person making the translation. A translation of literature or other material in a foreign language is to be accompanied by copies of the original publication.
(3) Where relevant information is contained in a document also containing irrelevant information, the irrelevant information is to be deleted and only the relevant information is to be submitted.
(4) Under § 20.63 (a) and (b), the names and other information that would identify patients or research subjects are to be deleted from any record before it is submitted to the Dockets Management Branch in order to preclude a clearly unwarranted invasion of personal privacy.
(5) Defamatory, scurrilous, or intemperate matter is to be deleted from a record before it is submitted to the Dockets Management Branch.
(6) The failure to comply with the requirements of this part or with § 12.80 or § 13.20 will result in rejection of the submission for filing or, if it is filed, in exclusion from consideration of any portion that fails to comply. If a submission fails to meet any requirement of this section and the deficiency becomes known to the Dockets Management Branch, the Dockets Management Branch shall not file the submission but return it with a copy of the applicable regulations indicating those provisions not complied with. A deficient submission may be corrected or supplemented and subsequently filed. The office of the Dockets Management
(d) The filing of a submission means only that the Dockets Management Branch has identified no technical deficiencies in the submission. The filing of a petition does not mean or imply that it meets all applicable requirements or that it contains reasonable grounds for the action requested or that the action requested is in accordance with law.
(e) All submissions to the Dockets Management Branch will be considered as submitted on the date they are postmarked or, if delivered in person during regular business hours, on the date they are delivered, unless a provision in this part, an applicable
(f) All submissions are to be mailed or delivered in person to the Dockets Management Branch, Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
(g) FDA ordinarily will not acknowledge or give receipt for documents, except:
(1) Documents delivered in person or by certified or registered mail with a return receipt requested; and
(2) Petitions for which acknowledgment of receipt of filing is provided by regulation or by customary practice, e.g., § 10.30(c) relating to a citizen petition.
(h) Saturdays, Sundays, and Federal legal holidays are included in computing the time allowed for the submission of documents, except that when the time for submission expires on a Saturday, Sunday, or Federal legal holiday, the period will be extended to include the next business day.
(i) All submissions to the Dockets Management Branch are representations that, to the best of the knowledge, information, and belief of the person making the submission, the statements made in the submission are true and accurate. All submissions are subject to the False Reports to the Government Act (18 U.S.C. 1001) under which a willfully false statement is a criminal offense.
(j) The availability for public examination and copying of submissions to the Dockets Management Branch is governed by the following rules:
(1) Except to the extent provided in paragraphs (j)(2) and (3) of this section, the following submissions, including all supporting material, will be on public display and will be available for public examination between 9 a.m. and 4 p.m., Monday through Friday. Requests for copies of submissions will be filed and handled in accordance with subpart C of part 20:
(i) Petitions.
(ii) Comments on petitions, on documents published in the
(iii) Objections and requests for hearings filed under part 12.
(iv) Material submitted at a hearing under § 12.32(a)(2) and parts 12, 13, and 15.
(v) Material placed on public display under the regulations in this chapter, e.g., agency guidance documents developed under § 10.115.
(2)(i) Material prohibited from public disclosure under § 20.63 (clearly unwarranted invasion of personal privacy) and, except as provided in paragraph (j)(3) of this section, material submitted with objections and requests for hearing filed under part 12, or at a hearing under part 12 or part 13, or an alternative form of public hearing before a public advisory committee or a hearing under § 12.32(a) (2) or (3), of the following types will not be on public display, will not be available for public examination, and will not be available for copying or any other form of verbatim transcription unless it is otherwise available for public disclosure under part 20:
(
(
(
(
(
(
(ii) Material submitted under paragraph (j)(2) of this section is to be segregated from all other submitted material and clearly so marked. A person who does not agree that a submission is properly subject to paragraph (j)(2) may request a ruling from the Associate Commissioner for Public Affairs whose decision is final, subject to judicial review under § 20.46.
(3) Material listed in paragraph (j)(2)(i) (
An administrative proceeding may be initiated in the following three ways:
(a) An interested person may petition the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action. A petition must be either: (1) In the form specified in other applicable FDA regulations, e.g., the form for a color additive petition in § 71.1, for a food additive petition in § 171.1, for a new drug application in § 314.50, for a new animal drug application in § 514.1, or (2) in the form for a citizen petition in § 10.30.
(b) The Commissioner may initiate a proceeding to issue, amend, or revoke a regulation or order or take or refrain from taking any other form of administrative action. FDA has primary jurisdiction to make the initial determination on issues within its statutory mandate, and will request a court to dismiss, or to hold in abeyance its determination of or refer to the agency for administrative determination, any issue which has not previously been determined by the agency or which, if it has previously been determined, the agency concluded should be reconsidered and subject to a new administrative determination. The Commissioner may utilize any of the procedures established in this part in reviewing and making a determination on any matter initiated under this paragraph.
(c) The Commissioner will institute a proceeding to determine whether to issue, amend, or revoke a regulation or order, or take or refrain from taking any other form of administrative action whenever any court, on its own initiative, holds in abeyance or refers
(a) This section applies to any petition submitted by a person (including a person who is not a citizen of the United States) except to the extent that other sections of this chapter apply different requirements to a particular matter.
(b) A petition (including any attachments) must be submitted in accordance with § 10.20 and in the following form:
Dockets Management Branch, Food and Drug Administration, Department of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
The undersigned submits this petition under ___ (relevant statutory sections, if known) of the ___ (Federal Food, Drug, and Cosmetic Act or the Public Health Service Act or any other statutory provision for which authority has been delegated to the Commissioner of Food and Drugs under 21 CFR 5.10) to request the Commissioner of Food and Drugs to ___ (issue, amend, or revoke a regulation or order or take or refrain from taking any other form of administrative action).
((1) If the petition requests the Commissioner to issue, amend, or revoke a regulation, the exact wording of the existing regulation (if any) and the proposed regulation or amendment requested.)
((2) If the petition requests the Commissioner to issue, amend, or revoke an order, a copy of the exact wording of the citation to the existing order (if any) and the exact wording requested for the proposed order.)
((3) If the petition requests the Commissioner to take or refrain from taking any other form of administrative action, the specific action or relief requested.)
(A full statement, in a well organized format, of the factual and legal grounds on which the petitioner relies, including all relevant information and views on which the petitioner relies, as well as representative information known to the petitioner which is unfavorable to the petitioner's position.)
(A) Claim for categorical exclusion under §§ 25.30, 25.31, 25.32, 25.33, or § 25.34 of this chapter or an environmental assessment under § 25.40 of this chapter.)
(The following information is to be submitted only when requested by the Commissioner following review of the petition: A statement of the effect of requested action on: (1) Cost (and price) increases to industry, government, and consumers; (2) productivity of wage earners, businesses, or government; (3) competition; (4) supplies of important materials, products, or services; (5) employment; and (6) energy supply or demand.)
The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.
(c) A petition which appears to meet the requirements of paragraph (b) of this section and § 10.20 will be filed by the Dockets Management Branch, stamped with the date of filing, and assigned a docket number. The docket number identifies the file established by the Dockets Management Branch for all submissions relating to the petition, as provided in this part. Subsequent submissions relating to the matter must refer to the docket number and will be filed in the docket file. Related petitions may be filed together and given the same docket number. The Dockets Management Branch will promptly notify the petitioner in writing of the filing and docket number of a petition.
(d) An interested person may submit written comments to the Dockets Management Branch on a filed petition, which comments become part of the docket file. The comments are to specify the docket number of the petition and may support or oppose the petition
(e)(1) The Commissioner shall, in accordance with paragraph (e)(2), rule upon each petition filed under paragraph (c) of this section, taking into consideration (i) available agency resources for the category of subject matter, (ii) the priority assigned to the petition considering both the category of subject matter involved and the overall work of the agency, and (iii) time requirements established by statute.
(2) Except as provided in paragraph (e)(4) of this section, the Commissioner shall furnish a response to each petitioner within 180 days of receipt of the petition. The response will either:
(i) Approve the petition, in which case the Commissioner shall concurrently take appropriate action (e.g., publication of a
(ii) Deny the petition; or
(iii) Provide a tentative response, indicating why the agency has been unable to reach a decision on the petition, e.g., because of the existence of other agency priorities, or a need for additional information. The tentative response may also indicate the likely ultimate agency response, and may specify when a final response may be furnished.
(3) The Commissioner may grant or deny such a petition, in whole or in part, and may grant such other relief or take other action as the petition warrants. The petitioner is to be notified in writing of the Commissioner's decision. The decision will be placed in the public docket file in the office of the Dockets Management Branch and may also be in the form of a notice published in the
(4) The Commissioner shall furnish a response to each petitioner within 90 days of receipt of a petition filed under section 505(j)(2)(C) of the act. The response will either approve or disapprove the petition. Agency action on a petition shall be governed by § 314.93 of this chapter.
(f) If a petition filed under paragraph (c) of this section requests the Commissioner to issue, amend, or revoke a regulation, § 10.40 or § 10.50 also apply.
(g) A petitioner may supplement, amend, or withdraw a petition in writing without agency approval and without prejudice to resubmission at anytime until the Commissioner rules on the petition, unless the petition has been referred for a hearing under parts 12, 13, 14, or 15. After a ruling or referral, a petition may be supplemented, amended, or withdrawn only with the approval of the Commissioner. The Commissioner may approve withdrawal, with or without prejudice against resubmission of the petition.
(h) In reviewing a petition the Commissioner may use the following procedures:
(1) Conferences, meetings, discussions, and correspondence under § 10.65.
(2) A hearing under parts 12, 13, 14, 15, or 16.
(3) A
(4) A proposal to issue, amend, or revoke a regulation, in accordance with § 10.40 or § 12.20.
(5) Any other specific public procedure established in this chapter and expressly applicable to the matter.
(i) The record of the administrative proceeding consists of the following:
(1) The petition, including all information on which it relies, filed by the Dockets Management Branch.
(2) All comments received on the petition, including all information submitted as a part of the comments.
(3) If the petition resulted in a proposal to issue, amend, or revoke a regulation, all of the documents specified in § 10.40(g).
(4) The record, consisting of any transcripts, minutes of meetings, reports,
(5) The Commissioner's decision on the petition, including all information identified or filed by the Commissioner with the Dockets Management Branch as part of the record supporting the decision.
(6) All documents filed with the Dockets Management Branch under § 10.65(h).
(7) If a petition for reconsideration or for a stay of action is filed under paragraph (j) of this section, the administrative record specified in § 10.33(k) or § 10.35(h).
(j) The administrative record specified in paragraph (i) of this section is the exclusive record for the Commissioner's decision. The record of the administrative proceeding closes on the date of the Commissioner's decision unless some other date is specified. Thereafter any interested person may submit a petition for reconsideration under § 10.33 or a petition for stay of action under § 10.35. A person who wishes to rely upon information or views not included in the administrative record shall submit them to the Commissioner with a new petition to modify the decision in accordance with this section.
(k) This section does not apply to the referral of a matter to a United States attorney for the initiation of court enforcement action and related correspondence, or to requests, suggestions, and recommendations made informally in routine correspondence received by FDA. Routine correspondence does not constitute a petition within the meaning of this section unless it purports to meet the requirements of this section. Action on routine correspondence does not constitute final administrative action subject to judicial review under § 10.45.
(l) The Dockets Management Branch will maintain a chronological list of each petition filed under this section and § 10.85, but not of petitions submitted elsewhere in the agency under § 10.25(a)(1), showing:
(1) The docket number;
(2) The date the petition was filed by the Dockets Management Branch;
(3) The name of the petitioner;
(4) The subject matter involved; and
(5) The disposition of the petition.
(a) The Commissioner may at any time reconsider a matter, on the Commissioner's own initiative or on the petition of an interested person.
(b) An interested person may request reconsideration of part or all of a decision of the Commissioner on a petition submitted under § 10.25. Each request for reconsideration must be submitted in accordance with § 10.20 and in the following form no later than 30 days after the date of the decision involved. The Commissioner may, for good cause, permit a petition to be filed after 30 days. In the case of a decision published in the
Dockets Management Branch, Food and Drug Administration, Department of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
The undersigned submits this petition for reconsideration of the decision of the Commissioner of Food and Drugs in Docket No. __.
(A concise statement of the decision of the Commissioner which the petitioner wishes to have reconsidered.)
(The decision which the petitioner requests the Commissioner to make upon reconsideration of the matter.)
(A full statement, in a well-organized format, of the factual and legal grounds upon which the petitioner relies. The grounds must demonstrate that relevant information and views contained in the administrative record were not previously or not adequately considered by the Commissioner.
(No new information or views may be included in a petition for reconsideration.)
(c) A petition for reconsideration relating to a petition submitted under
(d) The Commissioner shall promptly review a petition for reconsideration. The Commissioner may grant the petition when the Commissioner determines it is in the public interest and in the interest of justice. The Commissioner shall grant a petition for reconsideration in any proceeding if the Commissioner determines all of the following apply:
(1) The petition demonstrates that relevant information or views contained in the administrative record were not previously or not adequately considered.
(2) The petitioner's position is not frivolous and is being pursued in good faith.
(3) The petitioner has demonstrated sound public policy grounds supporting reconsideration.
(4) Reconsideration is not outweighed by public health or other public interests.
(e) A petition for reconsideration may not be based on information and views not contained in the administrative record on which the decision was made. An interested person who wishes to rely on information or views not included in the administrative record shall submit them with a new petition to modify the decision under § 10.25(a).
(f) The decision on a petition for reconsideration is to be in writing and placed on public display as part of the docket file on the matter in the office of the Dockets Management Branch. A determination to grant reconsideration will be published in the
(g) The Commissioner may consider a petition for reconsideration only before the petitioner brings legal action in the courts to review the action, except that a petition may also be considered if the Commissioner has denied a petition for stay of action and the petitioner has petitioned for judicial review of the Commissioner's action and requested the reviewing court to grant a stay pending consideration of review. A petition for reconsideration submitted later than 30 days after the date of the decision involved will be denied as untimely unless the Commissioner permits the petition to be filed after 30 days. A petition for reconsideration will be considered as submitted on the day it is received by the Dockets Management Branch.
(h) The Commissioner may initiate the reconsideration of all or part of a matter at any time after it has been decided or action has been taken. If review of the matter is pending in the courts, the Commissioner may request that the court refer the matter back to the agency or hold its review in abeyance pending administrative reconsideration. The administrative record of the proceeding is to include all additional documents relating to such reconsideration.
(i) After determining to reconsider a matter, the Commissioner shall review and rule on the merits of the matter under § 10.30(e). The Commissioner may reaffirm, modify, or overrule the prior decision, in whole or in part, and may grant such other relief or take such other action as is warranted.
(j) The Commissioner's reconsideration of a matter relating to a petition submitted under § 10.25(a)(2) is subject to § 10.30 (f) through (h), (j), and (k).
(k) The record of the administrative proceeding consists of the following:
(1) The record of the original petition specified in § 10.30(i).
(2) The petition for reconsideration, including all information on which it relies, filed by the Dockets Management Branch.
(3) All comments received on the petition, including all information submitted as a part of the comments.
(4) The Commissioner's decision on the petition under paragraph (f) of this section, including all information identified or filed by the Commissioner with the Dockets Management Branch as part of the record supporting the decision.
(5) Any
(6) All documents filed with the Dockets Management Branch under § 10.65(h).
(7) If the Commissioner reconsiders the matter, the administrative record relating to reconsideration specified in § 10.30(i).
(a) The Commissioner may at any time stay or extend the effective date of an action pending or following a decision on any matter.
(b) An interested person may request the Commissioner to stay the effective date of any administrative action. A stay may be requested for a specific time period or for an indefinite time period. A request for stay must be submitted in accordance with § 10.20 and in the following form no later than 30 days after the date of the decision involved. The Commissioner may, for good cause, permit a petition to be filed after 30 days. In the case of a decision published in the
Dockets Management Branch, Food and Drug Administration, Department of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
The undersigned submits this petition requesting that the Commissioner of Food and Drugs stay the effective date of the following matter.
(The specific administrative action being taken by the Commissioner for which a stay is requested, including the docket number or other citation to the action involved.)
(The length of time for which the stay is requested, which may be for a specific or indefinite time period.)
(A full statement, in a well-organized format, of the factual and legal grounds upon which the petitioner relies for the stay.)
(c) A petition for stay of action relating to a petition submitted under § 10.25(a)(2) is subject to the requirements of § 10.30 (c) and (d), except that it will be filed in the same docket file as the petition to which it relates.
(d) Neither the filing of a petition for a stay of action nor action taken by an interested person in accordance with any other administrative procedure in this part or in any other section of this chapter, e.g., the filing of a citizen petition under § 10.30 or a petition for reconsideration under § 10.33 or a request for an advisory opinion under § 10.85, will stay or otherwise delay any administrative action by the Commissioner, including enforcement action of any kind, unless one of the following applies:
(1) The Commissioner determines that a stay or delay is in the public interest and stays the action.
(2) A statute requires that the matter be stayed.
(3) A court orders that the matter be stayed.
(e) The Commissioner shall promptly review a petition for stay of action. The Commissioner may grant or deny a petition, in whole or in part; and may grant such other relief or take such other action as is warranted by the petition. The Commissioner may grant a stay in any proceeding if it is in the public interest and in the interest of justice. The Commissioner shall grant a stay in any proceeding if all of the following apply:
(1) The petitioner will otherwise suffer irreparable injury.
(2) The petitioner's case is not frivolous and is being pursued in good faith.
(3) The petitioner has demonstrated sound public policy grounds supporting the stay.
(4) The delay resulting from the stay is not outweighted by public health or other public interests.
(f) The Commissioner's decision on a petition for stay of action is to be in writing and placed on public display as part of the file on the matter in the office of the Dockets Management Branch. A determination to grant a stay will be published in the
(g) A petition for a stay of action submitted later than 30 days after the date of the decision involved will be denied as untimely unless the Commissioner permits the petition to be filed after 30 days. A petition for a stay of action is considered submitted on the day it is received by the Dockets Management Branch.
(h) The record of the administrative proceeding consists of the following:
(1) The record of the proceeding to which the petition for stay of action is directed.
(2) The petition for stay of action, including all information on which it relies, filed by the Dockets Management Branch.
(3) All comments received on the petition, including all information submitted as a part of the comments.
(4) The Commissioner's decision on the petition under paragraph (e) of this section, including all information identified or filed by the Commissioner with the Dockets Management Branch as part of the record supporting the decision.
(5) Any
(6) All documents filed with the Dockets Management Branch under § 10.65(h).
(a) The Commissioner may propose and promulgate regulations for the efficient enforcement of the laws administered by FDA whenever it is necessary or appropriate to do so. The issuance, amendment, or revocation of a regulation may be initiated in any of the ways specified in § 10.25.
(1) This section applies to any regulation: (i) Not subject to § 10.50 and part 12, or (ii) if it is subject to § 10.50 and part 12, to the extent that those provisions make this section applicable.
(2) A regulation proposed by an interested person in a petition submitted under § 10.25(a) will be published in the
(i) The petition contains facts demonstrating reasonable grounds for the proposal; and
(ii) The petition substantially shows that the proposal is in the public interest and will promote the objectives of the act and the agency.
(3) Two or more alternative proposed regulations may be published on the same subject to obtain comment on the different alternatives.
(4) A regulation proposed by an interested person in a petition submitted under § 10.25(a) may be published together with the Commissioner's preliminary views on the proposal and any alternative proposal.
(b) Except as provided in paragraph (e) of this section, each regulation must be the subject of a notice of proposed rulemaking published in the
(i) The name of the agency;
(ii) The nature of the action, e.g., proposed rule, or notice;
(iii) A summary in the first paragraph describing the substance of the document in easily understandable terms;
(iv) Relevant dates, e.g., comment closing date, and proposed effective date(s);
(v) The name, business address, and phone number of an agency contact person who can provide further information to the public about the notice;
(vi) An address for submitting written comments;
(vii) Supplementary information about the notice in the form of a preamble that summarizes the proposal and the facts and policy underlying it, includes references to all information on which the Commissioner relies for the proposal (copies or a full list of which are a part of the docket file on the matter in the office of the Dockets Management Branch), and cites the authority under which the regulation is proposed;
(viii) Either the terms or substance of the proposed regulation or a description of the subjects and issues involved;
(ix) A reference to the existence or lack of need for an environmental impact statement under § 25.52 of this chapter; and
(x) The docket number of the matter, which identifies the docket file established by the Dockets Management Branch for all relevant submissions.
(2) The proposal will provide 60 days for comment, although the Commissioner may shorten or lengthen this time period for good cause. In no event is the time for comment to be less than 10 days.
(3) After publication of the proposed rule, any interested person may request the Commissioner to extend the comment period for an additional specified period by submitting a written request to the Dockets Management Branch stating the grounds for the request. The request is submitted under § 10.35 but should be headed “REQUEST FOR EXTENSION OF COMMENT PERIOD.”
(i) A request must discuss the reason comments could not feasibly be submitted within the time permitted, or that important new information will shortly be available, or that sound public policy otherwise supports an extension of the time for comment. The Commissioner may grant or deny the request or may grant an extension for a time period different from that requested. An extension may be limited to specific persons who have made and justified the request, but will ordinarily apply to all interested persons.
(ii) A comment time extension of 30 days or longer will be published in the
(4) A notice of proposed rulemaking will request that four copies of all comments be submitted to the Dockets Management Branch, except that individuals may submit single copies. Comments will be stamped with the date of receipt and will be numbered chronologically.
(5) Persons submitting comments critical of a proposed regulation are encouraged to include their preferred alternative wording.
(c) After the time for comment on a proposed regulation has expired, the Commissioner will review the entire administrative record on the matter, including all comments and, in a notice published in the
(1) The quality and persuasiveness of the comments will be the basis for the Commissioner's decision. The number or length of comments will not ordinarily be a significant factor in the decision unless the number of comments is material where the degree of public interest is a legitimate factor for consideration.
(2) The decision of the Commissioner on the matter will be based solely upon the administrative record.
(3) A final regulation published in the
(4) The effective date of a final regulation may not be less than 30 days after the date of publication in the
(i) A regulation that grants an exemption or relieves a restriction; or
(ii) A regulation for which the Commissioner finds, and states in the notice good cause for an earlier effective date.
(d) The provisions for notice and comment in paragraphs (b) and (c) of this section apply only to the extent required by the Administrative Procedure Act (5 U.S.C. 551, 552, and 553). As a matter of discretion, however, the Commissioner may voluntarily follow those provisions in circumstances in which they are not required by the Administrative Procedure Act.
(e) The requirements of notice and public procedure in paragraph (b) of this section do not apply in the following situations:
(1) When the Commissioner determines for good cause that they are impracticable, unnecessary, or contrary to the public interest. In these cases, the notice promulgating the regulation will state the reasons for the determination, and provide an opportunity for comment to determine whether the regulation should subsequently be modified or revoked. A subsequent notice based on those comments may, but need not, provide additional opportunity for public comment.
(2) Food additive and color additive petitions, which are subject to the provisions of § 12.20(b)(2).
(3) New animal drug regulations, which are promulgated under section 512(i) of the act.
(f) In addition to the notice and public procedure required under paragraph (b) of this section, the Commissioner may also subject a proposed or final regulation, before or after publication in the
(1) Conferences, meetings, discussions, and correspondence under § 10.65.
(2) A hearing under parts 12, 13, 14, or 15.
(3) A notice published in the
(4) A draft of a proposed regulation placed on public display in the office of the Dockets Management Branch. If this procedure is used, the Commissioner shall publish an appropriate notice in the
(5) A revised proposal published in the
(6) A tentative final regulation or tentative revised final regulation placed on public display in the office of the Dockets Management Branch and, if deemed desirable by the Commissioner, published in the
(7) A final regulation published in the
(8) Any other public procedure established in this chapter and expressly applicable to the matter.
(g) The record of the administrative proceeding consists of all of the following:
(1) If the regulation was initiated by a petition, the administrative record specified in § 10.30(i).
(2) If a petition for reconsideration or for a stay of action is filed, the administrative record specified in §§ 10.33(k) and 10.35(h).
(3) The proposed rule published in the
(4) All comments received on the proposal, including all information submitted as a part of the comments.
(5) The notice promulgating the final regulation, including all information identified or filed by the Commissioner with the Dockets Management Branch
(6) The transcripts, minutes of meetings, reports,
(7) All documents submitted to the Dockets Management Branch under § 10.65(h).
(h) The record of the administrative proceeding closes on the date of publication of the final regulation in the
(i) The Dockets Management Branch shall maintain a chronological list of all regulations proposed and promulgated under this section and § 10.50 (which list will not include regulations resulting from petitions filed and assigned a docket number under § 10.30) showing—
(1) The docket number (for a petition submitted directly to a center, the list also includes the number or other designation assigned by the center, e.g., the number assigned to a food additive petition);
(2) The name of the petitioner, if any;
(3) The subject matter involved; and
(4) The disposition of the petition.
(a) This section applies to court review of final administrative action taken by the Commissioner, including action taken under §§ 10.25 through 10.40 and § 16.1(b), except action subject to § 10.50 and part 12.
(b) A request that the Commissioner take or refrain from taking any form of administrative action must first be the subject of a final administrative decision based on a petition submitted under § 10.25(a) or, where applicable, a hearing under § 16.1(b) before any legal action is filed in a court complaining of the action or failure to act. If a court action is filed complaining of the action or failure to act before the submission of the decision on a petition under § 10.25(a) or, where applicable, a hearing under § 16.1(b), the Commissioner shall request dismissal of the court action or referral to the agency for an initial administrative determination on the grounds of a failure to exhaust administrative remedies, the lack of final agency action as required by 5 U.S.C. 701
(c) A request that administrative action be stayed must first be the subject of an administrative decision based upon a petition for stay of action submitted under § 10.35 before a request is made that a court stay the action. If a court action is filed requesting a stay of administrative action before the Commissioner's decision on a petition submitted in a timely manner pursuant to § 10.35, the Commissioner shall request dismissal of the court action or referral to the agency for an initial determination on the grounds of a failure to exhaust administrative remedies, the lack of final agency action as required by 5 U.S.C. 701
(d) The Commissioner's final decision constitutes final agency action (reviewable in the courts under 5 U.S.C. 701
(1) It is the position of FDA except as otherwise provided in paragraph (d)(2) of this section, that:
(i) Final agency action exhausts all administrative remedies and is ripe for preenforcement judicial review as of the date of the final decision, unless applicable law explicitly requires that the petitioner take further action before judicial review is available;
(ii) An interested person is affected by, and thus has standing to obtain judicial review of final agency action; and
(iii) It is not appropriate to move to dismiss a suit for preenforcement judicial review of final agency action on the ground that indispenable parties are not joined or that it is an unconsented suit against the United States if the defect could be cured by amending the complaint.
(2) The Commissioner shall object to judicial review of a matter if:
(i) The matter is committed by law to the discretion of the Commissioner, e.g., a decision to recommend or not to recommend civil or criminal enforcement action under sections 302, 303, and 304 of the act; or
(ii) Review is not sought in a proper court.
(e) An interested person may request judicial review of a final decision of the Commissioner in the courts without first petitioning the Commissioner for reconsideration or for a stay of action, except that in accordance with paragraph (c) of this section, the person shall request a stay by the Commissioner under § 10.35 before requesting a stay by the court.
(f) The Commissioner shall take the position in an action for judicial review under 5 U.S.C. 701
(g) The Commissioner requests that all petitions for judicial review of a particular matter be filed in a single U.S. District court. If petitions are filed in more than one jurisdiction, the Commissioner will take appropriate action to prevent a multiplicity of suits in various jurisdictions, such as:
(1) A request for transfer of one or more suits to consolidate separate actions, under 28 U.S.C. 1404(a) or 28 U.S.C. 2112(a);
(2) A request that actions in all but one jurisdiction be stayed pending the conclusion of one proceeding;
(3) A request that all but one action be dismissed pending the conclusion of one proceeding, with the suggestion that the other plaintiffs intervene in that one suit; or
(4) A request that one of the suits be maintained as a class action in behalf of all affected persons.
(h)(1) For the purpose of 28 U.S.C. 2112(a), a copy of any petition filed in any U.S. Court of Appeals challenging a final action of the Commissioner shall be sent by certified mail, return receipt requested, or by personal delivery to the Chief Counsel of FDA. The petition copy shall be time-stamped by the clerk of the court when the original is filed with the court. The petition copy should be addressed to: Office of the Chief Counsel (GCF-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. The Chief Counsel requests that the purpose of all petitions mailed or delivered to the Office of Chief Counsel to satisfy 28
(2) If the Chief Counsel receives two or more petitions filed in two or more U.S. Courts of Appeals for review of any agency action within 10 days of the effective date of that action for the purpose of judicial review, the Chief Counsel will notify the U.S. Judicial Panel on Multidistrict Litigation of any petitions that were received within the 10-day period, in accordance with the applicable rule of the panel.
(3) For the purpose of determining whether a petition for review has been received within the 10-day period under paragraph (h)(2) of this section, the petition shall be considered to be received on the date of delivery, if personally delivered. If the delivery is accomplished by mail, the date of receipt shall be the date noted on the return receipt card.
(i) Upon judicial review of administrative action under this section:
(1) If a court determines that the administrative record is inadequate to support the action, the Commissioner shall determine whether to proceed with such action. (i) If the Commissioner decides to proceed with the action, the court will be requested to remand the matter to the agency to reopen the administrative proceeding and record, or on the Commissioner's own initiative the administrative proceeding and record may be reopened upon receipt of the court determination. A reopened administrative proceeding will be conducted under the provisions of this part and in accordance with any directions of the court.
(ii) If the Commissioner concludes that the public interest requires that the action remain in effect pending further administrative proceedings, the court will be requested not to stay the matter in the interim and the Commissioner shall expedite the further administrative proceedings.
(2) If a court determines that the administrative record is adequate, but the rationale for the action must be further explained:
(i) The Commissioner shall request either that further explanation be provided in writing directly to the court without further administrative proceedings, or that the administrative proceeding be reopened in accordance with paragraph (i)(1)(i) of this section; and
(ii) If the Commissioner concludes that the public interest requires that the action remain in effect pending further court or administrative proceedings, the court will be requested not to stay the matter in the interim and the Commissioner shall expedite the further proceedings.
(a) The Commissioner shall promulgate regulations and orders after an opportunity for a formal evidentiary public hearing under part 12 whenever all of the following apply:
(1) The subject matter of the regulation or order is subject by statute to an opportunity for a formal evidentiary public hearing.
(2) The person requesting the hearing has a right to an opportunity for a hearing and submits adequate justification for the hearing as required by §§ 12.20 through 12.22 and other applicable provisions in this chapter, e.g., §§ 314.200, 514.200, and 601.7(a).
(b) The Commissioner may order a formal evidentiary public hearing on any matter whenever it would be in the public interest to do so.
(c) The provisions of the act, and other laws, that afford a person who would be adversely affected by administrative action an opportunity for a formal evidentiary public hearing as listed below. The list imparts no right to a hearing where the statutory section provides no opportunity for a hearing.
(1) Section 401 on any action for the amendment or repeal of any definition and standard of identity for any dairy product (including products regulated under parts 131, 133, and 135 of this chapter) or maple sirup (regulated under § 168.140 of this chapter).
(2) Section 403(j) on regulations for labeling of foods for special dietary uses.
(3) Section 404(a) on regulations for emergency permit control.
(4) Section 406 on tolerances for poisonous substances in food.
(5) Section 409 (c), (d), and (h) on food additive regulations.
(6) Section 501(b) on tests or methods of assay for drugs described in official compendia.
(7) [Reserved]
(8) Section 502(h) on regulations designating requirements for drugs liable to deterioration.
(9) Section 502(n) on prescription drug advertising regulations.
(10) [Reserved]
(11) Section 507(f) on regulations for antibiotic drug certification.
(12) Section 512(n)(5) on regulations for animal antibiotic drugs and certification requirements.
(13) Section 721 (b) and (c) on regulations for color additive listing and certification.
(14) Section 4(a) of the Fair Packaging and Labeling Act on food, drug, device, and cosmetic labeling.
(15) Section 5(c) of the Fair Packaging and Labeling Act on additional economic regulations for food, drugs, devices, and cosmetics.
(16) Section 505 (d) and (e) on new drug applications.
(17) Section 512 (d), (e) and (m) (3) and (4) on new animal drug applications.
(18) Section 515(g) on device premarket approval applications and product development protocols.
(19) Section 351(a) of the Public Health Service Act on a biologics license for a biological product.
(20) Section 306 on debarment, debarment period and considerations, termination of debarment under section 306(d)(3), suspension, and termination of suspension.
(a) This section applies to any matter subject by statute to an opportunity for a formal evidentiary public hearing, as listed in § 10.50(c), and any matter subject to a hearing before a Public Board of Inquiry under part 13.
(b) In the case of a matter listed in § 10.50(c) (1) through (10) and (12) through (15):
(1) An interested person may meet or correspond with any FDA representative concerning a matter prior to publication of a notice announcing a formal evidentiary public hearing or a hearing before a Public Board of Inquiry on the matter; the provisions of § 10.65 apply to the meetings and correspondence; and
(2) Upon publication of a notice announcing a formal evidentiary public hearing or a hearing before a Public Board of Inquiry, the following separation of functions apply:
(i) The center responsible for the matter is, as a party to the hearing, responsible for all investigative functions and for presentation of the position of the center at the hearing and in any pleading or oral argument before the Commissioner. Representatives of the center may not participate or advise in any decision except as witness or counsel in public proceedings. There is to be no other communication between representatives of the center and representatives of the office of the Commissioner concerning the matter before the decision of the Commissioner. The Commissioner may, however, designate representatives of a center to advise the office of the Commissioner, or designate members of that office to advise a center. The designation will be in writing and filed with the Dockets Management Branch no later than the time specified in paragraph (b)(2) of this section for the application of separation of functions. All members of FDA other than representatives of the involved center (except those specifically designated otherwise) shall be available to advise and participate with the office of the Commissioner in its functions relating to the hearing and the final decision.
(ii) The Chief Counsel for FDA shall designate members of the office of General Counsel to advise and participate with the center in its functions in the hearing and members who are to advise the office of the Commissioner in its functions related to the hearing and the final decision. The members of the
(iii) The office of the Commissioner is responsible for the agency review and final decision of the matter, with the advice and participation of anyone in FDA other than representatives of the involved center and those members of the office of General Counsel designated to assist in the center's functions in the hearing.
(c) In a matter listed in § 10.50(c) (11) and (16) through (19), the provisions relating to separation of functions set forth in §§ 314.200(f), 514.200, and 601.7(a) are applicable before publication of a notice announcing a formal evidentiary public hearing or a hearing before a Public Board of Inquiry. Following publication of the notice of hearing, the rules in paragraph (b)(2) of this section apply.
(d) Except as provided in paragraph (e) of this section, between the date that separation of functions applies under paragraph (b) or (c) of this section and the date of the Commissioner's decision on the matter, communication concerning the matter involved in the hearing will be restricted as follows:
(1) No person outside the agency may have an ex parte communication with the presiding officer or any person representing the office of the Commissioner concerning the matter in the hearing. Neither the presiding officer nor any person representing the office of the Commissioner may have any ex parte communication with a person outside the agency concerning the matter in the hearing. All communications are to be public communications, as witness or counsel, under the applicable provisions of this part.
(2) A participant in the hearing may submit a written communication to the office of the Commissioner with respect to a proposal for settlement. These communications are to be in the form of pleadings, served on all other participants, and filed with the Dockets Management Branch like any other pleading.
(3) A written communication contrary to this section must be immediately served on all other participants and filed with the Dockets Management Branch by the presiding officer at the hearing, or by the Commissioner, depending on who received the communication. An oral communication contrary to this section must be immediately recorded in a written memorandum and similarly served on all other participants and filed with the Dockets Management Branch. A person, including a representative of a participant in the hearing, who is involved in an oral communication contrary to this section, must, if possible, be made available for cross-examination during the hearing with respect to the substance of that conversation. Rebuttal testimony pertinent to a written or oral communication contrary to this section will be permitted. Cross-examination and rebuttal testimony will be transcribed and filed with the Dockets Management Branch.
(e) The prohibitions specified in paragraph (d) of this section apply to a person who knows of a notice of hearing in advance of its publication from the time the knowledge is acquired.
(f) The making of a communication contrary to this section may, consistent with the interests of justice and the policy of the underlying statute, result in a decision adverse to the person knowingly making or causing the making of such a communication.
(a) This section applies when a Federal, State, or local court holds in abeyance, or refers to the Commissioner, any matter for an initial administrative determination under § 10.25(c) or § 10.45(b).
(b) The Commissioner shall promptly agree or decline to accept a court referral. Whenever feasible in light of agency priorities and resources, the Commissioner shall agree to accept a referral and shall proceed to determine the matter referred.
(c) In reviewing the matter, the Commissioner may use the following procedures:
(1) Conferences, meetings, discussions, and correspondence under § 10.65.
(2) A hearing under parts 12, 13, 14, 15, or 16.
(3) A notice published in the
(4) Any other public procedure established in other sections of this chapter and expressly applicable to the matter under those provisions.
(d) If the Commissioner's review of the matter results in a proposed rule, the provisions of § 10.40 or § 10.50 also apply.
(a) In addition to public hearings and proceedings established under this part and other sections of this chapter, meetings may be held and correspondence may be exchanged between representatives of FDA and an interested person outside FDA on a matter within the jurisdiction of the laws administered by the Commissioner. Action on meetings and correspondence does not constitute final administrative action subject to judicial review under § 10.45.
(b) The Commissioner may conclude that it would be in the public interest to hold an open public meeting to discuss a matter (or class of matters) pending before FDA, in which any interested person may participate.
(1) The Commissioner shall inform the public of the time and place of the meeting and of the matters to be discussed.
(2) The meeting will be informal, i.e., any interested person may attend and participate in the discussion without prior notice to the agency unless the notice of the meeting specifies otherwise.
(c) Every person outside the Federal Government may request a private meeting with a representative of FDA in agency offices to discuss a matter. FDA will make reasonable efforts to accommodate such requests.
(1) The person requesting a meeting may be accompanied by a reasonable number of employees, consultants, or other persons with whom there is a commercial arrangement within the meaning of § 20.81(a) of this chapter. Neither FDA nor any other person may require the attendance of a person who is not an employee of the executive branch of the Federal Government without the agreement of the person requesting the meeting. Any person may attend by mutual consent of the person requesting the meeting and FDA.
(2) FDA will determine which representatives of the agency will attend the meeting. The person requesting the meeting may request, but not require or preclude, the attendance of a specific FDA employee.
(3) A person who wishes to attend a private meeting, but who is not invited to attend either by the person requesting the meeting or by FDA, or who otherwise cannot attend the meeting, may request a separate meeting with FDA to discuss the same matter or an additional matter.
(d) FDA employees have a responsibility to meet with all segments of the public to promote the objectives of the laws administered by the agency. In pursuing this responsibility, the following general policy applies where agency employees are invited by persons outside the Federal Government to attend or participate in meetings outside agency offices as representatives of the agency.
(1) A person outside the executive branch may invite an agency representative to attend or participate in a meeting outside agency offices. The agency representative is not obligated to attend or participate, but may do so where it is in the public interest and will promote the objectives of the act.
(2) The agency representative may request that the meeting be open if
(3) An agency representative may not knowingly participate in a meeting that is closed on the basis of gender, race, or religion.
(e) An official transcript, recording, or memorandum summarizing the substance of any meeting described in this section will be prepared by a representative of FDA when the agency determines that such documentation will be useful.
(f) FDA promptly will file in the appropriate administrative file memoranda of meetings prepared by FDA representatives and all correspondence, including any written summary of a meeting from a participant, that relate to a matter pending before the agency.
(g) Representatives of FDA may initiate a meeting or correspondence on any matter concerning the laws administered by the Commissioner. Unless otherwise required by law, meetings may be public or private at FDA's discretion.
(h) A meeting of an advisory committee is subject to the requirements of part 14 of this chapter.
(a) This section applies to every significant FDA decision on any matter under the laws administered by the Commissioner, whether it is raised formally, for example, by a petition or informally, for example, by correspondence.
(b) FDA employees responsible for handling a matter are responsible for insuring the completeness of the administrative file relating to it. The file must contain:
(1) Appropriate documentation of the basis for the decision, including relevant evaluations, reviews, memoranda, letters, opinions of consultants, minutes of meetings, and other pertinent written documents; and
(2) The recommendations and decisions of individual employees, including supervisory personnel, responsible for handling the matter.
(i) The recommendations and decisions are to reveal significant controversies or differences of opinion and their resolution.
(ii) An agency employee working on a matter and, consistent with the prompt completion of other assignments, an agency employee who has worked on a matter may record individual views on that matter in a written memorandum, which is to be placed in the file.
(c) A written document placed in an administrative file must:
(1) Relate to the factual, scientific, legal or related issues under consideration;
(2) Be dated and signed by the author;
(3) Be directed to the file, to appropriate supervisory personnel, and to other appropriate employees, and show all persons to whom copies were sent;
(4) Avoid defamatory language, intemperate remarks, undocumented charges, or irrelevant matters (e.g., personnel complaints);
(5) If it records the views, analyses, recommendations, or decisions of an agency employee in addition to the author, be given to the other employees; and
(6) Once completed (i.e., typed in final form, dated, and signed) not be altered or removed. Later additions to or revisions of the document must be made in a new document.
(d) Memoranda or other documents that are prepared by agency employees and are not in the administrative file have no status or effect.
(e) FDA employees working on a matter have access to the administrative file on that matter, as appropriate for the conduct of their work. FDA employees who have worked on a matter have access to the administrative file on that matter so long as attention to their assignments is not impeded. Reasonable restrictions may be placed upon access to assure proper cataloging and storage of documents, the availability of the file to others, and the completeness of the file for review.
(a) A decision of an FDA employee, other than the Commissioner, on a
(1) At the request of the employee.
(2) On the initiative of the supervisor.
(3) At the request of an interested person outside the agency.
(4) As required by delegations of authority.
(b)(1) The review will be made by consultation between the employee and the supervisor or by review of the administrative file on the matter, or both. The review will ordinarily follow the established agency channels of supervision or review for that matter.
(2) A sponsor, applicant, or manufacturer of a drug or device regulated under the act or the Public Health Service Act (42 U.S.C. 262), may request review of a scientific controversy by an appropriate scientific advisory panel as described in section 505(n) of the act, or an advisory committee as described in section 515(g)(2)(B) of the act. The reason(s) for any denial of a request for such review shall be briefly set forth in writing to the requester. Persons who receive a Center denial of their request under this section may submit a request for review of the denial. The request should be sent to the Chief Mediator and Ombudsman.
(c) An interested person outside the agency may request internal agency review of a decision through the established agency channels of supervision or review. Personal review of these matters by center directors or the office of the Commissioner will occur for any of the following purposes:
(1) To resolve an issue that cannot be resolved at lower levels within the agency (e.g., between two parts of a center or other component of the agency, between two centers or other components of the agency, or between the agency and an interested person outside the agency).
(2) To review policy matters requiring the attention of center or agency management.
(3) In unusual situations requiring an immediate review in the public interest.
(4) As required by delegations of authority.
(d) Internal agency review of a decision must be based on the information in the administrative file. If an interested person presents new information not in the file, the matter will be returned to the appropriate lower level in the agency for reevaluation based on the new information.
(a) A representative of FDA may discuss orally or in writing with an interested person ideas and recommendations for notices or regulations. FDA welcomes assistance in developing ideas for, and in gathering the information to support, notices and regulations.
(b)
(2) A draft of a notice or proposed regulation or its preamble, or a portion of either, may be furnished to an interested person outside the executive branch only if it is made available to all interested persons by a notice published in the
(c) After publication of a notice or proposed regulation in the
(d)
(2) A draft of a final notice or regulation or its preamble, or any portion of either, may be furnished to an interested person outside the executive branch only if it is made available to all interested persons by a notice published in the
(i) The final notice or regulation and its preamble will be prepared solely on the basis of the administrative record.
(ii) If additional technical information from a person outside the executive branch is necessary to draft the final notice or regulation or its preamble, it will be requested by FDA in general terms and furnished directly to the Dockets Management Branch to be included as part of the administrative record.
(iii) If direct discussion by FDA of a draft of a final notice or regulation or its preamble is required with a person outside the executive branch, appropriate protective procedures will be undertaken to make certain that a full and impartial administrative record is established. Such procedures may include either:
(
(
(e) After a final regulation is published, an FDA representative may discuss any aspect of it with an interested person.
(f) In addition to the requirements of this section, the provisions of § 10.55 apply to the promulgation of a regulation subject to § 10.50 and part 12.
(g) A draft of a final food additive color additive, or new animal drug regulation may be furnished to the petitioner for comment on the technical accuracy of the regulation. Every meeting with a petitioner relating to the draft will be recorded in a written memorandum, and all memoranda and correspondence will be filed with the Dockets Management Branch as part of the administrative record of the regulation under the provisions of § 10.65.
(h) In accordance with 42 U.S.C 263f, the Commissioner shall consult with interested persons and with the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) before prescribing any performance standard for an electronic product. Accordingly, the Commissioner shall publish in the
(i) The provisions of § 10.65 apply to meetings and correspondence relating to draft notices and regulations.
(j) The provisions of this section restricting discussion and disclosure of draft notices and regulations do not apply to situations covered by §§ 20.83 through 20.89.
(a) An interested person may request an advisory opinion from the Commissioner on a matter of general applicability.
(1) The request will be granted whenever feasible.
(2) The request may be denied if:
(i) The request contains incomplete information on which to base an informed advisory opinion;
(ii) The Commissioner concludes that an advisory opinion cannot reasonably be given on the matter involved;
(iii) The matter is adequately covered by a prior advisory opinion or a regulation;
(iv) The request covers a particular product or ingredient or label and does not raise a policy issue of broad applicability; or
(v) The Commissioner otherwise concludes that an advisory opinion would not be in the public interest.
(b) A request for an advisory opinion is to be submitted in accordance with § 10.20, is subject to the provisions of § 10.30 (c) through (l), and must be in the following form:
Dockets Management Branch, Food and Drug Administration, Department of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
The undersigned submits this request for an advisory opinion of the Commissioner of Food and Drugs with respect to ___ (the general nature of the matter involved).
A.
(A concise statement of the issues and questions on which an opinion is requested.)
B.
(A full statement of all facts and legal points relevant to the request.)
The undersigned certifies that, to the best of his/her knowledge and belief, this request includes all data, information, and views relevant to the matter, whether favorable or unfavorable to the position of the undersigned, which is the subject of the request.
(c) The Commissioner may respond to an oral or written request to the agency as a request for an advisory opinion, in which case the request will be filed with the Dockets Management Branch and be subject to this section.
(d) A statement of policy or interpretation made in the following documents, unless subsequently repudiated by the agency or overruled by a court, will constitute an advisory opinion:
(1) Any portion of a
(2) Trade Correspondence (T.C. Nos. 1-431 and 1A-8A) issued by FDA between 1938 and 1946.
(3) Compliance policy guides issued by FDA beginning in 1968 and codified in the Compliance Policy Guides manual.
(4) Other documents specifically identified as advisory opinions, e.g., advisory opinions on the performance standard for diagnostic X-ray systems, issued before July 1, 1975, and filed in a permanent public file for prior advisory opinions maintained by the Freedom of Information Staff (HFI-35).
(e) An advisory opinion represents the formal position of FDA on a matter and except as provided in paragraph (f) of this section, obligates the agency to follow it until it is amended or revoked. The Commissioner may not recommend legal action against a person or product with respect to an action taken in conformity with an advisory opinion which has not been amended or revoked.
(f) In unusual situations involving an immediate and significant danger to health, the Commissioner may take appropriate civil enforcement action contrary to an advisory opinion before amending or revoking the opinion. This action may be taken only with the approval of the Commissioner, who may not delegate this function. Appropriate amendment or revocation of the advisory opinion involved will be expedited.
(g) An advisory opinion may be amended or revoked at any time after it has been issued. Notice of amendment or revocation will be given in the same manner as notice of the advisory opinion was originally given or in the
(h) Action undertaken or completed in conformity with an advisory opinion which has subsequently been amended or revoked is acceptable to FDA unless the Commissioner determines that substantial public interest considerations preclude continued acceptance. Whenever possible, an amended or revoked advisory opinion will state when action previously undertaken or completed
(i) An interested person may submit written comments on an advisory opinion or modified advisory opinion. Four copies of any comments are to be sent to the Dockets Management Branch for inclusion in the public file on the advisory opinion. Individuals may submit only one copy. Comments will be considered in determining whether further modification of an advisory opinion is warranted.
(j) An advisory opinion may be used in administrative or court proceedings to illustrate acceptable and unacceptable procedures or standards, but not as a legal requirement.
(k) A statement made or advice provided by an FDA employee constitutes an advisory opinion only if it is issued in writing under this section. A statement or advice given by an FDA employee orally, or given in writing but not under this section or § 10.90, is an informal communication that represents the best judgment of that employee at that time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
(a)
(b) [Reserved]
(c)
(d)
(a)
(b)
(2) Approval forms and all pertinent background information describing the activity will be included in the public file on standard-setting activities established by the Freedom of Information Staff.
(3) If a member of the public is invited by FDA to present views to, or to accompany, the FDA employee at a meeting, the invitations will be extended to a representative sampling of the public, including consumer groups, industry associations, professional societies, and academic institutions.
(4) An FDA employee appointed as the liaison representative to an activity shall refer all requests for information about or participation in the activity to the group or organization responsible for the activity.
(c)
(2) Approval forms and all pertinent background information describing the activity will be included in the public file on standard-setting activities established by the Freedom of Information Staff (HFI-35).
(3) The availability for public disclosure of records relating to the activity will be governed by part 20.
(4) If a member of the public is invited by FDA to present views to, or to accompany, the FDA employee at a meeting, the invitation will be extended to a representative sampling of the public, including consumer groups, industry associations, professional societies, and academic institutions.
(5) An FDA employee appointed as the liaison representative to an activity shall refer all requests for information about or participation in the activity to the group or organization responsible for the activity.
(d)
(i) Whether participation by the individual will be as a voting or nonvoting liaison representative;
(ii) That participation by the individual does not connote FDA agreement with, or endorsement of, any decisions reached; and
(iii) That participation by the individual precludes service as the deciding official on the standard involved if it should later come before FDA. The deciding official is the person who signs a document ruling upon the standard.
(2) The letter requesting official FDA participation, the approval form, and the Commissioner's or center director's letter, together with all pertinent background information describing the activities involved, will be included in the public file on standard-setting activities established by the Freedom of Information Staff (HFI-35).
(3) The availability for public disclosure of records relating to the activities will be governed by part 20.
(4) An FDA employee appointed as the liaison representative to an activity shall refer all requests for information about or participation in the activity to the group or organization responsible for the activity.
(5) The following minimum standards apply to an outside private standard-setting activity in which FDA employees participate:
(i) The activity will be based upon consideration of sound scientific and technological information, will permit revision on the basis of new information, and will be designed to protect the public against unsafe, ineffective, or deceptive products or practices.
(ii) The activity and resulting standards will not be designed for the economic benefit of any company, group, or organization, will not be used for such antitrust violations as fixing prices or hindering competition, and will not involve establishment of certification or specific approval of individual products or services.
(iii) The group or organization responsible for the standard-setting activity must have a procedure by which
(6) Membership of an FDA employee in an organization that also conducts a standard-setting activity does not invoke the provisions of this section unless the employee participates in the standard-setting activity. Participation in a standard-setting activity is subject to this section.
(7) The Commissioner may determine in writing that, because direct involvement by FDA in a particular standard-setting activity is in the public interest and will promote the objectives of the act and the agency, the participation is exempt from the requirements of paragraph (d)(1) (ii) and/or (iii) of this section. This determination will be included in the public file on standard-setting activities established by the Freedom of Information Staff and in any relevant administrative file. The activity may include the establishment and validation of analytical methods for regulatory use, drafting uniform laws and regulations, and the development of recommendations concerning public health and preventive medicine practices by national and international organizations.
(8) Because of the close daily cooperation between FDA and the associations of State and local government officials listed below in this paragraph, and the large number of agency employees who are members of or work with these associations, participation in the activities of these associations is exempt from paragraphs (d)(1) through (7) of this section, except that a list of the committees and other groups of these associations will be included in the public file on standard-setting activities established by the Freedom of Information Staff (HFI-35):
(i) American Association of Food Hygiene Veterinarians (AAFHV).
(ii) American Public Health Association (APHA).
(iii) Association of American Feed Control Officials, Inc. (AAFCO).
(iv) Association of Food and Drug Officials (AFDO).
(v) Association of Official Analytical Chemists (AOAC).
(vi) Association of State and Territorial Health Officials (ASTHO).
(vii) Conference for Food Protection (CFP).
(viii) Conference of State Health and Environmental Managers (COSHEM).
(ix) Conference of Radiation Control Program Directors (CRCPD).
(x) International Association of Milk, Food, and Environmental Sanitation, Inc. (IAMFES).
(xi) Interstate Shellfish Sanitation Conference (ISSC).
(xii) National Association of Boards of Pharmacy (NABP).
(xiii) National Association of Departments of Agriculture (NADA).
(xiv) National Conference on Interstate Milk Shipments (NCIMS).
(xv) National Conference of Local Environmental Health Administrators (NCLEHA).
(xvi) National Conference on Weights and Measures (NCWW).
(xvii) National Environmental Health Association (NEHA).
(xviii) National Society of Professional Sanitarians (NSPS).
(a)
(1) Public calendar entries will include:
(i) Significant meetings with members of the judiciary, representatives of Congress, or staffs of congressional committees when the meeting relates to a pending court case, administrative hearing, or other regulatory action or decision;
(ii) Significant meetings, conferences, seminars, and speeches; and
(iii) Social events sponsored by the regulated industry.
(2) The public calendar will not include reports of meetings that would prejudice law enforcement activities (e.g., a meeting with an informant) or invade privacy (e.g., a meeting with a candidate for possible employment at FDA), meetings with members of the press, or meetings with onsite contractors.
(b)
(c)
(1) Commissioner of Food and Drugs.
(2) Senior Associate Commissioners.
(3) Deputy Commissioners.
(4) Associate Commissioner for Regulatory Affairs.
(5) Center Directors.
(6) Chief Counsel for the Food and Drug Administration.
(d)
(1) Dockets Management Branch.
(2) Office of the Associate Commissioner for Public Affairs.
(3) The FDA home page, to the extent feasible.
(a) An organization may represent its members by filing petitions, comments, and objections, and otherwise participating in an administrative proceeding subject to this part.
(b) A petition, comment, objection, or other representation by an organization will not abridge the right of a member to take individual action of a similar type, in the member's own name.
(c) It is requested that each organization participating in FDA administrative proceedings file annually with the Dockets Management Branch a current list of all of the members of the organization.
(d) The filing by an organization of an objection or request for hearing under §§ 12.20 through 12.22 does not provide a member a legal right with respect to the objection or request for hearing that the member may individually exercise. A member of an organization wishing to file an objection or request for hearing must do so individually.
(e) In a court proceeding in which an organization participates, the Commissioner will take appropriate legal measures to have the case brought or considered as a class action or otherwise as binding upon all members of the organization except those specifically excluded by name. Regardless of whether the case is brought or considered as a class action or as otherwise binding upon all members of the organization except those specifically excluded by name, the Commissioner will take the position in any subsequent suit involving the same issues and a member of the organization that the issues are precluded from further litigation by the member under the doctrines of collateral estoppel or res judicata.
At any time in the course of a proceeding subject to this part, a person may propose settlement of the issues involved. A participant in a proceeding will have an opportunity to consider a proposed settlement. Unaccepted proposals of settlement and related matters, e.g., proposed stipulations not agreed to, will not be admissible in evidence in an FDA administrative proceeding. FDA will oppose the admission in evidence of settlement information in a court proceeding or in another administrative proceeding.
(a)
(b)
(1) Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agency's interpretation of or policy on a regulatory issue.
(2) Guidance documents include, but are not limited to, documents that relate to: The design, production, labeling, promotion, manufacturing, and testing of regulated products; the processing, content, and evaluation or approval of submissions; and inspection and enforcement policies.
(3) Guidance documents do not include: Documents relating to internal FDA procedures, agency reports, general information documents provided to consumers or health professionals, speeches, journal articles and editorials, media interviews, press materials, warning letters, memoranda of understanding, or other communications directed to individual persons or firms.
(c)
(1) “Level 1 guidance documents” include guidance documents that:
(i) Set forth initial interpretations of statutory or regulatory requirements;
(ii) Set forth changes in interpretation or policy that are of more than a minor nature;
(iii) Include complex scientific issues; or
(iv) Cover highly controversial issues.
(2) “Level 2 guidance documents” are guidance documents that set forth existing practices or minor changes in interpretation or policy. Level 2 guidance documents include all guidance documents that are not classified as Level 1.
(3) “You” refers to all affected parties outside of FDA.
(d)
(1) No. Guidance documents do not establish legally enforceable rights or responsibilities. They do not legally bind the public or FDA.
(2) You may choose to use an approach other than the one set forth in a guidance document. However, your alternative approach must comply with the relevant statutes and regulations. FDA is willing to discuss an alternative approach with you to ensure that it complies with the relevant statutes and regulations.
(3) Although guidance documents do not legally bind FDA, they represent the agency's current thinking. Therefore, FDA employees may depart from guidance documents only with appropriate justification and supervisoryconcurrence.
(e)
(f)
(1) You can provide input on guidance documents that FDA is developing under the procedures described in paragraph (g) of this section.
(2) You can suggest areas for guidance document development. Your suggestions should address why a guidance document is necessary.
(3) You can submit drafts of proposed guidance documents for FDA toconsider. When you do so, you should mark the document “Guidance Document Submission” and submit it to Dockets Management Branch (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
(4) You can, at any time, suggest that FDA revise or withdraw an already existing guidance document. Your suggestion should address why the guidance document should be revised or withdrawn and, if applicable, how it should be revised.
(5) Once a year, FDA will publish, both in the
(6) To participate in the development and issuance of guidance documents through one of the mechanisms described in paragraphs (f)(1), (f)(2), or (f)(4) of this section, you should contact the center or office that is responsible for the regulatory activity covered by the guidance document.
(7) If FDA agrees to draft or revise a guidance document, under a suggestion made under paragraphs (f)(1), (f)(2), (f)(3) or (f)(4) of this section, you can participate in the development of that guidance document under the procedures described in paragraph (g) of this section.
(g)
(1) FDA's procedures for the development and issuance of Level 1 guidance documents are as follows:
(i) Before FDA prepares a draft of a Level 1 guidance document, FDA can seek or accept early input from individuals or groups outside the agency. For example, FDA can do this by participating in or holding public meetings and workshops.
(ii) After FDA prepares a draft of a Level 1 guidance document, FDA will:
(A) Publish a notice in the
(B) Post the draft guidance document on the Internet and make it available in hard copy; and
(C) Invite your comment on the draft guidance document. Paragraph (h) of this section tells you how to submit your comments.
(iii) After FDA prepares a draft of a Level 1 guidance document, FDA also can:
(A) Hold public meetings or workshops; or
(B) Present the draft guidance document to an advisory committee for review.
(iv) After providing an opportunity for public comment on a Level 1 guidance document, FDA will:
(A) Review any comments received and prepare the final version of the guidance document that incorporates suggested changes, when appropriate;
(B) Publish a notice in the
(C) Post the guidance document on the Internet and make it availablein hard copy; and
(D) Implement the guidance document.
(v) After providing an opportunity for comment, FDA may decide that it should issue another draft of the guidance document. In this case, FDA will follow the steps in paragraphs (g)(1)(ii), (g)(1)(iii), and (g)(1)(iv) of this section.
(2) FDA will not seek your comment before it implements a Level 1 guidance document if the agency determines that prior public participation is not feasible or appropriate.
(3) FDA will use the following procedures for developing and issuing Level 1 guidance documents under the circumstances described in paragraph (g)(2) of this section:
(i) After FDA prepares a guidance document, FDA will:
(A) Publish a notice in the
(B) Post the guidance document on the Internet and make it available in hard copy;
(C) Immediately implement the guidance document; and
(D) Invite your comment when it issues or publishes the guidance document. Paragraph (h) of this section tells you how to submit your comments.
(ii) If FDA receives comments on the guidance document, FDA will review those comments and revise the guidance document when appropriate.
(4) FDA will use the following procedures for developing and issuing Level 2 guidance documents:
(i) After it prepares a guidance document, FDA will:
(A) Post the guidance document on the Internet and make it available in hard copy;
(B) Immediately implement the guidance document, unless FDA indicates otherwise when the document is made available; and
(C) Invite your comment on the Level 2 guidance document. Paragraph (h) of this section tells you how to submit your comments.
(ii) If FDA receives comments on the guidance document, FDA will review those comments and revise the document when appropriate. If a version is revised, the new version will be placed on the Internet.
(5) You can comment on any guidance document at any time. Paragraph (h) of this section tells you how to submit your comments. FDA will revise guidance documents in response to your comments when appropriate.
(h)
(1) If you choose to submit comments on any guidance document under paragraph (g) of this section, you must send them to the Dockets Management Branch (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
(2) Comments should identify the docket number on the guidance document, if such a docket number exists. For documents without a docket number, the title of the guidance document should be included.
(3) Comments will be available to the public in accordance with FDA's regulations on submission of documents to the Dockets Management Branch specified in § 10.20(j).
(i)
(1) A guidance document must:
(i) Include the term “guidance,”
(ii) Identify the center(s) or office(s) issuing the document,
(iii) Identify the activity to which and the people to whom the document applies,
(iv) Prominently display a statement of the document's nonbinding effect,
(v) Include the date of issuance,
(vi) Note if it is a revision to a previously issued guidance and identify the document that it replaces, and
(vii) Contain the word “draft” if the document is a draft guidance.
(2) Guidance documents must not include mandatory language such as “shall,” “must,” “required,” or “requirement,” unless FDA is using these words to describe a statutory or regulatory requirement.
(3) When issuing draft guidance documents that are the product of international negotiations (e.g., guidances resulting from the International Conference on Harmonisation), FDA need not apply paragraphs (i)(1) and (i)(2) of this section. However, any final guidance document issued according to this provision must contain the elements in paragraphs (i)(1) and (i)(2) of this section.
(j)
(k)
(1) The agency will periodically review existing guidance documents to determine whether they need to be changed or withdrawn.
(2) When significant changes are made to the statute or regulations, the agency will review and, if appropriate, revise guidance documents relating to that changed statute or regulation.
(3) As discussed in paragraph (f)(3) of this section, you may at anytime suggest that FDA revise a guidance document.
(l)
(1) All current and new FDA employees involved in the development, issuance, or application of guidance documents will be trained regarding the agency's GGP's.
(2) FDA centers and offices will monitor the development and issuance of guidance documents to ensure that GGP's are being followed.
(m)
(n)
(1) FDA will maintain on the Internet a current list of all guidance documents. New documents will be added to this list within 30 days of issuance.
(2) Once a year, FDA will publish in the
(3) FDA's guidance document lists will include the name of the guidance document, issuance and revision dates, and information on how to obtain copies of the document.
(o) What can you do if you believe that someone at FDA is not following these GGP's? If you believe that someone at FDA did not follow the procedures in this section or that someone at FDA treated a guidance document as a binding requirement, you should contact that person's supervisor in the center or office that issued the guidance document. If the issue cannot be resolved, you should contact the next highest supervisor. You can also contact the center or office ombudsman for assistance in resolving the issue. If you are unable to resolve the issue at the center or office level or if you feel that you are not making progress by going through the chain of command, you may ask the Office of the Chief Mediator and Ombudsman to become involved.
This guideline describes FDA's policy and procedures applicable to electronic media coverage of agency public administrative proceedings. It is a guideline intended to clarify and explain FDA's policy on the presence and operation of electronic recording equipment at such proceedings and to assure uniform and consistent application of practices and procedures throughout the agency.
(a)
(b)
(c)
(a) FDA has for many years willingly committed itself to a policy of openness. In many instances FDA has sought to make the open portions of agency public administrative proceedings more accessible to public participation. Similarly, FDA has sought, wherever possible, to allow full written media access to its proceedings, so that members of the press would have the opportunity to provide first-hand reports. However, because electronic media coverage presents certain difficulties that are easier to resolve with advance notice to the agency and all participants, FDA believes that codification of its policy will facilitate and further increase media access to its public administrative proceedings. The agency intends to refer to this guideline when notices of hearing, or individual advisory committee meetings, are published in the
(b) The designated presiding officer of a public administrative proceeding retains the existing discretionary authority set forth in specific regulations pertaining to each type of administrative proceeding to regulate the conduct
(c) This guideline provides the presiding officer with a degree of flexibility in that it sets forth the agency's policy as well as the procedures that presiding officers should ordinarily follow, but from which they may depart in particular situations if necessary, subject to the presumption of openness of public proceedings to electronic media coverage. The presiding officer's discretion to establish additional procedures or to limit electronic coverage is to be exercised only in the unusual circumstances defined in this guideline. Even though a presiding officer may establish additional procedures or limits as may be required in a particular situation, he or she will be guided by the policy expressed in this guideline in establishing these conditions. The presiding officer may also be less restrictive, taking into account such factors as the duration of a hearing and the design of the room.
(d) If a portion or all of a proceeding is closed to the public because material is to be discussed that is not disclosable to the public under applicable laws, the proceeding also will be closed to electronic media coverage.
(e) The agency requests advance notice of intent to record a proceeding electronically to facilitate the orderly conduct of the proceeding. Knowledge of anticipated media coverage will allow the presiding officer to make any special arrangements required by the circumstances of the proceeding. The agency believes that this guideline establishes sufficiently specific criteria to promote uniformity.
(f) The agency would like to allow all interested media representatives to videotape a proceeding in which they have an interest. However, should space limitations preclude a multitude of cameras, the presiding officer may require pool sharing. In such a case, pool sharing arrangements of the resulting videotape should be made between those allowed to film and those who were excluded. Arrangements for who is designated to present the pool and a method of distributing the resulting film or tape may be determined by the established networks' pooling system. However, the agency has a strong commitment to ensuring that media representatives other than the major networks also be able to obtain a copy of the tape at cost. FDA is concerned that if the network pool representative wishes to record only a short portion of a proceeding, but an excluded party wishes to record the entire proceeding, confusion will result. The agency expects the interested media representatives to negotiate a suitable agreement among themselves before commencement of the proceeding. For example, the network pool representatives might agree to record a portion of the proceeding up to a break in the proceeding, at which time, while the network representative is disassembling equipment, another media representative might set up to continue recording. If an agreement cannot be reached before the proceeding, the agency will use the time of receipt of any advance notice to determine the representation for each category of media, e.g., one network reporter, one independent reporter. The agency recommends that parties intending to videotape provide as much advance notice as possible, so that the agency may best respond to the needs of the electronic media.
(g) To ensure the timely conduct of agency hearings and to prevent disruptions, equipment is to be stationary during a proceeding and should be set up and taken down when the proceeding is not in progress. As noted previously, the presiding officer may, at his or her discretion, be less restrictive if appropriate.
(h) The agency recognizes that electronic media representatives may desire only short footage of a proceeding, a facsimile of the proceeding, and/or interview opportunities and may be unnecessarily restricted by requirements for setting up before a proceeding and then waiting until a break in the proceeding before being permitted to take down their equipment. To accommodate this possibility, FDA's Press Relations Staff will attempt to make arrangements to respond to such needs by, for example, requesting that the presiding officer provide a break shortly after commencement of the proceeding to permit take down of equipment.
(i) The agency is making a full commitment to allowing, whenever possible, electronic coverage of its public administrative proceedings subject to the limited restrictions established in this guideline.
(a) A person may record electronically any open public administrative proceeding, subject to the procedures specified in this guideline. The procedures include a presumption that agency public proceedings are open to the electronic media. Whenever possible, FDA will permit all interested persons access to record agency public administrative proceedings. Restrictions other than those listed in § 10.206 will be imposed only under exceptional circumstances.
(b) A videotape recording of an FDA public administrative proceeding is not an official record of the proceeding. The only official record is the written transcript of the proceeding, which is taken by the official reporter.
(a) To facilitate the agency's response to media needs, a person intending to videotape an FDA public administrative proceeding should, whenever possible, provide advance notice to the Press Relations Staff (HFI-20), Office of Public Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, in writing or by telephone (telephone 301-443-4177), at least 48 hours in advance of the proceeding. The Press Relations Staff will inform the presiding officer that the proceeding will be attended by representatives of the electronic media, and ascertain whether any special provisions in addition to those set forth in this subpart are required by the presiding officer. If so, the Press Relations Staff will function as a liaison between the presiding officer and the person intending to record the proceeding in facilitating any procedures in addition to those outlined in this subpart. The presiding officer will not deny access for failure to provide a 48-hour advance notice. Any advance notice may describe the intended length of recording if known, the amount and type of equipment to be used, and any special needs such as interviews.
(b) Cameras should be completely set up before a proceeding is scheduled to begin or during a break in the proceeding and should remain standing in the area designated for electronic media equipment. Cameras may be taken down only during breaks or after the hearing is over. Roving cameras will not be permitted during the proceeding. Any artificial lighting should be unobtrusive. Microphones, like cameras, should be in place before the start of a proceeding and may be taken down as indicated in this paragraph.
(c) When space in the hearing room is limited, the presiding officer may restrict the number of cameras or the equipment present. Should such a restriction become necessary, the pool arrangements are the responsibility of the participating media. The agency encourages the network pool to make copies of the tape, film, or other product available at cost to nonpool participants. However, if this is not possible, the agency may need to use the time of receipt of any advance notice to determine the representation for each category, e.g., one network reporter, one independent reporter, etc.
(d)
(e) Before or during the proceeding, the presiding officer may establish other conditions specific to the proceeding for which the request is being made. These conditions may be more or
(1) Electronic recording would result in a substantial likelihood of disruption that clearly cannot be contained by the procedures established in paragraphs (a) through (d) of this section.
(2) Electronic recording would result in a substantial likelihood of prejudicial impact on the fairness of the proceeding or the substantive discussion in a proceeding.
(3) There is a substantial likelihood that a witness' ability to testify may be impaired due to unique personal circumstances such as the age or psychological state of the witness or the particularly personal or private nature of the witness' testimony, if the witness' testimony were electronically recorded.
(f) Before the proceeding, the Press Relations Staff will, upon request, provide written copies of any additional conditions imposed by the presiding officer (as described in paragraph (e) of this section) to requesting members of the media. Any appeals should be made in accordance with paragraph (h) of this section.
(g) The presiding officer retains authority to restrict or discontinue videotaping or other recording of a proceeding, or parts of a proceeding, should such a decision become necessary. The presiding officer's responsibility to conduct the hearing includes the right and duty to remove a source of substantial disruption. In exercising his or her authority, the presiding officer shall observe the presumption that agency public proceedings are open to the electronic media. The presiding officer shall exercise his or her discretion to restrict or discontinue electronic coverage of a public proceeding, or portions of a public proceeding, only if he or she determines that the agency's interest in the fair and orderly administrative process is substantially threatened. A clear and substantial threat to the integrity of agency proceedings must clearly outweigh the public interest in electronic media coverage of the proceedings before additional restrictions are imposed on the electronic media during the course of the proceedings. The factors noted in paragraph (e) of this section indicate the kind of substantial threat to the agency interests that may require imposing additional restrictions during the course of the proceedings. If additional requirements are established during the hearing, the presiding officer shall notify immediately the Deputy Commissioner of Food and Drugs of that fact by telephone and submit a written explanation of the circumstances that necessitated such an action within 24 hours or sooner if requested by the Deputy Commissioner. In the absence or unavailability of the Deputy Commissioner, the presiding officer shall notify the Associate Commissioner for Regulatory Affairs.
(h) A decision by a presiding officer, made either before the proceeding or during the course of a proceeding, to establish requirements in addition to the minimum standards set forth in this guideline may be appealed by any adversely affected person who intends to record the proceeding electronically. Appeals may be made in writing or by phone to the Deputy Commissioner or, in his or her absence, to the Associate Commissioner for Regulatory Affairs. The filing of an appeal, whether before or during a proceeding, does not require the presiding officer to interrupt the proceeding. However, the Deputy Commissioner or, in his or her absence, the Associate Commissioner for Regulatory Affairs will resolve an appeal as
21 U.S.C. 321-393; 42 U.S.C. 262.
(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
(b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means.
(c) Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signatures to be equivalent to full handwritten signatures, initials, and other general signings as required by agency regulations, unless specifically excepted by regulation(s) effective on or after August 20, 1997.
(d) Electronic records that meet the requirements of this part may be used in lieu of paper records, in accordance with § 11.2, unless paper records are specifically required.
(e) Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall be readily available for, and subject to, FDA inspection.
(a) For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met.
(b) For records submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that:
(1) The requirements of this part are met; and
(2) The document or parts of a document to be submitted have been identified in public docket No. 92S-0251 as being the type of submission the agency accepts in electronic form. This docket will identify specifically what types of documents or parts of documents are acceptable for submission in electronic form without paper records and the agency receiving unit(s) (e.g., specific center, office, division, branch) to which such submissions may be made. Documents to agency receiving unit(s) not specified in the public docket will not be considered as official if they are submitted in electronic form; paper forms of such documents will be
(a) The definitions and interpretations of terms contained in section 201 of the act apply to those terms when used in this part.
(b) The following definitions of terms also apply to this part:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following:
(a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
(b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records.
(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.
(d) Limiting system access to authorized individuals.
(e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.
(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.
(g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.
(h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.
(i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.
(j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.
(k) Use of appropriate controls over systems documentation including:
(1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.
(2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.
Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Such procedures and controls shall include those identified in § 11.10, as appropriate, and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality.
(a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:
(1) The printed name of the signer;
(2) The date and time when the signature was executed; and
(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
(b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout).
Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.
(a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.
(b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individual's electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual.
(c) Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.
(1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.
(2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature.
(a) Electronic signatures that are not based upon biometrics shall:
(1) Employ at least two distinct identification components such as an identification code and password.
(i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual.
(ii) When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components.
(2) Be used only by their genuine owners; and
(3) Be administered and executed to ensure that attempted use of an individual's electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals.
(b) Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners.
Persons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include:
(a) Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password.
(b) Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging).
(c) Following loss management procedures to electronically deauthorize lost, stolen, missing, or otherwise potentially compromised tokens, cards, and other devices that bear or generate identification code or password information, and to issue temporary or permanent replacements using suitable, rigorous controls.
(d) Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management.
(e) Initial and periodic testing of devices, such as tokens or cards, that bear or generate identification code or password information to ensure that they function properly and have not been altered in an unauthorized manner.
21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 42 U.S.C. 201, 262, 263b-263n, 264; 15 U.S.C. 1451-1461; 5 U.S.C. 551-558, 701-721; 28 U.S.C. 2112.
The procedures in this part apply when—
(a) A person has a right to an opportunity for a hearing under the laws specified in § 10.50; or
(b) The Commissioner concludes that it is in the public interest to hold a formal evidentiary public hearing on any matter before FDA.
(a) A proceeding under section 409(f), 502(n), 512(n)(5), 701(e), or 721(d) of the act or section 4 or 5 of the Fair Packaging and Labeling Act may be initiated—
(1) By the Commissioner on the Commissioner's own initiative, e.g., as provided in § 170.15 for food additives; or
(2) By a petition—
(i) In the form specified elsewhere in this chapter, e.g., the form for a color additive petition in § 71.1; or
(ii) If no form is specified, by a petition under § 10.30.
(b) If the Commissioner receives a petition under paragraph (a)(2) of this section, the Commissioner will—
(1) If it involves any matter subject to section 701(e) of the act or section 4 or 5 of the Fair Packaging and Labeling Act, and meets the requirements for filing, follow the provisions of § 10.40 (b) through (f);
(2) If it involves a color additive or food additive, and meets the requirements for filing in §§ 71.1 and 71.2, or in §§171.1, 171.6, 171.7, and 171.100, publish a notice of filing of the petition within 30 days after the petition is filed instead of a notice of proposed rulemaking.
