[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2001 Edition]
[From the U.S. Government Printing Office]



[[Page i]]

          

                    21


          Parts 1 to 99

                         Revised as of April 1, 2001

Food and Drugs





          Containing a codification of documents of general 
          applicability and future effect
          As of April 1, 2001
          With Ancillaries
          Published by
          Office of the Federal Register
          National Archives and Records
          Administration

A Special Edition of the Federal Register



[[Page ii]]

                                      




                     U.S. GOVERNMENT PRINTING OFFICE
                            WASHINGTON : 2001



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[[Page iii]]




                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  Title 21:
          Chapter I--Food and Drug Administration, Department 
          of Health and Human Services                               3
  Finding Aids:
      Material Approved for Incorporation by Reference........     457
      Table of CFR Titles and Chapters........................     459
      Alphabetical List of Agencies Appearing in the CFR......     477
      List of CFR Sections Affected...........................     487



[[Page iv]]


      


                     ----------------------------

                     Cite this Code:  CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 21 CFR 1.1 refers to 
                       title 21, part 1, section 
                       1.

                     ----------------------------

[[Page v]]



                               EXPLANATION

    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.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, April 1, 2001), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

    Each volume of the Code contains amendments published in the Federal 
Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
dates and effective dates are usually not the same and care must be 
exercised by the user in determining the actual effective date. In 
instances where the effective date is beyond the cut-off date for the 
Code a note has been inserted to reflect the future effective date. In 
those instances where a regulation published in the Federal Register 
states a date certain for expiration, an appropriate note will be 
inserted following the text.

OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

OBSOLETE PROVISIONS

    Provisions that become obsolete before the revision date stated on 
the cover of each volume are not carried. Code users may find the text 
of provisions in effect on a given date in the past by using the 
appropriate numerical list of sections affected. For the period before 
January 1, 1986, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, or 1973-1985, published in seven separate volumes. For 
the period beginning January 1, 1986, a ``List of CFR Sections 
Affected'' is published at the end of each CFR volume.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
valid, the Director of the Federal Register must approve it. The legal 
effect of incorporation by reference is that the material is treated as 
if it were published in full in the Federal Register (5 U.S.C. 552(a)). 
This material, like any other properly issued regulation, has the force 
of law.
    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    Properly approved incorporations by reference in this volume are 
listed in the Finding Aids at the end of this volume.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed in 
the Finding Aids of this volume as an approved incorporation by 
reference, please contact the agency that issued the regulation 
containing that incorporation. If, after contacting the agency, you find 
the material is not available, please notify the Director of the Federal 
Register, National Archives and Records Administration, Washington DC 
20408, or call (202) 523-4534.

CFR INDEXES AND TABULAR GUIDES

    A subject index to the Code of Federal Regulations is contained in a 
separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Statutory 
Authorities and Agency Rules (Table I). A list of CFR titles, chapters, 
and parts and an alphabetical list of agencies publishing in the CFR are 
also included in this volume.
    An index to the text of ``Title 3--The President'' is carried within 
that volume.
    The Federal Register Index is issued monthly in cumulative form. 
This index is based on a consolidation of the ``Contents'' entries in 
the daily Federal Register.
    A List of CFR Sections Affected (LSA) is published monthly, keyed to 
the revision dates of the 50 CFR titles.

[[Page vii]]


REPUBLICATION OF MATERIAL

    There are no restrictions on the republication of material appearing 
in the Code of Federal Regulations.

INQUIRIES

    For a legal interpretation or explanation of any regulation in this 
volume, contact the issuing agency. The issuing agency's name appears at 
the top of odd-numbered pages.
    For inquiries concerning CFR reference assistance, call 202-523-5227 
or write to the Director, Office of the Federal Register, National 
Archives and Records Administration, Washington, DC 20408 or e-mail 
info@fedreg.nara.gov.

SALES

    The Government Printing Office (GPO) processes all sales and 
distribution of the CFR. For payment by credit card, call 202-512-1800, 
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a day. For payment by check, write to the Superintendent of Documents, 
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Customer Service call 202-512-1803.

ELECTRONIC SERVICES

    The full text of the Code of Federal Regulations, the LSA (List of 
CFR Sections Affected), The United States Government Manual, the Federal 
Register, Public Laws, Public Papers, Weekly Compilation of Presidential 
Documents and the Privacy Act Compilation are available in electronic 
format at www.access.gpo.gov/nara (``GPO Access''). For more 
information, contact Electronic Information Dissemination Services, U.S. 
Government Printing Office. Phone 202-512-1530, or 888-293-6498 (toll-
free). E-mail, gpoaccess@gpo.gov.
    The Office of the Federal Register also offers a free service on the 
National Archives and Records Administration's (NARA) World Wide Web 
site for public law numbers, Federal Register finding aids, and related 
information. Connect to NARA's web site at www.nara.gov/fedreg. The NARA 
site also contains links to GPO Access.

                              Raymond A. Mosley,
                                    Director,
                          Office of the Federal Register.

April 1, 2001.



