21 U.S.C.
United States Code, 2010 Edition
Title 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER X - MISCELLANEOUS
From the U.S. Government Printing Office, www.gpo.gov

SUBCHAPTER X—MISCELLANEOUS

Codification

Former subchapter IX of this chapter was redesignated as this subchapter.

§391. Separability clause

If any provision of this chapter is declared unconstitutional, or the applicability thereof to any person or circumstances is held invalid, the constitutionality of the remainder of the chapter and the applicability thereof to other persons and circumstances shall not be affected thereby.

(June 25, 1938, ch. 675, §1001, formerly §901, 52 Stat. 1059; renumbered §1001, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

§392. Exemption of meats and meat food products

(a) Law determinative of exemption

Meats and meat food products shall be exempt from the provisions of this chapter to the extent of the application or the extension thereto of the Meat Inspection Act, approved March 4, 1907, as amended [21 U.S.C. 601 et seq.].

(b) Laws unaffected

Nothing contained in this chapter shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of section 351 of Public Health Service Act [42 U.S.C. 262] (relating to viruses, serums, toxins, and analogous products applicable to man); the virus, serum, toxin, and analogous products provisions, applicable to domestic animals, of the Act of Congress approved March 4, 1913 (37 Stat. 832–833) [21 U.S.C. 151 et seq.]; the Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title 26, ch. 10), the Filled Milk Act of March 4, 1923 [21 U.S.C. 61 et seq.]; or the Import Milk Act of February 15, 1927 [21 U.S.C. 141 et seq.].

(June 25, 1938, ch. 675, §1002(b), (c), formerly §902(b), (c), 52 Stat. 1059; Pub. L. 90–399, §107, July 13, 1968, 82 Stat. 353; renumbered §1002(b), (c), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

References in Text

The Meat Inspection Act, approved March 4, 1907, as amended, referred to in subsec. (a), is act Mar. 4, 1907, ch. 2907, titles I to IV, as added Dec. 15, 1967, Pub. L. 90–201, 81 Stat. 584, which are classified generally to subchapters I to IV (§601 et seq.) of chapter 12 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 601 of this title and Tables.

Act of March 4, 1913, referred to in subsec. (b), is act Mar. 4, 1913, ch. 145, 37 Stat. 828, as amended. The provisions of such act referred to relating to viruses, etc., applicable to domestic animals, are contained in the eighth paragraph under the heading “Bureau of Animal Industry”, 37 Stat. 832, as amended, popularly known as the Virus-Serum-Toxin Act, which is classified generally to chapter 5 (§151 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 151 of this title and Tables.

The Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title 26, ch. 10), referred to in subsec. (b), is act June 6, 1896, ch. 337, 29 Stat. 253, as amended, which had been classified to chapter 10 (§1000 et seq.) of Title 26, Internal Revenue, and included as chapter 17 (§2350 et seq.) of Title 26, Internal Revenue Code of 1939. Such chapter 17 was covered by section 4831 et seq. of Title 26, Internal Revenue Code, prior to the repeal of section 4831 et seq. of Title 26 by Pub. L. 93–490, §3(a)(1), Oct. 26, 1974, 88 Stat. 1466.

The Filled Milk Act of March 4, 1923, referred to in subsec. (b), is act Mar. 4, 1923, ch. 262, 42 Stat. 1486, as amended, which is classified generally to chapter 3 (§61 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 61 of this title and Tables.

The Import Milk Act of February 15, 1927, referred to in subsec. (b), is act Feb. 15, 1927, ch. 155, 44 Stat. 1101, as amended, which is classified generally to subchapter IV (§141 et seq.) of chapter 4 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 141 of this title and Tables.

Codification

Subsecs. (a) and (b) of this section comprise respectively subsecs. (b) and (c) of section 1002 of act June 25, 1938. Subsecs. (a) and (d) of section 1002 of act June 25, 1938, which prescribed the effective date of this chapter and made appropriations available, are set out as notes under section 301 of this title and this section, respectively.

Amendments

1968—Subsec. (b). Pub. L. 90–399 substituted “section 262 of title 42 (relating to viruses, serums, toxins, and analogous products applicable to man)” for “the virus serum, and toxin Act of July 1, 1902” and inserted reference to “the virus, serum, toxin, and analogous products provisions, applicable to domestic animals, of the Act of Congress approved March 4, 1913”.

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968, see section 108(a) of Pub. L. 90–399, set out as an Effective Date and Transitional Provisions note under section 360b of this title.

Availability of Appropriations

Act June 25, 1938, ch. 675, §1002(d), formerly §902(d), 52 Stat. 1059; renumbered §1002(d), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784, provided that: “In order to carry out the provisions of this Act which take effect [see section 1002(a) of act June 25, 1938, set out as an Effective Date note under section 301 of this title] prior to the repeal of the Food and Drugs Act of June 30, 1906, as amended [former sections 1 to 5 and 7 to 15 of this title], appropriations available for the enforcement of such Act of June 30, 1906, are also authorized to be made available to carry out such provisions.”

§393. Food and Drug Administration

(a) In general

There is established in the Department of Health and Human Services the Food and Drug Administration (hereinafter in this section referred to as the “Administration”).