(c) [Reserved]
(d) The notice promulgating the regulation will describe how to submit objections and requests for hearing.
(e) On or before the 30th day after the date of publication of a final regulation, or of a notice withdrawing a proposal initiated by a petition under § 10.25(a), a person may submit to the Commissioner written objections and a request for a hearing. The 30-day period may not be extended except that additional information supporting an objection may be received after 30 days upon a showing of inadvertent omission and hardship, and if review of the objection and request for hearing will not thereby be impeded. If, after a final color additive regulation is published, a petition or proposal relating to the regulation is referred to an advisory committee in accordance with section 721(b)(5)(C) of the act, objections and
(a) A proceeding under section 505 (d) or (e), 512 (d), (e), (m) (3) or (4), of section 515(g)(1) of the act, or section 351(a) of the Public Health Service Act, may be initiated—
(1) By the Commissioner on the Commissioner's own initiative;
(2) By a petition in the form specified elsewhere in this chapter, e.g., § 314.50 for new drug applications, § 514.1 for new animal drug applications, § 514.2 for applications for animal feeds, or § 601.3 for licenses for biologic products; or
(3) By a petition under § 10.30.
(b) A notice of opportunity for hearing on a proposal to deny or revoke approval of all or part of an order will be published together with an explanation of the grounds for the proposed action. The notice will describe how to submit requests for hearing. A person subject to the notice has 30 days after its issuance to request a hearing. The 30-day period may not be extended.
(c) The Commissioner may use an optional procedure specified in § 10.30(h) to consider issuing, amending, or revoking an order.
(d) In a proceeding under sections 505(e), 512(e) or (m), or 515(e) of the act in which a party wishes to apply for reimbursement of certain expenses under the Equal Access to Justice Act (5 U.S.C. 504 and 504 note), FDA will follow the Department of Health and Human Services' regulations in 45 CFR part 13.
(a) Objections and requests for a hearing under § 12.20(d) must be submitted to the Dockets Management Branch and will be accepted for filing if they meet the following conditions:
(1) They are submitted within the time specified in § 12.20(e).
(2) Each objection is separately numbered.
(3) Each objection specifies with particularity the provision of the regulation or proposed order objected to.
(4) Each objection on which a hearing is requested specifically so states. Failure to request a hearing on an objection constitutes a waiver of the right to a hearing on that objection.
(5) Each objection for which a hearing is requested includes a detailed description and analysis of the factual information to be presented in support of the objection. Failure to include a description and analysis for an objection constitutes a waiver of the right to a hearing on that objection. The description and analysis may be used only for the purpose of determining whether a hearing has been justified under § 12.24, and do not limit the evidence that may be presented if a hearing is granted.
(i) A copy of any report, article, survey, or other written document relied upon must be submitted, except if the document is—
(
(
(ii) A summary of the nondocumentary testimony to be presented by any witnesses relied upon must be submitted.
(b) Requests for hearing submitted under § 12.21 will be submitted to the Dockets Management Branch and will be accepted for filing if they meet the following conditions:
(1) They are submitted on or before the 30th day after the date of publication of the notice of opportunity for hearing.
(2) They comply with §§ 314.200, 514.200, or 601.7(a).
(c) If an objection or request for a public hearing fails to meet the requirements of this section and the deficiency becomes known to the Dockets Management Branch, the Dockets Management Branch shall return it with a copy of the applicable regulations, indicating those provisions not complied
(d) If another person objects to a regulation issued in response to a petition submitted under § 12.20(a)(2), the petitioner may submit a written reply to the Dockets Management Branch.
As soon as practicable after the expiration of the time for filing objections to and requests for hearing on agency action involving the issuance, amendment, or revocation of a regulation under sections 502(n), 701(e), or 721(d) of the act or sections 4 or 5 of the Fair Packaging and Labeling Act, the Commissioner shall publish a notice in the
(a) As soon as possible the Commissioner will review all objections and requests for hearing filed under § 12.22 and determine—
(1) Whether the regulation should be modified or revoked under § 12.26;
(2) Whether a hearing has been justified; and
(3) Whether, if requested, a hearing before a Public Board of Inquiry under part 13 or before a public advisory committee under part 14 or before the Commissioner under part 15 has been justified.
(b) A request for a hearing will be granted if the material submitted shows the following:
(1) There is a genuine and substantial issue of fact for resolution at a hearing. A hearing will not be granted on issues of policy or law.
(2) The factual issue can be resolved by available and specifically identified reliable evidence. A hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions.
(3) The data and information submitted, if established at a hearing, would be adequate to justify resolution of the factual issue in the way sought by the person. A hearing will be denied if the Commissioner concludes that the data and information submitted are insufficient to justify the factual determination urged, even if accurate.
(4) Resolution of the factual issue in the way sought by the person is adequate to justify the action requested. A hearing will not be granted on factual issues that are not determinative with respect to the action requested, e.g., if the Commissioner concludes that the action would be the same even if the factual issue were resolved in the way sought, or if a request is made that a final regulation include a provision not reasonably encompassed by the proposal. A hearing will be granted upon proper objection and request when a food standard or other regulation is shown to have the effect of excluding or otherwise affecting a product or ingredient.
(5) The action requested is not inconsistent with any provision in the act or any regulation in this chapter particularizing statutory standards. The proper procedure in those circumstances is for the person requesting the hearing to petition for an amendment or waiver of the regulation involved.
(6) The requirements in other applicable regulations, e.g., §§ 10.20, 12.21, 12.22, 314.200, 514.200, and 601.7(a), and in the notice promulgating the final regulation or the notice of opportunity for hearing are met.
(c) In making the determination in paragraph (a) of this section, the Commissioner may use any of the optional procedures specified in § 10.30(h) or in other applicable regulations, e.g., §§ 314.200, 514.200, and 601.7(a).
(d) If it is uncertain whether a hearing has been justified under the principles in paragraph (b) of this section, and the Commissioner concludes that
If the Commissioner determines upon review of an objection or request for hearing that the regulation or order should be modified or revoked, the Commissioner will promptly take such action by notice in the
If the Commissioner determines upon review of the objections or requests for hearing that a hearing is not justified, in whole or in part, a notice of the determination will be published.
(a) The notice will state whether the hearing is denied in whole or in part. If the hearing is denied in part, the notice will be combined with the notice of hearing required by § 12.35, and will specify the objections and requests for hearing that have been granted and denied.
(1) Any denial will be explained. A denial based on an analysis of the information submitted to justify a hearing will explain the inadequacy of the information.
(2) The notice will confirm or modify or stay the effective date of the regulation or order involved.
(b) The record of the administrative proceeding relating to denial of a public hearing in whole or in part on an objection or request for hearing consists of the following:
(1) If the proceeding involves a regulation—
(i) The documents specified in § 10.40(g);
(ii) The objections and requests for hearing filed by the Dockets Management Branch;
(iii) If the proceeding involves a color additive regulation referred to an advisory committee in accordance with section 721(b)(5)(C) of the act, the committee's report and the record of the committee's proceeding; and
(iv) The notice denying a formal evidentiary public hearing.
(2) If the proceeding involves an order—
(i) The notice of opportunity for hearing;
(ii) The requests for hearing filed by the Dockets Management Branch;
(iii) The transcripts, minutes of meetings, reports,
(iv) The notice denying the hearing.
(c) The record specified in paragraph (b) of this section is the exclusive record for the Commissioner's decision on the complete or partial denial of a hearing. The record of the proceeding will be closed as of the date of the Commissioner's decision unless another date is specified. A person who requested and was denied a hearing may submit a petition for reconsideration under § 10.33 or a petition for stay of action under § 10.35. A person who wishes to rely upon information or views not included in the administrative record shall submit them to the Commissioner with a petition under § 10.25(a) to modify the final regulation or order.
(d) Denial of a request for a hearing in whole or in part is final agency action reviewable in the courts, under the statutory provisions governing the matter involved, as of the date of publication of the denial in the
(1) Before requesting a court for a stay of action pending review, a person shall first submit a petition for a stay of action under § 10.35.
(2) Under 28 U.S.C. 2112(a), FDA will request consolidation of all petitions on a particular matter.
(3) The time for filing a petition for judicial review of a denial of a hearing on an objection or issue begins on the date the denial is published in the
(a) A person with a right to submit objections and a request for hearing under § 12.20(d) may submit objections and waive the right to a hearing. The waiver may be either an explicit statement, or a failure to request a hearing, as provided in 12.22(a)(4).
(b) If a person waives the right to a hearing, the Commissioner will rule upon the person's objections under §§ 12.24 through 12.28. As a matter of discretion, the Commissioner may also order a hearing on the matter under any of the provisions of this part.
(c) If the Commissioner rules adversely on a person's objection, the person may petition for judicial review in a U.S. Court of Appeals under the act.
(1) The record for judicial review is the record designated in § 12.28(b)(1).
(2) The time for filing a petition for judicial review begins as of the date of publication of the Commissioner's ruling on the objections.
(a) A person with a right to request a hearing may waive that right and request one of the following alternatives:
(1) A hearing before a Public Board of Inquiry under part 13.
(2) A hearing before a public advisory committee under part 14.
(3) A hearing before the Commissioner under part 15.
(b) The request—
(1) May be on the person's own initiative or at the suggestion of the Commissioner.
(2) Must be submitted in the form of a citizen petition under § 10.30 before publication of a notice of hearing under § 12.35 or a denial of hearing under § 12.28; and
(3) Must be—
(i) In lieu of a request for a hearing under this part; or
(ii) If submitted after or with a request for hearing, in the form of a waiver of the right to request a hearing conditioned on an alternative form of hearing. Upon acceptance by the Commissioner, the waiver becomes binding and may be withdrawn only by waiving any right to any form of hearing unless the Commissioner determines otherwise.
(c) When more than one person requests and justifies a hearing under this part, an alternative form of hearing may by used only if all the persons concur and waive their right to request a hearing under this part.
(d) The Commissioner will determine whether an alternative form of hearing should be used, and if so, which alternative is acceptable, after considering the requests submitted and the appropriateness of the alternatives for the issues raised in the objections. The Commissioner's acceptance is binding unless, for good cause, the Commissioner determines otherwise.
(e) The Commissioner will publish a notice of an alternative form of hearing setting forth the following information:
(1) The regulation or order that is the subject of the hearing.
(2) A statement specifying any part of the regulation or order that has been stayed by operation of law or in the Commissioner's discretion.
(3) The time, date, and place of the hearing, or a statment that such information will be contained in a later notice.
(4) The parties to the hearing.
(5) The issues at the hearing. The statement of issues determines the scope of the hearing.
(6) If the hearing will be conducted by a Public Board of Inquiry, the time within which—
(i) The parties should submit nominees for the Board under § 13.10(b);
(ii) A notice of participation under § 12.45 should be filed; and
(iii) Participants should submit written information under § 13.25. The notice will list the contents of the portions of the administrative record relevant to the issues at the hearing before the Board. The portions listed will be placed on public display in the office of the Dockets Management Branch before the notice is published. Additional copies of material already submitted under § 13.25 need not be included with any later submissions.
(f)(1) The decision of a hearing before a Public Board of Inquiry or a public advisory committee under this section has legal status of and will be handled as an initial decision under § 12.120.
(2) The decision of a public hearing before the Commissioner under this section will be issued as a final order. The final order will have the same content as an initial decision, as specified in § 12.120 (b) and (c).
(3) Thereafter, the participants in the proceeding may pursue the administrative and court remedies specified in §§ 12.120 through 12.159.
(g) If a hearing before a public advisory committee or a hearing before the Commissioner is used as an alternative form of hearing, all submissions will be made to the Dockets Management Branch, and § 10.20(j) governs their availability for public examination and copying.
(h) This section does not affect the right to an opportunity for a hearing before a public advisory committee under section 515(g)(2) of the act regarding device premarket approval applications and product development protocols. Advisory committee hearing procedures are found in part 14.
(a) If the Commissioner determines upon review of the objections and requests for hearing that a hearing is justified on any issue, the Commissioner will publish a notice setting forth the following:
(1) The regulation or order that is the subject of the hearing.
(2) A statement specifying any part of the regulation or order that has been stayed by operation of law or in the Commissioner's discretion.
(3) The parties to the hearing.
(4) The issues of fact on which a hearing has been justified.
(5) A statement of any objections or requests for hearing for which a hearing has not been justified, which are subject to § 12.28.
(6) The presiding officer, or a statement that the presiding officer will be designated in a later notice.
(7) The time within which notices of participation should be filed under § 12.45.
(8) The date, time, and place of the prehearing conference, or a statement that the date, time, and place will be announced in a later notice. The pre-hearing conference may not commence until after the time expires for filing the notice of participation required by § 12.45(a).
(9) The time within which participants should submit written information and views under § 12.85. The notice will list the contents of the portions of the administrative record relevant to the issues at the hearing. The portions listed will be placed on public display in the office of the Dockets Management Branch before the notice is published. Additional copies of material already submitted under § 12.85 need not be included with any later submissions.
(b) The statement of the issues determines the scope of the hearing and the matters on which evidence may be introduced. The issues may be revised by the presiding officer. A participant may obtain interlocutory review by the Commissioner of a decision by the presiding officer to revise the issues to include an issue on which the Commissioner has not granted a hearing or to
(c) A hearing is deemed to begin on the date of publication of the notice of hearing.
(a) If no objections are filed and no hearing is requested on a regulation under § 12.20(e), the regulation is effective on the date specified in the regulation as promulgated.
(b) The Commissioner shall publish a confirmation of the effective date of the regulation. The
(a) If a person who is subject to a notice of opportunity for hearing under § 12.21(b) does not request a hearing, the Commissioner will—
(1) Publish a final order denying or withdrawing approval of an NDA, NADA, device premarket approval application, or biologics license, in whole or in part, or revoking a device product development protocol or notice of completion, or declaring that such a protocol has not been completed, and stating the effective date of the order; and
(2) If the order involves withdrawal of approval of an NADA, forthwith revoke, in whole or in part, the applicable regulation, under section 512(i) of the act.
(b) If a person who is subject to a notice of opportunity for hearing under § 12.21(b) requests a hearing and others do not, the Commissioner may issue a final order covering all the drug or device products at once or may issue more than one final order covering different drug or device products at different times.
(a) A person who has filed a notice of participation under § 12.45 may appear in person or by counsel or other representative in any hearing and, subject to § 12.89, may be heard concerning all relevant issues.
(b) The presiding officer may strike a person's appearance for violation of the rules of conduct in § 12.90.
(a) Within 30 days after publication of the notice of hearing under § 12.35, a person desiring to participate in a hearing is to file with the Dockets Management Branch under § 10.20 a notice of participation in the following form:
Dockets Management Branch, Food and Drug Administration, Department of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
Under 21 CFR part 12, please enter the participation of:
Service on the above will be accepted by:
The following statements are made as part of this notice of participation:
A.
B.
(b) An amendment to a notice of participation should be filed with the Dockets Management Branch and served on all participants.
(c) No person may participate in a hearing who has not filed a written notice of participation or whose participation has been stricken under paragraph (e) of this section.
(d) The presiding officer may permit the late filing of a notice of participation upon a showing of good cause.
(e) The presiding officer may strike the participation of a person for nonparticipation in the hearing or failure to comply with any requirement of this subpart, e.g., disclosure of information as required by § 12.85 or the prehearing order issued under § 12.92. Any person whose participation is stricken may petition the Commissioner for interlocutory review.
(a)
(b)
(c)
(d)
(e)
The presiding officer in a hearing will be the Commissioner, a member of the Commissioner's office to whom the responsibility for the matter involved
The functions of the presiding officer begin upon designation and end upon the filing of the initial decision.
The presiding officer has all powers necessary to conduct a fair, expeditious, and orderly hearing, including the power to—
(a) Specify and change the date, time, and place of oral hearings and conferences;
(b) Establish the procedures for use in developing evidentiary facts, including the procedures in § 12.92(b) and to rule on the need for oral testimony and cross-examination under § 12.87(b);
(c) Prepare statements of the areas of factual disagreement among the participants;
(d) Hold conferences to settle, simplify, or determine the issues in a hearing or to consider other matters that may expedite the hearing;
(e) Administer oaths and affirmations;
(f) Control the course of the hearing and the conduct of the participants;
(g) Examine witnesses and strike their testimony if they fail to respond fully to proper questions;
(h) Rule on, admit, exclude, or limit evidence;
(i) Set the time for filing pleadings;
(j) Rule on motions and other procedural matters;
(k) Rule on motions for summary decision under § 12.93;
(l) Conduct the hearing in stages if the number of parties is large or the issues are numerous and complex;
(m) Waive, suspend, or modify any rule in this subpart under § 10.19 if the presiding officer determines that no party will be prejudiced, the ends of justice will be served, and the action is in accordance with law;
(n) Strike the participation of any person under § 12.45(e) or exclude any person from the hearing under § 12.90, or take other reasonable disciplinary action; and
(o) Take any action for the fair, expeditious, and orderly conduct of the hearing.
(a) A participant may request the presiding officer to disqualify himself/herself and withdraw from the proceeding. The ruling on any such request may be appealed in accordance with § 12.97(b).
(b) A presiding officer who is aware of grounds for disqualification shall withdraw from the proceeding.
(a) If the presiding officer is unable to act for any reason, the Commissioner will assign the powers and duties to another presiding officer. The substitution will not affect the hearing, except as the new presiding officer may order.
(b) Any motion based on the substitution must be made within 10 days.
(a) Submissions, including pleadings in a hearing, are to be filed with the Dockets Management Branch under § 10.20 except that only two copies need be filed. To determine compliance with filing deadlines in a hearing, a submission is considered submitted on the date it is actually received by the Dockets Management Branch. When this part allows a response to a submission and prescribes a period of time for the filing of the response, an additional 3 days are allowed for the filing of the response if the submission is served by mail.
(b) The person making a submission shall serve copies of it on the other participants. Submissions of documentary data and information are not required to be served on each participant, but any accompanying transmittal letter, pleading, summary, statement of position, certification under paragraph (d) of this section, or similar document must be served on each participant.
(c) Service is accomplished by mailing a submission to the address shown
(d) All submissions are to be accompanied by a certificate of service, or a statement that service is not required.
(e) No written submission or other portion of the administrative record may be held in confidence, except as provided in § 12.105.
(a) A participant who believes that compliance with the filing and service requirements of this section constitutes an unreasonable financial burden may submit to the Commissioner a petition to participate in forma pauperis.
(b) The petition will be in the form specified in § 10.30 except that the heading will be “Request to Participate in Forma Pauperis, Docket No. __.” Filing and service requirements for the petition are described in paragraph (c) of this section, whether or not the petition is granted. The petition must demonstrate that either: (1) The person is indigent and a strong public interest justifies participation, or (2) the person's participation is in the public interest because it can be considered of primary benefit to the general public.
(c) The Commissioner may grant or deny the petition. If the petition is granted, the participant need file only one copy of each submission with the Dockets Management Branch. The Dockets Management Branch will make sufficient additional copies for the administrative record, and serve a copy on each other participant.
Before or during a hearing, a person may, under § 10.85, request the Commissioner for an advisory opinion on whether any regulation or order under consideration in the proceeding applies to a specific situation.
(a) Before the notice of hearing is published under § 12.35, the director of the center responsible for the matters involved in the hearing shall submit the following to the Dockets Management Branch:
(1) The relevant portions of the administrative record of the proceeding. Portions of the administrative record not relevant to the issues in the hearing are not part of the administrative record.
(2) All documents in the director's files containing factual information, whether favorable or unfavorable to the director's position, which relate to the issues involved in the hearing.
(3) All other documentary data and information relied upon.
(4) A narrative position statement on the factual issues in the notice of hearing and the type of supporting evidence the director intends to introduce.
(5) A signed statement that, to the director's best knowledge and belief, the submission complies with this section.
(b) Within 60 days of the publication of the notice of hearing or, if no participant will be prejudiced, within another period of time set by the presiding officer, each participant shall submit to the Dockets Management Branch all data and information specified in paragraph (a)(2) through (5) of this section, and any objections that the administrative record filed under paragraph (a)(1) of this section is incomplete. With respect to the data and information specified in paragraph (a)(2) of this section, participants shall exercise reasonable diligence in identifying documents in files comparable to those described in that paragraph.
(c) Submissions required by paragraphs (a) and (b) of this section may be supplemented later in the proceeding, with the approval of the presiding officer, upon a showing that the material contained in the supplement was not reasonably known or available
(d) A participant's failure to comply substantially and in good faith with this section constitutes a waiver of the right to participate further in the hearing; failure of a party to comply constitutes a waiver of the right to a hearing.
(e) Participants may reference each other's submissions. To reduce duplicative submissions, participants are encouraged to exchange and consolidate lists of documentary evidence. If a particular document is bulky or in limited supply and cannot reasonably be reproduced, and it constitutes relevant evidence, the presiding officer may authorize submission of a reduced number of copies.
(f) The presiding officer will rule on questions relating to this section.
(a) The objective of a formal evidentiary hearing is the fair determination of relevant facts consistent with the right of all interested persons to participate and the public interest in promptly settling controversial matters affecting the public health and welfare.
(b) Accordingly, the evidence at a hearing is to be developed to the maximum extent through written submissions, including written direct testimony, which may be in narrative or in question-and-answer form.
(1) In a hearing, the issues may have general applicability and depend on general facts that do not concern particular action of a specific party, e.g., the safety or effectiveness of a class of drug products, the safety of a food or color additive, or a definition and standard of identity for a food; or the issues may have specific applicability to past action and depend upon particular facts concerning only that party, e.g., the applicability of a grandfather clause to a particular brand of a drug or the failure of a particular manufacturer to meet required manufacturing and processing specifications or other general standards.
(i) If the proceeding involves general issues, direct testimony will be submitted in writing, except on a showing that written direct testimony is insufficient for a full and true disclosure of relevant facts and that the participant will be prejudiced if unable to present oral direct testimony. If the proceeding involves particular issues, each party may determine whether, and the extent to which, each wishes to present direct testimony orally or in writing.
(ii) Oral cross-examination of witnesses will be permitted if it appears that alternative means of developing the evidence are insufficient for a full and true disclosure of the facts and that the party requesting oral cross-examination will be prejudiced by denial of the request or that oral cross-examination is the most effective and efficient means to clarify the matters at issue.
(2) Witnesses shall give testimony under oath.
(c) Except as provided in paragraph (d) of this section, in a hearing involving issuing, amending, or revoking a regulation or order, the originator of the proposal or petition or of any significant modification will be, within the meaning of 5 U.S.C. 556(d), the proponent of the regulation or order, and will have the burden of proof. A participant who proposes to substitute a new provision for a provision objected to has the burden of proof in relation to the new provision.
(d) At a hearing involving issuing, amending, or revoking a regulation or order relating to the safety or effectiveness of a drug, device, food additive, or color additive, the participant who is contending that the product is safe or effective or both and who is requesting approval or contesting withdrawal of approval has the burden of proof in establishing safety or effectiveness or both and thus the right to approval. The burden of proof remains on that participant in an amendment or revocation proceeding.
(a) A nonparty participant may—
(1) Attend all conferences (including the prehearing conference), oral proceedings, and arguments;
(2) Submit written testimony and documentary evidence for inclusion in the record;
(3) File written objections, briefs, and other pleadings; and
(4) Present oral argument.
(b) A nonparty participant may not—
(1) Submit written interrogatories; and
(2) Conduct cross-examination.
(c) A person whose petition is the subject of the hearing has the same right as a party.
(d) A nonparty participant will be permitted additional rights if the presiding officer concludes that the participant's interests would not be adequately protected otherwise or that broader participation is required for a full and true disclosure of the facts, but the rights of a nonparty participant may not exceed the rights of a party.
All participants in a hearing will conduct themselves with dignity and observe judicial standards of practice and ethics. They may not indulge in personal attacks, unseemly wrangling, or intemperate accusations or characterizations. Representatives of parties shall, to the extent possible, restrain clients from improprieties in connection with any proceeding. Disrespectful, disorderly, or contumacious language or conduct, refusal to comply with directions, use of dilatory tactics, or refusal to adhere to reasonable standards of orderly and ethical conduct during any hearing, constitute grounds for immediate exclusion from the proceeding by the presiding officer.
A prehearing conference will commence at the date, time, and place announced in the notice of hearing, or in a later notice, or as specified by the presiding officer in a notice modifying a prior notice. At that conference the presiding officer will establish the methods and procedures to be used in developing the evidence, determine reasonable time periods for the conduct of the hearing, and designate the times and places for the production of witnesses for direct and cross-examination if leave to conduct oral examination is granted on any issue, as far as practicable at that time.
(a) Participants in a hearing are to appear at the prehearing conference prepared to discuss and resolve all matters specified in paragraph (b) of this section.
(1) To expedite the hearing, participants are encouraged to prepare in advance for the prehearing conference. Participants should cooperate with each other, and request information and begin preparation of testimony at the earliest possible time. Failure of a participant to appear at the prehearing conference or to raise matters that could reasonably be anticipated and resolved at that time will not delay the progress of the hearing, and constitutes a waiver of the rights of the participant regarding such matters as objections to the agreements reached, actions taken, or rulings issued by the presiding officer and may be grounds for striking the participation under § 12.45.
(2) Participants shall bring to the prehearing conference the following specific information, which will be filed with the Dockets Management Branch under § 12.80:
(i) Any additional information to supplement the submission filed under § 12.85, which may be filed if approved under § 12.85(c).
(ii) A list of all witnesses whose testimony will be offered, orally or in writing, at the hearing, with a full curriculum vitae for each. Additional witnesses may later be identified, with the approval of the presiding officer, on a showing that the witness was not reasonably available at the time of the prehearing conference or the relevance of the witness' views could not reasonably have been foreseen at that time.
(iii) All prior written statements including articles and any written statement signed or adopted, or a recording
(
(
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(b) The presiding officer will conduct a prehearing conference for the following purposes:
(1) To determine the areas of factual disagreement to be considered at the hearing. The presiding officer may hold conferences off the record in an effort to reach agreement on disputed factual questions.
(2) To identify the most appropriate techniques for developing evidence on issues in controversy and the manner and sequence in which they will be used, including, where oral examination is to be conducted, the sequence in which witnesses will be produced for, and the time and place of, oral examination. The presiding officer may consider—
(i) Submission of narrative statements of position on factual issues in controversy;
(ii) Submission of evidence or identification of previously submitted evidence to support such statements, such as affidavits, verified statements of fact, data, studies, and reports;
(iii) Exchange of written interrogatories directed to particular witnesses;
(iv) Written requests for the production of additional documentation, data, or other relevant information;
(v) Submission of written questions to be asked by the presiding officer of a specific witness; and
(vi) Identification of facts for which oral examination and/or cross-examination is appropriate.
(3) To group participants with substantially like interests for presenting evidence, making motions and objections, including motions for summary decision, filing briefs, and presenting oral argument.
(4) To hear and rule on objections to admitting into evidence information submitted under § 12.85.
(5) To obtain stipulations and admissions of facts.
(6) To take other action that may expedite the hearing.
(c) The presiding officer shall issue, orally or in writing, a prehearing order reciting the actions taken at the prehearing conference and setting forth the schedule for the hearing. The order will control the subsequent course of the hearing unless modified by the presiding officer for good cause.
(a) After the hearing commences, a participant may move, with or without supporting affidavits, for a summary decision on any issue in the hearing. Any other participant may, within 10 days after service of the motion, which time may be extended for an additional 10 days for good cause, serve opposing affidavits or countermove for summary decision. The presiding officer may set the matter for argument and call for the submission of briefs.
(b) The presiding officer will grant the motion if the objections, requests for hearing, other pleadings, affidavits, and other material filed in connection with the hearing, or matters officially noticed, show that there is no genuine issue as to any material fact and that a participant is entitled to summary decision.
(c) Affidavits should set forth facts that would be admissible in evidence and show affirmatively that the affiant is competent to testify to the matters stated. When a properly supported motion for summary decision is made, a participant opposing the motion may not rest upon mere allegations or denials or general descriptions of positions and contentions; affidavits or other responses must set forth specific facts showing that there is a genuine issue of fact for the hearing.
(d) Should it appear from the affidavits of a participant opposing the motion that for sound reasons stated, facts essential to justify the opposition cannot be presented by affidavit, the presiding officer may deny the motion for summary decision, order a continuance to permit affidavits or additional
(e) If on motion under this section a summary decision is not rendered upon the whole case or for all the relief asked. and evidentiary facts need to be developed, the presiding officer will issue an order specifying the facts that appear without substantial controversy and directing further evidentiary proceedings. The facts so specified will be deemed established.
(f) A participant may obtain interlocutory review by the Commissioner of a summary decision of the presiding officer.
(a) A hearing consists of the development of evidence and the resolution of factual issues as set forth in this subpart and in the prehearing order.
(b) All orders, transcripts, written statements of position, written direct testimony, written interrogatories and responses, and any other written material submitted in the proceeding is a part of the administrative record of the hearing, and will be promptly placed on public display in the office of the Dockets Management Branch, except as provided in § 12.105.
(c) Written evidence, identified as such, is admissible unless a participant objects and the presiding officer excludes it on objection of a participant or on the presiding officer's own initiative.
(1) The presiding officer may exclude written evidence as inadmissible only if—
(i) The evidence is irrelevant, immaterial, unreliable, or repetitive;
(ii) Exclusion of part or all of the written evidence of a participant is necessary to enforce the requirements of this subpart; or
(iii) The evidence was not submitted as required by § 12.85.
(2) Items of written evidence are to be submitted as separate documents, sequentially numbered, except that a voluminous document may be submitted in the form of a cross-reference to the documents filed under § 12.85.
(3) Written evidence excluded by the presiding officer as inadmissible remains a part of the administrative record, as an offer of proof, for judicial review.
(d) Testimony, whether on direct or on cross-examination, is admissible as evidence unless a participant objects and the presiding officer excludes it.
(1) The presiding officer may exclude oral evidence as inadmissible only if—
(i) The evidence is irrelevant, immaterial, unreliable, or repetitive; or
(ii) Exclusion of part or all of the evidence is necessary to enforce the requirements of this part.
(2) If oral evidence is excluded as inadmissible, the participant may take written exception to the ruling in a brief to the Commissioner, without taking oral exception at the hearing. Upon review, the Commissioner may reopen the hearing to permit the evidence to be admitted if the Commissioner determines that its exclusion was erroneous and prejudicial.
(e) The presiding officer may schedule conferences as needed to monitor the program of the hearing, narrow and simplify the issues, and consider and rule on motions, requests, and other matters concerning the development of the evidence.
(f) The presiding officer will conduct such proceedings as are necessary for the taking of oral testimony, for the oral examination of witnesses by the presiding officer on the basis of written questions previously submitted by the parties, and for the conduct of cross-examination of witnesses by the parties. The presiding officer shall exclude irrelevant or repetitious written questions and limit oral cross-examination to prevent irrelevant or repetitious examination.
(g) The presiding officer shall order the proceedings closed for the taking of oral testimony relating to matters specified in § 10.20(j)(2)(i) (
(a) Official notice may be taken of such matters as might be judicially noticed by the courts of the United States or of any other matter peculiarly within the general knowledge of FDA as an expert agency.
(b) If official notice is taken of a material fact not appearing in the evidence of record, a participant, on timely request, will be afforded an opportunity to show the contrary.
(a) Promptly after the taking of evidence is completed, the presiding officer will announce a schedule for the filing of briefs. Briefs are to be filed ordinarily within 45 days of the close of the hearing. Briefs must include a statement of position on each issue, with specific and complete citations to the evidence and points of law relied on. Briefs must contain proposed findings of fact and conclusions of law.
(b) The presiding officer may, as a matter of discretion, permit oral argument after the briefs are filed.
(c) Briefs and oral argument are to refrain from disclosing specific details of written and oral testimony and documents relating to matters specified in § 10.20(j)(2)(i)(
(a) Except as provided in paragraph (b) of this section and in §§ 12.35(b), 12.45(e), 12.93(f), and 12.99(d), when an interlocutory appeal is specifically authorized by this subpart, rulings of the presiding officer may not be appealed to the Commissioner before the Commissioner's consideration of the entire record of the hearing.
(b) A ruling of the presiding officer is subject to interlocutory appeal to the Commissioner if the presiding officer certifies on the record or in writing that immediate review is necessary to prevent exceptional delay, expense, or prejudice to any participant, or substantial harm to the public interest.
(c) When an interlocutory appeal is made to the Commissioner, a participant may file a brief with the Commissioner only if specifically authorized by the presiding officer or the Commissioner, and if such authorization is granted, within the period the Commissioner directs. If a participant is authorized to file a brief, any other participant may file a brief in opposition, within the period the Commissioner directs. If no briefs are authorized, the appeal will be presented as an oral argument to the Commissioner. The oral argument will be transcribed. If briefs are authorized, oral argument will be heard only at the discretion of the Commissioner.
(a) The presiding officer will arrange for a verbatim stenographic transcript of oral testimony and for necessary copies of the transcript.
(b) One copy of the transcript will be placed on public display in the office of the Dockets Management Branch upon receipt.
(c) Except as provided in § 12.105, copies of the transcript may be obtained by application to the official reporter and payment of costs thereof or under part 20.
(d) Witnesses, participants, and counsel have 30 days from the time the transcript becomes available to propose corrections in the transcript of oral testimony. Corrections are permitted only for transcription errors. The presiding officer shall promptly order justified corrections.
(a) A motion on any matter relating to the proceeding is to be filed under § 12.80, and must include a draft order, except one made in the course of an oral hearing before the presiding officer.
(b) A response may be filed within 10 days of service of a motion. The time may be shortened or extended by the presiding officer for good cause shown.
(c) The moving party has no right to reply, except as permitted by the presiding officer.
(d) The presiding officer shall rule upon the motion and may certify that ruling to the Commissioner for interlocutory review.
(a) The record of a hearing consistsof—
(1) The order or regulation or notice of opportunity for hearing that gave rise to the hearing;
(2) All objections and requests for hearing filed by the Dockets Management Branch under §§ 12.20 through 12.22;
(3) The notice of hearing published under § 12.35;
(4) All notices of participation filed under § 12.45;
(5) All
(6) All submissions filed under § 12.82, e.g., the submissions required by § 12.85, all other documentary evidence and written testimony, pleadings, statements of position, briefs, and other similar documents;
(7) The transcript, written order, and all other documents relating to the prehearing conference, prepared under § 12.92;
(8) All documents relating to any motion for summary decision under § 12.93;
(9) All documents of which official notice is taken under § 12.95;
(10) All pleadings filed under § 12.96;
(11) All documents relating to any interlocutory appeal under § 12.97;
(12) All transcripts prepared under § 12.98; and
(13) Any other document relating to the hearing and filed with the Dockets Management Branch by the presiding officer or any participant;
(b) The record of the administrative proceeding is closed—
(1) With respect to the taking of evidence, when specified by the presiding officer; and
(2) With respect to pleadings, at the time specified in § 12.96(a) for the filing of briefs.
(c) The presiding officer may reopen the record to receive further evidence at any time before the filing of the initial decision.
Documents in the record will be publicly available in accordance with § 10.20(j). Documents available for examination or copying will be placed on public display in the office of the Dockets Management Branch promptly upon receipt in that office.
(a) The presiding officer shall prepare and file an initial decision as soon as possible after the filing of briefs and oral argument.
(b) The initial decision must contain—
(1) Findings of fact based issued upon relevant, material, and reliable evidence of record;
(2) Conclusions of law;
(3) A discussion of the reasons for the findings and conclusions, including a discussion of the significant contentions made by any participant;
(4) Citations to the record supporting the findings and conclusions;
(5) An appropriate regulation or order supported by substantial evidence of record and based upon the findings of fact and conclusions of law; and
(6) An effective date for the regulation or order.
(c) The initial decision must refrain from disclosing specific details of matters specified in § 10.20(j)(2)(i) (
(d) The initial decision is to be filed with the Dockets Management Branch and served upon all participants. Once the initial decision is filed with the Dockets Management Branch, the presiding officer has no further jurisdiction over the matter, and any motions or requests filed with the Dockets Management Branch will be decided by the Commissioner.
(e) The initial decision becomes the final decision of the Commissioner by operation of law unless a participant files exceptions with the Dockets Management Branch under § 12.125(a) or the Commissioner files a notice of review under § 12.125(f).
(f) Notice that an initial decision has become the decision of the Commissioner without appeal to or review by the Commissioner will be published in
(a) A participant may appeal an initial decision to the Commissioner by filing exceptions with the Dockets Management Branch, and serving them on the other participants, within 60 days of the date of the initial decision.
(b) Exceptions must specifically identify alleged errors in the findings of fact or conclusions of law in the initial decision, and provide supporting citations to the record. Oral argument before the Commissioner may be requested in the exceptions.
(c) Any reply to the exceptions is to be filed and served within 60 days of the end of the period for filing exceptions.
(d) The Commissioner may extend the time for filing exceptions under paragraph (a) of this section or replies to exceptions under paragraph (c) of this section only upon a showing by a participant of extraordinary circumstances. Such an extension shall be requested by filing a written request with the Commissioner's Executive Secretariat (HF-40) and serving copies of the request on the Dockets Management Branch (HFA-305), the Chief Counsel (GCF-1), and all hearing participants.
(e) If the Commissioner decides to hear oral argument, the participants will be informed of the date, time, and place, the amount of time allotted to each participant, and the issues to be addressed.
(f) Within 10 days following the expiration of the time for filing exceptions (including any extensions), the Commissioner may file with the Dockets Management Branch, and serve on the participants, a notice of the Commissioner's determination to review the initial decision. The Commissioner may invite the participants to file briefs or present oral argument on the matter. The time for filing briefs or presenting oral argument will be specified in that or a later notice.
(a) On appeal from or review of the initial decision, the Commissioner has all the powers given to make the initial decision. On the Commissioner's own initiative or on motion, the Commissioner may remand the matter to the presiding officer for any further action necessary for a proper decision.
(b) The scope of the issues on appeal is the same as the scope of the issues at the public hearing unless the Commissioner specifies otherwise.
(c) As soon as possible after the filing of briefs and any oral argument, the Commissioner will issue a final decision in the proceeding, which meets the requirements established in § 12.120 (b) and (c).
(d) The Commissioner may adopt the initial decision as the final decision.
(e) Notice of the Commissioner's decision will be published in the
Following notice or publication of the final decisions, a participant may petition the Commissioner for reconsideration of any part or all of the decision under § 10.33 or may petition for a stay of the decision under § 10.35.
(a) The Commissioner's final decision constitutes final agency action from which a participant may petition for judicial review under the statutes governing the matter involved. Before requesting an order from a court for a stay of action pending review, a participant shall first submit a petition for a stay of action under § 10.35.
(b) Under 28 U.S.C. 2112(a), FDA will request consolidation of all petitions related to a particular matter.
The Chief Counsel for FDA has been designated by the Secretary as the officer on whom copies of petitions of judicial review are to be served. This officer is responsible for filing the record on which the final decision is based. The record of the proceeding is certified by the Commissioner.
5 U.S.C. 551-558, 701-721; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b-263n, 264.
The procedures in this part apply when—
(a) The Commissioner concludes, as a matter of discretion, that it is in the public interest to hold a public hearing before a Public Board of Inquiry (
(b) Under specific sections of this chapter a matter before FDA is subject to a hearing before a Board; or
(c) Under § 12.32, a person who has a right to an opportunity for a formal evidentiary public hearing waives that opportunity and requests that a Board act as an administrative law tribunal concerning the matters involved, and the Commissioner decides to accept this request.
If the Commissioner determines that a Board should be established to conduct a hearing on any matter, a notice of hearing will be published in the
(a) If the hearing is under § 13.1 (a) or (b), all applicable information described in § 12.32(e).
(1) Any written document that is to be the subject matter of the hearing will be published as a part of the notice, or the notice will refer to it if the document has already been published in the
(2) For purposes of a hearing under § 13.1 (a) or (b), all participants who file a notice of participation under § 12.32(e)(6)(ii) are deemed to be parties and entitled to participate in selection of the Board under § 13.15(b).
(b) If the hearing is in lieu of a formal evidentiary hearing, as provided in § 13.1(c), all of the information described in § 12.32(e).
(a) All members of a Board are to have medical, technical, scientific, or other qualifications relevant to the issues to be considered, are subject to the conflict of interest rules applicable to special Government employees, and are to be free from bias or prejudice concerning the issues involved. A member of a Board may be a full-time or part-time Federal Government employee or may serve on an FDA advisory committee but, except with the agreement of all parties, may not currently be a full-time or part-time employee of FDA or otherwise act as a special Government employee of FDA.
(b) Within 30 days of publication of the notice of hearing, the director of the center of FDA responsible for a
(1) Any two or more persons entitled to nominate members may agree upon a joint list of five qualified nominees.
(2) The lists of nominees must be submitted to the persons entitled to submit a list of nominees under this paragraph but not to all participants. Within 10 days of receipt of the lists of nominees, such persons may submit comments to the Dockets Management Branch on whether the nominees of the other persons meet the criteria established in paragraph (a) of this section. A person submitting comments to the Dockets Management Branch shall submit them to all persons entitled to submit a list of nominees.
(3) The lists of nominees and comments on them are to be held in confidence by the Dockets Management Branch as part of the administrative record of the proceeding and are not to be made available for public disclosure, and all persons who submit or receive them shall similarly hold them in confidence. This portion of the administrative record remains confidential but is available for judicial review in the event that it becomes relevant to any issue before a court.
(c) After reviewing the lists of nominees and any comments, the Commissioner will choose three qualified persons as members of a Board. One member will be from the lists of nominees submitted by the director of the center and by any person whose petition was granted and is the subject of the hearing. The second will be from the lists of nominees submitted by the other parties. The Commissioner may choose the third member from any source. That member is the Chairman of the Board.
(1) If the Commissioner is unable to find a qualified person with no conflict of interest from among a list of nominees or if additional information is needed, the Commissioner will request the submission of the required additional nominees or information.
(2) If a person fails to submit a list of nominees as required by paragraph (b) of this section, the Commissioner may choose a qualified member without further consultation with that person.
(3) The Commissioner will announce the members of a Board by filing a memorandum in the record of the proceeding and sending a copy to all participants.
(d) Instead of using the selection method in paragraphs (b) and (c) of this section, the director of the center, the other parties to the proceeding, and any person whose petition was granted and is the subject of the hearing, may, with the approval of the Commissioner, agree that a standing advisory committee listed in § 14.80 constitutes the Board for a particular proceeding, or that another procedure is to be used for selection of the members of the Board, or that the Board consists of a larger number of members.
(e) The members of a Board serve as consultants to the Commissioner and are special Government employees or Government employees. A Board functions as an administrative law tribunal in the proceeding and is not an advisory committee subject to the requirements of the Federal Advisory Committee Act or part 14.
(f) The Chairman of the Board has the authority of a presiding officer set out in § 12.70.
(a) The proceeding of a Board are subject to the provisions of § 10.55 relating to separation of functions and ex parte communications. Representatives of the participants in any proceeding before a Board, including any members of the office of the Chief Counsel of FDA assigned to advise the center responsible for the matter, may have no contact with the members of the Board, except as participants in the proceeding, and may not participate in the deliberations of the Board.
(b) Administrative support for a Board is to be provided only by the office of the Commissioner and the office of the Chief Counsel for FDA.
(a) Submissions are to be filed with the Dockets Management Branch under § 10.20.
(b) The person making a submission shall serve copies of it on each participant in the proceeding, except as provided in §§ 13.10(b)(2) and 13.45. Submissions of documentary data and information need not be sent to each participant, but any accompanying transmittal letter, summary, statement of position, certification under paragraph (d) of this section, or similar document must be.
(c) A submission must be mailed to the address shown in the notice of appearance or personally delivered.
(d) All submissions are to be accompanied by a certificate of service, or a statement that service is not required.
(e) No written submission or other portion of the administrative record may be held in confidence, except as provided in §§ 13.10(b)(2) and 13.45.
(f) A participant who believes that compliance with the requirements of this section constitutes an unreasonable financial burden may submit to the Commissioner a petition to participate in forma pauperis in the form and manner specified in § 12.82.
(a) Before the notice of hearing is published under § 13.5, the director of the center responsible for the matters involved in the hearing must submit to the Dockets Management Branch—
(1) The relevant portions of the existing administrative record of the proceeding. Portions of the administrative record not relevant to the issues in the hearing are not part of the administrative record;
(2) A list of all persons whose views will be presented orally or in writing at the hearing;
(3) All documents in the director's files containing factual information, whether favorable or unfavorable to the director's position, which relate to the issues involved in the hearing.
(4) All other documentary information relied on; and
(5) A signed statement that, to the best of the director's knowledge and belief, the submission complies with this section.
(b) Within the time prescribed in the notice of hearing published under § 13.5, each participant shall submit to the Dockets Management Branch all information specified in paragraph (a)(2) through (5) of this section and any objections that the administrative record filed under paragraph (a)(1) of this section is incomplete. With respect to the information specified in paragraph (a)(3) of this section, participants are to exercise reasonable diligence in identifying documents in files comparable to those described in that paragraph.
(c) The submissions required by paragraphs (a) and (b) of this section may be supplemented later in the proceeding, with the approval of the Board, on a showing that the views of the persons or the material contained in the supplement was not known or reasonably available when the initial submission was made or that the relevance of the views of the persons or the material contained in the supplement could not reasonably have been foreseen.
(d) The failure to comply substantially and in good faith with this section in the case of a participant constitutes a waiver of the right to participate further in the hearing and in
(e) The Chairman rules on questions relating to this section. Any participant dissatisfied with a ruling may petition the Commissioner for interlocutory review.
(a) The purpose of a Board is to review medical, scientific, and technical issues fairly and expeditiously. The proceedings of a Board are conducted as a scientific inquiry rather than a legal trial.
(b) A Board may not hold its first hearing until after all participants have submitted the information required by § 13.25.
(c) The Chairman calls the first hearing of the Board. Notice of the time and location of the first hearing is to be published at least 15 days in advance and the hearing will be open to the public. All participants will have an opportunity at the first hearing to make an oral presentation of the information and views which in their opinion are pertinent to the resolution of the issues being considered by a Board. A participant's presentation may be made by more than one person. The Chairman determines the order of the presentation. Participants may not interrupt a presentation, but members of the Board may ask questions. At the conclusion of a presentation, each of the other participants may briefly comment on the presentation and may request that the Board conduct further questioning on specified matters. Members of the Board may then ask further questions. Any other participant may be permitted to ask questions if the Chairman determines that it will help resolve the issues.
(d) The hearing is informal and the rules of evidence do not apply. No motions or objections relating to the admissibility of information and views may be made or considered, but other participants may comment upon or rebut all such information and views. No participant may interrupt the presentation of another participant for any reason.
(e) Within the time specified by the Board after its first hearing, participants may submit written rebuttal information and views in accordance with § 13.20. The Chariman will then schedule a second hearing, if requested and justified by a participant. A second hearing, and any subsequent hearing, will be called only if the Chairman concludes that it is needed to fully and fairly present information that cannot otherwise adequately be considered and to properly resolve the issues. Notice of the time and location of any hearing is to be published at least 15 days in advance. The hearing is open to the public.
(f) A Board may consult with any person who it concludes may have information or views relevant to the issues.
(1) The consultation may occur only at an announced hearing of a Board. Participants have the right to suggest or, with the permission of the Chairman, ask questions of the consultant and present rebuttal information and views, as provided in paragraphs (c) and (d) of this section except that written statements may be submitted to the Board with the consent of all participants.
(2) A participant may submit a request that the Board consult with a specific person who may have information or views relevant to the issues. The request will state why the person should be consulted and why the person's views cannot be furnished to the Board by means other than having FDA arrange for the person's appearance. The Board may, in its discretion, grant or deny the request.
(g) All hearings are to be transcribed. All hearings are open to the public, except that a hearing under § 10.20(j)(3) is closed to all persons except those persons making and participating in the presentation and Federal Government executive branch employees and special Government employees. At least a majority of Board members are to be present at every hearing. The executive sessions of a Board, during which a Board deliberates on the issues, are to be closed and are not transcribed. All members of the Board shall vote on the report of the Board.
(h) All legal questions are to be referred to the Chief counsel for FDA for resolution. The Chief Counsel's advice on any matter of procedure or legal authority is to be transmitted in writing and made a part of the record or presented in open session and transcribed.
(i) At the conclusion of all public hearings the Board will announce that the record is closed to receiving information. The Board will provide an opportunity for participants to submit written statements of their positions, with proposed findings and conclusions, and may in its discretion, provide an opportunity for participants to summarize their positions orally.
(j) The Board will prepare a decision on all issues. The decision is to include specific findings and references supporting and explaining the Board's conclusions, and a detailed statement of the reasoning on which the conclusions are based. Any member of the Board may file a separate report stating additional or dissenting views.
(a) The administrative record of a hearing before a Board consists of the following:
(1) All relevant
(2) All written submissions under § 13.20.
(3) The transcripts of all hearings of the Board.
(4) The initial decision of the Board.
(b) The record of the administrative proceeding is closed—
(1) Relevant to receiving information and data, at the time specified in § 13.30(i); and
(2) Relevant to pleadings, at the time specified in § 13.30(i) for filing a written statement of position with proposed findings and conclusions.
(c) The Board may, in its discretion, reopen the record to receive further evidence at any time before filing an initial decision.
(a) The availability for public examination and copying of each document which is a part of the administrative record of the hearing is governed by § 10.20(j). Each document available for public examination or copying is placed on public display in the office of the Dockets Management Branch promptly upon receipt in that office.
(b) Lists of nominees and comments submitted on them under § 13.10(b)(3) are not subject to disclosure unless they become an issue in a court proceeding.
The administrative record of the hearing specified in § 13.40(a) constitutes the exclusive record for decision.
5 U.S.C. App. 2; 15 U.S.C. 1451-1461; 21 U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.
(a) This part governors the procedures when any of the following applies:
(1) The Commissioner concludes, as a matter of discretion, that it is in the public interest for a standing or ad hoc policy or technical public advisory committee (
(2) Under specific provisions in the act or other sections of this chapter, a matter is subject to a hearing before an advisory committee. The specific provisions are—
(i) Section 14.120 on review of a performance standard for an electronic product by the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC);
(ii) Section 14.140 on review of the safety of color additives;
(iii) Section 14.160 on review of the safety and effectiveness of human prescription drugs;
(iv) Section 330.10 on review of the safety and effectiveness of over-the-counter drugs;
(v) Section 601.25 on review of the safety and effectiveness of biological drugs;
(vi) Part 860, on classification of devices;
(vii) Section 514(g)(5) of the act on establishment, amendment, or revocation of a device performance standard;
(viii) Section 515 of the act on review of device premarket approval applications and product development protocols; and
(ix) Section 520(f) of the act on review of device good manufacturing practice regulations.
(3) A person who has a right to an opportunity for a formal evidentiary public hearing under part 12 waives that opportunity and instead under § 12.32 requests a hearing before an advisory committee, and the Commissioner, as a matter of discretion, accepts the request.
(b) In determining whether a group is a
(1) An advisory committee may be a standing advisory committee or an ad hoc advisory committee. All standing advisory committees are listed in § 14.100.
(2) An advisory committee may be a policy advisory committee or a technical advisory committee. A policy advisory committee advises on broad and general matters. A technical advisory committee advises on specific technical or scientific issues, which may relate to regulatory decisions before FDA.
(3) An advisory committee includes any of its subgroups when the subgroup is working on behalf of the committee. Section 14.40(d) describes when a subgroup will be established as an advisory committee separate from the parent committee.
(4) A committee composed entirely of full-time Federal Government employees is not an advisory committee.
(5) An advisory committee ordinarily has a fixed membership, a defined purpose of providing advice to the agency on a particular subject, regular or periodic meetings, and an organizational structure, for example, a chairman and staff, and serves as a source of independent expertise and advice rather than as a representative of or advocate for any particular interest. The following groups are not advisory committees:
(i) A group of persons convened on an ad hoc basis to discuss a matter of current interest to FDA, but which has no continuing function or organization and does not involve substantial special preparation.
(ii) A group of two or more FDA consultants meeting with the agency on an ad hoc basis.
(iii) A group of experts who are employed by a private company or a trade association which has been requested by FDA to provide its views on a regulatory matter pending before FDA.
(iv) A consulting firm hired by FDA to provide advice regarding a matter.
(6) An advisory committee that is utilized by FDA is subject to this subpart even though it was not established by FDA. In general, a committee is
(i) A committee formed by an independent scientific or technical organization is utilized if FDA requests advice of that committee rather than of the parent organization, or if the circumstances show that the advice given is that of the committee and not of the parent organization. A committee formed by an independent scientific or technical organization is not utilized if FDA requests advice of the organization rather than of a committee and if the recommendations of any committee formed in response to the request are subject to substantial independent policy and factual review by the governing body of the parent organization.
(ii) A committee is not utilized by FDA if it provides only information, as contrasted with advice or opinions or recommendations.
(iii) FDA is charged with seeking out the views of all segments of the public on enforcement of the laws administered by the Commissioner. The fact that a group of individuals or a committee meets regularly with FDA, for
(7) The inclusion of one or two FDA consultants who are special Government employees on an internal FDA committee does not make that committee an advisory committee.
(8) A Public Board of Inquiry established under part 13, or other similar group convened by agreement between the parties to a regulatory proceeding pending before FDA to review and prepare an initial decision on the issues in lieu of a formal evidentiary public hearing, is acting as an administrative law tribunal and is not an advisory committee.
(9) An open public conference or meeting conducted under § 10.65(b) is not an advisory committee meeting.
(10) An FDA committee that primarily has operational responsibility rather than that of providing advice and recommendations is not an advisory committee, for example, the Research Involving Human Subjects Committee (RIHSC).
(c) This part applies only when a committee convenes to conduct committee business. Site visits, social gatherings, informal discussions by telephone or during meals or while traveling or at other professional functions, or other similar activities do not constitute a meeting.
(d) An advisory committee that is utilized but not established by FDA is subject to this part only to the extent of such utilization, and not concerning any other activities of such committee.
(e) Any conference or meeting between an employee of FDA and a committee or group which is not an advisory committee shall be subject to § 10.65 or other provisions specifically applicable to the committee or group, for example, part 13 for a Public Board of Inquiry.
(f) This part applies to all FDA advisory committees, except to the extent that specific statutes require otherwise for a particular committee, for example, TEPRSSC, the Board of Tea Experts, and advisory committees established under the Medical Device Amendments of 1976.
(a) An advisory committee is utilized to conduct public hearings on matters of importance that come before FDA, to review the issues involved, and to provide advice and recommendations to the Commissioner.
(b) The Commissioner has sole discretion concerning action to be taken and policy to be expressed on any matter considered by an advisory committee.
A person who alleges noncompliance by the Commissioner or an advisory committee with any provision of this part or the Federal Advisory Committee Act may pursue the following administrative remedies:
(a) If the person objects to any action, including a failure to act, other than denial of access to an advisory committee document, the person shall submit a petition in the form and in accordance with the requirements of § 10.30. The provisions of § 10.45 relating to exhaustion of administrative remedies are applicable.
(1) If the person objects to past action, the person shall submit the petition within 30 days after the action objected to. If the Commissioner determines that there was noncompliance with any provision of this subpart or of the Federal Advisory Committee Act, the Commissioner will grant any appropriate relief and take appropriate steps to prevent its future recurrence.
(2) If the person objects to proposed future action, the Commissioner will expedite the review of the petition and make a reasonable effort to render a decision before the action concerned in the petition.
(3) If the person objects to action that is imminent or occurring and which could not reasonably have been anticipated, e.g., the closing of a portion of a meeting which is made known
(b) If the person objects to a denial of access to an advisory committee document, administrative review is in accordance with the procedures established by the Department of Health and Human Services under 45 CFR 5.34.
This part applies to Congress, individual Members of Congress, and other employees or representatives of Congress in the same way that they apply to any other member of the public, except that disclosure of advisory committee records to Congress is governed by § 20.87.
(a) FDA may enter into contracts with independent scientific or technical organizations to obtain advice and recommendations on particular matters, and these organizations may in turn undertake such work through existing or new committees. Whether a particular committee working under such a contract is an advisory committee subject to the Federal Advisory Committee Act and this subpart depends upon application of the criteria and principles in § 14.1(b).
(b) The following minimum standards apply to any committee of an independent scientific or technical organization which is working under a contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory committee:
(1) The committee shall give public notice of its meetings and agenda, and provide interested persons an opportunity to submit relevant information and views in writing at any time, and orally at specified times. The notice may be published in the
(2) Minutes of open sessions are to be maintained, with all written submissions attached which were made to the committee in open session. After approval, the minutes are to be forwarded to the Dockets Management Branch and placed on public display. The extent to which the committee maintains minutes of closed sessions is in the discretion of the committee.
(3) In selecting the members of the committee, the organization involved is to apply the principles relating to conflicts of interest that FDA uses in establishing a public advisory committee. Those principles are set out or cross-referenced in this part and in part 19. Upon request, FDA will assist or provide guidance to any organization in meeting this requirement.
(a) Before the first of each month, and at least 15 days in advance of a meeting, the Commissioner will publish a notice in the
(b) The
(1) The name of the committee;
(2) The date, time, and place of the meeting;
(3) The general function of the committee;
(4) A list of all agenda items, showing whether each will be discussed in an open or closed portion of the meeting;
(5) If any portion of the meeting is closed, a statement of the time of the open and closed portions;
(6) The nature of the subjects to be discussed during, and the reasons for closing, any closed portion of the meeting;
(7) The time set aside for oral statements and other public participation;
(8) The name, address, and telephone number of the advisory committee executive secretary and any other agency employee designated as responsible for the administrative support for the advisory committee;
(9) A statement that written submissions may be made to the advisory committee through the executive secretary at any time, unless a cutoff date has been established under § 14.35(d)(2);
(10) When a notice is published in the
(c) If a public hearing before an advisory committee is used in lieu of a formal evidentiary public hearing under § 14.1(a)(3), an initial notice of hearing is to be published separately in the
(d) A list of advisory committee meetings will be distributed to the press by the Associate Commissioner for Public Affairs.
(a) No advisory committee may conduct a meeting except at the call or with the advance approval of, and with an agenda approved by, the designated Federal employee or alternate. No meeting may be held in the absence of the designated Federal employee.
(1) If any matter is added to the agenda after its publication in the
(2) The advisory committee meeting is to be conducted in accordance with the approved final agenda insofar as practical.
(b) Advisory committee meetings will be held at places that are reasonably accessible to the public. All advisory committee meetings will be held in Washington, DC, or Rockville, MD, or the immediate vicinity, unless the Commissioner receives and approves a written request from the advisory committee for a different location. A different location may be approved when one or more of the following applies:
(1) The total cost of the meeting to the Government will be reduced.
(2) A substantial number of the committee members will be at the location at no expense to FDA for other reasons, e.g., for a meeting of a professional association.
(3) It is a central location more readily accessible to committee members.
(4) There is a need for increased participation available at that location.
(5) The committee wishes to review work or facilities in a specific location.
(6) The committee is concerned with matters that functionally or historically occur in some other location, e.g., the Board of Tea Experts and the Science Advisory Board of the National Center for Toxicological Research will generally hold meetings in Brooklyn, NY, and in the Little Rock, AR, vicinity, respectively.
(c) Advisory committee members may, with the approval of FDA, conduct onsite visits relevant to their work.
(d) Unless the committee charter provides otherwise, a quorum for an advisory committee is a majority of the current voting members of the committee, except as provided in § 14.125(c) for TEPRSSC. Any matter before the advisory committee is to be decided by a majority vote of the voting members present at the time, except that the designated Federal official may require that any final report be voted upon by all current voting members of the committee. Any current voting member of the committee may file a separate report with additional or minority views.
(e) If space is available, any interested person may attend any portion of any advisory committee meeting which is not closed.
(f) Whenever feasible, meetings are to be held in government facilities or other facilities involving the least expense to the public. The size of the meeting room is to be reasonable, considering such factors as the size of the committee, the number of persons expected to attend a meeting, and the resources and facilities available.
(g) The Commissioner may authorize a meeting to be held by conference telephone call. For these meetings, a speaker phone will be provided in a conference room located in Washington, DC, or Rockville, MD, or the immediate vicinity, to permit public participation in open portions of the meetings, as provided in §§ 14.25 and 14.29. These meetings generally will be brief, and authorized—
(1) For the purpose of taking final votes or otherwise confirming actions taken by the committee at other meetings; or
(2) Where time does not permit a meeting to be held at a central location.
(h) Any portion of a meeting will be closed by the committee chairman only when matters are to be discussed which the Commissioner has determined may be considered in closed session under § 14.27(b). If a portion of the meeting is closed, the closed portion will be held after the conclusion of the open portion whenever practicable.
(i) Any committee member may take notes during meetings and report and discuss committee deliberations after a meeting is completed and before official minutes or a report are available, within the rules and regulations adopted by FDA and by the advisory committee with the concurrence of FDA, including all of the following:
(1) There may be no attribution of individual views expressed in a closed session or revealing of numerical votes.
(2) There may be no reporting or discussion of any particular matter if the committee or FDA specifically so directs, e.g., where deliberations are incomplete or involve a sensitive regulatory decision that requires preparation or implementation.
(3) There may be no reporting or discussion of information prohibited from public disclosure under § 14.75.
(4) Notes or minutes kept or reports prepared by a committee member have no status or effect unless adopted into the official minutes or report by the committee. It is the responsibility of each committee member to make certain that the official minutes and reports are complete and accurate and fully reflect what happened at any meeting the committee member attended.
An advisory committee meeting has the following portions:
(a)
(b)
(c)
(d)
(a) No committee meeting may be entirely closed. A portion of a meeting may be closed only in accordance with a written determination by the Commissioner under this section.
(b) The executive secretary or other designated agency employee shall prepare the initial request for a determination to close a portion of a meeting, specifying the matter(s) to be discussed during the closed portion and the reasons why the portion should be closed. The Commissioner, based upon this request and with the concurrence of the Chief Counsel, will determine whether to close a portion of a meeting. The reasons for closing a portion of a meeting will be announced in the
(1) Any determination to close a portion of a meeting restricts the closing to the shortest possible time consistent with the policy in this section.
(2) A portion of a meeting may be closed only if the Commissioner determines that the closing is permitted under 5 U.S.C. 552b(c), and that the closing is necessary.
(3) Portions of meetings may ordinarily be closed if they concern the review, discussion, and evaluation of drafts or regulations, guidance documents or similar preexisting internal agency documents, but only if their premature disclosure would significantly impede proposed agency action; review of trade secrets and confidential commercial or financial information; consideration of matters involving investigatory files compiled for law enforcement purposes; and review of matters, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
(4) Portions of meetings ordinarily may not be closed if they concern review, discussion, and evaluation of general preclinical and clinical test protocols and procedures for a class of drugs or devices; consideration of labeling requirements for a class of marketed drugs and devices; review of information on specific investigational or marketed drugs and devices that have previously been made public; presentation of any other information not exempt from public disclosure under 5 U.S.C. 552b(c); the formulation of advice and recommendations to FDA on matters that do not independently justify closing.
(5) No portion of a meeting devoted to matters other than those designated in paragraph (b) (1) through (3) of this section may be closed.
(6) A matter which is properly considered in an open portion of a meeting may instead be considered in a closed portion only if it is so inextricably intertwined with matters to be discussed in a closed portion that it is not feasible to separate them or discussion of the matter in an open portion would compromise the matters to be discussed in the closed portion.
(c) Attendance at a closed portion of a meeting is governed by the following rules:
(1) A portion of a meeting closed for the presentation or discussion of information that constitutes a trade secret or confidential commercial or financial information as defined in § 20.61 may be attended only by voting advisory committee members, nonvoting members representing consumer interests who are also special government employees as provided in § 14.80(b), the executive secretary of the advisory committee, a transcriber, consultants, and such other regular employees of FDA (including members of the Office of the Chief Counsel) as the chairman of the advisory committee may invite, and by those persons authorized to be present under § 14.25(c), for presentation of information prohibited from public disclosure. A person making a presentation described in § 14.25(c) may be accompanied by a reasonable number of employees, consultants, or other persons in a commercial arrangement within the meaning of § 20.81(a).
(2) A portion of a meeting that has been closed for consideration of existing internal agency documents falling within § 20.62 where premature disclosure is likely to significantly impede proposed agency action; personnel, medical, and similar files, disclosure of which would be a clearly unwarranted invasion of personal privacy within the meaning of § 20.63; or investigatory records compiled for law enforcement
(3) If a person other than a person permitted to attend in accordance with paragraph (c) (1) and (2) of this section attempts to attend a closed portion of a meeting without the approval of the executive secretary and the chairman, and the matter is brought to their attention, the person will be required to leave the meeting immediately. This inadvertent and unauthorized attendance does not enable other unauthorized persons to attend, nor does it, of itself, constitute grounds for release of transcripts of closed portions or any other documents otherwise exempt from disclosure under § 14.75 and part 20.
(4) If a person other than a person permitted to attend in accordance with paragraphs (c) (1) and (2) of this section is allowed by the executive secretary and the chairman to attend a closed portion of a meeting, that portion is open to attendance by any interested person.
(a) For each meeting, the open portion for public participation, which constitutes a public hearing under § 14.25(a), will be at least 1 hour, unless public participation does not last that long, and may last for whatever longer time the committee chairman determines will facilitate the work of the committee. The
(b) An interested person who wishes to be assured of the right to make an oral presentation at a meeting shall inform the executive secretary or other designated agency employee, orally or in writing, before the meeting.
(1) The person shall state the general nature of the presentation and the approximate time desired. Whenever possible, all written information to be discussed by that person at the meeting should be furnished in advance to the executive secretary or other designated agency employee. This material may be distributed or mailed by FDA to the committee members in advance of the meeting if time permits, and otherwise will be distributed to the members when they arrive for the meeting. The mailing or distribution may be undertaken only by FDA unless FDA grants permission to a person to mail or distribute the material
(2) Before the meeting, the executive secretary or other designated agency employee shall determine the amount of time allocated to each person for oral presentation and the time that the presentation is to begin. Each person will be so informed in writing, if time permits, or by telephone. FDA may require persons with common interests to make joint presentations.
(c) The chairman of the committee shall preside at the meeting in accordance with § 14.30 and be accompanied by other committee members, who serve as a panel in conducting the hearing portion of the meeting.
(d) Each person may use the allotted time as desired, consistent with an orderly hearing. A person may be accompanied by additional persons, and may present any written information or views for inclusion in the record of the hearing, subject to the requirements of § 14.35(c).
(e) If a person is absent at the time specified for that person's presentation, the persons following will appear in order. An attempt will be made to hear the person at the conclusion of the hearing. Interested persons attending the hearing who did not request an opportunity to make an oral presentation may be given an opportunity to do so at the discretion of the chairman.
(f) The chairman and other members may question a person concerning that
(g) Participants may question a committee member only with that member's permission and only about matters before the committee.
(h) The hearing is informal, and the rules of evidence do not apply. No motions or objections relating to the admissibility of information and views may be made or considered, but other participants may comment upon or rebut matters presented. No participant may interrrupt the presentation of another participant.
(a) The advisory committee chairman has the authority to conduct hearings and meetings, including the authority to adjourn a hearing or meeting if the chairman determines that adjournment is in the public interest, to discontinue discussion of a matter, to conclude the open portion of a meeting, or to take any other action to further a fair and expeditious hearing or meeting.
(b) If the chairman is not a full-time employee of FDA, the executive secretary or other designated agency employee, or alternate, is to be the
(a) A committee may confer with any person who may have information or views relevant to any matter pending before the committee.
(b) An interested person may submit to the committee a written request that it confer with specific persons about any matter pending before the committee. The request is to contain adequate justification. The committee may, in its discretion, grant the request.
(c) A committee may confer with a person who is not a Federal Government executive branch employee only during the open portions of a meeting. The person may, however, submit views in writing to the committee as part of the administrative record under § 14.70. The person may participate at the closed portions of a meeting only if appointed as a special Government employee by the Commissioner as provided in paragraph (e) of this section. This paragraph (c) is not intended to bar the testimony of a person during a closed portion of a meeting about matters prohibited from public disclosure under §§ 14.25(c) and 14.27(c).
(d) To prevent inadvertent violation of Federal conflict of interest laws and laws prohibiting disclosure of trade secrets (18 U.S.C. 208, 21 U.S.C. 331(j), 18 U.S.C. 1905), Federal executive branch employees who are not employees of the Department may not confer, testify, or otherwise participate (other than as observers) at any portion of an advisory committee meeting unless they are appointed as special Government employees by the Commissioner under paragraph (e) of this section. this paragraph does not apply to Federal executive branch employees who are appointed as members of TEPRSSC, as provided in § 14.127.
(e) The Commissioner may appoint persons as special Government employees to be consultants to an advisory committee. Consultants may be appointed to provide expertise, generally concerning a highly technical matter, not readily available from the members of the committee. Consultants may be either from outside the Government or from agencies other than the Food and Drug Administration. Reports, data, information, and other written submissions made to a public advisory committee by a consultant are part of the administrative record itemized in § 14.70.
The Commissioner shall prepare and provide to all committee members a compilation of materials bearing upon
(a) All applicable conflict of interest laws and regulations and a summary of their principal provisions;
(b) All applicable laws and regulations relating to trade secrets and confidential commercial or financial information that may not be disclosed publicly and a summary of their principal provisions;
(c) All applicable laws, regulations, and guidance documents relating to the subject matter covered by the advisory committee and a summary of their principal provisions;
(d) All applicable laws, regulations, including the regulations in part 20 of this chapter, advisory committee charters,
(e) Instructions on whom to contact when questions arise; and
(f) Other material relating to FDA and the subject matter covered by the committee which may facilitate the work of the committee.
(a) Ten copies of written submissions to a committee are to be sent to the executive secretary unless an applicable
(b) At the request of a committee, or on the Commissioner's own initiative, the Commissioner may issue in the
(c) At the request of a committee, or on the Commissioner's own initiative, the Commissioner may at any time request the applicant or sponsor of an application or petition about a specific product on which action is pending before FDA, and is being reviewed by an advisory committee, to present or discuss safety, effectiveness, or other data concerning the product during a regularly scheduled meeting of the committee. The request may be for an oral presentation or for a concise, well-organized written summary of pertinent information for review by the committee members before the meeting, or both. Unless specified otherwise, one copy of the written summary along with a proposed agenda outlining the topics to be covered and identifying the participating industry staff members or consultants that will present each topic is to be submitted to the executive secretary or other designated agency employee at least 3 weeks before the meeting.
(d) An interested person may submit to a committee written information or views on any matter being reviewed. Voluminous data is to be accompanied by a summary. A submission is to be made to the executive secretary and not directly to a committee member.
(1) FDA will distribute submissions to each member, either by mail or at the next meeting. Submissions will be considered by the committee in its review of the matter.
(2) A committee may establish, and give public notice of, a cutoff date after which submissions about a matter will no longer be received or considered.
(e) The Commissioner will provide the committee all information the Commissioner deems relevant. A member will, upon request, also be provided any material available to FDA which the member believes appropriate for an independent judgment on the matter, e.g., raw data underlying a summary or report, or a briefing on the legal aspects of the matter.
(a) In addition to these rules, an advisory committee may, with the concurrence of the designated Federal employee, adopt additional rules which are not inconsistent with this subpart or with other legal requirements.
(b) Any additional rules will be included in the minutes of the meeting when adopted and in the materials compiled under § 14.33 and will be available for public disclosure under § 14.65(c).
(a) An advisory committee may be established or renewed whenever it is necessary or appropriate for the committee to hold a public hearing and to review and make recommendations on any matter pending before FDA. Except for committees established by statute, before a committee is established or renewed it must first be approved by the Department pursuant to 45 CFR part 11 and by the General Services Administration.
(b) When an advisory committee is established or renewed, the Commissioner will issue a
(c) No committee may meet or take action until its charter is prepared and filed as required by section 9(c) of the Federal Advisory Committee Act. This requirement is to be met by an advisory committee utilized by FDA, even though it is not established by the agency, prior to utilization.
(d) The regulations of the Department cited in paragraph (a) of this section provide that the charter of a parent committee may incorporate information concerning activities of a subgroup. In such instances, a subgroup will not be established as a committee distinct from the parent committee. However, a subgroup will be established as a separate committee when the charter of the parent committee does not incorporate the activities of the subgroup, or when the subgroup includes members who are not all drawn from the parent committee.
(e) An advisory committee not required to be established by law will be established or utilized only if it is in the public interest and only if its functions cannot reasonably be performed by other existing advisory committees or by FDA.
(f) An advisory committee must meet the following standards:
(1) Its purpose is clearly defined.
(2) Its membership is balanced fairly in terms of the points of view represented in light of the functions to be performed. Although proportional representation is not required, advisory committee members are selected without regard to race, color, national origin, religion, age, or sex.
(3) It is constituted and utilizes procedures designed to assure that its advice and recommendations are the result of the advisory committee's independent judgment.
(4) Its staff is adequate. The Commissioner designates an executive secretary and alternate for every advisory committee, who are employees of FDA. The executive secretary is responsible for all staff support unless other agency employees are designated for this function.
(5) Whenever feasible, or required by statute, it includes representatives of the public interest.
(a) Except as provided in paragraph (c) of this section, a standing advisory committee is terminated when it is no longer needed, or not later than 2 years after its date of establishment unless it is renewed for an additional 2-year period. A committee may be renewed for as many 2-year periods as the public interest requires. The requirements for establishment of a committee under § 14.40 also apply to its renewal.
(b) FDA will issue a
(c) TEPRSSC is a permanent statutory advisory committee established by section 358(f)(1)(A) of the Public Health Service Act (42 U.S.C. 263f(f)(1)(A), as added by the Radiation Control for Health and Safety Act of 1968, and is not subject to termination and renewal under paragraph (a) of this section, except that a new charter is prepared and filed at the end of each 2-year period as provided in § 14.40(c). Also, the statutory medical device classification panels established under section 513(b)(1) of the act and part 860, and the statutory medical device good manufacturing practice advisory committees established under section 520(f)(3) of the act, are specifically exempted from the normal 2-year duration period.
(d) The Board of Tea Experts is a permanent statutory advisory committee established by the Tea Importation Act (21 U.S.C. 42) and is not subject to termination and renewal under paragraph (a) of this section, except that a new charter is prepared and filed at the end of each 2-year period as provided in § 14.40(c).
(e) Color additive advisory committees are required to be established under the circumstances specified in section 721(b)(5) (C) and (D) of the act. A color additive advisory committee is subject to the termination and renewal requirements of the Federal Advisory Committee Act and of this part.
(a) The executive secretary or other designated agency employee prepares detailed minutes of all advisory committee meetings, except that less detailed minutes may be prepared for open portions of meetings which under § 14.61, must be transcribed or recorded by the agency. Their accuracy is approved by the committee and certified by the chairman. The approval and certification may be accomplished by mail or by telephone.
(b) The minutes include the following:
(1) The time and place of the meeting.
(2) The members, committee staff, and agency employees present, and the names and affiliations or interests of public participants.
(3) A copy of or reference to all written information made available for consideration by the committee at the proceedings.
(4) A complete and accurate description of matters discussed and conclusions reached. A description is to be kept separately for the following portions of the meeting to facilitate their public disclosure: The open portions specified in § 14.25 (a) and (b), any closed portion during which a presentation is made under § 14.25(c), and any closed deliberative portion under § 14.25(d). The minutes of a closed deliberative portion of a meeting may not refer to members by name, except upon their request, or to data or information described in § 14.75(b). Any inadvertent references that occur are to be deleted before public disclosure.
(5) A copy of or reference to all reports received, issued, or approved by the committee.
(6) The extent to which the meeting was open to the public.