[[Page ix]]



                               THIS TITLE

    Title 21--Food and Drugs is composed of nine volumes. The parts in 
these volumes are arranged in the following order: Parts 1-99, 100-169, 
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-end. The 
first eight volumes, containing parts 1-1299, comprise Chapter I--Food 
and Drug Administration, Department of Health and Human Services. The 
ninth volume, containing part 1300 to end, includes Chapter II--Drug 
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes 
represent all current regulations codified under this title of the CFR 
as of April 1, 2001.

    Redesignation tables for Chapter I--Food and Drug Administration 
appear in the Finding Aids section for the volumes containing parts 170-
199 and 500-599.

[[Page x]]





[[Page 1]]



                        TITLE 21--FOOD AND DRUGS




                   (This book contains parts 1 to 99)

  --------------------------------------------------------------------
                                                                    Part

chapter i --Food and Drug Administration, Department of 
  Health and Human Services.................................           1

Cross References: 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.

[[Page 3]]



CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES




  --------------------------------------------------------------------

                          SUBCHAPTER A--GENERAL
Part                                                                Page
1               General enforcement regulations.............           5
2               General administrative rulings and decisions          14
3               Product jurisdiction........................          20
5               Delegations of authority and organization...          24
7               Enforcement policy..........................          72
10              Administrative practices and procedures.....          81
11              Electronic records; electronic signatures...         119
12              Formal evidentiary public hearing...........         122
13              Public hearing before a public board of 
                    inquiry.................................         140
14              Public hearing before a public advisory 
                    committee...............................         144
15              Public hearing before the Commissioner......         171
16              Regulatory hearing before the Food and Drug 
                    Administration..........................         174
17              Civil money penalties hearings..............         180
19              Standards of conduct and conflicts of 
                    interest................................         192
20              Public information..........................         194
21              Protection of privacy.......................         223
25              Environmental impact considerations.........         239
26              Mutual recognition of pharmaceutical good 
                    manufacturing practice reports, medical 
                    device quality system audit reports, and 
                    certain medical device product 
                    evaluation reports: United States and 
                    The European Community..................         250
50              Protection of human subjects................         282
54              Financial disclosure by clinical 
                    investigators...........................         291
56              Institutional Review Boards.................         294
58              Good laboratory practice for nonclinical 
                    laboratory studies......................         302
60              Patent term restoration.....................         316
70              Color additives.............................         324
71              Color additive petitions....................         331

[[Page 4]]

73              Listing of color additives exempt from 
                    certification...........................         338
74              Listing of color additives subject to 
                    certification...........................         385
80              Color additive certification................         424
81              General specifications and general 
                    restrictions for provisional color 
                    additives for use in foods, drugs, and 
                    cosmetics...............................         430
82              Listing of certified provisionally listed 
                    colors and specifications...............         437
83-98

[Reserved]

99              Dissemination of information on unapproved/
                    new uses for marketed drugs, biologics, 
                    and devices.............................         442


  Editorial Note: For nomenclature changes to chapter I see 59 FR 14366, 
Mar. 28, 1994.

[[Page 5]]





                          SUBCHAPTER A--GENERAL



PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents




                      Subpart A--General Provisions

Sec.
1.1  General.
1.3  Definitions.
1.4  Authority citations.

                Subpart B--General Labeling Requirements

1.20  Presence of mandatory label information.
1.21  Failure to reveal material facts.
1.23  Procedures for requesting variations and exemptions from required 
          label statements.
1.24  Exemptions from required label statements.

Subparts C-D  [Reserved]

                     Subpart E--Imports and Exports

1.83  Definitions.
1.90  Notice of sampling.
1.91  Payment for samples.
1.94  Hearing on refusal of admission.
1.95  Application for authorization to relabel and recondition.
1.96  Granting of authorization to relabel and recondition.
1.97  Bonds.
1.99  Costs chargeable in connection with relabeling and reconditioning 
          inadmissible imports.

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 343, 352, 355, 
360b, 362, 371; 42 U.S.C. 216.

    Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 1.1  General.

    (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 package in Sec. 1.20 and of principal display 
panel in Secs. 101.1, 201.60, 501.1, 701.10 and 801.60 of this chapter; 
and the requirements pertaining to uniform location, lack of 
qualification, and separation of the net quantity declaration in 
Secs. 101.105(f), 201.62(e), 501.105(f), 701.13(f) and 801.62(e) of this 
chapter to type size requirements for net quantity declaration in 
Secs. 101.105(i), 201.62(h), 501.105(i), 701.13(i) and 801.62(h) of this 
chapter, to initial statement of ounces in the dual declaration of net 
quantity in Secs. 101.105(j) and (m), 201.62(i) and (k), 501.105(j) and 
(m), 701.13(j) and (m) and 801.62(i) and (k) of this chapter, to initial 
statement of inches in declaration of net quantity in Secs. 201.62(m), 
701.13(o) and 801.62(m) of this chapter, to initial statement of square 
inches in declaration of net quantity in Secs. 201.62(n), 701.13(p) and 
801.62(n) of this chapter, to prohibition of certain supplemental net 
quantity statements in Secs. 101.105(o), 201.62(o), 501.105(o), 
701.13(q) and 801.62(o) of this chapter, and to servings representations 
in Sec. 501.8 of this chapter are provided for solely by the Fair 
Packaging and Labeling Act. The other requirements of this part are 
issued under both the Fair Packaging and Labeling Act and the Federal 
Food, Drug, and Cosmetic Act, or by the latter act solely, and are not 
limited in their application by section 10 of the Fair Packaging and 
Labeling Act.