(b) Mission

The Administration shall—

(1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;

(2) with respect to such products, protect the public health by ensuring that—

(A) foods are safe, wholesome, sanitary, and properly labeled;

(B) human and veterinary drugs are safe and effective;

(C) there is reasonable assurance of the safety and effectiveness of devices intended for human use;

(D) cosmetics are safe and properly labeled; and

(E) public health and safety are protected from electronic product radiation;


(3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and

(4) as determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products.

(c) Interagency collaboration

The Secretary shall implement programs and policies that will foster collaboration between the Administration, the National Institutes of Health, and other science-based Federal agencies, to enhance the scientific and technical expertise available to the Secretary in the conduct of the duties of the Secretary with respect to the development, clinical investigation, evaluation, and postmarket monitoring of emerging medical therapies, including complementary therapies, and advances in nutrition and food science.

(d) Commissioner

(1) Appointment

There shall be in the Administration a Commissioner of Food and Drugs (hereinafter in this section referred to as the “Commissioner”) who shall be appointed by the President by and with the advice and consent of the Senate.

(2) General powers

The Secretary, through the Commissioner, shall be responsible for executing this chapter and for—

(A) providing overall direction to the Food and Drug Administration and establishing and implementing general policies respecting the management and operation of programs and activities of the Food and Drug Administration;

(B) coordinating and overseeing the operation of all administrative entities within the Administration;

(C) research relating to foods, drugs, cosmetics, devices, and tobacco products in carrying out this chapter;

(D) conducting educational and public information programs relating to the responsibilities of the Food and Drug Administration; and

(E) performing such other functions as the Secretary may prescribe.

(e) Technical and scientific review groups

The Secretary through the Commissioner of Food and Drugs may, without regard to the provisions of title 5 governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, establish such technical and scientific review groups as are needed to carry out the functions of the Administration, including functions under this chapter, and appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups.

(f) Agency plan for statutory compliance

(1) In general

Not later than 1 year after November 21, 1997, the Secretary, after consultation with appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry, shall develop and publish in the Federal Register a plan bringing the Secretary into compliance with each of the obligations of the Secretary under this chapter. The Secretary shall review the plan biannually and shall revise the plan as necessary, in consultation with such persons.

(2) Objectives of agency plan

The plan required by paragraph (1) shall establish objectives and mechanisms to achieve such objectives, including objectives related to—

(A) maximizing the availability and clarity of information about the process for review of applications and submissions (including petitions, notifications, and any other similar forms of request) made under this chapter;

(B) maximizing the availability and clarity of information for consumers and patients concerning new products;

(C) implementing inspection and postmarket monitoring provisions of this chapter;

(D) ensuring access to the scientific and technical expertise needed by the Secretary to meet obligations described in paragraph (1);

(E) establishing mechanisms, by July 1, 1999, for meeting the time periods specified in this chapter for the review of all applications and submissions described in subparagraph (A) and submitted after November 21, 1997; and

(F) eliminating backlogs in the review of applications and submissions described in subparagraph (A), by January 1, 2000.

(g) Annual report

The Secretary shall annually prepare and publish in the Federal Register and solicit public comment on a report that—

(1) provides detailed statistical information on the performance of the Secretary under the plan described in subsection (f) of this section;

(2) compares such performance of the Secretary with the objectives of the plan and with the statutory obligations of the Secretary; and

(3) identifies any regulatory policy that has a significant negative impact on compliance with any objective of the plan or any statutory obligation and sets forth any proposed revision to any such regulatory policy.

(h) Annual report regarding food

Not later than February 1 of each year, the Secretary shall submit to Congress a report, including efforts to coordinate and cooperate with other Federal agencies with responsibilities for food inspections, regarding—

(1) information about food facilities including—

(A) the appropriations used to inspect facilities registered pursuant to section 350d of this title in the previous fiscal year;

(B) the average cost of both a non-high-risk food facility inspection and a high-risk food facility inspection, if such a difference exists, in the previous fiscal year;

(C) the number of domestic facilities and the number of foreign facilities registered pursuant to section 350d of this title that the Secretary inspected in the previous fiscal year;

(D) the number of domestic facilities and the number of foreign facilities registered pursuant to section 350d of this title that were scheduled for inspection in the previous fiscal year and which the Secretary did not inspect in such year;

(E) the number of high-risk facilities identified pursuant to section 350j of this title that the Secretary inspected in the previous fiscal year; and

(F) the number of high-risk facilities identified pursuant to section 350j of this title that were scheduled for inspection in the previous fiscal year and which the Secretary did not inspect in such year.


(2) information about food imports including—

(A) the number of lines of food imported into the United States that the Secretary physically inspected or sampled in the previous fiscal year;

(B) the number of lines of food imported into the United States that the Secretary did not physically inspect or sample in the previous fiscal year; and

(C) the average cost of physically inspecting or sampling a line of food subject to this chapter that is imported or offered for import into the United States; and


(3) information on the foreign offices of the Food and Drug Administration including—

(A) the number of foreign offices established; and

(B) the number of personnel permanently stationed in each foreign office.

(i) Public availability of annual food reports

The Secretary shall make the reports required under subsection (h) available to the public on the Internet Web site of the Food and Drug Administration.