(7) The extent of public participation, including a list of members of the public who presented oral or written statements.
(c) For a meeting that has a closed portion, either (1) the minutes of the closed portion are available for public disclosure under § 14.75(a)(6)(i), or (2) if under § 14.75(a)(6)(ii) they are not promptly available, the executive secretary or other designated agency employee shall prepare a brief summary of the matters considered in an informative manner to the public, consistent with 5 U.S.C. 552(b).
(d) Where a significant portion of the meeting of a committee is closed, the committee will issue a report at least annually setting forth a summary of its activities and related matters informative to the public consistent with 5 U.S.C. 552(b). This report is to be a compilation of or be prepared from the individual reports on closed portions of
(a) The agency will arrange for a transcript or recording to be made for each portion of a meeting.
(b) A transcript or recording of an open portion of a meeting made by FDA is to be included in the record of the committee proceedings.
(c) A transcript or recording of any closed portion of a meeting made by FDA will not be included in the administrative record of the committee proceedings. The transcript or recording will be retained as confidential by FDA, and will not be discarded or erased.
(d) Any transcript or recording of a meeting or portion thereof which is publicly available under this section will be available at actual cost of duplication, which will be, where applicable, the fees established in § 20.42. FDA may furnish the requested transcript or recording for copying to a private contractor who shall charge directly for the cost of copying under § 20.51.
(e) A person attending any open portion of a meeting may, consistent with the orderly conduct of the meeting, record or otherwise take a transcript of the meeting. This transcription will not be part of the administrative record.
(f) Only FDA may make a transcript or recording of a closed portion of a meeting.
(a) Public inquiries on general committee matters, except requests for records, are to be directed to: Committee Management Officer (HFA-306), Office of Management and Operations, Food and Drug Administration, Department of Health and Human Services, 5600 Fishers Lane, Rockville, MD 20857.
(b) Public inquiries on matters relating to a specific committee, except requests for records, are to be directed to the executive secretary or the designated agency employee listed in the
(c) Requests for public advisory committee records, including minutes, are to be made, to FDA's Freedom of Information Staff (HFI-35) under § 20.40 and the related provisions of part 20.
(a) Advice or recommendations of an advisory committee may be given only on matters covered in the administrative record of the committee's proceedings. Except as specified in other FDA regulations, the administrative record consists of all the following items relating to the matter:
(1) Any transcript or recording of an open portion of a meeting.
(2) The minutes of all portions of all meetings, after any deletions under § 14.60(b)(4).
(3) All written submissions to and information considered by the committee.
(4) All reports made by the committee.
(5) Any reports prepared by a consultant under § 14.31(e).
(b) The record of the proceeding is closed at the time the advisory committee renders its advice or recommendations or at any earlier time specified by the committee or in other sections in this chapter.
(a) The administrative record and other committee records are available for public disclosure under part 20, except as provided in paragraph (b) of this section, at the following times:
(1) The written information for consideration by the committee at any meeting: at the same time it is made available to the committee.
(2) The transcript or recording of any open portion of a meeting: as soon as it is available.
(3) The minutes of any open portion of a meeting: after they have been approved by the committee and certified by the chairman.
(4) The brief summary of any closed portion of a meeting prepared under § 14.60(c): as soon as it is available.
(5) All written information or views submitted to the committee at an open portion of a meeting: as soon as they are submitted.
(6) The minutes or portions thereof of a closed portion of a meeting—
(i) For a matter not directed to be maintained as confidential under § 14.22(i)(2): After they have been approved by the committee and certified by the chairman; and
(ii) For a matter directed to be maintained as confidential under § 14.22(i)(2): After the advice or report of the committee relevant to those minutes or portions thereof is acted upon by the Commissioner, or upon a determination by the Commissioner that such minutes or portions thereof may be made available for public disclosure without undue interference with agency or advisory committee operations.
(7) Formal advice or a report of the committee: After it has been acted upon, i.e., approved, disapproved, or rejected as inadequate, by the Commissioner, or upon a determination by the Commissioner that such formal advice or report may be made available for public disclosure without undue interference with agency or committee operations. Such formal advice or report may be retained as confidential while it is under active advisement.
(8) Any other committee records relating to the matter, except transcripts and recordings of closed portions of meetings: After the advice or report of the committee relevant to those records is acted upon by the Commissioner, or upon a determination by the Commissioner that the records may be made available for public disclosure without undue interference with agency or committee operations.
(b) The following information contained in the administrative record is not available for public examination or copying except as provided in § 12.32(g):
(1) Material provided to the committee by FDA that is exempt from public disclosure under part 20 and the regulations referenced there.
(2) Material provided to the advisory committee by a person making a presentation described in § 14.25(c) and which is prohibited from public disclosure under part 20 and the regulations referenced there.
(c) The Dockets Management Branch (HFA-305) will maintain a file for each committee containing the following principal records for ready access by the public:
(1) The committee charter.
(2) A list of committee members and their curricula vitae.
(3) The minutes of committee meetings.
(4) Any formal advice or report of the committee.
(a) Members of a policy advisory committee—
(1) Shall have diverse interests, education, training, and experience; specific technical expertise is not a requirement;
(2) Are subject to the conflict of interest laws and regulations either as special Government employees or as members of the uniformed services, including the Commissioned Corps of the Public Health Service (the Commissioner has determined that, because members representing particular interests, e.g., a representative of labor, industry, consumers, or agriculture, are included on advisory committees specifically for the purpose of representing these interests, any financial interest covered by 18 U.S.C. 208(a) in the class which the member represents is irrelevant to the services which the Government expects from them and thus is hereby exempted under 18 U.S.C. 208(b) as too remote and inconsequential to affect the integrity of their services); and
(3) Shall be voting members.
(b)
(i) Shall have expertise in the subject matter with which the committee is
(ii) Except for members of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC), are subject to the conflict of interest laws and regulations either as special Government employees or as members of the uniformed services, including the Commissioned Corps of the Public Health Service.
(2) The Commissioner shall, when required by statute, and may when not required by statute, provide for nonvoting members of a technical advisory committee to serve as representatives of and liaison with interested organizations. Nonvoting members—
(i) Shall be selected by the interested organizations, as provided in § 14.84; technical expertise in the subject matter with which the committee is involved is not a requirement; and
(ii) May be special Government employees subject to the conflict of interest laws and regulations, except as provided in § 14.84(e).
(c) A person may serve as a voting or nonvoting member on only one FDA advisory committee unless the Commissioner determines in writing that dual membership will aid the work of the committees involved and is in the public interest.
(d) Members of FDA advisory committees, and the chairman, are appointed from among those nominated under §§ 14.82 and 14.84 and from any other sources by the Secretary, or, by delegation of authority, by the Assistant Secretary for Health, or the Commissioner.
(e) Members appointed to an advisory committee serve for the duration of the committee, or until their terms of appointment expire, they resign, or they are removed from membership by the Commissioner.
(f) A committee member may be removed from membership for good cause. Good cause includes excessive absenteeism from committee meetings, a demonstrated bias that interferes with the ability to render objective advice, failure to abide by the procedures established in this subpart, or violation of other applicable rules and regulations, e.g., for nonvoting members, the provisions of § 14.86(c).
(g) Consultants appointed under § 14.31(e) are not members of advisory committees.
(a) The Commissioner will publish one or more notices in the
(b) The notice announcing the establishment of a new committee under § 14.40(b) will invite the submission of nominations for voting members.
(c) A person may nominate one or more qualified persons to an advisory committee. Nominations will specify the advisory committee for which the nominee is recommended and will include a complete curriculum vitae of the nominee. Nominations are to state that the nominee is aware of the nomination, is willing to serve as a member of the advisory committee, and appears to have no conflict of interest that would preclude membership.
(d) Voting members serve as individuals and not as representatives of any group or organization which nominated them or with which they may be affiliated.
(a) This section applies when the Commissioner concludes that a technical advisory committee should include nonvoting members to represent and serve as a liaison with interested individuals and organizations.
(b) Except when the Commissioner concludes otherwise, nonvoting members of a technical advisory committee are selected in accordance with paragraphs (c) and (d) of this section and
(c) To select a nonvoting member to represent consumer interests, except as provided in paragraph (c)(5) of this section, the Commissioner publishes a notice in the
(1) A period of 30 days will be permitted for submission of nominations for that committee or subcommittee. Interested persons may nominate one or more qualified persons to represent consumer interests. Although nominations from individuals will be accepted, individuals are encouraged to submit their nominations through consumer organizations as defined in paragraph (c)(3) of this section. Nominations of qualified persons for general consideration as nonvoting members of unspecified advisory committees or subcommittees may be made at any time. All nominations are to be submitted in writing to the Office of Consumer Affairs (HFE-40), Food and Drug Administration, Rm. 16-85, 5600 Fishers Lane, Rockville, MD 20857.
(2) A complete curriculum vitae of any nominee is to be included. Nominations must state that the nominee is aware of the nomination, is willing to serve as a member of an advisory committee, and appears to have no conflict of interest. The nomination must state whether a nominee is interested only in a particular advisory committee or subcommittee, or whether the nominee is interested in becoming a member of any advisory committee or subcommittee. Nominations that do not comply with the requirements of this paragraph will not be considered.
(3) The Office of Consumer Affairs will compile a list of organizations whose objectives are to promote, encourage, and contribute to the advancement of consumer education and to the resolution of consumer problems. All organizations listed are entitled to vote upon the nominees. The list will include organizations representing the public interest, consumer advocacy groups, and consumer/health branches of Federal, State, and local governments. Any organization that meets the criteria may be included on such list on request.
(4) The executive secretary, or other designated agency employee, will review the list of nominees and select three to five qualified nominees to be placed on a ballot. Names not selected will remain on a list of eligible nominees and be reviewed periodically by the Office of Consumer Affairs to determine continued interest. Upon selection of the nominees to be placed on the ballot, the curriculum vitae for each of the nominees will be sent to each of the organizations on the list complied under paragraph (c)(3) of this section, together with a ballot to be filled out and returned within 30 days. After the time for return of the ballots has expired, the ballots will be counted and the nominee who has received the highest number of votes will be selected as the nonvoting member representing consumer interests for that particular advisory committee or subcommittee. In the event of a tie, the Commissioner will select the winner by lot from among those tied for the highest number of votes.
(5) If a member representing consumer interests resigns or is removed before termination of the committee on which the member is serving, the following procedures will be used to appoint a replacement to serve out the term of the former member:
(i) The Commissioner will appoint the runner-up, in order of number of ballots received, on the original ballot submitted under paragraph (c)(4) of this section to fill the vacancy. If the runner-up is no longer willing to serve as a member, then the next runner-up will be appointed.
(ii) If none of the nominees on the original ballot is willing to serve, or if there was only one nominee on the original ballot, the Office of Consumer Affairs will contact by telephone eligible individuals whose names have been submitted in the past as candidates for membership as representatives of consumer interests. A list of persons who are interested in serving on an advisory committee will then be prepared. The curricula vitae of these persons, together with a ballot, will be sent to
(d) To select a nonvoting member to represent industry interests, the Commissioner will publish, for each committee for which the Commissioner has determined to appoint a nonvoting member, a notice requesting that, within 30 days, any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests send a letter stating that interest to the FDA employee designated in the notice. After 30 days, a letter will be sent to each organization that has expressed an interest, attaching a complete list of all such organizations, and stating that it is their responsibility to consult with each other in selecting, within 60 days after receipt of the letter, a single nonvoting member to represent industry interests for that committee. If no individual is selected within 60 days, the Commissioner will select the nonvoting member representing industry interests.
(e) The Commissioner has determined that, because nonvoting members representing consumer and industry interests are included on advisory committees specifically for the purpose of representing such interests and have no vote, any financial interest covered by 18 U.S.C. 208(a) in the class which the member represents is irrelevant to the services the Government expects from them and thus is hereby exempted under 18 U.S.C. 208(b) as too remote and inconsequential to affect the integrity of their services.
(a) A nonvoting member of an advisory committee selected to represent and serve as a liaison with interested individuals, associations, and organizations has the same rights as any other committee member except that—
(1) A nonvoting member may vote only on procedural matters such as additional rules adopted under § 14.39(a), approval of minutes under § 14.60(a), decisions on transcripts under § 14.61(b), and future meeting dates;
(2) A nonvoting member who is a representative of industry interest may have access to data and information that constitute a trade secret or confidential commercial or financial information as defined in § 20.61 only if the person has been appointed as a special Government employee under § 14.80(b).
(b) A nonvoting member of an advisory committee is subject to, and shall abide by, all rules and regulations adopted by FDA and the committee.
(c) It is the responsibility of the nonvoting consumer and industry members of an advisory committee to represent the consumer and industry interests in all deliberations.
(1) A nonvoting member does not represent any particular organization or group, but rather represents all interested persons within the class which the member is selected to represent. Accordingly, an interested person within the class represented by that nonvoting member may, upon request, have access to all written statements or oral briefings concerning the committee prepared by the nonvoting member for distribution to any person outside the committee. When documents are prepared with non-Government funds, persons desiring copies may be required to pay a reasonable fee to cover printing and similar costs.
(2) The nonvoting member reviews all official committee minutes to assure their completeness and accuracy.
(3) The nonvoting member acts as a liaison between the committee and the interested persons whom that member represents, and transmits requests for information from the committee and relevant information and views to the
(4) A nonvoting industry member represents all members of the industry, and not any particular association, company, product, or ingredient. If a matter comes before the committee that directly or indirectly affects the company employing the nonvoting industry member, the member shall so inform the committee but need not be absent during the discussion or decline to participate in the discussion. a nonvoting industry member may not discuss the company's position as such, but may discuss any matter in general terms. All presentations and discussions of scientific data and their interpretation on behalf of a company will occur in open session, except as provided in § 14.25(c).
(5) A nonvoting member of an advisory committee may not make any presentation to that advisory committee during a hearing conducted by that committee.
(6) Although a nonvoting member serves in a representative capacity, the nonvoting member shall exercise restraint in performing such functions and may not engage in unseemly advocacy or attempt to exert undue influence over the other members of the committee.
(d) A nonvoting member of an advisory committee may be removed by the Commissioner for failure to comply with this section as well as § 14.80(f).
In selecting members of an ad hoc advisory committee, the Commissioner may use the procedures in §§ 14.82 and 14.84 or any other procedure deemed appropriate.
(a)(1) Except as provided in paragraphs (a) (2) and (3) of this section, all voting advisory committee members shall, and nonvoting members may, be appointed as special Government employees and receive a consultant fee and be reimbursed for travel expenses, including per diem in lieu of subsistence, unless such compensation and reimbursement are waived.
(2) Members of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) are not appointed as special Government employees. Any member of TEPRSSC who is not a Federal employee or member of the uniformed services, including the Commissioned Corps of the Public Health Service, shall receive a consultant fee and be reimbursed for travel expenses, including per diem in lieu of subsistence, unless such compensation and reimbursement are waived.
(3) Voting and nonvoting advisory committee members who are members of the uniformed services, including the Commissioned Corps of the Public Health Service, provide service on Food and Drug Administration advisory committees as part of their assigned functions, are not appointed as special government employees, but are reimbursed by the Food and Drug Administration for travel expenses.
(b) Notwithstanding the member's primary residence, an advisory committee member, while attending meetings of the full committee or a subcommittee, will be paid whether the meetings are held in the Washington, DC, area or elsewhere.
(c) A committee member who participates in any agency-directed assignment will be paid at an hourly rate when doing assigned work at home, a place of business, or in an FDA facility located within the member's commuting area, and at a daily rate when required to travel outside of that commuting area to perform the assignment. A committee member will not be paid for time spent on normal preparation for a committee meeting.
(1) An agency-directed assignment is an assignment that meets the following criteria:
(i) An activity that requires undertaking a definitive study. The activity must produce a tangible end product, usually a written report. Examples are:
(
(
(
(
(ii) The performance of an IND or NDA review or similar review.
(2) A committee member who undertakes a special assignment, the end product of which does not represent the end product of the advisory committee, but rather of the committee member's own assignment, can be compensated. Should this preparatory work by members collectively result in an end product of the committee, this is to be considered normal meeting preparation and committee members are not to be compensated for this work.
(d) Salary while in travel status is authorized when a committee member's ordinary pursuits are interrupted for the substantial portion of an additional day beyond the day or days spent in performing those services, and as a consequence the committee member loses some regular compensation. This applies on weekends and holidays if the special Government employee loses income that would otherwise be earned on that day. For travel purposes, a substantial portion of a day is defined as 50 percent of the working day, and the traveler will be paid at a daily rate.
Standing advisory committees and the dates of their establishment are as follows:
(a)
(i) Date established: March 2, 1897.
(ii) Function: Advises on establishment of uniform standards of purity, quality, and fitness for consumption of all tea imported into the United States under 21 U.S.C. 42.
(2)
(i) Date established: June 26, 1992.
(ii) Function: The board shall provide advice primarily to the agency's Senior Science Advisor and, as needed, to the Commissioner and other appropriate officials on specific complex and technical issues as well as emerging issues within the scientific community in industry and academia. Additionally, the board will provide advice to the agency on keeping pace with technical and scientific evolutions in the fields of regulatory science; on formulating an appropriate research agenda; and on upgrading its scientific and research facilities to keep pace with these changes. It will also provide the means for critical review of agency sponsored intramural and extramural scientific research programs.
(b)
(i) Date established: July 9, 1984.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of allergenic biological products intended for use in the diagnosis, prevention, or treatment of human disease.
(2)
(i) Date established: October 28, 1988.
(ii) Function: Reviews and evaluates data relating to the safety, effectiveness, and appropriate use of biological response modifiers which are intended for use in the prevention and treatment of a broad spectrum of human diseases.
(3)
(i) Date established: May 13, 1980.
(ii) Function: Reviews and evaluates data on the safety and effectiveness, and appropriate use of blood products intended for use in the diagnosis, prevention, or treatment of human diseases.
(4) [Reserved]
(5)
(i) Date established: December 31, 1979.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of
(6)
(i) Date established: June 21, 1995.
(ii) Function: Reviews and evaluates available scientific data concerning the safety of products which may be at risk for transmission of spngiform encephalopathies having an impact on the public health.
(c)
(i) Date established: May 1, 1978.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in the field of anesthesiology and surgery.
(2)
(i) Date established: October 7, 1980.
(ii) Function: Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of infectious diseases and disorders.
(3)
(i)
(ii) Function: Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of acquired immune deficiency syndrome (AIDS), AIDS-related complex (ARC), and other viral, fungal, and mycobacterial infections.
(4)
(i) Date established: April 5, 1974.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in arthritic conditions.
(5)
(i) Date established: August 27, 1970.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in cardiovascular and renal disorders.
(6)
(i) Date established: October 7, 1980.
(ii) Function: Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of dermatologic and ophthalmic disorders.
(7)
(i) Date established: May 31, 1978.
(ii) Function: Reviews and evaluates data on risk management plans, provides active surveillance methodologies, trademark studies, methodologies for risk management communication, and related issues.
(8)
(i) Date established: August 27, 1970.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in endocrine and metabolic disorders.
(9)
(i) Date established: March 23, 1978.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in the practice of obstetrics, gynecology, and related specialties.
(10)
(i) Date established: March 3, 1978.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in gastrointestinal diseases.
(11)
(i) Date established: September 1, 1978.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in treatment of cancer.
(12)
(i) Date established: June 4, 1974.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in neurological disease.
(13)
(i) Date established: June 4, 1974.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in the practice of psychiatry and related fields.
(14)
(i) Date established: February 17, 1972.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in the treatment of pulmonary disease and diseases with allergic and/or immunologic mechanisms.
(15)
(i) Date established: August 30, 1967.
(ii) Function: Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology.
(16)
(i) Date established: January 22, 1990.
(ii) Function: Gives advice on scientific and technical issues concerning the safety and effectiveness of human generic drug products for use in the treatment of a broad spectrum of human diseases.
(17)
(i) Date established: August 27, 1991.
(ii) Functions: The committee reviews and evaluates available data concerning the safety and effectiveness of over-the-counter (nonprescription) human drug products for use in the treatment of a broad spectrum of human symptoms and diseases.
(18)
(i) Date established: February 12, 1998.
(ii) Function: Provides advice on scientific, technical, and medical issues concerning drug compounding by pharmacists and licensed practitioners.
(d)
(i)
(ii)
(2)
(i) Date established: May 17, 1987.
(ii) Function: Reviews proposed regulations for good manufacturing practices governing the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of devices, and makes recommendations on the feasibility and reasonableness of the proposed regulations.
(3)
(i) Date established: October 18, 1968.
(ii) Function: Advises on technical feasibility, reasonableness, and practicability of performance standards for electronic products to control the emission of radiation under 42 U.S.C. 263f(f)(1)(A).
(4)
(i) Date established: July 6, 1993.
(ii) Function: Advises on developing appropriate quality standards and regulations for the use of mammography facilities.
(e)
(1) Date established: June 2, 1973.
(2) Function: Advises on establishment and implementation of a research program that will assist the Commissioner of Food and Drugs tofulfill regulatory responsibilities.
(f)
(1) Date established: April 24, 1984.
(2) Function: Reviews and evaluates available data concerning safety and effectiveness of marketed and investigational new animal drugs, feeds, and devices for use in the treatment and prevention of animal disease and increased animal production.
(g)
(1) Date established: December 15, 1991.
(2) Function: The committee provides advice on emerging food safety, food science, and nutrition issues that FDA considers of primary importance in the next decade.
For
The Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC), consisting of 15 members, is established in accordance with the Radiation Control for Health and Safety Act of 1968 (42 U.S.C. 263f(f)(1)(A)) to provide consultation before the Commissioner prescribes any performance standard for an electronic product.
(a) In performing its function of advising the Commissioner, TEPRSSC—
(1) May propose electronic product radiation safety standards to the Commissioner for consideration;
(2) Provides consultation to the Commissioner on all performance standards proposed for consideration under 42 U.S.C. 263f; and
(3) May make recommendations to the Commissioner on any other matters it deems necessary or appropriate in fulfilling the purposes of the act.
(b) Responsibility for action on performance standards under 42 U.S.C. 263f rests with the Commissioner, after receiving the advice of TEPRSSC.
(a) When the Commissioner is considering promulgation of a performance standard for an electronic product, or an amendment of an existing standard, before issuing a proposed regulation in the
(b) The agenda and other material to be considered at any meeting will be sent to members whenever possible at least 2 weeks before the meeting.
(c) Ten members constitute a quorum, provided at least three members are present from each group specified in 42 U.S.C. 263f(f)(1)(A) and in § 14.127(a), i.e., Government, industry, and the public.
(d) The chairman of TEPRSSC will ordinarily submit a report to the Commissioner of the committee's consideration of any proposed performance standard for an electronic product within 60 days after consideration. If the chairman believes that more time is needed, the chairman will inform the Director of the Center for Devices and Radiological Health in writing, in which case an additional 30 days will be allowed to make the report.
(e) Sections 14.1 through 14.7 apply to TEPRSSC, except where other provisions are specifically included in §§ 14.120 through 14.130.
(a) The Commissioner will appoint the members after consultation with public and private organizations concerned with the technical aspect of electronic product radiation safety. TEPRSSC consists of 15 members, each of whom is technically qualified by training and experienced in one or more fields of science or engineering applicable to electronic product radiation safety, as follows:
(1) Five members selected from government agencies, including State and Federal Governments.
(2) Five members selected from the affected industries after consultation with industry representatives.
(3) Five members selected from the general public, of whom at least one shall be a representative of organized labor.
(b) The Commissioner will appoint a committee member as chairman of TEPRSSC.
(c) Appointments of members are for a term of 3 years or as specified by the Commissioner.
(1) The chairman is appointed for a term concurrent with the chairman's term as a member of TEPRSSC. If the chairmanship becomes vacant without
(2) Members may not be reappointed for a second consecutive full term.
(d) A person otherwise qualified for membership is not eligible for selection as a member of TEPRSSC from Government agencies or the general public if the Commissioner determines that the person does not meet the requirements of the conflict of interest laws and regulations.
(e) Retention of membership is conditioned upon the following:
(1) Continued status as a member of the group from which the member was selected as specified in paragraph (a) of this section.
(2) Absence of any conflict of interest during the term of membership as specified in paragraph (d) of this section.
(3) Active participation in TEPRSSC activities.
(f) Appointment as a member of TEPRSSC is conditioned on certification that the prospective member:
(1) Agrees to the procedures and criteria specified in this subpart.
(2) Has no conflict of interest as specified in paragraph (d) of this section.
(3) Will notify the executive secretary of TEPRSSC before any change in representative status on TEPRSSC which may be contrary to the conditions of the appointment.
(g) Members of TEPRSSC who are not full-time officers or employees of the United States receive compensation under § 14.95, in accordance with 42 U.S.C. 210(c).
(a) In accordance with 42 U.S.C. 263f(f)(1)(B), all proceedings of TEPRSSC are recorded, and the record of each proceeding is available for public inspection.
(b) All proceedings of TEPRSSC are open except when the Commissioner has determined, under § 14.27, that a portion of a meeting may be closed.
The Commissioner will establish a color additive advisory committee under the following circumstances:
(a) The Commissioner concludes, as a matter of discretion, that it would be in the public interest for a color additive advisory committee to review and make recommendations about the safety of a color additive on which important issues are pending before FDA and for interested persons to present information and views at an oral public hearing before a color additive advisory committee.
(b) There is an issue arising under section 721(b)(5)(B) of the act concerning the safety of a color additive, including its potential or actual carcinogenicity, that requires the exercise of scientific judgment and a person who would be adversely affected by the issuance, amendment, or repeal of a regulation listing a color additive requests that the matter, or the Commissioner as a matter of discretion determines that the matter should, be referred to a color additive advisory committee.
(1) Paragraph (b) does not apply to any issue arising under the transitional provisions in section 203 of the Color Additive Amendments of 1960 relating to provisional listing of commercially established colors. A color additive advisory committee to consider any such matter will be established under paragraph (a) of this section.
(2) A request for establishment of a color additive advisory committee is to be made in accordance with § 10.30. The Commissioner may deny any petition if inadequate grounds are stated for establishing a color additive advisory committee. A request for establishment of a color additive advisory committee may not rest on mere allegations or denials, but must set forth specific facts showing that there is a genuine and substantial issue of fact that requires scientific judgment and justifies a hearing before a color additive advisory committee. When it conclusively appears from the request for a
(3) Establishment of a color additive advisory committee on the request of an interested person is conditioned upon receipt of the application fee specified in § 14.155.
(4) Any person adversely affected may request referral of the matter to a color additive advisory committee at any time before, or within 30 days after, publication of an order of the Commissioner acting upon a color additive petition or proposal.
(a) A color additive advisory committee reviews all available information relating to the matter referred to it, including all information contained in any pertinent color additive petition and in FDA files. All information reviewed is placed on public display and is available for review at the office of the Dockets Management Branch.
(b) The Commissioner specifies to the color additive advisory committee, in writing, the issues on which review and recommendations are requested.
(c) The date of the first meeting of a color additive advisory committee, following receipt of the administrative record by each of the committee members, is designated as the beginning of the period allowed for consideration of the matter by the committee. Within 60 days after the first meeting, unless the time is extended as provided in paragraph (d) of this section, the chairman of the committee shall certify to the Commissioner the report containing the recommendations of the committee, including any minority report. The report states the recommendations of the committee and the reasons or basis for them. The report includes copies of all material considered by the committee in addition to the administrative record furnished to it.
(d) If the chairman concludes that the color additive advisory committee needs additional time, the chairman shall so inform the Commissioner in writing and may certify the report of the committee to the Commissioner within 90 days instead of 60 days.
(e) More than one matter may be handled concurrently by a color additive advisory committee.
(a) A color additive advisory committee is subject to all the requirements of the Federal Advisory Committee Act and this part.
(b) All interested persons have a right to consult with the color additive advisory committee reviewing a matter and to submit information and views to a color additive advisory committee, in accordance with the procedures in this part.
(a) The members of a color additive advisory committee are selected in the following manner:
(1) If a color additive advisory committee is established for purposes that do not include review of an issue arising under section 721(b)(5)(B) of the act, or is established on the initiative of the Commissioner, the Commissioner may use the procedure in paragraph (a)(2) of this section to select the members or may use an existing standing advisory committee listed in § 14.100, or may establish a new advisory committee under this subpart. Once the Commissioner has established a color additive advisory committee under this paragraph and has referred to it a matter relating to a color additive, no interested person may subsequently request that an additional or different color additive advisory committee be established to review and make recommendations about that color additive.
(2) If the Commissioner established a color additive advisory committee to review an issue arising under section 721(b)(5)(B) of the act on the request of
(i) Except as provided in paragraph (a)(2) (ii) and (iii) of this section, the Commissioner will request the National Academy of Sciences to select the members of a color additive advisory committee from among experts qualified in the subject matter to be reviewed by the committee, and of adequately diversified professional backgrounds. The Commissioner will appoint one of the members as the chairman.
(ii) If the National Academy of Sciences is unable or refuses to select the members of a color additive advisory committee, the Commissioner will select the members.
(iii) If the Commissioner and the requesting party agree, section 721(b)(5)(D) of the act may be waived and the matter may be referred to any standing advisory committee listed in § 14.100 or to any advisory committee established under any other procedure that is mutually agreeable. Once the Commissioner has established a color additive advisory committee and has referred to it a matter relating to a color additive, no interested person may subsequently request that an additional or different color additive advisory committee be established to review and make recommendations about that color additive.
(b) Members of a color additive advisory committee are subject to the requirements of the Federal Advisory Committee Act and this subpart, except that no member of a color additive advisory committee may by reason of such membership alone be a special government employee or be subject to the conflict of interest laws and regulations.
(a) When a matter is referred to a color additive advisory committee, all related costs, including personal compensation of committee members, travel, materials, and other costs, are borne by the person requesting the referral, such costs to be assessed on the basis of actual cost to the government. The compensation of such costs includes personal compensation of committee members at a rate not to exceed $128.80 per member per day.
(b) In the case of a request for referral to a color additive advisory committee, a special advance deposit is to be made in the amount of $2,500. Where required, further advances in increments of $2,500 each are to be made upon request of the Commissioner. All deposits for referrals to a color additive advisory committee in excess of actual expenses will be refunded to the depositor.
(c) All deposits and fees required by this section are to be paid by money order, bank draft, or certified check drawn to the order of the Food and Drug Administration, collectable at par in Washington, DC. All deposits and fees are to be forwarded to the Associate Commissioner for Management and Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, and after appropriate record of them is made, they will be transmitted to the Treasurer of the United States for deposit in the special account “Salaries and Expenses, Certification, Inspection, and Other Services, Food and Drug Administration.”
(d) The Commissioner may waive or refund such fees in whole or in part when, in the Commissioner's judgment, such action will promote the public interest. Any person who believes that payment of these fees will be a hardship may petition the Commissioner under § 10.30 to waive or refund the fees.
The standing technical advisory committees for human prescription drugs are established to advise the Commissioner:
(a) Generally on the safety and effectiveness, including the labeling and advertising, and regulatory control of the human prescription drugs falling within the pharmacologic class covered by
(b) Specifically on any particular matter involving a human prescription drug pending before FDA, including whether the available information is adequate to support a determination that—
(1) A particular IND study may properly be conducted;
(2) A particular drug meets the statutory standard for proof of safety and effectiveness necessary for approval or continued approval for marketing; or
(3) A particular drug is properly classified as a new drug, an old drug, or a banned drug.
(a) Any matter involving a human prescription drug under review within the agency may, in the discretion of the Commissioner, be the subject of a public hearing and continuing or periodic review by the appropriate standing technical advisory committee for human prescription drugs. The Commissioner's determinations on the agenda of the committee are based upon the priorities of the various matters pending before the agency which fall within the pharmacologic class covered by that committee.
(b) High priority for such hearing and review by the appropriate standing technical advisory committee for human prescription drugs are given to the following types of human prescription drugs:
(1) Investigational drugs which are potential therapeutic advances over currently marketed products from the standpoint of safety or effectiveness, or which pose significant safety hazards, or which present narrow benefit-risk considerations requiring a close judgmental decision on approval for marketing, or which have a novel delivery system or formulation, or which are the subject of major scientific or public controversy, or which may be subject to special regulatory requirements such as a limitation on clinical trials, a patient followup requirement, postmarketing Phase IV studies, distributional controls, or boxed warnings.
(2) Marketed drugs for which an important new use has been discovered or which pose newly discovered safety hazards, or which are the subject of major scientific or public controversy, or which may be subject to important regulatory actions such as withdrawal of approval for marketing, boxed warnings, distributional controls, or newly required scientific studies.
(c) The committee may request the Commissioner for an opportunity to hold a public hearing and to review any matter involving a human prescription drug which falls within the pharmacologic class covered by the committee. The Commissioner may, after consulting with the committtee on such request, grant or deny the request in light of the priorities of the other matters pending before the committee. Whenever feasible, consistent with the other work of the committee, the request will be granted.
(d) For a drug that meets any of the criteria established in paragraph (b) of this section, one or more members of or consultants to the appropriate advisory committee may be selected for more detailed monitoring of the matter and consultation with FDA on behalf of the committee. The member or consultant may be invited to attend appropriate meetings and shall assist the center in any briefing of the committee on that matter.
(e) An advisory committee may obtain advice and recommendations from other agency advisory committees, consultants, and experts which the advisory committee and the center conclude would facilitate the work of the advisory committee.
(f) Presentation of all relevant information about the matter will be made in open session unless it relates to an IND the existence of which has not previously been disclosed to the public as defined in § 20.81 or is otherwise prohibited from public disclosure under part 20 and the regulations referenced therein. Sections 314.430 and 601.51 determine whether, and the extent to which, relevant information may be made available for public disclosure, summarized and discussed in open session but not otherwise made available for public
Any interested person may request, under § 10.30, that a specific matter relating to a particular human prescription drug be submitted to an appropriate advisory committee for a hearing and review and recommendations. The request must demonstrate the importance of the matter and the reasons why it should be submitted for a hearing at that time. The Commissioner may grant or deny the request.
Advice and recommendations given by a committee on a specific drug or a class of drugs are ordinarily in the form of a written report. The report may consist of the approved minutes of the meeting or a separate written report. The report responds to the specific issues or questions which the Commissioner has addressed to the advisory committee, and states the basis of the advice and recommendations of the committee.
5 U.S.C. 553; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b-263n, 264.
The procedures in this part apply when:
(a) The Commissioner concludes, as a matter of discretion, that it is in the public interest to permit persons to present information and views at a public hearing on any matter pending before the Food and Drug Administation.
(b) The act or regulation specifically provides for a public hearing before the Commissioner on a matter, e.g., § 330.10(a)(8) relating to over-the-counter drugs and sections 520 (b) and (f)(1)(B), and 521 of the act relating to proposals to allow persons to order custom devices, to proposed device good manufacturing practice regulations, and to proposed exemptions from preemption of State and local device requirements under § 808.25(e).
(c) A person who has right to an opportunity for a formal evidentiary public hearing under part 12 waives that opportunity and instead requests under § 12.32 a public hearing before the Commissioner, and the Commissioner, as a matter of discretion, accepts the request.
(a) If the Commissioner determines that a public hearing should be held on a matter, the Commissioner will publish a notice of hearing in the
(1) If the hearing is under § 15.1 (a) or (b), the notice will state the following:
(i) The purpose of the hearing and the subject matter to be considered. If a written document is to be the subject matter of the hearing, it will be published as part of the notice, or reference made to it if it has already been published in the
(ii) The time, date, and place of the hearing, or a statement that the information will be contained in a subsequent notice.
(2) If the hearing is in lieu of a formal evidentiary public hearing under § 15.1(c), all of the information described in § 12.32(e).
(b) The scope of the hearing is determined by the notice of hearing and any regulation under which the hearing is held. If a regulation, e.g., § 330.10(a)(10), limits a hearing to review of an existing administrative record, information not already in the record may not be considered at the hearing.
(c) The notice of hearing may require participants to submit the text of their presentations in advance of the hearing if the Commissioner determines that advance submissions are necessary for the panel to formulate useful questions to be posed at the hearing under § 15.30(e). The notice may provide for the submission of a comprehensive outline as an alternative to the submission of the text if the Commissioner determines that submission of an outline will be sufficient.
(a) The notice of hearing will provide persons an opportunity to file a written notice of participation with the Dockets Management Branch within a specified period of time containing the information specified in the notice, e.g., name of participant, address, phone number, affiliation, if any, topic of presentation and approximate amount of time requested for the presentation. If the public interest requires, e.g., a hearing is to be conducted within a short period of time or is to be primarily attended by individuals without an organizational affiliation, the notice may name a specific FDA employee and telephone number to whom an oral notice of participation may be given or provide for submitting notices of participation at the time of the hearing. A written or oral notice of participation must be received by the designated person by the close of business of the day specified in the notice.
(b) Promptly after expiration of the time for filing a notice, the Commissioner will determine the amount of time allotted to each person and the approximate time that oral presentation is scheduled to begin. If more than one hearing is held on the same subject, a person will ordinarily be allotted time for a presentation at only one hearing.
(c) Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and to request time for a joint presentation. The Commissioner may require joint presentations by persons with common interests.
(d) The Commissioner will prepare a hearing schedule showing the persons making oral presentations and the time alloted to each person, which will be filed with the Dockets Management Branch and mailed or telephoned before the hearing to each participant.
(e) The hearing schedule will state whether participants must be present by a specified time to be sure to be heard in case the absence of participants advances the schedule.
A person may submit information or views on the subject of the hearing in writing to the Dockets Management Branch, under § 10.20. The record of the hearing will remain open for 15 days after the hearing is held for any additional written submissions, unless the notice of the hearing specifies otherwise or the presiding officer rules otherwise.
(a) The Commissioner or a designee may preside at the hearing, except where a regulation provides that the Commissioner will preside personally. The presiding officer may be accompanied by other FDA employees or other Federal Government employees designated by the Commissioner, who may serve as a panel in conducting the hearing.
(b) The hearing will be transcribed.
(c) Persons may use their alloted time in whatever way they wish, consistent with a reasonable and orderly hearing. A person may be accompanied by any number of additional persons, and may present any written information or views for inclusion in the record of the hearing, subject to the requirements of § 15.25. The presiding officer may allot additional time to any person when the officer concludes that it is in the public interest, but may not reduce the time allotted for any person without the consent of the person.
(d) If a person is not present at the time specified for the presentation, the persons following will appear in order, with adjustments for those appearing at their scheduled time. An attempt will be made to hear any person who is late at the conclusion of the hearing. Other interested persons attending the hearing who did not request an opportunity to make an oral presentation will be given an opportunity to make an oral presentation at the conclusion of the hearing, in the discretion of the presiding officer, to the extent that time permits.
(e) The presiding officer and any other persons serving on a panel may question any person during or at the conclusion of the presentation. No other person attending the hearing may question a person making a presentation. The presiding officer may, as a matter of discretion, permit questions to be submitted to the presiding officer or panel for response by them or by persons attending the hearing.
(f) The hearing is informal in nature, and the rules of evidence do not apply. No motions or objections relating to the admissibility of information and views may be made or considered, but other participants may comment upon or rebut all such information and views. No participant may interrupt the presentation of another participant at any hearing for any reason.
(g) The hearing may end early only if all persons scheduled for a later presentation have already appeared or it is past the time specified in the hearing schedule, under § 15.21(e), by which participants must be present.
(h) The Commissioner or the presiding officer may, under § 10.19, suspend, modify, or waive any provision of this part.
(a) The administrative record of a public hearing before the Commissioner consists of the following:
(1) All relevant
(2) All written submissions under § 15.25.
(3) The transcript of the oral hearing.
(b) The record of the administrative proceeding will be closed at the time specified in § 15.25.
Section 10.20(j) governs the availability for public examination and copying of each document in the administrative record of the hearing
15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
The procedures in this part apply when:
(a) The Commissioner is considering any regulatory action, including a refusal to act, and concludes, as a matter of discretion, on the Commissioner's initiative or at the suggestion of any person, to offer an opportunity for a regulatory hearing to obtain additional information before making a decision or taking action.
(b) The act or a regulation provides a person with an opportunity for a hearing on a regulatory action, including proposed action, and the act or a regulation either specifically provides an opportunity for a regulatory hearing under this part or provides an opportunity for a hearing for which no procedures are specified by regulation. Listed below are the statutory and regulatory provisions under which regulatory hearings are available:
(1) Statutory provisions:
(2) Regulatory provisions:
(a) This part does not apply to the following:
(1) Informal presentation of views before reporting a criminal violation under section 305 of the act and section 5 of the Federal Import Milk Act and § 1210.31.
(2) A hearing on a refusal of admission of a food, drug, device, or cosmetic under section 801(a) of the act and § 1.94, or of an electronic product under section 360(a) of the Public Health Service Act and § 1005.20.
(3) Factory inspections, recalls (except mandatory recalls of medical devices intended for human use), regulatory letters, and similar compliance activities related to law enforcement.
(4) A hearing on an order for relabeling, diversion, or destruction of shell eggs under section 361 of the Public Health Service Act (42 U.S.C. 264) and §§ 101.17(h) and 115.50 of this chapter.
(b) If a regulation provides a person with an opportunity for hearing and specifies some procedures for the hearing but not a comprehensive set of procedures, the procedures in this part apply to the extent that they are supplementary and not in conflict with the other procedures specified for the hearing. Thus, the procedures in subpart A of part 108 relating to emergency permit control are supplemented by the nonconflicting procedures in this part, e.g., the right to counsel, public notice of the hearing, reconsideration and stay, and judicial review.
(a) A regulatory hearing is initiated by a notice of opportunity for hearing from FDA. The notice will—
(1) Be sent by mail, telegram, telex, personal delivery, or any other mode of written communication;
(2) Specify the facts and the action that are the subject of the opportunity for a hearing;
(3) State that the notice of opportunity for hearing and the hearing are governed by this part; and
(4) State the time within which a hearing may be requested, and state the name, address, and telephone number of the FDA employee to whom any request for hearing is to be addressed.
(5) Refer to FDA's guideline on electronic media coverage of its administrative proceedings (21 CFR part 10, subpart C).
(b) A person offered an opportunity for a hearing has the amount of time specified in the notice, which may not be less than 3 working days after receipt of the notice, within which to request a hearing. The request may be filed by mail, telegram, telex, personal delivery, or any other mode of written communication, addressed to the designated FDA employee. If no response is filed within that time, the offer is deemed to have been refused and no hearing will be held.
(c) If a hearing is requested, the Commissioner will designate a presiding officer, and the hearing will take place at a time and location agreed upon by the party requesting the hearing, the FDA,
(d) A notice of opportunity for hearing under this section will not operate to delay or stay any administrative action, including enforcement action by the agency unless the Commissioner, as a matter of discretion, determines that delay or a stay is in the public interest.
(a) A regulatory hearing required by the act or a regulation under § 16.1(b) will be initiated in the same manner as other regulatory hearings subject to the additional procedures in this section.
(b) [Reserved]
(c) The notice will state whether any action concerning the matter that is the subject of the opportunity for hearing is or is not being taken pending the hearing under paragraph (d) of this section.
(d) The Commissioner may take such action pending a hearing under this section as the Commissioner concludes is necessary to protect the public health, except where expressly prohibited by statute or regulation. A hearing to consider action already taken, and not stayed by the Commissioner, will be conducted on an expedited basis.
(e) The hearing may not be required to be held at a time less than 2 working days after receipt of the request for hearing.
(f) Before the hearing, FDA will give to the party requesting the hearing reasonable notice of the matters to be considered at the hearing, including a comprehensive statement of the basis for the decision or action taken or proposed that is the subject of the hearing and a general summary of the information that will be presented by FDA at the hearing in support of the decision or action. This information may be given orally or in writing, in the discretion of FDA.
(g) FDA and the party requesting the hearing will, if feasible, at least 1 day before the hearing provide to each other written notice of any published articles or written information to be presented at or relied on at the hearing. A copy will also be provided in advance if the other participant could not reasonably be expected to have or be able to obtain a copy. If written notice or a copy is not provided, the presiding officer may, if time permits, allow the party who did not receive the notice or copy additional time after the close of the hearing to make a submission concerning the article or information.
(a) A request for a hearing may be denied, in whole or in part, if the Commissioner or the FDA official to whom the authority to make the final decision on the matter has been delegated under part 5 determines that no genuine and substantial issue of fact has been raised by the material submitted. If the Commissioner or his or her delegate determines that a hearing is not justified, written notice of the determination will be given to the parties explaining the reason for denial.
(b) After a hearing commences, the presiding officer may issue a summary decision on any issue in the hearing if the presiding officer determines from the material submitted in connection with the hearing, or from matters officially noticed, that there is no genuine and substantial issue of fact respecting that issue. For the purpose of this paragraph, a hearing commences upon the receipt by FDA of a request for hearing submitted under § 16.22(b).
(c) The Commissioner or his or her delegate may review any summary decision of the presiding officer issued under paragraph (b) of this section at the request of a party or on the Commissioner's or his or her delegate's own initiative.
Whenever the Commissioner has delegated authority under part 5 on a matter for which a regulatory hearing is available under this part, the functions of the Commissioner under this part may be performed by any of the officials to whom the authority has been delegated, e.g., a center director.
(a) An FDA employee to whom the Commissioner delegates such authority, or any other agency employee designated by an employee to whom such authority is delegated, or, consistent with 5 CFR 930.209(b) or (c), an administrative law judge to whom such authority is delegated, may serve as the presiding officer and conduct a regulatory hearing under this part.
(b) In a regulatory hearing required by the act or a regulation, the presiding officer is to be free from bias or prejudice and may not have participated in the investigation or action that is the subject of the hearing or be subordinate to a person, other than the Commissioner, who has participated in such investigation or action.
(c)(1) The Commissioner or the delegate under § 16.40 is not precluded by this section from prior participation in the investigation or action that is the subject of the hearing. If there has been prior participation, the Commissioner or the delegate should, if feasible, designate a presiding officer for the hearing who is not a subordinate. Thus, if the Commissioner's authority to make a final decision has been delegated to a center director, the presiding officer may be an official in another center or the office of the Commissioner. The exercise of general supervisory responsibility, or the designation of the presiding officer, does not constitute prior participation in the investigation or action that is the subject of the hearing so as to preclude the Commissioner or delegate from designating a subordinate as the presiding officer.
(2) The party requesting a hearing may make a written request to have the Commissioner or the delegate under § 16.40 be the presiding officer, notwithstanding paragraph (c)(1) of this section. If accepted, as a matter of discretion, by the Commissioner or the delegate, the request is binding upon the party making the request.
(3) A different presiding officer may be substituted for the one originally designated under § 16.22 without notice to the parties.
(a) Regulatory hearings are not subject to the separation of functions rules in § 10.55.
(b) Those persons who are directly involved in the investigation or presentation of the position of FDA or any party at a regulatory hearing that is required by the act or a regulation should avoid any off-the-record communication on the matter to the presiding officer or the Commissioner or their advisors if the communication is inconsistent with the requirement of § 16.95(b)(1) that the administrative record be the exclusive record for decision. If any communication of this type occurs, it is to be reduced to writing and made part of the record, and the other party provided an opportunity to respond.
(c) A copy of any letter or memorandum of meeting between a participant in the hearing and the presiding officer or the Commissioner, e.g., a response by the presiding officer to a request for a change in the time of the hearing, is to be sent to all participants by the person writing the letter or the memorandum.
(a) A regulatory hearing is public, except when the Commissioner determines that all or part of a hearing should be closed to prevent a clearly unwarranted invasion of personal privacy; to prevent the disclosure of a
(1) The Commissioner may determine that a regulatory hearing is closed either on the Commissioner's initiative or on a request by the party asking for a regulatory hearing, in the request for the hearing.
(2) If the hearing is a private hearing, no persons other than the party requesting the hearing, counsel and witnesses, and an employee or consultant or other person subject to a commercial arrangement as defined in § 20.81(a) and FDA representatives with a direct professional interest in the subject matter of the proceeding are entitled to attend.
(b) A regulatory hearing will be conducted by a presiding officer. Employees of FDA will first give a full and complete statement of the action which is the subject of the hearing, together with the information and reasons supporting it, and may present any oral or written information relevant to the hearing. The party requesting the hearing may then present any oral or written information relevant to the hearing. All parties may confront and conduct reasonable cross-examination of any person (except for the presiding officer and counsel for the parties) who makes any statement on the matter at the hearing.
(c) The hearing is informal in nature, and the rules of evidence do not apply. No motions or objections relating to the admissibility of information and views will be made or considered, but any other party may comment upon or rebut all such data, information, and views.
(d) The presiding officer may order the hearing to be transcribed. The party requesting the hearing may have the hearing transcribed, at the party's expense, in which case a copy of the transcript is to be furnished to FDA. Any transcript of the hearing will be included with the presiding officer's report of the hearing.
(e) The presiding officer shall prepare a written report of the hearing. All written material presented at the hearing will be attached to the report. Whenever time permits, the parties to the hearing will be given the opportunity to review and comment on the presiding officer's report of the hearing.
(f) The presiding officer shall include as part of the report of the hearing a finding on the credibility of witnesses (other than expert witnesses) whenever credibility is a material issue, and shall include a recommended decision, with a statement of reasons, unless the Commissioner directs otherwise.
(g) The presiding officer has the power to take such actions and make such rulings as are necessary or appropriate to maintain order and to conduct a fair, expeditious, and impartial hearing, and to enforce the requirements of this part concerning the conduct of hearings. The presiding officer may direct that the hearing be conducted in any suitable manner permitted by law and these regulations.
(h) The Commissioner or the presiding officer has the power under § 10.19 to suspend, modify, or waive any provision of this part.
Any party to a hearing under this part has the right at all times to be advised and accompanied by counsel.
(a) The administrative record of the regulatory hearing consists of the following:
(1) The notice of opportunity for hearing and the response.
(2) All written information and views submitted to the presiding officer at the hearing or after if specifically permitted by the presiding officer.
(3) Any transcript of the hearing.
(4) The presiding officer's report of the hearing and comments on the report under § 16.60(e).
(5) All letters and memoranda of meetings or communications between
(b) The record of the regulatory hearing is closed to the submission of information and views, at the close of the hearing, unless the presiding officer specifically permits additional time for a further submission.
Part 20 governs the availability for public disclosure of each document that is a part of the administrative record of a regulatory hearing.
(a) With respect to a regulatory hearing at the Commissioner's initiative under § 16.1(a), the Commissioner shall consider the administrative record of the hearing specified in § 16.80(a) together with all other relevant information and views available to FDA in determining whether regulatory action should be taken and, if so, in what form.
(b) With respect to a regulatory hearing required by the act or a regulation under § 16.1(b)—
(1) The administrative record of the hearing specified in § 16.80(a) constitutes the exclusive record for decision;
(2) On the basis of the administrative record of the hearing, the Commissioner shall issue a written decision stating the reasons for the Commissioner's administrative action and the basis in the record; and
(3) For purposes of judicial review under § 10.45, the record of the administrative proceeding consists of the record of the hearing and the Commissioner's decision.
After any final administrative action that is the subject of a hearing under this part, any party may petition the Commissioner for reconsideration of any part or all of the decision or action under § 10.33 or may petition for a stay of the decision or action under § 10.35.
Section 10.45 governs the availability of judicial review concerning any regulatory action which is the subject of a hearing under this part
21 U.S.C. 331, 333, 337, 351, 352, 355, 360, 360c, 360f, 360i, 360j, 371; 42 U.S.C. 262, 263b, 300aa-28; 5 U.S.C. 554, 555, 556, 557.
This part sets forth practices and procedures for hearings concerning the administrative imposition of civil money penalties by FDA. Listed below are the statutory provisions that as of August 28, 1995, authorize civil money penalties that are governed by these procedures.
(a) Section 303 (b)(2) through (b)(4) of the Federal Food, Drug, and Cosmetic Act (the act) authorizing civil money penalties for certain violations of the act that relate to prescription drug marketing practices.
(b) Section 303(g) of the act authorizing civil money penalties for certain violations of the act that relate to medical devices.
(c) Section 307 of the act authorizing civil money penalties for certain actions in connection with an abbreviated new drug application or certain actions in connection with a person or individual debarred under section 306 of the act.
(d) Section 351(d)(2)(B) of the Public Health Service Act (the PHS Act) authorizing civil money penalties for violations of biologic recall orders.
(e) Section 354(h)(2) of the PHS Act, as amended by the Mammography Quality Standards Act of 1992, authorizing civil money penalties for failure to obtain a certificate, failure to comply with established standards, among other things.
(f) Section 2128 of the PHS Act authorizing civil money penalties for intentionally destroying, altering, falsifying, or concealing any record or report required to be prepared, maintained, or submitted by vaccine manufacturers pursuant to that section of the PHS Act.
The following definitions are applicable in this part:
(a) For specific acts giving rise to civil money penalty actions brought under 21 U.S.C. 333(g)(1):
(1)
(2)
(3)
(4)
(b)
(c)
(d) Any term that is defined in the act has the same definition for civil money penalty actions that may be brought under that act.
(e) Any term that is defined in Title 21 of the Code of Federal Regulations has the same definition for civil money penalty actions that may arise from the application of the regulation(s).
(f) Any term that is defined in the PHS Act has the same definition for civil money penalty actions that may be brought under that act.
(g)
(a) The Center with principal jurisdiction over the matter involved shall begin all administrative civil money penalty actions by serving on the respondent(s) a complaint signed by the Office of the Chief Counsel attorney for
(b) The complaint shall state:
(1) The allegations of liability against the respondent, including the statutory basis for liability, the identification of violations that are the basis for the alleged liability, and the reasons that the respondent is responsible for the violations;
(2) The amount of penalties and assessments that the Center is seeking;
(3) Instructions for filing an answer to request a hearing, including a specific statement of the respondent's right to request a hearing by filing an answer and to retain counsel to represent the respondent; and
(4) That failure to file an answer within 30 days of service of the complaint will result in the imposition of the proposed amount of penalties and assessments, as provided in § 17.11.
(c) The Center may, on motion, subsequently amend its complaint to conform with the evidence adduced during the administrative process, as justice may require.
(d) The presiding officer will be assigned to the case upon the filing of the complaint under this part.
(a) Service of a complaint may be made by:
(1) Certified or registered mail or similar mail delivery service with a return receipt record reflecting receipt; or
(2) Delivery in person to:
(i) An individual respondent; or
(ii) An officer or managing or general agent in the case of a corporation or unincorporated business.
(b) Proof of service, stating the name and address of the person on whom the complaint was served, and the manner and date of service, may be made by:
(1) Affidavit or declaration under penalty of perjury of the individual serving the complaint by personal delivery;
(2) A United States Postal Service or similar mail delivery service return receipt record reflecting receipt; or
(3) Written acknowledgment of receipt by the respondent or by the respondent's counsel or authorized representative or agent.
(a) The respondent may request a hearing by filing an answer with the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, within 30 days of service of the complaint. Unless stated otherwise, an answer shall be deemed to be a request for hearing.
(b) In the answer, the respondent:
(1) Shall admit or deny each of the allegations of liability made in the complaint; allegations not specifically denied in an answer are deemed admitted;
(2) Shall state all defenses on which the respondent intends to rely;
(3) Shall state all reasons why the respondent contends that the penalties and assessments should be less than the requested amount; and
(4) Shall state the name, address, and telephone number of the respondent's counsel, if any.
(c) If the respondent is unable to file an answer meeting the requirements of paragraph (b) of this section within the time provided, the respondent shall, before the expiration of 30 days from service of the complaint, file a request for an extension of time within which to file an answer that meets the requirements of paragraph (b) of this section. The presiding officer may, for good cause shown, grant the respondent up to 30 additional days within which to file an answer that meets the requirements of paragraph (b) of this section.
(d) The respondent may, on motion, amend its answer to conform with the evidence as justice may require.
(a) If the respondent does not file an answer within the time prescribed in § 17.9 and if service has been effected as provided in § 17.7, the presiding officer shall assume the facts alleged in the complaint to be true, and, if such facts establish liability under the relevant statute, the presiding officer shall
(1) The maximum amount of penalties provided for by law for the violations alleged; or
(2) The amount asked for in the complaint, whichever amount is smaller.
(b) Except as otherwise provided in this section, by failing to file a timely answer, the respondent waives any right to a hearing and to contest the amount of the penalties and assessments imposed under paragraph (a) of this section, and the initial decision shall become final and binding upon the parties 30 days after it is issued.
(c) If, before such a decision becomes final, the respondent files a motion seeking to reopen on the grounds that extraordinary circumstances prevented the respondent from filing an answer, the initial decision shall be stayed pending a decision on the motion.
(d) If, on such motion, the respondent can demonstrate extraordinary circumstances excusing the failure to file an answer in a timely manner, the presiding officer may withdraw the decision under paragraph (a) of this section, if such a decision has been issued, and shall grant the respondent an opportunity to answer the complaint as provided in § 17.9(a).
(e) If the presiding officer decides that the respondent's failure to file an answer in a timely manner is not excused, he or she shall affirm the decision under paragraph (a) of this section, and the decision shall become final and binding upon the parties 30 days after the presiding officer issues the decision on the respondent's motion filed under paragraph (c) of this section.
After an answer has been filed, the Center shall serve a notice of hearing on the respondent. Such notice shall include:
(a) The date, time, and place of a prehearing conference, if any, or the date, time, and place of the hearing if there is not to be a prehearing conference;
(b) The nature of the hearing and the legal authority and jurisdiction under which the hearing is to be held;
(c) A description of the procedures for the conduct of the hearing;
(d) The names, addresses, and telephone numbers of the representatives of the government and of the respondent, if any; and
(e) Such other matters as the Center or the presiding officer deems appropriate.
(a) The parties to the hearing shall be the respondent and the Center(s) with jurisdiction over the matter at issue. No other person may participate.
(b) The parties may at any time prior to a final decision by the entity deciding any appeal agree to a settlement of all or a part of the matter. The settlement agreement shall be filed in the docket and shall constitute complete or partial resolution of the administrative case as so designated by the settlement agreement. The settlement document shall be effective upon filing in the docket and need not be ratified by the presiding officer or the Commissioner of Food and Drugs.
(c) The parties may be represented by counsel, who may be present at the hearing.
(a) At any time after the filing of a complaint, a party may move, with or without supporting affidavits (which, for purposes of this part, shall include declarations under penalty of perjury), for a summary decision on any issue in the hearing. The other party may, within 30 days after service of the motion, which may be extended for an additional 10 days for good cause, serve opposing affidavits or countermove for summary decision.
The presiding officer may set the matter for argument and call for the submission of briefs.
(b) The presiding officer shall grant the motion if the pleadings, affidavits, and other material filed in the record, or matters officially noticed, show that there is no genuine issue as to any material fact and that the party is entitled to summary decision as a matter of law.
(c) Affidavits shall set forth only such facts as would be admissible in evidence and shall show affirmatively
(d) If, on motion under this section, a summary decision is not rendered on all issues or for all the relief asked, and if additional facts need to be developed, the presiding officer will issue an order specifying the facts that appear without substantial controversy and directing further evidentiary proceedings on facts still at issue. The facts specified not to be at issue shall be deemed established.
(e) Except as provided in § 17.18, a party may not obtain interlocutory review by the entity deciding the appeal (currently the DAB) of a partial summary decision of the presiding officer. A review of final summary decisions on all issues may be had through the procedure set forth in § 17.47.
(a) Except as provided in paragraph (b) of this section, rulings of the presiding officer may not be appealed before consideration on appeal of the entire record of the hearing.
(b) A ruling of the presiding officer is subject to interlocutory appeal to the entity deciding the appeal (currently the DAB) if the presiding officer certifies on the record or in writing that immediate review is necessary to prevent exceptional delay, expense, or prejudice to any participant, or substantial harm to the public interest.
(c) When an interlocutory appeal is made, a participant may file a brief on the appeal only if specifically authorized by the presiding officer or the entity deciding the appeal (currently the DAB), and if such authorization is granted, only within the period allowed by the presiding officer or the entity deciding the appeal. If a participant is authorized to file a brief, any other participant may file a brief in opposition, within the period allowed by the entity deciding the appeal (currently the DAB). The deadline for filing an interlocutory appeal is subject to the discretion of the presiding officer.
(a) The presiding officer shall conduct a fair and impartial hearing, avoid delay, maintain order, and assure that a record of the proceeding is made.
(b) The presiding officer has the authority to:
(1) Set and change the date, time, and place of the hearing on reasonable notice to the parties;
(2) Continue or recess the hearing in whole or in part for a reasonable time;
(3) Require parties to attend conferences for settlement, to identify or simplify the issues, or to consider other matters that may aid in the expeditious disposition of the proceeding;
(4) Administer oaths and affirmations;
(5) Issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation;
(6) Rule on motions and other procedural matters;
(7) Regulate the scope and timing of discovery consistent with § 17.23;
(8) Regulate the course of the hearing and the conduct of the parties;
(9) Examine witnesses;
(10) Upon motion of a party for good cause shown, the presiding officer may allow a witness to be recalled for additional testimony;
(11) Receive, rule on, exclude, or limit evidence;
(12) Upon motion of a party or on the presiding officer's own motion, take official notice of facts;
(13) Upon motion of a party, decide cases, in whole or in part, by summary decision when there is no genuine issue of material fact;
(14) Conduct any conference, argument, or hearing on motions in person or by telephone;
(15) Consolidate related or similar proceedings or sever unrelated matters;
(16) Limit the length of pleadings;
(17) Waive, suspend, or modify any rule in this part if the presiding officer
(18) Issue protective orders pursuant to § 17.28; and
(19) Exercise such other authority as is necessary to carry out the responsibilities of the presiding officer under this part.
(c) The presiding officer does not have the authority to find Federal statutes or regulations invalid.
No party or person (except employees of the presiding officer's office) shall communicate in any way with the presiding officer on any matter at issue in a case, unless on notice and opportunity for all parties to participate. This provision does not prohibit a person or party from inquiring about the status of a case or asking routine questions concerning administrative functions or procedures.
(a) The presiding officer may schedule prehearing conferences as appropriate.
(b) Upon the motion of any party, the presiding officer shall schedule at least one prehearing conference at a reasonable time in advance of the hearing.
(c) The presiding officer may use a prehearing conference to discuss the following:
(1) Simplification of the issues;
(2) The necessity or desirability of amendments to the pleadings, including the need for a more definite statement;
(3) Stipulations and admissions of fact as to the contents and authenticity of documents;
(4) Whether the parties can agree to submission of the case on a stipulated record;
(5) Whether a party chooses to waive appearance at an oral hearing and to submit only documentary evidence (subject to the objection of the other party) and written argument;
(6) Limitation of the number of witnesses;
(7) Scheduling dates for the exchange of witness lists and of proposed exhibits;
(8) Discovery and scheduling dates for completion of discovery;
(9) The date, time, and place for the hearing; and
(10) Such other matters as may tend to expedite the fair and just disposition of the proceedings.
(d) The presiding officer shall issue an order containing all matters agreed upon by the parties or ordered by the presiding officer at a prehearing conference.
(a) No later than 60 days prior to the hearing, unless otherwise ordered by the presiding officer, a party may make a request to another party for production, inspection, and copying of documents that are relevant to the issues before the presiding officer. Documents must be provided no later than 30 days after the request has been made.
(b) For the purpose of this part, the term
(c) Requests for documents, requests for admissions, written interrogatories, depositions, and any forms of discovery, other than those permitted under paragraphs (a) and (e) of this section, are not authorized.
(d)(1) Within 10 days of service of a request for production of documents, a party may file a motion for a protective order.
(2) The presiding officer may grant a motion for a protective order, in whole or in part, if he or she finds that the discovery sought:
(i) Is unduly costly or burdensome,
(ii) Will unduly delay the proceeding, or
(iii) Seeks privileged information.
(3) The burden of showing that a protective order is necessary shall be on the party seeking the order.
(4) The burden of showing that documents should be produced is on the party seeking their production.
(e) The presiding officer shall order depositions upon oral questions only upon a showing that:
(1) The information sought cannot be obtained by alternative methods, and
(2) There is a substantial reason to believe that relevant and probative evidence may otherwise not be preserved for presentation by a witness at the hearing.
(a) At least 30 days before the hearing, or by such other time as is specified by the presiding officer, the parties shall exchange witness lists, copies of prior written statements of proposed witnesses, and copies of proposed hearing exhibits, including written testimony.
(b)(1) If a party objects to the proposed admission of evidence not exchanged in accordance with paragraph (a) of this section, the presiding officer will exclude such evidence if he or she determines that the failure to comply with paragraph (a) of this section should result in its exclusion.
(2) Unless the presiding officer finds that extraordinary circumstances justified the failure to make a timely exchange of witness lists under paragraph (a) of this section, he or she must exclude from the party's hearing evidence the testimony of any witness whose name does not appear on the witness list.
(3) If the presiding officer finds that extraordinary circumstances existed, the presiding officer must then determine whether the admission of the testimony of any witness whose name does not appear on the witness lists exchanged under paragraph (a) of this section would cause substantial prejudice to the objecting party. If the presiding officer finds that there is not substantial prejudice, the evidence may be admitted. If the presiding officer finds that there is substantial prejudice, the presiding officer may exclude the evidence, or at his or her discretion, may postpone the hearing for such time as is necessary for the objecting party to prepare and respond to the evidence.
(c) Unless a party objects within 5 days prior to the hearing, documents exchanged in accordance with paragraph (a) of this section will be deemed to be authentic for the purpose of admissibility at the hearing.
(a) A party wishing to procure the appearance and testimony of any individual at the hearing may, when authorized by law, request that the presiding officer issue a subpoena.
(b) A subpoena requiring the attendance and testimony of an individual may also require the individual to produce documents at the hearing.
(c) A party seeking a subpoena shall file a written request therefor not less than 20 days before the date fixed for the hearing unless otherwise allowed by the presiding officer, upon a showing by the party of good cause. Such request shall specify any documents to be produced and shall designate the witnesses and describe the address and location thereof with sufficient particularity to permit such witnesses to be found.
(d) The subpoena shall specify the time and place at which the witness is to appear and any documents the witness is to produce.
(e) The party seeking the subpoena shall serve it in the manner prescribed for service of a complaint in § 17.7.
(f) If a party or the individual to whom the subpoena is directed believes a subpoena to be unreasonable, oppressive, excessive in scope, or unduly burdensome, or if it wishes to raise any other objection or privilege recognized by law, the party or individual may file a motion to quash the subpoena within 10 days after service or on or before the time specified in the subpoena for compliance if it is less than 10 days after service. Such a filing will state the basis for the motion to quash. The presiding officer may quash or modify the subpoena or order it implemented, as justice may require.
(a) A party or a prospective witness may file a motion for a protective order with respect to discovery sought by a party or with respect to the hearing, seeking to limit the availability or disclosure of evidence.
(b) When issuing a protective order, the presiding officer may make any order which justice requires to protect a party or person from oppression or undue burden or expense, or to protect trade secrets or confidential commercial information, as defined in § 20.61 of this chapter, information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, or other information that would be withheld from public disclosure under 21 CFR part 20. Such orders may include, but are not limited to, one or more of the following:
(1) That the discovery not be had;
(2) That the discovery may be had only on specified terms and conditions, including a designation of the time or place;
(3) That the discovery may be had only through a method of discovery provided for by this part other than that requested;
(4) That certain matters not be inquired into, or that the scope of discovery be limited to certain matters;
(5) That the contents of discovery or evidence be sealed;
(6) That the information not be disclosed to the public or be disclosed only in a designated way; or
(7) That the parties simultaneously file specified documents or information enclosed in sealed envelopes to be opened as directed by the presiding officer.
The party requesting a subpoena shall pay the cost of the fees and mileage of any witness subpoenaed in the amounts that would be payable to a witness in a proceeding in a United States District Court. A check for witness fees and mileage shall accompany the subpoena when served.
(a) In computing any period of time under this part or in an order issued thereunder, the time begins with the day following the act or event, and includes the last day of the period, unless either such day is a Saturday, Sunday, or Federal holiday, in which event the time includes the next business day.
(b) When the period of time allowed is less than 7 days, intermediate Saturdays, Sundays, and Federal holidays shall be excluded from the computation.
(c) When a document has been served or issued by placing it in the mail, an additional 5 days will be added to the time permitted for any response.
(a)
(2) The first page of every pleading and paper filed in the proceeding shall contain a caption setting forth the title of the action, the case number assigned by the Office of the Chief Counsel, and designation of the pleading or paper (e.g., “motion to quash subpoena”).
(3) Every pleading shall be signed by, and shall contain the address and telephone number of, the party or the person on whose behalf the pleading was filed, or his or her counsel.
(4) Pleadings or papers are considered filed when they are received by the Dockets Management Branch.
(b)
(c)
(a) Any application to the presiding officer for an order or ruling shall be by motion. Motions shall state the relief sought, the authority relied upon, and the facts alleged, and shall be filed
(b) Except for motions made during a prehearing conference or at the hearing, all motions shall be in writing. The presiding officer may require that oral motions be reduced to writing.
(c) Within 15 days after a written motion is served, or such other time as may be fixed by the presiding officer, any party may file a response to such motion.
(d) The presiding officer may not grant a written motion before the time for filing responses thereto has expired, except upon consent of the parties or following a hearing on the motion, but may overrule or deny such motion without awaiting a response.
(a) The presiding officer shall conduct a hearing on the record to determine whether the respondent is liable for a civil money penalty and, if so, the appropriate amount of any such civil money penalty considering any aggravating or mitigating factors.
(b) In order to prevail, the Center must prove respondent's liability and the appropriateness of the penalty under the applicable statute by a preponderance of the evidence.
(c) The respondent must prove any affirmative defenses and any mitigating factors by a preponderance of the evidence.
(d) The hearing shall be open to the public unless otherwise ordered by the presiding officer, who may order closure only to protect trade secrets or confidential commercial information, as defined in § 20.61 of this chapter, information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, or other information that would be withheld from public disclosure under part 20 of this chapter.
(a) When determining an appropriate amount of civil money penalties and assessments, the presiding officer and the Commissioner of Food and Drugs or entity designated by the Commissioner to decide the appeal (currently the DAB) shall evaluate any circumstances that mitigate or aggravate the violation and shall articulate in their opinions the reasons that support the penalties and assessments imposed.
(b) The presiding officer and the entity deciding the appeal shall refer to the factors identified in the statute under which the penalty is assessed for purposes of determining the amount of penalty.
(c) Nothing in this section shall be construed to limit the presiding officer or the entity deciding the appeal from considering any other factors that in any given case may mitigate or aggravate the offense for which penalties and assessments are imposed.
(a) The presiding officer may sanction a person, including any party or counsel for:
(1) Failing to comply with an order, subpoena, rule, or procedure governing the proceeding;
(2) Failing to prosecute or defend an action; or
(3) Engaging in other misconduct that interferes with the speedy, orderly, or fair conduct of the hearing.
(b) Any such sanction, including, but not limited to, those listed in paragraphs (c), (d), and (e) of this section, shall reasonably relate to the severity and nature of the failure or misconduct.
(c) When a party fails to comply with a discovery order, including discovery and subpoena provisions of this part, the presiding officer may:
(1) Draw an inference in favor of the requesting party with regard to the information sought;
(2) Prohibit the party failing to comply with such order from introducing evidence concerning, or otherwise relying upon, testimony relating to the information sought; and
(3) Strike any part of the pleadings or other submissions of the party failing to comply with such request.
(d) The presiding officer may exclude from participation in the hearing any
(e) If a party fails to prosecute or defend an action under this part after service of a notice of hearing, the presiding officer may dismiss the action or may issue an initial decision imposing penalties and assessments.
(f) The presiding officer may refuse to consider any motion, request, response, brief, or other document that is not filed in a timely fashion or in compliance with the rules of this part.
(g) Sanctions imposed under this section may be the subject of an interlocutory appeal as allowed in § 17.18(b), provided that no such appeal will stay or delay a proceeding.
(a) Except as provided in paragraph (b) of this section, testimony at the hearing shall be given orally by witnesses under oath or affirmation.
(b) Direct testimony shall be admitted in the form of a written declaration submitted under penalty of perjury. Any such written declaration must be provided to all other parties along with the last known address of the witness. Any prior written statements of witnesses proposed to testify at the hearing shall be exchanged as provided in § 17.25(a).
(c) The presiding officer shall exercise reasonable control over the manner and order of questioning witnesses and presenting evidence so as to:
(1) Make the examination and presentation effective for the ascertainment of the truth;
(2) Avoid undue consumption of time; and
(3) Protect witnesses from harassment or undue embarrassment.
(d) The presiding officer shall permit the parties to conduct such cross-examination as may be required for a full disclosure of the facts.
(e) At the discretion of the presiding officer, a witness may be cross-examined on relevant matters without regard to the scope of his or her direct examination. To the extent permitted by the presiding officer, a witness may be cross-examined on relevant matters with regard to the scope of his or her direct examination. To the extent permitted by the presiding officer, cross-examination on matters outside the scope of direct examination shall be conducted in the manner of direct examination and may proceed by leading questions only if the witness is a hostile witness, an adverse party, or a witness identified with an adverse party.
(f) Upon motion of any party, the presiding officer may order witnesses excluded so that they cannot hear the testimony of the other witnesses. This rule does not authorize exclusion of:
(1) A party who is an individual;
(2) In the case of a party that is not an individual, an officer or employee of the party designated to be the party's sole representative for purposes of the hearing; or
(3) An individual whose presence is shown by a party to be essential to the presentation of its case, including an individual employed by a party engaged in assisting counsel for the party.
(g) If a witness' testimony is submitted in writing prior to cross-examination, the cross-examining party need not subpoena the witness or pay for his or her travel to the hearing. The sponsoring party is responsible for producing the witness at its own expense, and failure to do so shall result in the striking of the witness' testimony.
(a) The presiding officer shall determine the admissibility of evidence.
(b) Except as provided in this part, the presiding officer shall not be bound by the “Federal Rules of Evidence.” However, the presiding officer may apply the “Federal Rules of Evidence” when appropriate, e.g., to exclude unreliable evidence.
(c) The presiding officer shall exclude evidence that is not relevant or material.
(d) Relevant evidence may be excluded if its probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or by considerations of undue delay or needless presentation of cumulative evidence.
(e) Relevant evidence may be excluded if it is privileged under Federal law.
(f) Evidence of furnishing or offering or promising to furnish, or accepting or offering or promising to accept, a valuable consideration in settling or attempting to settle a civil money penalty assessment which was disputed as to either validity or amount, is not admissible to prove liability for or invalidity of the civil money penalty or its amount. Evidence of conduct or statements made in settlement negotiations is likewise not admissible. This rule does not require the exclusion of any evidence otherwise discoverable merely because it is presented in the course of settlement negotiations. This rule also does not require exclusion when the evidence is offered for another purpose, such as proving bias or prejudice of a witness or opposing a contention of undue delay.
(g) The presiding officer may in his or her discretion permit the parties to introduce rebuttal witnesses and evidence.
(h) All documents and other evidence offered or taken for the record shall be open to examination by all parties, unless otherwise ordered by the presiding officer pursuant to § 17.28.
(a) The hearing will be recorded and transcribed. Witnesses, participants, and counsel have 30 days from the time the transcript becomes available to propose corrections in the transcript of oral testimony. Corrections are permitted only for transcription errors. The presiding officer shall promptly order justified corrections. Transcripts may be obtained following the hearing from the Dockets Management Branch at a cost not to exceed the actual cost of duplication.
(b) The transcript of testimony, exhibits, and other evidence admitted at the hearing and all papers and requests filed in the proceeding constitute the administrative record for the decision by the presiding officer and the entity designated by the Commissioner of Food and Drugs to decide the appeal, currently the DAB.
(c) The administrative record may be inspected and copied (upon payment of a reasonable fee) by anyone unless otherwise ordered by the presiding officer, who shall upon motion of any party order otherwise when necessary to protect trade secrets or confidential commercial information, as defined in § 20.61 of this chapter, information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, or other information that would be withheld from public disclosure under part 20.