[42 FR 15553, Mar. 22, 1977, as amended at 58 FR 17085, Apr. 1, 1993]



Sec. 1.3  Definitions.

    (a) Labeling includes all written, printed, or graphic matter 
accompanying an article at any time while such article is in interstate 
commerce or held for sale after shipment or delivery in interstate 
commerce.
    (b) Label means any display of written, printed, or graphic matter 
on the immediate container of any article, or any such matter affixed to 
any consumer commodity or affixed to or appearing upon a package 
containing any consumer commodity.

[[Page 6]]



Sec. 1.4  Authority citations.

    (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.

[54 FR 39630, Sept. 27, 1989]



                Subpart B--General Labeling Requirements



Sec. 1.20  Presence of mandatory label information.

    The term package means any container or wrapping in which any food, 
drug, device, or cosmetic is enclosed for use in the delivery or display 
of such commodities to retail purchasers, but does not include:
    (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 requirement contained in this part that any word, statement, or other 
information appear on the label shall not be considered to be complied 
with unless such word, statement, or information also appears on the 
outer container or wrapper of the retail package of the article, or, as 
stated in paragraph (e) of this section, such information is easily 
legible by virtue of the transparency of the outer wrapper or container. 
Where a consumer commodity is marketed in a multiunit retail package 
bearing the mandatory label information as required by this part and the 
unit containers are not intended to be sold separately, the net weight 
placement requirement of

[[Page 7]]

Sec. 101.105(f) applicable to such unit containers is waived if the 
units are in compliance with all the other requirements of this part.



Sec. 1.21  Failure to reveal material facts.

    (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.



Sec. 1.23  Procedures for requesting variations and exemptions from required label statements.

    Section 403(e) of the act (in this part 1, the term act means the 
Federal Food, Drug, and Cosmetic Act) provides for the establishment by 
regulation of reasonable variations and exemptions for small packages 
from the required declaration of net quantity of contents. Section 
403(i) of the act provides for the establishment by regulation of 
exemptions from the required declaration of ingredients where such 
declaration is impracticable, or results in deception or unfair 
competition. Section 502(b) of the act provides for the establishment by 
regulation of reasonable variations and exemptions for small packages 
from the required declaration of net quantity of contents. Section 
602(b) of the act provides for the establishment by regulation of 
reasonable variations and exemptions for small packages from the 
required declaration of net quantity of contents. Section 5(b) of the 
Fair Packaging and Labeling Act provides for the establishment by 
regulation of exemptions from certain required declarations of net 
quantity of contents, identity of commodity, identity and location of 
manufacturer, packer, or distributor, and from declaration of net 
quantity of servings represented, based on a finding that full 
compliance with such required declarations is impracticable or not 
necessary for the adequate protection of consumers, and a further 
finding that the nature, form, or quantity of the packaged consumer 
commodity or other good and sufficient reasons justify such exemptions. 
The Commissioner, on his own initiative or on petition of an interested 
person, may propose a variation or exemption based upon any of the 
foregoing statutory provisions, including proposed findings if section 
5(b) of the Fair Packaging and Labeling Act applies, pursuant to parts 
10, 12, 13, 14, 15, 16, and 19 of this chapter.



Sec. 1.24  Exemptions from required label statements.

    The following exemptions are granted from label statements required 
by this part:
    (a) Foods. (1) While held for sale, a food shall be exempt from the 
required declaration of net quantity of contents specified in this part 
if said food is received in bulk containers at a retail establishment 
and is accurately weighed, measured, or counted either within the view 
of the purchaser or in compliance with the purchaser's order.
    (2) Random food packages, as defined in Sec. 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,

[[Page 8]]

and placement requirements of Sec. 101.105 of this chapter if the 
accurate statement of net weight is presented conspicuously on the 
principal display panel of the package. In the case of food packed in 
random packages at one place for subsequent shipment and sale at 
another, the price sections of the label may be left blank provided they 
are filled in by the seller prior to retail sale. This exemption shall 
also apply to uniform weight packages of cheese and cheese products 
labeled in the same manner and by the same type of equipment as random 
food packages exempted by this paragraph (a)(2) except that the labels 
shall bear a declaration of price per pound and not price per specified 
number of pounds.
    (3) Individual serving-size packages of foods containing less than 
\1/2\ ounce or less than \1/2\ fluid ounce for use in restaurants, 
institutions, and passenger carriers, and not intended for sale at 
retail, shall be exempt from the required declaration of net quantity of 
contents specified in this part.
    (4) Individually wrapped pieces of penny candy and other 
confectionery of less than one-half ounce net weight per individual 
piece shall be exempt from the labeling requirements of this part when 
the container in which such confectionery is shipped is in conformance 
with the labeling requirements of this part. Similarly, when such 
confectionery items are sold in bags or boxes, such items shall be 
exempt from the labeling requirements of this part, including the 
required declaration of net quantity of contents specified in this part 
when the declaration on the bag or box meets the requirements of this 
part.
    (5)(i) Soft drinks packaged in bottles shall be exempt from the 
placement requirements for the statement of identity prescribed by 
Sec. 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 Sec. 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 
Sec. 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 Sec. 101.5 of this chapter. The 
declaration required by Sec. 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 
Sec. 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 Sec. 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 Sec. 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 Sec. 101.5 of this chapter. The 
declaration required by Sec. 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.