(June 25, 1938, ch. 675, §1003, formerly §903, as added Pub. L. 100–607, title V, §503(a), Nov. 4, 1988, 102 Stat. 3121; amended Pub. L. 100–690, title II, §2631, Nov. 18, 1988, 102 Stat. 4244; Pub. L. 105–115, title IV, §§406, 414, Nov. 21, 1997, 111 Stat. 2369, 2377; renumbered §1003 and amended Pub. L. 111–31, div. A, title I, §§101(b)(2), 103(m), June 22, 2009, 123 Stat. 1784, 1838; Pub. L. 111–353, title II, §201(b), Jan. 4, 2011, 124 Stat. 3925.)

Amendments

2011—Subsecs. (h), (i). Pub. L. 111–353 added subsecs. (h) and (i).

2009—Subsec. (d)(2)(C). Pub. L. 111–31, §103(m), struck out “and” after “cosmetics,” and inserted “, and tobacco products” after “devices”.

1997—Subsec. (b). Pub. L. 105–115, §406(a)(2), added subsec. (b). Former subsec. (b) redesignated (d).

Subsec. (c). Pub. L. 105–115, §414, added subsec. (c). Former subsec. (c) redesignated (e).

Subsecs. (d), (e). Pub. L. 105–115, §406(a)(1), redesignated subsecs. (b) and (c) as (d) and (e), respectively.

Subsecs. (f), (g). Pub. L. 105–115, §406(b), added subsecs. (f) and (g).

1988—Subsec. (b)(2). Pub. L. 100–690 substituted “shall be responsible for executing this chapter and” for “shall be responsible”.

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Effective Date

Pub. L. 100–607, title V, §503(c), Nov. 4, 1988, 102 Stat. 3121, provided that:

“(1) Except as provided in paragraph (2), the amendments made by this title [enacting this section and amending sections 5315 and 5316 of Title 5, Government Organization and Employees] shall take effect on the date of enactment of this Act [Nov. 4, 1988].

“(2) Section 903(b)(1) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a) of this section) [now 1003(d)(1), 21 U.S.C. 393(b)(1)] shall apply to the appointments of Commissioners of Food and Drugs made after the date of enactment of this Act.”

Office of Minor Use and Minor Species Animal Drug Development

Pub. L. 108–282, title I, §102(b)(7), Aug. 2, 2004, 118 Stat. 905, provided that: “The Secretary of Health and Human Services shall establish within the Center for Veterinary Medicine (of the Food and Drug Administration), an Office of Minor Use and Minor Species Animal Drug Development that reports directly to the Director of the Center for Veterinary Medicine. This office shall be responsible for overseeing the development and legal marketing of new animal drugs for minor uses and minor species. There is authorized to be appropriated to carry out this subsection $1,200,000 for fiscal year 2004 and such sums as may be necessary for each fiscal year thereafter.”

Regulations for Sunscreen Products

Section 129 of Pub. L. 105–115 provided that: “Not later than 18 months after the date of enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall issue regulations for over-the-counter sunscreen products for the prevention or treatment of sunburn.”

Construction of 2011 Amendment

Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

FDA Study of Mercury Compounds in Drugs and Food

Section 413 of Pub. L. 105–115 provided that:

“(a) List and Analysis.—The Secretary of Health and Human Services shall, acting through the Food and Drug Administration—

“(1) compile a list of drugs and foods that contain intentionally introduced mercury compounds, and

“(2) provide a quantitative and qualitative analysis of the mercury compounds in the list under paragraph (1).

The Secretary shall compile the list required by paragraph (1) within 2 years after the date of enactment of the Food and Drug Administration Modernization Act of 1997 [Nov. 21, 1997] and shall provide the analysis required by paragraph (2) within 2 years after such date of enactment.

“(b) Study.—The Secretary of Health and Human Services, acting through the Food and Drug Administration, shall conduct a study of the effect on humans of the use of mercury compounds in nasal sprays. Such study shall include data from other studies that have been made of such use.

“(c) Study of Mercury Sales.—

“(1) Study.—The Secretary of Health and Human Services, acting through the Food and Drug Administration and subject to appropriations, shall conduct, or shall contract with the Institute of Medicine of the National Academy of Sciences to conduct, a study of the effect on humans of the use of elemental, organic, or inorganic mercury when offered for sale as a drug or dietary supplement. Such study shall, among other things, evaluate—

“(A) the scope of mercury use as a drug or dietary supplement; and

“(B) the adverse effects on health of children and other sensitive populations resulting from exposure to, or ingestion or inhalation of, mercury when so used.

In conducting such study, the Secretary shall consult with the Administrator of the Environmental Protection Agency, the Chair of the Consumer Product Safety Commission, and the Administrator of the Agency for Toxic Substances and Disease Registry, and, to the extent the Secretary believes necessary or appropriate, with any other Federal or private entity.

“(2) Regulations.—If, in the opinion of the Secretary, the use of elemental, organic, or inorganic mercury offered for sale as a drug or dietary supplement poses a threat to human health, the Secretary shall promulgate regulations restricting the sale of mercury intended for such use. At a minimum, such regulations shall be designed to protect the health of children and other sensitive populations from adverse effects resulting from exposure to, or ingestion or inhalation of, mercury. Such regulations, to the extent feasible, should not unnecessarily interfere with the availability of mercury for use in religious ceremonies.”