Any party may file a posthearing brief. The presiding officer shall fix the time for filing such briefs (which shall be filed simultaneously), which shall not exceed 60 days from the date the parties received the transcript of the hearing or, if applicable, the stipulated record. Such briefs may be accompanied by proposed findings of fact and conclusions of law. The presiding officer may permit the parties to file responsive briefs. No brief may exceed 30 pages (exclusive of proposed findings and conclusions) unless the presiding officer has previously found that the issues in the proceeding are so complex, or the administrative record is so voluminous, as to justify longer briefs, in which case the presiding officer may set a longer page limit. Proposed findings of fact and conclusions of law shall not exceed 30 pages unless the presiding officer has previously found that the issues in the proceeding are so complex, or the administrative record is so voluminous, as to justify longer proposed findings and conclusions, in which case the presiding officer may set a longer page limit.
(a) The presiding officer shall issue an initial decision based only on the administrative record. The decision shall contain findings of fact, conclusions of law, and the amount of any penalties and assessments imposed.
(b) The findings of fact shall include a finding on each of the following issues:
(1) Whether the allegations in the complaint are true, and, if so, whether respondent's actions identified in the complaint violated the law;
(2) Whether any affirmative defenses are meritorious; and
(3) If the respondent is liable for penalties or assessments, the appropriate amount of any such penalties or assessments, considering any mitigating or aggravating factors that he or she finds in the case.
(c) The presiding officer shall serve the initial decision or the decision granting summary decision on all parties within 90 days after the time for submission of posthearing briefs and responsive briefs (if permitted) has expired. If the presiding officer believes that he or she cannot meet the 90-day deadline, he or she shall notify the Commissioner of Food and Drugs or other entity designated by the Commissioner to decide the appeal of the reason(s) therefor, and the Commissioner or that entity may then set a new deadline.
(d) Unless the initial decision or the decision granting summary decision of the presiding officer is timely appealed, the initial decision or the decision granting summary decision shall constitute the final decision of FDA and shall be final and binding on the parties 30 days after it is issued by the presiding officer.
(a) Either the Center or any respondent may appeal an initial decision, including a decision not to withdraw a default judgment, or a decision granting summary decision to the Commissioner of Food and Drugs or other entity the Commissioner designates to decide the appeal. The Commissioner has currently designated the Departmental Appeals Board (DAB) to decide appeals under this part. Parties may appeal to the DAB by filing a notice of appeal with the DAB, rm. 637-D, Hubert H. Humphrey Bldg., 200 Independence Ave. SW., Washington, DC 20201, and the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, in accordance with this section.
(b)(1) A notice of appeal may be filed at any time within 30 days after the presiding officer issues an initial decision or decision granting summary decision.
(2) The Commissioner or the entity designated by the Commissioner to hear appeals may, within his or her discretion, extend the initial 30-day period for an additional period of time if the Center or any respondent files a request for an extension within the initial 30-day period and shows good cause.
(c) A notice of appeal shall be accompanied by a written brief of no greater length than that allowed for the posthearing brief. The notice must identify specific exceptions to the initial decision, must support each exception with citations to the record, and must explain the basis for each exception.
(d) The opposing party may file a brief of no greater length than that allowed for the posthearing brief in opposition to exceptions within 30 days of receiving the notice of appeal and accompanying brief, unless such time period is extended by the Commissioner or the entity designated by the Commissioner to hear appeals on request of the opposing party for good cause shown. Any brief in opposition to exceptions shall be filed with the Dockets Management Branch and the DAB (addresses above).
(e) The appellant may file a reply brief not more than 10 pages in length within 10 days of being served with appellee's brief.
(f) There is no right to appear personally before the Commissioner of Food and Drugs or other entity deciding the appeal (currently the DAB).
(g) The entity deciding the appeal will consider only those issues raised before the presiding officer, except that the appellee may make any argument based on the record in support of the initial decision or decision granting summary decision.
(h) If on appeal the entity deciding the appeal considers issues not adequately briefed by the parties, the entity may ask for additional briefing. However, no such additional briefs will be considered unless so requested.
(i) If any party demonstrates to the satisfaction of the entity deciding the appeal (currently the DAB) that additional evidence not presented at the hearing is relevant and material and that there were reasonable grounds for
(j) The Commissioner of Food and Drugs or other entity deciding the appeal (currently the DAB) will issue a decision on the appeal within 60 days, if practicable, of the due date for submission of the appellee's brief. In the decision, the entity deciding the appeal may decline to review the case, affirm the initial decision or decision granting summary decision (with or without an opinion), or reverse the initial decision or decision granting summary decision, or increase, reduce, reverse, or remand any civil money penalty determined by the presiding officer in the initial decision. If the entity deciding the appeal declines to review the case, the initial decision or the decision granting summary decision shall constitute the final decision of FDA and shall be final and binding on the parties 30 days after the declination by the entity deciding the appeal.
(k) The standard of review on a disputed issue of fact is whether the initial decision is supported by substantial evidence on the whole record. The standard of review on a disputed issue of law is whether the initial decision is erroneous.
No error in either the admission or the exclusion of evidence, and no error or defect in any ruling or order or in any act done or omitted by the presiding officer or by any of the parties is grounds for vacating, modifying, or otherwise disturbing an otherwise appropriate ruling or order or act, unless refusal to take such action appears to the presiding officer or the Commissioner of Food and Drugs or other entity deciding the appeal (currently the DAB) to be inconsistent with substantial justice. The presiding officer and the entity deciding the appeal at every stage of the proceeding will disregard any error or defect in the proceeding that does not affect the substantial rights of the parties.
(a) The final decision of the Commissioner of Food and Drugs or other entity deciding the appeal (currently the DAB) constitutes final agency action from which a respondent may petition for judicial review under the statutes governing the matter involved. Although the filing of a petition for judicial review does not stay a decision under this part, a respondent may file a petition for stay of such decision under § 10.35 of this chapter.
(b) The Chief Counsel of FDA has been designated by the Secretary of Health and Human Services as the officer on whom copies of petitions for judicial review are to be served. This officer is responsible for filing the record on which the final decision is based. The record of the proceeding is certified by the entity deciding the appeal (currently the DAB).
(c) Exhaustion of an appeal to the entity deciding the appeal (currently the DAB) is a jurisdictional prerequisite to judicial review.
All amounts assessed pursuant to this part shall be delivered to the Director, Division of Financial Management (HFA-100), Food and Drug Administration, rm. 11-61, 5600 Fishers Lane, Rockville, MD 20857, and shall be deposited as miscellaneous receipts in the Treasury of the United States.
21 U.S.C. 371.
This part governs the standards of conduct for, and establishes regulations to prevent conflicts of interest by, all Food and Drug Administration employees.
(a) The provisions of 45 CFR part 73, establishing standards of conduct for all Department employees, are fully applicable to all Food and Drug Administration employees, except that such regulations shall be applicable to special government employees, i.e., consultants to the Food and Drug Administration, only to the extent stated in subpart L of 45 CFR part 73.
(b) The provisions of 45 CFR part 73a supplement the Department standards of conduct and apply only to Food and Drug Administration employees except special government employees.
The following code of ethics, adopted by Congress on July 11, 1958, shall apply to all Food and Drug Administration employees:
Any person in Government service should:
1. Put loyalty to the highest moral principles and to country above loyalty to persons, party, or Government department.
2. Uphold the Constitution, laws, and legal regulations of the United States and of all governments therein and never be a party to their evasion.
3. Give a full day's labor for a full day's pay; giving to the performance of his duties his earnest effort and best thought.
4. Seek to find and employ more efficient and economical ways of getting tasks accomplished.
5. Never discriminate unfairly by the dispensing of special favors or privileges to anyone, whether for remuneration or not; and never accept, for himself or his family, favors or benefits under circumstances which might be construed by reasonable persons as influencing the performance of his governmental duties.
6. Make no private promises of any kind binding upon the duties of office, since a Government employee has no private word which can be binding on public duty.
7. Engage in no business with the Government, either directly or indirectly, which is inconsistent with the conscientious performance of his governmental duties.
8. Never use any information coming to him confidentially in the performance of governmental duties as a means for making private profit.
9. Expose corruption wherever discovered.
10. Uphold these principles, ever conscious that public office is a public trust.
(a) The Commissioner shall establish a permanent five-member Conflict of Interest Review Board, which shall review and make recommendations to the Commissioner on all specific or policy matters relating to conflicts of interest arising within the Food and Drug Administration that are forwarded to it by: (1) The Associate Commissioner for Management and Operations or (2) anyone who is the subject of an adverse determination by the Associate Commissioner for Management and Operations on any matter arising under the conflict of interest laws, except a determination of an apparent violation of law. The Director, Division of Ethics and Program Integrity, Office of Management and Operations, shall serve as executive secretary of the Review Board.
(b) It shall be the responsibility of every Food and Drug Administration employee with whom any specific or policy issue relating to conflicts of interest is raised, or who otherwise wishes to have any such matter resolved, to forward the matter to the Associate Commissioner for Management and Operations for resolution, except that reporting of apparent violations of law are governed by § 19.21.
(c) All general policy relating to conflicts of interest shall be established in guidance documents pursuant to the provisions of § 10.90(b) of this chapter and whenever feasible shall be incorporated in regulations in this subpart.
(d) All decisions relating to specific individuals shall be placed in a public file established for this purpose by the Freedom of Information Staff, e.g., a determination that a consultant may serve on an advisory committee with specific limitations or with public disclosure of stock holdings, except that such determination shall be written in a way that does not identify the individual in the following situations:
(1) A determination that an employee must dispose of prohibited financial interests or refrain from incompatible outside activities in accordance with established Department or agency regulations.
(2) A determination that a proposed consultant is not eligible for employment by the agency.
(3) A determination that public disclosure of any information would constitute an unwarranted invasion of personal privacy in violation of § 20.63 of this chapter.
(a) The Office of Internal Affairs, Office of the Commissioner, is responsible for obtaining factual information for the Food and Drug Administration on any matter relating to allegations of misconduct, impropriety, conflict of interest, or other violations of Federal statutes by agency personnel.
(b) Any Food and Drug Administration employee who has factual information showing or who otherwise believes that any present or former Food and Drug Administration employee has violated or is violating any provision of this subpart or of 45 CFR parts 73 or 73a or of any statute listed in appendix A to 45 CFR part 73 should report such information directly to the Office of Internal Affairs. Any such reports shall be in writing or shall with the assistance of the Office of Internal Affairs, be reduced to writing, and shall be promptly investigated.
(c) Any report pursuant to paragraph (b) of this section and any records relating to an investigation of such reports shall be maintained in strict confidence in the files of the Office of Internal Affairs, shall be exempt from public disclosure, and may be reviewed only by authorized Food and Drug Administration employees who are required to do so in the performance of their duties.
Within 1 year after termination of employment with the Food and Drug Administration, no former Food and Drug Administration employee, including a special government employee, shall appear personally before the Food and Drug Administration or other federal agency or court as agent or attorney for any person other than the United States in connection with any proceeding or matter in which the United States is a party or has a direct and substantial interest and which was under his official responsibility at any time within one year preceding termination of such responsibility. The term
No former Food and Drug Administration employee, including a special government employee, shall knowingly act as agent or attorney for anyone other than United States in connection with any judicial or other proceeding, application, request for a ruling or other determination, contract, claim, controversy, charge, accusation, or other particular matter involving a specific party or parties in which the United States is a party or has a direct and substantial interest and in which he participated personally and substantially through decision, approval, disapproval, recommendation, rendering
5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21 U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.
(a) No officer or employee of the Food and Drug Administration or of any other office or establishment in the Department of Health and Human Services, except as authorized by the Commissioner of Food and Drugs pursuant to this section or in the discharge of his official duties under the laws administered by the Food and Drug Administration, shall give any testimony before any tribunal pertaining to any function of the Food and Drug Administration or with respect to any information acquired in the discharge of his official duties.
(b) Whenever a subpoena, in appropriate form, has been lawfully served upon an officer or employee of the Food and Drug Administration commanding the giving of any testimony, such officer or employee shall, unless otherwise authorized by the Commissioner, appear in response thereto and respectfully decline to testify on the grounds that it is prohibited by this section.
(c) A person who desires testimony from any employee may make written request therefor, verified by oath, directed to the Commissioner setting forth his interest in the matter sought to be disclosed and designating the use to which such testimony will be put in the event of compliance with such request:
(a) Any request for records of the Food and Drug Administration, whether it be by letter or by a subpena duces tecum or by any other writing, shall be handled pursuant to the procedures established in subpart B of this part, and shall comply with the rules governing public disclosure established in subparts C, D, E, and F of this part and in other regulations cross-referenced in § 20.100(c).
(b) Whenever a subpoena duces tecum, in appropriate form, has been lawfully served upon an officer or employee of the Food and Drug Administration commanding the production of any record, such officer or employee shall appear in response thereto, respectfully decline to produce the record on the ground that it is prohibited by this section, and state that the production of the record(s) involved will be handled by the procedures established in this part.
(a) Upon request, the Food and Drug Administration will certify the authenticity of copies of records that are requested to be disclosed pursuant to this part or will authenticate copies of records previously disclosed.
(b) A request for certified copies of records or for authentication of records shall be sent in writing to the Freedom
(a) The Food and Drug Administration will make the fullest possible disclosure of records to the public, consistent with the rights of individuals to privacy, the property rights of persons in trade secrets and confidential commercial or financial information, and the need for the agency to promote frank internal policy deliberations and to pursue its regulatory activities without disruption.
(b) Except where specifically exempt pursuant to the provisions of this part, all Food and Drug Administration records shall be made available for public disclosure.
(c) Except as provided in paragraph (d) of this section, all nonexempt records shall be made available for public disclosure upon request regardless whether any justification or need for such records have been shown.
(d) Under § 21.71 of this chapter, a statement of the purposes to which the record requested is to be put, and a certification that the record will be so used, may be requested when:
(1) The requested record is contained in a Privacy Act Record System as defined in § 21.3(c) of this chapter;
(2) The requester is a person other than the individual who is the subject of the record that is so retrieved or a person acting on his behalf; and
(3) The disclosure is one that is discretionary, i.e., not required under this part.
Any record of the Food and Drug Administration that is disclosed in an authorized manner to any member of the public is available for disclosure to all members of the public, except that:
(a) Data and information subject to the exemptions established in § 20.61 for trade secrets and confidential commercial or financial information, and in § 20.63 for personal privacy, shall be disclosed only to the persons for the protection of whom these exemptions exist.
(b) The limited disclosure of records permitted in § 7.87(c) of this chapter for section 305 hearing records, in § 20.80(b) regarding certain limitations on exemptions, in § 20.103(b) for certain correspondence, and in § 20.104(b) for certain summaries of oral discussions, shall be subject to the special rules stated therein.
(c) Disclosure of a record about an individual, as defined in § 21.3(a) of this chapter, that is retrieved by the individual's name or other personal identifier and is contained in a Privacy Act Record System, as defined in § 21.3(c) of this chapter, shall be subject to the special requirements of part 21 of this chapter. Disclosure of such a record to an individual who is the subject of the record does not invoke the rule established in this section that such records shall be made available for disclosure to all members of the public.
If a record contains both disclosable and nondisclosable information, the nondisclosable information will be deleted and the remaining record will be disclosed unless the two are so inextricably intertwined that it is not feasible to separate them or release of the disclosable information would compromise or impinge upon the nondisclosable portion of the record.
(a) Any written request to the Food and Drug Administration for existing records not prepared for routine distribution to the public shall be deemed to be a request for records pursuant to the Freedom of Information Act, whether or not the Freedom of Information Act is mentioned in the request, and shall be governed by the provisions of this part.
(b) Records or documents prepared by the Food and Drug Administration for routine public distribution, e.g., pamphlets, speeches, and educational materials, shall be furnished free of charge upon request as long as the supply lasts. The provisions of this part shall
(c) All existing Food and Drug Administration records are subject to routine destruction according to standard record retention schedules.
(a) The Freedom of Information Act and the provisions of this part apply only to existing records that are reasonably described in a request filed with the Food and Drug Administration pursuant to the procedures established in subpart C of this part.
(b) The Commissioner may, in his discretion, prepare new records in order to respond adequately to a request for information when he concludes that it is in the public interest and promotes the objectives of the act and the agency.
The provisions of this part apply to all records in Food and Drug Administration files.
(a) Indexes shall be maintained, and revised at least quarterly, for the following Food and Drug Administration records:
(1) Final orders published in the
(2) Statements of policy and interpretation adopted by the agency and still in force and not published in the
(3) Administrative staff manuals and instructions to staff that affect a member of the public.
(b) A copy of each such index is available at cost from the Freedom of Information Staff (HFI-35), Food and Drug Administration, Room 12A-16, 5600 Fishers Lane, Rockville, MD 20857.
Marking records submitted to the Food and Drug Administration as confidential, or with any other similar term, raises no obligation by the Food and Drug Administration to regard such records as confidential, to return them to the person who has submitted them, to review them pursuant to the procedures established in § 20.44, to withhold them from disclosure to the public, or to advise the person submitting them when a request for their public disclosure is received or when they are in fact disclosed.
A determination that data or information submitted to the Food and Drug Administration will be held in confidence and will not be available for public disclosure shall be made only in the form of a regulation published or cross-referenced in this part or by a written determination pursuant to the procedure established in § 20.44.
Except pursuant to the procedure established in § 20.44 for presubmission review of records, no person may withdraw records submitted to the Food and Drug Administration. All Food and Drug Administration records shall be retained by the agency until disposed of pursuant to routine record disposal procedures.
(a) The Office responsible for agency compliance with the Freedom of Information Act and this part is:
(b) All requests for agency records shall be sent in writing to this office.
(a) Unless unusual circumstances dictate otherwise, the Food and Drug Administration shall maintain and dispose of files of requests and reponses furnished thereto within the time limits authorized by GSA General Records Schedule 14, FPMR 101-11-4, January 10, 1977, as follows:
(1) Files created by the receipt of and response to freedom of information requests, except denials and/or appeals, may be destroyed 2 years from date of final response.
(2) Files created by a freedom of information request which was wholly or partially denied may be destroyed 5 years after the denial letter was issued.
(3) Files created by a freedom of information request which was wholly or partially denied and which denial was subsequently appealed to the Department of Health and Human Services may be destroyed 4 years after final determination by FDA or 3 years after final adjudication by courts, whichever is later.
(b) This destruction schedule will automatically be revised whenever the time limits pertaining to these records are revised by the GSA General Records Schedule.
The names of Food and Drug Administration employees will not be deleted from disclosable records except where such deletion is necessary to prevent disclosure of an informant or danger to the life or physical safety of the employee or under other extraordinary circumstances.
(a) All requests for Food and Drug Administration records shall be filed in writing by mailing the request or delivering it to the Freedom of Information Staff (HFI-35), Food and Drug Administration, Room 12A-16, 5600 Fishers Lane, Rockville, MD 20857.
(b) A request for Food and Drug Administration records shall reasonably describe the records being sought, in a way that they can be identified and located. A request should include all pertinent details that will help identify the records sought.
(1) If the description is insufficient to locate the records requested, the Food and Drug Administration will so notify the person making the request and indicate the additional information needed to identify the records requested.
(2) Every reasonable effort shall be made by the Food and Drug Administration to assist in the identification and location of the records sought.
(c) Upon receipt of a request for records, the Freedom of Information Staff shall enter it in a public log. The log shall state the date received, the name of the person making the request, the nature of the record requested, the action taken on the request, the date of determination letter sent pursuant to § 20.41(b), and the date(s) any records are subsequently furnished.
(d) A request by an individual, as defined in § 21.3(a) of this chapter, for a record about himself shall be subject to:
(1) The special requirements of part 21 of this chapter (the privacy regulations), and not to the provisions of this subpart, if the record requested is retrieved by the individual's name or other personal identifier and is contained in a Privacy Act Record System, as defined in § 21.3(c) of this chapter.
(2) The provisions of this subpart if the record requested is not retrieved by the individual's name or other personal identifier, whether or not the record is contained in a Privacy Act Record System.
(a) All time limitations prescribed pursuant to this section shall begin as of the time at which a request for records is logged in by the Freedom of Information Staff pursuant to § 20.40(c). An oral request for records shall not begin any time requirement. A written request for records sent elsewhere
(b) Within 10 working days (excepting Saturdays, Sundays, and legal public holidays) after a request for records is logged in at the Freedom of Information Staff, a letter shall be sent to the persons making the request determining whether, or to the extent which, the agency will comply with the request, and, if any records are denied, the reasons therefor.
(1) If all of the records requested have been located and a final determination has been made with respect to disclosure of all of the records requested, the letter shall so state.
(2) If all of the records have not been located or a final determination has not yet been made with respect to disclosure of all of the records requested, e.g., because it is necessary to consult the person affected pursuant to § 20.45, the letter shall state the extent to which the records involved shall be disclosed pursuant to the rules established in this part.
(3) In the following unusual circumstances, the time for sending this letter may be extended for up to an additional 10 working days by written notice to the person making the request setting forth the reasons for such extension and the time within which a determination is expected to be dispatched:
(i) The need to search for and collect the requested records from field facilities or other establishments that are separate from the Freedom of Information Staff.
(ii) The need to search for, collect, and appropriately examine a voluminous amount of separate and distinct records which are demanded in a single request.
(iii) The need for consultation, which shall be conducted with all practicable speed, with another agency having a substantial interest in the determination of the request or among two or more components of the Food and Drug Administration having substantial subject-matter interest therein.
(4) If any record is denied, the letter shall state the right of the person requesting such records to appeal any adverse determination to the Assistant Secretary for Health, Department of Health and Human Services, in accordance with the provisions of 45 CFR 5.34.
(a)
(1)
(2)
(3)
(b)
(2) If, under paragraph (a)(3) of this section, there is no charge for the first 2 hours of search time, and those 2 hours are spent on a computer search, then the 2 free hours are the first 2 hours of the operator's own operation.
(3) If, under paragraph (a)(2) or (a)(3) of this section, there is no charge for the first 100 pages of duplication, then those 100 pages are the first 100 pages of photocopies of standard size pages, or the first 100 pages of computer printout. If this method to calculate the fee reduction cannot be used, then the total duplication fee will be reduced by the normal charge for photocopying a standard size page, multiplied by 100.
(4) No charge will be made if the costs of routine collection and processing of the fee are likely to equal or exceed the amount of the fee.
(5) If it is determined that a requester (acting either alone or together with others) is breaking down a single request into a series of requests in order to avoid (or reduce) the fees charged, all these requests may be aggregated for purposes of calculating the fees charged.
(6) Interest will be charged on unpaid bills beginning on the 31st day following the day the bill was sent. Provisions in 45 CFR part 30, the Department of Health and Human Services regulations governing claims collection, will be used in assessing interest, administrative costs, and penalties, and in taking actions to encourage payment.
(c)
(1)
(2)
(3)
(i) The document has already been printed in large numbers;
(ii) The program office determines that using existing stock to answer this request, and any other anticipated Freedom of Information requests, will not interfere with program requirements; and
(iii) The Freedom of Information Officer determines that the lower fee is adequate to recover the prorated share of the original printing costs.
(4)
(5)
(6)
(7)
(d)
(2)
(3)
(a)
(1) Is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the Government; and
(2) It is not primarily in the commercial interest of the requester. These two tests are explained in paragraphs (b) and (c) of this section.
(b)
(1) Whether the records to be disclosed pertain to the operations or activities of the Federal Government;
(2) Whether disclosure of the records would reveal any meaningful information about Government operations or activities that is not already public knowledge;
(3) Whether disclosure will advance the understanding of the general public as distinguished from a narrow segment of interested persons. Under this factor, the Food and Drug Administration may consider whether the requester is in a position to contribute to public understanding. For example, the Food and Drug Administration may consider whether the requester has such knowledge or expertise as may be necessary to understand the information, and whether the requester's intended use of the information would be likely to disseminate the information to the public. An unsupported claim to be doing research for a book or article does not demonstrate that likelihood, while such a claim by a representative of the news media is better evidence; and
(4) Whether the contribution to public understanding will be a significant one, i.e., will the public's understanding of the Government's operations be substantially greater as a result of the disclosure.
(c)
(1) Whether disclosure would further a commercial interest of the requester, or of someone on whose behalf the requester is acting. Commercial interests include interests relating to business, trade, and profit. Both profit and nonprofit-making corporations have commercial interests, as well as individuals, unions, and other associations. The interest of a representative of the news media in using the information for news dissemination purposes will not be considered a commercial interest.
(2) If disclosure would further a commercial interest of the requester, whether that effect outweighs the advancement of the public interest as defined in paragraph (b) of this section.
(d)
(e)
(a) Any person who is considering submission of data or information voluntarily to the Food and Drug Administration may forward to the Director of the Center involved, or to the Associate Commissioner for Regulatory Affairs, a request for presubmission review of the records involved to determine whether the Food and Drug Administration will or will not make part or all of them available for public disclosure upon request if they are submitted. Any such request shall state why the data or information involved fall within an exemption from public disclosure set out in subpart D of this part and shall enclose the records involved.
(b) Pending a determination upon such request, the records involved shall be held confidentially and separately by the Food and Drug Administration and shall not be received as part of Food and Drug Administration files.
(c) Pursuant to such a request, the Food and Drug Administration shall make a determination whether part or all of the records involved will be made available for public disclosure upon request if they are submitted. A determination of confidentiality will be made only if it is concluded that the data or information involved fall within an exemption from public disclosure set out in subpart D of this part and are relevant to and important for agency activity.
(d) After a determination is made pursuant to this section, the Food and Drug Administration shall receive as part of its files the records for which a request for confidentiality has been granted and shall so mark or designate those records. The person requesting the presubmission review shall have the option of submitting or withdrawing the records for which a request for confidentiality has been denied. No copy or summary of records withdrawn pursuant to this section, or any correspondence or memoranda or records relating thereto, shall be retained in Food and Drug Administration files.
(e) A determination of confidentiality pursuant to this section is subject to the limitations established in subpart E of this part except that the data or information involved shall not be subject to discretionary release pursuant to § 20.82. Such a determination of confidentiality by the Food and Drug Administration means that the Food and Drug Administration will not make the data or information involved available for public disclosure unless ordered to do so by a court.
(f) A determination based upon a presubmission review pursuant to this section shall be made in writing and shall be signed only by the Associate Commissioner for Public Affairs.
(g) Data and information that may be required to be submitted to the Food and Drug Administration but that are submitted voluntarily instead are not subject to the provisions of this section and will be handled as if they had been required to be submitted.
(h) No request under this section shall be accepted if the status of the records involved is already determined by § 20.111 or by any other regulation published or cross-referenced in this part.
In situations where the confidentiality of data or information is uncertain and there is a request for public disclosure, the Food and Drug Administration will consult with the person who has submitted or divulged the data or information or who would be affected by disclosure before determining whether or not such data or information is available for public disclosure.
Where the Food and Drug Administration consults with a person who will be affected by a proposed disclosure of data or information contained in Food and Drug Administration records pursuant to § 20.45, and rejects the person's request that part or all of the records not be made available for public disclosure, the decision constitutes final agency action that is subject to judicial review pursuant to 5 U.S.C. chapter 7. The person affected will be permitted 5 days after receipt of notification of such decision within which to institute suit in a United States District Court to enjoin release of the records involved. If suit is brought, the Food and Drug Administration will not disclose the records involved until the matter and all related appeals have been concluded.
(a) A denial of a request for records, in whole or in part, shall be signed by the Associate Commissioner for Public Affairs.
(b) The name and title or position of each person who participated in the denial of a request for records shall be set forth in the letter denying the request. This requirement may be met by attaching a list of such individuals to the letter.
(c) A letter denying a request for records, in whole or in part, shall state the reasons for the denial and shall state that an appeal may be made to the Assistant Secretary for Health, Department of Health and Human Services, pursuant to the provisions of 45 CFR 5.34.
(d) Minor deletions of nondisclosable data and information from disclosable records shall not be deemed to be a denial of a request for records.
The Food and Drug Administration will make every reasonable effort to comply fully with all requests for disclosure of nonexempt records. Nonspecific requests or requests for a large number of documents that require the deployment of a substantial amount of agency man-hours to search for and compile will be processed taking into account the staff-hours required, the tasks from which these resources must be diverted, the impact that this diversion will have upon the agency's consumer protection activities, and the public policy reasons justifying the requests. A decision on the processing of such a request for information shall be
Upon receipt of a request for a record or document which is contained in Food and Drug Administration files but which is available elsewhere at a lower cost, the person requesting the record or document shall be referred to the primary source of the record or document.
The Food and Drug Administration is furnishing a number of records to the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22162, which reproduces and distributes such information to the public at cost. A single copy of each such record shall be available for public review at the Food and Drug Administration. All persons requesting copies of such records shall be answered by referring the person requesting the records to NTIS.
The Food and Drug Administration may furnish requested records to a private contractor for copying after deletion of all nondisclosable data and information. Under these circumstances, the Food and Drug Administration will charge the person requesting the records for all of the fees involved pursuant to § 20.42.
(a) A person requesting disclosure of records shall be permitted an opportunity to review them without the necessity for copying them where the records involved contain only disclosable data and information. Under these circumstances, the Food and Drug Administration will charge only for the costs of searching for the records.
(b) Where a request is made for review of records without copying, and the records involved contain both disclosable and nondisclosable information, the records containing nondisclosable information shall first be copied with the nondisclosable information blocked out and the Food and Drug Administration will charge for the costs of searching and copying.
Whenever the Food and Drug Administration denies a request for a record or portion thereof on the grounds that the record or portion thereof is exempt from public disclosure as trade secret or confidential commercial or financial data and information under § 20.61, and the person requesting the record subsequently contests the denial in the courts, the Food and Drug Administration will so inform the person affected, i.e., the person who submitted the record, and will require that such person intervene to defend the exempt status of the record. If a court requires the Food and Drug Administration to itemize and index such records, the Food and Drug Administration will so inform the person affected and will require that such person undertake the itemization and indexing of the records. If the affected person fails to intervene to defend the exempt status of the records and to itemize and index the disputed records, the Food and Drug Administration will take this failure into consideration in deciding whether that person has waived such exemption so as to require the Food and Drug Administration to promptly
(a) The exemptions established in this subpart shall apply to all Food and Drug Administration records, except as provided in subpart E of this part. Accordingly, a record that is ordinarily available for public disclosure in accordance with the provisions in subpart F of this part or of another regulation cross-referenced in § 20.100(c) is not available for such disclosure to the extent that it falls within an exemption contained in this subpart, except as provided by the limitations on exemptions specified in subpart E of this part. For example, correspondence that is ordinarily disclosable under § 20.103 is not disclosable to the extent that it contains trade secrets exempt from disclosure under § 20.61 and is not subject to discretionary release under § 20.82.
(b) Where application of one or more exemptions results in a record being disclosable in part and nondisclosable in part, the rule established in § 20.22 shall apply.
(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationship between the trade secret and the productive process.
(b) Commercial or financial information that is privileged or confidential means valuable data or information which is used in one's business and is of a type customarily held in strict confidence or regarded as privileged and not disclosed to any member of the public by the person to whom it belongs.
(c) Data and information submitted or divulged to the Food and Drug Administration which fall within the definitions of a trade secret or confidential commercial or financial information are not available for public disclosure.
(d) A person who submits records to the Government may designate part or all of the information in such records as exempt from disclosure under exemption 4 of the Freedom of Information Act. The person may make this designation either at the time the records are submitted to the Government or within a reasonable time thereafter. The designation must be in writing. Where a legend is required by a request for proposals or request for quotations, pursuant to 48 CFR 352.215-12, then that legend is necessary for this purpose. Any such designation will expire 10 years after the records were submitted to the Government.
(e) The procedures in this paragraph apply to records on which the submitter has designated information as provided in paragraph (d) of this section. These procedures also apply to records that were submitted to the Food and Drug Administration when the agency has substantial reason to believe that information in the records could reasonably be considered exempt under exemption 4 of the Freedom of Information Act. Certain exceptions to these procedures are set forth in paragraph (f) of this section.
(1) When the Food and Drug Administration receives a request for such records and determines that disclosure may be required, the Food and Drug Administration will make reasonable efforts to notify the submitter about these facts. The notice will include a copy of the request, and it will inform the submitter about the procedures and time limits for submission and consideration of objections to disclosure. If the Food and Drug Administration must notify a large number of submitters, notification may be done by posting or publishing a notice in a place where the submitters are reasonably likely to become aware of it.
(2) The submitter has 5 working days from receipt of the notice to object to disclosure of any part of the records and to state all bases for its objections.
(3) The Food and Drug Administration will give consideration to all bases that have been stated in a timely manner by the submitter. If the Food and
(4) If a requester files suit under the Freedom of Information Act to obtain records covered by this paragraph, the Food and Drug Administration will promptly notify the submitter.
(5) Whenever the Food and Drug Administration sends a notice to a submitter under paragraph (e)(1) of this section, the Food and Drug Administration will notify the requester that the Food and Drug Administration is giving the submitter a notice and an opportunity to object. Whenever the Food and Drug Administration sends a notice to a submitter under paragraph (e)(3) of this section, the Food and Drug Administration will notify the requester of this fact.
(f) The notice requirements in paragraph (e) of this section do not apply in the following situations:
(1) The Food and Drug Administration decided not to disclose the records;
(2) The information has previously been published or made generally available;
(3) Disclosure is required by a regulation issued after notice and opportunity for public comment, that specifies narrow categories of records that are to be disclosed under the Freedom of Information Act, but in this case a submitter may still designate records as described in paragraph (d) of this section, and in exceptional cases, the Food and Drug Administration may, at its discretion, follow the notice procedures in paragraph (e) of this section;
(4) The information requested has not been designated by the submitter as exempt from disclosure when the submitter had an opportunity to do so at the time of submission of the information or within a reasonable time thereafter, unless the Food and Drug Administration has substantial reason to believe that disclosure of the information would result in competitive harm; or
(5) The designation appears to be obviously frivolous, but in this case the Food and Drug Administration will still give the submitter the written notice required by paragraph (e)(3) of this section (although this notice need not explain our decision or include a copy of the records), and the Food and Drug Administration will notify the requester as described in paragraph (e)(5) of this section.
All communications within the Executive Branch of the Federal government which are in written form or which are subsequently reduced to writing may be withheld from public disclosure except that factual information which is reasonably segregable in accordance with the rule established in § 20.22 is available for public disclosure.
(a) The names or other information which would identify patients or research subjects in any medical or similar report, test, study, or other research project shall be deleted before the record is made available for public disclosure.
(b) The names and other information which would identify patients or research subjects should be deleted from any record before it is submitted to the Food and Drug Administration. If the Food and Drug Administration subsequently needs the names of such individuals, a separate request will be made.
(c) Requests for deletion of business or product names prior to disclosure of any record to the public shall not be granted on the ground of privacy, but such deletion may be justified under another exemption established in this subpart, e.g., the exemption for trade
(d) Names of individuals conducting investigations, studies, or tests on products or ingredients shall not be deleted prior to disclosure of any record to the public unless extraordinary circumstances are shown.
(e) A request for all records relating to a specific individual will be denied as a clearly unwarranted invasion of personal privacy unless accompanied by the written consent of the individual named.
(f) The names and any information that would identify the voluntary reporter or any other person associated with an adverse event involving a human drug, biologic, or medical device product shall not be disclosed by the Food and Drug Administration or by a manufacturer in possession of such reports in response to a request, demand, or order. Information that would identify the voluntary reporter or persons identified in the report includes, but is not limited to, the name, address, institution, or any other information that would lead to the identities of the reporter or persons identified in a report. This provision does not affect disclosure of the identities of reporters required by a Federal statute or regulation to make adverse event reports. Disclosure of the identities of such reporters is governed by the applicable Federal statutes and regulations.
(1)
(ii) Identities of the voluntary reporter and the person who experienced the reported adverse event may be disclosed pursuant to a court order in the course of medical malpractice litigation involving both parties; or (iii) The report, excluding the identities of any other individuals, shall be disclosed to the person who is the subject of the report upon request.
(2)
(a) Records or information compiled for law enforcement purposes may be withheld from public disclosure pursuant to the provisions of this section to the extent that disclosure of such records or information:
(1) Could reasonably be expected to interfere with enforcement proceedings;
(2) Would deprive a person to a right to a fair trial or an impartial adjudication;
(3) Could reasonably be expected to constitute an unwarranted invasion of personal privacy;
(4) Could reasonably be expected to disclose the identity of a confidential source, including a State, local, or foreign agency or authority or any private institution which furnished information on a confidential basis; and information furnished by a confidential source in the case of a record compiled by the Food and Drug Administration or any other criminal law enforcement authority in the course of a criminal investigation or by an agency conducting a lawful national security intelligence investigation;
(5) Would disclose techniques and procedures for law enforcement investigations or prosecutions or would disclose guidelines for law enforcement investigations or prosecutions, if such disclosure could reasonably be expected to risk circumvention of the law; or
(6) Could reasonably be expected to endanger the life or physical safety of any individual.
(b) Records include all records relating to regulatory enforcement action, including both administrative and
(c) Any record which is disclosed to any person, including any person who is the subject of a Food and Drug Administration investigation, and any data or information received from any person who is the subject of a Food and Drug Administration investigation relating to such investigation, is available for public disclosure at that time in accordance with the rule established in § 20.21, except that:
(1) Disclosure of such records shall be subject to the other exemptions established in this subpart and to the limitations on exemptions established in subpart E of this part.
(2) The record of a section 305 hearing shall be available for public disclosure only in accordance with the provisions of § 7.87 of this chapter.
(d) Records for law enforcement purposes shall be subject to the following rules:
(1) No such record is available for public disclosure prior to the consideration of regulatory enforcement action based upon that record's being closed, except as provided in § 20.82. The Commissioner will exercise his discretion to disclose records relating to possible criminal prosecution pursuant to § 20.82 prior to consideration of criminal prosecution being closed only very rarely and only under circumstances that demonstrate a compelling public interest.
(2) After the consideration of regulatory enforcement action is closed, such records shall be made available for public disclosure except to the extent that other exemptions from disclosure in this subpart are applicable. No statements of witnesses obtained through promises of confidentiality are available for public disclosure.
(3) The consideration of regulatory enforcement action based upon a particular record shall be deemed to be closed within the meaning of this section:
(i) If it relates to administrative action, when a final decision has been made not to take such action or such action has been taken and the matter has been concluded.
(ii) If it relates to court action, when a final decision has been made not to recommend such action to a United States attorney based upon that record, or a recommendation has been finally refused by a United States attorney, or court action has been instituted and the matter and all related appeals have been concluded, or the statute of limitations runs.
(iii) If it relates to both administrative and court action, when the events described in both paragraph (d)(3) (i) and (ii) of this section have occurred.
(4) Prior to disclosure of any record specifically reflecting consideration of possible criminal prosecution of any individual, all names and other information that would identify an individual who was considered for criminal prosecution but who was not prosecuted shall be deleted unless the Commissioner concludes that there is a compelling public interest in the disclosure of such names.
(e) Names and other information that would identify a Food and Drug Administration employee shall be deleted from records prior to public disclosure only pursuant to § 20.32.
(a) The limitations on exemptions established in this subpart shall apply to all Food and Drug Administration records, except as specifically provided herein. Accordingly, a record that is ordinarily exempt from public disclosure in accordance with the provisions in subpart D of this part is available for such disclosure to the extent that it falls within a limitation on the exemption contained in this subpart. For example, an investigatory record that is ordinarily exempt from disclosure under § 20.64 is disclosable to Congress in accordance with the provisions of § 20.87.
(b) Disclosure of a record to any member of the public pursuant to the provisions in § 20.81, data and information previously disclosed to the public, in § 20.82, discretionary disclosure by
(c) Disclosure to government employees and special government employees of records exempt from public disclosure shall subject those persons to the same restrictions with respect to the disclosure of such records as any Food and Drug Administration employee.
(d) In the case of a record in a Privacy Act Record System, as defined in § 21.3(c) of this chapter:
(1) The availability to an individual, as defined in § 21.3(a), of a record about himself that is retrieved by the individual's name or other personal identifier and is contained in a Privacy Act Record System shall be subject to the special requirements of part 21 of this chapter (the privacy regulations) and shall not be subject to the exemptions in subpart D of this part except that where the system is exempt and the requested record is not available under § 21.61 of this chapter, the provisions of this part shall apply.
(2) The availability of a record about an individual to persons other than the individual who is the subject of the record shall be subject to the special requirements of part 21, subpart G, of this chapter (restrictions on disclosure in the privacy regulations), and shall not be subject to the limitations on exemptions in this subpart except as provided in part 21, subpart G, of this chapter.
(a) Any Food and Drug Administration record that is otherwise exempt from public disclosure pursuant to subpart D of this part is available for public disclosure to the extent that it contains data or information that have previously been disclosed in a lawful manner to any member of the public, other than an employee or consultant or pursuant to other commerical arrangements with appropriate safeguards for secrecy.
(1) For purposes of this section, an individual shall be deemed to be a consultant only if disclosure of the information was necessary in order to perform that specific consulting service and the purpose of the disclosure was solely to obtain that service. The number of consultants who have received such information shall have been limited to the number reasonably needed to perform that particular consulting service.
(2) For purposes of this section, other commercial arrangements shall include licenses, contracts, and similar legal relationships between business associates.
(3) For purposes of this section, data and information disclosed to clinical investigators or members of institutional review committees, whether required by regulations of the Food and Drug Administration, or made voluntarily, if accompanied by appropriate safeguards to assure secrecy and otherwise in accordance with this section, are not deemed to have been previously disclosed to any member of the public within the meaning of paragraph (a) of this section.
(b) Any data or information furnished to the Food and Drug Administration for a presubmission review pursuant to the procedure established in § 20.44 shall be accompanied by a statement that the information has not previously been published or disclosed to anyone other than as provided in paragraph (a) of this section.
(c) Any statement relating to prior public disclosure is subject to the False Reports to the Government Act, 18 U.S.C. 1001.
(a) Except as provided in paragraph (b) of this section, the Commissioner may, in his discretion, disclose part or all of any Food and Drug Administration record that is otherwise exempt from disclosure pursuant to subpart D of this part. The Commissioner shall exercise his discretion to disclose such records whenever he determines that such disclosure is in the public interest, will promote the objectives of the act and the agency, and is consistent with the rights of individuals to privacy, the property rights of persons in trade secrets, and the need for the agency to promote frank internal policy deliberations and to pursue its regulatory activities without disruption.
(b) The Commissioner shall not make available for public disclosure any record that is:
(1) Exempt from public disclosure pursuant to § 20.61.
(2) Exempt from public disclosure pursuant to § 20.63.
(3) Prohibited from public disclosure pursuant to 21 U.S.C. 331(j), 42 U.S.C. 263g(d), 42 U.S.C. 263i, or 18 U.S.C. 1905.
(4) Contained in a Privacy Act Record System where disclosure would constitute a clearly unwarranted invasion of personal privacy or is otherwise in violation of 5 U.S.C. 552a(b), as applied in part 21, subpart G, of this chapter (restrictions on disclosure in the privacy regulations).
(c) Discretionary disclosure of a record pursuant to this section shall invoke the requirement that the record shall be disclosed to any person who requests it pursuant to § 20.21, but shall not set a precedent for discretionary disclosure of any similar or related record and shall not obligate the Commissioner to exercise his discretion to disclose any other record that is exempt from disclosure.
(a) Records of the Food and Drug Administration which the Commissioner has determined are not available for public disclosure, either in the form of a regulation published or cross-referenced in this part or by a written determination pursuant to the procedure established in § 20.44, shall nevertheless be made available for public disclosure in compliance with a final court order requiring such disclosure.
(b) Where the Food and Drug Administration record ordered disclosed under paragraph (a) of this section is a record about an individual that is not available for public disclosure under § 20.63, the Food and Drug Administration shall attempt to notify the individual who is the subject of the record of the disclosure, by sending a notice to the individual's last known address.
(c) Paragraph (b) of this section shall not apply where the name or other personal identifying information is deleted prior to disclosure.
Data and information otherwise exempt from public disclosure may be disclosed to Food and Drug Administration consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other special government employees for use only in their work with the Food and Drug Administration. Such persons are thereafter subject to the same restrictions with respect to the disclosure of such data and information as any other Food and Drug Administration employee.
Any Food and Drug Administration record otherwise exempt from public disclosure may be disclosed to other Federal government departments and agencies, except that trade secrets and confidential commercial or financial information prohibited from disclosure by 21 U.S.C. 331(j), 21 U.S.C. 360(j)(c), 42 U.S.C. 263g(d) and 42 U.S.C. 263i(e) may be released only as provided by those sections. Any disclosure under this section shall be pursuant to a written agreement that the record shall not be
Data and information otherwise exempt from public disclosure may be revealed in Food and Drug Administration administrative proceedings pursuant to parts 10, 12, 13, 14, 15, 17, and 19 of this chapter or court proceedings, where data or information are relevant. The Food and Drug Administration will take appropriate measures, or request that appropriate measures be taken, to reduce disclosure to the minimum necessary under the circumstances.
(a) All records of the Food and Drug Administration shall be disclosed to Congress upon an authorized request.
(b) An authorized request for Food and Drug Administration records by Congress shall be made by the chairman of a committee or subcommittee of Congress acting pursuant to committee business.
(c) An individual member of Congress who requests a record for his own use or on behalf of any constituent shall be subject to the same rules in this part that apply to any other member of the public.
(a) A State or local government official commissioned by the Food and Drug Administration pursuant to 21 U.S.C. 372(a) shall have the same status with respect to disclosure of Food and Drug Administration records as any special government employee.
(b) Communications with State and local government officials with respect to law enforcement activities undertaken pursuant to a contract between the Food and Drug Administration and such officials shall be subject to the rules for public disclosure established in § 20.64.
(c) Communications with State and local government officials who are not commissioned pursuant to 21 U.S.C. 372(a) or under a contract to perform law enforcement activities shall have the same status as communications with any member of the public, except that:
(1) Investigatory records compiled for law enforcement purposes by State and local government officials who perform counterpart functions to the Food and Drug Administration at the State and local level, and trade secrets and confidential commercial or financial information obtained by such officials, which are voluntarily disclosed to the Food and Drug Administration as part of cooperative law enforcement and regulatory efforts, shall be exempt from public disclosure to the same extent to which the records would be so exempt pursuant to §§ 20.61 and 20.64, as if they had been prepared by or submitted directly to Food and Drug Administration employees, except that investigatory records shall be exempt from disclosure for a longer period of time if the State or local government officials so require as a condition of their furnishing the information to the Food and Drug Administration.
(2) Disclosure of investigatory records compiled for law enforcement purposes by the Food and Drug Administration to State and local government officials who perform counterpart functions to the Food and Drug Administratrion at the State and local level as part of cooperative law enforcement efforts does not invoke the rule established in § 20.21 that such records shall be made available for disclosure to all members of the public.
(d)(1) The Commissioner of Food and Drugs, or any other officer or employee of the Food and Drug Administration whom the Commissioner may designate to act on his or her behalf for the purpose, may authorize the disclosure of confidential commercial information submitted to the Food and Drug Administration, or incorporated into agency-prepared records, to State government officials as part of cooperative
(i) The State government agency has provided both a written statement establishing its authority to protect confidential commercial information from public disclosure and a written commitment not to disclose any such information provided without the written permission of the sponsor or written confirmation by the Food and Drug Administration that the information no longer has confidential status; and
(ii) The Commissioner of Food and Drugs or the Commissioner's designee makes one or more of the following determinations:
(A) The sponsor of the product application has provided written authorization for the disclosure;
(B) Disclosure would be in the interest of public health by reason of the State government's possessing information concerning the safety, effectiveness, or quality of a product or information concerning an investigation, or by reason of the State government being able to exercise its regulatory authority more expeditiously than the Food and Drug Administration; or
(C) The disclosure is to a State government scientist visiting the Food and Drug Administration on the agency's premises as part of a joint review or long-term cooperative training effort authorized under section 708 of the Federal Food, Drug, and Cosmetic Act (the act), the review is in the interest of public health, the Food and Drug Administration retains physical control over the information, the Food and Drug Administration requires the visiting State government scientist to sign a written commitment to protect the confidentiality of the information, and the visiting State government scientist provides a written assurance that he or she has no financial interest in the regulated industry of the type that would preclude participation in the review of the matter if the individual were subject to the conflict of interest rules applicable to the Food and Drug Administration advisory committee members under § 14.80(b)(1) of this chapter. Subject to all the foregoing conditions, a visiting State government scientist may have access to trade secret information, entitled to protection under section 301(j) of the act, in those cases where such disclosures would be a necessary part of the joint review or training.
(2) Except as provided under paragraph (d)(1)(ii)(C) of this section, this provision does not authorize the disclosure to State government officials of trade secret information concerning manufacturing methods and processes prohibited from disclosure by section 301(j) of the act, unless pursuant to an express written authorization provided by the submitter of the information.
(3) Any disclosure under this section of information submitted to the Food and Drug Administration or incorporated into agency-prepared records does not invoke the rule established in § 20.21 that such records shall be made available to all members of the public.
(e)(1) The Senior Associate Commissioner for Policy, Planning, and Legislation, or the Deputy Commissioner for International and Constituent Relations, or any other officer or employee of the Food and Drug Administration whom the Senior Associate Commissioner for Policy, Planning, and Legislation or the Deputy Commissioner for International and Constituent Relations may designate to act on their behalf for the purpose, may authorize the disclosure to, or receipt from, an official of a State government agency of nonpublic, predecisional documents concerning the Food and Drug Administration's or the other government agency's regulations or other regulatory requirements, or other nonpublic information relevant to either agency's activities, as part of efforts to improve Federal-State uniformity, cooperative regulatory activities, or implementation of Federal-State agreements, provided that:
(i) The State government agency has the authority to protect such nonpublic documents from public disclosure and will not disclose any such documents provided without the written confirmation by the Food and Drug Administration that the documents no longer have nonpublic status; and
(ii) The Senior Associate Commissioner for Policy, Planning, and Legislation or the Deputy Commissioner for
(2) Any exchange under this section of nonpublic documents does not invoke the rule established at § 20.21 that such records shall be made available to all members of the public.
(3) For purposes of this paragraph, the term
Communications with foreign government officials shall have the same status as communications with any member of the public, except that:
(a) Investigatory records compiled for law enforcement purposes by foreign government officials who perform counterpart functions to the Food and Drug Administration in a foreign country, and trade secrets and confidential commercial or financial information obtained by such officials, which are voluntarily disclosed to the Food and Drug Administration as part of cooperative law enforcement and regulatory efforts, shall be exempt from public disclosure to the same extent to which the records would be so exempt pursuant to §§ 20.61 and 20.64, as if they had been prepared by or submitted directly to Food and Drug Administration employees, except that investigatory records shall be exempt from disclosure for a longer period of time if the foreign government officials so require as a condition of their furnishing the information to the Food and Drug Administration.
(b) Disclosure of investigatory records compiled for law enforcement purposes by the Food and Drug Administration to foreign government officials who perform counterpart functions to the Food and Drug Administration in a foreign country as part of cooperative law enforcement efforts does not invoke the rule established in § 20.21 that such records shall be made available for disclosure to all members of the public.
(c)(1) The Commissioner of Food and Drugs, or any other officer or employee of the Food and Drug Administration whom the Commissioner may designate to act on his or her behalf for the purpose, may authorize the disclosure of confidential commercial information submitted to the Food and Drug Administration, or incorporated into agency-prepared records, to foreign government officials who perform counterpart functions to the Food and Drug Administration as part of cooperative law enforcement or regulatory efforts, provided that:
(i) The foreign government agency has provided both a written statement establishing its authority to protect confidential commercial information from public disclosure and a written commitment not to disclose any such information provided without the written permission of the sponsor or written confirmation by the Food and Drug Administration that the information no longer has confidential status; and
(ii) The Commissioner of Food and Drugs or the Commissioner's designee makes one or more of the following determinations:
(A) The sponsor of the product application has provided written authorization for the disclosure;
(B) Disclosure would be in the interest of public health by reason of the foreign government's possessing information concerning the safety, efficacy, or quality of a product or information concerning an investigation; or
(C) The disclosure is to a foreign scientist visiting the Food and Drug Administration on the agency's premises as part of a joint review or long-term cooperative training effort authorized under section 708 of the act, the review
(2) Except as provided under paragraph (c)(1)(ii)(C) of this section, this provision does not authorize the disclosure to foreign government officials of other countries of trade secret information concerning manufacturing methods and processes prohibited from disclosure by section 301(j) of the act, unless pursuant to an express written authorization provided by the submitter of the information.
(3) Any disclosure under this section of information submitted to the Food and Drug Administration or incorporated into agency-prepared records does not invoke the rule established in § 20.21 that such records shall be made available to all members of the public.
(d)(1) The Senior Associate Commissioner for Policy, Planning, and Legislation, or the Deputy Commissioner for International and Constituent Relations, or any other officer or employee of the Food and Drug Administration whom the Senior Associate Commissioner for Policy, Planning, and Legislation or the Deputy Commissioner for International and Constituent Relations may designate to act on their behalf for the purpose, may authorize the disclosure to, or receipt from, an official of a foreign government agency of nonpublic, predecisional documents concerning the Food and Drug Administration's or the other government agency's regulations or other regulatory requirements, or other nonpublic information relevant to either agency's activities, as part of cooperative efforts to facilitate global harmonization of regulatory requirements, cooperative regulatory activities, or implementation of international agreements, provided that:
(i) The foreign government agency has the authority to protect such nonpublic documents from public disclosure and will not disclose any such documents provided without the written confirmation by the Food and Drug Administration that the documents no longer have nonpublic status; and
(ii) The Senior Associate Commissioner for Policy, Planning, and Legislation or the Deputy Commissioner for International and Constituent Relations or their designee makes the determination that the exchange is reasonably necessary to facilitate global harmonization of regulatory requirements, cooperative regulatory activities, or implementation of international agreements.
(2) Any exchange under this section of nonpublic documents does not invoke the rule established in § 20.21 that such records shall be made available to all members of the public.
(e) For purposes of this section, the term “official of a foreign government agency” includes, but is not limited to, employees (whether temporary or permanent) of and agents contracted by the foreign government, or by an international organization established by law, treaty, or other governmental action and having responsibility to facilitate global or regional harmonization of standards and requirements in FDA's areas of responsibility or to promote and coordinate public health efforts. For such officials, the statement and commitment required by paragraph (c)(1)(i) of this section shall be provided on behalf of both the organization and the individual.
(a) Data and information otherwise exempt from public disclosure may be
(b) A written agreement between the Food and Drug Administration and any contractor shall be entered into before data and information otherwise exempt from public disclosure may be disclosed to the contractor. The contractor shall agree to establish and follow security precautions considered by the Food and Drug Administration to be necessary to ensure proper and confidential handling of the data and information. The written agreement shall include, where appropriate, provisions establishing:
(1) Restrictions on access to the data and information by the contractor, its employees, or other persons;
(2) Physical storage requirements;
(3) Requirements for the handling and accountability of the data and information by the contractor and its employees;
(4) Limitations on reproduction, transmission, and disclosure of the data and information;
(5) A requirement of advance approval by the Food and Drug Administration of the use by the contractor of subcontractors, vendors, or suppliers;
(6) Procedures to be followed when the contractor employs time-shared computer operations;
(7) Methods of destroying source documents or related waste material; and
(8) The period during which the contractor may retain such data and information.
Nothing in this part or this chapter shall prevent the Food and Drug Administration from using any data or information, whether obtained voluntarily or involuntarily and whether or not it is available for public disclosure, as the basis for taking any administrative or court enforcement action within its jurisdiction. Data and information otherwise exempt from public disclosure are nevertheless available for public disclosure to the extent necessary to effectuate such action, e.g., the brand name, code designation, and distribution information are released when a product is recalled.
(a) The provisions set forth in this subpart or cross-referenced in paragraph (c) of this section state the way in which specific categories of Food and Drug Administration records are handled upon a request for public disclosure. The exemptions established in subpart D of this part and the limitations on exemptions established in subpart E of this part shall be applicable to all Food and Drug Administration records, as provided in §§ 20.60 and 20.80. Accordingly, a record that is ordinarily available for public disclosure in accordance with this part or under other regulations is not available for such disclosure to the extent that it falls within an exemption contained in subpart D of this part except as provided by the limitations on exemptions specified in subpart E of this part.
(b) The Commissioner, on his own initiative or on the petition of any interested person, may amend this subpart or promulgate and cross-reference additional regulations to state the status of additional categories of documents to settle pending questions or to reflect court decisions.
(c) In addition to the provisions of this part, rules on the availability of the following specific categories of Food and Drug Administration records are established by regulations in this chapter:
(1) Section 305 hearing records, in § 7.87(c) of this chapter.
(2) Flavor ingredient records and notes, in § 101.22(i)(4)(iv) of this chapter.
(3) Environmental assessments; finding of no significant impact, in § 25.51 of this chapter, or draft and final environmental impact statements, in § 25.52 of this chapter.
(4) Color additive petitions, in § 71.15 of this chapter.
(5) Food standard temporary permits, in § 130.17(k) of this chapter.
(6) Information on thermal processing of low-acid foods packaged in hermetically sealed containers, in § 108.35(l) of this chapter.
(7) Food additive petitions, in §§ 171.1(h) and 571.1(h) of this chapter.
(8) Action levels for natural and unavoidable defects in food for human use, in § 110.110(e) of this chapter.
(9) Drug establishment registrations and drug listings, in § 207.37 of this chapter.
(10) Investigational new animal drug notices, in § 514.12 of this chapter.
(11) New animal drug application files, in § 514.11 of this chapter.
(12) Investigational new animal drug notice and a new animal drug application file for an antibiotic drug, in § 514.10 of this chapter.
(13) Methadone patient records, in § 291.505(g) of this chapter.
(14) Investigational new drug notice, in § 312.130 of this chapter.
(15) Labeling for and lists of approved new drug applications, in § 314.430 of this chapter.
(16) Master file for a new drug application, in § 312.420 of this chapter.
(17) New drug application file, in § 314.430 of this chapter.
(18) Data and information submitted for in vitro diagnostic products, in § 809.4 of this chapter.
(19) Data and information submitted for OTC drug review, in § 330.10(a)(2) of this chapter.
(20) Investigational new drug notice for an antibiotic drug, in § 431.70 of this chapter.
(21) Antibiotic drug file, in § 314.430 of this chapter.
(22) Data and information submitted for biologics review, in § 601.25(b)(2) of this chapter.
(23) Investigational new drug notice for a biological product, in § 601.50 of this chapter.
(24) Applications for biologics licenses for biological products, in § 601.51 of this chapter.
(25) Cosmetic establishment registrations, in § 710.7 of this chapter.
(26) Cosmetic product ingredient and cosmetic raw material composition statements, § 720.8 of this chapter.
(27) Cosmetic product experience reports, in § 730.7 of this chapter.
(28) Device premarket notification submissions, in § 807.95 of this chapter.
(29) Electronic product information, in §§ 1002.4 and 1002.42 of this chapter.
(30) Data and information submitted to the Commissioner or to classification panels in connection with the classification or reclassification of devices intended for human use, in § 860.5 of this chapter.
(31) Data and information submitted in offers to develop a proposed performance standard for medical devices, in § 861.26 of this chapter.
(32) Investigational device exemptions in § 812.38 of this chapter.
(33) Health claims petitions, in § 101.70 of this chapter.
(34) Premarket approval application, in § 814.9 of this chapter.
(35) Report of certain adverse experiences with a medical device, in § 803.9 of this chapter.
(36) Disqualification determination of an institutional review board, in § 56.122 of this chapter.
(37) Disqualification determination of a nonclinical laboratory, in § 58.213 of this chapter.
(38) Minutes or records regarding a public advisory committee, in § 14.65(c) of this chapter.
(39) Data submitted regarding persons receiving an implanted pacemaker device or lead, in § 805.25 of this chapter.
(40) Humanitarian device exemption application, in § 814.122 of this chapter.
(41) Premarket notifications for food contact substances, in § 170.102 of this chapter.
(a) All Food and Drug Administration records relating to administrative
(b) To the extent that any of such records fall within the exemption for investigatory records established in § 20.64, the Commissioner determines that they are subject to discretionary release pursuant to § 20.82.
(c) Records relating to administrative enforcement action that are not disclosed to any member of the public constitute investigatory records that are subject to the rules for disclosure established in § 20.64. For example, an establishment inspection report is an investigatory record and thus subject to § 20.64 except insofar as the Commissioner exercises his discretion to release it pursuant to § 20.82.
(a) All records and documents filed in the courts are available for public disclosure unless the court orders otherwise. The Food and Drug Administration will make available for public disclosure such records or documents if the agency can determine that it has an accurate copy of the actual record or document filed in the court. If the Food and Drug Administration cannot determine whether it has an accurate copy of such a record or document, the person requesting a copy shall be referred to the court involved.
(b) After a recommendation for court action has been finally refused by a United States attorney, the correspondence with the United States attorney and the Department of Justice with respect to that recommendation, including the pleadings recommended for filing with the court, is available for public disclosure. Prior to disclosure of any record specifically reflecting consideration of possible criminal prosecution of any individual, all names and other information that would identify an individual who was considered for criminal prosecution but who was not prosecuted shall be deleted unless the Commissioner concludes that there is a compelling public interest in the disclosure of such names.
(a) All correspondence to and from members of the public, members of Congress, organization or company officials, or other persons, except members of the Executive Branch of the Federal Government and special government employees, is available for public disclosure.
(b) Any such correspondence is available for public disclosure at the time that it is sent or received by the Food and Drug Administration unless a different time for such disclosure is specified in other rules established or cross-referenced in this part, e.g., correspondence relating to an IND notice or an NDA in § 314.430 of this chapter.
(a) All written summaries of oral discussions, whether in person or by telephone, with members of the public, members of Congress, organization or company officials, or other persons, except members of the Executive Branch of the Federal government or special government employees, are available for public disclosure.
(b) Any such summary is available for public disclosure at the time that it is prepared by the Food and Drug Administration unless a different time for such disclosure is specified in other rules established or cross-referenced in this part, e.g., summaries of oral discussions relating to a food additive petition in § 171.1(h)(3) of this chapter.
(c) If more than one summary of an oral discussion exists in a Food and Drug Administration file, all such summaries shall be disclosed in response to any request for such summary.
(a) Any list that may be prepared by the Food and Drug Administration of testing and research being conducted by or with funds provided by the Food and Drug Administration is available for public disclosure.
(b) Any contract relating to agency testing and research, and any progress report relating thereto, is available for public disclosure.
(c) The results of all testing or research conducted by or with funds provided by the Food and Drug Administration, such as toxicological testing, compliance assays, methodology studies, and product testing, are available for public disclosure when the final report is complete and accepted by the responsible Food and Drug Administration official, after deletion of any information that would reveal confidential investigative techniques and procedures, e.g., the use of “markers” to document adulteration of a product. If such results are disclosed in an authorized manner to any member of the public before the final report is available, they are immediately available for public disclosure to any member of the public who requests them.
(d) Access to all raw data, slides, worksheets, and other similar working materials shall be provided at the same time that the final report is disclosed.
(a) The following types of reports and studies prepared by or with funds provided by the Food and Drug Administration are available for public disclosure upon their acceptance by the responsible agency official:
(1) Quarterly and annual reports of the agency.
(2) External investigations or review of agency needs and performance.
(3) Surveys, compilations, and summaries of data and information.
(4) Consumer surveys.
(5) Compliance surveys.
(6) Compliance programs, except that names of specific firms, the location of specific activities, and details about sampling numbers or sizes shall be deleted until implementation of the program is completed.
(7) Work plans prepared by Food and Drug Administration centers, field offices, and other components, except that names of specific firms, the location of specific activities, and details about sampling numbers or sizes shall be deleted until implementation of the plan is completed.
(b) The following types of reports and studies prepared by or with funds provided by the Food and Drug Administration are not available for public disclosure:
(1) Internal audits of agency needs and performance.
(2) Records relating to the internal planning and budget process.
(3) Legislative proposals or comments prior to submission to Congress.
(a) All Food and Drug Administration Staff Manuals and instructions to staff that affect a member of the public are available for public disclosure. An index of all such manuals is available at the Food and Drug Administration's Freedom of Information Public Room in accordance with § 20.26.
(b) Manuals relating solely to internal personnel rules and practices are not available for public disclosure except to the extent that the Commissioner determines that they should be disclosed pursuant to § 20.82.
(c) All Food and Drug Administration action levels which are used to determine when the agency will take regulatory action against a violative product, limits of sensitivity and variability of analytical methods which are used in determining whether a product violates the law, and direct reference levels above which Food and Drug Administration field offices may request legal action directly to the office of the General Counsel, are available for public disclosure.
(a) All written agreements and understandings signed by the Food and Drug Administration and other departments, agencies, and organizations are available for public disclosure.
(b) A permanent file of all such agreements and understandings is available for public review during working hours in the Food and Drug Administration's Freedom of Information Public Room.
(c) All such agreements and understandings shall be published in the
(d) Agreements and understandings signed by officials of FDA with respect to activities of the Office of Criminal Investigations are exempt from the requirements set forth in paragraphs (b) and (c) of this section. Although such agreements and understandings will not be put on display in FDA's Freedom of Information Public Room or published in the
(a) All data and information obtained by the Food and Drug Administration by contract, including all progress reports pursuant to a contract, are available for public disclosure when accepted by the responsible agency official except to the extent that they remain subject to an exemption established in subpart D of this part, e.g., they relate to law enforcement matters as provided in § 20.88(b).
(b) Upon the awarding of a contract by the Food and Drug Administration, the technical proposal submitted by the successful offeror will be available for public disclosure. All cost proposals and the technical proposals of unsuccessful offerors submitted in response to a request for proposals are exempt from disclosure as confidential commercial or financial information pursuant to § 20.61.
(a) The name, title, grade, position description, salary, work address, and work telephone number for every Food and Drug Administration employee are available for public disclosure. The home address and home telephone number of any such employee are not available for public disclosure.
(b) Statistics on the prior employment experience of present agency employees, and subsequent employment of past agency employees, are available for public disclosure.
(a) The provisions of this section shall apply only to data and information submitted voluntarily to the Food and Drug Administration, whether in the course of a factory inspection or at any other time, and not as a part of any petition, application, master file, or other required submission or request for action. Data and information that may be required to be submitted to the Food and Drug Administration but that are submitted voluntarily instead are not subject to the provisions of this section and will be handled as if they had been required to be submitted.
(b) A determination that data or information submitted voluntarily will be held in confidence and will not be
(c) The following data and information submitted voluntarily to the Food and Drug Administration are available for public disclosure unless extraordinary circumstances are shown:
(1) All safety, effectiveness, and functionality data and information for a marketed ingredient or product, except as provided in § 330.10(a)(2) of this chapter for OTC drugs.
(2) A protocol for a test or study, unless it is shown to fall within the exemption established in § 20.61 for trade secrets and confidential commercial or financial information.
(3) Adverse reaction reports, product experience reports, consumer complaints, and other similar data and information shall be disclosed as follows:
(i) If submitted by a consumer or user of the product, the record is available for public disclosure after deletion of names and other information that would identify the person submitting the information.
(ii) If submitted by the manufacturer of the product, the record is available for public disclosure after deletion of:
(
(
(
(iii) If submitted by a third party, such as a physician or hospital or other institution, the record is available for public disclosure after deletion of:
(
(
(iv) If obtained through a Food and Drug Administration investigation, the record shall have the same status as the initial report which led to the investigation, i.e., it shall be disclosed in accordance with paragraph (c)(3)(i) through (iii) of this section.
(v) Any compilation of data, information, and reports prepared in a way that does not reveal data or information which is not available for public disclosure under this section is available for public disclosure.
(vi) If a person requests a copy of any such record relating to a specific individual or a specific incident, such request will be denied unless accompanied by the written consent to such disclosure of the person who submitted the report to the Food and Drug Administration and the individual who is the subject of the report. The record will be disclosed to the individual who is the subject of the report upon request.
(4) A list of all ingredients contained in a food or cosmetic, whether or not it is in descending order of predominance, or a list of all active ingredients and any inactive ingredients previously disclosed to the public as defined in § 20.81 contained in a drug, or a list of all ingredients or components in a device. A particular ingredient or component or group of ingredients or components shall be deleted from any such list for a cosmetic or device prior to public disclosure upon a determination made pursuant to § 20.44 that the ingredient or ingredients fall within the exemption established in § 20.61 for trade secrets and confidential commercial information, and a notation shall be made that any such ingredient list is incomplete.
(5) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is shown to fall within the exemption established in § 20.61.
(d) The following data and information submitted voluntarily to the Food and Drug Administration are not available for public disclosure unless they have been previously disclosed to the public as defined in § 20.81 or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in § 20.61:
(1) All safety, effectiveness, and functionality data and information for a developmental ingredient or product that has not previously been disclosed to the public as defined in § 20.81.
(2) Manufacturing methods or processes, including quality control procedures.
(3) Production, sales, distribution, and similar data and information, except that any compilation of such data and information aggregated and prepared in a way that does not reveal data or information which is not available for public disclosure under this provision is available for public disclosure.
(4) Quantitative or semiquantitative formulas.
(e) For purposes of this regulation, safety, effectiveness, and functionality data include all studies and tests of an ingredient or a product on animals and humans and all studies and tests on the ingredient or product for identity, stability, purity, potency, bioavailability, performance, and usefulness.
(a) A voluntary drug experience report to the Food and Drug Administration on FDA Form 3500 shall be handled in accordance with the rules established in § 20.111(c)(3)(iii).
(b) If a person requests a copy of any such record relating to a specific individual or a specific incident, such request will be denied unless accompanied by the written consent to such disclosure of the person who submitted the report to the Food and Drug Administration and the individual who is the subject of the report.
Voluntary reports of defects in products subject to the jurisdiction of the Food and Drug Administration are available for public disclosure:
(a) If the report is submitted by the manufacturer, after deletion of data and information falling within the exemptions established in § 20.61 for trade secrets and confidential commercial or financial information and in § 20.63 for personal privacy.
(b) If the report is submitted by any person other than the manufacturer, after deletion of names and other information that would identify the person submitting the report and any data or information falling within the exemption established in § 20.63 for personal privacy.
Data and information submitted to the Food and Drug Administration pursuant to a cooperative quality assurance agreement shall be handled in accordance with the rules established in § 20.111.
Data or information in Food and Drug Administration files which provide a means for deciphering or decoding a manufacturing date or sales date or use date contained on the label or in labeling or otherwise used in connection with a product subject to the jurisdiction of the Food and Drug Administration are available for public disclosure.
Information submitted to the Food and Drug Administration pursuant to section 510 (a)-(j) of the act shall be subject only to the special disclosure provisions established in §§ 207.37 and 807.37 of this chapter.
(a) The following computer printouts are available for public inspection in the Food and Drug Administration's Freedom of Information Public Room:
(1) A numerical listing of all new drug applications and abbreviated new drug applications approved since 1938, showing the NDA number, the trade name, the applicant, the approval date, and, where applicable, the date the approval was withdrawn and the date the Food and Drug Administration was notified that marketing of the product was discontinued.
(2) A numerical listing of all new drug applications and abbreviated new drug applications approved since 1938 which are still approved, showing the same information as is specified in paragraph (a)(1) of this section except that it does not show a withdrawal date.
(3) A listing of new drug applications, abbreviated new drug applications, which were approved since 1938 and which are still approved, covering marketed prescription drug products except prescription drug products covered by applications deemed approved under the Drug Amendments of 1962 and not yet determined to be effective in the Drug Efficacy Study Implementation program. The listing includes the name of the active ingredient, the type of dosage form, the route of administration, the trade name of the product, the name of the application holder, and the strength or potency of the product. The listing also includes, for each active ingredient in a particular dosage form for which there is more than one approved application, an evaluation of the therapeutic equivalence of the drug products covered by such applications.
(b) Other computer printouts containing IND and NDA information are available to the extent that they do not reveal data or information prohibited from disclosure under §§ 20.61, 312.130, and 314.430 of this chapter.
All advisory committee records shall be handled in accordance with the rules established in parts 10, 12, 13, 14, 15, 16, and 19 of this chapter.
Names and addresses of individuals in Food and Drug Administration records shall not be sold or rented. Names and addresses shall not be disclosed if disclosure is prohibited as a clearly unwarranted invasion of personal privacy, e.g., lists of names and home addresses of Food and Drug Administration employees, which shall not be disclosed under § 20.110.
21 U.S.C. 371; 5 U.S.C. 552, 552a.
(a) This part establishes procedures to implement the Privacy Act of 1974 (5 U.S.C. 552a). It applies to records about individuals that are maintained, collected, used, or disclosed by the Food and Drug Administration and contained in Privacy Act Record Systems.
(b) This part does not:
(1) Apply to Food and Drug Administration record systems that are not Privacy Act Record Systems or make available to an individual records that may include references to him but that are not retrieved by his name or other personal identifier, whether or not contained in a Privacy Act Record System. part 20 of this chapter (the public information regulations) and other regulations referred to therein determine when records are made available in such cases.
(2) Make any records available to persons other than (i) individuals who are the subjects of the records, (ii) persons accompanying such individuals under § 21.43, (iii) persons provided records pursuant to individual consent under § 21.72, or (iv) persons acting on behalf of such individuals as legal guardians under § 21.75. Part 20 of this chapter (the public information regulations) and other regulations referred to therein determine when Food and Drug Administration records are disclosable to members of the public generally. Subpart G of this part limits the provisions of part 20 of this chapter with respect to disclosures of records about individuals from Privacy Act Record Systems to persons other than individuals who are the subjects of the records.
(3) Make available information compiled by the Food and Drug Administration in reasonable anticipation of court litigation or formal administrative proceedings. The availability of such information to any member of the public, including any subject individual or party to such litigation or proceeding shall be governed by applicable constitutional principles, rules of discovery, and part 20 of this chapter (the public information regulations).
(4) Apply to personnel records maintained by the Division of Human Resources Management, Food and Drug Administration, except as provided in § 21.32. Such records are subject to regulations of the Office of Personnel Management in 5 CFR parts 293, 294, and 297.
As used in this part:
(a)
(b)
(c)
(d)
(e)
(f)
Information about individuals in Food and Drug Administration records shall be collected, maintained, used, and disseminated so as to protect the right to privacy of the individual to the fullest possible extent consistent with laws relating to disclosure of information to the general public, the law enforcement responsibilities of the agency, and administrative and program management needs.
(a) The Food and Drug Administration shall issue in the
(b) The notice shall include the following information:
(1) The name and location(s) of the system.
(2) The categories of individuals about whom records are maintained in the system.
(3) The categories of records maintained in the system.
(4) The authority for the system.
(5) Each routine use of the records contained in the system (i.e., use outside the Department of Health and Human Services that is compatible with the purpose for which the records were collected and described in the notice) including the categories of users and the purposes of such use.
(6) The policies and practices of the Food and Drug Administration regarding storage, retrievability (i.e., how the records are indexed and what intra-agency uses are made of the records), access controls, retention, and disposal of the records in that system.
(7) The title and business address of the official who is responsible for the system of records.
(8) The notification procedure, i.e., the address of the FDA Privacy Act Coordinator, whom any individual can contact to seek notification whether the system contains a record about him/her.
(9) The record access and contest procedures, which shall be the same as the notification procedure except that a reference shall be included to any exemption from access and contest.
(10) Where any records in the system are subject to an exemption under § 21.61, a reference to this exemption.
(11) The categories of sources of records in the system.
(a) The Food and Drug Administration shall notify the designated Department official, the Office of Management and Budget (Information Systems Division), and the Congress of proposals to change or establish Privacy Act Record Systems in accordance with procedures of the Department and the Office of Management and Budget.