[[Page 9]]

    (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 \1/2\-
liquid pint and \1/2\-gallon measure-containers, as defined in the 
``Measure Container Code of National Bureau of Standards Handbook 44,'' 
Specifications, Tolerances, and Other Technical Requirements for 
Weighing and Measuring Devices, Sec. 4.45 ``Measure-Containers,'' which 
is incorporated by reference, are exempt from the requirements of 
Sec. 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 \1/2\ 
pint and \1/2\ gallon, respectively. Copies are available from the 
Center for Food Safety and Applied Nutrition (HFS-150), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street NW., suite 700, Washington, DC.
    (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 \1/2\-
gallon measure-containers, as defined in the ``Measure Container Code of 
National Bureau of Standards Handbook 44,'' Specifications, Tolerances, 
and Other Technical Requirements for Weighing and Measuring Devices, 
Sec. 4.45 ``Measure-Containers,'' which is incorporated by reference, 
are exempt from the dual net-contents declaration requirement of 
Sec. 101.105(j) of this chapter. Copies are available from the Center 
for Food Safety and Applied Nutrition (HFS-150), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street NW., suite 700, Washington, DC.
    (iii) The foods named in paragraph (a)(6)(i) of this section, when 
measured by and packaged in \1/2\-liquid pint, 1-liquid pint, 1-liquid 
quart, \1/2\-gallon, and 1-gallon measured-containers, as defined in the 
``Measure Container Code of National Bureau of Standards Handbook 44,'' 
Specifications, Tolerances, and Other Technical Requirements for 
Weighing and Measuring Devices, Sec. 4.45 ``Measure-Containers,'' which 
is incorporated by reference, are exempt from the requirement of 
Sec. 101.105(f) of this chapter that the declaration of net contents be 
located within the bottom 30 percent of the principal display panel. 
Copies are available from the Center for Food Safety and Applied 
Nutrition (HFS-150), Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204, or available for inspection at the Office of the 
Federal Register, 800 North Capitol Street NW., suite 700, Washington, 
DC.
    (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 Sec. 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 \1/2\ pint and \1/2\ gallon, respectively.
    (ii) The products listed in paragraph (a)(7)(i) of this section, 
when packaged in glass or plastic containers of \1/2\-pint, 1-pint, 1-
quart, \1/2\-gallon, and 1-gallon capacities are exempt from the 
placement requirement of Sec. 101.105(f) of this chapter that the 
declaration of net contents be located within the bottom 30 percent of 
the principal display panel, provided that other required label 
information is conspicuously displayed on the cap or outside closure and 
the required net quantity of contents declaration is conspicuously 
blown, formed, or molded into or permanently applied to that part of the 
glass or plastic container that is at or above the shoulder of the 
container.
    (iii) The products listed in paragraph (a)(7)(i) of this section, 
when packaged in containers of 1-pint, 1-quart, and \1/2\-

[[Page 10]]

gallon capacities are exempt from the dual net-contents declaration 
requirement of Sec. 101.105(j) of this chapter.
    (8) Wheat flour products, as defined by Secs. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 
Sec. 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 Secs. 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 Sec. 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 Sec. 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 Sec. 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 
Secs. 137.211, 137.215, and Secs. 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 Sec. 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 \1/2\-pint, 1-pint, 1-quart, \1/2\-gallon, and 
1-gallon capacities are exempt from the placement requirement of 
Sec. 101.105(f) of this chapter that the declaration of net contents be 
located within the bottom 30 percent of the principal display panel: 
Provided, That other required label information is conspicuously 
displayed on the cap or outside closure and the required net

[[Page 11]]

quantity of contents declaration is conspicuously blown, formed, or 
molded into or permanently applied to that part of the glass or plastic 
container that is at or above the shoulder of the container.
    (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 \1/2\-gallon capacities are exempt from the dual net-contents 
declaration requirement of Sec. 101.105(j) of this chapter.
    (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 
Sec. 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 \1/2\ 
pint (or half pint) and \1/2\ gallon (or half gallon), respectively.
    (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) Drugs. Liquid over-the-counter veterinary preparations intended 
for injection shall be exempt from the declaration of net quantity of 
contents in terms of the U.S. gallon of 231 cubic inches and quart, 
pint, and fluid-ounce subdivisions thereof as required by Sec. 201.62 
(b), (i), and (j) of this chapter, and from the dual declaration 
requirements of Sec. 201.62(i) of this chapter, if such declaration of 
net quantity of contents is expressed in terms of the liter and 
milliliter, or cubic centimeter, with the volume expressed at 68  deg.F 
(20  deg.C).
    (c) Cosmetics. Cosmetics in packages containing less than one-fourth 
ounce avoirdupois or one-eighth fluid ounce shall be exempt from 
compliance with the requirements of section 602(b)(2) of the Federal 
Food, Drug, and Cosmetic Act and section 4(a)(2) of the Fair Packaging 
and Labeling Act:
    (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.