Management Activities Study

Pub. L. 102–571, title II, §205, Oct. 29, 1992, 106 Stat. 4502, directed Comptroller General to conduct a study of management of activities of the Food and Drug Administration that are related to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances and submit an interim report to Congress, not later than 6 months after Oct. 29, 1992, with a final report to be submitted not later than 12 months after Oct. 29, 1992.

Congressional Findings

Section 502 of Pub. L. 100–607 provided that: “Congress finds that—

“(1) the public health has been effectively protected by the presence of the Food and Drug Administration during the last eighty years;

“(2) the presence and importance of the Food and Drug Administration must be guaranteed; and

“(3) the independence and integrity of the Food and Drug Administration need to be enhanced in order to ensure the continuing protection of the public health.”

§393a. Office of Pediatric Therapeutics

(a) Establishment

The Secretary of Health and Human Services shall establish an Office of Pediatric Therapeutics within the Food and Drug Administration.

(b) Duties

The Office of Pediatric Therapeutics shall be responsible for coordination and facilitation of all activities of the Food and Drug Administration that may have any effect on a pediatric population or the practice of pediatrics or may in any other way involve pediatric issues, including increasing pediatric access to medical devices.

(c) Staff

The staff of the Office of Pediatric Therapeutics shall coordinate with employees of the Department of Health and Human Services who exercise responsibilities relating to pediatric therapeutics and shall include—

(1) one or more additional individuals with expertise concerning ethical issues presented by the conduct of clinical research in the pediatric population; and

(2) one or more additional individuals with expertise in pediatrics as may be necessary to perform the activities described in subsection (b) of this section.

(Pub. L. 107–109, §6, Jan. 4, 2002, 115 Stat. 1414; Pub. L. 110–85, title III, §306(a), Sept. 27, 2007, 121 Stat. 864.)

Codification

Section was enacted as part of the Best Pharmaceuticals for Children Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Amendments

2007—Subsec. (b). Pub. L. 110–85 inserted “, including increasing pediatric access to medical devices” before period at end.

§394. Scientific review groups

Without regard to the provisions of title 5 governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, the Commissioner of Food and Drugs may—

(1) establish such technical and scientific review groups as are needed to carry out the functions of the Food and Drug Administration (including functions prescribed under this chapter); and

(2) appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups.

(June 25, 1938, ch. 675, §1004, formerly §903, as added Pub. L. 101–635, title III, §301, Nov. 28, 1990, 104 Stat. 4584; renumbered §904, Pub. L. 103–43, title XX, §2006(1), June 10, 1993, 107 Stat. 209; renumbered §1004, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

§395. Loan repayment program

(a) In general

(1) Authority for program

Subject to paragraph (2), the Secretary shall carry out a program of entering into contracts with appropriately qualified health professionals under which such health professionals agree to conduct research, as employees of the Food and Drug Administration, in consideration of the Federal Government agreeing to repay, for each year of such service, not more than $20,000 of the principal and interest of the educational loans of such health professionals.

(2) Limitation

The Secretary may not enter into an agreement with a health professional pursuant to paragraph (1) unless such professional—

(A) has a substantial amount of educational loans relative to income; and

(B) agrees to serve as an employee of the Food and Drug Administration for purposes of paragraph (1) for a period of not less than 3 years.

(b) Applicability of certain provisions

With respect to the National Health Service Corps Loan Repayment Program established in subpart III of part D of title III of the Public Health Service Act [42 U.S.C. 254l et seq.], the provisions of such subpart shall, except as inconsistent with subsection (a) of this section, apply to the program established in such subsection in the same manner and to the same extent as such provisions apply to the National Health Service Corps Loan Repayment Program.

(c) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1994 through 1996.

(June 25, 1938, ch. 675, §1005, formerly §905, as added Pub. L. 103–43, title XX, §2006(2), June 10, 1993, 107 Stat. 210; renumbered §1005, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

References in Text

The Public Health Service Act, referred to in subsec. (b), is act July 1, 1944, ch. 373, 58 Stat. 682, as amended. Subpart III of part D of title III of the Act is classified generally to subpart III [§254l et seq.] of part D of subchapter II of chapter 6A of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

§396. Practice of medicine

Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.

(June 25, 1938, ch. 675, §1006, formerly §906, as added Pub. L. 105–115, title II, §214, Nov. 21, 1997, 111 Stat. 2348; renumbered §1006, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

§397. Contracts for expert review

(a) In general

(1) Authority

The Secretary may enter into a contract with any organization or any individual (who is not an employee of the Department) with relevant expertise, to review and evaluate, for the purpose of making recommendations to the Secretary on, part or all of any application or submission (including a petition, notification, and any other similar form of request) made under this chapter for the approval or classification of an article or made under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) with respect to a biological product. Any such contract shall be subject to the requirements of section 379 of this title relating to the confidentiality of information.

(2) Increased efficiency and expertise through contracts

The Secretary may use the authority granted in paragraph (1) whenever the Secretary determines that use of a contract described in paragraph (1) will improve the timeliness of the review of an application or submission described in paragraph (1), unless using such authority would reduce the quality, or unduly increase the cost, of such review. The Secretary may use such authority whenever the Secretary determines that use of such a contract will improve the quality of the review of an application or submission described in paragraph (1), unless using such authority would unduly increase the cost of such review. Such improvement in timeliness or quality may include providing the Secretary increased scientific or technical expertise that is necessary to review or evaluate new therapies and technologies.