(b) The Food and Drug Administration shall issue a notice, in accordance with paragraph (d) of this section and § 21.20(b), of any change in a Privacy Act Record System which:
(1) Increases the number or types of individuals about whom records are maintained;
(2) Expands the type or amount of information about individuals that is maintained;
(3) Increases the number of categories of agencies or other persons who may have access to those records;
(4) Alters the manner in which the records are organized so as to change the nature or scope of those records, such as the combining of two or more existing systems;
(5) Modifies the way in which the system operates or its location(s) in a manner that alters the process by which individuals can exercise their rights under this part, such as the ways in which they seek access or request amendment of a record; or
(6) Changes the equipment configuration on which the system is operated so as to create the potential for greater access, such as adding a telecommunications capability.
(c) The Food and Drug Administration shall issue a notice of its intention to establish new Privacy Act Record Systems in accordance with paragraph (d) of this section and § 21.20(b).
(d) Notices under paragraphs (b) and (c) of this section shall be published in the
(a) Systems of records that are required to be operated, or as a matter of practical necessity must be operated, by contractors to accomplish Food and Drug Administration functions, from which information is retrieved by individual names or other personal identifiers, may be subject to the provisions of this part. If the contract is agreed to on or after September 27, 1975, the criminal penalties set forth in 5 U.S.C. 552a(i) are applicable to such contractor, and any employee of such contractor, for disclosures prohibited in § 21.71 or for maintenance of a system of records without notice as required in § 21.20.
(b) A contract is considered to accomplish a Food and Drug Administration function if the proposal or activity it supports is principally operated on behalf of and is under the direct management of the Food and Drug Administration. Systems of records from which information is retrieved by individual names or other personal identifiers and that are operated under contracts to accomplish Food and Drug Administration functions are deemed to be maintained by the agency and shall be subject to the procedures and requirements of this part.
(c) A contract is not considered to accomplish a Food and Drug Administration function if the program or activity it supports is not principally operated on behalf of, or is not under the direct management of, the Food and Drug Administration. For example, this part does not apply to systems of records:
(1) Operated under contract with the Food and Drug Administration by State or local government agencies, or organizations representing such agencies, when such agencies or organizations are also performing State or local government functions.
(2) Operated by contractors with the Food and Drug Administration by individuals or organizations whose primary function is delivery of health services, such as hospitals, physicians, pharmacists, and other health professionals, and that report information concerning products, e.g., injuries or product defects, to the Food and Drug Administration. Before such contractors submit information to the Food and Drug Administration, the names and other personal identifiers of patients or research subjects in any medical or similar report, test, study, or other research project shall be deleted, unless the contract provides otherwise. If the Food and Drug Administration subsequently needs the names of such individuals, a separate request will be made.
(3) Relating to individuals whom the contractor employs, or with whom the contractor otherwise deals, in the course of providing goods and services to the Food and Drug Administration.
(4) Operated under grants.
(d) The requirements of this part shall apply when a contractor who operates a system of records not subject to this part reports to the Food and Drug Administration information that is a system of records about individuals from which personal information is retrieved by names or other personal identifiers. Where the information would be a new Privacy Act Record System, or a change in an existing Privacy Act Record System of a type described in § 21.21, the Food and Drug Administration shall comply with the requirements of § 21.21.
(e) The Food and Drug Administration will review all contracts before award to determine whether operation of a system from which information is retrieved by individual names or other personal identifiers will be required of the contractor, by the terms of the contract or as a matter of practical necessity. If such operation will be required, the solicitation and contract shall include the following clause, or a clause of similar effect:
Whenever the contractor or any of his employees is required by this contract to operate a system of records from which information is retrieved by individual names or other personal identifiers in order to accomplish a Food and Drug Administration function, the contractor and every employee is considered to be an employee of the Food and Drug Administration and shall operate such system of records in accordance with the Privacy Act of 1974 (5 U.S.C. 552a), regulations of the Food and Drug Administration in 21 CFR part 21, and rules of conduct that apply to Food and Drug Administration employees who work with such systems of records. The contractor and his employees are subject to the criminal penalties set forth in 5 U.S.C. 552a(i) for violations of the Privacy Act.
(a) Food and Drug Administration records that are stored, processed, and serviced by the National Archives and Records Administration in accordance with 44 U.S.C. 3103 shall be considered to be maintained by the Food and Drug Administration. The National Archives and Records Administration shall not disclose the record except to authorized Food and Drug Administration employees.
(b) Each Food and Drug Administration record pertaining to an identifiable individual that was transferred to the National Archives of the United States as a record determined by the National Archives to have sufficient historical or other value to warrant its continued preservation shall be considered to be maintained by the National Archives and shall not be subject to the provisions of this part.
(a) Present and former Food and Drug Administration employees desiring access to personnel records about themselves should consult system notices applicable to the agency's personnel records that are published by the Office of Personnel Management and the Department as well as any notice issued by the Food and Drug Administration.
(b)(1) The procedures of the Office of Personnel Management at 5 CFR parts 293, 294, and 297 rather than the procedures in § 21.33 and subparts D through F of this part, govern systems of personnel records about Food and Drug
(i) The Office of Personnel Management maintains.
(ii) Are maintained by the Division of Human Resources Management, Food and Drug Administration.
(iii) Are maintained by Department Regional Offices, concerning field employees.
(2) The Office of Personnel Management's procedures may, if necessary, be supplemented in the Food and Drug Administration Staff Manual Guide. Current Food and Drug Administration employees should mail or deliver written requests under the Privacy Act for access to personnel records described in this paragraph to the Office of Personnel Management in accordance with 5 CFR 297.106, the Director, Division of Human Resources Management (HFA-400), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or the personnel officer in the servicing HHS Regional Personnel Office. An employee may consult with or direct his or her request to the FDA Privacy Act Coordinator (HFI-30). Requests for access to personnel records of former employees that are located in Federal Records Centers should be directed to the Office of Personnel Management. Requests under the Privacy Act for amendment of personnel records should be directed to these same officials who are responsibile for access to personnel records under this paragraph.
(3) With respect to records subject to paragraph (b)(1) of this section:
(i) Refusal to grant access to a record, or refusal to amend a record upon request of an employee, shall only be made by the Associate Commissioner for Management and Operations or his or her designate; and
(ii) Appeals of refusals under paragraph (b)(3)(i) of this section may be made to the Office of Personnel Management in accordance with 5 CFR 297.108(g)(3) and 297.113(b).
(c) Any other Privacy Act Record Systems that contain personnel records, or records that otherwise concern agency employees, that are maintained by offices of the Food and Drug Administration rather than the Division of Human Resources Management but which are not subject to the Department's notice for personnel records in operating offices are subject to this part, except that refusals under this part to grant access to or amend records about present or former employees shall be made by the Associate Commissioner for Management and Operations rather than the Associate Commissioner for Public Affairs.
(d) The following procedures shall govern requests under the Privacy Act for personnel records that are maintained by the operating offices of the Food and Drug Administration in which employees work:
(1) An employee shall upon request be told whether records about him are maintained. An employee shall be given access to records about himself that are subject to this paragraph in response to an oral or written request and through informal procedures, rather than the procedures specified in §§ 21.40 through 21.43.
(2) Employee identity may be verified, if necessary, by an FDA ID card rather than in accordance with § 21.44.
(3) Generally no fee shall be charged for records requested under this paragraph. However, in cases where the records requested are voluminous, a fee may be charged in accordance with § 21.45.
(4) Records that are subject to this paragraph shall be available for access to an individual, except to the extent that access is refused by the Associate Commissioner for Management and Operations or his or her designate on the grounds that the record is subject to an exemption under § 21.61 or 5 CFR 297.111.
(5) Requests under the Privacy Act for amendment of records subject to this paragraph should be directed to the Director, Division of Human Resources Management (HFA-400). Such requests shall be reviewed in accordance with subpart E of this part. Refusal to amend a record subject to this paragraph (d)(5) shall only be made by the Associate Commissioner for Management and Operations or his or her designate.
(6) Appeals of refusals under paragraph (d) (4) or (5) of this section may
(7) Disclosures of records subject to this paragraph are subject to subpart G of this part.
(a) In general, an individual is entitled to have access to any medical records about himself in Privacy Act Record Systems maintained by the Food and Drug Administration.
(b) The Food and Drug Administration may apply the following special procedures in disclosing medical records to an individual:
(1) The agency may review the records to determine whether disclosure of the record to the individual who is the subject of the records might have an adverse effect on him. If it is determined that disclosure is not likely to have an adverse effect on the individual, the record shall be disclosed to him. If it is determined that disclosure is very likely to have an adverse effect on the individual, he may be requested to designate, in writing, a representative to whom the record shall be disclosed. Such representative may be a physician, other health professional, or other responsible person who would be willing to review the record and discuss it with the individual.
(2) The availability of the record may be subject to any procedures for disclosure to an individual of medical records about himself under part 20 of this chapter, in addition to or in lieu of the procedures in paragraph (b)(1), that are not inconsistent with § 21.41(f).
(a) An individual may request that the Food and Drug Administration notify him whether a Privacy Act Record System contains records about him that are retrieved by reference to his name or other personal identifier. An individual may at the same time, or after receiving notification that such a record about him exists, requests that he be given access to the record.
(b) An individual desiring notification or access to records shall mail or deliver a request for records in any Food and Drug Administration Privacy Act Records System to the FDA Privacy Act Coordinator (HFI-30), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
(c) Requests shall be in writing and shall name the Privacy Act Record System or Systems concerning which the individual requests notification of whether there are records about him that are retrieved by reference to his name or other personal identifier. To help assure a prompt response, an individual should indicate that he is making a “Privacy Act Request” on the envelope and in a prominent manner in the letter.
(d) An individual who merely wishes to be notified whether a Privacy Act Record System contains a record about him ordinarily need not provide any verification of his identity other than his name. The mere fact that the Food and Drug Administration has a record about an individual in any of its Privacy Act Records Systems would not be likely to constitute a clearly unwarranted invasion of personal privacy. Where mere disclosure of the fact that a record about the individual exists would be a clearly unwarranted invasion of personal privacy, further
(e) An individual who requests that he be given access to a copy of records about himself, if any exist, should indicate whether he prefers (1) to have copies of any such records mailed to him in accordance with § 21.43(a)(1), which may involve a fee under § 21.45, including information to verify his identity under § 21.44 or (2) to use the procedures for access in person under § 21.43(a)(2).
(f) A request for notification and access may be submitted under this subpart concerning any Privacy Act Record System that is exempt under § 21.61, as indicated in the notice for the system. An individual seeking access to records under § 21.65(b)(2) to investigatory records compiled for law enforcement purposes other than criminal law enforcement purposes should submit a description of the right, benefit, or privilege that he believes he was denied as the result of the Food and Drug Administration's maintenance of the records. Where the system is exempt under § 21.61, and access to the requested records is not granted under § 21.65, the request shall be handled under the provisions of part 20 of this chapter (the public information regulations).
(a) An individual or his guardian under § 21.75 shall not be required to show any justification or need to obtain notification under § 21.42 or access to a record under § 21.43.
(b) The Food and Drug Administration will determine whether a request by an individual for records about himself is appropriately treated as a request under this subpart, or under the provision of part 20 of this chapter (the public information regulations), or both. Where appropriate, the Food and Drug Administration will consult with the individual concerning the appropriate treatment of the request.
(c) The FDA Privacy Act Coordinator (HFI-30) in the Freedom of Information Staff shall be responsibile for the handling of Privacy Act requests received by the Food and Drug Administration. Requests mailed or delivered to any other office shall be promptly redirected to the FDA Privacy Act Coordinator. Where this procedure would unduly delay the agency's response, however, the agency employee who received the request should consult with the FDA Privacy Act Coordinator and obtain advice as to whether the employee can respond to the request directly.
(d) Upon receipt of a request by the FDA Privacy Act Coordinator, a record shall promptly be made that a request has been received and the date.
(e) A letter in accordance with § 21.42 responding to the request for notification shall issue as promptly as possible after receipt of the request by the Food and Drug Administration. Upon determination by the Freedom of Information Staff that a request for access to records is appropriately treated as a request under part 20 of this chapter rather than part 21, or under both parts, the time limitations prescribed in § 21.41 shall apply. In any case, access to available records shall be provided as promptly as possible.
(f) Except as provided in § 21.32, an individual's access to records about him/herself that are retrieved by his/her name or other personal identifiers and contained in any Privacy Act Record System may only be denied by the Associate Commissioner for Public Affairs or his or her designate. An individual shall not be denied access to any record that is otherwise available to him/her under this part except on the grounds that it is exempt under § 21.65(a)(2), that it was compiled in reasonable anticipation of court litigation of formal administrative proceedings, or to the extent that it is exempt or prohibited from disclosure because it includes a trade secret or commercial or financial information that is privileged or confidential information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy of another individual.
(g) The FDA Privacy Act Coordinator shall ensure that records are maintained of the number, status, and disposition of requests under this subpart, including the number of requests for records exempt from access under this subpart and other information required
(a) The FDA shall respond to an individual's request for notification as to whether a Privacy Act Record System contains records about him that are retrieved by his name or other personal identifier by sending a letter under this paragraph.
(1) If there are no records about the individual that are retrieved by his name or other personal identifier in the named Privacy Act Record System, or the requester is not an “individual” under § 21.3(a), the letter shall so state. Where appropriate, the letter shall indicate that the Food and Drug Administration's public information regulations in part 20 of this chapter prescribe general rules governing the availability of information to members of the public, and that a request may be made in accordance with part 20 of this chapter for records that are not retrieved by the requester's name or other personal identifier from a Privacy Act Record System.
(2) If there are records about the individual that are retrieved by his name or other personal identifier and the named Privacy Act Record System is not exempt from individual access and contest under § 21.61, or the system is exempt but access is allowed or required under § 21.65, the letter shall inform him that the records exist and shall either:
(i) Enclose a copy of the records under § 21.43(a)(1) or indicate that the records will be sent under separate cover, where there has been adequate verification of the identity of the individual under § 21.44 and the fees under § 21.45 do not exceed $25, or
(ii) Inform the individual of the procedures to obtain access to the records by mail or in person under § 21.43(a)(2), as well as the approximate dates by which the requested records can be provided (if the records are not —hen available), the locations at which access in person may be had, and the information needed, if any, to verify the identity of the individual under § 21.44.
(3) If the named Privacy Act Record System contains records about the individual that are retrieved by his name or other personal identifier, and the system is exempt from individual access and contest under § 21.61 and access is not allowed or required under § 21.65, the letter should inform him that the records are exempted from access and contest by § 21.61. The letter shall also inform him if the records sought are not available because they were compiled in reasonable anticipation of court litigation or formal administrative proceedings or are otherwise not available under § 21.41(b). Where appropriate, the letter shall also indicate whether the records are available under part 20 of this chapter (the public information regulations), and it may disclose the records in accordance with part 20.
(4) If the named Privacy Act Record System contains records about the individual that are retrieved by his name or other personal identifier, but a final determination has not yet been made with respect to disclosure of all of the records covered by the request, e.g., because it is necessary to consult another person or agency having an interest in the confidentiality of the records, the letter shall explain the circumstances and indicate when a final answer will be given.
(b) Except as provided in § 21.32, access to a record may only be denied by the Associate Commissioner for Public Affairs or his or her designate. If access to any record is denied wholly or in substantial part, the letter shall state
(c) If a request for a copy of the records will result in a fee of more than $25, the letter shall specify or estimate the fee involved. Where the individual has requested a copy of any records about him and copying the records would result in a fee of over $50, the Food and Drug Administration shall require advance deposit as well as payment of any amount not yet received as a result of any previous request by the individual for a record about himself, under this subpart or part 20 of this chapter (the public information regulations) before the records are made available. If the fee is less than $50, prepayment shall not be required unless payment has not yet been received for records disclosed as a result of a previous request by the individual for a record about himself under this subpart or part 20 of this chapter.
(a) Access may be granted to requested records by:
(1) Mailing a copy of the records to the requesting individual, or
(2) Permitting the requesting individual to review the records in person between 9 a.m. and 4 p.m. at the office of the FDA Privacy Act Coordinator, at the Freedom of Information Staff Public Room at the address shown in § 20.30 of this chapter, or at any Food and Drug Administration field office listed in § 5.115 of this chapter or at another location or time upon which the Food and Drug Administration and the individual agree. Arrangement for such review can be made by consultation between the FDA Privacy Act Coordinator and the individual. An individual seeking to review records in person shall generally be permitted access to the file copy, except that where the records include nondisclosable information, a copy shall be made of that portion of the records, with the nondisclosable information blocked out. Where the individual is not given a copy of the record to retain, no charge shall be made for the cost of copying a record to make it available to an individual who reviews a record in person under this paragraph.
(b) An individual may request that a record be disclosed to or discussed in the presence of another individual, such as an attorney. The individual may be required to furnish a written statement authorizing the disclosure or discussion in such other individual's presence.
(c) The Food and Drug Administration will make every reasonable effort to assure that records made available under this section can be understood by the individual, such as by providing an oral or written explanation of the records.
(a) An individual seeking access to records in a Privacy Act Record System may be required to comply with reasonable requirements to enable the Food and Drug Administration to determine his identity. The identification required shall be suitable considering the nature of the records sought. No identification shall be required to receive access to information that is required to be disclosed to any member of the public under part 20 of this chapter (the public information regulations).
(b) An individual who appears in person for access to records about himself shall be required to provide at least one document to identify himself, e.g., driver's license, passport, or alien or voter registration card to verify his identity. If an individual does not have any such document or requests access to records about himself without appearing in person under circumstances in which his identity cannot be verified from the request itself, he shall be required to certify in writing that he is the individual he claims to be and that he understands that the knowing and willful request for or acquisition of a record pertaining to an individual under false pretenses is a criminal offense subject to a $5,000 fine.
(c) In making requests under § 21.75, a parent of a minor child or legal guardian of an incompetent individual may be required to verify his relationship to
(d) Where an individual seeks access to particularly sensitive records, such as medical records, the individual may be required to provide additional information beyond that specified in paragraph (b) or (c) of this section, such as the individual's years of attendance at a particular educational institution, rank attained in the uniformed services, date or place of birth, names of parents, an occupation, or the specific times the individual received medical treatment.
(a) Where applicable, fees for copying records shall be charged in accordance with the schedule set forth in this section. Fees may only be charged where an individual has requested that a copy be made of a record to which he is granted access. No fee may be charged for making a search of a Privacy Act Record System whether the search is manual, mechanical, or electronic. Where a copy of the record must be made to provide access to the record, e.g., computer printout where no screen reading is available, the copy shall be made available to the individual without cost. Where a medical record is made available to a representative designated by the individual under § 21.33, no fee will be charged.
(b) The fee schedule is as follows:
(1) Copying of records susceptible to photocopying—$.10 per page.
(2) Copying of records not susceptible to photocopying, e.g., punch cards or magnetic tapes—at actual cost to the determined on a case-by-case basis.
(3) No charge will be made if the total amount of copying for an individual does not exceed $25.
(c) When a fee is to be assessed, the individual shall be notified prior to the processing of the copies, and be given an opportunity to amend his request. Payment shall be made by check or money order made payable to the “Food and Drug Administration,” and shall be sent to the Accounting Branch (HFA-120), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Advance deposit shall be required where the total amount exceeds $50.
(a) An individual who received access to a record about himself under subpart D of this part may request that the record be amended if he believes that the record or an item of information is not accurate, relevant to a Food and Drug Administration purpose, timely, or complete.
(b) Amendments under this subpart shall not violate existing statute, regulation, or administrative procedure.
(1) This subpart does not permit alteration of evidence presented in the course of judicial proceedings or Food and Drug Administration adjudicatory or rule making proceedings or collateral attack upon that which has already been the subject of any such proceedings.
(2) If the accuracy, relevancy, timeliness, or completeness of the records may be contested in any other pending or imminent agency proceeding, the Food and Drug Administration may refer the individual to the other proceeding as the appropriate means to obtain relief. If the accuracy, relevance, timeliness, or completeness of a record is, or has been, an issue in another agency proceeding, the request under this section shall be disposed of in accordance with the decision in the other proceeding, absent unusual circumstances.
(c) Requests to amend records shall be submitted, in writing, to the FDA Privacy Act Coordinator in accordance with § 21.40(b). Such requests shall include information sufficient to enable the Food and Drug Administration to locate the record, a brief description of the items of information requested to be amended, and the reasons why the record should be amended together with any appropriate documentation or arguments in support of the requested
(d) Written acknowledgement of the receipt of a request to amend a record shall be provided within 10 working days to the individual who requested the amendment. Such acknowledgement may request any additional information needed to verify identity or make a determination. No acknowledgement need be made if the request can be reviewed, processed, and the individual notified of the agency's agreement with the request or refusal within the 10-day period.
(a) The Food and Drug Administration shall take one of the following actions on a request for amendment of records as promptly as possible:
(1) Amend any portion of the record which the agency has determined, based upon a preponderance of the evidence, is not accurate, relevant to a Food and Drug Administration purpose, timely, or complete, and, in accordance with paragraph (d)(3) of this section, inform the individual and previous recipients of the record that has been amended of the amendment.
(2) Inform the individual of its refusal to amend any portion of the record in the manner requested, the reason for the refusal, and the opportunity for administrative appeal to the Commissioner of Food and Drugs. Except as provided in § 21.32, such refusal may only be issued by the Associate Commissioner for Public Affairs or his or her designate.
(3) Where another agency was the source of and has control of the record, refer the request to that agency.
(b) The agency may, for good cause, extend the period for taking action an additional 30 working days if notice is provided to the individual explaining the circumstances of the delay.
(c) The officials charged with reviewing a record to determine how to respond to a request to amend it, shall assess its accuracy, relevance to a Food and Drug Administration purpose, timeliness, or completeness. The determination shall be made in the light of the purpose for which the records or system is used, the agency's need for the record, and the possible adverse consequences to the individual from the record if not amended. Whenever the Food and Drug Administration receives a request for deletion of a record, or portions of a record, it shall consider anew whether the contested information in the record is relevant and necessary to a Food and Drug Administration purpose.
(d) If the Food and Drug Administration agrees with an individual's request, it shall take the following actions:
(1) So inform the individual in writing.
(2) In accordance with statute, regulation, or procedure, amend the record to make it accurate, relevant to a Food and Drug Administration purpose, timely, or complete, making note of the date and fact of the amendment.
(3) If an accounting was made under § 21.71(d) of a disclosure of the record under § 21.71(a), provide a copy of the record as amended, to all previous recipients of the record.
(a) If an individual disagrees with a refusal under § 21.51(a)(2) to amend a record, he or she may appeal that refusal to the Commissioner of Food and Drugs, Rm. 14-71, 5600 Fishers Lane, Rockville, MD 20857.
(b) If, upon appeal, the Commissioner upholds the refusal to amend the record as requested, he shall inform the individual:
(1) Of his decision and the reasons for it.
(2) Of the individual's right to file with the Food and Drug Administration a concise statement of the individual's reasons for disagreeing with the agency's decision not to amend the record as requested.
(3) That the statement of disagreement will be made available to all persons listed in an accounting as having previously received the record and any
(4) That the individual has a right to seek judicial review of the refusal to amend the record.
(c) If the Commissioner on administrative appeal or a court on judicial review determines that the record should be amended in accordance with the individual's request, the Food and Drug Administration shall proceed in accordance with § 21.51(d).
(d) A final determination on the individual's administrative appeal of the initial refusal to amend the record shall be concluded within 30 working days of the request for such review under paragraph (a) of this section, unless the Commissioner extends such period for good cause and informs the individual in writing of the reasons for the delay and of the approximate date on which a decision of the appeal can be expected.
When an individual has filed a statement of disagreement under § 21.52(b)(2), the Food and Drug Administration shall:
(a) Mark any portion of the record that is disputed to assure that the record will clearly show that portion is disputed whenever the record is disclosed.
(b) In any subsequent disclosure under § 21.70 or § 21.71(a), provide a copy of the statement of disagreement and, if the Food and Drug Administration deems it appropriate, a concise statement of the agency's reasons for not making the amendment(s) requested. While the individual shall have access to any such statement, it shall not be subject to a request for amendment under § 21.50.
(c) If an accounting was made under § 21.71(d) and (e) of a disclosure of the record under § 21.71(a), provide to all previous recipients of the record a copy of the statement of disagreement and the agency statement, if any.
Whenever the Food and Drug Administration is notified that a record that it received from another agency was amended or is the subject of a statement of disagreement, the Food and Drug Administration shall:
(a) Discard the record, or clearly note the amendment or the fact of disagreement in its copy of the record, and
(b) Refer persons who subsequently request the record to the agency that provided it.
(c) If an accounting was made under § 21.71 (d) and (e) of the disclosure of the record under § 21.71(a), inform all previous recipients of the record about the amendment or provide to them the statement of disagreement and the agency statement, if any.
It is the policy of the Food and Drug Administration that record systems should be exempted from the Privacy Act only to the extent essential to the performance of law enforcement functions under the laws that are administered and enforced by the Food and Drug Administration or that govern the agency.
(a) Investigatory records compiled for law enforcement purposes, including criminal law enforcement purposes, in the Food and Drug Administration Privacy Act Record Systems listed in paragraph (b) of this section are exempt from the following provisions of the Privacy Act (5 U.S.C. 552a) and of this part:
(1) Such records are exempt from 5 U.S.C. 552a(c)(3) and § 21.71(e)(4), requiring that an individual be provided with the accounting of disclosures of records about himself from a Privacy Act Record System.
(2) Except where access is required under 5 U.S.C. 552a(k)(2) and § 21.65(a)(2), (such records are exempt from 5 U.S.C. 552a(d)(1) through (4) and (f)) and §§ 21.40 through 21.54, requiring procedures for an individual to be given notification of and access to records about himself in a Privacy Act Record System and to be allowed to challenge the accuracy, relevance, timeliness, and completeness of such records.
(3) Such records are exempt from 5 U.S.C. 552a(e)(4)(G) and (H) and § 21.20(b)(1) requiring inclusion in the notice for the system of information about agency procedures for notification, access, and contest.
(4) Such records are exempt from 5 U.S.C. 552a(e)(3) requiring that individuals asked to supply information be provided a form outlining the authority for the request, the purposes for which the information will be used, the routine uses in the notice for the Privacy Act Record System, and the consequences to the individual of not providing the information, but only with respect to records compiled by the Food and Drug Administration in a criminal law enforcement investigation where the conduct of the investigation would be prejudiced by such procedures.
(b) Records in the following Food and Drug Administration Privacy Act Record Systems that concern individuals who are subject to Food and Drug Administration enforcement action and consist of investigatory records compiled for law enforcement purposes, including criminal law enforcement purposes, are exempt under 5 U.S.C. 552a(j)(2) and (k)(2) from the provisions enumerated in paragraph (a) of this section:
(1) Bio-research Monitoring Information System—HHS/FDA/09-10-0010.
(2) Regulated Industry Employee Enforcement Records—HHS/FDA/ACMO/09-10-002.
(3) Employee Conduct Investigative Records—HHS/FDA/ACMO/09-10-0013.
(c) The system described in paragraph (b)(3) of this section includes investigatory records compiled solely for the purpose of determining suitability, eligibility, or qualification for Federal civilian employment, military service, Federal contracts, and access to classified information. These records are exempt from disclosure under 5 U.S.C. 552a(k)(5) to the extent that the disclosure would reveal the identity of a source who furnished information to the Government under a promise of confidentiality, which must be an express promise if the information was furnished after September 27, 1975. Any individual who is refused access to a record that would reveal a confidential source shall be advised in a general way that the record includes information that would reveal a confidential source.
(a) Where a Privacy Act Record System is exempt and the requested records are unavailable under § 21.61, an individual may nevertheless make a request under § 21.40 for notification concerning whether any records about him exist and request access to such records where they are retrieved by his name or other personal identifier.
(b) An individual making a request under paragraph (a) of this section;
(1) May be given access to the records where available under part 20 of this chapter (the public information regulations) or the Commissioner may, in his discretion, entertain a request under any or all of the provisions of §§ 21.40 through 21.54; and
(2) Shall be given access upon request if the records requested are subject to 5 U.S.C. 552a(k)(2) and not to 5 U.S.C. 552a(j)(2) (i.e., because they consist of investigatory material compiled for law enforcement purposes other than criminal law enforcement purposes) and maintenance of the records resulted in denial to the individual of any right, benefit, or privilege to which he would otherwise be entitled by Federal law, or for which he would otherwise be eligible. An individual given access to a record under this paragraph (b)(2) is not entitled to seek amendment under subpart E of this part. The FDA may refuse to disclose a record that would reveal the identity of a source who furnished information to the Government under a promise of
(c) The Commissioner shall not make available any record that is prohibited from public disclosure under § 20.82(b) of this chapter.
(d) Discretionary disclosure of a record pursuant to paragraph (b)(1) of this section shall not set a precedent for discretionary disclosure of a similar or related record and shall not obligate the Commissioner to exercise his discretion to disclose any other record in a system that is exempt under § 21.61.
(a) A record about an individual which is contained in a Privacy Act Record System may be disclosed:
(1) To the individual who is the subject of the record, or his legal guardian under § 21.75;
(2) To a third party pursuant to a written request by, or within a written consent of, the individual to whom the record pertains, or his legal guardian under § 21.75;
(3) To any person:
(i) Where the names and other identifying information are first deleted, and under circumstances in which the recipient is unlikely to know the identity of the subject of the record;
(ii) Where disclosure is required by part 20 of this chapter (the public information regulations); or
(4) Within the Department of Health and Human Services to officers and employees who have a need for the record in the performance of their duties in connection with the laws administered and enforced by the Food and Drug Administration or that govern the agency. For purposes of this section, officers or employees of the Department shall include the following categories of individuals, who shall thereafter be subject to the same restrictions with respect to disclosure as any Food and Drug Administration employee: Food and Drug Administration consultants and advisory committees, State and local government employees for use only in their work with the Food and Drug Administration, and contractors and their employees to the extent that the records of such contractors are subject to the requirements of this part under § 21.30.
(b) No accounting is required for any disclosure or use under paragraph (a) of this section.
(a) Except as provided in § 21.70, a record about an individual that is contained in a Privacy Act Record System shall not be disclosed by any method of communication except under any of the following circumstances, which are subject to the limitations of paragraphs (b) and (c) of this section and to the accounting requirement of paragraph (d) of this section:
(1) To those officers and employees of the agency which maintains the record who have a need for the record in the perfomance of their duties;
(2) Required under section 552 of the Freedom of Information Act;
(3) For a routine use as described in the routine use section of each specific system notice;
(4) To the Bureau of Census for purposes of planning or carrying out a census or survey or related activity pursuant to the provisions of title 13 of the U.S. Code;
(5) To a recipient who has provided the agency with advance adequate written assurance that the record will be used solely as a statistical research or reporting record, and that the record is to be transferred in a form that is not individually identifiable;
(6) To the National Archives and Records Administration of the United States as a record which has sufficient historical or other value to warrant its continued preservation by the U.S.
(7) To another agency or to an instrumentality of any government jurisdiction within or under the control of the United States for a civil or criminal law enforcement activity if the activity is authorized by law, and if the head of the agency or instrumentality has made a written request to the agency which maintains the record specifying the particular portion desired and the law enforcement activity for which the record is sought;
(8) To a person pursuant to a showing of compelling circumstances affecting the health or safety of an individual if, upon such disclosure, notification is transmitted to the last known address of such individual;
(9) To either House of Congress or, to the extent of matter within its jurisdiction, any committee or subcommittee thereof, any joint committee of Congress or subcommittee of any such joint committee;
(10) To the Comptroller General, or any of his or her authorized representatives in the course of the performance of the duties of the General Accounting Office;
(11) Pursuant to the order of a court of competent jurisdiction; or
(12) To a consumer reporting agency in accordance with section 3(d) of the Federal Claims Collection Act of 1966 (31 U.S.C. 952(d)). (This “Special Disclosure” statement does not apply to any FDA system of records.)
(b) The Food and Drug Administration may in its discretion refuse to make a disclosure permitted under paragraph (a) of this section, if the disclosure would in the judgment of the agency, invade the privacy of the individual or be inconsistent with the purpose for which the information was collected.
(c) The Food and Drug Administration may require any person requesting a disclosure of a record under paragraph (a) of this section to provide:
(1) Information about the purposes to which the disclosed record is to be put, and
(2) A written statement certifying that the record will be used only for the stated purposes and will not be further disclosed without the written permission of the Food and Drug Administration.
(d) An accounting shall be made, in accordance with paragraph (e) of this section, of any disclosure under paragraph (a) of this section of a record that is not a disclosure under § 21.70.
(e) Where an accounting is required under paragraph (d) of this section, the Food and Drug Administration shall:
(1) Record the name and address of the person or agency to whom the disclosure is made and the date, nature, and purpose of the disclosure. The accounting shall not be considered a Privacy Act Record System.
(2) Retain the accounting for 5 years or for the life of the record, whichever is longer, following the disclosure.
(3) Notify those recipients listed in the accounting of amendments or disputes concerning the records previously disclosed to them pursuant to § 21.51(d)(3), § 21.53(c), or § 21.54(c).
(4) Except when the record is exempt from individual access and contest under § 21.61 or to the extent that the accounting describes a transfer for a law enforcement purpose pursuant to paragraph (a)(7) of this section, make the accounting available to the individual to whom the record pertains, in accordance with procedures of subpart D of this part.
(f) A single accounting may be used to cover disclosure(s) that consist of a continuing dialogue between two agencies over a prolonged period, such as discussion of an enforcement action between the Food and Drug Administration and the Department of Justice. In such cases, a general notation may be made that, as of a certain date, contract was initiated, to continue until resolution of the matter.
(a) Individuals may consent to disclosure of records about themselves to other persons in several ways, for example:
(1) An individual may give consent at the time that the information is collected for disclosure for specific purposes or to specific persons.
(2) An individual may give consent for disclosure of his records to a specific person.
(3) An individual may request the Food and Drug Administration to transcribe a specific record for submission to another person.
(b) In each case the consent shall be in writing and shall specify the individual, organizational unit, or class of individuals or organizational units to whom the record may be disclosed, which record may be disclosed, and, if applicable, for what time period. A blanket consent to release all of an individual's records to unspecified individuals or organizational units will not be honored. Verification of the identity of the individual and, where applicable, of the person to whom the record is to be disclosed shall be made in accordance with § 21.44. Consent documents shall be retained for a period of at least 2 years. If such documents are used as a means of accounting for the disclosure, they shall be retained as provided in § 21.71(e)(2).
(a) The Food and Drug Administration shall make reasonable efforts to assure that a record about an individual in a Privacy Act Record System is accurate, relevant to a Food and Drug Administration purpose, timely, and complete before such record is disclosed under § 21.71.
(b) Paragraph (a) of this section shall not apply to disclosures that are required under part 20 of this chapter (the public information regulations) or made to other Federal Government departments and agencies. Where appropriate, the letter disclosing the information shall indicate that the Food and Drug Administration has not reviewed the record to assure that it is accurate, relevant, timely, and complete.
Whenever an individual has filed a statement of disagreement with the Food and Drug Administration concerning a refusal to amend a record under § 21.51(a)(2) or with another agency that provides the record to the Food and Drug Administration, the Food and Drug Administration shall in any subsequent disclosure under this subpart provide a copy of the statement of disagreement and a concise statement by the agency, if one has been prepared, of the reasons for not making the amendment(s) requested.
For the purposes of this part, the parent of any individual who is a minor or the legal guardian of any individual who has been declared to be incompetent due to physical or mental incapacity or age by a court of competent jurisdiction may act on behalf of the individual.
21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 Comp., p. 356-360.
The National Environmental Policy Act of 1969 (NEPA), as amended, directs that, to the fullest extent possible, the policies, regulations, and public laws of the United States shall be interpreted and administered in accordance with the policies set forth in NEPA. All agencies of the Federal Government shall comply with the procedures in section 102(2) of NEPA except where compliance would be inconsistent with other statutory requirements. The regulations in this part implement section 102(2) of NEPA in a manner that is consistent with FDA's authority under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. This part also supplements the regulations for implementing the procedural provisions of NEPA that were published by the Council on Environmental Quality (CEQ) in 40 CFR parts 1500 through 1508 and the procedures included in the “HHS General Administration Manual, part 30: Environmental Protection” (45 FR 76519 to 76534, November 19, 1980).
(a) Definitions that apply to the terms used in this part are set forth in the CEQ regulations under 40 CFR part 1508. The terms and the sections of 40 CFR part 1508 in which they are defined follow:
(1) Categorical exclusion (40 CFR 1508.4).
(2) Cooperating agency (40 CFR 1508.5).
(3) Cumulative impact (40 CFR 1508.7).
(4) Effects (40 CFR 1508.8).
(5) Environmental assessment (EA) (40 CFR 1508.9).
(6) Environmental document (40 CFR 1508.10).
(7) Environmental impact statement (EIS) (40 CFR 1508.11).
(8) Federal agency (40 CFR 1508.12).
(9) Finding of no significant impact (40 CFR 1508.13).
(10) Human environment (40 CFR 1508.14).
(11) Lead agency (40 CFR 1508.16).
(12) Legislation (40 CFR 1508.17).
(13) Major Federal action (40 CFR 1508.18).
(14) Mitigation (40 CFR 1508.20).
(15) NEPA process (40 CFR 1508.21).
(16) Notice of intent (40 CFR 1508.22).
(17) Proposal (40 CFR 1508.23).
(18) Scope (40 CFR 1508.25).
(19) Significantly (40 CFR 1508.27).
(b) The following terms are defined solely for the purpose of implementing the supplemental procedures provided by this part and are not necessarily applicable to any other statutory or regulatory requirements:
(1)
(2)
(3)
(4)
(5)
(c) The following acronyms are used in this part:
(1) CEQ—Council on Environmental Quality.
(2) CGMP—Current good manufacturing practice.
(3) EA—Environmental assessment.
(4) EIS—Environmental impact statement.
(5) The act—Federal Food, Drug, and Cosmetic Act.
(6) FIFRA—Federal Insecticide, Fungicide, and Rodenticide Act.
(7) FONSI—Finding of no significant impact.
(8) GLP—Good laboratory practice.
(9) GRAS—Generally recognized as safe.
(10) HACCP—Hazard analysis critical control point.
(11) IDE—Investigational device exemption.
(12) IND—Investigational new drug application.
(13) INAD—Investigational new animal drug application.
(14) NADA—New animal drug application.
(15) NDA—New drug application.
(16) NEPA—National Environmental Policy Act of 1969.
(17) OTC—Over-the-counter.
(18) PDP—Product development protocol.
(19) PMA—Premarket approval application.
(a) All FDA's policies and programs will be planned, developed, and implemented to achieve the policies declared by NEPA and required by CEQ's regulations to ensure responsible stewardship of the environment for present and future generations.
(b) Assessment of environmental factors continues throughout planning and is integrated with other program planning at the earliest possible time to ensure that planning and decisions reflect environmental values, to avoid delays later in the process, and to avoid potential conflicts.
(c) For actions initiated by the agency, the NEPA process will begin when the agency action under consideration is first identified. For actions initiated by applicants or petitioners, NEPA planning begins when FDA receives from an applicant or petitioner an EA or a claim that a categorical exclusion applies, or when FDA personnel consult with applicants or petitioners on the NEPA-related aspects of their requested actions. FDA may issue a public call for environmental data or otherwise consult with affected individuals or groups when a contemplated action in which it is or may be involved poses potential significant environmental effects.
(d) Environmental documents shall concentrate on timely and significant issues, not amass needless detail.
(e) If a proposed action for which an EIS will be prepared involves possible environmental effects that are required to be considered under statutes or Executive Orders other than those referred to under “Authority” in this part, these effects shall be considered in the NEPA review, consistent with 40 CFR 1502.25 and the HHS General Administration Manual, part 30: Environmental Protection.
(a) All applications or petitions requesting agency action require the submission of an EA or a claim of categorical exclusion. A claim of categorical exclusion shall include a statement of compliance with the categorical exclusion criteria and shall state that to the applicant's knowledge, no extraordinary circumstances exist. Failure to submit an adequate EA for an application or petition requesting action by the agency of a type specified in § 25.20, unless the agency can determine that the action qualifies for exclusion under
(b) The responsible agency officials will evaluate the information contained in the EA to determine whether it is accurate and objective, whether the proposed action may significantly affect the quality of the human environment, and whether an EIS will be prepared. If significant effects requiring the preparation of an EIS are identified, FDA will prepare an EIS for the action in accordance with the procedures in subparts D and E of this part. If significant effects requiring the preparation of an EIS are not identified, resulting in a decision not to prepare an EIS, the responsible agency official will prepare a FONSI in accordance with § 25.41.
(c) Classes of actions that individually or cumulatively do not significantly affect the quality of the human environment ordinarily are excluded from the requirement to prepare an EA or an EIS. The classes of actions that qualify as categorical exclusions are set forth in §§ 25.30, 25.31, 25.32, 25.33, or 25.34.
(d) A person submitting an application or petition of a type subject to categorical exclusion under §§ 25.30, 25.31, 25.32, 25.33, or 25.34, or proposing to dispose of an article as provided in § 25.30(d) or 25.32(h), is not required to submit an EA if the person states that the action requested qualifies for a categorical exclusion, citing the particular categorical exclusion that is claimed, and states that to the applicant's knowledge, no extraordinary circumstances exist.
There are certain regulatory actions that, because of their immediate importance to the public health or safety, may make full adherence to the procedural provisions of NEPA and CEQ's regulations impossible. For such actions, the responsible agency official shall consult with CEQ about alternative arrangements before the action is taken, or after the action is taken, if time does not permit prior consultation with CEQ.
Any proposed action of a type specified in this section ordinarily requires at least the preparation of an EA, unless it is an action in a specific class that qualifies for exclusion under §§ 25.30, 25.31, 25.32, 25.33, or 25.34:
(a) Major recommendations or reports made to Congress on proposals for legislation in instances where the agency has primary responsibility for the subject matter involved.
(b) Destruction or other disposition of articles condemned after seizure or whose distribution or use has been enjoined, unless categorically excluded in §§ 25.30(d) or 25.32(h).
(c) Destruction or other disposition of articles following detention or recall at agency request, unless categorically excluded in §§ 25.30(d) or 25.32(h).
(d) Disposition of FDA laboratory waste materials, unless categorically excluded in § 25.30(m).
(e) Intramural and extramural research supported in whole or in part through contracts, other agreements, or grants, unless categorically excluded in § 25.30 (e) or (f).
(f) Establishment by regulation of labeling requirements, a standard, or a monograph, unless categorically excluded in §§ 25.30(k) or 25.31 (a), (b), (c), (h), (i), or (j), or 25.32 (a) or (p).
(g) Issuance, amendment, and enforcement of FDA regulations, or an exemption or variance from FDA regulations, unless categorically excluded in § 25.30 (h), (i), or (j), or § 25.32 (e), (g), (n), or (p).
(h) Withdrawal of existing approvals of FDA-approved articles, unless categorically excluded in §§ 25.31 (d) or (k), 25.32(m), or 25.33 (g) or (h).
(i) Approval of food additive petitions and color additive petitions, approval of requests for exemptions for investigational use of food additives, the granting of requests for exemption from regulation as a food additive
(j) Establishment of a tolerance for unavoidable poisonous or deleterious substances in food or in packaging materials to be used for food.
(k) Affirmation of a food substance as GRAS for humans or animals, on FDA's initiative or in response to a petition, under parts 182, 184, 186, or 582 of this chapter and establishment or amendment of a regulation for a prior-sanctioned food ingredient, as defined in §§ 170.3(l) and 181.5(a) of this chapter, unless categorically excluded in § 25.32 (f), (k), or (r).
(l) Approval of NDA's, abbreviated applications, applications for marketing approval of a biologic product, supplements to such applications, and actions on IND's, unless categorically excluded in § 25.31 (a), (b), (c), (e), or (l).
(m) Approval of NADA's, abbreviated applications, supplements, and actions on INAD's, unless categorically excluded under § 25.33 (a), (c), (d), or (e).
(n) Approval of PMA's for medical devices, notices of completion of PDP's for medical devices, authorizations to commence clinical investigation under an approved PDP, or applications for an IDE, unless categorically excluded in § 25.34.
As required under 40 CFR 1508.4, FDA will require at least an EA for any specific action that ordinarily would be excluded if extraordinary circumstances indicate that the specific proposed action may significantly affect the quality of the human environment (see 40 CFR 1508.27 for examples of significant impacts). Examples of such extraordinary circumstances include:
(a) Actions for which available data establish that, at the expected level of exposure, there is the potential for serious harm to the environment; and
(b) Actions that adversely affect a species or the critical habitat of a species determined under the Endangered Species Act or the Convention on International Trade in Endangered Species of Wild Flora and Fauna to be endangered or threatened or wild flora or fauna that are entitled to special protection under some other Federal law.
(a) There are no categories of agency actions that routinely significantly affect the quality of the human environment and that therefore ordinarily require the preparation of an EIS.
(b) EIS's are prepared for agency actions when evaluation of data or information in an EA or otherwise available to the agency leads to a finding by the responsible agency official that a proposed action may significantly affect the quality of the human environment.
The classes of actions listed in this section and §§ 25.31 through 25.34 are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:
(a) Routine administrative and management activities, including inspections, and issuance of field compliance programs, program circulars, or field investigative assignments.
(b) Recommendation for an enforcement action to be initiated in a Federal court.
(c) Agency requests for initiation of recalls.
(d) Destruction or disposition of any FDA-regulated article condemned after seizure or the distribution or use of which has been enjoined or following detention or recall at agency request if the method of destruction or disposition of the article, including packaging material, is in compliance with all Federal, State, and local requirements.
(e) Extramural contracts, other agreements, or grants for statistical and epidemiological studies, surveys and inventories, literature searches, and report and manual preparation, or any other studies that will not result in the production or distribution of any
(f) Extramural contracts, other agreements, and grants for research for such purposes as to develop analytical methods or other test methodologies.
(g) Activities of voluntary Federal-State cooperative programs, including issuance of model regulations proposed for State adoption.
(h) Issuance, amendment, or revocation of procedural or administrative regulations and guidance documents, including procedures for submission of applications for product development, testing and investigational use, and approval.
(i) Corrections and technical changes in regulations.
(j) Issuance of CGMP regulations, HACCP regulations, establishment standards, emergency permit control regulations, GLP regulations, and issuance or denial of permits, exemptions, variances, or stays under these regulations.
(k) Establishment or repeal by regulation of labeling requirements for marketed articles if there will be no increase in the existing levels of use or change in the intended uses of the product or its substitutes.
(l) Routine maintenance and minor construction activities such as:
(1) Repair to or replacement of equipment or structural components (e.g., door, roof, or window) of facilities controlled by FDA;
(2) Lease extensions, renewals, or succeeding leases;
(3) Construction or lease construction of 10,000 square feet or less of occupiable space;
(4) Relocation of employees into existing owned or currently leased space;
(5) Acquisition of 20,000 square feet or less of occupiable space in a structure that was substantially completed before the issuance of solicitation for offers; and
(6) Acquisition of between 20,000 square feet and 40,000 square feet of occupiable space if it constitutes less than 40 percent of the occupiable space in a structure that was substantially completed before the solicitation for offers.
(m) Disposal of low-level radioactive waste materials (as defined in the Nuclear Regulatory Commission regulations at 10 CFR 61.2) and chemical waste materials generated in the laboratories serviced by the contracts administered by FDA, if the waste is disposed of in compliance with all applicable Federal, State, and local requirements.
The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:
(a) Action on an NDA, abbreviated application, application for marketing approval of a biologic product, or a supplement to such applications, or action on an OTC monograph, if the action does not increase the use of the active moiety.
(b) Action on an NDA, abbreviated application, or a supplement to such applications, or action on an OTC monograph, if the action increases the use of the active moiety, but the estimated concentration of the substance at the point of entry into the aquatic environment will be below 1 part per billion.
(c) Action on an NDA, abbreviated application, application for marketing approval of a biologic product, or a supplement to such applications, or action on an OTC monograph, for substances that occur naturally in the environment when the action does not alter significantly the concentration or distribution of the substance, its metabolites, or degradation products in the environment.
(d) Withdrawal of approval of an NDA or an abbreviated application.
(e) Action on an IND.
(f) Testing and release by the Center for Biologics Evaluation and Research of lots or batches of a licensed biologic product.
(g) Establishment of bioequivalence requirements for a human drug or a comparability determination for a biologic product subject to licensing.
(h) Issuance, revocation, or amendment of a standard for a biologic product.
(i) Revocation of a license for a biologic product.
(j) Action on an application for marketing approval for marketing of a biologic product for transfusable human blood or blood components and plasma.
The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:
(a) Issuance, amendment, or repeal of a food standard.
(b) Action on a request for exemption for investigational use of a food additive if the food additive to be shipped under the request is intended to be used for clinical studies or research.
(c) Approval of a color additive petition to change a provisionally listed color additive to permanent listing for use in food, drugs, devices, or cosmetics.
(d) Testing and certification of batches of a color additive.
(e) Issuance of an interim food additive regulation.
(f) Affirmation of a food substance as GRAS for humans or animals on FDA's initiative or in response to a petition, under parts 182, 184, 186, or 582 of this chapter, and establishment or amendment of a regulation for a prior-sanctioned food ingredient, as defined in §§ 170.3(l) and 181.5(a) of this chapter, if the substance or food ingredient is already marketed in the United States for the proposed use.
(g) Issuance and enforcement of regulations relating to the control of communicable diseases or to interstate conveyance sanitation under parts 1240 and 1250 of this chapter.
(h) Approval of a request for diversion of adulterated or misbranded food for humans or animals to use as animal feeds.
(i) Approval of a food additive petition or GRAS affirmation petition, the granting of a request for exemption from regulation as a food additive under § 170.39 of this chapter, or allowing a notification submitted under 21 U.S.C. 348(h) to become effective, when the substance is present in finished food-packaging material at not greater than 5 percent-by-weight and is expected to remain with finished food-packaging material through use by consumers or when the substance is a component of a coating of a finished food-packaging material.
(j) Approval of a food additive petition or GRAS affirmation petition, the granting of a request for exemption from regulation as a food additive under § 170.39 of this chapter, or allowing a notification submitted under 21 U.S.C. 348(h) to become effective, when the substance is to be used as a component of a food-contact surface of permanent or semipermanent equipment or of another food-contact article intended for repeated use.
(k) Approval of a food additive petition, color additive petition, or GRAS affirmation petition, or allowing a notification submitted under 21 U.S.C. 348(h) to become effective, for substances added directly to food that are intended to remain in food through ingestion by consumers and that are not intended to replace macronutrients in food.
(l) Approval of a petition for color additives used in contact lenses, sutures, filaments used as supporting haptics in intraocular lenses, bone cement, and in other FDA-regulated products having similarly low levels of use.
(m) Action to prohibit or otherwise restrict or reduce the use of a substance in food, food packaging, or cosmetics.
(n) Issuance, amendment, or revocation of a regulation pertaining to infant formulas.
(o) Approval of a food additive petition for the intended expression product(s) present in food derived from new plant varieties.
(p) Issuance, amendment, or revocation of a regulation in response to a reference amount petition as described in § 101.12(h) of this chapter, a nutrient content claim petition as described in § 101.69 of this chapter, a health claim petition as described in § 101.70 of this chapter, or a petition pertaining to the label declaration of ingredients as described in § 101.103 of this chapter.
(q) Approval of a food additive petition, the granting of a request for exemption from regulation as a food additive under § 170.39 of this chapter, or allowing a notification submitted under 21 U.S.C. 348(h) to become effective for a substance registered by the Environmental Protection Agency under FIFRA for the same use requested in the petition, request for exemption, or notification.
(r) Approval of a food additive petition, color additive, GRAS affirmation petition, or allowing a notification submitted under 21 U.S.C. 348(h) to become effective for a substance that occurs naturally in the environment, when the action does not alter significantly the concentration or distribution of the substance, its metabolites, or degradation products in the environment.
The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:
(a) Action on an NADA, abbreviated application, or a supplement to such applications, if the action does not increase the use of the drug. Actions to which this categorical exclusion applies may include:
(1) An animal drug to be marketed under the same conditions of approval as a previously approved animal drug;
(2) A combination of previously approved animal drugs;
(3) A new premix or other formulation of a previously approved animal drug;
(4) Changes specified in § 514.8 (a)(5), (a)(6), or (d) of this chapter;
(5) A change of sponsor;
(6) A previously approved animal drug to be contained in medicated feed blocks under § 510.455 of this chapter or as a liquid feed supplement under § 558.5 of this chapter; or
(7) Approval of a drug for use in animal feeds if such drug has been approved under § 514.2 or 514.9 of this chapter for other uses.
(b) [Reserved]
(c) Action on an NADA, abbreviated application, or a supplement to such applications, for substances that occur naturally in the environment when the action does not alter significantly the concentration or distribution of the substance, its metabolites, or degradation products in the environment.
(d) Action on an NADA, abbreviated application, or a supplement to such applications, for:
(1) Drugs intended for use in nonfood animals;
(2) Anesthetics, both local and general, that are individually administered;
(3) Nonsystemic topical and ophthalmic animal drugs;
(4) Drugs for minor species, including wildlife and endangered species, when the drug has been previously approved for use in another or the same species where similar animal management practices are used; and
(5) Drugs intended for use under prescription or veterinarian's order for therapeutic use in terrestrial species.
(e) Action on an INAD.
(f) Action on an application submitted under section 512(m) of the act.
(g) Withdrawal of approval of an NADA or an abbreviated NADA.
(h) Withdrawal of approval of a food additive petition that reduces or eliminates animal feed uses of a food additive.
The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:
(a) Action on a device premarket notification submission under subpart E of part 807 of this chapter.
(b) Classification or reclassification of a device under part 860 of this chapter.
(c) Issuance, amendment, or repeal of a standard for a class II medical device or an electronic product, and issuance of exemptions or variances from such a standard.
(d) Approval of a PMA or a notice of completion of a PDP or amended or supplemental applications or notices for a class III medical device if the device is of the same type and for the same use as a previously approved device.
(e) Changes in the PMA or a notice of completion of a PDP for a class III medical device that do not require submission of an amended or supplemental application or notice.
(f) Issuance of a restricted device regulation if it will not result in increases in the existing levels of use or changes in the intended uses of the product or its substitutes.
(g) Action on an application for an IDE or an authorization to commence a clinical investigation under an approved PDP.
(h) Issuance of a regulation exempting from preemption a requirement of a State or political subdivision concerning a device, or a denial of an application for such exemption.
(a) As defined by CEQ in 40 CFR 1508.9, an EA is a concise public document that serves to provide sufficient evidence and analysis for an agency to determine whether to prepare an EIS or a FONSI. The EA shall include brief discussions of the need for the proposal, of alternatives as required by section 102(2)(E) of NEPA, of the environmental impacts of the proposed action and alternatives, and a listing of agencies and persons consulted. An EA shall be prepared for each action not categorically excluded in §§ 25.30, 25.31, 25.32, 25.33, or 25.34. The EA shall focus on relevant environmental issues relating to the use and disposal from use of FDA-regulated articles and shall be a concise, objective, and well-balanced document that allows the public to understand the agency's decision. If potentially adverse environmental impacts are identified for an action or a group of related actions, the EA shall discuss any reasonable alternative course of action that offers less environmental risk or that is environmentally preferable to the proposed action. The use of a scientifically justified tiered testing approach, in which testing may be stopped when the results suggest that no significant impact will occur, is an acceptable approach.
(b) Generally, FDA requires an applicant to prepare an EA and make necessary corrections to it. Ultimately, FDA is responsible for the scope and content of EA's and may include additional information in environmental documents when warranted.
(c) Information concerning the nature and scope of information that an applicant or petitioner shall submit in an EA may be obtained from the center or other office of the agency having responsibility for the action that is the subject of the environmental evaluation. Applicants and petitioners are encouraged to submit proposed protocols for environmental studies for technical review by agency staff. Applicants and petitioners also are encouraged to consult applicable FDA EA guidance documents, which provide additional advice on how to comply with FDA regulations.
(d) Consistent with 40 CFR 1500.4(j) and 1502.21, EA's may incorporate by reference information presented in other documents that are available to FDA and to the public.
(e) The agency evaluates the information contained in an EA and any public input to determine whether it is accurate and objective, whether the proposed action may significantly affect the quality of the human environment, and whether an EIS or a FONSI will be prepared. The responsible agency official designated in part 5 of this chapter as responsible for the underlying action examines the environmental risks of the proposed action and the alternative courses of action, selects a course of action, and ensures that any necessary mitigating measures are implemented as a condition for approving the selected course of action.
(a) As defined by the CEQ regulations (40 CFR 1508.13), a FONSI is a document prepared by a Federal agency stating briefly why an action, not otherwise excluded, will not significantly affect the human environment and for which, therefore, an EIS will not be prepared. A FONSI includes the EA or a summary of it and a reference to any other related environmental documents.
(b) The agency official(s) responsible for approving the FONSI will sign the document, thereby establishing that the official(s) approve(s) the conclusion not to prepare an EIS for the action under consideration.
(a) As defined by CEQ regulations (40 CFR 1508.11) and section 102(2)(C) of NEPA, an EIS should be a clear, concise, and detailed written statement describing:
(1) The environmental impacts of a proposed action;
(2) Any adverse effects that cannot be avoided if the action is implemented;
(3) Alternatives to the action;
(4) The relationship between local short-term uses of the environment and the maintenance and enhancement of long-term productivity; and
(5) Any irreversible and irretrievable commitments of resources that would be involved in the proposed action should it be implemented.
(b) The CEQ regulations (40 CFR 1501.7 and part 1502) describe the process for determining the scope of an EIS and provide detailed requirements for the preparation of draft and final EIS's. CEQ format and procedures for preparing EIS shall be followed.
(c) Under the conditions prescribed in 40 CFR 1502.9, the agency will prepare a supplement for a draft or final EIS and introduce the supplement into the administrative record.
(a) In cases requiring environmental impact statements, at the time of its decision, the agency shall prepare a concise public record of decision.
(b) The record of decision shall:
(1) State what the decision was;
(2) Identify and discuss alternatives considered by the agency in reaching its decision;
(3) State whether all practicable means to avoid or minimize environmental harm have been adopted, and if not, why not; and
(4) Summarize the program for monitoring and enforcing the practicable means adopted to avoid or minimize the environmental harm.
For actions requiring the preparation of an EIS, FDA and other affected Federal agencies will agree which will be the lead agency and which will be the cooperating agencies. The responsibilities of lead agencies and cooperating agencies are described in the CEQ regulations (40 CFR 1501.5 and 1501.6, respectively). If an action affects more than one center within FDA, the Commissioner of Food and Drugs will designate one of these units to be responsible for coordinating the preparation of any required environmental documentation.
(a) The person designated in part 5 of this chapter as the responsible agency official for the underlying action is responsible for preparing environmental documents or ensuring that they are prepared.
(b) The responsible agency official will weigh any environmental impacts of each alternative course of action, including possible mitigation measures, and will balance environmental impacts with the agency's objectives in choosing an appropriate course of action. The weighing of any environmental impacts of alternatives in selecting a final course of action will be reflected in the agency's record of formal decisionmaking as required by 40 CFR 1505.2.
(a) To the extent actions are not protected from disclosure by existing law applicable to the agency's operation, FDA will involve the public in preparing and implementing its NEPA procedures and will provide public notice of NEPA-related hearings, public meetings, and the availability of environmental documents.
(b) Many FDA actions involving investigations, review, and approval of applications, and premarket notifications for human drugs, animal drugs, biologic products, and devices are protected from disclosure under the Trade Secret Act, 18 U.S.C. 1905, and 301(j) of
(a) Data and information that are protected from disclosure by 18 U.S.C. 1905 or 21 U.S.C. 331(j) or 360j(c) shall not be included in the portion of environmental documents that is made public. When such data and information are pertinent to the environmental review of a proposed action, an applicant or petitioner shall submit such data and information separately in a confidential section and shall summarize the confidential data and information in the EA to the extent possible.
(b) FONSI's and EA's will be available to the public in accordance with 40 CFR 1506.6 as follows:
(1) When the proposed action is the subject of a notice of proposed rulemaking or a notice of filing published in the
(2) For actions for which notice is not published in the
(3) For a limited number of actions, the agency may make the FONSI and EA available for public review (including review by State and areawide information clearinghouses) for 30 days before the agency makes its final determination whether to prepare an EIS and before the action may begin, as described in 40 CFR 1501.4(e). This procedure will be followed when the proposed action is, or is closely similar to, one that normally requires an EIS or when the proposed action is one without precedent.
(a) If FDA determines that an EIS is necessary for an action involving investigations or approvals for drugs, animal drugs, biologic products, or devices, an EIS will be prepared but will become available only at the time of the approval of the product. Disclosure will be made in accordance with 40 CFR 1506.6 and part 20 of this chapter. The EIS will in all other respects conform to the requirements for EIS's as specified in 40 CFR part 1502 and 1506.6(f).
(b) Comments on the EIS may be submitted after the approval of the drug, animal drug, biologic product, or device. Those comments can form the basis for the agency to consider beginning an action to withdraw the approval of applications for a drug, animal drug, or biologic product, or to withdraw premarket notifications or premarket approval applications for devices.
(c) In those cases where the existence of applications and premarket notifications for drugs, animal drugs, biologic products, or devices has already been disclosed before the agency approves
(d) Draft and final EIS's, comments, and responses will be included in the administrative record and will be available from the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
(a) In accordance with Executive Order 12114, “Environmental Effects Abroad of Major Federal Actions” of January 4, 1979 (44 FR 1957, January 9, 1979), the responsible agency official, in analyzing actions under his or her program, shall consider the environmental effects abroad, including whether the actions involve:
(1) Potential environmental effects on the global commons and areas outside the jurisdiction of any nation, e.g., oceans and the upper atmosphere.
(2) Potential environmental effects on a foreign nation not participating with or otherwise involved in an FDA activity.
(3) The export of products (or emissions) that in the United States are prohibited or strictly regulated because their effects on the environment create a serious public health risk.
(4) Potential environmental effects on natural and ecological resources of global importance designated under the Executive Order.
(b) Before deciding on any action falling into the categories specified in paragraph (a) of this section, the responsible agency official shall determine, in accordance with section 2-3 of the Executive Order, whether such actions may have a significant environmental effect abroad.
(c) If the responsible agency official determines that an action may have a significant environmental effect abroad, the responsible agency official shall determine, in accordance with section 2-4 (a) and (b) of the Executive Order, whether the subject action calls for:
(1) An EIS;
(2) A bilateral or multilateral environmental study; or
(3) A concise environmental review.
(d) In preparing environmental documents under this subpart, the responsible official shall:
(1) Determine, as provided in section 2-5 of the Executive Order, whether proposed actions are subject to the exemptions, exclusions, and modification in contents, timing, and availability of documents.
(2) Coordinate all communications with foreign governments concerning environmental agreements and other arrangements in implementing the Executive Order.
5 U.S.C. 552; 15 U.S.C. 1453, 1454, 1455; 18 U.S.C. 1905; 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 360c, 360d, 360e, 360f, 360g, 360h, 360i, 360j, 360l, 360m, 371, 374, 381, 382, 383, 393; 42 U.S.C. 216, 241, 242l, 262, 264, 265.
This part substantially reflects relevant provisions of the framework agreement and its sectoral annexes on pharmaceutical good manufacturing practices (GMP's) and medical devices of the “Agreement on Mutual Recognition Between the United States of America and the European Community” (the MRA), signed at London May 18, 1998. For codification purposes, certain provisions of the MRA have been modified for use in this part. This modification is done for purposes of clarity only and shall not affect the text of the MRA concluded between the United States and the European Community (EC), or the rights and obligations of the United States or the EC under that agreement. Whereas the parties to the MRA are the United States and EC, this part is relevant only to the Food and Drug Administration's (FDA's) implementation of the MRA, including the sectoral annexes reflected in subparts A and B of this part. This part does not govern implementation of the MRA by the EC, which will implement the MRA in accordance with its internal procedures, nor does this part address implementation of the MRA by other concerned U.S. Federal agencies. For purposes of
(a)
(b)
(c)
(1) GMP's mean the requirements found in the legislations, regulations, and administrative provisions for methods to be used in, and the facilities or controls to be used for, the manufacturing, processing, packing, and/or holding of a drug to assure that such drug meets the requirements as to safety, and has the identity and strength, and meets the quality and purity characteristics that it purports or is represented to possess.
(2) GMP's are that part of quality assurance which ensures that products are consistently produced and controlled to quality standards. For the purpose of this subpart, GMP's include, therefore, the system whereby the manufacturer receives the specifications of the product and/or process from the marketing authorization/product authorization or license holder or applicant and ensures the product is made in compliance with its specifications (qualified person certification in the EC).
(d)
(e)
(f)
The provisions of this subpart govern the exchange between the parties and normal endorsement by the receiving regulatory authority of official good manufacturing practices (GMP's) inspection reports after a transitional period aimed at determination of the equivalence of the regulatory systems of the parties, which is the cornerstone of this subpart.
(a) The provisions of this subpart shall apply to pharmaceutical inspections carried out in the United States and Member States of the European Community (EC) before products are marketed (hereafter referred to as “preapproval inspections”) as well as during their marketing (hereafter referred to as “postapproval inspections”).
(b) Appendix A of this subpart names the laws, regulations, and administrative provisions governing these inspections and the good manufacturing practices (GMP's) requirements.
(c) Appendix B of this subpart lists the authorities participating in activities under this subpart.
(d) Sections 26.65, 26.66, 26.67, 26.68, 26.69, and 26.70 of subpart C of this part do not apply to this subpart.
(a) The provisions of this subpart will apply to medicinal products for human or animal use, intermediates and starting materials (as referred to in the European Community (EC)) and to drugs for human or animal use, biological products for human use, and active pharmaceutical ingredients (as referred to in the United States), only to the extent they are regulated by the authorities of both parties as listed in Appendix B of this subpart.
(b) Human blood, human plasma, human tissues and organs, and veterinary immunologicals (under 9 CFR 101.2, “veterinary immunologicals” are referred to as “veterinary biologicals”) are excluded from the scope of this subpart. Human plasma derivatives (such as immunoglobulins and albumin), investigational medicinal products/new drugs, human radiopharmaceuticals, and medicinal gases are also excluded during the transition phase; their situation will be reconsidered at the end of the transition period. Products regulated by the Food and Drug Administration's Center for Biologics Evaluation and Research as devices are not covered under this subpart.
(c) Appendix C of this subpart contains an indicative list of products covered by this subpart.
A 3-year transition period will start immediately after the effective date described in § 26.80(a).
(a) The criteria to be used by the parties to assess equivalence are listed in Appendix D of this subpart. Information pertaining to the criteria under European Community (EC) competence will be provided by the EC.
(b) The authorities of the parties will establish and communicate to each other their draft programs for assessing the equivalence of the respective regulatory systems in terms of quality assurance of the products and consumer protection. These programs will be carried out, as deemed necessary by the regulatory authorities, for post- and preapproval inspections and for various product classes or processes.
(c) The equivalence assessment shall include information exchanges (including inspection reports), joint training, and joint inspections for the purpose of assessing regulatory systems and the authorities' capabilities. In conducting the equivalence assessment, the parties will ensure that efforts are made to save resources.
(d) Equivalence assessment for authorities added to Appendix B of this subpart after the effective date described in § 26.80(a) will be conducted as described in this subpart, as soon as practicable.
The authorities listed in Appendix B of this subpart will actively participate in these programs to build a sufficient body of evidence for their equivalence determination. Both parties will exercise good faith efforts to complete equivalence assessment as expeditiously as possible to the extent the resources of the authorities allow.
As soon as possible, the authorities will jointly determine the essential information which must be present in inspection reports and will cooperate to develop mutually agreed inspection report format(s).
(a) Equivalence is established by having in place regulatory systems covering the criteria referred to in Appendix D of this subpart, and a demonstrated pattern of consistent performance in accordance with these criteria. A list of authorities determined as equivalent shall be agreed to by the Joint Sectoral Committee at the end of the transition period, with reference to any limitation in terms of inspection type (e.g., postapproval or preapproval) or product classes or processes.
(b) The parties will document insufficient evidence of equivalence, lack of opportunity to assess equivalence or a
Authorities not currently listed as equivalent, or not equivalent for certain types of inspections, product classes or processes may apply for reconsideration of their status once the necessary corrective measures have been taken or additional experience is gained.
(a) The operational period shall start at the end of the transition period and its provisions apply to inspection reports generated by authorities listed as equivalent for the inspections performed in their territory.
(b) In addition, when an authority is not listed as equivalent based on adequate experience gained during the transition period, the Food and Drug Administration (FDA) will accept for normal endorsement (as provided in § 26.12) inspection reports generated as a result of inspections conducted jointly by that authority on its territory and another authority listed as equivalent, provided that the authority of the Member State in which the inspection is performed can guarantee enforcement of the findings of the inspection report and require that corrective measures be taken when necessary. FDA has the option to participate in these inspections, and based on experience gained during the transition period, the parties will agree on procedures for exercising this option.
(c) In the European Community (EC), the qualified person will be relieved of responsibility for carrying the controls laid down in Article 22 paragraph 1(b) of Council Directive 75/319/EEC (see Appendix A of this subpart) provided that these controls have been carried out in the United States and that each batch/lot is accompanied by a batch certificate (in accordance with the World Health Organization Certification Scheme on the Quality of Medicinal Products) issued by the manufacturer certifying that the product complies with requirements of the marketing authorization and signed by the person responsible for releasing the batch/lot.
(a) Inspection reports (containing information as established under § 26.8), including a good manufacturing practice (GMP) compliance assessment, prepared by authorities listed as equivalent, will be provided to the authority of the importing party. Based on the determination of equivalence in light of the experience gained, these inspection reports will normally be endorsed by the authority of the importing party, except under specific and delineated circumstances. Examples of such circumstances include indications of material inconsistencies or inadequacies in an inspection report, quality defects identified in the postmarket surveillance or other specific evidence of serious concern in relation to product quality or consumer safety. In such cases, the authority of the importing party may request clarification from the authority of the exporting party which may lead to a request for reinspection. The authorities will endeavor to respond to requests for clarification in a timely manner.
(b) Where divergence is not clarified in this process, an authority of the importing country may carry out an inspection of the production facility.
Postapproval good manufacturing practice (GMP) inspection reports concerning products covered by this subpart will be transmitted to the authority of the importing country within 60-calendar days of the request. Should a new inspection be needed, the inspection report will be transmitted within 90-calendar days of the request.
(a) A preliminary notification that an inspection may have to take place will be made as soon as possible.
(b) Within 15-calendar days, the relevant authority will acknowledge receipt of the request and confirm its ability to carry out the inspection. In
(c) Reports of preapproval inspections will be sent within 45-calendar days of the request that transmitted the appropriate information and detailed the precise issues to be addressed during the inspection. A shorter time may be necessary in exceptional cases and these will be described in the request.
Monitoring activities for the purpose of maintaining equivalence shall include review of the exchange of inspection reports and their quality and timeliness; performance of a limited number of joint inspections; and the conduct of common training sessions.
(a) Each party has the right to contest the equivalence of a regulatory authority. This right will be exercised in an objective and reasoned manner in writing to the other party.
(b) The issue shall be discussed in the Joint Sectoral Committee promptly upon such notification. Where the Joint Sectoral Committee determines that verification of equivalence is required, it may be carried out jointly by the parties in a timely manner, under § 26.6.
(c) Efforts will be made by the Joint Sectoral Committee to reach unanimous consent on the appropriate action. If agreement to suspend is reached in the Joint Sectoral Committee, an authority may be suspended immediately thereafter. If no agreement is reached in the Joint Sectoral Committee, the matter is referred to the Joint Committee as described in § 26.73. If no unanimous consent is reached within 30 days after such notification, the contested authority will be suspended.
(d) Upon the suspension of authority previously listed as equivalent, a party is no longer obligated to normally endorse the inspection reports of the suspended authority. A party shall continue to normally endorse the inspection reports of that authority prior to suspension, unless the authority of the receiving party decides otherwise based on health or safety considerations. The suspension will remain in effect until unanimous consent has been reached by the parties on the future status of that authority.
(a) A Joint Sectoral Committee is set up to monitor the activities under both the transitional and operational phases of this subpart.
(b) The Joint Sectoral Committee will be cochaired by a representative of the Food and Drug Administration (FDA) for the United States and a representative of the European Community (EC) who each will have one vote. Decisions will be taken by unanimous consent.
(c) The Joint Sectoral Committee's functions will include:
(1) Making a joint assessment, which must be agreed by both parties, of the equivalence of the respective authorities;
(2) Developing and maintaining the list of equivalent authorities, including any limitation in terms of inspecting type or products, and communicating the list to all authorities and the Joint Committee;
(3) Providing a forum to discuss issues relating to this subpart, including concerns that an authority may be no longer equivalent and opportunity to review product coverage; and
(4) Consideration of the issue of suspension.
(d) The Joint Sectoral Committee shall meet at the request of either party and, unless the cochairs otherwise agree, at least once each year. The Joint Committee will be kept informed of the agenda and conclusions of meetings of the Joint Sectoral Committee.
(a) The parties and authorities shall inform and consult one another, as permitted by law, on proposals to introduce new controls or to change existing
(b) The parties shall notify each other in writing of any changes to Appendix B of this subpart.
The authorities will establish an appropriate means of exchanging information on any confirmed problem reports, corrective actions, recalls, rejected import consignments, and other regulatory and enforcement problems for products subject to this subpart.
(a) The details of an alert system will be developed during the transitional period. The system will be maintained in place at all times. Elements to be considered in developing such a system are described in Appendix E of this subpart.
(b) Contact points will be agreed between both parties to permit authorities to be made aware with the appropriate speed in case of quality defect, recalls, counterfeiting, and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the product.
Each party recognizes that the importing country has a right to fulfill its legal responsibilities by taking actions necessary to ensure the protection of human and animal health at the level of protection it deems appropriate. This includes the suspension of the distribution, product detention at the border of the importing country, withdrawal of the batches and any request for additional information or inspection as provided in § 26.12.
[Copies of EC documents may be obtained from the European Document Research, 1100 17th St. NW., suite 301, Washington, DC 20036. EC documents may be viewed on the European Commission Pharmaceuticals Units web site at “http://dg3.eudra.org”.]
[Copies of FDA documents may be obtained from the Government Printing Office, 1510 H St. NW., Washington, DC 20005. FDA documents, except the FDA Compliance Program Guidance Manual, may be viewed on FDA's Internet web site at “http://www.FDA.gov”.]
(a) The purpose of this subpart is to specify the conditions under which a party will accept the results of quality system-related evaluations and inspections and premarket evaluations of the
(b) This subpart is intended to evolve as programs and policies of the parties evolve. The parties will review this subpart periodically, in order to assess progress and identify potential enhancements to this subpart as Food and Drug Administration (FDA) and European Community (EC) policies evolve over time.
(a) The provisions of this subpart shall apply to the exchange and, where appropriate, endorsement of the following types of reports from conformity assessment bodies (CAB's) assessed to be equivalent:
(1) Under the U.S. system, surveillance/postmarket and initial/preapproval inspection reports;
(2) Under the U.S. system, premarket (510(k)) product evaluation reports;
(3) Under the European Community (EC) system, quality system evaluation reports; and
(4) Under the EC system, EC type examination and verification reports.
(b) Appendix A of this subpart names the legislation, regulations, and related procedures under which:
(1) Products are regulated as medical devices by each party;
(2) CAB's are designated and confirmed; and
(3) These reports are prepared.
(c) For purposes of this subpart, equivalence means that: CAB's in the EC are capable of conducting product and quality systems evaluations against U.S. regulatory requirements in a manner equivalent to those conducted by FDA; and CAB's in the United States are capable of conducting product and quality systems evaluations against EC regulatory requirements in a manner equivalent to those conducted by EC CAB's.
(a) There are three components to this subpart each covering a discrete range of products:
(1)
(2)
(3)
(b) Additional products and procedures may be made subject to this subpart by agreement of the parties.