[42 FR 15553, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 47 
FR 32421, July 27, 1982; 49 FR 13339, Apr. 4, 1984; 54 FR 9033, Mar. 3, 
1989; 58 FR 2174, Jan. 6, 1993; 61 FR 14478, Apr. 2, 1996]

Subparts C-D  [Reserved]



                     Subpart E--Imports and Exports



Sec. 1.83  Definitions.

    For the purposes of regulations prescribed under section 801(a), 
(b), and (c) of the Federal Food, Drug, and Cosmetic Act:
    (a) The term owner or consignee means the person who has the rights 
of a consignee under the provisions of sections 483, 484, and 485 of the 
Tariff Act of 1930, as amended (19 U.S.C. 1483, 1484, 1485).
    (b) The term district director means the director of the district of 
the Food and Drug Administration having jurisdiction over the port of 
entry through which an article is imported or offered for import, or 
such officer of the district as he may designate to act in his behalf in 
administering and enforcing the provisions of section 801 (a), (b), and 
(c).

[[Page 12]]



Sec. 1.90  Notice of sampling.

    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.



Sec. 1.91  Payment for samples.

    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 
Sec. 1.95.



Sec. 1.94  Hearing on refusal of admission.

    (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.



Sec. 1.95  Application for authorization to relabel and recondition.

    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.



Sec. 1.96  Granting of authorization to relabel and recondition.

    (a) When authorization contemplated by Sec. 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

[[Page 13]]

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.

[42 FR 15553, Mar. 22, 1977, as amended at 54 FR 9033, Mar. 3, 1989]



Sec. 1.97  Bonds.

    (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.



Sec. 1.99  Costs chargeable in connection with relabeling and reconditioning inadmissible imports.

    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:

 
                                                                  Hours
 
Gross number of working hours in 52 40-hr weeks................    2,080
Less:
  9 legal public holidays--New Years Day, Washington's                72
   Birthday, Memorial Day, Independence Day, Labor Day,
   Columbus Day, Veterans Day, Thanksgiving Day, and Christmas
   Day.........................................................
  Annual leave--26 d...........................................      208
  Sick leave--13 d.............................................      104
                                                                --------
      Total....................................................      384
      Net number of working hours..............................    1,696
Gross number of working hours in 52 40-hr weeks................    2,080
Working hour equivalent of Government contributions for              176
 employee retirement, life insurance, and health benefits
 computed at 8\1/2\ pct. of annual rate of pay of employee.....
                                                                --------
      Equivalent annual working hours..........................    2,256
                                                                --------
Support required to equal to 1 man-year........................    2,256
      Equivalent gross annual working hours charged to Food and    4,512
       Drug appropriation......................................
 


    Note: Ratio of equivalent gross annual number of working hours 
charged to Food and Drug appropriation to net number of annual working 
hours 4,512/1,696=266 pct.

    (e) The minimum charge for services of supervising officers and of 
analysts shall be not less than the charge for 1 hour, and time after 
the first hour shall be computed in multiples of 1

[[Page 14]]

hour, disregarding fractional parts less than \1/2\ hour.



PART 2--GENERAL ADMINISTRATIVE RULINGS AND DECISIONS--Table of Contents




                      Subpart A--General Provisions

Sec.
2.5  Imminent hazard to the public health.
2.10  Examination and investigation samples.
2.19  Methods of analysis.

                    Subpart B--Human and Animal Foods

2.25  Grain seed treated with poisonous substances; color identification 
          to prevent adulteration of human and animal food.
2.35  Use of secondhand containers for the shipment or storage of food 
          and animal feed.

Subparts C--E  [Reserved]

                       Subpart F--Caustic Poisons

2.110  Definition of ammonia under Federal Caustic Poison Act.

  Subpart G--Provisions Applicable to Specific Products Subject to the 
                  Federal Food, Drug, and Cosmetic Act

2.125  Use of chlorofluorocarbon propellants in self-pressurized 
          containers.

    Authority: 21 U.S.C. 321, 331, 335, 342, 346a, 348, 351, 352, 355, 
360b, 361, 371, 372, 374; 15 U.S.C. 402, 409.

    Source: 42 FR 15559, Mar. 22, 1977, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 2.5  Imminent hazard to the public health.

    (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 imminent hazard may be declared at 
any point in the chain of events which may ultimately result in harm to 
the public health. The occurrence of the final anticipated injury is not 
essential to establish that an imminent hazard of such occurrence 
exists.
    (b) In exercising his judgment on whether an imminent hazard exists, 
the Commissioner will consider the number of injuries anticipated and 
the nature, severity, and duration of the anticipated injury.



Sec. 2.10  Examination and investigation samples.

    (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 analysis includes examinations and 
tests.
    (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

[[Page 15]]

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.

In addition to the quantity of sample set forth in this paragraph, the 
officer or employee shall, if practicable, collect such further amount 
as he estimates will be sufficient for use as trial exhibits.
    (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

[[Page 16]]

quantity it estimates to be sufficient for analysis.