(b) Review of expert review

(1) In general

Subject to paragraph (2), the official of the Food and Drug Administration responsible for any matter for which expert review is used pursuant to subsection (a) of this section shall review the recommendations of the organization or individual who conducted the expert review and shall make a final decision regarding the matter in a timely manner.

(2) Limitation

A final decision by the Secretary on any such application or submission shall be made within the applicable prescribed time period for review of the matter as set forth in this chapter or in the Public Health Service Act (42 U.S.C. 201 et seq.).

(June 25, 1938, ch. 675, §1007, formerly §907, as added Pub. L. 105–115, title IV, §415, Nov. 21, 1997, 111 Stat. 2377; renumbered §1007, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

References in Text

The Public Health Service Act, referred to in subsec. (b)(2), is act July 1, 1944, ch. 373, 58 Stat. 682, as amended, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

§398. Notices to States regarding imported food

(a) In general

If the Secretary has credible evidence or information indicating that a shipment of imported food or portion thereof presents a threat of serious adverse health consequences or death to humans or animals, the Secretary shall provide notice regarding such threat to the States in which the food is held or will be held, and to the States in which the manufacturer, packer, or distributor of the food is located, to the extent that the Secretary has knowledge of which States are so involved. In providing notice to a State, the Secretary shall request the State to take such action as the State considers appropriate, if any, to protect the public health regarding the food involved.

(b) Rule of construction

Subsection (a) of this section may not be construed as limiting the authority of the Secretary with respect to food under any other provision of this chapter.

(June 25, 1938, ch. 675, §1008, formerly §908, as added Pub. L. 107–188, title III, §310, June 12, 2002, 116 Stat. 673; renumbered §1008, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

§399. Grants to enhance food safety

(a) In general

The Secretary is authorized to make grants to eligible entities to—

(1) undertake examinations, inspections, and investigations, and related food safety activities under section 372 of this title;

(2) train to the standards of the Secretary for the examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including as such examination, inspection, and investigation relate to retail food establishments;

(3) build the food safety capacity of the laboratories of such eligible entity, including the detection of zoonotic diseases;

(4) build the infrastructure and capacity of the food safety programs of such eligible entity to meet the standards as outlined in the grant application; and

(5) take appropriate action to protect the public health in response to—

(A) a notification under section 398 of this title, including planning and otherwise preparing to take such action; or

(B) a recall of food under this chapter.

(b) Eligible entities; application

(1) In general

In this section, the term “eligible entity” means an entity—

(A) that is—

(i) a State;

(ii) a locality;

(iii) a territory;

(iv) an Indian tribe (as defined in section 450b(e) of title 25); or

(v) a nonprofit food safety training entity that collaborates with 1 or more institutions of higher education; and


(B) that submits an application to the Secretary at such time, in such manner, and including such information as the Secretary may reasonably require.

(2) Contents

Each application submitted under paragraph (1) shall include—

(A) an assurance that the eligible entity has developed plans to engage in the types of activities described in subsection (a);

(B) a description of the types of activities to be funded by the grant;

(C) an itemization of how grant funds received under this section will be expended;

(D) a description of how grant activities will be monitored; and

(E) an agreement by the eligible entity to report information required by the Secretary to conduct evaluations under this section.

(c) Limitations

The funds provided under subsection (a) shall be available to an eligible entity that receives a grant under this section only to the extent such entity funds the food safety programs of such entity independently of any grant under this section in each year of the grant at a level equal to the level of such funding in the previous year, increased by the Consumer Price Index. Such non-Federal matching funds may be provided directly or through donations from public or private entities and may be in cash or in-kind, fairly evaluated, including plant, equipment, or services.

(d) Additional authority

The Secretary may—

(1) award a grant under this section in each subsequent fiscal year without reapplication for a period of not more than 3 years, provided the requirements of subsection (c) are met for the previous fiscal year; and

(2) award a grant under this section in a fiscal year for which the requirement of subsection (c) has not been met only if such requirement was not met because such funding was diverted for response to 1 or more natural disasters or in other extenuating circumstances that the Secretary may determine appropriate.

(e) Duration of awards

The Secretary may award grants to an individual grant recipient under this section for periods of not more than 3 years. In the event the Secretary conducts a program evaluation, funding in the second year or third year of the grant, where applicable, shall be contingent on a successful program evaluation by the Secretary after the first year.

(f) Progress and evaluation

(1) In general

The Secretary shall measure the status and success of each grant program authorized under the FDA Food Safety Modernization Act (and any amendment made by such Act), including the grant program under this section. A recipient of a grant described in the preceding sentence shall, at the end of each grant year, provide the Secretary with information on how grant funds were spent and the status of the efforts by such recipient to enhance food safety. To the extent practicable, the Secretary shall take the performance of such a grant recipient into account when determining whether to continue funding for such recipient.

(2) No duplication

In carrying out paragraph (1), the Secretary shall not duplicate the efforts of the Secretary under other provisions of this chapter or the FDA Food Safety Modernization Act that require measurement and review of the activities of grant recipients under either this chapter or such Act.

(g) Supplement not supplant

Grant funds received under this section shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this section.