The regulatory authorities shall have the responsibility of implementing the provisions of this subpart, including the designation and monitoring of conformity assessment bodies (CAB's). Regulatory authorities will be specified in Appendix C of this subpart. Each party will promptly notify the other party in writing of any change in the regulatory authority for a country.
There will be a 3-year transition period immediately following the date described in § 26.80(a). During the transition period, the parties will engage in confidence-building activities for the purpose of obtaining sufficient evidence to make determinations concerning the equivalence of conformity assessment bodies (CAB's) of the other party with respect to the ability to perform quality system and product evaluations or other reviews resulting in reports to be exchanged under this subpart.
Each party shall designate conformity assessment bodies (CAB's) to participate in confidence building activities by transmitting to the other party a list of CAB's which meet the criteria for technical competence and
(a) At the beginning of the transitional period, the Joint Sectoral Group will establish a joint confidence building program calculated to provide sufficient evidence of the capabilities of the designated conformity assessment bodies (CAB's) to perform quality system or product evaluations to the specifications of the parties.
(b) The joint confidence building program should include the following actions and activities:
(1) Seminars designed to inform the parties and CAB's about each party's regulatory system, procedures, and requirements;
(2) Workshops designed to provide the parties with information regarding requirements and procedures for the designation and surveillance of CAB's;
(3) Exchange of information about reports prepared during the transition period;
(4) Joint training exercises; and
(5) Observed inspections.
(c) During the transition period, any significant problem that is identified with a CAB may be the subject of cooperative activities, as resources allow and as agreed to by the regulatory authorities, aimed at resolving the problem.
(d) Both parties will exercise good faith efforts to complete the confidence building activities as expeditiously as possible to the extent that the resources of the parties allow.
(e) Both the parties will each prepare annual progress reports which will describe the confidence building activities undertaken during each year of the transition period. The form and content of the reports will be determined by the parties through the Joint Sectoral Committee.
(a) During the transition period, the parties will jointly determine the necessary information which must be present in quality system and product evaluation reports.
(b) The parties will jointly develop a notification and alert system to be used in case of defects, recalls, and other problems concerning product quality that could necessitate additional actions (e.g., inspections by the parties of the importing country) or suspension of the distribution of the product.
(a) In the final 6 months of the transition period, the parties shall proceed to a joint assessment of the equivalence of the conformity assessment bodies (CAB's) that participated in the confidence building activities. CAB's will be determined to be equivalent provided they have demonstrated proficiency through the submission of a sufficient number of adequate reports. CAB's may be determined to be equivalent with regard to the ability to perform any type of quality system or product evaluation covered by this subpart and with regard to any type of product covered by this subpart. The parties shall develop a list contained in Appendix E of this subpart of CAB's determined to be equivalent, which shall contain a full explanation of the scope of the equivalency determination, including any appropriate limitations, with regard to performing any type of quality system or product evaluation.
(b) The parties shall allow CAB's not listed for participation in this subpart, or listed for participation only as to certain types of evaluations, to apply for participation in this subpart once the necessary measures have been taken or sufficient experience has been gained, in accordance with § 26.46.
(c) Decisions concerning the equivalence of CAB's must be agreed to by both parties.
(a) The operational period will start at the end of the transition period after the parties have developed the list of conformity assessment bodies (CAB's)
(b) The operational period will apply to quality system evaluation reports and product evaluation reports generated by CAB's listed in accordance with this subpart for the evaluations performed in the respective territories of the parties, except if the parties agree otherwise.
(a) Listed European Community (EC) conformity assessment bodies (CAB's) will provide FDA with reports of quality system evaluations, as follows:
(1) For preapproval quality system evaluations, EC CAB's will provide full reports; and
(2) For surveillance quality system evaluations, EC CAB's will provide abbreviated reports.
(b) Listed U.S. CAB's will provide to the EC Notified Body of the manufacturer's choice:
(1) Full reports of initial quality system evaluations;
(2) Abbreviated reports of quality systems surveillance audits.
(c) If the abbreviated reports do not provide sufficient information, the importing party may request additional clarification from the CAB.
(d) Based on the determination of equivalence in light of the experience gained, the quality system evaluation reports prepared by the CAB's listed as equivalent will normally be endorsed by the importing party, except under specific and delineated circumstances. Examples of such circumstances include indications of material inconsistencies or inadequacies in a report, quality defects identified in postmarket surveillance or other specific evidence of serious concern in relation to product quality or consumer safety. In such cases, the importing party may request clarification from the exporting party which may lead to a request for reinspection. The parties will endeavor to respond to requests for clarification in a timely manner. Where divergence is not clarified in this process, the importing party may carry out the quality system evaluation.
(a) European Community (EC) conformity assessment bodies (CAB's) listed for this purpose will, subject to the specifications and limitations on the list, provide to FDA 510(k) premarket notification assessment reports prepared to U.S. medical device requirements.
(b) U.S. CAB's will, subject to the specifications and limitations on the list, provide to the EC Notified Body of the manufacturer's choice, type examination, and verification reports prepared to EC medical device requirements.
(c) Based on the determination of equivalence in light of the experience gained, the product evaluation reports prepared by the CAB's listed as equivalent will normally be endorsed by the importing party, except under specific and delineated circumstances. Examples of such circumstances include indications of material inconsistencies, inadequacies, or incompleteness in a product evaluation report, or other specific evidence of serious concern in relation to product safety, performance, or quality. In such cases, the importing party may request clarification from the exporting party which may lead to a request for a reevaluation. The parties will endeavor to respond to requests for clarification in a timely manner. Endorsement remains the responsibility of the importing party.
Quality system evaluation reports covered by § 26.41 concerning products covered by this subpart shall be transmitted to the importing party within 60-calendar days of a request by the importing party. Should a new inspection be requested, the time period shall be extended by an additional 30-calendar days. A party may request a new inspection, for cause, identified to the other party. If the exporting party cannot perform an inspection within a specified period of time, the importing
Transmission of product evaluation reports will take place according to the importing party's specified procedures.
Monitoring activities will be carried out in accordance with § 26.69.
(a) During the operational period, additional conformity assessment bodies (CAB's) will be considered for equivalence using the procedures and criteria described in §§ 26.36, 26.37, and 26.39, taking into account the level of confidence gained in the overall regulatory system of the other party.
(b) Once a designating authority considers that such CAB's, having undergone the procedures of §§ 26.36, 26.37, and 26.39, may be determined to be equivalent, it will then designate those bodies on an annual basis. Such procedures satisfy the procedures of § 26.66(a) and (b).
(c) Following such annual designations, the procedures for confirmation of CAB's under § 26.66(c) and (d) shall apply.
(a) The Joint Sectoral Committee for this subpart is set up to monitor the activities under both the transitional and operational phases of this subpart.
(b) The Joint Sectoral Committee will be cochaired by a representative of the Food and Drug Administration (FDA) for the United States and a representative of the European Community (EC) who will each have one vote. Decisions will be taken by unanimous consent.
(c) The Joint Sectoral Committee's functions will include:
(1) Making a joint assessment of the equivalence of conformity assessment bodies (CAB's);
(2) Developing and maintaining the list of equivalent CAB's, including any limitation in terms of their scope of activities and communicating the list to all authorities and the Joint Committee described in subpart C of this part;
(3) Providing a forum to discuss issues relating to this subpart, including concerns that a CAB may no longer be equivalent and opportunity to review product coverage; and
(4) Consideration of the issue of suspension.
During both the transitional and operational phases of this subpart, both parties intend to continue to participate in the activities of the Global Harmonization Task Force (GHTF) and utilize the results of those activities to the extent possible. Such participation involves developing and reviewing documents developed by the GHTF and jointly determining whether they are applicable to the implementation of this subpart.
(a) The parties and authorities shall inform and consult with one another, as permitted by law, of proposals to introduce new controls or to change existing technical regulations or inspection procedures and to provide the opportunity to comment on such proposals.
(b) The parties shall notify each other in writing of any changes to Appendix A of this subpart.
(a) An alert system will be set up during the transition period and maintained thereafter by which the parties will notify each other when there is an immediate danger to public health. Elements of such a system will be described in an Appendix F of this subpart. As part of that system, each party shall notify the other party of any confirmed problem reports, corrective actions, or recalls. These reports are regarded as part of ongoing investigations.
(b) Contact points will be agreed between both parties to permit authorities to be made aware with the appropriate speed in case of quality defect, batch recalls, counterfeiting and other problems concerning quality, which
[Copies of EC documents may be obtained from the European Document Research, 1100 17th St. NW., suite 301, Washington, DC 20036.]
[Copies of FDA documents may be obtained from the Government Printing Office, 1510 H St. NW., Washington, DC 20005. FDA documents may be viewed on FDA's Internet web site at “http://www.fda.gov”.]
[The lists of medical devices included in these tables are subject to change as a result of the Food and Drug Administration Modernization Act of 1997.]
(a) The following terms and definitions shall apply to this subpart only:
(1)
(2)
(3)
(b) Other terms concerning conformity assessment used in this part shall have the meaning given elsewhere in this part or in the definitions contained in “Guide 2: Standardization and Related Activities—General Vocabulary of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC)” (ISO/IEC Guide 2) (1996 edition), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the International Organization for Standardization, 1, rue de Varembé, Case postale 56, CH-1211 Genève 20, Switzerland, or on the Internet at “http://www.iso.ch” or may be examined at the Food and Drug Administration's Medical Library, 5600 Fishers Lane, rm. 11B-40, Rockville, MD 20857, or the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. In the event of an inconsistency between the ISO/IEC Guide 2 and definitions in this part, the definitions in this part shall prevail.
This part specifies the conditions by which each party will accept or recognize results of conformity assessment procedures, produced by the other party's conformity assessment bodies (CAB's) or authorities, in assessing conformity to the importing party's requirements, as specified on a sector-specific basis in subparts A and B of this part, and to provide for other related cooperative activities. The objective of such mutual recognition is to provide effective market access throughout the territories of the parties with regard to conformity assessment for all products covered under this part. If any obstacles to such access arise, consultations will promptly be held. In the absence of a satisfactory outcome of such consultations, the party alleging its market access has been denied may, within 90 days of such consultation, invoke its right to terminate the “Agreement on Mutual Recognition Between the United States of America and the European Community,” from which this part is derived, in accordance with § 26.80.
(a) The United States shall, as specified in subparts A and B of this part, accept or recognize results of specified procedures, used in assessing conformity to specified legislative, regulatory, and administrative provisions of the United States, produced by the other party's conformity assessment bodies (CAB's) and/or authorities.
(b) The European Community (EC) and its Member States shall, as specified in subparts A and B of this part, accept or recognize results of specified procedures, used in assessing conformity to specified legislative, regulatory, and administrative provisions of the EC and its Member States, produced by the other party's CAB's and/or authorities.
(c) Where sectoral transition arrangements have been specified in subparts A and B of this part, the obligations in paragraphs (a) and (b) of this section will apply following the successful completion of those sectoral transition arrangements, with the understanding that the conformity assessment procedures utilized assure
(a) This part applies to conformity assessment procedures for products and/or processes and to other related cooperative activities as described in this part.
(b) Subparts A and B of this part may include:
(1) A description of the relevant legislative, regulatory, and administrative provisions pertaining to the conformity assessment procedures and technical regulations;
(2) A statement on the product scope and coverage;
(3) A list of designating authorities;
(4) A list of agreed conformity assessment bodies (CAB's) or authorities or a source from which to obtain a list of such bodies or authorities and a statement of the scope of the conformity assessment procedures for which each has been agreed;
(5) The procedures and criteria for designating the CAB's;
(6) A description of the mutual recognition obligations;
(7) A sectoral transition arrangement;
(8) The identity of a sectoral contact point in each party's territory; and
(9) A statement regarding the establishment of a Joint Sectoral Committee.
(c) This part shall not be construed to entail mutual acceptance of standards or technical regulations of the parties and, unless otherwise specified in subpart A or B of this part, shall not entail the mutual recognition of the equivalence of standards or technical regulations.
The parties agree to implement the transitional commitments on confidence building as specified in subparts A and B of this part.
(a) The parties agree that each sectoral transitional arrangement shall specify a time period for completion.
(b) The parties may amend any transitional arrangement by mutual agreement.
(c) Passage from the transitional phase to the operational phase shall proceed as specified in subparts A and B of this part, unless either party documents that the conditions provided in such subpart for a successful transition are not met.
The parties shall ensure that the designating authorities specified in subpart B of this part have the power and competence in their respective territories to carry out decisions under this part to designate, monitor, suspend, remove suspension of, or withdraw conformity assessment bodies (CAB's).
The following procedures shall apply with regard to the designation of conformity assessment bodies (CAB's) and the inclusion of such bodies in the list of CAB's in subpart B of this part:
(a) The designating authority identified in subpart B of this part shall designate CAB's in accordance with the procedures and criteria set forth in subpart B of this part;
(b) A party proposing to add a CAB to the list of such bodies in subpart B of this part shall forward its proposal of one or more designated CAB's in writing to the other party with a view to a decision by the Joint Committee;
(c) Within 60 days following receipt of the proposal, the other party shall indicate its position regarding either its confirmation or its opposition. Upon confirmation, the inclusion in subpart B of this part of the proposed CAB or CAB's shall take effect; and
(d) In the event that the other party contests on the basis of documented evidence the technical competence or compliance of a proposed CAB, or indicates in writing that it requires an additional 30 days to more fully verify such evidence, such CAB shall not be included on the list of CAB's in subpart B of this part. In this instance, the Joint Committee may decide that the body concerned be verified. After the completion of such verification, the
The following procedures shall apply with regard to the suspension of a conformity assessment body (CAB) listed in subpart B of this part.
(a) A party shall notify the other party of its contestation of the technical competence or compliance of a CAB listed in subpart B of this part and the contesting party's intent to suspend such CAB. Such contestation shall be exercised when justified in an objective and reasoned manner in writing to the other party;
(b) The CAB shall be given prompt notice by the other party and an opportunity to present information in order to refute the contestation or to correct the deficiencies which form the basis of the contestation;
(c) Any such contestation shall be discussed between the parties in the Joint Sectoral Committee described in subpart B of this part. If there is no Joint Sectoral Committee, the contesting party shall refer the matter directly to the Joint Committee. If agreement to suspend is reached by the Joint Sectoral Committee or, if there is no Joint Sectoral Committee, by the Joint Committee, the CAB shall be suspended;
(d) Where the Joint Sectoral Committee or Joint Committee decides that verification of technical competence or compliance is required, it shall normally be carried out in a timely manner by the party in whose territory the body in question is located, but may be carried out jointly by the parties in justified cases;
(e) If the matter has not been resolved by the Joint Sectoral Committee within 10 days of the notice of contestation, the matter shall be referred to the Joint Committee for a decision. If there is no Joint Sectoral Committee, the matter shall be referred directly to the Joint Committee. If no decision is reached by the Joint Committee within 10 days of the referral to it, the CAB shall be suspended upon the request of the contesting party;
(f) Upon the suspension of a CAB listed in subpart B of this part, a party is no longer obligated to accept or recognize the results of conformity assessment procedures performed by that CAB subsequent to suspension. A party shall continue to accept the results of conformity assessment procedures performed by that CAB prior to suspension, unless a regulatory authority of the party decides otherwise based on health, safety or environmental considerations or failure to satisfy other requirements within the scope of subpart B of this part; and
(g) The suspension shall remain in effect until agreement has been reached by the parties upon the future status of that body.
The following procedures shall apply with regard to the withdrawal from subpart B of this part of a conformity assessment body (CAB):
(a) A party proposing to withdraw a CAB listed in subpart B of this part shall forward its proposal in writing to the other party;
(b) Such CAB shall be promptly notified by the other party and shall be provided a period of at least 30 days from receipt to provide information in order to refute or to correct the deficiencies which form the basis of the proposed withdrawal;
(c) Within 60 days following receipt of the proposal, the other party shall indicate its position regarding either its confirmation or its opposition. Upon confirmation, the withdrawal from the list in subpart B of this part of the CAB shall take effect;
(d) In the event the other party opposes the proposal to withdraw by supporting the technical competence and compliance of the CAB, the CAB shall not at that time be withdrawn from the list of CAB's in subpart B of this part. In this instance, the Joint Sectoral Committee or the Joint Committee may decide to carry out a joint verification of the body concerned. After the completion of such verification, the proposal for withdrawal of the CAB may be resubmitted to the other party; and
(e) Subsequent to the withdrawal of a CAB listed in subpart B of this part, a party shall continue to accept the results of conformity assessment procedures performed by that CAB prior to withdrawal, unless a regulatory authority of the party decides otherwise based on health, safety, and environmental considerations or failure to satisfy other requirements within the scope of subpart B of this part.
The following shall apply with regard to the monitoring of conformity assessment bodies (CAB's) listed in subpart B of this part:
(a) Designating authorities shall assure that their CAB's listed in subpart B of this part are capable and remain capable of properly assessing conformity of products or processes, as applicable, and as covered in subpart B of this part. In this regard, designating authorities shall maintain, or cause to maintain, ongoing surveillance over their CAB's by means of regular audit or assessment;
(b) The parties undertake to compare methods used to verify that the CAB's listed in subpart B of this part comply with the relevant requirements of subpart B of this part. Existing systems for the evaluation of CAB's may be used as part of such comparison procedures;
(c) Designating authorities shall consult as necessary with their counterparts, to ensure the maintenance of confidence in conformity assessment procedures. With the consent of both parties, this consultation may include joint participation in audits/inspections related to conformity assessment activities or other assessments of CAB's listed in subpart B of this part; and
(d) Designating authorities shall consult, as necessary, with the relevant regulatory authorities of the other party to ensure that all technical requirements are identified and are satisfactorily addressed.
Each party recognizes that the conformity assessment bodies (CAB's) listed in subpart B of this part fulfill the conditions of eligibility to assess conformity in relation to its requirements as specified in subpart B of this part. The parties shall specify the scope of the conformity assessment procedures for which such bodies are listed.
(a) The parties shall exchange information concerning the implementation of the legislative, regulatory, and administrative provisions identified in subparts A and B of this part.
(b) Each party shall notify the other party of legislative, regulatory, and administrative changes related to the subject matter of this part at least 60 days before their entry into force. Where considerations of safety, health or environmental protection require more urgent action, a party shall notify the other party as soon as practicable.
(c) Each party shall promptly notify the other party of any changes to its designating authorities and/or conformity assessment bodies (CAB's).
(d) The parties shall exchange information concerning the procedures used to ensure that the listed CAB's under their responsibility comply with the legislative, regulatory, and administrative provisions outlined in subpart B of this part.
(e) Regulatory authorities identified in subparts A and B of this part shall consult as necessary with their counterparts, to ensure the maintenance of confidence in conformity assessment procedures and to ensure that all technical requirements are identified and are satisfactorily addressed.
Each party shall appoint and confirm in writing contact points to be responsible for activities under subparts A and B of this part.
(a) A Joint Committee consisting of representatives of the United States and the European Community (EC) will be established. The Joint Committee shall be responsible for the effective functioning of the “Agreement on Mutual Recognition Between the United States of America and the European
(b) The Joint Committee may establish Joint Sectoral Committees comprised of appropriate regulatory authorities and others deemed necessary.
(c) The United States and the EC shall each have one vote in the Joint Committee. The Joint Committee shall make its decisions by unanimous consent. The Joint Committee shall determine its own rules and procedures.
(d) The Joint Committee may consider any matter relating to the effective functioning of that agreement. In particular it shall be responsible for:
(1) Listing, suspension, withdrawal and verification of conformity assessment bodies (CAB's) in accordance with that agreement;
(2) Amending transitional arrangements in the sectoral annexes to that agreement;
(3) Resolving any questions relating to the application of that agreement not otherwise resolved in the respective Joint Sectoral Committees;
(4) Providing a forum for discussion of issues that may arise concerning the implementation of that agreement;
(5) Considering ways to enhance the operation of that agreement;
(6) Coordinating the negotiation of additional sectoral annexes to that agreement; and
(7) Considering whether to amend that agreement in accordance with § 26.80.
(e) When a party introduces new or additional conformity assessment procedures affecting a sectoral annex to that agreement, the parties shall discuss the matter in the Joint Committee with a view to bringing such new or additional procedures within the scope of that agreement and the relevant sectoral annex.
(a) Nothing in this part shall be construed to limit the authority of a party to determine, through its legislative, regulatory, and administrative measures, the level of protection it considers appropriate for safety; for protection of human, animal, or plant life or health; for the environment; for consumers; and otherwise with regard to risks within the scope of the applicable subpart A or B of this part.
(b) Nothing in this part shall be construed to limit the authority of a regulatory authority to take all appropriate and immediate measures whenever it ascertains that a product may:
(1) Compromise the health or safety of persons in its territory;
(2) Not meet the legislative, regulatory, or administrative provisions within the scope of the applicable subpart A or B of this part; or
(3) Otherwise fail to satisfy a requirement within the scope of the applicable subpart A or B of this part. Such measures may include withdrawing the products from the market, prohibiting their placement on the market, restricting their free movement, initiating a product recall, and preventing the recurrence of such problems, including through a prohibition on imports. If the regulatory authority takes such action, it shall inform its counterpart authority and the other party within 15 days of taking such action, providing its reasons.
Either party may suspend its obligations under subpart A or B of this part, in whole or in part, if:
(a) A party suffers a loss of market access for the party's products within the scope of subpart A or B of this part as a result of the failure of the other party to fulfill its obligations under this part;
(b) The adoption of new or additional conformity assessment requirements as referenced in § 26.73(e) results in a loss of market access for the party's products within the scope of subpart B of this part because conformity assessment bodies (CAB's) designated by the party in order to meet such requirements have not been recognized by the party implementing the requirements; or
(c) The other party fails to maintain legal and regulatory authorities capable of implementing the provisions of this part.
(a) Each party agrees to maintain, to the extent required under its laws, the
(b) In particular, neither party shall disclose to the public, nor permit a conformity assessment body (CAB) to disclose to the public, information exchanged under this part that constitutes trade secrets, confidential commercial or financial information, or information that relates to an ongoing investigation.
(c) A party or a CAB may, upon exchanging information with the other party or with a CAB of the other party, designate the portions of the information that it considers to be exempt from disclosure.
(d) Each party shall take all precautions reasonably necessary to protect information exchanged under this part from unauthorized disclosure.
Each party shall endeavor to ensure that fees imposed for services under this part shall be commensurate with the services provided. Each party shall ensure that, for the sectors and conformity assessment procedures covered under this part, it shall charge no fees with respect to conformity assessment services provided by the other party.
Except where there is written agreement between the parties, obligations contained in mutual recognition agreements concluded by either party with a party not a party to the agreement from which this part is derived (a third party) shall have no force and effect with regard to the other party in terms of acceptance of the results of conformity assessment procedures in the third party.
The agreement from which this part is derived shall apply, on the one hand, to the territories in which the Treaty establishing the European Community (EC) is applied, and under the conditions laid down in that Treaty and, on the other hand, to the territory of the United States.
(a) The “Agreement on Mutual Recognition Between the United States of America and the European Community,” from which this part is derived, including its sectoral annexes on telecommunication equipment, electromagnetic compatibility, electrical safety, recreational craft, pharmaceutical Good Manufacturing Practices (GMP) inspections, and medical devices shall enter into force on the first day of the second month following the date on which the parties have exchanged letters confirming the completion of their respective procedures for the entry into force of that agreement.
(b) That agreement including any sectoral annex may, through the Joint Committee, be amended in writing by the parties to that agreement. Those parties may add a sectoral annex upon the exchange of letters. Such annex shall enter into force 30 days following the date on which those parties have exchanged letters confirming the completion of their respective procedures for the entry into force of the sectoral annex.
(c) Either party to that agreement may terminate that agreement in its entirety or any individual sectoral annex thereof by giving the other party to that agreement 6-months notice in writing. In the case of termination of one or more sectoral annexes, the parties to that agreement will seek to achieve by consensus to amend that agreement, with a view to preserving the remaining Sectoral Annexes, in accordance with the procedures in this section. Failing such consensus, that agreement shall terminate at the end of 6 months from the date of notice.
(d) Following termination of that agreement in its entirety or any individual sectoral annex thereof, a party to that agreement shall continue to accept the results of conformity assessment procedures performed by conformity assessment bodies under that agreement prior to termination, unless a regulatory authority in the party decides otherwise based on health, safety and environmental considerations or failure to satisfy other requirements within the scope of the applicable sectoral annex.
(a) The sectoral annexes referred to in § 26.80(a), as well as any new sectoral annexes added pursuant to § 26.80(b), shall form an integral part of the “Agreement on Mutual Recognition Between the United States of America and the European Community,” from which this part is derived.
(b) For a given product or sector, the provisions contained in subparts A and B of this part shall apply in the first place, and the provisions of subpart C of this part in addition to those provisions. In the case of any inconsistency between the provisions of subpart A or B of this part and subpart C of this part, subpart A or B shall prevail, to the extent of that inconsistency.
(c) The agreement from which this part is derived shall not affect the rights and obligations of the parties under any other international agreement.
(d) In the case of subpart B of this part, the parties shall review the status of such subpart at the end of 3 years from the date described in § 26.80(a).
21 U.S.C 321, 343, 346, 346a, 348, 350a, 350b, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-263n.
(a) This part applies to all clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. Additional specific obligations and commitments of, and standards of conduct for, persons who sponsor or monitor clinical investigations involving particular test articles may also be found in other parts (e.g., parts 312 and 812). Compliance with these parts is intended to protect the rights and safety of subjects involved in investigations filed with the Food and Drug Administration pursuant to sections 403, 406, 409, 412, 413, 502, 503, 505, 510, 513-516, 518-520, 721, and 801 of the Federal Food, Drug, and Cosmetic Act and sections 351 and 354-360F of the Public Health Service Act.
(b) References in this part to regulatory sections of the Code of Federal
As used in this part:
(a)
(b)
(1) A color additive petition, described in part 71.
(2) A food additive petition, described in parts 171 and 571.
(3) Data and information about a substance submitted as part of the procedures for establishing that the substance is generally recognized as safe for use that results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, described in §§ 170.30 and 570.30.
(4) Data and information about a food additive submitted as part of the procedures for food additives permitted to be used on an interim basis pending additional study, described in § 180.1.
(5) Data and information about a substance submitted as part of the procedures for establishing a tolerance for unavoidable contaminants in food and food-packaging materials, described in section 406 of the act.
(6) An investigational new drug application, described in part 312 of this chapter.
(7) A new drug application, described in part 314.
(8) Data and information about the bioavailability or bioequivalence of drugs for human use submitted as part of the procedures for issuing, amending, or repealing a bioequivalence requirement, described in part 320.
(9) Data and information about an over-the-counter drug for human use submitted as part of the procedures for classifying these drugs as generally recognized as safe and effective and not misbranded, described in part 330.
(10) Data and information about a prescription drug for human use submitted as part of the procedures for classifying these drugs as generally recognized as safe and effective and not misbranded, described in this chapter.
(11) [Reserved]
(12) An application for a biologics license, described in part 601 of this chapter.
(13) Data and information about a biological product submitted as part of the procedures for determining that licensed biological products are safe and effective and not misbranded, described in part 601.
(14) Data and information about an in vitro diagnostic product submitted as part of the procedures for establishing, amending, or repealing a standard for these products, described in part 809.
(15) An
(16) Data and information about a medical device submitted as part of the procedures for classifying these devices, described in section 513.
(17) Data and information about a medical device submitted as part of the procedures for establishing, amending, or repealing a standard for these devices, described in section 514.
(18) An application for premarket approval of a medical device, described in section 515.
(19) A product development protocol for a medical device, described in section 515.
(20) Data and information about an electronic product submitted as part of the procedures for establishing, amending, or repealing a standard for these products, described in section 358 of the Public Health Service Act.
(21) Data and information about an electronic product submitted as part of the procedures for obtaining a variance from any electronic product performance standard, as described in § 1010.4.
(22) Data and information about an electronic product submitted as part of the procedures for granting, amending, or extending an exemption from a radiation safety performance standard, as described in § 1010.5.
(23) Data and information about a clinical study of an infant formula when submitted as part of an infant formula notification under section
(24) Data and information submitted in a petition for a nutrient content claim, described in § 101.69 of this chapter, or for a health claim, described in § 101.70 of this chapter.
(25) Data and information from investigations involving children submitted in a new dietary ingredient notification, described in § 190.6 of this chapter.
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
(o)
(p)
(q)
(r)
(s)
Except as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
(a) The obtaining of informed consent shall be deemed feasible unless, before use of the test article (except as provided in paragraph (b) of this section), both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following:
(1) The human subject is confronted by a life-threatening situation necessitating the use of the test article.
(2) Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject.
(3) Time is not sufficient to obtain consent from the subject's legal representative.
(4) There is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject.
(b) If immediate use of the test article is, in the investigator's opinion, required to preserve the life of the subject, and time is not sufficient to obtain the independent determination required in paragraph (a) of this section in advance of using the test article, the determinations of the clinical investigator shall be made and, within 5 working days after the use of the article, be
(c) The documentation required in paragraph (a) or (b) of this section shall be submitted to the IRB within 5 working days after the use of the test article.
(d)(1) Under 10 U.S.C. 1107(f) the President may waive the prior consent requirement for the administration of an investigational new drug to a member of the armed forces in connection with the member's participation in a particular military operation. The statute specifies that only the President may waive informed consent in this connection and the President may grant such a waiver only if the President determines in writing that obtaining consent: Is not feasible; is contrary to the best interests of the military member; or is not in the interests of national security. The statute further provides that in making a determination to waive prior informed consent on the ground that it is not feasible or the ground that it is contrary to the best interests of the military members involved, the President shall apply the standards and criteria that are set forth in the relevant FDA regulations for a waiver of the prior informed consent requirements of section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)). Before such a determination may be made that obtaining informed consent from military personnel prior to the use of an investigational drug (including an antibiotic or biological product) in a specific protocol under an investigational new drug application (IND) sponsored by the Department of Defense (DOD) and limited to specific military personnel involved in a particular military operation is not feasible or is contrary to the best interests of the military members involved the Secretary of Defense must first request such a determination from the President, and certify and document to the President that the following standards and criteria contained in paragraphs (d)(1) through (d)(4) of this section have been met.
(i) The extent and strength of evidence of the safety and effectiveness of the investigational new drug in relation to the medical risk that could be encountered during the military operation supports the drug's administration under an IND.
(ii) The military operation presents a substantial risk that military personnel may be subject to a chemical, biological, nuclear, or other exposure likely to produce death or serious or life-threatening injury or illness.
(iii) There is no available satisfactory alternative therapeutic or preventive treatment in relation to the intended use of the investigational new drug.
(iv) Conditioning use of the investigational new drug on the voluntary participation of each member could significantly risk the safety and health of any individual member who would decline its use, the safety of other military personnel, and the accomplishment of the military mission.
(v) A duly constituted institutional review board (IRB) established and operated in accordance with the requirements of paragraphs (d)(2) and (d)(3) of this section, responsible for review of the study, has reviewed and approved the investigational new drug protocol and the administration of the investigational new drug without informed consent. DOD's request is to include the documentation required by § 56.115(a)(2) of this chapter.
(vi) DOD has explained:
(A) The context in which the investigational drug will be administered, e.g., the setting or whether it will be self-administered or it will be administered by a health professional;
(B) The nature of the disease or condition for which the preventive or therapeutic treatment is intended; and
(C) To the extent there are existing data or information available, information on conditions that could alter the effects of the investigational drug.
(vii) DOD's recordkeeping system is capable of tracking and will be used to track the proposed treatment from supplier to the individual recipient.
(viii) Each member involved in the military operation will be given, prior to the administration of the investigational new drug, a specific written information sheet (including information required by 10 U.S.C. 1107(d)) concerning the investigational new drug,
(ix) Medical records of members involved in the military operation will accurately document the receipt by members of the notification required by paragraph (d)(1)(viii) of this section.
(x) Medical records of members involved in the military operation will accurately document the receipt by members of any investigational new drugs in accordance with FDA regulations including part 312 of this chapter.
(xi) DOD will provide adequate followup to assess whether there are beneficial or adverse health consequences that result from the use of the investigational product.
(xii) DOD is pursuing drug development, including a time line, and marketing approval with due diligence.
(xiii) FDA has concluded that the investigational new drug protocol may proceed subject to a decision by the President on the informed consent waiver request.
(xiv) DOD will provide training to the appropriate medical personnel and potential recipients on the specific investigational new drug to be administered prior to its use.
(xv) DOD has stated and justified the time period for which the waiver is needed, not to exceed one year, unless separately renewed under these standards and criteria.
(xvi) DOD shall have a continuing obligation to report to the FDA and to the President any changed circumstances relating to these standards and criteria (including the time period referred to in paragraph (d)(1)(xv) of this section) or that otherwise might affect the determination to use an investigational new drug without informed consent.
(xvii) DOD is to provide public notice as soon as practicable and consistent with classification requirements through notice in the
(xviii) Use of the investigational drug without informed consent otherwise conforms with applicable law.
(2) The duly constituted institutional review board, described in paragraph (d)(1)(v) of this section, must include at least 3 nonaffiliated members who shall not be employees or officers of the Federal Government (other than for purposes of membership on the IRB) and shall be required to obtain any necessary security clearances. This IRB shall review the proposed IND protocol at a convened meeting at which a majority of the members are present including at least one member whose primary concerns are in nonscientific areas and, if feasible, including a majority of the nonaffiliated members. The information required by § 56.115(a)(2) of this chapter is to be provided to the Secretary of Defense for further review.
(3) The duly constituted institutional review board, described in paragraph (d)(1)(v) of this section, must review and approve:
(i) The required information sheet;
(ii) The adequacy of the plan to disseminate information, including distribution of the information sheet to potential recipients, on the investigational product (e.g., in forms other than written);
(iii) The adequacy of the information and plans for its dissemination to health care providers, including potential side effects, contraindications, potential interactions, and other pertinent considerations; and
(iv) An informed consent form as required by part 50 of this chapter, in those circumstances in which DOD determines that informed consent may be obtained from some or all personnel involved.
(4) DOD is to submit to FDA summaries of institutional review board meetings at which the proposed protocol has been reviewed.
(5) Nothing in these criteria or standards is intended to preempt or limit FDA's and DOD's authority or obligations under applicable statutes and regulations.
(a) The IRB responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve that investigation without requiring that informed consent of all research subjects be obtained if the IRB (with the concurrence of a licensed physician who is a member of or consultant to the IRB and who is not otherwise participating in the clinical investigation) finds and documents each of the following:
(1) The human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions.
(2) Obtaining informed consent is not feasible because:
(i) The subjects will not be able to give their informed consent as a result of their medical condition;
(ii) The intervention under investigation must be administered before consent from the subjects' legally authorized representatives is feasible; and
(iii) There is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the clinical investigation.
(3) Participation in the research holds out the prospect of direct benefit to the subjects because:
(i) Subjects are facing a life-threatening situation that necessitates intervention;
(ii) Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the intervention to provide a direct benefit to the individual subjects; and
(iii) Risks associated with the investigation are reasonable in relation to what is known about the medical condition of the potential class of subjects, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity.
(4) The clinical investigation could not practicably be carried out without the waiver.
(5) The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator has committed to attempting to contact a legally authorized representative for each subject within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent. The investigator will summarize efforts made to contact legally authorized representatives and make this information available to the IRB at the time of continuing review.
(6) The IRB has reviewed and approved informed consent procedures and an informed consent document consistent with § 50.25. These procedures and the informed consent document are to be used with subjects or their legally authorized representatives in situations where use of such procedures and documents is feasible. The IRB has reviewed and approved procedures and information to be used when providing an opportunity for a family member to object to a subject's participation in the clinical investigation consistent with paragraph (a)(7)(v) of this section.
(7) Additional protections of the rights and welfare of the subjects will be provided, including, at least:
(i) Consultation (including, where appropriate, consultation carried out by the IRB) with representatives of the communities in which the clinical investigation will be conducted and from which the subjects will be drawn;
(ii) Public disclosure to the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation, of plans for the investigation and its risks and expected benefits;
(iii) Public disclosure of sufficient information following completion of the clinical investigation to apprise the community and researchers of the study, including the demographic characteristics of the research population, and its results;
(iv) Establishment of an independent data monitoring committee to exercise oversight of the clinical investigation; and
(v) If obtaining informed consent is not feasible and a legally authorized representative is not reasonably available, the investigator has committed, if feasible, to attempting to contact within the therapeutic window the subject's family member who is not a legally authorized representative, and asking whether he or she objects to the subject's participation in the clinical investigation. The investigator will summarize efforts made to contact family members and make this information available to the IRB at the time of continuing review.
(b) The IRB is responsible for ensuring that procedures are in place to inform, at the earliest feasible opportunity, each subject, or if the subject remains incapacitated, a legally authorized representative of the subject, or if such a representative is not reasonably available, a family member, of the subject's inclusion in the clinical investigation, the details of the investigation and other information contained in the informed consent document. The IRB shall also ensure that there is a procedure to inform the subject, or if the subject remains incapacitated, a legally authorized representative of the subject, or if such a representative is not reasonably available, a family member, that he or she may discontinue the subject's participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. If a legally authorized representative or family member is told about the clinical investigation and the subject's condition improves, the subject is also to be informed as soon as feasible. If a subject is entered into a clinical investigation with waived consent and the subject dies before a legally authorized representative or family member can be contacted, information about the clinical investigation is to be provided to the subject's legally authorized representative or family member, if feasible.
(c) The IRB determinations required by paragraph (a) of this section and the documentation required by paragraph (e) of this section are to be retained by the IRB for at least 3 years after completion of the clinical investigation, and the records shall be accessible for inspection and copying by FDA in accordance with § 56.115(b) of this chapter.
(d) Protocols involving an exception to the informed consent requirement under this section must be performed under a separate investigational new drug application (IND) or investigational device exemption (IDE) that clearly identifies such protocols as protocols that may include subjects who are unable to consent. The submission of those protocols in a separate IND/IDE is required even if an IND for the same drug product or an IDE for the same device already exists. Applications for investigations under this section may not be submitted as amendments under §§ 312.30 or 812.35 of this chapter.
(e) If an IRB determines that it cannot approve a clinical investigation because the investigation does not meet the criteria in the exception provided under paragraph (a) of this section or because of other relevant ethical concerns, the IRB must document its findings and provide these findings promptly in writing to the clinical investigator and to the sponsor of the clinical investigation. The sponsor of the clinical investigation must promptly disclose this information to FDA and to the sponsor's clinical investigators who are participating or are asked to participate in this or a substantially equivalent clinical investigation of the sponsor, and to other IRB's that have been, or are, asked to review this or a substantially equivalent investigation by that sponsor.
(a)
(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
(2) A description of any reasonably foreseeable risks or discomforts to the subject.
(3) A description of any benefits to the subject or to others which may reasonably be expected from the research.
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records.
(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
(8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
(b)
(1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
(3) Any additional costs to the subject that may result from participation in the research.
(4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
(5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.
(6) The approximate number of subjects involved in the study.
(c) The informed consent requirements in these regulations are not intended to preempt any applicable Federal, State, or local laws which require additional information to be disclosed for informed consent to be legally effective.
(d) Nothing in these regulations is intended to limit the authority of a physician to provide emergency medical care to the extent the physician is permitted to do so under applicable Federal, State, or local law.
(a) Except as provided in § 56.109(c), informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of consent. A copy shall be given to the person signing the form.
(b) Except as provided in § 56.109(c), the consent form may be either of the following:
(1) A written consent document that embodies the elements of informed consent required by § 50.25. This form may be read to the subject or the subject's legally authorized representative, but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed.
(2) A
In addition to other responsibilities assigned to IRBs under this part and part 56 of this chapter, each IRB must review clinical investigations involving children as subjects covered by this subpart D and approve only those clinical investigations that satisfy the criteria described in § 50.51, § 50.52, or § 50.53 and the conditions of all other applicable sections of this subpart D.
Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which no greater than minimal risk to children is presented may involve children as subjects only if the IRB finds and documents that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians as set forth in § 50.55.
Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, may involve children as subjects only if the IRB finds and documents that:
(a) The risk is justified by the anticipated benefit to the subjects;
(b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and
(c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians as set forth in § 50.55.
Any clinical investigation within the scope described in§§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is not likely to contribute to the well-being of the subject, may involve children as subjects only if the IRB finds and documents that:
(a) The risk represents a minor increase over minimal risk;
(b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;
(c) The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition that is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and
(d) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians as set forth in § 50.55.
If an IRB does not believe that a clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter and involving children as subjects meets the requirements of § 50.51, § 50.52, or § 50.53, the clinical investigation may proceed only if:
(a) The IRB finds and documents that the clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and
(b) The Commissioner of Food and Drugs, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, determines either:
(1) That the clinical investigation in fact satisfies the conditions of § 50.51, § 50.52, or § 50.53, as applicable, or
(2) That the following conditions are met:
(i) The clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;
(ii) The clinical investigation will be conducted in accordance with sound ethical principles; and
(iii) Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians as set forth in § 50.55.
(a) In addition to the determinations required under other applicable sections of this subpart D, the IRB must determine that adequate provisions are made for soliciting the assent of the children when in the judgment of the IRB the children are capable of providing assent.
(b) In determining whether children are capable of providing assent, the IRB must take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in clinical investigations under a particular protocol, or for each child, as the IRB deems appropriate.
(c) The assent of the children is not a necessary condition for proceeding with the clinical investigation if the IRB determines:
(1) That the capability of some or all of the children is so limited that they cannot reasonably be consulted, or
(2) That the intervention or procedure involved in the clinical investigation holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the clinical investigation.
(d) Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement if it finds and documents that:
(1) The clinical investigation involves no more than minimal risk to the subjects;
(2) The waiver will not adversely affect the rights and welfare of the subjects;
(3) The clinical investigation could not practicably be carried out without the waiver; and
(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
(e) In addition to the determinations required under other applicable sections of this subpart D, the IRB must determine that the permission of each child's parents or guardian is granted.
(1) Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient, if consistent with State law, for clinical investigations to be conducted under § 50.51 or § 50.52.
(2) Where clinical investigations are covered by § 50.53 or § 50.54 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child if consistent with State law.
(f) Permission by parents or guardians must be documented in accordance with and to the extent required by § 50.27.
(g) When the IRB determines that assent is required, it must also determine whether and how assent must be documented.
(a) Children who are wards of the State or any other agency, institution, or entity can be included in clinical investigations approved under § 50.53 or § 50.54 only if such clinical investigations are:
(1) Related to their status as wards; or
(2) Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards.
(b) If the clinical investigation is approved under paragraph (a) of this section, the IRB must require appointment of an advocate for each child who is a ward.
(1) The advocate will serve in addition to any other individual acting on behalf of the child as guardian or in loco parentis.
(2) One individual may serve as advocate for more than one child.
(3) The advocate must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child's participation in the clinical investigation.
(4) The advocate must not be associated in any way (except in the role as advocate or member of the IRB) with the clinical investigation, the investigator(s), or the guardian organization.
21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c-360j, 371, 372, 373, 374, 375, 376, 379; 42 U.S.C. 262.
(a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in marketing applications, required by law, for new human drugs and biological products and marketing applications and reclassification petitions for medical devices.
(b) The agency reviews data generated in these clinical studies to determine whether the applications are approvable under the statutory requirements. FDA may consider clinical studies inadequate and the data inadequate if, among other things, appropriate steps have not been taken in the design, conduct, reporting, and analysis of the studies to minimize bias. One potential source of bias in clinical studies is a financial interest of the clinical investigator in the outcome of the study because of the way payment is arranged (e.g., a royalty) or because the investigator has a proprietary interest in the product (e.g., a patent) or because the investigator has an equity interest in the sponsor of the covered study. This section and conforming regulations require an applicant whose submission relies in part on clinical data to disclose certain financial arrangements between sponsor(s) of the covered studies and the clinical investigators and certain interests of the clinical investigators in the product under study or in the sponsor of the covered studies. FDA will use this information, in conjunction with information about the design and purpose of the study, as well as information obtained through on-site inspections, in the agency's assessment of the reliability of the data.
For the purposes of this part:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
The requirements in this part apply to any applicant who submits a marketing application for a human drug, biological product, or device and who submits covered clinical studies. The applicant is responsible for making the appropriate certification or disclosure statement where the applicant either contracted with one or more clinical investigators to conduct the studies or submitted studies conducted by others not under contract to the applicant.
For purposes of this part, an applicant must submit a list of all clinical investigators who conducted covered clinical studies to determine whether the applicant's product meets FDA's marketing requirements, identifying those clinical investigators who are full-time or part-time employees of the sponsor of each covered study. The applicant must also completely and accurately disclose or certify information concerning the financial interests of a clinical investigator who is not a full-time or part-time employee of the sponsor for each covered clinical study. Clinical investigators subject to investigational new drug or investigational device exemption regulations must provide the sponsor of the study with sufficient accurate information needed to allow subsequent disclosure or certification. The applicant is required to
(a) The applicant (of an application submitted under sections 505, 506, 510(k), 513, or 515 of the Federal Food, Drug, and Cosmetic Act, or section 351 of the Public Health Service Act) that relies in whole or in part on clinical studies shall submit, for each clinical investigator who participated in a covered clinical study, either a certification described in paragraph (a)(1) of this section or a disclosure statement described in paragraph (a)(3) of this section.
(1) Certification: The applicant covered by this section shall submit for all clinical investigators (as defined in § 54.2(d)), to whom the certification applies, a completed Form FDA 3454 attesting to the absence of financial interests and arrangements described in paragraph (a)(3) of this section. The form shall be dated and signed by the chief financial officer or other responsible corporate official or representative.
(2) If the certification covers less than all covered clinical data in the application, the applicant shall include in the certification a list of the studies covered by this certification.
(3) Disclosure Statement: For any clinical investigator defined in § 54.2(d) for whom the applicant does not submit the certification described in paragraph (a)(1) of this section, the applicant shall submit a completed Form FDA 3455 disclosing completely and accurately the following:
(i) Any financial arrangement entered into between the sponsor of the covered study and the clinical investigator involved in the conduct of a covered clinical trial, whereby the value of the compensation to the clinical investigator for conducting the study could be influenced by the outcome of the study;
(ii) Any significant payments of other sorts from the sponsor of the covered study, such as a grant to fund ongoing research, compensation in the form of equipment, retainer for ongoing consultation, or honoraria;
(iii) Any proprietary interest in the tested product held by any clinical investigator involved in a study;
(iv) Any significant equity interest in the sponsor of the covered study held by any clinical investigator involved in any clinical study; and
(v) Any steps taken to minimize the potential for bias resulting from any of the disclosed arrangements, interests, or payments.
(b) The clinical investigator shall provide to the sponsor of the covered study sufficient accurate financial information to allow the sponsor to submit complete and accurate certification or disclosure statements as required in paragraph (a) of this section. The investigator shall promptly update this information if any relevant changes occur in the course of the investigation or for 1 year following completion of the study.
(c) Refusal to file application. FDA may refuse to file any marketing application described in paragraph (a) of this section that does not contain the information required by this section or a certification by the applicant that the applicant has acted with due diligence to obtain the information but was unable to do so and stating the reason.
(a)
(b)
(c)
(1) Initiating agency audits of the data derived from the clinical investigator in question;
(2) Requesting that the applicant submit further analyses of data, e.g., to evaluate the effect of the clinical investigator's data on overall study outcome;
(3) Requesting that the applicant conduct additional independent studies to confirm the results of the questioned study; and
(4) Refusing to treat the covered clinical study as providing data that can be the basis for an agency action.
(a)
(1) Complete records showing any financial interest or arrangement as described in § 54.4(a)(3)(i) paid to such clinical investigators by the sponsor of the covered study.
(2) Complete records showing significant payments of other sorts, as described in § 54.4(a)(3)(ii), made by the sponsor of the covered clinical study to the clinical investigator.
(3) Complete records showing any financial interests held by clinical investigators as set forth in § 54.4(a)(3)(iii) and (a)(3)(iv).
(b)
(1) For any application submitted for a covered product, an applicant shall retain records as described in paragraph (a) of this section for 2 years after the date of approval of the application.
(2) The person maintaining these records shall, upon request from any properly authorized officer or employee of FDA, at reasonable times, permit such officer or employee to have access to and copy and verify these records.
21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-263n.
(a) This part contains the general standards for the composition, operation, and responsibility of an Institutional Review Board (IRB) that reviews clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. Compliance with this part is intended to protect the rights and welfare of human subjects involved in such investigations.
(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
As used in this part:
(a)
(b)
(1) A color additive petition, described in part 71.
(2) Data and information regarding a substance submitted as part of the procedures for establishing that a substance is generally recognized as safe for a use which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, described in § 170.35.
(3) A food additive petition, described in part 171.
(4) Data and information regarding a food additive submitted as part of the procedures regarding food additives permitted to be used on an interim basis pending additional study, described in § 180.1.
(5) Data and information regarding a substance submitted as part of the procedures for establishing a tolerance for unavoidable contaminants in food and food-packaging materials, described in section 406 of the act.
(6) An investigational new drug application, described in part 312 of this chapter.
(7) A new drug application, described in part 314.
(8) Data and information regarding the bioavailability or bioequivalence of drugs for human use submitted as part of the procedures for issuing, amending, or repealing a bioequivalence requirement, described in part 320.
(9) Data and information regarding an over-the-counter drug for human use submitted as part of the procedures for classifying such drugs as generally recognized as safe and effective and not misbranded, described in part 330.
(10) An application for a biologics license, described in part 601 of this chapter.
(11) Data and information regarding a biological product submitted as part of the procedures for determining that licensed biological products are safe and effective and not misbranded, as described in part 601 of this chapter.
(12) An
(13) Data and information regarding a medical device for human use submitted as part of the procedures for classifying such devices, described in part 860.
(14) Data and information regarding a medical device for human use submitted as part of the procedures for establishing, amending, or repealing a standard for such device, described in part 861.
(15) An application for premarket approval of a medical device for human use, described in section 515 of the act.
(16) A product development protocol for a medical device for human use, described in section 515 of the act.
(17) Data and information regarding an electronic product submitted as part of the procedures for establishing, amending, or repealing a standard for such products, described in section 358 of the Public Health Service Act.
(18) Data and information regarding an electronic product submitted as part of the procedures for obtaining a variance from any electronic product performance standard, as described in § 1010.4.
(19) Data and information regarding an electronic product submitted as part of the procedures for granting, amending, or extending an exemption from a radiation safety performance standard, as described in § 1010.5.
(20) Data and information regarding an electronic product submitted as part of the procedures for obtaining an exemption from notification of a radiation safety defect or failure of compliance with a radiation safety performance standard, described in subpart D of part 1003.
(21) Data and information about a clinical study of an infant formula when submitted as part of an infant formula notification under section 412(c) of the Federal Food, Drug, and Cosmetic Act.
(22) Data and information submitted in a petition for a nutrient content claim, described in § 101.69 of this chapter, and for a health claim, described in § 101.70 of this chapter.
(23) Data and information from investigations involving children submitted in a new dietary ingredient notification, described in § 190.6 of this chapter.
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(a) Except as provided in §§ 56.104 and 56.105, any clinical investigation which must meet the requirements for prior submission (as required in parts 312, 812, and 813) to the Food and Drug Administration shall not be initiated unless that investigation has been reviewed and approved by, and remains subject to continuing review by, an IRB meeting the requirements of this part.
(b) Except as provided in §§ 56.104 and 56.105, the Food and Drug Administration may decide not to consider in support of an application for a research or marketing permit any data or information that has been derived from a clinical investigation that has not been approved by, and that was not subject to initial and continuing review by, an IRB meeting the requirements of this part. The determination that a clinical investigation may not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any other applicable regulations to submit the results of the investigation to the Food and Drug Administration.
(c) Compliance with these regulations will in no way render inapplicable pertinent Federal, State, or local laws or regulations.
The following categories of clinical investigations are exempt from the requirements of this part for IRB review:
(a) Any investigation which commenced before July 27, 1981 and was subject to requirements for IRB review under FDA regulations before that date, provided that the investigation remains subject to review of an IRB which meets the FDA requirements in effect before July 27, 1981.
(b) Any investigation commenced before July 27, 1981 and was not otherwise subject to requirements for IRB review under Food and Drug Administration regulations before that date.
(c) Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the institution is subject to IRB review.
(d) Taste and food quality evaluations and consumer acceptance studies, if wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient at or below the level and for a use found to
On the application of a sponsor or sponsor-investigator, the Food and Drug Administration may waive any of the requirements contained in these regulations, including the requirements for IRB review, for specific research activities or for classes of research activities, otherwise covered by these regulations.
(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, cultural backgrounds, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review the specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards or professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable catgory of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with those subjects.
(b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the instituton's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.
(c) Each IRB shall include at least one member whose primary concerns are in the scientific area and at least one member whose primary concerns are in nonscientific areas.
(d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
(e) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
(f) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.
In order to fulfill the requirements of these regulations, each IRB shall:
(a) Follow written procedures: (1) For conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; (2) for determining which projects require review more often than annually and which projects need verification from sources other than the investigator that no material changes have occurred since previous IRB review; (3) for ensuring prompt reporting to the IRB of changes in research activity; and (4) for ensuring
(b) Follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Food and Drug Administration of: (1) Any unanticipated problems involving risks to human subjects or others; (2) any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB; or (3) any suspension or termination of IRB approval.
(c) Except when an expedited review procedure is used (see § 56.110), review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.
(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by these regulations.
(b) An IRB shall require that information given to subjects as part of informed consent is in accordance with § 50.25. The IRB may require that information, in addition to that specifically mentioned in § 50.25, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
(c) An IRB shall require documentation of informed consent in accordance with § 50.27 of this chapter, except as follows:
(1) The IRB may, for some or all subjects, waive the requirement that the subject, or the subject's legally authorized representative, sign a written consent form if it finds that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context; or
(2) The IRB may, for some or all subjects, find that the requirements in § 50.24 of this chapter for an exception from informed consent for emergency research are met.
(d) In cases where the documentation requirement is waived under paragraph (c)(1) of this section, the IRB may require the investigator to provide subjects with a written statement regarding the research.
(e) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. For investigations involving an exception to informed consent under § 50.24 of this chapter, an IRB shall promptly notify in writing the investigator and the sponsor of the research when an IRB determines that it cannot approve the research because it does not meet the criteria in the exception provided under § 50.24(a) of this chapter or because of other relevant ethical concerns. The written notification shall include a statement of the reasons for the IRB's determination.
(f) An IRB shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.
(g) An IRB shall provide in writing to the sponsor of research involving an exception to informed consent under § 50.24 of this chapter a copy of information that has been publicly disclosed under § 50.24(a)(7)(ii) and (a)(7)(iii) of this chapter. The IRB shall provide this information to the sponsor promptly so that the sponsor is aware that such disclosure has occurred. Upon receipt, the sponsor shall provide
(h) When some or all of the subjects in a study are children, an IRB must determine that the research study is in compliance with part 50, subpart D of this chapter, at the time of its initial review of the research. When some or all of the subjects in a study that is ongoing on April 30, 2001 are children, an IRB must conduct a review of the research to determine compliance with part 50, subpart D of this chapter, either at the time of continuing review or, at the discretion of the IRB, at an earlier date.
(a) The Food and Drug Administration has established, and published in the
(b) An IRB may use the expedited review procedure to review either or both of the following: (1) Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk, (2) minor changes in previously approved research during the period (of 1 year or less) for which approval is authorized. Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the IRB chairperson from among the members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the nonexpedited review procedure set forth in § 56.108(c).
(c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals which have been approved under the procedure.
(d) The Food and Drug Administration may restrict, suspend, or terminate an institution's or IRB's use of the expedited review procedure when necessary to protect the rights or welfare of subjects.
(a) In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied:
(1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies that subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons.
(4) Informed consent will be sought from each prospective subject or the
(5) Informed consent will be appropriately documented, in accordance with and to the extent required by § 50.27.
(6) Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
(7) Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
(b) When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons, are likely to be vulnerable to coercion or undue influence additional safeguards have been included in the study to protect the rights and welfare of these subjects.
(c) In order to approve research in which some or all of the subjects are children, an IRB must determine that all research is in compliance with part 50, subpart D of this chapter.
Research covered by these regulations that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB.
An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the Food and Drug Administration.
In complying with these regulations, institutions involved in multi-institutional studies may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed at avoidance of duplication of effort.
(a) An institution, or where appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:
(1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects.
(2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.
(3) Records of continuing review activities.
(4) Copies of all correspondence between the IRB and the investigators.
(5) A list of IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications, licenses, etc., sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution; for example: full-time employee, part-time employee, a member of governing panel or board, stockholder, paid or unpaid consultant.
(6) Written procedures for the IRB as required by § 56.108 (a) and (b).
(7) Statements of significant new findings provided to subjects, as required by § 50.25.
(b) The records required by this regulation shall be retained for at least 3 years after completion of the research,
(c) The Food and Drug Administration may refuse to consider a clinical investigation in support of an application for a research or marketing permit if the institution or the IRB that reviewed the investigation refuses to allow an inspection under this section.
(a) If apparent noncompliance with these regulations in the operation of an IRB is observed by an FDA investigator during an inspection, the inspector will present an oral or written summary of observations to an appropriate representative of the IRB. The Food and Drug Administration may subsequently send a letter describing the noncompliance to the IRB and to the parent institution. The agency will require that the IRB or the parent institution respond to this letter within a time period specified by FDA and describe the corrective actions that will be taken by the IRB, the institution, or both to achieve compliance with these regulations.
(b) On the basis of the IRB's or the institution's response, FDA may schedule a reinspection to confirm the adequacy of corrective actions. In addition, until the IRB or the parent institution takes appropriate corrective action, the agency may:
(1) Withhold approval of new studies subject to the requirements of this part that are conducted at the institution or reviewed by the IRB;
(2) Direct that no new subjects be added to ongoing studies subject to this part;
(3) Terminate ongoing studies subject to this part when doing so would not endanger the subjects; or
(4) When the apparent noncompliance creates a significant threat to the rights and welfare of human subjects, notify relevant State and Federal regulatory agencies and other parties with a direct interest in the agency's action of the deficiencies in the operation of the IRB.
(c) The parent institution is presumed to be responsible for the operation of an IRB, and the Food and Drug Administration will ordinarily direct any administrative action under this subpart against the institution. However, depending on the evidence of responsibility for deficiencies, determined during the investigation, the Food and Drug Administration may restrict its administrative actions to the IRB or to a component of the parent institution determined to be responsible for formal designation of the IRB.
(a) Whenever the IRB or the institution has failed to take adequate steps to correct the noncompliance stated in the letter sent by the agency under § 56.120(a), and the Commissioner of Food and Drugs determines that this noncompliance may justify the disqualification of the IRB or of the parent institution, the Commissioner will institute proceedings in accordance with the requirements for a regulatory hearing set forth in part 16.
(b) The Commissioner may disqualify an IRB or the parent institution if the Commissioner determines that:
(1) The IRB has refused or repeatedly failed to comply with any of the regulations set forth in this part, and
(2) The noncompliance adversely affects the rights or welfare of the human subjects in a clinical investigation.
(c) If the Commissioner determines that disqualification is appropriate, the Commissioner will issue an order that explains the basis for the determination and that prescribes any actions to be taken with regard to ongoing clinical research conducted under the review of the IRB. The Food and Drug Administration will send notice of the disqualification to the IRB and the parent institution. Other parties with a direct interest, such as sponsors and clinical investigators, may also be sent a notice of the disqualification. In
(d) The Food and Drug Administration will not approve an application for a research permit for a clinical investigation that is to be under the review of a disqualified IRB or that is to be conducted at a disqualified institution, and it may refuse to consider in support of a marketing permit the data from a clinical investigation that was reviewed by a disqualified IRB as conducted at a disqualified institution, unless the IRB or the parent institution is reinstated as provided in § 56.123.
A determination that the Food and Drug Administration has disqualified an institution and the administrative record regarding that determination are disclosable to the public under part 20.
An IRB or an institution may be reinstated if the Commissioner determines, upon an evaluation of a written submission from the IRB or institution that explains the corrective action that the institution or IRB plans to take, that the IRB or institution has provided adequate assurance that it will operate in compliance with the standards set forth in this part. Notification of reinstatement shall be provided to all persons notified under § 56.121(c).
Disqualification of an IRB or of an institution is independent of, and neither in lieu of nor a precondition to, other proceedings or actions authorized by the act. The Food and Drug Administration may, at any time, through the Department of Justice institute any appropriate judicial proceedings (civil or criminal) and any other appropriate regulatory action, in addition to or in lieu of, and before, at the time of, or after, disqualification. The agency may also refer pertinent matters to another Federal, State, or local government agency for any action that that agency determines to be appropriate.
21 U.S.C. 342, 346, 346a, 348, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 262, 263b-263n.
(a) This part prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. Compliance with this part is intended to assure the quality and integrity of the safety data filed pursuant to sections 406, 408, 409, 502, 503, 505, 506, 510, 512-516, 518-520, 721, and 801 of the Federal Food, Drug, and Cosmetic Act and sections 351 and 354-360F of the Public Health Service Act.
(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
As used in this part, the following terms shall have the meanings specified:
(a)
(b)
(c)
(d)
(e)
(1) A color additive petition, described in part 71.
(2) A food additive petition, described in parts 171 and 571.
(3) Data and information regarding a substance submitted as part of the procedures for establishing that a substance is generally recognized as safe for use, which use results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, described in §§ 170.35 and 570.35.
(4) Data and information regarding a food additive submitted as part of the procedures regarding food additives permitted to be used on an interim basis pending additional study, described in § 180.1.
(5) An
(6) A
(7) Data and information regarding an over-the-counter drug for human use, submitted as part of the procedures for classifying such drugs as generally recognized as safe and effective and not misbranded, described in part 330.
(8) Data and information about a substance submitted as part of the procedures for establishing a tolerance for unavoidable contaminants in food and food-packaging materials, described in parts 109 and 509.
(9) [Reserved]
(10) A
(11) A
(12) [Reserved]
(13) An
(14) An
(15) An
(16) A
(17) Data and information regarding a medical device submitted as part of the procedures for classifying such devices, described in part 860.
(18) Data and information regarding a medical device submitted as part of the procedures for establishing, amending, or repealing a performance standard for such devices, described in part 861.
(19) Data and information regarding an electronic product submitted as part of the procedures for obtaining an exemption from notification of a radiation safety defect or failure of compliance with a radiation safety performance standard, described in subpart D of part 1003.
(20) Data and information regarding an electronic product submitted as part of the procedures for establishing, amending, or repealing a standard for such product, described in section 358 of the Public Health Service Act.
(21) Data and information regarding an electronic product submitted as part of the procedures for obtaining a variance from any electronic product performance standard as described in § 1010.4.
(22) Data and information regarding an electronic product submitted as part of the procedures for granting, amending, or extending an exemption from any electronic product performance standard, as described in § 1010.5.
(23) A premarket notification for a food contact substance, described in part 170, subpart D, of this chapter.
(f)
(1) A person who initiates and supports, by provision of financial or other resources, a nonclinical laboratory study;
(2) A person who submits a nonclinical study to the Food and Drug Administration in support of an application for a research or marketing permit; or
(3) A testing facility, if it both initiates and actually conducts the study.
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
(o)
(p)
When a sponsor conducting a nonclinical laboratory study intended to be submitted to or reviewed by the Food and Drug Administration utilizes the services of a consulting laboratory, contractor, or grantee to perform an analysis or other service, it shall notify the consulting laboratory, contractor, or grantee that the service is part of a nonclinical laboratory study that must be conducted in compliance with the provisions of this part.
(a) A testing facility shall permit an authorized employee of the Food and Drug Administration, at reasonable times and in a reasonable manner, to inspect the facility and to inspect (and in the case of records also to copy) all records and specimens required to be maintained regarding studies within the scope of this part. The records inspection and copying requirements shall not apply to quality assurance unit records of findings and problems, or to actions recommended and taken.
(b) The Food and Drug Administration will not consider a nonclinical laboratory study in support of an application for a research or marketing permit if the testing facility refuses to permit inspection. The determination that a nonclinical laboratory study will not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any applicable statute or regulation to submit the results of the study to the Food and Drug Administration.
(a) Each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions.
(b) Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study.
(c) There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol.
(d) Personnel shall take necessary personal sanitation and health precautions designed to avoid contamination of test and control articles and test systems.
(e) Personnel engaged in a nonclinical laboratory study shall wear clothing appropriate for the duties they perform. Such clothing shall be changed as often as necessary to prevent microbiological, radiological, or chemical contamination of test systems and test and control articles.
(f) Any individual found at any time to have an illness that may adversely affect the quality and integrity of the nonclinical laboratory study shall be excluded from direct contact with test systems, test and control articles and any other operation or function that may adversely affect the study until the condition is corrected. All personnel shall be instructed to report to their immediate supervisors any health or medical conditions that may reasonably be considered to have an adverse effect on a nonclinical laboratory study.
For each nonclinical laboratory study, testing facility management shall:
(a) Designate a study director as described in § 58.33, before the study is initiated.
(b) Replace the study director promptly if it becomes necessary to do so during the conduct of a study.
(c) Assure that there is a quality assurance unit as described in § 58.35.
(d) Assure that test and control articles or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable.
(e) Assure that personnel, resources, facilities, equipment, materials, and methodologies are available as scheduled.
(f) Assure that personnel clearly understand the functions they are to perform.
(g) Assure that any deviations from these regulations reported by the quality assurance unit are communicated to the study director and corrective actions are taken and documented.
For each nonclinical laboratory study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. The study director shall assure that:
(a) The protocol, including any change, is approved as provided by § 58.120 and is followed.
(b) All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.
(c) Unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.
(d) Test systems are as specified in the protocol.
(e) All applicable good laboratory practice regulations are followed.
(f) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.
(a) A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part. For any given study, the quality assurance unit shall be entirely separate from and independent of the personnel engaged in the direction and conduct of that study.
(b) The quality assurance unit shall:
(1) Maintain a copy of a master schedule sheet of all nonclinical laboratory studies conducted at the testing facility indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director.
(2) Maintain copies of all protocols pertaining to all nonclinical laboratory
(3) Inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for reinspection. Any problems found during the course of an inspection which are likely to affect study integrity shall be brought to the attention of the study director and management immediately.
(4) Periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken.
(5) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.
(6) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the nonclinical laboratory study.
(7) Prepare and sign a statement to be included with the final study report which shall specify the dates inspections were made and findings reported to management and to the study director.
(c) The responsibilities and procedures applicable to the quality assurance unit, the records maintained by the quality assurance unit, and the method of indexing such records shall be in writing and shall be maintained. These items including inspection dates, the study inspected, the phase or segment of the study inspected, and the name of the individual performing the inspection shall be made available for inspection to authorized employees of the Food and Drug Administration.
(d) A designated representative of the Food and Drug Administration shall have access to the written procedures established for the inspection and may request testing facility management to certify that inspections are being implemented, performed, documented, and followed-up in accordance with this paragraph.
Each testing facility shall be of suitable size and construction to facilitate the proper conduct of nonclinical laboratory studies. It shall be designed so that there is a degree of separation that will prevent any function or activity from having an adverse effect on the study.
(a) A testing facility shall have a sufficient number of animal rooms or areas, as needed, to assure proper: (1) Separation of species or test systems, (2) isolation of individual projects, (3) quarantine of animals, and (4) routine or specialized housing of animals.
(b) A testing facility shall have a number of animal rooms or areas separate from those described in paragraph (a) of this section to ensure isolation of studies being done with test systems or test and control articles known to be biohazardous, including volatile substances, aerosols, radioactive materials, and infectious agents.
(c) Separate areas shall be provided, as appropriate, for the diagnosis, treatment, and control of laboratory animal diseases. These areas shall provide effective isolation for the housing of animals either known or suspected of being diseased, or of being carriers of disease, from other animals.
(d) When animals are housed, facilities shall exist for the collection and disposal of all animal waste and refuse or for safe sanitary storage of waste before removal from the testing facility. Disposal facilities shall be so provided and operated as to minimize vermin infestation, odors, disease hazards, and environmental contamination.
There shall be storage areas, as needed, for feed, bedding, supplies, and equipment. Storage areas for feed and bedding shall be separated from areas housing the test systems and shall be protected against infestation or contamination. Perishable supplies shall be preserved by appropriate means.
(a) As necessary to prevent contamination or mixups, there shall be separate areas for:
(1) Receipt and storage of the test and control articles.
(2) Mixing of the test and control articles with a carrier, e.g., feed.
(3) Storage of the test and control article mixtures.
(b) Storage areas for the test and/or control article and test and control mixtures shall be separate from areas housing the test systems and shall be adequate to preserve the identity, strength, purity, and stability of the articles and mixtures.
Separate laboratory space shall be provided, as needed, for the performance of the routine and specialized procedures required by nonclinical laboratory studies.
Space shall be provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies.
Equipment used in the generation, measurement, or assessment of data and equipment used for facility environmental control shall be of appropriate design and adequate capacity to function according to the protocol and shall be suitably located for operation, inspection, cleaning, and maintenance.
(a) Equipment shall be adequately inspected, cleaned, and maintained. Equipment used for the generation, measurement, or assessment of data shall be adequately tested, calibrated and/or standardized.
(b) The written standard operating procedures required under § 58.81(b)(11) shall set forth in sufficient detail the methods, materials, and schedules to be used in the routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment, and shall specify, when appropriate, remedial action to be taken in the event of failure or malfunction of equipment. The written standard operating procedures shall designate the person responsible for the performance of each operation.
(c) Written records shall be maintained of all inspection, maintenance, testing, calibrating and/or standardizing operations. These records, containing the date of the operation, shall describe whether the maintenance operations were routine and followed the written standard operating procedures. Written records shall be kept of nonroutine repairs performed on equipment as a result of failure and malfunction. Such records shall document the nature of the defect, how and when the defect was discovered, and any remedial action taken in response to the defect.
(a) A testing facility shall have standard operating procedures in writing setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the
(b) Standard operating procedures shall be established for, but not limited to, the following:
(1) Animal room preparation.
(2) Animal care.
(3) Receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles.
(4) Test system observations.
(5) Laboratory tests.
(6) Handling of animals found moribund or dead during study.
(7) Necropsy of animals or postmortem examination of animals.
(8) Collection and identification of specimens.
(9) Histopathology.
(10) Data handling, storage, and retrieval.
(11) Maintenance and calibration of equipment.
(12) Transfer, proper placement, and identification of animals.
(c) Each laboratory area shall have immediately available laboratory manuals and standard operating procedures relative to the laboratory procedures being performed. Published literature may be used as a supplement to standard operating procedures.
(d) A historical file of standard operating procedures, and all revisions thereof, including the dates of such revisions, shall be maintained.
All reagents and solutions in the laboratory areas shall be labeled to indicate identity, titer or concentration, storage requirements, and expiration date. Deteriorated or outdated reagents and solutions shall not be used.
(a) There shall be standard operating procedures for the housing, feeding, handling, and care of animals.
(b) All newly received animals from outside sources shall be isolated and their health status shall be evaluated in accordance with acceptable veterinary medical practice.
(c) At the initiation of a nonclinical laboratory study, animals shall be free of any disease or condition that might interfere with the purpose or conduct of the study. If, during the course of the study, the animals contract such a disease or condition, the diseased animals shall be isolated, if necessary. These animals may be treated for disease or signs of disease provided that such treatment does not interfere with the study. The diagnosis, authorizations of treatment, description of treatment, and each date of treatment shall be documented and shall be retained.
(d) Warm-blooded animals, excluding suckling rodents, used in laboratory procedures that require manipulations and observations over an extended period of time or in studies that require the animals to be removed from and returned to their home cages for any reason (e.g., cage cleaning, treatment, etc.), shall receive appropriate identification. All information needed to specifically identify each animal within an animal-housing unit shall appear on the outside of that unit.
(e) Animals of different species shall be housed in separate rooms when necessary. Animals of the same species, but used in different studies, should not ordinarily be housed in the same room when inadvertent exposure to control or test articles or animal mixup could affect the outcome of either study. If such mixed housing is necessary, adequate differentiation by space and identification shall be made.
(f) Animal cages, racks and accessory equipment shall be cleaned and sanitized at appropriate intervals.
(g) Feed and water used for the animals shall be analyzed periodically to ensure that contaminants known to be capable of interfering with the study and reasonably expected to be present in such feed or water are not present at levels above those specified in the protocol. Documentation of such analyses shall be maintained as raw data.
(h) Bedding used in animal cages or pens shall not interfere with the purpose or conduct of the study and shall be changed as often as necessary to keep the animals dry and clean.
(i) If any pest control materials are used, the use shall be documented. Cleaning and pest control materials that interfere with the study shall not be used.
(a) The identity, strength, purity, and composition or other characteristics which will appropriately define the test or control article shall be determined for each batch and shall be documented. Methods of synthesis, fabrication, or derivation of the test and control articles shall be documented by the sponsor or the testing facility. In those cases where marketed products are used as control articles, such products will be characterized by their labeling.
(b) The stability of each test or control article shall be determined by the testing facility or by the sponsor either: (1) Before study initiation, or (2) concomitantly according to written standard operating procedures, which provide for periodic analysis of each batch.
(c) Each storage container for a test or control article shall be labeled by name, chemical abstract number or code number, batch number, expiration date, if any, and, where appropriate, storage conditions necessary to maintain the identity, strength, purity, and composition of the test or control article. Storage containers shall be assigned to a particular test article for the duration of the study.
(d) For studies of more than 4 weeks' duration, reserve samples from each batch of test and control articles shall be retained for the period of time provided by § 58.195.
Procedures shall be established for a system for the handling of the test and control articles to ensure that:
(a) There is proper storage.
(b) Distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage.
(c) Proper identification is maintained throughout the distribution process.
(d) The receipt and distribution of each batch is documented. Such documentation shall include the date and quantity of each batch distributed or returned.
(a) For each test or control article that is mixed with a carrier, tests by appropriate analytical methods shall be conducted:
(1) To determine the uniformity of the mixture and to determine, periodically, the concentration of the test or control article in the mixture.
(2) To determine the stability of the test and control articles in the mixture as required by the conditions of the study either:
(i) Before study initiation, or
(ii) Concomitantly according to written standard operating procedures which provide for periodic analysis of the test and control articles in the mixture.
(b) [Reserved]
(c) Where any of the components of the test or control article carrier mixture has an expiration date, that date shall be clearly shown on the container. If more than one component has an expiration date, the earliest date shall be shown.
(a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain, as applicable, the following information:
(1) A descriptive title and statement of the purpose of the study.
(2) Identification of the test and control articles by name, chemical abstract number, or code number.
(3) The name of the sponsor and the name and address of the testing facility at which the study is being conducted.
(4) The number, body weight range, sex, source of supply, species, strain, substrain, and age of the test system.
(5) The procedure for identification of the test system.
(6) A description of the experimental design, including the methods for the control of bias.
(7) A description and/or identification of the diet used in the study as well as solvents, emulsifiers, and/or other materials used to solubilize or suspend the test or control articles before mixing with the carrier. The description shall include specifications for acceptable levels of contaminants that are reasonably expected to be present in the dietary materials and are known to be capable of interfering with the purpose or conduct of the study if present at levels greater than established by the specifications.
(8) Each dosage level, expressed in milligrams per kilogram of body weight or other appropriate units, of the test or control article to be administered and the method and frequency of administration.
(9) The type and frequency of tests, analyses, and measurements to be made.
(10) The records to be maintained.
(11) The date of approval of the protocol by the sponsor and the dated signature of the study director.
(12) A statement of the proposed statistical methods to be used.
(b) All changes in or revisions of an approved protocol and the reasons therefor shall be documented, signed by the study director, dated, and maintained with the protocol.
(a) The nonclinical laboratory study shall be conducted in accordance with the protocol.