[42 FR 15559, Mar. 22, 1977, as amended at 63 FR 51299, Sept. 25, 1998]



Sec. 2.19  Methods of 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 Analytical Chemists, 2200 
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street NW., suite 700, Washington, DC. In the absence of an AOAC method, 
the Commissioner will furnish a copy of the particular method, or a 
reference to the published method, that the Food and Drug Administration 
will use in its enforcement program. Other methods may be used for 
quality control, specifications, contracts, surveys, and similar 
nonregulatory functions, but it is expected that they will be calibrated 
in terms of the method which the Food and Drug Administration uses in 
its enforcement program. Use of an AOAC method does not relieve the 
practioner of the responsibility to demonstrate that he can perform the 
method properly through the use of positive and negative controls and 
recovery and reproducibility studies.

[42 FR 15559, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 54 
FR 9034, Mar. 3, 1989]



                    Subpart B--Human and Animal Foods



Sec. 2.25  Grain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food.

    (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 
et seq.) in the labeling of the treated seed, the Food and Drug 
Administration has encountered many cases where such surplus stocks of 
treated wheat, corn, oats, rye, barley, and sorghum seed had been mixed 
with untreated seed and sent to market for food or feed use. This has 
resulted in livestock injury and in legal actions under the Federal 
Food, Drug, and Cosmetic Act against large quantities of food 
adulterated through such admixture of poisonous treated seeds with good 
food. Criminal cases were brought against some firms and individuals. 
Where the treated seeds are prominently colored, buyers and users or 
processors of agricultural food seed for food purposes are able to 
detect the admixture of the poisonous seed and thus reject the lots; but 
most such buyers, users, and processors do not have the facilities or 
scientific equipment to determine the presence of the poisonous chemical 
at the time crops are delivered, in cases where the treated seeds have 
not been so colored. A suitable color for this use is one that is in 
sufficient contrast to the natural color of the food seed as to make 
admixture of treated, denatured seeds with good food easily apparent, 
and is so applied that it is not readily removed.
    (b) On and after December 31, 1964, the Food and Drug Administration 
will

[[Page 17]]

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.



Sec. 2.35  Use of secondhand containers for the shipment or storage of food and animal feed.

    (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 storage and 
shipment of articles containing or bearing disease organisms or 
poisonous or deleterious substances.
    (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.

Subparts C-E  [Reserved]



                       Subpart F--Caustic Poisons



Sec. 2.110  Definition of ammonia under Federal Caustic Poison Act.

    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 NH3.



  Subpart G--Provisions Applicable to Specific Products Subject to the 
                  Federal Food, Drug, and Cosmetic Act



Sec. 2.125  Use of chlorofluorocarbon propellants in self-pressurized containers.

    (a) As used in this section:
    (1) Chlorofluorocarbon means any fully halogenated 
chlorofluoroalkane.
    (2) Propellant means a liquefied or compressed gas that is used in 
whole or in part to expel from the same self-pressurized container or 
from a separate container a liquid or solid material different from the 
propellant, but the term does not include the use of a 
chlorofluorocarbon as an aerating

[[Page 18]]

agent for foamed or sprayed food products.
    (b) Chlorofluorocarbons are widely used in products subject to the 
Federal Food, Drug, and Cosmetic Act, with the principal use being as 
propellants in self-pressurized containers. Information recently 
developed indicates that chlorofluorocarbons may reduce the amount of 
ozone in the stratosphere and thus increase the amount of ultraviolet 
radiation reaching the earth. An increase in ultraviolet radiation may 
increase the incidence of skin cancer, change the climate, and produce 
other effects of unknown magnitude on humans, animals, and plants. 
Chlorofluorocarbons may also affect the climate by increasing infrared 
absorption in the atmosphere.
    (c) Except as provided in paragraph (e) of this section, any food, 
drug, device, or cosmetic in a self-pressurized container that contains 
a chlorofluorocarbon propellant is adulterated and/or misbranded in 
violation of the act, and any drug product in a self-pressurized 
container that contains a chlorofluorocarbon propellant is a new drug or 
a new animal drug.
    (d) The use of a chlorofluorocarbon as a propellant in a self-
pressurized container of a drug product will not result in the drug 
product being adulterated and/or misbranded provided a new drug 
application, a new animal drug application, or in the case of a 
certifiable antibiotic an antibiotic application for the drug product 
has been approved, a petition has been filed as provided by paragraph 
(f) of this section, and paragraph (e) of this section has been amended 
to specify the use as essential.
    (e) The adulteration and misbranding provisions of paragraph (c) of 
this section shall not apply to the following essential uses of 
chlorofluorocarbons:
    (1) Metered-dose steriod human drugs for nasal inhalation,
    (2) Metered-dose steriod human drugs for oral inhalation,
    (3) Metered-dose adrenergic bronchodilator human drugs for oral 
inhalation,
    (4) Contraceptive vaginal foams for human use, and
    (5) Metered-dose ergotamine tartrate drug products administered by 
oral inhalation for use in humans.
    (6) Intrarectal hydrocortisone acetate for human use.
    (7) Polymyxin B sulfate-bacitracin zinc-neomycin sulfate soluble 
antibiotic powder without excipients, for topical use on humans.
    (8) Anesthetic drugs for topical use on accessible mucous membranes 
of humans where a cannula is used for application.
    (9) Metered-dose nitroglycerin human drugs administered to the oral 
cavity.
    (10) Metered-dose cromolyn sodium human drugs administered by oral 
inhalation.
    (11) Metered-dose ipratropium bromide for oral inhalation.
    (12) Metered-dose atropine sulfate aerosol human drugs administered 
by oral inhalation.
    (13) Metered-dose nedocromil sodium human drugs administered by oral 
inhalation.
    (14) Metered-dosed ipratropium bromide and albuterol sulfate, in 
combination, administered by oral inhalation for human use.
    (15) Sterile aerosol talc administered intrapleurally by 
thoracoscopy for human use.
    (f) Any person may file a petition in accordance with part 10 of 
this chapter to amend paragraph (e) of this section to specify a use of 
chlorofluorocarbons in a product as not being subject to the 
adulteration and misbranding provisions in paragraph (c) of this 
section. The petition must be supported by an adequate showing that:
    (1) There are no technically feasible alternatives to the use of a 
chlorofluorocarbon in the product,
    (2) The product provides a substantial health benefit, environmental 
benefit, or other public benefit that would not be obtainable without 
the use of the chlorofluorocarbon, and
    (3) The use does not involve a significant release of 
chlorofluorocarbons into the atmosphere or that the release is warranted 
in view of the consequence if the use were not permitted.
    (g) Any holder of an approved new drug application or new animal 
drug application for a drug product containing a chlorofluorocarbon in a 
self-pressurized container, except those drug products listed in 
paragraph (e) of this section, shall submit to the Food