(h) Authorization of appropriations

For the purpose of making grants under this section, there are authorized to be appropriated such sums as may be necessary for fiscal years 2011 through 2015.

(June 25, 1938, ch. 675, §1009, formerly §909, as added Pub. L. 107–188, title III, §311, June 12, 2002, 116 Stat. 673; renumbered §1009 and amended Pub. L. 111–31, div. A, title I, §§101(b)(2), 103(n), June 22, 2009, 123 Stat. 1784, 1838; Pub. L. 111–353, title II, §210(a), Jan. 4, 2011, 124 Stat. 3948.)

References in Text

The FDA Food Safety Modernization Act, referred to in subsec. (f), is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, which enacted chapter 27 (§2201 et seq.) and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables.

Amendments

2011—Pub. L. 111–353 amended section generally. Prior to amendment, section related to grants to States for inspections.

2009—Subsec. (b). Pub. L. 111–31, §103(n), made technical amendment to reference in original act which appears in text as reference to section 398 of this title.

Construction of 2011 Amendment

Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

§399a. Office of the Chief Scientist

(a) Establishment; appointment

The Secretary shall establish within the Office of the Commissioner an office to be known as the Office of the Chief Scientist. The Secretary shall appoint a Chief Scientist to lead such Office.

(b) Duties of the Office

The Office of the Chief Scientist shall—

(1) oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs of the Food and Drug Administration;

(2) track and, to the extent necessary, coordinate intramural research awards made by each center of the Administration or science-based office within the Office of the Commissioner, and ensure that there is no duplication of research efforts supported by the Reagan-Udall Foundation for the Food and Drug Administration;

(3) develop and advocate for a budget to support intramural research;

(4) develop a peer review process by which intramural research can be evaluated;

(5) identify and solicit intramural research proposals from across the Food and Drug Administration through an advisory board composed of employees of the Administration that shall include—

(A) representatives of each of the centers and the science-based offices within the Office of the Commissioner; and

(B) experts on trial design, epidemiology, demographics, pharmacovigilance, basic science, and public health; and


(6) develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed for premarket review.

(June 25, 1938, ch. 675, §1010, formerly §910, as added Pub. L. 110–85, title VI, §602, Sept. 27, 2007, 121 Stat. 898; renumbered §1010, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

§399b. Office of Women's Health

(a) Establishment

There is established within the Office of the Commissioner, an office to be known as the Office of Women's Health (referred to in this section as the “Office”). The Office shall be headed by a director who shall be appointed by the Commissioner of Food and Drugs.

(b) Purpose

The Director of the Office shall—

(1) report to the Commissioner of Food and Drugs on current Food and Drug Administration (referred to in this section as the “Administration”) levels of activity regarding women's participation in clinical trials and the analysis of data by sex in the testing of drugs, medical devices, and biological products across, where appropriate, age, biological, and sociocultural contexts;

(2) establish short-range and long-range goals and objectives within the Administration for issues of particular concern to women's health within the jurisdiction of the Administration, including, where relevant and appropriate, adequate inclusion of women and analysis of data by sex in Administration protocols and policies;

(3) provide information to women and health care providers on those areas in which differences between men and women exist;

(4) consult with pharmaceutical, biologics, and device manufacturers, health professionals with expertise in women's issues, consumer organizations, and women's health professionals on Administration policy with regard to women;

(5) make annual estimates of funds needed to monitor clinical trials and analysis of data by sex in accordance with needs that are identified; and

(6) serve as a member of the Department of Health and Human Services Coordinating Committee on Women's Health (established under section 237a(b)(4) of title 42).

(c) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.

(June 25, 1938, ch. 675, §1011, as added Pub. L. 111–148, title III, §3509(g), Mar. 23, 2010, 124 Stat. 536.)

Codification

Another section 1011 of act June 25, 1938, ch. 675, was enacted by Pub. L. 111–353, title II, §209(a), Jan. 4, 2011, 124 Stat. 3945, and is classified to section 399c of this title.

§399c. Improving the training of State, local, territorial, and tribal food safety officials

(a) Training

The Secretary shall set standards and administer training and education programs for the employees of State, local, territorial, and tribal food safety officials relating to the regulatory responsibilities and policies established by this chapter, including programs for—

(1) scientific training;

(2) training to improve the skill of officers and employees authorized to conduct inspections under sections 372 and 374 of this title;

(3) training to achieve advanced product or process specialization in such inspections;

(4) training that addresses best practices;

(5) training in administrative process and procedure and integrity issues;

(6) training in appropriate sampling and laboratory analysis methodology; and

(7) training in building enforcement actions following inspections, examinations, testing, and investigations.

(b) Partnerships with State and local officials

(1) In general

The Secretary, pursuant to a contract or memorandum of understanding between the Secretary and the head of a State, local, territorial, or tribal department or agency, is authorized and encouraged to conduct examinations, testing, and investigations for the purposes of determining compliance with the food safety provisions of this chapter through the officers and employees of such State, local, territorial, or tribal department or agency.

(2) Content

A contract or memorandum described under paragraph (1) shall include provisions to ensure adequate training of such officers and employees to conduct such examinations, testing, and investigations. The contract or memorandum shall contain provisions regarding reimbursement. Such provisions may, at the sole discretion of the head of the other department or agency, require reimbursement, in whole or in part, from the Secretary for the examinations, testing, or investigations performed pursuant to this section by the officers or employees of the State, territorial, or tribal department or agency.