(b) The test systems shall be monitored in conformity with the protocol.
(c) Specimens shall be identified by test system, study, nature, and date of collection. This information shall be located on the specimen container or shall accompany the specimen in a manner that precludes error in the recording and storage of data.
(d) Records of gross findings for a specimen from postmortem observations should be available to a pathologist when examining that specimen histopathologically.
(e) All data generated during the conduct of a nonclinical laboratory study, except those that are generated by automated data collection systems, shall be recorded directly, promptly, and legibly in ink. All data entries shall be dated on the date of entry and signed or initialed by the person entering the data. Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or identified at the time of the change. In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input. Any change in automated data entries shall be made so as not to obscure the original entry, shall indicate the reason for change, shall be dated, and the responsible individual shall be identified.
(a) A final report shall be prepared for each nonclinical laboratory study and shall include, but not necessarily be limited to, the following:
(1) Name and address of the facility performing the study and the dates on which the study was initiated and completed.
(2) Objectives and procedures stated in the approved protocol, including any changes in the original protocol.
(3) Statistical methods employed for analyzing the data.
(4) The test and control articles identified by name, chemical abstracts number or code number, strength, purity, and composition or other appropriate characteristics.
(5) Stability of the test and control articles under the conditions of administration.
(6) A description of the methods used.
(7) A description of the test system used. Where applicable, the final report shall include the number of animals used, sex, body weight range, source of supply, species, strain and substrain, age, and procedure used for identification.
(8) A description of the dosage, dosage regimen, route of administration, and duration.
(9) A description of all cirmcumstances that may have affected the quality or integrity of the data.
(10) The name of the study director, the names of other scientists or professionals, and the names of all supervisory personnel, involved in the study.
(11) A description of the transformations, calculations, or operations performed on the data, a summary and analysis of the data, and a statement of the conclusions drawn from the analysis.
(12) The signed and dated reports of each of the individual scientists or other professionals involved in the study.
(13) The locations where all specimens, raw data, and the final report are to be stored.
(14) The statement prepared and signed by the quality assurance unit as described in § 58.35(b)(7).
(b) The final report shall be signed and dated by the study director.
(c) Corrections or additions to a final report shall be in the form of an amendment by the study director. The amendment shall clearly identify that part of the final report that is being added to or corrected and the reasons for the correction or addition, and shall be signed and dated by the person responsible.
(a) All raw data, documentation, protocols, final reports, and specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids) generated as a result of a nonclinical laboratory study shall be retained.
(b) There shall be archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. Conditions of storage shall minimize deterioration of the documents or specimens in accordance with the requirements for the time period of their retention and the nature of the documents or specimens. A testing facility may contract with commercial archives to provide a repository for all material to be retained. Raw data and specimens may be retained elsewhere provided that the archives have specific reference to those other locations.
(c) An individual shall be identified as responsible for the archives.
(d) Only authorized personnel shall enter the archives.
(e) Material retained or referred to in the archives shall be indexed to permit expedient retrieval.
(a) Record retention requirements set forth in this section do not supersede the record retention requirements of any other regulations in this chapter.
(b) Except as provided in paragraph (c) of this section, documentation records, raw data and specimens pertaining to a nonclinical laboratory study and required to be made by this part shall be retained in the archive(s) for whichever of the following periods is shortest:
(1) A period of at least 2 years following the date on which an application for a research or marketing permit, in support of which the results of the nonclinical laboratory study were submitted, is approved by the Food and Drug Administration. This requirement does not apply to studies supporting investigational new drug applications (IND's) or applications for investigational device exemptions (IDE's), records of which shall be governed by the provisions of paragraph (b)(2) of this section.
(2) A period of at least 5 years following the date on which the results of the nonclinical laboratory study are submitted to the Food and Drug Administration in support of an application for a research or marketing permit.
(3) In other situations (e.g., where the nonclinical laboratory study does not result in the submission of the study in support of an application for a research or marketing permit), a period of at least 2 years following the date on which the study is completed, terminated, or discontinued.
(c) Wet specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids), samples of test or control articles, and specially prepared material, which are relatively fragile and differ markedly in stability and quality during storage, shall be retained only as long as the quality of the preparation affords evaluation. In no case shall retention be required for longer periods than those set forth in paragraphs (a) and (b) of this section.
(d) The master schedule sheet, copies of protocols, and records of quality assurance inspections, as required by § 58.35(c) shall be maintained by the quality assurance unit as an easily accessible system of records for the period of time specified in paragraphs (a) and (b) of this section.
(e) Summaries of training and experience and job descriptions required to be maintained by § 58.29(b) may be retained along with all other testing facility employment records for the length of time specified in paragraphs (a) and (b) of this section.
(f) Records and reports of the maintenance and calibration and inspection of equipment, as required by § 58.63(b) and (c), shall be retained for the length of time specified in paragraph (b) of this section.
(g) Records required by this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records.
(h) If a facility conducting nonclinical testing goes out of business, all raw data, documentation, and other material specified in this section shall be transferred to the archives of the sponsor of the study. The Food and Drug Administration shall be notified in writing of such a transfer.
(a) The purposes of disqualification are:
(1) To permit the exclusion from consideration of completed studies that were conducted by a testing facility which has failed to comply with the requirements of the good laboratory practice regulations until it can be adequately demonstrated that such noncompliance did not occur during, or did not affect the validity or acceptability of data generated by, a particular study; and
(2) To exclude from consideration all studies completed after the date of disqualification until the facility can satisfy the Commissioner that it will conduct studies in compliance with such regulations.
(b) The determination that a nonclinical laboratory study may not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for
The Commissioner may disqualify a testing facility upon finding all of the following:
(a) The testing facility failed to comply with one or more of the regulations set forth in this part (or any other regulations regarding such facilities in this chapter);
(b) The noncompliance adversely affected the validity of the nonclinical laboratory studies; and
(c) Other lesser regulatory actions (e.g., warnings or rejection of individual studies) have not been or will probably not be adequate to achieve compliance with the good laboratory practice regulations.
(a) Whenever the Commissioner has information indicating that grounds exist under § 58.202 which in his opinion justify disqualification of a testing facility, he may issue to the testing facility a written notice proposing that the facility be disqualified.
(b) A hearing on the disqualification shall be conducted in accordance with the requirements for a regulatory hearing set forth in part 16 of this chapter.
(a) If the Commissioner, after the regulatory hearing, or after the time for requesting a hearing expires without a request being made, upon an evaulation of the administrative record of the disqualification proceeding, makes the findings required in § 58.202, he shall issue a final order disqualifying the facility. Such order shall include a statement of the basis for that determination. Upon issuing a final order, the Commissioner shall notify (with a copy of the order) the testing facility of the action.
(b) If the Commissioner, after a regulatory hearing or after the time for requesting a hearing expires without a request being made, upon an evaluation of the administrative record of the disqualification proceeding, does not make the findings required in § 58.202, he shall issue a final order terminating the disqualification proceeding. Such order shall include a statement of the basis for that determination. Upon issuing a final order the Commissioner shall notify the testing facility and provide a copy of the order.
(a) Once a testing facility has been disqualified, each application for a research or marketing permit, whether approved or not, containing or relying upon any nonclinical laboratory study conducted by the disqualified testing facility may be examined to determine whether such study was or would be essential to a decision. If it is determined that a study was or would be essential, the Food and Drug Administration shall also determine whether the study is acceptable, notwithstanding the disqualification of the facility. Any study done by a testing facility before or after disqualification may be presumed to be unacceptable, and the person relying on the study may be required to establish that the study was not affected by the circumstances that led to the disqualification, e.g., by submitting validating information. If the study is then determined to be unacceptable, such data will be eliminated from consideration in support of the application; and such elimination may serve as new information justifying the termination or withdrawal of approval of the application.
(b) No nonclinical laboratory study begun by a testing facility after the date of the facility's disqualification shall be considered in support of any application for a research or marketing permit, unless the facility has been reinstated under § 58.219. The determination that a study may not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any other applicable regulation to submit the results of the study to the Food and Drug Administration.
(a) Upon issuance of a final order disqualifying a testing facility under § 58.206(a), the Commissioner may notify all or any interested persons. Such notice may be given at the discretion of the Commissioner whenever he believes that such disclosure would further the public interest or would promote compliance with the good laboratory practice regulations set forth in this part. Such notice, if given, shall include a copy of the final order issued under § 58.206(a) and shall state that the disqualification constitutes a determination by the Food and Drug Administration that nonclinical laboratory studies performed by the facility will not be considered by the Food and Drug Administration in support of any application for a research or marketing permit. If such notice is sent to another Federal Government agency, the Food and Drug Administration will recommend that the agency also consider whether or not it should accept nonclinical laboratory studies performed by the testing facility. If such notice is sent to any other person, it shall state that it is given because of the relationship between the testing facility and the person being notified and that the Food and Drug Administration is not advising or recommending that any action be taken by the person notified.
(b) A determination that a testing facility has been disqualified and the administrative record regarding such determination are disclosable to the public under part 20 of this chapter.
(a) Disqualification of a testing facility under this subpart is independent of, and neither in lieu of nor a precondition to, other proceedings or actions authorized by the act. The Food and Drug Administration may, at any time, institute against a testing facility and/or against the sponsor of a nonclinical laboratory study that has been submitted to the Food and Drug Administration any appropriate judicial proceedings (civil or criminal) and any other appropriate regulatory action, in addition to or in lieu of, and prior to, simultaneously with, or subsequent to, disqualification. The Food and Drug Administration may also refer the matter to another Federal, State, or local government law enforcement or regulatory agency for such action as that agency deems appropriate.
(b) The Food and Drug Administration may refuse to consider any particular nonclinical laboratory study in support of an application for a research or marketing permit, if it finds that the study was not conducted in accordance with the good laboratory practice regulations set forth in this part, without disqualifying the testing facility that conducted the study or undertaking other regulatory action.
Termination of a testing facility by a sponsor is independent of, and neither in lieu of nor a precondition to, proceedings or actions authorized by this subpart. If a sponsor terminates or suspends a testing facility from further participation in a nonclinical laboratory study that is being conducted as part of any application for a research or marketing permit that has been submitted to any Center of the Food and Drug Administration (whether approved or not), it shall notify that Center in writing within 15 working days of the action; the notice shall include a statement of the reasons for such action. Suspension or termination of a testing facility by a sponsor does not relieve it of any obligation under any other applicable regulation to submit the results of the study to the Food and Drug Administration.
A testing facility that has been disqualified may be reinstated as an acceptable source of nonclinical laboratory studies to be submitted to the Food and Drug Administration if the Commissioner determines, upon an evaluation of the submission of the testing facility, that the facility can adequately assure that it will conduct future nonclinical laboratory studies in compliance with the good laboratory
21 U.S.C. 348, 355, 360e, 360j, 371, 379e; 35 U.S.C. 156; 42 U.S.C. 262.
(a) This part sets forth procedures and requirements for the Food and Drug Administration's review of applications for the extension of the term of certain patents under 35 U.S.C. 156. Patent term restoration is available for certain patents related to drug products (as defined in 35 U.S.C. 156(f)(2)), and to medical devices, food additives, or color additives subject to regulation under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act. Food and Drug Administration actions in this area include:
(1) Assisting the United States Patent and Trademark Office in determining eligibility for patent term restoration;
(2) Determining the length of a product's regulatory review period;
(3) If petitioned, reviewing and ruling on due diligence challenges to the Food and Drug Administration's regulatory review period determinations; and
(4) Conducting hearings to review initial Food and Drug Administration findings on due diligence challenges.
(b) References in this part to the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
(a) The purpose of this part is to establish a thorough yet efficient process for the Food and Drug Administration review of patent term restoration applications. To achieve this purpose, the regulations are intended to:
(1) Facilitate determinations of patent term restoration eligibility and regulatory review period length, and
(2) Ensure that parties interested in due diligence challenges will have an opportunity to participate in that process, including informal hearings.
(b) The regulations are intended to complement those promulgated by the United States Patent and Trademark Office to implement those parts of the law which are under that agency's jurisdiction. These regulations shall be construed in light of these objectives.
(a) The definitions contained in 35 U.S.C. 156 apply to those terms when used in this part.
(b) The following definitions of terms apply to this part:
(1) The term
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(i) Section 505(b) of the Act or section 351 of the Public Health Service Act (human drug products);
(ii) Section 515 of the Act (medical devices);
(iii) Section 409 or 721 of the Act (food and color additives); or
(iv) Section 512 of the Act (animal drug products).
(12)
(i) Human drug products submitted under section 505(b) of the Act or section 351 of the Public Health Service Act;
(ii) Medical devices submitted under section 515 of the Act;
(iii) Food and color additives submitted under section 409 or 721 of the Act; or
(iv) Animal drug products submitted under section 512 of the Act.
(13)
(14)
(15)
(16)
(a) Upon written request from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in determining whether a patent related to a product is eligible for patent term restoration as follows:
(1) Verifying whether the product was subject to a regulatory review period before its commercial marketing or use;
(2) For human drug products, food additives, color additives, and medical devices, determining whether the permission for commercial marketing or use of the product after the regulatory review period is the first permitted commercial marketing or use of the product either:
(i) Under the provision of law under which the regulatory review period occurred; or
(ii) Under the process claimed in the patent when the patent claims a method of manufacturing the product that primarily uses recombinant de-oxy-ribo-nucleic acid (DNA) technology in the manufacture of the product;
(3) For animal drug products, determining whether the permission for commercial marketing or use of the product after the regulatory review period:
(i) Is the first permitted commercial marketing or use of the product; or
(ii) Is the first permitted commercial marketing or use of the product for administration to a food-producing animal, whichever is applicable, under the provision of law under which the regulatory review period occurred;
(4) Informing the U.S. Patent and Trademark Office whether the patent term restoration application was submitted within 60 days after the product was approved for marketing or use, or, if the product is an animal drug approved for use in a food-producing animal, verifying whether the application was filed within 60 days of the first approval for marketing or use in a food-producing animal; and
(5) Providing the U.S. Patent and Trademark Office with any other information relevant to the U.S. Patent and Trademark Office's determination of whether a patent related to a product is eligible for patent term restoration.
(b) FDA will notify the U.S. Patent and Trademark Office of its findings in writing, send a copy of this notification to the applicant, and file a copy of the notification in the docket established for the application in FDA's Dockets Management Branch (HFA-305), rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
(a) FDA will consult its records and experts to verify the dates contained in the application and to determine the length of the product's regulatory review period under § 60.22. The application shall contain information relevant to the determination of the regulatory review period as stated in the “Guidelines for Extension of Patent Term Under 35 U.S.C. 156” published on October 9, 1984, in PTO's
(b) After determining the length of the regulatory review period, FDA will notify PTO in writing of its determination, send a copy of this determination to the applicant, and file a copy of the determination in the docket established for the application in FDA's
(c) FDA will also publish the regulatory review period determination in the
(1) The name of the applicant;
(2) The trade name and generic name (if applicable) of the product;
(3) The number of the patent for which an extension of the term is sought;
(4) The approved indications or uses for the product;
(5) An explanation of any discrepancies between the dates in the application and FDA records;
(6) Where appropriate, an explanation that FDA has no record in which to review the date(s) contained in the application; and
(7) The regulatory review period determination, including a statement of the length of the testing and approval phases and the dates used in calculating each phase.
In determining a product's regulatory review period, which consists of the sum of the lengths of a testing phase and an approval phase, FDA will review the information in each application using the following definitions of the testing phase and the approval phase for that class of products.
(a) For human drugs:
(1) The testing phase begins on the date an exemption under section 505(i) of the Act becomes effective (or the date an exemption under former section 507(d) of the Act became effective) for the approved human drug product and ends on the date a marketing application under section 351 of the Public Health Service Act or section 505 of the act is initially submitted to FDA (or was initially submitted to FDA under former section 507 of the Act), and
(2) The approval phase begins on the date a marketing application under section 351 of the Public Health Service Act or section 505(b) of the Act is initially submitted to FDA (or was initially submitted under former section 507 of the Act) and ends on the date the application is approved.
(b) For food and color additives:
(1) The testing phase begins on the date a major health or environmental effects test is begun and ends on the date a petition relying on the test and requesting the issuance of a regulation for use of the additive under section 409 or 721 of the Act is initially submitted to FDA.
(2) The approval phase begins on the date a petition requesting the issuance of a regulation for use of the additive under section 409 or 721 of the Act is initially submitted to FDA and ends upon whichever of the following occurs last:
(i) The regulation for the additive becomes effective; or
(ii) Objections filed against the regulation that result in a stay of effectiveness are resolved and commercial marketing is permitted; or
(iii) Proceedings resulting from objections to the regulation, after commercial marketing has been permitted and later stayed pending resolution of the proceedings, are finally resolved and commercial marketing is permitted.
(c) For medical devices:
(1) The testing phase begins on the date a clinical investigation on humans is begun and ends on the date an application for premarket approval of the device or a notice of completion of a product development protocol is initially submitted under section 515 of the Act. For purposes of this part, a clinical investigation is considered to begin on whichever of the following dates applies:
(i) If an investigational device exemption (IDE) under section 520(g) of the Act is required, the effective date of the exemption.
(ii) If an IDE is not required, but institutional review board (IRB) approval under section 520(g)(3) of the Act is required, the IRB approval date.
(iii) If neither an IDE nor IRB approval is required, the date on which the device is first used with human subjects as part of a clinical investigation to be filed with FDA to secure premarket approval of the device.
(2) The approval phase either:
(i) Begins on the date an application for premarket approval of the device is initially submitted under section 515 of the Act and ends on the date the application is approved; or
(ii) Begins on the date a notice of completion of a product development protocol is initially submitted under section 515 of the Act and ends on the date the protocol is declared to be completed.
(d) For animal drugs:
(1) The testing phase begins on the date a major health or environmental effects test is begun or the date on which the agency acknowledges the filing of a notice of claimed investigational exemption for a new animal drug, whichever is earlier, and ends on the date a marketing application under section 512 of the Act is initially submitted to FDA.
(2) The approval phase begins on the date a marketing application under section 512 of the Act is initially submitted to FDA and ends on the date the application is approved.
(e) For purposes of this section, a “major health or environmental effects test” may be any test which:
(1) Is reasonably related to the evaluation of the product's health or environmental effects, or both:
(2) Produces data necessary for marketing approval; and
(3) Is conducted over a period of no less than 6 months duration, excluding time required to analyze or evaluate test results.
(f) For purposes of determining the regulatory review period for any product, a marketing application, a notice of completion of a product development protocol, or a petition is
(a) Any person may request a revision of the regulatory review period determination within 60 days after its initial publication in the
(1) The type of action requested;
(2) The identity of the product;
(3) The identity of the applicant;
(4) The FDA docket number; and
(5) The basis for the request for revision, including any documentary evidence.
(b) Unless the applicant is the person requesting the revision, the applicant shall respond to the request within 15 days. In responding to the request, the applicant may submit information which is relevant to the events during the regulatory review period but which was not included in the original patent term restoration application. A request for a revision is not equivalent to a due diligence petition under § 60.30 or a request for a hearing under § 60.40. If no response is submitted, FDA will decide the matter on the basis of the information in the patent term restoration application, request for revision, and FDA records.
(c) FDA shall apply the provisions of § 60.22 in considering the request for a revision of the regulatory review period determination. lf FDA revises its prior determination, FDA will notify PTO of the revision, send a copy of this
(a) FDA will consider a regulatory review period determination to be final upon expiration of the 180-day period for filing a due diligence petition under § 60.30 unless FDA receives:
(1) New information from PTO records, FDA records, or FDA centers that affects the regulatory review period determination;
(2) A request under § 60.24 for revision of the regulatory review period determination;
(3) A due diligence petition filed under § 60.30; or
(4) A request for a hearing filed under § 60.40.
(b) FDA will notify PTO that the regulatory review period determination is final upon:
(1) The expiration of the 180-day period for filing a due diligence petition; or
(2) If FDA has received a request for a revision, a due diligence petition, or a request for a hearing, upon resolution of the request for a revision, the petition, or the hearing, whichever is later. FDA will send a copy of the notification to the applicant and file a copy of the notification in the docket established for the application in FDA's Dockets Management Branch (HFA-305), rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
(a) FDA will determine the regulatory review period for a product within 30 days of the receipt of a written request from PTO for such a determination and a copy of the patent term restoration application.
(b) FDA may extend the 30-day period if:
(1) A related FDA action that may affect the regulatory review period determination is pending; or
(2) PTO requests that FDA temporarily suspend the determination process; or
(3) PTO or FDA receives new information about the product that warrants an extension of the time required for the determination of the regulatory review period.
(c) This section does not apply to applications withdrawn by the applicant or applications that PTO determines are ineligible for patent term restoration.
(a) Any person may file a petition with FDA, no later than 180 days after the publication of a regulatory review period determination under § 60.20, that challenges FDA's determination by alleging that the applicant for patent term restoration did not act with due diligence in seeking FDA approval of the product during the regulatory review period.
(b) The petition shall be filed in accordance with § 10.20, under the docket number of the
(c) The petition shall claim that the applicant did not act with due diligence during some part of the regulatory review period and shall set forth sufficient facts, including dates if possible, to merit an investigation by FDA of whether the applicant acted with due diligence.
(d) The petition shall contain a certification that the petitioner has served a true and complete copy of the petition upon the applicant by certified or registered mail (return receipt requested) or by personal delivery.
(a) The applicant shall file with FDA a written response to the petition no later than 30 days after the applicant's receipt of a copy of the petition.
(b) The applicant's response may present additional facts and circumstances to address the assertions in the petition, but shall be limited to the issue of whether the applicant acted with due diligence during the regulatory review period. The applicant's response may include documents that were not in the original patent extension application.
(c) If the applicant does not respond to the petition, FDA will decide the matter on the basis of the information submitted in the patent term restoration application, due diligence petition, and FDA records.
(a) Within 90 days after FDA receives a petition filed under § 60.30(a), the agency will either deny the petition under paragraph (b) or (c) of this section or investigate and determine under § 60.36 whether the applicant acted with due diligence during the regulatory review period. FDA will publish its due diligence determination in the
(b) FDA may deny a due diligence petition without considering the merits of the petition if:
(1) The petition is not filed in accordance with § 60.30;
(2) The petition is not filed in accordance with § 10.20;
(3) The petition does not contain the information required by § 10.30;
(4) The petition fails to contain information or allegations upon which it may reasonably be determined that the applicant did not act with due diligence during the applicable regulatory review period; or
(5) The petition fails to allege a sufficient total amount of time during which the applicant did not exercise due diligence such that, even if the petition were granted, the petition would not affect the maximum patent extension the applicant sought in the application.
(a) In determining the due diligence of an applicant, FDA will examine the facts and circumstances of the applicant's actions during the regulatory review period to determine whether the applicant exhibited that degree of attention, continuous directed effort, and timeliness as may reasonably be expected from, and are ordinarily exercised by, a person during a regulatory review period. FDA will take into consideration all relevant factors, such as the amount of time between the approval of an investigational exemption or research permit and the commencement of a clinical investigation and the amount of time required to conduct a clinical investigation.
(b) For purposes of this part, the actions of the marketing applicant shall be imputed to the applicant for patent term restoration. The actions of an agent, attorney, contractor, employee, licensee, or predecessor in interest of the marketing applicant or applicant for patent term restoration shall be imputed to the applicant for patent term restoration.
(a) Any person may request, not later than 60 days after the publication under § 60.34(a) of FDA's due diligence determination, that FDA conduct an informal hearing on the due diligence determination.
(b) The request for a hearing under this section shall:
(1) Be sent by mail, personal delivery, or any other mode of written communication to the Dockets Management Branch and filed under the relevant product file;
(2) Specify the facts and the action that are the subject of the hearing;
(3) Provide the name and address of the person requesting the hearing; and
(4) Certify that the requesting party has served a true and complete copy of the request upon the petitioner and the applicant by certified or registered
(c) The request shall state whether the requesting party seeks a hearing within 30 days or 60 days of FDA's receipt of the request.
Ten days before the hearing, FDA will notify the requesting party, the applicant, and the petitioner, orally or in writing, of the date, time, and location of the hearing. The agency will provide the requesting party, the applicant, and the petitioner with an opportunity to participate as a party in the hearing.
The due diligence hearing shall be conducted in accordance with this part, supplemented by the nonconflicting procedures in part 16. During the due diligence hearing, the applicant and the petitioner shall enjoy all the rights and privileges accorded a person requesting a hearing under part 16. The standard of due diligence set forth in § 60.36 will apply in the due diligence hearing. The party requesting the due diligence hearing shall have the burden of proof at the hearing.
Within 30 days after the completion of the due diligence hearing, the Commissioner will affirm or revise the determination made under § 60.34(a) and will publish the due diligence redetermination in the
21 U.S.C. 321, 341, 342, 343, 348, 351, 360b, 361, 371, 379e.
(a)
(b)
(c)
(d)
(e)
(f) A
(g) For a material otherwise meeting the definition of
(h) The exemption that applies to a pesticide chemical, soil or plant nutrient, or other agricultural chemical, where its coloring effect results solely from its aiding, retarding, or otherwise affecting directly or indirectly, the growth or other natural physiological processes of produce of the soil, applies only to color developed in such product through natural physiological processes such as enzymatic action. If the pesticide chemical, soil or plant nutrient, or other agricultural chemical itself acts as a color or carries as an ingredient a color, and because of this property colors the produce of the soil, it is a
(i)
(j) The term
(k) The term
(l) The term
(m) The term
(n) The term
(o) The term
(p) The term
(q) The term
(r) The term
(s) The term
(t) The term
(u) The
(v) The terms
(a)
(b)
(c)
(a)
(2) If a petition for a definition and standard of identity contains a proposal for a color additive regulation, and the petitioner fails to designate it as such, the Commissioner, upon determining that the petition includes a proposal for a color additive regulation, shall so notify the petitioner and shall thereafter proceed in accordance with the regulations in part 71 of this chapter.
(3) A regulation will not be issued allowing the use of a color additive in a food for which a definition and standard of identity is established, unless its issuance is in conformance with section 401 of the act or with the terms of a temporary permit issued under § 130.17 of this chapter. When the contemplated use of such additive complies with the terms of a temporary permit, the color additive regulation will be conditioned on such compliance and will expire with the expiration of the temporary permit.
(b)
(2) If an application for a new drug inferentially contains a proposal for a color additive regulation, and the applicant fails to designate it as such, the Commissioner, upon determining that the application includes a proposal for a color additive regulation, shall so notify the applicant and shall thereafter proceed in accordance with the regulations in part 71 of this chapter.
(3) Where a petition for a color additive must be filed in accordance with paragraph (b)(2) of this section, the date of filing of the color additive petition shall be considered as the date of filing of the new-drug application.
(a) Different color additives may cause similar or related pharmacological or biological effects, and, in the absence of evidence to the contrary, those that do so will be considered to have additive toxic effects.
(b) Food additives may also cause pharmacological or biological effects similar or related to such effects caused by color additives, and, in the absence of evidence to the contrary, those that do so will be considered as having additive toxic effects.
(c) Pesticide chemicals may also cause pharmacological or biological effects similar or related to such effects caused by color additives, and, in the absence of evidence to the contrary, those that do so will be considered to have additive toxic effects.
(d) In establishing tolerances for color additives, the Commissioner will take into consideration, among other things, the amount of any common component permitted in other color additives, in food additives, and in pesticide chemical residues as well as the similar biological activity (such as cholinesterase inhibition) produced by such substance.
(a) Each petition for the listing of a color additive shall be accompanied by a deposit of $3,000.00 if the proposal is for listing the color additive for use generally in or on foods, in or on drugs, and in or on cosmetics.
(b) If the petition for the listing is for use in or on foods only, the deposit shall be $3,000.00.
(c) If the petition for the listing is for use in or on drugs and/or cosmetics only, the deposit shall be $2,600.00.
(d) The provisions of paragraphs (a), (b), and (c) of this section shall be applicable, whether or not the proposal contemplates any tolerances, limitations, or other restrictions placed upon the use of the color additive.
(e) If a petition proposing the issuance of a regulation is withdrawn before it is finally accepted for filing, the deposit, less a $600.00 fee for clerical handling and administrative and technical review, shall be returned to the petitioner.
(f) If a petition proposing the issuance of a regulation is withdrawn within 30 days after filing, the deposit, less $1,800.00 if the petition is covered by paragraph (a) or (b) of this section, and less $1,600.00, if the petition is covered by paragraph (c) of this section, shall be returned to the petitioner.
(g) When a petition is withdrawn after filing and resubmitted within 6 months, it shall be accompanied by a deposit of $1,800.00 for a petition filed under paragraph (a) or (b) of this section, and $1,600.00 for a petition filed under paragraph (c) of this section. If a petition is resubmitted after 6 months, it shall be accompanied by the deposit that would be required if it were being submitted for the first time.
(h) When the resubmission pertains to a petition that had been withdrawn before acceptance for filing, a new advance deposit shall be made in full as prescribed in paragraph (a), (b), or (c) of this section.
(i) After a color additive has been listed, any request for an amendment or additional tolerance shall be accompanied by a deposit of $1,800.00 for use in the items specified in paragraphs (a) and (b) of this section, or $1,600.00 for use in items specified in paragraph (c) of this section.
(j) The fee for services in listing a diluent under § 80.35 for use in color additive mixtures shall be $250.00.
(k) Objections and request for public hearing under section 721(d) of the act or section 203(d)(2)(C) of Pub. L. 86-618 (74 Stat. 404; 21 U.S.C. 379e, note) shall be accompanied by a filing fee of $250.00.
(l) In the event of a referral of a petition under this section to an advisory committee, all costs related thereto (including personal compensation of committee members, travel materials, and other costs) shall be borne by the person or organization requesting the referral, such costs to be assessed on the basis of actual cost to the Government:
(m) In the case of requests of referrals to advisory committees, a special advance deposit shall be made in the amount of $2,500.00. Where required, further advance in increments of $2,500.00 each shall be made upon request of the Commissioner of Food and Drugs. All deposits for referrals to advisory committees in excess of actual expenses shall be refunded to the depositor.
(n) All requests for pharmacological or other scientific studies shall be accompanied by an advance deposit of $5,000.00. Further advance deposits shall be made upon request of the Commissioner of Food and Drugs when necessary to prevent arrears in such cost. Any deposits in excess of actual expenses will be refunded to the depositor. If a request is denied the advance deposit will be refunded less such costs as are incurred for review of the request.
(o) The person who files a petition for judicial review of an order under section 721(d) of the act shall pay the costs of preparing a transcript of the record on which the order is based.
(p) All deposits and fees required by the regulations in this section shall be paid by money order, bank draft or certified check drawn to the order of the Food and Drug Administration, collectable at par at Washington, DC All deposits and fees shall be forwarded to
(q) The Commissioner of Food and Drugs may waive or refund such fees in whole or in part when in his judgment such action will promote the public interest.
(r) Any person who believes that payment of these fees will work a hardship on him may petition the Commissioner of Food and Drugs to waive or refund the fees.
Straight colors shall be packaged in containers which prevent changes in composition. Packages shall be sealed so that they cannot be opened without breaking the seal. An unavoidable change in moisture content caused by the ordinary and customary exposure that occurs in good storage, packing, and distribution practice is not considered a change in composition. If the packaging material is a food additive it shall be authorized by an appropriate regulation in parts 170 through 189 of this chapter.
(a)
(1) The name of the straight color or the name of each ingredient comprising the color additive, if it is a mixture.
(2) A statement indicating general limitations for the use of the color additive, such as “for food use only”; “for food, drug, and cosmetic use”; “for use in drugs for external application only.”
(3) Where regulations issued impose quantitative limitations for a general or specific use of a straight color, the amount of each such straight color in terms of weight per unit/volume or percent by weight.
(4) An expiration date if stability data require it.
(b)
(c)
(d)
In accordance with section 721(b)(5)(A)(iii) of the act, the following safety factor will be applied in determining whether the proposed use of a color additive will be safe: Except where evidence is submitted which justifies use of a different safety factor, a safety factor of 100 to 1 will be used in applying animal experimentation data to man; that is, a color additive for use by man will not be granted a tolerance that will exceed 1/100th of the maximum no-effect level for the most susceptible experimental animals tested. The various species of experimental animals used in the tests shall conform to good pharmacological practice.
(a) In deciding whether a petition is complete and suitable for filing and in reaching a decision on any petition filed, the Commissioner will apply the “safe-for-use” principle. This will require the presentation of all needed scientific data in support of a proposed listing to assure that each listed color additive will be safe for its intended use or uses in or on food, drugs, or cosmetics. The Commissioner may list a color additive for use generally in or on food, in or on drugs, or in or on cosmetics when he finds from the data presented that such additive is suitable and may safely be employed for such general use; he may list an additive only for more limited use or uses for which it is proven suitable and may safely be employed; and he is authorized to prescribe broadly the conditions under which the additive may be safely employed for such use or uses. This may allow the use of a particular dye, pigment, or other substance with certain diluents, but not with others, or at a higher concentration with some than with others.
(b) The safety for external color additives will normally be determined by tests for acute oral toxicity, primary irritation, sensitization, subacute dermal toxicity on intact and abraded skin, and carcinogenicity by skin application. The Commissioner may waive any of such tests if data before him otherwise establish that such test is not required to determine safety for the use proposed.
(c) Upon written request describing the proposed use of a color additive and the proposed experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a color additive whether he believes the experiments planned will yield data adequate for an evaluation of the safety of the additive.
Whenever, in the consideration of a petition or a proposal to list a color additive or to alter an existing listing, the data before the Commissioner fail to show that it would be safe to list the color additive for all the uses proposed or at the levels proposed, the Commissioner will notify the petitioner and other interested persons by publication in the
(a)
(b)
(c)
All requests for and procedures governing any advisory committee on the anticancer clause shall be subject to the provisions of part 14 of this chapter, and particularly subpart H of that part.
The Commissioner will consider requests by any interested person who desires the Food and Drug Administration to conduct scientific studies to support a petition for a regulation for a color additive. If favorably acted upon, such studies will be limited to pharmacological investigations, studies of the chemical and physical structure of the color additive, and methods of analysis of the pure color additive (including impurities) and its identification and determination in foods, drugs, or cosmetics, as the case may be. All requests for such studies shall be accompanied by the fee prescribed in § 70.19.
21 U.S.C. 321, 342, 348, 351, 355, 360, 360b-360f, 360h-360j, 361, 371, 379e, 381; 42 U.S.C. 216, 262.
(a) Any interested person may propose the listing of a color additive for use in or on any food, drug, or cosmetic or for coloring the human body. Such proposal shall be made in a petition in the form prescribed in paragraph (c) of this section. The petition shall be submitted in triplicate (quadruplicate, if intended uses include uses in meat, meat food product, or poultry product). If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petitioner shall state the post-office address in the United States to which published notices or orders issued or objections filed pursuant to section 721 of the act may be sent.
(b) Pertinent information may be incorporated in, and will be considered as part of, a petition on the basis of specific reference to such information submitted to and retained in the files of the Food and Drug Administration. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized in a written statement signed by the person who submitted the information. Any reference to published information offered in support of a color additive petition should be accompanied by reprints or photostatic copies of such references.
(c) Petitions shall include the following data and be submitted in the following form:
Petitioner submits this pursuant to section 721(b)(1) of the Federal Food, Drug, and Cosmetic Act requesting listing by the Commissioner of the color additive _____ as suitable and safe for use in or on _____ subject to the conditions that _______. [Petitioner may propose a listing for general use in food, drugs, or cosmetics or, if such general listing is not believed suitable and safe, the petitioner shall describe the conditions under which he believes the additive can be safely used and for which it will be suitable. These conditions may include tolerance limitations, specifications as to the manner in which the additive may be added or used, and directions and other labeling or packaging safeguards that should be applied. The level of use proposed should not be higher than reasonably required to accomplish the intended color effect.]
Attached hereto, in triplicate (quadruplicate, if intended uses include uses in meat, meat food product, or poultry product), and constituting a part of this petition are the following:
A. The name and all pertinent information concerning the color additive, including chemical identity and composition of the color additive, its physical, chemical, and biological properties, and specifications prescribing its component(s) and identifying and limiting the reaction byproducts and other impurities.
The petition shall contain a description of the chemical and physical tests relied upon to identify the color additive and shall contain a full description of the methods used in, and the facilities and controls used for, the production of the color additive. These shall establish that it is a substance of reproducible composition. Alternative methods and controls and variations in methods and controls, within reasonable limits, that do not affect the characteristics of the substance or the reliability of the controls may be specified.
The petition shall supply a list of all substances used in the synthesis, extraction, or other method of preparation of any straight color, regardless of whether they undergo chemical change in the process. Each substance should be identified by its common or usual name and its complete chemical name, using structural formulas when necessary for specific identification. If any proprietary preparation is used as a component, the proprietary name should be followed by a complete quantitive statement of composition. Reasonable alternatives for any listed substance may be specified.
If the petitioner does not himself perform all the manufacturing, processing, and packing operations for a color additive, the petitioner shall identify each person who will perform a part of such operations and designate the part.
The petition shall include stability data, and, if the data indicate that it is needed to insure the identity, strength, quality, or purity of the color additive, the expiration period that will be employed as well as any packaging and labeling precautions needed to preserve stability.
B. The amount of the color additive proposed for use and the color effect intended to be achieved, together with all directions, recommendations, and suggestions regarding the proposed use, as well as specimens of the labeling proposed for the color additive. If the color effect results or may reasonably be expected to result from use of the color additive in packaging material, the petitioner shall show how this may occur and what residues may reasonably be anticipated.
Typewritten or other draft-labeling copy will be accepted for consideration of the petition provided final printed labeling identical in content to the draft copy is submitted as soon as available, and prior to the marketing of the color additive. The printed labeling shall conform in prominence and conspicuousness with the requirements of the act.
If the color additive is one for which a tolerance limitation is required to assure its safety, the level of use proposed should be no higher than the amount reasonably required to accomplish the intended physical or other technical effect, even though the safety data may support a higher tolerance. If the safety data will not support the use of the amount of the color additive reasonably needed to accomplish the desired color effect, the requested tolerance will not be established. Petitioners are expected to propose the use of color additives in accordance with sound color chemistry.
C.1. A description of practicable methods to determine the pure color and all intermediates, subsidiary colors, and other components of the color additive.
2. A description of practicable methods to determine the amount of the color additive in any raw, processed, and/or finished food, drug, or cosmetic in which use of the color additive is proposed. (The tests proposed shall be those that can be used for food, drug, or cosmetic control purposes and can be applied with consistent results by any properly equipped laboratory and trained personnel.)
3. A description of methods for identification and determination of any substance formed in or on such food, drug, or cosmetic because of the use of the color additive. (If it is the petitioner's view that any such method would not be needed, under the terms of section 721(b)(5)(A)(iv), a statement shall be submitted in lieu of methods as to the basis for such view.)
D. Full reports of investigation made with respect to the safety of the color additive.
(A petition will be regarded as incomplete unless it includes full reports of adequate tests reasonably applicable to show whether or not the color additive will be safe for its intended use. The reports ordinarily should include detailed data derived from appropriate animal and other biological experiments in which the methods used and the results obtained are clearly set forth. The petition shall not omit without explanation any data that would influence the evaluation of the safety of the color additive).
E. Complete data which will allow the Commissioner to consider, among other things, the probable consumption of, and/or other relevant exposure from the additive and of any substance formed in or on food, drugs, or cosmetics because of such additive; and the cumulative effect, if any, of such additive in the diet of man or animals, taking into account the same or any chemically or pharmacologically related substance or substances in the diet including, but not limited to food additives and pesticide chemicals for which tolerances or exemptions from tolerances have been established.
F. Proposed tolerances and other limitations on the use of the color additive, if tolerances and limitations are required in order to insure its safety. A petitioner may include a proposed regulation.
G. If exemption from batch certification is requested, the reasons why it is believed such certification is not necessary (including supporting data to establish the safety of the intended use).
H. If submitting a petition to alter an existing regulation issued pursuant to section 721(b) of the act, full information on each proposed change that is to be made in the original regulation must be submitted. The petition may omit statements made in the original petition concerning which no change is proposed. A supplemental petition must be submitted for any change beyond the variations provided for in the original petition and the regulation issued on the basis of the original petition.
I. The prescribed fee of $ __ for admitting the color additive to listing is enclosed (unless there is an advance deposit adequate to cover the fee).
Yours very truly,
J. The petitioner is required to submit either a claim for categorical exclusion under § 25.30 or 25.32 of this chapter or an environmental assessment under § 25.40 of this chapter.
(d) The petitioner will be notified of the date on which his petition is filed; and an incomplete petition, or one that has not been submitted in triplicate, will be retained but not filed. A petition shall be retained but shall not be filed if any of the data listed in the above form are lacking or are not set forth so as to be readily understood or if the prescribed fee has not been submitted. The petitioner will be notified in what respects his petition is incomplete.
(e) The petition must be signed by the petitioner or by his attorney or authorized agent, who is a resident of the United States.
(f) The data specified under the several lettered headings should be submitted on separate sheets or sets of sheets, suitably identified. If such data have already been submitted with an earlier application, the present petition may incorporate it by specific reference to the earlier petition.
(g) If nonclinical laboratory studies are involved, petitions filed with the Commissioner under section 721(b) of the act shall include with respect to each nonclinical study contained in the petition, either a statement that the study was conducted in compliance with the good laboratory practice regulations set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.
(h) [Reserved]
(i) If clinical investigations involving human subjects are involved, petitions filed with the Commissioner under section 721(b) of the act shall include statements regarding each such clinical investigation contained in the petition that it either was conducted in compliance with the requirements for institutional review set forth in part 56 of this chapter, or was not subject to such requirements in accordance with §§ 56.104 or 56.105, and that it was conducted in compliance with the requirements for informed consent set forth in part 50 of this chapter.
(j)(1) If intended uses of the color additive include uses in meat, meat food product, or poultry product subject to regulation by the U.S. Department of Agriculture (USDA) under the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451
(2) FDA will ask USDA to advise whether the proposed meat and poultry uses comply with the FMIA and PPIA or, if not, whether use of the substance would be permitted in products under USDA jurisdiction under specified conditions or restrictions.
At 65 FR 51762, Aug. 25, 2000, § 71.1 was amended in paragraph (a) by revising the third sentence, in paragraph (c) in the petition by revising the introductory paragraph preceding paragraph A., and by adding paragraph (j). The revised and added text contains information collection and recordkeeping requirements and will not become effective until approval has been given by the Office of Management and Budget.
(a) Except where the petition involves a new drug, the Commissioner, within 15 days after receipt, will notify the petitioner of acceptance or nonacceptance of a petition, and if not accepted the reasons therefor. If accepted, the date of the notification letter sent to petitioner becomes the date of filing for the purposes of section 721(d)(1) of the act. If the petitioner desires, he may supplement a deficient petition after being notified regarding deficiencies. If the supplementary material or explanation of the petition is deemed acceptable, petitioner shall be notified. The date of such notification becomes the date of filing. If the petitioner does not wish to supplement or explain the petition and requests in writing that it be filed as submitted, the petition shall be filed and the petitioner so notified. The date of such notification becomes the date of filing. Where the petition involves a new
(b) The Commissioner will cause to be published in the
The Commissioner may request samples of the color additive, articles used as components thereof, or of the food, drug, or cosmetic in which the color additive is proposed to be used, or which comprises the color additive, and any additional information needed to clarify a submitted method or other aspect of a petition at any time while a petition is under consideration. The Commissioner shall specify in the request for a sample of the color additive, or articles used as components thereof, or of the food, drug, or cosmetic in which the color additive is proposed to be used, or which comprises the color additive, a quantity deemed adequate to permit tests of analytical methods to determine quantities of the color additive present in products for which it is intended to be used or adequate for any study or investigation reasonably required with respect to the safety of the color additive or the physical or technical effect it produces. The date used for computing the 90-day limit for the purposes of section 721(d)(1) of the act shall be moved forward 1 day for each day, after mailing date of the request, taken by the petitioner to submit the information and/or sample. If the information or sample is requested a reasonable time in advance of the 180 days, but is not submitted within such 180 days after filing of the petition, the petition will be considered withdrawn without prejudice.
(a)
(b)
(c)
(2) At any time before the order provided for in § 71.20 has been forwarded to the
(a) The following data and information in a color additive petition are available for public disclosure, unless extraordinary circumstances are shown, after the notice of filing of the petition is published in the
(1) All safety and functionality data and information submitted with or incorporated by reference in the petition.
(2) A protocol for a test or study, unless it is shown to fall within the exemption established for trade secrets and confidential commercial information in § 20.61 of this chapter.
(3) Adverse reaction reports, product experience reports, consumer complaints, and other similar data and information, after deletion of:
(i) Names and any information that would identify the person using the product.
(ii) Names and any information that would identify any third party involved with the report, such as a physician or hospital or other institution.
(4) A list of all ingredients contained in a color additive, whether or not it is in descending order of predominance. A particular ingredient or group of ingredients shall be deleted from any such list prior to public disclosure if it is shown to fall within the exemption established in § 20.61 of this chapter, and a notation shall be made that any such ingredient list is incomplete.
(5) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is shown to fall within the exemption established in § 20.61 of this chapter.
(6) All records showing the Food and Drug Administration's testing of or action on a particular lot of a certifiable color additive.
(b) The following data and information in a color additive petition are not available for public disclosure unless they have been previously disclosed to the public as defined in § 20.81 of this chapter or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in § 20.61 of this chapter:
(1) Manufacturing methods or processes, including quality control procedures.
(2) Production, sales, distribution, and similar data and information, except that any compilation of such data and information aggregated and prepared in a way that does not reveal data or information which is not available for public disclosure under this provision is available for public disclosure.
(3) Quantitative or semiquantitative formulas.
(c) All correspondence and written summaries of oral discussions relating to a color additive petition are available for public disclosure in accordance with the provisions of part 20 of this chapter when the color additive regulation is published in the
(d) For purposes of this regulation, safety and functionality data include all studies and tests of a color additive on animals and humans and all studies and tests on a color additive for identity, stability, purity, potency, performance, and usefulness.
A manufacturer, packer, or distributor of a color additive or color additive mixture may petition for an exemption from certification pursuant to part 10 of this chapter. Any such petition shall show why such certification is not necessary for the protection of public health.
The Commissioner will forward for publication in the
(a) A regulation listing in part 73 or 74 of this chapter the color additive on the appropriate list or lists as provided under section 721(b)(1).
(1) Such a regulation may list the color additive for use generally in or on foods, drugs, or cosmetics or for use in coloring the human body, as the case may be, or may prescribe the conditions under which the color additive may be safely used (including, but not limited to, specifications as to the particular food, drug, or cosmetic or classes of food, drugs, or cosmetics in or on which such color additive may be used, or for the material intended for coloring the human body; the maximum quantity of any straight color or diluent that may be used or permitted to remain in or on such food, drug, or cosmetic or article intended for coloring the human body; the manner in which such color additive may be added to or used in or on such food, drug, or cosmetic or for coloring the human body; and any directions or other labeling or packing requirements for such color additives deemed necessary to assure the safety of such use).
(2) Such regulations shall list the color additive only for the use or uses for which it has been found suitable and for which it may safely be employed. Alternatively, the Commissioner shall by order deny the petition, and notify the petitioner of such order and the reasons therefor.
(3) The regulation shall list any use or uses in meat, meat food product, or poultry product subject to the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601
(b) Whenever the Commissioner finds that batch certification is not necessary for the protection of the public health he will, by order, exempt the color additive from the certification procedure. In determining whether certification of a color additive is necessary, the Commissioner will consider the composition of the additive, its manufacturing process, possible impurities, its toxic potential, control and analytical procedures necessary to assure compliance with the listing specifications, and the variability of its composition.
The Commissioner shall refuse to issue a regulation listing a color additive, if in his judgment the data before him show that such proposed use would promote deception of the consumer or would result in misbranding or adulteration within the meaning of the act. Such a finding shall be by order published in the
(a) When the Commissioner cannot conclude from the information before him that there is a basis for exempting a color additive from the requirement of batch certification, he will so order by appropriate listing in part 74 of this chapter. The Commissioner's order shall state in detail the specifications that shall be met by the color additive.
(b) Each order shall state a period of time after which use of a color additive subject to batch certification but not from a batch certified by procedure prescribed in this section would result in adulteration of the product in which it is used.
If information becomes available to the Commissioner that a color additive that has been granted exemption from certification should not, for the protection of the public health, be so exempted, such exemption will be canceled by a notice published in the
Where a petition for a regulation to list a color additive has not been received and the Commissioner has available facts which demonstrate that a color additive should be listed and/or that certification procedure is not necessary in order to protect the public health, he may list such color additive by appropriate regulation and listing in part 73 or 74 of this chapter.
(a) Objections and hearings relating to color additive regulations under section 721 (b) and (c) of the act shall be governed by parts 10, 12, 13, 14, 15, 16, and 19 of this chapter.
(b) The fees specified in § 70.19 of this chapter shall be applicable.
(a) A shipment or other delivery of a color additive or of a food, drug, or cosmetic containing such a color additive for investigational use by experts qualified to determine safety shall be exempt from the requirements of section 402(c), 501(a), or 601(e) of the act, provided that the color additive or the food, drug, or cosmetic containing the color additive bears a label which states prominently, “Caution—Contains new color additive—For investigational use only.” No animals used in such investigations, or their products, such as milk or eggs, shall be used for food purposes, unless the sponsor or the investigator has submitted to the Commissioner data demonstrating that such use will be consistent with the public health, and the Commissioner, proceeding as he would in a matter involving section 409(i) of the act, has notified the sponsor or investigator that the proposed disposition for food is authorized. Any person who contests a refusal to grant such authorization shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter.
(b) The person who introduced such shipment or who delivers the color additive or a food, drug, or cosmetic containing such an additive into interstate commerce shall maintain adequate records showing the name and post-office address of the expert to whom the color additive is shipped, date, quantity, and batch or code mark of each shipment and delivery for a period of 2 years after such shipment and delivery. Upon the request of a properly authorized employee of the Department, at reasonable times, he shall make such records available for inspection and copying.
21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.
Nomenclature changes to part 73 appear at 66 FR 66742, Dec. 27, 2001.
The following substances may be safely used as diluents in color additive mixtures for food use exempt from certification, subject to the condition that each straight color in the mixture has been exempted from certification or, if not so exempted, is from a batch that has previously been certified and has not changed in composition since certification. If a specification for a particular diluent is not set forth in this part 73, the material shall be of a purity consistent with its intended use.
(a)
(2) Substances meeting the definitions and specifications set forth under subchapter B of this chapter, and which are used only as prescribed by such regulations.
(3) The following:
(b)
(ii)
(2)
(3)
(a)
(i) Alkaline aqueous solution, alkaline propylene glycol, ethyl alcohol or alkaline solutions thereof, edible vegetable oils or fats, mono- and diglycerides from the glycerolysis of edible vegetable oils or fats. The alkaline alcohol or aqueous extracts may be treated with food-grade acids to precipitate annatto pigments, which are separated from the liquid and dried, with or without intermediate recrystallization, using the solvents listed under paragraph (a)(1)(ii) of this section. Food-grade alkalis or carbonates may be added to adjust alkalinity.
(ii) Acetone, ethylene dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene chloride, tri-chloro-ethyl-ene.
(2) Color additive mixtures for food use made with annatto extract may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.
(b)
(1) Arsenic (as As), not more than 3 parts per million; lead as Pb, not more than 10 parts per million.
(2) When solvents listed under paragraph (a)(1)(ii) of this section are used, annatto extract shall contain no more solvent residue than is permitted of the corresponding solvents in spice oleoresins under applicable food additive regulations in parts 170 through 189 of this chapter.
(c)
(d)
(e)
(a)
(2) Astaxanthin may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with astaxanthin may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods.
(b)
(c)
(1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish.
(2) The quantity of color additive in feed is such that the color additive shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed.
(d)
(2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section shall be declared in accordance with § 501.4 of this chapter.
(3) The presence of the color additive in salmonid fish that have been fed feeds containing astaxanthin shall be declared in accordance with §§ 101.22(k)(2) and 101.100(a)(2) of this chapter.
(e)
(a)
(2) Color additive mixtures made with dehydrated beets may contain as diluents only those substances listed in this subpart as safe and suitable for use in color additive mixtures for coloring foods.
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for food use made with canthaxanthin may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring foods.
(b)
(c)
(i) The quantity of canthaxanthin does not exceed 30 milligrams per pound of solid or semisolid food or per pint of liquid food; and
(ii) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.
(2) Canthaxanthin may be safely used in broiler chicken feed to enhance the yellow color of broiler chicken skin in accordance with the following conditions: The quantity of canthaxanthin incorporated in the feed shall not exceed 4.41 milligrams per kilogam (4 grams per ton) of complete feed to supplement other known sources of xanthophyll and associated carotenoids to accomplish the intended effect.
(3) Canthaxanthin may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions:
(i) Canthaxanthin may be added to the fish feed only in the form of a stabilized color additive mixture;
(ii) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish; and
(iii) The quantity of color additive in feed shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed.
(d)
(2) For purposes of coloring fish, the labeling of the color additive and any premixes prepared therefrom shall bear expiration dates (established through generally accepted stability testing methods) for the sealed and open container, other information required by § 70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c)(3) of this section.
(3) The presence of the color additive in finished fish feed prepared according to paragraph (c)(3) of this section shall be declared in accordance with § 501.4 of this chapter.
(4) The presence of the color additive in salmonid fish that have been fed feeds containing canthaxanthin shall be declared in accordance with §§ 101.22(b), (c), and (k)(2), and 101.100(a)(2) of this chapter.
(e)
(a)
(2) The food-grade acids, alkalis, and salts listed in this subparagraph may be employed to assist caramelization, in amounts consistent with good manufacturing practice.
(i) Acids:
(ii) Alkalis:
(iii) Salts: Ammonium, sodium, or potassium carbonate, bicarbonate, phosphate (including dibasic phosphate and monobasic phosphate), sulfate, and sulfite.
(3) Polyglycerol esters of fatty acids, identified in § 172.854 of this chapter, may be used as antifoaming agents in amounts not greater than that required to produce the intended effect.
(4) Color additive mixtures for food use made with caramel may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for food use made with β-apo-8′-carotenal may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.
(b)
(c)
(1) The quantity of β-apo-8′-carotenal does not exceed 15 milligrams per pound of solid or semisolid food or 15 milligrams per pint of liquid food.
(2) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.
(d)
(e)
(a)
(2) Color additive mixtures for food use made with β-carotene may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.
(b)
(c)
(d)
(e)
(a)
(2) The color additive carmine is the aluminum or calcium-aluminum lake on an aluminum hydroxide substrate of the coloring principles, chiefly carminic acid, obtained by an aqueous extraction of cochineal (
(3) Color additive mixtures for food use made with cochineal extract or carmine may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.
(b)
(2) Carmine shall conform to the following specifications:
(c)
(d)
(e)
(a)
(2) Color additive mixtures made with sodium copper chlorophyllin may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods.
(b)
(1) Moisture, not more than 5.0 percent.
(2) Solvent residues (acetone, ethanol, and hexane), not more than 50 parts per million, singly or, in combination.
(3) Total copper, not less than 4 percent and not more than 6 percent.
(4) Free copper, not more than 200 parts per million.
(5) Lead (as Pb), not more than 10 parts per million.
(6) Arsenic (as As), not more than 3 parts per million.
(7) Mercury (as Hg), not more than 0.5 part per million.
(8) Ratio of absorbance at 405 nanometers (nm) to absorbance at 630 nm, not less than 3.4 and not more than 3.9.
(9) Total copper chlorophyllins, not less than 95 percent of the sample dried at 100 °C for 1 hour.
(c)
(d)
(e)
(a)
(2) Color additive mixtures for food use made with toasted partially defatted cooked cottonseed flour may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for food use made with grape color extract may
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for food use made with grape skin extract (enocianina) may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods.
(b)
(c)
(1) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless artificial color is authorized by such standards.
(2) Its use in alcoholic beverages shall be in accordance with the provisions of parts 4 and 5, title 27 CFR.
(d)
(e)
(a)
(2) Haematococcus algae meal may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with haematococcus algae meal may contain only those diluents that are suitable and are listed in this subpart as safe for use in
(b)
(c)
(1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish.
(2) The quantity of astaxanthin in finished feed, from haematococcus algae meal when used alone or in combination with other astaxanthin color additive sources listed in this part 73, shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed.
(d)
(2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section shall be declared in accordance with § 501.4 of this chapter.
(3) The presence of the color additive in salmonid fish that have been fed feeds containing haematococcus algae meal shall be declared in accordance with §§ 101.22(b), (c), and (k)(2), and 101.100(a)(2) of this chapter.
(e)
(a)
(2) Color additive mixtures for food use made with synthetic iron oxide may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring foods.
(b)
(2) Synthetic iron oxide for dog and cat food use shall conform to the following specifications:
(c)
(2) Synthetic iron oxide may be safely used for the coloring of dog and cat foods in an amount not exceeding 0.25 percent by weight of the finished food.
(d)
(e)
(a)
(2) Color additive mixtures made with fruit juice may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods.
(b)
(c)
(d)
(a)
(2) Color additive mixtures made with vegetable juice may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods.
(b)
(c)
(d)
(a)
(b)
(1) The color additive is used to enhance the yellow color of chicken skin and eggs.
(2) The quantity of the color additive incorporated in the feed is such that the finished feed:
(i) Is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in paragraph (b)(1) of this section; and
(ii) Meets the tolerance limitation for ethoxyquin in animal feed prescribed in § 573.380 of this chapter.
(c)
(1) A statement of the concentrations of xanthophyll and ethoxyquin contained therein.
(2) Adequate directions to provide a final product complying with the limitations prescribed in paragraph (b) of this section.
(d)
(a)
(2) The color additive tagetes (Aztec marigold) extract is a hexane extract of the flower petals of the Aztec marigold (
(b)
(2) Tagetes (Aztec marigold) extract shall be prepared from tagetes (Aztec marigold) petals meeting the specifications set forth in paragraph (b)(1) of this section and shall conform to the following additional specifications:
(c)
(1) The color additives are used to enhance the yellow color of chicken skin and eggs.
(2) The quantity of the color additives incorporated in the feed is such that the finished feed:
(i) Is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in paragraph (c)(1) of this section; and
(ii) Meets the tolerance limitation for ethoxyquin in animal feed prescribed in § 573.380 of this chapter.
(d)
(1) A statement of the concentrations of xanthophyll and ethoxyquin contained therein.
(2) Adequate directions to provide a final product complying with the limitations prescribed in paragraph (c) of this section.
(e)
(a)
(2) Color additive mixtures for food use made with carrot oil may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for food use made with corn endosperm oil may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods.
(b)
(c)
(1) The color additive is used to enhance the yellow color of chicken skin and eggs.
(2) The quantity of the color additive incorporated in the feed is such that the finished feed is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in paragraph (c)(1) of this section.
(d)
(e)
(a)
(2) Color additive mixtures made with paprika may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods.
(b)
(c)
(d)
(a)
(2) Color additive mixtures made with paprika oleoresin may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods.
(b)
(c)
(d)
(e)
(a)
(2) Phaffia yeast may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with phaffia yeast may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods.
(b)
(c)
(1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish.
(2) The quantity of astaxanthin in finished feed, from phaffia yeast when used alone or in combination with other astaxanthin color additive sources listed in this part 73, shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed.
(d)
(2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section shall be declared in accordance with § 501.4 of this chapter.
(3) The presence of the color additive in salmonid fish that have been fed feeds containing phaffia yeast shall be declared in accordance with §§ 101.22(b), (c), and (k)(2) and 101.100(a)(2) of this chapter.
(e)
(a)
(2) Color additive mixtures made with riboflavin may contain as diluents only those substances listed in this subpart as safe and suitable for use in color additive mixtures for coloring foods.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures made with saffron may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods.
(b)
(c)
(d)
(a)
(2) Color additive mixtures for food use made with titanium dioxide may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods, and the following: Silicon dioxide, SiO
(b)
(c)
(1) The quantity of titanium dioxide does not exceed 1 percent by weight of the food.
(2) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.
(d)
(e)
(a)
(2) Color additive mixtures made with turmeric may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods.
(b)
(c)
(d)
(a)
(2) Color additive mixtures made with turmeric oleoresin may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods.
(b)
(c)
(d)
(e)
The following diluents may be safely used in color additive mixtures that are exempt from certification and which are to be used for coloring drugs, subject to the condition that each straight color in the mixture has been exempted from certification or, if not so exempted, is from a batch that has previously been certified and has not changed in composition since certification. Such listing of diluents is not to be construed as superseding any of the other requirements of the Federal Food, Drug, and Cosmetic Act with respect to drugs, including new drugs. If a definition and specification for a particular diluent is not set forth in this subpart, the material shall be of a purity consistent with its intended use.
(a)
(2)
(b)
(a)
(2) Color additive mixtures for drug use made with alumina (dried aluminum hydroxide) may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(1) For coloring procedure, the color additive is blended with the polyethylene resin. The mixture is heated to a temperature of 500°-550 °F. and extruded through a fixed orifice. The filaments are cooled, oriented by drawing, and set by annealing.
(2) The quantity of the color additive does not exceed 2 percent by weight of the suture material.
(3) The dyed suture shall conform in all respects to the requirements of the U.S.P. XX (1980).
(4) When the sutures are used for the purpose specified in their labeling, there is no migration of the color additive to the surrounding tissue.
(5) If the suture is a new drug, an approved new drug application, pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act, is in effect for it.
(d)
(e)
(a)
(b)
(c)
(1) The dyed suture shall conform in all respects to the requirements of the United States Pharmacopeia XX (1980).
(2) The level of the ferric ammonium citrate-pyrogallol complex shall not exceed 3 percent of the total weight of the suture material.
(3) When the sutures are used for the purposes specified in their labeling, there is no migration of the color additive to the surrounding tissue.
(4) If the suture is a new drug, an approved new drug application, pursuant to section 505 of the act, is in effect for it.
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with annatto extract may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring ingested drugs.
(b)
(c)
(d)
(a)
(2) Color additive mixtures for drug use made with calcium carbonate may contain only those diluents listed in
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for ingested drug use made with canthaxanthin may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring ingested drugs.
(b)
(c)
(d)
(a)
(2) The diluents in color additive mixtures for drug use containing caramel shall be limited to those listed in this subpart as safe and suitable in color additive mixtures for coloring drugs.
(b)
(c)
(a)
(2) The diluents in color additive mixtures for drug use containing β-carotene are limited to those listed in this subpart as safe and suitable in color additive mixtures for coloring ingested drugs.
(b)
(c)
(d)
(a)
(2) Color additive mixtures for drug use made with carmine and cochineal extract may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(a)
(2) Color additive mixtures for drug use made with potassium sodium copper chlorophyllin may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with dihydroxyacetone may contain only those diluents that are listed in this subpart as safe and suitable in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with bismuth oxychloride may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with synthetic iron oxide may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with ferric ammonium ferrocyanide may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with ferric ferrocyanide may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with chromium hydroxide green may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with chromium oxide greens may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with guanine may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(1) The dyed suture shall conform in all respects to the requirements of the United States Pharmacopeia XX (1980).
(2) The level of the ferric ammonium citrate-pyrogallol complex shall not exceed 3 percent of the total weight of the suture material.
(3) When the sutures are used for the purposes specified in their labeling, there is no migration of the color additive to the surrounding tissues.
(4) If the suture is a new drug, an approved new drug application, pursuant to section 505 of the act, is in effect for it.
(d)
(e)
(a)
(2) Color additive mixtures made with pyrophyllite are limited to those listed in this subpart as safe and suitable in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(1) The quantity of color additive does not exceed 1.0 percent by weight of the suture.
(2) When the sutures are used for the purposes specified in their labeling, there is no migration of the color additive to the surrounding tissue.
(3) If the suture is a new drug, an approved new drug application, pursuant to section 505 of the act, is in effect for it.
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with mica may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with talc may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with titanium dioxide may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring drugs, and the following: Silicon dioxide, SiO
(b)
(c)
(d)
(a)
(2) Color additive mixtures for external drug use made with aluminum powder may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with bronze powder may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with copper powder may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with zinc oxide may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(1) The amount of bismuth citrate in the cosmetic shall not be in excess of 0.5 percent (w/v).
(2) The cosmetic may not be used for coloring eyelashes, eyebrows, or hair on parts of the body other than the scalp.
(d)
(2) The label of a cosmetic containing the color additive bismuth citrate shall bear, in addition to other information required by law, the following statement, conspicuously displayed thereon:
Keep this product out of children's reach. Do not use on cut or abraded scalp. Do not use to color eyelashes, eyebrows, or hair on parts of the body other than the scalp. Wash hands thoroughly after each use.
(e)
(a)
(b)
(c)
(d)
(e)
(a)
(b)
(1) It shall not be used at a level in excess of 0.1 percent.
(2) It may be used only in combination with the following substances:
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Color additive mixtures of bismuth oxychloride may contain the following diluents:
(i) For coloring cosmetics generally, only those diluents listed under § 73.1001(a)(1);
(ii) For coloring externally applied cosmetics, only those diluents listed in § 73.1001(b) and, in addition, nitrocellulose.
(b)
(c)
(d)
(a)
(2) Color additive mixtures of guaiazulene for cosmetic use may contain the following diluent:
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Color additive mixtures of guanine may contain the following diluents:
(i) For coloring cosmetics generally, only those diluents listed under § 73.1001(a)(1);
(ii) For coloring externally applied cosmetics, only those diluents listed in § 73.1001(b) and, in addition, nitrocellulose.
(b)
(c)
(d)
(a)
(b)
(c)
(1) The amount of the lead acetate in the cosmetic shall be such that the lead content, calculated as Pb, shall
(2) The cosmetic is not to be used for coloring mustaches, eyelashes, eyebrows, or hair on parts of the body other than the scalp.
(d)
(2) The label of the cosmetic containing the color additive lead acetate, in addition to other information required by the act, shall bear the following cautionary statement, conspicuously displayed thereon:
(e)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) Color additive mixtures of silver may contain only those diluents listed in § 73.1001(b) and, in addition, nitrocellulose.
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(1) The amount of luminescent zinc sulfide in facial makeup preparations shall not exceed 10 percent by weight of the final product.
(2) Facial makeup preparations containing luminescent zinc sulfide are intended for use only on limited, infrequent occasions, e.g., Halloween, and not for regular or daily use.
(d)
(2) The label of a facial makeup preparation containing the color additive shall bear, in addition to other information required by the law, the following statement conspicuously displayed:
Do not use in the area of the eye.
(e)
(a)
(b)
(2) Authorization and compliance with these uses shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the contact lens made from the color additives.
(c)
(d)
(a)
(b)
(2) Authorization and compliance with this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act). A person intending to introduce a device containing 1,4-bis-[(2-methyl-phenyl)-amino]-9,10-anthra-cene-dione listed under this section into commerce shall submit to the Food and Drug Administration either a premarket notification in accordance with subpart E of part 807 of this chapter, if the device is not subject to premarket approval, or submit and receive approval of an original or supplemental premarket approval application if the device is subject to premarket approval.
(c)
(d)
(a)
(b)
(2) Authorization and compliance with these uses shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with respect to contact lenses made from the color additives.
(c)
(d)
(a)
(b)
(2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the contact lens in which the color additive is used.
(c)
(d)
(a)
(b)
(c)
(2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the polymethylmethacrylate bone cement in which chlorophyllin-copper complex, oil soluble, is used.
(d)
(e)
(a)
(b)
(2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the contact lens in which the color additive is used.
(c)
(d)
(a)
(b)
(2) Authorization and compliance with this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lenses in which the additive is used.
(c)
(d)
(a)
(b)
(2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the contact lens in which the color additive is used. A person intending to introduce a device containing C.I. Vat Orange 1 into commerce shall submit to the Food and Drug Administration either a premarket notification in accordance with subpart E of part 807 of this chapter, if the device is not subject to premarket approval, or submit and receive approval of an original or supplemental premarket approval application if the device is subject to premarket approval.
(c)
(d)
(a)
(b)
(1) The quantity of the color additive does not exceed 1.1×10
(2) When used as specified in the labeling, there is no measurable migration of the color additive from the contact lens to the surrounding ocular tissue.
(3) Authorization for this use shall not be construed as waiving any of the requirements of section 510(k) and 515 of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used.
(c)
(d)
(a)
(b)
(2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used.
(c)
(d)
(a)
(b)
(2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used.
(c)
(d)
(a)
(b)
(2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used.
(c)
(d)
(a)
(b)
(2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used.
(c)
(d)
(a)
(1) Reactive Black 5 [2,7-naphthalenedisulfonic acid, 4-amino-5-hydroxy-3,6-bis((4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-tetrasodium salt] (CAS Reg. No. 17095-24-8);
(2) Reactive Blue 21 [copper, (29
(3) Reactive Orange 78 [2-naphthalenesulfonic acid, 7-(acetylamino)-4-hydroxy-3-((4-((2-(sulfooxy)ethyl) sulfonyl)phenyl)azo)-] CAS Reg. No. 68189-39-9);
(4) Reactive Yellow 15 [benzensulfonic acid, 4-(4,5-dihydro-4-((2-methoxy-5-methyl-4-((2-(sulfooxy)ethyl) sulfonyl)phenyl)azo)-3-methyl-5-oxo-1
(5) Reactive Blue No. 19 [2-anthracene-sulfonic acid, 1-amino-9,10-dihydro-9,10-dioxo-4-((3-((2-(sulfooxy)ethyl)sulfonyl)phenyl)amino)-, disodium salt] (CAS Reg. No. 2580-78-1);
(6) Reactive Blue No. 4 [2-anthracenesulfonic acid, 1-amino-4-(3-((4,6-dichloro-s-triazin-2-yl)amino)-4-sulfoanilino)-9,10-dihydro-9,10-dioxo, disodium salt] (CAS Reg. No. 4499-01-8);
(7) C.I. Reactive Red 11 [5-((4,6-dichloro-1,3,5-triazin-2-yl)amino)-4-hydroxy-3-((1-sulfo-2-naphthalenyl)azo)-2, 7-naphthalenedisulfonic acid, trisodium salt] (CAS Reg. No. 12226-08-3);
(8) C.I. Reactive Yellow 86 [1,3-benzenedisulfonic acid, 4-((5-aminocarbonyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl)azo)-6-(4,6-dichloro-1,3,5-triazin-2-yl)amino)-, disodium salt] (CAS Reg. No. 61951-86-8);
(9) C.I. Reactive Blue 163 [triphenodioxazinedisulfonic acid, 6,13-dichloro-3, 10-bis((4-((4.6-dichloro-1,3,5-triazin-2-yl)amino) sulfophenyl)amino)-, tetrasodium salt] (CAS Reg. No. 72847-56-4); and
(10) C.I. Reactive Red 180 [5-(benzoylamino)-4-hydroxy-3-((1-sulfo-6-((2-(sulfooxy)ethyl)sulfonyl)-2-naphthalenyl)azo)-2,7- naphthalenedisulfonic acid, tetrasodium salt] (CAS Reg. No. 98114-32-0).
(b)
(2) As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive dyes.
(3) Authorization and compliance with this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act). A person intending to introduce a device containing a poly(hydroxyethyl methacrylate)-dye copolymer listed under this section into commerce shall submit to the Food and Drug Administration either a premarket notification in accordance with subpart E of part 807 of this chapter, if the device is not subject to premarket approval, or submit and receive approval of an original or supplemental premarket approval application if the device is subject to premarket approval.
(c)
(d)
(a)
(b)
(2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used.
(c)
(d)
(a)
(b)
(2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used.
(c)
(d)
(a)
(b)
(2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the additive is used.
(c)
(d)
(a)
(b)
(2) Authorization and compliance with this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the additive is used.
(c)
(d)
(a)
(b)
(2) Authorization and compliance with this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lenses in which the additive is used.
(c)
(d)
(a)
(1) C.I. Reactive Red 180 [5-(benzoylamino)-4-hydroxy-3-((1-sulfo-6-((2-(sulfooxy)ethyl)sulfonyl)-2-naphthalenyl)azo)-2,7-naphthalenedisulfonic acid, tetrasodium salt] (CAS Reg. No. 98114-32-0).
(2) C.I. Reactive Black 5 [2,7-naphthalenedisulfonic acid, 4-amino-5-hydroxy-3,6-bis((4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-, tetrasodium salt] (CAS Reg. No. 17095-24-8).
(3) C.I. Reactive Orange 78 [2-naphthalenesulfonic acid, 7-(acetylamino)-4-hydroxy-3-((4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-] (CAS Reg. No. 68189-39-9).
(4) C.I. Reactive Yellow 15 [benzenesulfonic acid, 4-(4,5-dihydro-4-((2-methoxy-5-methyl-4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-3-methyl-5-oxo-1
(5) C.I. Reactive Blue No. 19 [2-anthracenesulfonic acid, 1-amino-9,10-dihydro-9,10-dioxo-4-((3-((2-(sulfooxy)ethyl)sulfonyl)phenyl)amino)-, disodium salt] (CAS Reg. No. 2580-78-1).
(6) C.I. Reactive Blue 21 [copper, (29
(b)
(2) As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive dye.
(3) Authorization and compliance with this use shall not be construed as
(c)
(d)
(a)
(b)
(2) Authorization and compliance with this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the contact lenses in which the additive is used.
(c)
(d)
21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.
(a)
(2) Color additive mixtures for food use (including dietary supplements) made with FD&C Blue No. 1 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for food use (including dietary supplements) made with FD&C Blue No. 2 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for food use (including dietary supplements) made with FD&C Green No. 3 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring food.
(b)
(c)
(d)
(e)
(a)
(2) The diluents in color additive mixtures for food use containing Orange B are limited to those listed in part 73 of this chapter as safe and suitable in color additive mixtures for coloring foods.
(b)
(c)
(d)
(e)
(a)
(2) The following diluents may be used in aqueous suspension, in the percentages specified, to facilitate application to oranges in accordance with paragraph (c)(1) of this section:
(i) Suitable diluents used in accordance with § 73.1(a) of this chapter.
(ii) Volatile solvents that leave no residue after application to the orange.
(iii) Salts of fatty acids meeting the requirements of § 172.863 of this chapter.
(iv) Sodium tripolyphosphate, not more than 0.05 percent.
(b)
(c)
(2) Oranges colored with Citrus Red No. 2 shall bear not more than 2.0 parts per million of such color additive, calculated on the basis of the weight of the whole fruit.
(d)
(1) The statement (or its equivalent) “To be used only for coloring skins of oranges.”
(2) Directions for use to limit the amount of the color additive to not more than 2.0 parts per million, calculated on the basis of the weight of the whole fruit.
(e)
(a)
(2) Color additive mixtures for food use made with FD&C Red No. 3 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for food use (including dietary supplements) made with FD&C Red No. 40 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods.
(3) The listing of this color additive includes lakes prepared as described in § 82.51 of this chapter, except that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by § 82.51 of this chapter.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for food use made with FD&C Yellow No. 5 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods.
(b)
(c)
(d)
(2) Foods for human use that contain FD&C Yellow No. 5, including butter, cheese, and ice cream, shall specifically declare the presence of FD&C Yellow No. 5 by listing the color additive as FD&C Yellow No. 5 among the list of ingredients.
(e)
(a)
(2) Color additive mixtures for food use made with FD&C Yellow No. 6 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods.
(b)
(c)
(d)
(2) [Reserved]
(e)
(a)
(2) For externally applied drugs, the color additive FD&C Blue No. 1 shall conform in identity to the requirements of § 74.2101(a).
(3) Color additive mixtures for drug use made with FD&C Blue No. 1 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.
(b)
(2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter.
(c)
(2) FD&C Blue No. 1 Aluminum Lake may be safely used for coloring drugs intended for use in the area of the eye, in amounts consistent with current good manufacturing practice, subject to the restrictions on the use of color additives in § 70.5(b) and (c) of this chapter.