[[Page 19]]

and Drug Administration on or before October 1, 1978, either a 
supplemental application providing for a revised formulation complying 
with the requirements of Sec. 314.70 or Sec. 514.8 of this chapter or a 
letter requesting that a new drug application or a new animal drug 
application for the drug product containing chlorofluorocarbon be 
withdrawn and that the right to a hearing on the withdrawal of the 
application is waived.
    (h)(1) Each manufacturer of a drug product listed in paragraph (e) 
of this section that is not covered by an approved new drug application 
shall submit a new drug application in accord with Sec. 314.50 of this 
chapter on or before June 15, 1978.
    (2) An abbreviated new drug application conforming to Sec. 314.94 of 
this chapter is acceptable in lieu of a full new drug application for 
any product included in the classes of products in paragraph (e) of this 
section if the product is one that is described under Sec. 314.92 of 
this chapter. A finding has been made that an abbreviated new drug 
application may be submitted for the following products included in the 
classes of products listed in paragraph (e) of this section:
    (i) Ergotamine tartrate supplied in a metered-dose aerosol form 
suitable for oral inhalation for the treatment of migraine headaches. 
Each measured dose must deliver a dose of the active ingredient 
equivalent to that contained in the product that has been the subject of 
a separate finding that an abbreviated new drug application is suitable.
    (ii) Isoproterenol hydrochloride supplied in a metered-dose aerosol 
form suitable for oral inhalation for use as an adrenergic 
bronchodilator. Each measured dose must deliver a dose of the active 
ingredient equivalent to that contained in the products that have been 
the subject of a separate finding that an abbreviated new drug 
application is suitable.
    (iii) Epinephrine, epinephrine bitartrate, or epinephrine 
hydrochloride (racemic) in a metered-dose aerosol form suitable for oral 
inhalation for use as an adrenergic bronchodilator. Each measured dose 
must deliver a dose of the active ingredient equivalent to that 
specified in an OTC proposed or final monograph issued under the 
provisions of 21 CFR part 330.
    (iv) Nonoxynol 9 in an aerosol foam suitable for vaginal 
administration as a contraceptive foam. The aerosol foam must contain 8 
to 12.5 percent of nonoxynol 9.
    (i) Any sponsor of an ``Investigational New Drug Application'' (IND) 
or ``Notice of Claimed Exemption for a New Animal Drug'' (INAD) for a 
drug product containing a chlorofluorocarbon shall:
    (1) Amend the IND or INAD on or before December 15, 1978, to revise 
the formulation removing the chlorofluorocarbon.
    (2) Submit the information required under paragraph (f) of this 
section to amend paragraph (e) of this section to show that the use of 
chlorofluorocarbon is essential, or
    (3) Submit the information required under paragraph (j) of this 
section requesting that studies with the drug product containing a 
chlorofluorocarbon propellant be allowed to be performed.
    (j) Any sponsor of an IND or INAD who wishes to initiate or continue 
a study beyond December 15, 1978 on a drug product containing a 
chlorofluorocarbon shall submit a petition in accordance with part 10 of 
this chapter requesting that studies be permitted to collect the data to 
show that the use of the chlorofluorocarbon is an essential use. The 
petitions must be supported by the following:
    (1) A description of the drug product,
    (2) An explanation why a chlorofluorocarbon propellant is used in 
the product rather than another propellant or another dosage form of the 
product, and
    (3) The benefit that the investigational product is believed to have 
and that the sponsor hopes to demonstrate by the studies.
    (k) The Commissioner will initiate action to withdraw approval of an 
application or terminate an IND or INAD notice in accordance with the 
applicable provisions of section 505 of the act and parts 312 and 314 of 
this chapter, or section 512 of the act and parts 511 and 514 of this 
chapter upon failure of a

[[Page 20]]

holder of an approved new drug application or approved new animal drug 
application or sponsor of an IND or INAD notice to comply with the 
applicable provisions of this section.
    (l) Food, drug, device, or cosmetic products manufactured or 
packaged on or after December 15, 1978, and finished products initially 
introduced into interstate commerce on or after April 15, 1979, shall 
comply with this regulation.