(3) Effect

Nothing in this subsection shall be construed to limit the authority of the Secretary under section 372 of this title.

(c) Extension service

The Secretary shall ensure coordination with the extension activities of the National Institute of Food and Agriculture of the Department of Agriculture in advising producers and small processors transitioning into new practices required as a result of the enactment of the FDA Food Safety Modernization Act and assisting regulated industry with compliance with such Act.

(d) National Food Safety Training, Education, Extension, Outreach and Technical Assistance Program

(1) In general

In order to improve food safety and reduce the incidence of foodborne illness, the Secretary shall, not later than 180 days after January 4, 2011, enter into one or more memoranda of understanding, or enter into other cooperative agreements, with the Secretary of Agriculture to establish a competitive grant program within the National Institute for Food and Agriculture to provide food safety training, education, extension, outreach, and technical assistance to—

(A) owners and operators of farms;

(B) small food processors; and

(C) small fruit and vegetable merchant wholesalers.

(2) Implementation

The competitive grant program established under paragraph (1) shall be carried out in accordance with section 7625 of title 7.

(e) Authorization of appropriations

There are authorized to be appropriated such sums as may be necessary to carry out this section for fiscal years 2011 through 2015.

(June 25, 1938, ch. 675, §1011, as added Pub. L. 111–353, title II, §209(a), Jan. 4, 2011, 124 Stat. 3945.)

References in Text

The FDA Food Safety Modernization Act, referred to in subsec. (c), is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, which enacted chapter 27 (§2201 et seq.) and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables.

Codification

Another section 1011 of act June 25, 1938, ch. 675, was enacted by Pub. L. 111–148, title III, §3509(g), Mar. 23, 2010, 124 Stat. 536, and is classified to section 399b of this title.

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

§399d. Employee protections

(a) In general

No entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food may discharge an employee or otherwise discriminate against an employee with respect to compensation, terms, conditions, or privileges of employment because the employee, whether at the employee's initiative or in the ordinary course of the employee's duties (or any person acting pursuant to a request of the employee)—

(1) provided, caused to be provided, or is about to provide or cause to be provided to the employer, the Federal Government, or the attorney general of a State information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of any provision of this chapter or any order, rule, regulation, standard, or ban under this chapter, or any order, rule, regulation, standard, or ban under this chapter; 1

(2) testified or is about to testify in a proceeding concerning such violation;

(3) assisted or participated or is about to assist or participate in such a proceeding; or

(4) objected to, or refused to participate in, any activity, policy, practice, or assigned task that the employee (or other such person) reasonably believed to be in violation of any provision of this chapter, or any order, rule, regulation, standard, or ban under this chapter.

(b) Process

(1) In general

A person who believes that he or she has been discharged or otherwise discriminated against by any person in violation of subsection (a) may, not later than 180 days after the date on which such violation occurs, file (or have any person file on his or her behalf) a complaint with the Secretary of Labor (referred to in this section as the “Secretary”) alleging such discharge or discrimination and identifying the person responsible for such act. Upon receipt of such a complaint, the Secretary shall notify, in writing, the person named in the complaint of the filing of the complaint, of the allegations contained in the complaint, of the substance of evidence supporting the complaint, and of the opportunities that will be afforded to such person under paragraph (2).

(2) Investigation

(A) In general

Not later than 60 days after the date of receipt of a complaint filed under paragraph (1) and after affording the complainant and the person named in the complaint an opportunity to submit to the Secretary a written response to the complaint and an opportunity to meet with a representative of the Secretary to present statements from witnesses, the Secretary shall initiate an investigation and determine whether there is reasonable cause to believe that the complaint has merit and notify, in writing, the complainant and the person alleged to have committed a violation of subsection (a) of the Secretary's findings.

(B) Reasonable cause found; preliminary order

If the Secretary concludes that there is reasonable cause to believe that a violation of subsection (a) has occurred, the Secretary shall accompany the Secretary's findings with a preliminary order providing the relief prescribed by paragraph (3)(B). Not later than 30 days after the date of notification of findings under this paragraph, the person alleged to have committed the violation or the complainant may file objections to the findings or preliminary order, or both, and request a hearing on the record. The filing of such objections shall not operate to stay any reinstatement remedy contained in the preliminary order. Any such hearing shall be conducted expeditiously. If a hearing is not requested in such 30-day period, the preliminary order shall be deemed a final order that is not subject to judicial review.

(C) Dismissal of complaint

(i) Standard for complainant

The Secretary shall dismiss a complaint filed under this subsection and shall not conduct an investigation otherwise required under subparagraph (A) unless the complainant makes a prima facie showing that any behavior described in paragraphs (1) through (4) of subsection (a) was a contributing factor in the unfavorable personnel action alleged in the complaint.

(ii) Standard for employer

Notwithstanding a finding by the Secretary that the complainant has made the showing required under clause (i), no investigation otherwise required under subparagraph (A) shall be conducted if the employer demonstrates, by clear and convincing evidence, that the employer would have taken the same unfavorable personnel action in the absence of that behavior.