(d)
(e)
(a)
(2) Color additive mixtures for use in ingested drugs made with FD&C Blue No. 2 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.
(b) The color additive FD&C Blue No. 2 for use in coloring ingested drugs shall conform to the specifications in § 74.102(b).
(c) The color additive FD&C Blue No. 2 may be safely used for coloring ingested drugs in amounts consistent with current good manufacturing practice.
(d)
(e)
(a)
(2) Color additive mixtures for use in externally applied drugs made with D&C Blue No. 4 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(1) The dyed suture shall conform in all respects to the requirements of the United States Pharmacopeia XX (1980).
(2) The quantity of the color additive does not exceed 2.5 percent by weight of the suture.
(3) When the sutures are used for the purposes specified in their labeling, the color additive does not migrate to the surrounding tissue.
(4) If the suture is a new drug, a new-drug application approved pursuant to section 505 of the act is in effect for it.
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with FD&C Green No. 3 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(a)
(2) Color additive mixtures for use in drugs made with D&C Green No. 5 may contain only those diluents that are suitable and those that are listed in part 73 of this chapter for use in color additive mixtures for coloring drugs.
(b)
(2) D&C Green No. 5 for use in coloring drugs shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice:
(c)
(i) The quantity of color additive does not exceed 0.6 percent by weight of the suture.
(ii) When the sutures are used for the purposes specified in their labeling, there is no migration of the color additive to the surrounding tissue.
(iii) If the suture is a new drug, an approved new drug application, under section 505 of the act, is in effect for it.
(2) D&C Green No. 5 may be safely used for coloring drugs generally, including drugs intended for use in the area of the eye, in amounts consistent with current good manufacturing practice.
(d)
(e)
(a)
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for use in externally applied drugs made with D&C Green No. 8 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for use in externally applied drugs made with D&C Orange No. 4 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with D&C Orange No. 5 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with D&C Orange No. 10 may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with D&C Orange No. 11 may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for ingested drug used made with FD&C Red No. 3 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring ingested drugs.
(b)
(c)
(d)
(a)
(2) Color additive mixtures for use in externally applied drugs made with FD&C Red No. 4 may contain only those diluents that are suitable and that are listed in part 73 of this chapter
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with D&C Red No. 6 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with D&C Red No. 7 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with D&C Red No. 17 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with D&C Red No. 21 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with Red No. 22 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with D&C Red No. 27 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with D&C Red No. 28 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with D&C Red No. 30 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with D&C Red No. 31 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with D&C Red No. 33 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with D&C Red No. 34 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with D&C Red No. 36 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures made with D&C Red No. 39 may contain the following diluents: Water, acetone, isopropyl alcohol, and specially denatured alcohols used in accordance with 26 CFR part 212.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with FD&C Red No. 40 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.
(3) The listing of this color additive includes lakes prepared as described in §§ 82.51 and 82.1051 of this chapter, except that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by §§ 82.51 or 82.1051 of this chapter.)
(b)
(2) Other lakes of FD&C Red No. 40 may be safely used in coloring drugs, subject to the restrictions on the use of color additives in § 70.5 of this chapter, in amounts consistent with current good manufacturing practice.
(c)
(d)
(a)
(2) Color additive mixtures for use in externally applied drugs made with D&C Violet No. 2 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter.
(3) Color additive mixtures for drug use made with FD&C Yellow No. 5 may contain only those diluents that are suitable and are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.
(b)
(2) FD&C Yellow No. 5 Aluminum Lake may be safely used for coloring drugs intended for use in the area of the eye, when prepared in accordance with § 82.51 of this chapter.
(c)
(2) The label of OTC and prescription drug products intended for human use administered orally, nasally, rectally, or vaginally, or for use in the area of the eye, containing FD&C Yellow No. 5 shall specifically declare the presence of FD&C Yellow No. 5 by listing the color additive using the names FD&C Yellow No. 5 and tartrazine. The label shall bear a statement such as “Contains FD&C Yellow No. 5 (tartrazine) as a color additive” or “Contains color additives including FD&C Yellow No. 5 (tartrazine).” The labels of certain drug products subject to this labeling requirement that are also cosmetics, such as: antibacterial mouthwashes and fluoride toothpastes, need not comply with this requirement provided they comply with the requirements of § 701.3 of this chapter.
(3) For prescription drugs for human use containing FD&C Yellow No. 5 that are administered orally, nasally, vaginally, or rectally, or for use in the area of the eye, the labeling required by § 201.100(d) of this chapter shall, in addition to the label statement required under paragraph (c)(2) of this section, bear the warning statement “This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.” This warning statement shall appear in the “Precautions” section of the labeling.
(d)
(a)
(2) Color additive mixtures for drug use made with FD&C Yellow No. 6 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.
(b)
(c)
(2) [Reserved]
(d)
(a)
(2) Color additive mixtures for use in externally applied drugs made with D&C Yellow No. 7 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for drug use made with Ext. D&C Yellow No. 7 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures for use in externally applied drugs made with D&C Yellow No. 8 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures made with D&C Yellow No. 10 for drug use may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.
(b)
(c)
(d)
(e)
(a)
(2) Color additive mixtures, for drug use made with D&C Yellow No. 11 may contain only those diluents that are
(b)
(c)
(d)
(e)
(a)
(b)
(2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter.
(c)
(2) FD&C Blue No. 1 Aluminum Lake may be safely used for coloring cosmetics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice.
(d)
(e)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(2) The listing of this color additive includes lakes prepared as described in §§ 82.51 and 82.1051 of this chapter, except that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by § 82.51 or § 82.1051 of this chapter.
(b)
(1) The color additive may be used in amounts consistent with current good manufacturing practice.
(2) The color additive shall not be exposed to oxidizing or reducing agents that may affect the integrity of the color additives or any other condition that may affect their integrity.
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(e)
(a)
(b)
(2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter.
(c)
(2) FD&C Yellow No. 5 Aluminum Lake may be safely used for coloring cosmetics intended for use in the area of the eye, subject to the restrictions on use of color additives in § 70.5(b) and (c) of this chapter, in amounts consistent with current good manufacturing practice.
(d)
(e)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(i) The quantity of the color additive does not exceed 0.5 percent by weight of the suture or haptic material.
(ii) The dyed suture shall conform in all respects to the requirements of the U.S. Pharmacopeia.
(2) The color additive [phthalocyaninato(2-)] copper may be safely used for coloring contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.
(3) Authorization for these uses shall not be construed as waiving any of the requirements of section 510(k), 515, or 520(g) the Federal Food, Drug, and Cosmetic Act with respect to the medical device in which [phthalocyaninato(2-)] copper is used.
(d)
(e)
(a)
(b)
(2) The color additive FD&C Blue No. 2-Aluminum Lake on alumina for use in bone cement shall be prepared in accordance with the requirements of § 82.51 of this chapter.
(c)
(i) The quantity of color additive does not exceed 1 percent by weight of the suture;
(ii) The dyed suture shall conform in all respects to the requirements of the United States Pharmacopeia XX (1980); and
(iii) When the sutures are used for the purposes specified in their labeling, the color additive does not migrate to the surrounding tissues.
(2) The color additive FD&C Blue No. 2-Aluminum Lake on alumina may be safely used for coloring bone cement at a level not to exceed 0.1 percent by weight of the bone cement.
(3) Authorization and compliance with these uses shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the medical device in which the color additive FD&C Blue No. 2 and the color additive FD&C Blue No. 2-Aluminum Lake on alumina are used.
(d)
(e)
(a)
(b)
(c)
(i) Not to exceed 0.2 percent by weight of the suture material for coloring polyethylene terephthalate surgical sutures for general surgical use;
(ii) Not to exceed 0.25 percent by weight of the suture material for coloring plain or chromic collagen absorbable sutures for general surgical use;
(iii) Not to exceed 0.5 percent by weight of the suture material for coloring plain or chromic collagen absorbable sutures for ophthalmic surgical use;
(iv) Not to exceed 0.5 percent by weight of the suture material for coloring polypropylene surgical sutures for general surgical use; and
(v) Not to exceed 0.5 percent by weight of the suture material for coloring polydioxanone synthetic absorbable sutures for ophthalmic and general surgical use.
(2) Authorization for these uses shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the medical device in which the color additive is used.
(d)
(e)
(a)
(b)
(c)
(i) Not to exceed 0.03 percent by weight of the lens material for coloring contact lenses;
(ii) Not to exceed 0.75 percent by weight of the suture material for coloring polyethylene terephthalate surgical sutures, including sutures for ophthalmic use;
(iii) Not to exceed 0.1 percent by weight of the suture material for coloring polyglycolic acid surgical sutures with diameter greater than U.S.P. size 8-0, including sutures for ophthalmic use;
(iv) Not to exceed 0.5 percent by weight of the suture material for coloring polyglycolic acid surgical sutures with diameter not greater than U.S.P. size 8-0, including sutures for ophthalmic use;
(v) Not to exceed 0.21 percent by weight of the suture material for coloring poly(glycolic acid-
(vi) Not to exceed 0.10 percent by weight of the haptic material for coloring polymethylmethacrylate support haptics of intraocular lenses.
(2) Authorization for these uses shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the medical device in which D&C Green No. 6 is used.
(d)
(e)
(a)
(b)
(2) Authorization for this use shall not be construed as waiving any of the requirements of section 510(k), 515, and 520(g) of the Federal Food, Drug, and
(c)
(d)
(a)
(b)
(2) D&C Violet No. 2 may be safely used for coloring sutures for use in surgery subject to the following conditions:
(i) At a level not to exceed 0.2 percent by weight of the suture material for coloring copolymers of 90 percent glycolide and 10 percent L-lactide synthetic absorbable sutures for use in general and ophthalmic surgery; and
(ii) At a level not to exceed 0.3 percent by weight of the suture material for coloring polydioxanone synthetic absorbable sutures for use in general and ophthalmic surgery.
(iii) At a level not to exceed 0.25 percent by weight of the suture material for coloring poliglecaprone 25 (ε-caprolactone/glycolide copolymer) synthetic absorbable sutures for use in general surgery.
(iv) At a level not to exceed 0.1 percent by weight of the suture material for coloring poly(ε-caprolactone) absorbable sutures for use in general surgery.
(v) At a level not to exceed 0.2 percent by weight of the suture material for coloring glycolide/dioxanone/trimethylene carbonate tripolymer absorbable sutures for use in general surgery.
(vi) At a level not to exceed 0.2 percent by weight of the suture material for coloring absorbable sutures prepared from homopolymers of glycolide for use in general surgery.
(3) The color additive, D&C Violet No. 2, may be safely used for coloring polymethylmethacrylate intraocular lens haptics at a level not to exceed 0.2 percent by weight of the haptic material.
(4) The color additive, D&C Violet No. 2, may be safely used for coloring absorbable meniscal tacks made from poly (L-lactic acid) at a level not to exceed 0.15 percent by weight of the tack material.
(5) Authorization for these uses shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the medical devices in which the color additive is used.
(c)
(d)
(a)
(b)
(c)
(2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used.
(d)
(e)
The dye is dissolved in glacial acetic and 8
(A) Spectrophotometer (Cary 118 or equivalent).
(B) Separatory funnels—one 1000 mL and one 500 mL.
Use
(A) Glacial Acetic Acid (ACS grade).
(B) Diethyl ether (Anhydrous)—Note and follow safety precautions on container.
(C) 8
(D) 2% (w/w) NaOH—Pour ca 190 mL H
(E) Ethanol (95%).
Weigh a 250 mL beaker to tenths of a mg and add 100 mg of dye. Record weight to tenths of a mg.
The following work must be performed in the hood.
Add 75 mL of 8
Place the beaker on a hot plate and heat with stirring, until all of the dye is in solution.
Remove the beaker from the hot plate, cover with a watch glass and allow to cool to room temperature (1-2 hrs).
When the dye solution is at room temperature, transfer the solution to a 1000 mL separatory funnel.
Rinse the beaker three times with 50 mL portions of H
Add 150 mL of ether to the funnel, stopper and shake for 10 seconds, then invert funnel and open stopcock to remove gas buildup.
Shake the funnel for one minute, opening the stopcock a few times while the funnel is inverted to remove gas buildup. (Use this shake procedure throughout method.)
Allow the funnel to stand until the layers have separated.
Transfer the bottom (aqueous) layer to a 500 mL separatory funnel, add 100 mL of ether, stopper and shake for one minute.
When the layers have separated, drain off the bottom layer into a waste beaker.
Rinse the 500 mL sep. funnel with 100 mL H
When the layers have separated, drain off the bottom aqueous layer into the waste beaker.
Rinse the 500 mL funnel at least three times (total) and repeat the 100 mL water washes until no color is present in the aqueous layer. Discard the bottom aqueous layer to the waste beaker after each separation.
Shake the ether layer twice more with 100 mL portions of H
Remove the unsulfonated subsidiary color from the ether by shaking the ether layer for one minute with 20 mL of 2% (w/w) NaOH.
If there is any color left in the ether, shake for one minute with another 20 mL portion of 2% (w/w) NaOH. After the layers have separated, drain off the aqueous alkaline layer into the 100 mL beaker.
If color remains in the ether layer, repeat the above step for a total of three washes of the ether with 2% (w/w) NaOH. Note: Three washes is usually sufficient to remove the unsulfonated subsidiary.
With the stopper removed,
Appropriately label a 250 mL beaker.
Spectrophotometer Parameters:
(1) Record the visible spectrum of a blank. Fill the reference cell with distilled water and the sample cell with ethanol (95%).
(2) Rinse the sample cell with 2-3 mL of the ether soluble material (in ethanol solution); then fill the cell. Record the visible spectrum of the ether soluble material.
(3) Compare the spectra obtained to the spectra attached. The attached spectra represents 150% of the absorbance at each wavelength for similarly analyzed D&C Red No. 6 Lot AA5169.
The spectra of the current sample must not exceed the attached spectra at any wavelength in order to
21 U.S.C. 371, 379e.
(a)
(b)
(1) 100 pounds or less—$30.
(2) Over 100 pounds but not over 1,000 pounds—$30 plus 6 cents for each pound over 100 pounds.
(3) Over 1,000 pounds—$84 plus 2 cents for each pound over 1,000 pounds.
(c)
(d)
(e)
A request for certification of a batch of color additive shall:
(a) Be addressed to the Commissioner of Food and Drugs.
(b) Be prepared in the manner set forth in paragraph (j) of this section.
(c) Be submitted in duplicate.
(d) Be signed by a responsible officer of the person requesting certification of the batch. In the case of a foreign manufacturer, the request for certification must be signed by a responsible officer of such firm, and, by his agent who resides in the United States.
(e) Show the name and post office address of the actual manufacturer in
(f) Be accompanied by the fee prescribed in § 80.10 unless the person has established with the Food and Drug Administration an advanced deposit to be used for prepayment of such fees. In no case shall the Commissioner consider a request for certification of a batch of color additive if the fee accompanying such request is less than that required by § 80.10 or if such fee exceeds the amount held in the advance deposit account of the manufacturer submitting such request for certification.
(g) Be accompanied by the sample prescribed in § 80.22 consisting of:
(1) Four ounces in the case of straight colors and lakes.
(2) Two ounces in the case of repacks and mixtures.
(h) The name of a color additive shall be given in the following manner:
(1) The name of a straight color shall be the name of the color as listed in parts 74 and 81 of this chapter.
(2) The name of a lake shall be the name derived in the manner described in part 82 of this chapter.
(3) The name of a mixture shall be the name given to such mixture by the person requesting certification.
(4) The name of a repack shall be the name described in paragraph (h)(1), (2), or (3) of this section, whichever is applicable.
(i) The information and samples enumerated in paragraphs (a) to (h), inclusive, of this section are the minimum required. Additional information and samples shall be submitted at the request of the Food and Drug Administration when such additional information and samples are necessary to determine compliance with the requirements of § 80.31 for the issuance of a certificate.
(j) The form for submission of the application shall be one of the following, depending upon whether the color additive is a straight color, a lake, a repack of a previously certified color additive, or a color additive mixture.
(1)
In accordance with the regulations promulgated under the Federal Food, Drug, and Cosmetic Act, we hereby make application for the certification of a batch of straight color additive.
(State proposed uses)
The accompanying sample was taken after the batch was mixed in accordance with 21 CFR 80.22 and is accurately representative thereof.
(2)
In accordance with the regulations promulgated under the Federal Food, Drug, and Cosmetic Act, we hereby make application for the certification of a batch of color additive lake.
(State proposed uses)
The accompanying sample was taken after the batch was mixed in accordance with 21 CFR 80.22 and is accurately representative thereof.
(3)
In accordance with the regulations promulgated under the Federal Food, Drug, and Cosmetic Act, we hereby make application for the certification of a batch of color additive repack.
(State proposed uses)
The accompanying sample was taken after the batch was mixed in accordance with 21 CFR 80.22 and is accurately representative thereof.
(4)
In accordance with the regulations promulgated under the Federal Food, Drug, and Cosmetic Act, we hereby make application for the certification of a batch of color additive mixture.
as certifiedLot number
(
(State proposed uses)
The accompanying sample was taken after the batch was mixed in accordance with 21 CFR 80.22 and is accurately representative thereof.
A sample of a batch of color additive which is to accompany a request for certification shall:
(a) Be taken only after such batch has been so thoroughly mixed as to be of uniform composition throughout.
(b) Held under the control of the person requesting certification until certified.
(c) Be labeled to show:
(1) The name of the color additive.
(2) The manufacturer's batch number.
(3) The quantity of such batch.
(4) The name and post-office address of the person requesting certification of such batch.
(5) Be accompanied by any label or labeling intended to be used.
(a) If the Commissioner determines, after such investigations as he considers to be necessary, that:
(1) A request submitted in accordance with § 80.21 appears to contain no untrue statement of a material fact;
(2) Such color additive conforms to the specifications and any other conditions set forth therefor in parts 81 and 82 of this chapter.
(3) The batch covered by such request otherwise appears to comply with the regulations in this chapter, the Commissioner shall issue to the person who submitted such request a certificate showing the lot number assigned to such batch and that such batch, subject to the terms, conditions, and restrictions prescribed by part 74, 81, and 82 of this chapter, is a certified batch.
(b) If the Commissioner determines, after such investigation as he considers to be necessary, that a request submitted in accordance with § 80.21, or the batch of color additive covered by such request, does not comply with the requirements prescribed by paragraph (a) of this section for the issuance of a certificate, the Commissioner shall refuse to certify such batch and shall give notice thereof to the person who submitted such request, stating his reasons for refusal. Any person who contests such refusal shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter.
(a) If a certificate is obtained through fraud or misrepresentation of a material fact, such certificate shall not be effective, and a color additive from the batch on which such certificate was issued shall be considered to be from a batch that has not been certified in accordance with the regulations in this part. Whenever, the Commissioner learns that any certificate has been obtained through fraud or material misrepresentation, he shall notify the holder of the certificate that it is of no effect.
(b) If between the time a sample of color additive accompanying a request for certification is taken and the time a certificate covering the batch of such color additive is received by the person to whom it is issued, any such color additive becomes changed in composition, such certificates shall not be effective with respect to such changed color additive and such changed color additive shall be considered to be from a batch that has not been certified in accordance with the regulations in this part.
(c) If at any time after a certificate is received by the person to whom it is issued any color additive from the batch covered by such certificate becomes changed in composition, such certificate shall expire with respect to such changed color additive. After such expiration, such color additive shall be considered to be from a batch that has not been certified in accordance with this part; except that such color additive shall not be so considered when
(d) A certificate shall expire with respect to any color additive covered thereby if the package in which such color additive was closed for shipment or delivery is opened. After such expiration such color additive shall be considered to be from a batch that has not been certified, except that such color additive shall not be so considered when the package is opened;
(1) and such color additive is used, subject to the restrictions prescribed by paragraphs (f), (g), and (h) of this section, in coloring a food, drug, or cosmetic;
(2) for the purpose of certifying a batch made by repacking such color;
(3) for the purpose of certifying a batch of a mixture in which such color is used as an ingredient; or
(4) for the purpose of preparing a batch of a mixture for which exemption from certification has been authorized; or
(5) when the package is reopened solely for repackaging by the person to whom such certificate was issued.
(e) A certificate shall not be effective with respect to a package of color additive and such color additive shall be considered to be from a batch that has not been certified if such package is shipped or delivered under a label which does not bear all words, statements, and other information required by § 70.25 of this chapter to appear thereon.
(f) A certificate shall not be effective with respect to a package of color additive, and such color additive shall be considered to be from a batch that has not been certified if:
(1) Such package has not been sealed in accordance with § 70.20 of this chapter.
(2) Such package has been sealed in accordance with § 70.20 of this chapter and the seal has been broken, intentionally or accidentally, unless such seal has been broken for the purpose of using color additive in accordance with § 80.38, or, such package has been opened by a duly authorized representative of the Administration or Department in the performance of his official duties, and he has immediately resealed the package in conformance with § 70.20 of this chapter.
(g) A certificate shall not be effective with respect to a package of color additive and such color additive shall be considered to be from a batch that has not been certified if such color additive is used in any manner other than that for which it was certified.
(h) When the listing or the specifications for a color additive are revoked or amended, the final order effecting the revocation or amendment may specify, in addition to its own effective date, a date on which all certificates for existing batches and portions of batches of such a color additive theretofore issued under such revoked or amended regulations shall cease to be effective; and any such lots of the color additive shall be regarded as uncertified after the date specified unless a new certificate can be and is obtained in conformance with the new regulations. When a certificate thus ceases to be effective for a color additive, any certificates previously issued for a color additive mixture containing that color additive shall cease to be effective on the same date. Use of such color additive or color additive mixture after such specified date without the new certificate in preparing foods, drugs, or cosmetics will result in such food, drugs, or cosmetics being adulterated. When a certified color additive has been used in food, drugs, or cosmetics and the status of the color additive is thereafter changed by amendment or revocation of its listing or specification regulations, such food, drugs, and cosmetics will not be regarded as adulterated by reason of the use of such color additive, unless the hazard to health is such that existing stocks of the foods, drugs, or cosmetics cannot be safely used, in which cases findings to that effect will be made and regulations appropriate for such special cases will be issued.
(a) When it appears to the Commissioner that a person has:
(1) Obtained, or attempted to obtain, a certificate through fraud or misrepresentation of a material fact.
(2) Falsified the records required to be kept by § 80.39; or
(3) Failed to keep such records, or to make them available, or to accord full opportunity to make inventory of stocks on hand or otherwise to check the correctness of such records, as required by § 80.39; or
(4) Refused to permit duly authorized employees of the Food and Drug Administration free access to all manufacturing facilities, processes, and formulae involved in the manufacture of color additives and intermediates from which such color additives are derived; he may immediately suspend certification service to such person and may continue such suspension until adequate corrective action has been taken.
(b) Any person who contests suspension of service shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter.
(a)
(b)
(c)
The provisions of § 80.35 with respect only to diluents for use in cosmetic color additive mixtures were stayed, until a regulation is effected listing safe diluents for cosmetic use, including cosmetics which color the human body, 29 FR 18495, Dec. 29, 1964.
Immediately after the sample that is to accompany a request for certification of a batch of color additive is taken, the batch shall be:
(a) Stored in containers of such kind as to prevent change in composition.
(b) Held under the control of the person requesting certification until certified.
(c) Marked, by labeling or otherwise, in a manner such that there can be no question as to the identity of the batch and no question that it is not to be used until the requested certificate has been issued.
(a) Immediately upon notification that a batch of color additive has been certified, the person requesting certification thereof shall identify such batch, by labeling, with the certified lot number.
(b) The person requesting certification shall maintain storage in such manner as to prevent change in composition until such batch has been packaged and labeled as required by §§ 70.20 and 70.25 of this chapter, except
(a) The person to whom a certificate is issued shall keep complete records showing the disposal of all the color additive from the batch covered by such certificate. Upon the request of any officer or employee of the Food and Drug Administration or of any other officer or employee acting on behalf of the Secretary of Health and Human Services, such person, at all reasonable hours until at least 2 years after disposal of all such color additive, shall make such records available to any such officer or employee, and shall accord to such officer or employee full opportunity to make inventory of stocks of such color additive on hand and otherwise to check the correctness of such records.
(b) The records required to be kept by paragraph (a) of this section shall show:
(1) Each quantity used by such person from such batch and the date and kind of such use.
(2) The date and quantity of each shipment or delivery from such batch, and the name and post-office address of the person to whom such shipment or delivery was made.
(c) The records required to be kept by paragraph (a) of this section shall be kept separately from all other records.
21 U.S.C. 371, 379e, 379e note.
The Commissioner of Food and Drugs finds that the following lists of color additives are provisionally listed under section 203(b) of the Color Additive Amendments of 1960 (sec. 203(b), 74 Stat. 405 (21 U.S.C. 379e note)). Except for color additives for which petitions have been filed, progress reports are required by January 1, 1968, and at 6-month intervals thereafter. Specifications for color additives listed in paragraphs (a), (b), and (c) of this section appear in the respective designated sections. The listing of color additives in this section is not to be construed as a listing for surgical suture use unless color additive petitions have been submitted for such use or the Commissioner has been notified of studies underway to establish the safety of the color additive for such use. The color additives listed in paragraphs (a), (b), and (c) of this section may not be used in products which are intended to be used in the area of the eye. The color additives listed in paragraphs (a), (b), and (c) of this section are provisionally listed until the closing dates set forth therein.
(a)
(b)
(c)
For
(a)
(b) [Reserved]
(c)
(1) Groups of 50 rats are being fed diets containing FD&C Red No. 1 at levels of 5 percent, 2 percent, 1 percent, 0.5 percent, and 0 percent. At this stage of the tests, which have now been in progress for from 15 months to 18 months, 116 animals from the 250 being fed FD&C Red No. 1 at various levels and 27 of the 100 controls have died. Of these, 11 being fed at the 5 percent level, 16 being fed at the 2 percent level, 11 being fed at the 1 percent level, and 2 being fed at the 0.5 percent level, have shown liver damage. None of the controls that have died have shown liver damage.
(2) Groups of 100 mice are being fed diets containing 2 percent, 1 percent, 0.5 percent, and 0.1 percent FD&C Red No. 1, with 400 mice as controls. All mice on dosage levels of 2 percent and 1 percent died before the seventieth week. Gross liver damage has been observed in all groups fed at the 0.5 percent diet and above.
(3) Groups of 4 dogs are being fed diets containing 2 percent, 1 percent, 0.25 percent, and 0 percent FD&C Red No. 1. Three of the dogs on the 2 percent dosage level died before 32 weeks; the other is living. Three of the dogs on the 1 percent dosage level died or were sacrificed within 13 months. All deceased or sacrificed dogs have shown liver damage grossly and/or microscopically. Deceased dogs on the 1 percent and 2 percent dosage level showed poor physical condition.
(d)
(1) Rats of the Osborne-Mendel and Sprague-Dawley strains were fed FD&C Red No. 4 for 2 years at levels of 5 percent, 2 percent, 1 percent, and 0.5 percent of the diet. No effect was found.
(2) Mice of the C3Hf and C57BL strains were fed FD&C Red No. 4 for 2 years at levels of 2 percent and 1 percent of the diet. No effect was found.
(3) Dogs were fed FD&C Red No. 4 at levels of 2 percent and 1 percent of the diet. Adverse effects were found at both levels in the urinary bladder and in the adrenals. Three dogs of five fed on the 2-percent level died after 6 months, 9 months, and 5
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l) [Reserved]
(m)
(n)
(o)
(p) [Reserved]
(q)(1)
(2)
(r) [Reserved]
(s)
(t)
(u)
For
(a) Certificates issued heretofore for colors being removed from the provisional list (§ 81.10(a)) are cancelled and of no effect after December 1, 1960, and use of such color additives in drugs or cosmetics after that date will result in adulteration.
(b)(1) Certificates issued heretofore for the color additive designated FD&C Red No. 1 are cancelled as of the date of the publication of this Order, and use of this color additive in the manufacture of foods, drugs, or cosmetics after that date will result in adulteration.
(2) The Commissioner finds that no action needs to be taken to remove foods, drugs, and cosmetics containing this color additive from the market on the basis of the scientific evidence before him, taking into account that the additive is not an acute toxic substance and that it is only used in small amounts in foods, drugs, and cosmetics.
(c) Certificates issued for FD&C Red No. 4 and all mixtures containing this color additive are cancelled and have no effect after September 23, 1976 insofar as food, ingested drugs, and ingested cosmetics are concerned, and use of this color additive in the manufacture of food, ingested drugs, and ingested cosmetics after this date will result in adulteration. The certificates
(d) Certificates issued for the following color additives and all mixtures containing these color additives are canceled and have no effect after October 4, 1966, and use of such color additives in the manufacture of foods, drugs, or cosmetics after that date will result in adulteration:
(e) Certificates issued for the following color additives and all mixtures containing these color additives are canceled and have no effect after July 1, 1968, and use of such color additives in the manufacture of drugs or cosmetics after that date will result in adulteration:
(f) Certificates issued for D&C Yellow No. 11 and all mixtures containing this color additive are canceled and have no effect after April 30, 1968, insofar as ingested use is concerned. Use of this color additive in the manufacture of ingested drugs or cosmetics subject to ingestion after that date will result in adulteration.
(g) Certificates issued for D&C Red No. 17, D&C Red No. 31, D&C Red No. 34, D&C Orange No. 4, and D&C Violet No. 2, and all mixtures containing these color additives, are canceled and have no effect after December 31, 1968, insofar as ingested use is concerned. Use of these color additives in the manufacture of ingested drugs or cosmetics subject to ingestion after that date will result in adulteration.
(h)(1) Certificates issued for FD&C Violet No. 1 and all mixtures containing this color additive are canceled and have no effect after April 10, 1973, and use of such color additive in the manufacture of foods, drugs, or cosmetics after that date will result in adulteration.
(2) The Commissioner finds that no action needs to be taken to remove foods, drugs, and cosmetics containing this color additive from the market on the basis of the scientific evidence before him.
(i) Certificates issued prior to July 1, 1968, for D&C Brown No. 1 and Ext. D&C Violet No. 2 and all mixtures containing these colors are canceled and have no effect. This cancellation does not apply to certificates issued after March 15, 1973, for D&C Brown No. 1 and Ext. D&C Violet No. 2, which are provisionally listed in § 81.1(b) and (c) respectively for coloring externally applied cosmetics.
(j)(1) Certificates issued for FD&C Red No. 2 and all mixtures containing this color additive are canceled and have no effect after January 28, 1976, and use of this color additive in the manufacture of food, drugs, or cosmetics after this date will result in adulteration.
(2) The Commissioner finds, on the basis of the scientific evidence before him, that no action has to be taken to remove from the market food, drugs, and cosmetics containing the color additive.
(k)(1) Certificates issued for D&C Red No. 10, D&C Red No. 11, D&C Red No.
(2) The Commissioner finds, on the basis of the scientific evidence before him, that no action has to be taken to remove from the market, drug and cosmetic products containing the color additives.
(l)(1) Certificates issued for Ext. D&C Yellow No. 1 and all mixtures containing this color additive are cancelled and have no effect after December 13, 1977, and use of this color additive in the manufacture of drugs or cosmetics after this date will result in adulteration.
(2) The Commissioner finds, on the basis of the scientific evidence before him, that no action has to be taken to remove from the market drugs and cosmetics containing the color additive.
(m)(1) Certificates issued for Ext. D&C Green No. 1 and all mixtures containing this color additive are cancelled and have no effect after November 29, 1977, and use of the color additive in the manufacture of drugs or cosmetics after this date will result in adulteration.
(2) The Commissioner finds, on the basis of the scientific evidence before him, that no action has to be taken to remove from the market drugs and cosmetics containing the color additive.
(n)(1) Certificates issued for D&C Orange No. 10, D&C Orange No. 11, their lakes, and all mixtures containing these color additives are cancelled and have no effect as pertains to their use in ingested drugs and cosmetics after April 28, 1981 and use of these color additives in the manufacture of ingested drugs or cosmetics after this date will result in adulteration.
(2) The agency finds, on the basis of the scientific evidence before it, that no action has to be taken to remove from the market drugs and cosmetics to which the color additives were added on or before April 28, 1981.
(o)(1) Certificates issued for D&C Blue No. 6 and all mixtures containing this color additive are cancelled insofar as its use in drugs and cosmetics is concerned and have no effect after December 13, 1977, and use of the color additive in the manufacture of drugs or cosmetics after this date will result in adulteration. The color will continue to be certified for use in the coloring of surgical sutures.
(2) The Commissioner finds, on the basis of the scientific evidence before him, that no action has to be taken to remove from the market drugs and cosmetics containing the color additive.
(p)(1) Certificates issued for D&C Green No. 6, its lakes and all mixtures containing this color additive are cancelled and have no effect as pertains to their use in ingested drugs and cosmetics after May 4, 1982 and use of the color additive in the manufacture of ingested drugs or cosmetics after this date will result in adulteration.
(2) The agency finds, on the basis of the scientific evidence before it, that no action has to be taken to remove from the market ingested drugs and cosmetics containing the color additive.
(q) [Reserved]
(r)(1) Certificates issued for D&C Red No. 19 and D&C Red No. 37, their lakes, and all mixtures containing these color additives are cancelled and have no effect as pertains to their use in ingested drugs and cosmetics after February 4, 1983, and use of these color additives in the manufacture of ingested drugs or cosmetics after this date will result in adulteration.
(2) The agency finds, on the scientific evidence before it, that no action has to be taken to remove from the market ingested drugs and cosmetics to which D&C Red No. 19 and D&C Red No. 37 were added on or before February 4, 1983, or externally applied drugs and cosmetics to which D&C Red No. 37 was added on or before June 6, 1986.
(3) Certificates issued for D&C Red No. 37, its lakes, and all mixtures containing this color additive are cancelled and have no effect as pertains to its use in externally applied drugs and cosmetics after June 6, 1986, and use of this color additive in the manufacture of externally applied drugs or cosmetics after this date will result in adulteration.
(4) Certificates issued for D&C Red No. 19, its lakes, and all mixtures containing this color additive are cancelled and have no effect as pertains to its use in externally applied drugs and cosmetics after July 15, 1988, and use of this color in the manufacture of externally applied drugs or cosmetics after this date will result in adulteration.
(5) The agency finds, on the scientific evidence before it, that no action has to be taken to remove from the market externally applied drugs and cosmetics to which D&C Red No. 19 was added on or before July 15, 1988.
(s)(1) Certificates issued for D&C Red No. 8 and D&C Red No. 9, their lakes, and all mixtures containing these color additives are canceled and have no effect as pertains to their use in mouthwash, dentifrices, and ingested drugs, except ingested drug lip products, after January 6, 1987, and use of these color additives in the manufacture of mouthwash, dentifrices, and ingested drugs, except ingested drug lip products, after this date will result in adulteration.
(2) The agency finds, on the basis of the scientific evidence before it, that no action has to be taken to remove from the market mouthwash, dentifrices, and ingested drugs to which the color additives were added on or before January 6, 1987. Ingested drug lip products, however, are regulated for use in §§ 74.1308 and 74.1309.
(3) Certificates issued for D&C Red No. 8, and D&C Red No. 9, their lakes, and all mixtures containing these color additives are cancelled and have no effect as pertains to their use in ingested drug and cosmetic lip products and in externally applied drugs and cosmetics after July 15, 1988, and use of these color additives in the manufacture of ingested drugs and cosmetic lip products and in externally applied drugs and cosmetics after this date will result in adulteration.
(4) The agency finds, on the basis of the scientific evidence before it, that no action has to be taken to remove from the market ingested drug and cosmetic lip products and externally applied drugs and cosmetics to which the color additives were added on or before July 15, 1988.
(t)(1) Certificates issued for D&C Orange No. 17, its lakes, and all mixtures containing this color additive are cancelled and have no effect as pertains to its use in ingested drugs and ingested cosmetics after March 31, 1983 and use of this color additive in the manufacture of ingested drugs or ingested cosmetics after this date will result in adulteration.
(2) The agency finds, on the scientific evidence before it, that no action has to be taken to remove from the market drugs and cosmetics to which the color additive was added on or before March 31, 1983.
(3) Certificates issued for D&C Orange No. 17, its lakes and all mixtures containing this color additive are cancelled and have no effect as pertains to its use in externally applied drugs and cosmetics after July 15, 1988, and use of this color in the manufacture of externally applied drugs or cosmetics after this date will result in adulteration.
(4) The agency finds, on the scientific evidence before it, that no action has to be taken to remove from the market externally applied drugs and cosmetics to which D&C Orange No. 17 was added on or before July 15, 1988.
(u)(1) Certificates issued for FD&C Red No. 3 and all mixtures containing this color additive are cancelled and have no effect as pertains to their use in cosmetics and externally applied drugs after January 29, 1990. Certificates issued for FD&C Red No. 3 lakes and all mixtures containing these lakes are cancelled and have no effect as pertains to their use in food, drugs, and cosmetics after January 29, 1990. Certificates issued for D&C Red No. 3 lakes and all mixtures containing those lakes are cancelled and have no effect as pertains to their use in drugs and cosmetics after January 29, 1990. Use of this color additve in the manufacture of cosmetics and of externally applied drugs and any use of the lakes of FD&C Red No. 3 (including the lakes of D&C Red No. 3) after this date will result in adulteration.
(2) The agency finds, on the scientific evidence before it, that no action must be taken to remove from the market food, drugs, and cosmetics to which the provisionally listed color additive or its lakes were added on or before January 29, 1990.
For
Certificates issued for the color additives listed in § 81.25 and for all mixtures containing these color additives are limited to the conditions stated in § 81.25. The use of these color additives in drugs and cosmetics in any other manner will result in adulteration. Each of these color additives shall bear a label statement of the tolerance and use limitations applicable to it.
21 U.S.C. 371, 379e, 379e note.
For the purposes of this part:
(a)-(f) [Reserved]
(g) The term
(h) The term
(i) The term
(j) The term
(k)-(m) [Reserved]
(n) The term
(o)-(p) [Reserved]
(q) The definitions and interpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act shall be applicable also to such terms when used in this part.
No batch of a straight color listed in subpart B, C, or D shall be certified under this part unless:
(a) It is free from all impurities (other than those named in paragraph (b) of this section or in the specifications set forth in such paragraph for
(b) It conforms to the following specifications:
(1) In the case of a straight color listed in subpart B:
(i) Lead (as Pb), not more than 0.001 percent.
(ii) Arsenic (as As
(iii) Heavy metals (except Pb and As) (by precipitation as sulfides), not more than trace.
(2) In the case of a straight color listed in subpart C or D:
(i) Lead (as Pb), not more than 0.002 percent.
(ii) Arsenic (as As
(iii) Heavy metals (except Pb and As) (by precipitation as sulfides), not more than 0.003 percent.
(3) In the case of a straight color which contains a barium salt listed in subpart C or D—soluble barium (in dilute HCl) (as BaCl
(a) A batch of a mixture which contains no straight color listed in subpart C or D may be certified for use in food, drugs and cosmetics, if:
(1) Each coal-tar color used as an ingredient in mixing such batch is from a previously certified batch and such color has not changed in composition in any manner whatever since such previous certification, except by mixing into such batch of mixture;
(2) Each diluent in such batch of mixture is harmless and suitable for use therein; and
(3) No diluent (except resins, natural gum, pectin and, in the case of mixtures which are aqueous solutions or aqueous pastes, sodium benzoate in a quantity of not more than
(b) A batch of a mixture which contains no straight color listed in subpart D, or which contains a diluent not permitted by paragraph (a)(3) of this section, may be certified in accordance with the provisions of this part, for use only in drugs and cosmetics, if:
(1) Each coal-tar color used as an ingredient in mixing such batch is from a previously certified batch and such color has not changed in composition in any manner whatever since such previous certification, except by mixing into such batch of mixture.
(2) Each diluent in such batch of mixture is harmless and suitable for use therein.
(c) A batch of a mixture which contains a straight color listed in subpart D may be certified in accordance with the provisions of this part, for use only in externally applied drugs and cosmetics, if:
(1) Each coal-tar color used as an ingredient in mixing such batch is from a previously certified batch and such color has not changed in composition in any manner whatever since such previous certification, except by mixing into such batch of mixture; and
(2) Each diluent in such batch of mixture is harmless and suitable for use therein.
A batch of a straight color listed in this subpart may be certified, in accordance with the provisions of the regulations in this part, for use in food, drugs, and cosmetics, if such batch conforms to the requirements of § 82.5 and to the specifications in this subpart set forth for such color.
(a)(1)
(2)
(b) Each lake made as prescribed in paragraph (a) of this section shall be considered to be a straight color and to be listed therein under the name which is formed as follows:
(1) The listed name of the color from which the lake is prepared;
(2) The name of the basic radical combined in such color; and
(3) The word “Lake”.
The color additive FD&C Blue No. 1 shall conform in identity and specifications to the requirements of § 74.101(a)(1) and (b) of this chapter.
The color additive FD&C Blue No. 2 shall conform in identity and specifications to the requirements of § 74.102(a)(1) and (b) of this chapter.
The color additive FD&C Green No. 3 shall conform in identity and specifications to the requirements of § 74.203(a)(1) and (b) of this chapter.
The color additive FD&C Red No. 4 shall conform in identity and specifications to the requirements of § 74.1304(a)(1) and (b) of this chapter. FD&C Red No. 4 is restricted to use in externally applied drugs and cosmetics.
The color additive FD&C Yellow No. 5 shall conform in identity and specifications to the requirements of § 74.705 (a)(1) and (b) of this chapter.
(a) The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the requirements of § 74.706 (a)(1) and (b) of this chapter.
(b) All lakes including current D&C external and D&C lakes of FD&C Yellow No. 6 shall be manufactured from previously certified batches of the straight color additive.
A batch of a straight color listed in this subpart may be certified, in accordance with the provisions of this part, for use only in drugs and cosmetics, if such batch conforms to the requirements of § 82.5 and to the specifications set forth in this subpart for such color.
(a)(1)
(2)
(b) Each lake made as prescribed in paragraph (a) of this section shall be considered to be a straight color and to be listed therein under the name which is formed as follows:
(1) The listed name of the color from which the lake is prepared, except that
(2) The name of the basic radical combined in such color; and
(3) The word “Lake.”
The color additive D&C Blue No. 4 shall conform in identity and specifications to the requirements of § 74.1104(a)(1) and (b) of this chapter. D&C Blue No. 4 is restricted to use in externally applied drugs and cosmetics.
The color additive D&C Green No. 5 shall conform in identity and specifications to the requirements of § 74.1205(a)(1) and (b)(2) of this chapter.
The color additive D&C Green No. 6 shall conform in identity and specifications to the requirements of § 74.1206 (a) and (b) of this chapter. D&C Green No. 6 is restricted to use in externally applied drugs and cosmetics.
The color additive D&C Orange No. 4 shall conform in identity and specifications to the requirements of § 74.1254(a)(1) and (b) of this chapter. D&C Orange No. 4 is restricted to use in externally applied drugs and cosmetics.
(a) The color additive D&C Orange No. 5 shall conform in identity and specifications to the requirements of § 74.1255(a)(1) and (b) of this chapter. D&C Orange No. 5 is restricted to the uses described in this section.
(b) The color additive D&C Orange No. 5. may be safely used for coloring externally applied drugs in amounts not exceeding 5 milligrams per daily dose of the drug. The color additive D&C Orange No. 5 may be safely used for coloring lipsticks and other cosmetics intended to be applied to the lips in amounts not exceeding 5.0 percent by weight of the finished cosmetic products, and for coloring mouthwashes, dentifrices, and externally applied cosmetics in amounts consistent with current good manufacturing practice.
The color additive D&C Orange No. 10 shall conform in identity and specifications to the requirements to § 74.1260(a)(1) and (b) of this chapter. D&C Orange No. 10 is restricted to use in externally applied drugs and cosmetics.
The color additive D&C Orange No. 11 shall conform in identity and specifications to the requirements of § 74.1261(a)(1) and (b) of this chapter. D&C Orange No. 11 is restricted to use in externally applied drugs and cosmetics.
(a) The color additive D&C Red No. 6 shall conform in identity and specifications to the requirements of § 74.1306 (a)(1) and (b) of this chapter.
(b) The color additive D&C Red No. 6 may be safely used for coloring drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7 does not exceed 5 milligrams per daily dose of the drug.
(a) The color additive D&C Red No. 7 shall conform in identity and specifications to the requirements of § 74.1307 (a)(1) and (b) of this chapter.
(b) The color additive D&C Red No. 7 may be safely used for coloring drugs
The color additive D&C Red No. 17 shall conform in identity and specifications to the requirements of § 74.1317 (a)(1) and (b) of this chapter. D&C Red No. 17 is restricted to use in externally applied drugs and cosmetics.
The color additive D&C Red No. 21 shall conform in identity and specifications to the requirements of § 74.1321 (a)(1) and (b) of this chapter.
The color additive D&C Red No. 22 shall conform in identity and specifications to the requirements of § 74.1322 (a)(1) and (b) of this chapter.
The color additive D&C Red No. 27 shall conform in identity and specifications to the requirements of § 74.1327 (a)(1) and (b) of this chapter.
The color additive D&C Red No. 28 shall conform in identity and specifications to the requirements of § 74.1328 (a)(1) and (b) of this chapter.
The color additive D&C Red No. 30 shall conform in identity and specifications to the requirements of § 74.1330 (a)(1) and (b) of this chapter.
The color additive D&C Red No. 31 shall conform in identity and specifications to the requirements of § 74.1331(a)(1) and (b) of this chapter. D&C Red No. 31 is restricted to use in externally applied drugs and cosmetics.
(a) The color additive D&C Red. No. 33 shall conform in identity and specifications to the requirements of § 74.1333(a) (1) and (b) of this chapter.
(b) All lakes of D&C Red. No. 33 shall be manufactured from previously certified batches of the straight color additive.
Calcium salt of 3-hydroxy-4-[(1-sulfo-2 -naph-thal-enyl)azol-2-naph-thal-ene-carboxylic acid.
(a) The color additive D&C Red No. 36 shall conform in identity and specifications to the requirements of § 74.1336 (a)(1) and (b) of this chapter.
(b) All lakes of D&C Red No. 36 shall be manufactured from previously certified batches of the straight color additive.
The color additive D&C Violet No. 2 shall conform in identity and specifications to the requirements of § 74.1602(a)(1) and (b) of this chapter.
The color additive D&C Yellow No. 7 shall conform in identity and specifications to the requirements of § 74.1707(a)(1) and (b) of this chapter. D&C Yellow No. 7 is restricted to use in externally applied drugs and cosmetics.
The color additive D&C Yellow No. 8 shall conform in identity and specifications to the requirements of § 74.1707(a)(1) and (b) of this chapter. D&C Yellow No. 8 is restricted to use in externally applied drugs and cosmetics.
The color additive D&C Yellow No. 10 shall conform in identity and specifications to the requirements of § 74.1710(a)(1) and (b) of this chapter.
A batch of a straight color listed in this subpart may be certified, in accordance with the provisions of this part, for use in externally applied drugs and cosmetics, if such batch conforms to the requirements of § 82.5 and to the specifications set forth in this subpart for such color.
(a)(1)
(2)
(b) Each lake made as prescribed in paragraph (a) of this section shall be considered to be a straight color and to be listed therein under the name which is formed as follows:
(1) The listed name of the color from which the lake is prepared;
(2) The name of the basic radical combined in such color; and
(3) The word “Lake.” (For example, the name of a lake prepared by extending the color Ext. D&C Yellow No. 2 upon a substratum is “Ext. D&C Yellow No. 2—Calcium Lake,” and a lake prepared by extending the barium salt prepared from Ext. D&C Red No. 2 upon the substratum is “Ext. D&C Red No. 2—Barium Lake.”)
The color additive Ext. D&C Yellow No. 7 shall conform in identity with specifications to the requirements of § 74.1707a(a)(1) and (b) of this chapter. Ext. D&C Yellow No. 7 is restricted to use in externally applied drugs and cosmetics.
21 U.S.C. 321, 331, 351, 352, 355, 360, 360c, 360e, 360aa-360aaa-6, 371, and 374; 42 U.S.C. 262.
(a) This part applies to the dissemination of information on human drugs, including biologics, and devices where the information to be disseminated:
(1) Concerns the safety, effectiveness, or benefit of a use that is not included in the approved labeling for a drug or device approved by the Food and Drug Administration for marketing or in the statement of intended use for a device cleared by the Food and Drug Administration for marketing; and
(2) Will be disseminated to a health care practitioner, pharmacy benefit manager, health insurance issuer, group health plan, or Federal or State Government agency.
(b) This part does not apply to a manufacturer's dissemination of information that responds to a health care practitioner's unsolicited request.
(a)
(b) For purposes of this part, a
(c)
(1) Amounts paid for the diagnosis, cure, mitigation, treatment, or prevention of disease, or amounts paid for the purpose of affecting any structure or function of the body;
(2) Amounts paid for transportation primarily for and essential to medical care referred to in paragraph (c)(1) of this section; and
(3) Amounts paid for insurance covering medical care referred to in paragraphs (c)(1) and (c)(2) of this section.
(d)
(e)
(1) Such term does not include a group health plan.
(2) For purposes of this part, the term
(i) A Federally qualified health maintenance organization (as defined in section 1301(a) of the Public Health Service Act (42 U.S.C. 300e(a)));
(ii) An organization recognized under State law as a health maintenance organization; or
(iii) A similar organization regulated under State law for solvency in the same manner and to the same extent as such a health maintenance organization.
(f)
(g)
(h)
(i) A
(1) Has not been written, edited, excerpted, or published specifically for, or at the request of, a drug or device manufacturer;
(2) Has not been edited or significantly influenced by such a manufacturer;
(3) Is not solely distributed through such a manufacturer, but is generally available in bookstores or other distribution channels where medical textbooks are sold;
(4) Does not focus on any particular drug or device of a manufacturer that disseminates information under this part and does not have a primary focus on new uses of drugs or devices that are marketed or are under investigation by a manufacturer supporting the dissemination of information; and
(5) Does not present materials that are false or misleading.
(j)
(1) That is published by an organization that has an editorial board, that uses experts who have demonstrated expertise in the subject of an article under review by the organization and who are independent of the organization, to review and objectively select, reject, or provide comments about proposed articles, and that has a publicly stated policy, to which the organization adheres, of full disclosure of any conflict of interest or biases for all authors or contributors involved with the journal or organization;
(2) Whose articles are peer-reviewed and published in accordance with the regular peer-review procedures of the organization;
(3) That is generally recognized to be of national scope and reputation;
(4) That is indexed in the Index Medicus of the National Library of Medicine of the National Institutes of Health; and
(5) That is not in the form of a special supplement that has been funded in whole or in part by one or more manufacturers.
(k)
(1) For drugs, a supplement to support a new use to an approved new drug application;
(2) For biologics, a supplement to an approved license application;
(3) For devices that are the subject of a cleared 510(k) submission and devices that are exempt from the 510(k) process, a new 510(k) submission to support a new use or, for devices that are the subject of an approved premarket approval application, a supplement to support a new use to an approved premarket approval application.
(a) A manufacturer may disseminate written information concerning the safety, effectiveness, or benefit of a use not described in the approved labeling for an approved drug or device or in the statement of intended use for a cleared device, provided that the manufacturer complies with all other relevant requirements under this part. Such information shall:
(1) Be about a drug or device that has been approved, licensed, or cleared for marketing by FDA;
(2) Be in the form of:
(i) An unabridged reprint or copy of an article, peer-reviewed by experts qualified by scientific training or experience to evaluate the safety or effectiveness of the drug or device involved, which was published in a scientific or medical journal. In addition, the article must be about a clinical investigation with respect to the drug or device and must be considered to be scientifically sound by the experts described in this paragraph; or
(ii) An unabridged reference publication that includes information about a clinical investigation with respect to the drug or device, which experts qualified by scientific training or experience to evaluate the safety or effectiveness of the drug or device that is the subject of the clinical investigation would consider to be scientifically sound;
(3) Not pose a significant risk to the public health;
(4) Not be false or misleading. FDA may consider information disseminated under this part to be false or misleading if, among other things, the information includes only favorable publications when unfavorable publications exist or excludes articles, reference publications, or other information required under § 99.103(a)(4) or the information presents conclusions that clearly cannot be supported by the results of the study; and
(5) Not be derived from clinical research conducted by another manufacturer unless the manufacturer disseminating the information has the permission of such other manufacturer to make the dissemination.
(b) For purposes of this part:
(1) FDA will find that all journal articles and reference publications (as those terms are defined in § 99.3) are scientifically sound except:
(i) Letters to the editor;
(ii) Abstracts of a publication;
(iii) Those regarding Phase 1 trials in healthy people;
(iv) Flagged reference publications that contain little or no substantive discussion of the relevant clinical investigation; and
(v) Those regarding observations in four or fewer people that do not reflect any systematic attempt to collect data, unless the manufacturer demonstrates to FDA that such reports could help guide a physician in his/her medical practice.
(2) A reprint or copy of an article or reference publication is “unabridged” only if it retains the same appearance, form, format, content, or configuration as the original article or publication. Such reprint, copy of an article, or reference publication shall not be disseminated with any information that is promotional in nature. A manufacturer may cite a particular discussion about a new use in a reference publication in the explanatory or other information attached to or otherwise accompanying the reference publication under § 99.103.
(a) Any information disseminated under this part shall include:
(1) A prominently displayed statement disclosing:
(i) For a drug, “This information concerns a use that has not been approved by the Food and Drug Administration.” For devices, the statement shall read, “This information concerns a use that has not been approved or cleared by the Food and Drug Administration.” If the information to be disseminated includes both an approved and unapproved use or uses or a cleared and uncleared use or uses, the manufacturer shall modify the statement to identify the unapproved or uncleared new use or uses. The manufacturer shall permanently affix the statement to the front of each reprint or copy of an article from a scientific or medical journal and to the front of each reference publication disseminated under this part;
(ii) If applicable, the information is being disseminated at the expense of the manufacturer;
(iii) If applicable, the names of any authors of the information who were employees of, or consultants to, or received compensation from the manufacturer, or who had a significant financial interest in the manufacturer during the time that the study that is the subject of the dissemination was conducted up through 1 year after the time the article/reference publication was written and published;
(iv) If applicable, a statement that there are products or treatments that have been approved or cleared for the use that is the subject of the information being disseminated; and
(v) The identification of any person that has provided funding for the conduct of a study relating to the new use of a drug or device for which such information is being disseminated; and
(2) The official labeling for the drug or device;
(3) A bibliography of other articles (that concern reports of clinical investigations both supporting and not supporting the new use) from a scientific reference publication or scientific or medical journal that have been previously published about the new use of the drug or device covered by the information that is being disseminated, unless the disseminated information already includes such a bibliography; and
(4) Any additional information required by FDA under § 99.301(a)(2). Such
(i) Objective and scientifically sound information pertaining to the safety or effectiveness of the new use of the drug or device and which FDA determines is necessary to provide objectivity and balance. This may include information that the manufacturer has submitted to FDA or, where appropriate, a summary of such information and any other information that can be made publicly available; and
(ii) An objective statement prepared by FDA, based on data or other scientifically sound information, bearing on the safety or effectiveness of the new use of the drug or device.
(b) Except as provided in paragraphs (a)(1)(i) and (a)(4) of this section, the statements, bibliography, and other information required by this section shall be attached to such disseminated information.
(c) For purposes of this section, factors to be considered in determining whether a statement is “prominently displayed” may include, but are not limited to, type size, font, layout, contrast, graphic design, headlines, spacing, and any other technique to achieve emphasis or notice. The required statements shall be outlined, boxed, highlighted, or otherwise graphically designed and presented in a manner that achieves emphasis or notice and is distinct from the other information being disseminated.
A manufacturer disseminating information on a new use under this part may only disseminate that information to a health care practitioner, a pharmacy benefit manager, a health insurance issuer, a group health plan, or a Federal or State Government agency.
(a) Sixty days before disseminating any written information concerning the safety, effectiveness, or benefit of a new use for a drug or device, a manufacturer shall submit to the agency:
(1) An identical copy of the information to be disseminated, including any information (e.g., the bibliography) and statements required under § 99.103;
(2) Any other clinical trial information which the manufacturer has relating to the effectiveness of the new use, any other clinical trial information that the manufacturer has relating to the safety of the new use, any reports of clinical experience pertinent to the safety of the new use, and a summary of such information. For purposes of this part, clinical trial information includes, but is not limited to, published papers and abstracts, even if not intended for dissemination, and unpublished manuscripts, abstracts, and data analyses from completed or ongoing investigations. The reports of clinical experience required under this paragraph shall include case studies, retrospective reviews, epidemiological studies, adverse event reports, and any other material concerning adverse effects or risks reported for or associated with the new use. If the manufacturer has no knowledge of clinical trial information relating to the safety or effectiveness of the new use or reports of clinical experience pertaining to the safety of the new use, the manufacturer shall provide a statement to that effect;
(3) An explanation of the manufacturer's method of selecting the articles for the bibliography (e.g., the databases or sources and criteria (i.e., subject headings/keywords) used to generate the bibliography and the time period covered by the bibliography); and
(4) If the manufacturer has not submitted a supplemental application for the new use, one of the following:
(i) If the manufacturer has completed studies needed for the submission of a supplemental application for the new use:
(A) A copy of the protocol for each completed study or, if such protocol was submitted to an investigational new drug application or an investigational device exemption, the number(s) for the investigational new drug application or investigational device exemption covering the new use, the date of submission of the protocol(s), the protocol number(s), and the date of any amendments to the protocol(s); and
(B) A certification stating that, “On behalf of [insert manufacturer's name], I certify that [insert manufacturer's name] has completed the studies needed for the submission of a supplemental application for [insert new use] and will submit a supplemental application for such new use to the Food and Drug Administration no later than [insert date no later than 6 months from date that dissemination of information under this part can begin]”; or
(ii) If the manufacturer has planned studies that will be needed for the submission of a supplemental application for the new use:
(A) The proposed protocols and schedule for conducting the studies needed for the submission of a supplemental application for the new use. The protocols shall comply with all applicable requirements in parts 312 of this chapter (investigational new drug applications) and 812 of this chapter (investigational device exemptions). The schedule shall include the projected dates on which the manufacturer expects the principal study events to occur (e.g., initiation and completion of patient enrollment, completion of data collection, completion of data analysis, and submission of the supplemental application); and
(B) A certification stating that, “On behalf of [insert manufacturer's name], I certify that [insert manufacturer's name] will exercise due diligence to complete the clinical studies necessary to submit a supplemental application for [insert new use] and will submit a supplemental application for such new use to the Food and Drug Administration no later than [insert date no later than 36 months from date that dissemination of information under this part can begin or no later than such time period as FDA may specify pursuant to an extension granted under § 99.303(a)];” or
(iii) An application for exemption from the requirement of a supplemental application; or
(5) If the manufacturer has submitted a supplemental application for the new use, a cross-reference to that supplemental application.
(b) The manufacturer's attorney, agent, or other authorized official shall sign the submission and certification statement or application for exemption. If the manufacturer does not have a place of business in the United States, the submission and certification statement or application for exemption shall contain the signature, name, and address of the manufacturer's attorney, agent, or other authorized official who resides or maintains a place of business in the United States.
(c) The manufacturer shall send three copies of the submission and certification statement or application for exemption to FDA. The outside of the shipping container shall be marked as “Submission for the Dissemination of Information on an Unapproved/New Use.” The manufacturer shall send the submission and certification statement or application for exemption to the appropriate FDA component listed in paragraphs (c)(1) through (c)(3) of this section.
(1) For biological products and devices regulated by the Center for Biologics Evaluation and Research, the Advertising and Promotional Labeling Staff (HFM-602), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852;
(2) For human drug products, the Division of Drug Marketing, Advertising, and Communications (HFD-40), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; or
(3) For medical devices, the Promotion and Advertising Policy Staff (HFZ-302), Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850.
(d) The 60-day period shall begin when FDA receives a manufacturer's submission, including, where applicable, a certification statement or an application for an exemption.
(a) A manufacturer may request, prior to or at the time of making a submission to FDA under § 99.201, that FDA extend the 36-month time period for completing the studies and submitting a supplemental application for the new use that is the subject of the information to be disseminated. Such request must set forth the reasons that such studies cannot be completed and submitted in a supplemental application within 36 months.
(b) A manufacturer who has certified that it will complete the studies necessary to submit a supplemental application for a new use within a specified period of time from the date that dissemination of information under this part can begin under § 99.201(a)(4)(ii), but later finds that it will be unable to complete such studies and submit a supplemental application within that time period may request an extension of time from FDA. The manufacturer, in its request for extension, shall identify the product, the new use, and shall:
(1) Describe the study or studies that cannot be completed on time and explain why the study or studies cannot be completed on time;
(2) Describe the current status of the incomplete study or studies and summarize the work conducted, including the dates on which principal events concerning the study or studies occurred; and
(3) Estimate the additional time needed to complete the studies and submit a supplemental application. The requested extension shall not exceed an additional 24 months.
(c) The manufacturer shall send three copies of the request for extension to the same FDA office that received the manufacturer's initial submission and certification statement. The outside of the envelope shall be marked as “Request for Time Extension—Dissemination of Information on an Unapproved Use.”
(a) In certain circumstances, described in paragraph (b) of this section, a manufacturer may submit an application for an exemption from the requirement to submit a supplemental application for a new use for purposes of disseminating information on that use.
(b) The manufacturer's application for an exemption shall identify the basis for the proposed exemption and shall include materials demonstrating that it would be economically prohibitive or that it would be unethical to conduct the studies necessary to submit a supplemental application for the new use.
(1) If the basis for the manufacturer's application for exemption is that it would be economically prohibitive to incur the costs necessary to submit a supplemental application for a new use, the manufacturer shall, at a minimum, provide:
(i) Evidence explaining why existing data characterizing the safety and effectiveness of the drug or device, including data from the study described in the information to be disseminated, are not adequate to support the submission of a supplemental application for the new use. Such evidence shall include an analysis of all data relevant to the safety and effectiveness of the use, a summary of those data, and any documentation resulting from prior discussions with the agency concerning the adequacy of the existing data; and
(ii) Evidence demonstrating that the cost of the study or studies for the new use reasonably exceeds the expected revenue from the new use minus the costs of goods sold and marketing and administrative expenses attributable to the new use of the product. Such evidence shall include:
(A) A description of the additional studies that the manufacturer believes are necessary to support the submission of a supplemental application for the new use, including documentation from prior discussions, if any, with the agency concerning the studies that would be needed, and an estimate of the projected costs for such studies;
(B) The expected patient population for the new use;
(C) The expected revenue for the new use, including an explanation of the price at which the drug or device will be sold;
(D) Any exclusivity for the drug or device for the new use; and
(E) Any other information that the manufacturer has showing that conducting the studies on the new use would be economically prohibitive; and
(iii) An attestation by a responsible individual of the manufacturer or an individual acting on the manufacturer's behalf verifying that the estimates included with the submission are accurate and were prepared in accordance with generally accepted accounting procedures. The data underlying and supporting the estimates shall be made available to FDA upon request. Alternatively, a manufacturer may submit a report of an independent certified public accountant in accordance with the Statement of Standards for Attestation established by the American Institute of Certified Public Accountants and agreed upon procedures performed with respect to the estimates submitted under this section.
(2) If the basis for the manufacturer's application for exemption is that it would be unethical to conduct the studies necessary for the supplemental application for a new use, the manufacturer shall provide evidence:
(i) Explaining why existing data characterizing the safety and effectiveness of the drug or device, including data from the study described in the information to be disseminated, are not adequate to support the submission of a supplemental application for the new use. Such evidence shall include an analysis of all data relevant to the safety and effectiveness of the new use, a summary of those data, and any documentation resulting from prior discussions with the agency concerning the adequacy of the existing data; and
(ii) Explaining why it would be unethical to conduct the further studies that would be necessary for the approval of the new use. Such evidence shall establish that, notwithstanding the insufficiency of available data to support the submission of a supplemental application for the new use, the data are persuasive to the extent that withholding the drug or device in a controlled study (e.g., by providing no therapy, a placebo, an alternative therapy, or an alternative dose) would pose an unreasonable risk of harm to human subjects. In assessing the appropriateness of conducting studies to support the new use, the manufacturer may provide evidence showing that the new use is broadly accepted as current standard medical treatment or therapy. The manufacturer shall also address the possibility of conducting studies in different populations or of modified design (e.g., adding the new therapy to existing treatments or using an alternative dose if monotherapy studies could not be conducted).
(a)
(1) Determine that the manufacturer does not comply with the requirements under this part and that, as a result, the manufacturer shall not disseminate any information under this part;
(2) After providing the manufacturer notice and an opportunity for a meeting, determine that the information submitted regarding a new use fails to provide data, analyses, or other written matter that is objective and balanced and:
(i) Require the manufacturer to disseminate additional information, including information that the manufacturer has submitted to FDA or, where appropriate, a summary of such information or any other information that can be made publicly available, which, in the agency's opinion:
(A) Is objective and scientifically sound;
(B) Pertains to the safety or effectiveness of the new use; and
(C) Is necessary to provide objectivity and balance; and
(ii) Require the manufacturer to disseminate an objective statement prepared by FDA that is based on data or other scientifically sound information available to the agency and bears on
(3) Require the manufacturer to maintain records that will identify individual recipients of the information that is to be disseminated when such individual records are warranted due to special safety considerations associated with the new use.
(b)
(1) If the manufacturer has planned studies that will be needed for the submission of a supplemental application for the new use, review the manufacturer's proposed protocols and schedule for completing such studies and determine whether the proposed protocols are adequate and whether the proposed schedule for completing the studies is reasonable. FDA shall notify the manufacturer of its determination; or
(2) If the manufacturer has completed studies that the manufacturer believes would be an adequate basis for the submission of a supplemental application for the new use, conduct a review of the protocols submitted for such studies to determine whether they are adequate. FDA shall notify the manufacturer of its determination.
(a) Upon review of a drug or device manufacturer's proposed protocols and schedules for conducting studies needed for the submission of a supplemental application for a new use, FDA may, with or without a request for an extension from the manufacturer, determine that such studies cannot be completed and submitted within 36 months. The agency may exercise its discretion in extending the time period for completing the studies and submitting a supplemental application. Extensions under this paragraph are not subject to any time limit, but shall be made before the manufacturer begins the studies needed for the submission of a supplemental application for the new use.
(b) The manufacturer may, after beginning the studies needed for the submission of a supplemental application for a new use, request in writing that FDA extend the time period for conducting studies needed for the submission of a supplemental application for a new use and submitting a supplemental application to FDA. FDA may grant or deny the request or, after consulting the manufacturer, grant an extension different from that requested by the manufacturer. FDA may grant a manufacturer's request for an extension if FDA determines that the manufacturer has acted with due diligence to conduct the studies needed for the submission of a supplemental application for a new use and to submit such a supplemental application to FDA in a timely manner and that, despite such actions, the manufacturer needs additional time to complete the studies and submit the supplemental application. Extensions under this paragraph shall not exceed 24 months.
(c) If FDA extends the time period for completing the studies and submitting a supplemental application under paragraph (a) of this section after the manufacturer has submitted a certification under § 99.201(a)(4)(ii)(B), or if FDA grants a manufacturer's request for an extension under paragraph (b) of this section, the manufacturer shall submit a new certification under § 99.201(a)(4)(ii)(B) that sets forth the timeframe within which clinical studies will be completed and a supplemental application will be submitted to FDA.
(a) Within 60 days after receipt of an application for an exemption from the requirement of a supplemental application, FDA shall approve or deny the application.
(1) If FDA does not act on the application for an exemption within the 60-day period, the application for an exemption shall be deemed to be approved.
(2) If an application for an exemption is deemed to be approved, FDA may, at any time, terminate such approval if it determines that the requirements for granting an exemption have not been met. FDA shall notify the manufacturer if the approval is terminated.
(b) In reviewing an application for an exemption, FDA shall consider the materials submitted by the manufacturer
(c) FDA may grant an application for an exemption if FDA determines that:
(1) It would be economically prohibitive for the manufacturer to incur the costs necessary to submit a supplemental application for a new use, which at a minimum requires:
(i) That existing data characterizing the safety and effectiveness of the drug or device, including data from the study described in the information to be disseminated are not adequate to support the submission of a supplemental application for the new use; and
(ii) That the cost of the study or studies for the new use reasonably exceeds the expected revenue from the new use minus the cost of goods sold and marketing and administrative expenses attributable to the new use of the product, and there are not less expensive ways to obtain the needed information; or
(2) It would be unethical to conduct clinical studies needed to support the submission of a supplemental application for the new use because:
(i) Existing data characterizing the safety and effectiveness of the drug or device, including data from the study described in the information to be disseminated are not adequate to support the submission of a supplemental application for the new use; and
(ii) Although available evidence would not support the submission of a supplemental application for the new use, the data are persuasive to the extent that withholding the drug or device in a controlled study would pose an unreasonable risk of harm to human subjects and no studies in different populations or of modified design can be utilized. In determining whether it would be unethical to conduct clinical studies, the agency shall consider, in addition to the persuasiveness of available evidence of effectiveness, whether the new use of the drug or device is broadly accepted as current standard medical treatment or therapy.
(a)
(b)
(1) Provide to the manufacturer an opportunity to bring itself into compliance with the requirements under this part if the manufacturer's noncompliance constitutes a minor violation of these requirements; or
(2) Order the manufacturer to cease dissemination of information and to take corrective action. FDA shall issue such an order only after it has:
(i) Provided notice to the manufacturer regarding FDA's intent to issue an order to cease dissemination; and
(ii) Provided to the manufacturer an opportunity for a meeting. FDA need not provide an opportunity for a meeting if the manufacturer certified that it will submit a supplemental application for the new use within 6 months of the date that dissemination can begin and the noncompliance involves a failure to submit such supplemental application.
(c)
(1) In the case of a manufacturer that has submitted a supplemental application for the new use, FDA determines
(2) In the case of a manufacturer that has certified that it will submit a supplemental application for the new use within 6 months, the manufacturer has not, within the 6-month period, submitted a supplemental application for the new use;
(3) In the case of a manufacturer that has certified that it will submit a supplemental application for the new use within 36 months or within such time as FDA has determined to be appropriate under § 99.303(a) or (b), such manufacturer has not submitted the supplemental application within the certified time, or FDA, after an informal hearing, has determined that the manufacturer is not acting with due diligence to initiate or complete the studies necessary to support a supplemental application for the new use; or
(4) In the case of a manufacturer that has certified that it will submit a supplemental application for the new use within 36 months or within such time as FDA has determined to be appropriate under § 99.303(a) or (b), the manufacturer has discontinued or terminated the clinical studies that would be necessary to support a supplemental application for a new use.
(d)
(e)
(a) FDA may, at any time, terminate the approval of an application for an exemption from the requirement to file a supplemental application if:
(1) The application for an exemption had been deemed to be approved because the agency had not acted on the application within 60 days after its receipt by FDA;
(2) The manufacturer is disseminating written information on the new use; and
(3) FDA determines that it would be economically and ethically possible for the manufacturer to conduct the clinical studies needed to submit a supplemental application for the new use.
(b) If FDA terminates a deemed approval of an application for an exemption under paragraph (a) of this section, FDA also may:
(1) Order the manufacturer to cease disseminating information; and
(2) Order the manufacturer to take action to correct the information that has been disseminated if FDA determines that the new use described in the disseminated information would pose a significant risk to public health.
(c) FDA shall notify the manufacturer if it terminates the deemed approval of an application for an exemption under paragraph (a) of this section. If FDA also issues an order to cease dissemination of information, the manufacturer shall comply with the order no later than 60 days after its receipt.
(d) FDA may, at any time, terminate the approval of an application for an exemption from the requirement to file a supplemental application for a new use if, after consulting with the manufacturer that was granted such exemption, FDA determines that the manufacturer no longer meets the requirements for an exemption on the basis that it is economically prohibitive or unethical to conduct the studies needed to submit a supplemental application for the new use.
(e) If FDA terminates an approval of an application for an exemption under paragraph (d) of this section, the manufacturer must, within 60 days of being
The dissemination of information relating to a new use for a drug or device may constitute labeling, evidence of a new intended use, adulteration, or misbranding of the drug or device if such dissemination fails to comply with section 551 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360aaa) and the requirements of this part. A manufacturer's failure to exercise due diligence in submitting the clinical studies that are necessary for the approval of a new use that is the subject of information disseminated under this part or in beginning or completing such clinical studies shall be deemed a failure to comply with section 551 of the act and the requirements of this part.
(a) A manufacturer disseminating information under this part shall:
(1) Maintain records sufficient to allow the manufacturer to take corrective action as required by FDA. The manufacturer shall make such records available to FDA, upon request, for inspection and copying. Such records shall either:
(i) Identify, by name, those persons receiving the disseminated information; or
(ii) Identify, by category, the recipients of the disseminated information, unless FDA requires the manufacturer to retain records identifying individual recipients of the disseminated information. Manufacturers whose records identify recipients by category only shall:
(A) Identify subcategories of recipients where appropriate (e.g., oncologists, pediatricians, obstetricians, etc.); and
(B) Ensure that any corrective action to be taken will be sufficiently conspicuous to individuals within that category of recipients;
(2) Maintain an identical copy of the information disseminated under this part; and
(3) Upon the submission of a supplemental application to FDA, notify the appropriate office identified in § 99.201(c) of this part.
(b) A manufacturer disseminating information on a new use for a drug or device shall, on a semiannual basis, submit to the FDA office identified in § 99.201(c) of this part:
(1) A list containing the titles of articles and reference publications relating to the new use of drugs or devices that the manufacturer disseminated to a health care practitioner, pharmacy benefit manager, health insurance issuer, group health plan, or Federal or State Government agency. The list shall cover articles and reference publications disseminated in the 6-month period preceding the date on which the manufacturer provides the list to FDA;
(2) A list identifying the categories of health care practitioners, pharmacy benefit managers, health insurance issuers, group health plans, or Federal or State Government agencies that received the articles and reference publications in the 6-month period described in paragraph (b)(1) of this section. The list shall also identify which category of recipients received a particular article or reference publication;
(3) A notice and summary of any additional clinical research or other data relating to the safety or effectiveness of the new use, and, if the manufacturer possesses such clinical research or other data, a copy of the research or data. Such other data may include, but is not limited to, new articles published in scientific or medical journals, reference publications, and summaries of adverse effects that are or may be associated with the new use;
(4) If the manufacturer is conducting studies necessary for the submission of
(5) If the manufacturer was granted an exemption from the requirements to submit a supplemental application for the new use, any new or additional information that relates to whether the manufacturer continues to meet the requirements for such exemption. This information may include, but is not limited to, new or additional information regarding revenues from the product that is the subject of the dissemination and new or additional information regarding the persuasiveness of the data on the new use, including information regarding whether the new use is broadly accepted as current standard medical treatment or therapy.
(c) A manufacturer shall maintain a copy of all information, lists, records, and reports required or disseminated under this part for 3 years after it has ceased dissemination of such information and make such documents available to FDA for inspection and copying.
A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabetical list of agencies publishing in the CFR are included in the CFR Index and Finding Aids volume to the Code of Federal Regulations which is published separately and revised annually.
Material Approved for Incorporation by Reference
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
List of CFR Sections Affected
The Director of the Federal Register has approved under 5 U.S.C. 552(a) and 1 CFR Part 51 the incorporation by reference of the following publications. This list contains only those incorporations by reference effective as of the revision date of this volume. Incorporations by reference found within a regulation are effective upon the effective date of that regulation. For more information on incorporation by reference, see the preliminary pages of this volume.
All changes in this volume of the Code of Federal Regulations which were made by documents published in the
For the period before January 1, 2001, see the “List of CFR Sections Affected, 1949-1963, 1964-1972, 1973-1985, and 1986-2000” published in 11 separate volumes.