(iii) Violation standard

The Secretary may determine that a violation of subsection (a) has occurred only if the complainant demonstrates that any behavior described in paragraphs (1) through (4) of subsection (a) was a contributing factor in the unfavorable personnel action alleged in the complaint.

(iv) Relief standard

Relief may not be ordered under subparagraph (A) if the employer demonstrates by clear and convincing evidence that the employer would have taken the same unfavorable personnel action in the absence of that behavior.

(3) Final order

(A) In general

Not later than 120 days after the date of conclusion of any hearing under paragraph (2), the Secretary shall issue a final order providing the relief prescribed by this paragraph or denying the complaint. At any time before issuance of a final order, a proceeding under this subsection may be terminated on the basis of a settlement agreement entered into by the Secretary, the complainant, and the person alleged to have committed the violation.

(B) Content of order

If, in response to a complaint filed under paragraph (1), the Secretary determines that a violation of subsection (a) has occurred, the Secretary shall order the person who committed such violation—

(i) to take affirmative action to abate the violation;

(ii) to reinstate the complainant to his or her former position together with compensation (including back pay) and restore the terms, conditions, and privileges associated with his or her employment; and

(iii) to provide compensatory damages to the complainant.

(C) Penalty

If such an order is issued under this paragraph, the Secretary, at the request of the complainant, shall assess against the person against whom the order is issued a sum equal to the aggregate amount of all costs and expenses (including attorneys’ and expert witness fees) reasonably incurred, as determined by the Secretary, by the complainant for, or in connection with, the bringing of the complaint upon which the order was issued.

(D) Bad faith claim

If the Secretary finds that a complaint under paragraph (1) is frivolous or has been brought in bad faith, the Secretary may award to the prevailing employer a reasonable attorneys’ fee, not exceeding $1,000, to be paid by the complainant.

(4) Action in court

(A) In general

If the Secretary has not issued a final decision within 210 days after the filing of the complaint, or within 90 days after receiving a written determination, the complainant may bring an action at law or equity for de novo review in the appropriate district court of the United States with jurisdiction, which shall have jurisdiction over such an action without regard to the amount in controversy, and which action shall, at the request of either party to such action, be tried by the court with a jury. The proceedings shall be governed by the same legal burdens of proof specified in paragraph (2)(C).

(B) Relief

The court shall have jurisdiction to grant all relief necessary to make the employee whole, including injunctive relief and compensatory damages, including—

(i) reinstatement with the same seniority status that the employee would have had, but for the discharge or discrimination;

(ii) the amount of back pay, with interest; and

(iii) compensation for any special damages sustained as a result of the discharge or discrimination, including litigation costs, expert witness fees, and reasonable attorney's fees.

(5) Review

(A) In general

Unless the complainant brings an action under paragraph (4), any person adversely affected or aggrieved by a final order issued under paragraph (3) may obtain review of the order in the United States Court of Appeals for the circuit in which the violation, with respect to which the order was issued, allegedly occurred or the circuit in which the complainant resided on the date of such violation. The petition for review must be filed not later than 60 days after the date of the issuance of the final order of the Secretary. Review shall conform to chapter 7 of title 5. The commencement of proceedings under this subparagraph shall not, unless ordered by the court, operate as a stay of the order.

(B) No judicial review

An order of the Secretary with respect to which review could have been obtained under subparagraph (A) shall not be subject to judicial review in any criminal or other civil proceeding.

(6) Failure to comply with order

Whenever any person has failed to comply with an order issued under paragraph (3), the Secretary may file a civil action in the United States district court for the district in which the violation was found to occur, or in the United States district court for the District of Columbia, to enforce such order. In actions brought under this paragraph, the district courts shall have jurisdiction to grant all appropriate relief including, but not limited to, injunctive relief and compensatory damages.

(7) Civil action to require compliance

(A) In general

A person on whose behalf an order was issued under paragraph (3) may commence a civil action against the person to whom such order was issued to require compliance with such order. The appropriate United States district court shall have jurisdiction, without regard to the amount in controversy or the citizenship of the parties, to enforce such order.

(B) Award

The court, in issuing any final order under this paragraph, may award costs of litigation (including reasonable attorneys’ and expert witness fees) to any party whenever the court determines such award is appropriate.

(c) Effect of section

(1) Other laws

Nothing in this section preempts or diminishes any other safeguards against discrimination, demotion, discharge, suspension, threats, harassment, reprimand, retaliation, or any other manner of discrimination provided by Federal or State law.

(2) Rights of employees

Nothing in this section shall be construed to diminish the rights, privileges, or remedies of any employee under any Federal or State law or under any collective bargaining agreement. The rights and remedies in this section may not be waived by any agreement, policy, form, or condition of employment.

(d) Enforcement

Any nondiscretionary duty imposed by this section shall be enforceable in a mandamus proceeding brought under section 1361 of title 28.

(e) Limitation

Subsection (a) shall not apply with respect to an employee of an entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food who, acting without direction from such entity (or such entity's agent), deliberately causes a violation of any requirement relating to any violation or alleged violation of any order, rule, regulation, standard, or ban under this chapter.

(June 25, 1938, ch. 675, §1012, as added Pub. L. 111–353, title IV, §402, Jan. 4, 2011, 124 Stat. 3968.)

Construction

Nothing in this section to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title.

1 So in original.