[43 FR 11316, Mar. 17, 1978, as amended at 44 FR 3961, Jan. 19, 1979; 44 
FR 30334, May 26, 1979; 45 FR 22902, April 4, 1980; 51 FR 4591, Feb. 6, 
1986; 52 FR 15717, Apr. 30, 1987; 54 FR 9034, Mar. 3, 1989; 55 FR 39267, 
Sept. 26, 1990; 57 FR 17980, Apr. 28, 1992; 58 FR 6088, Jan. 26, 1993; 
61 FR 15700, Apr. 9, 1996; 61 FR 25392, May 21, 1996]



PART 3--PRODUCT JURISDICTION--Table of Contents




   Subpart A--Assignment of Agency Component for Review of Premarket 
                              Applications

Sec.
3.1  Purpose.
3.2  Definitions.
3.3  Scope.
3.4  Designated agency component.
3.5  Procedures for identifying the designated agency component.
3.6  Product jurisdiction officer.
3.7  Request for designation.
3.8  Letter of designation.
3.9  Effect of letter of designation.
3.10  Stay of review time.

Subpart B  [Reserved]

    Authority: 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.

    Source: 56 FR 58756, Nov. 21, 1991, unless otherwise noted.



   Subpart A--Assignment of Agency Component for Review of Premarket 
                              Applications



Sec. 3.1  Purpose.

    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.



Sec. 3.2  Definitions.

    For the purpose of this part:
    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) Agency component means the Center for Biologics Evaluation and 
Research, the Center for Devices and Radiological Health, or the Center 
for Drug Evaluation and Research.
    (c) Applicant means any person who submits or plans to submit an 
application to the Food and Drug Administration for premarket review. 
For purposes of this section, the terms ``sponsor'' and ``applicant'' 
have the same meaning.
    (d) Biological product has the meaning given the term in section 
351(a) of the Public Health Service Act (42 U.S.C. 262(a)).
    (e) Combination product includes:
    (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

[[Page 21]]

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 an approved individually specified drug, device, or 
biological product where both are required to achieve the intended use, 
indication, or effect and where upon approval of the proposed product 
the labeling of the approved product would need to be changed, e.g., to 
reflect a change in intended use, dosage form, strength, route of 
administration, or significant change in dose; or
    (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) Device has the meaning given the term in section 201(h) of the 
act.
    (g) Drug has the meaning given the term in section 201(g)(1) of the 
act.
    (h) FDA means Food and Drug Administration.
    (i) Letter of designation means the written notice issued by the 
product jurisdiction officer specifying the agency component with 
primary jurisdiction for a combination product.
    (j) Letter of request means an applicant's written submission to the 
product jurisdiction officer seeking the designation of the agency 
component with primary jurisdiction.
    (k) Premarket review includes the examination of data and 
information in an application for premarket review described in sections 
505, 510(k), 513(f), 515, or 520(g) or 520(l) of the act or section 351 
of the Public Health Service Act of data and information contained in 
any investigational new drug (IND) application, investigational device 
exemption (IDE), new drug application (NDA), biologics license 
application, device premarket notification, device reclassification 
petition, and premarket approval application (PMA).
    (l) Product means any article that contains any drug as defined in 
section 201(g)(1) of the act; any device as defined in section 201(h) of 
the act; or any biologic as defined in section 351(a) of the Public 
Health Service Act (42 U.S.C. 262(a)).
    (m) Product jurisdiction officer is the person or persons 
responsible for designating the component of FDA with primary 
jurisdiction for the premarket review and regulation of a combination 
product or any product requiring a jurisdictional designation under this 
part.
    (n) Sponsor means ``applicant'' (see Sec. 3.2(c)).

[56 FR 58756, Nov. 21, 1991 as amended at 64 FR 398, Jan. 5, 1999; 64 FR 
56447, Oct. 20, 1999]



Sec. 3.3  Scope.

    This section applies to:
    (a) Any combination product, or
    (b) Any product where the agency component with primary jurisdiction 
is unclear or in dispute.



Sec. 3.4  Designated agency component.

    (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.



Sec. 3.5  Procedures for identifying the designated agency component.

    (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

[[Page 22]]

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 Dr., Rockville, MD 20857, and 
are entitled ``Intercenter Agreement Between the Center for Drug 
Evaluation and Research and the Center for Devices and Radiological 
Health;'' ``Intercenter Agreement Between the Center for Devices and 
Radiological Health and the Center for Biologics Evaluation and 
Research;'' ``Intercenter Agreement Between the Center for Drug 
Evaluation and Research and the Center for Biologics Evaluation and 
Research.'' The availability of any amendments to these intercenter 
agreements will be announced by Federal Register notice.
    (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 Sec. 3.7 to request a 
designation of the agency component with primary jurisdiction before 
submitting the application.



Sec. 3.6  Product jurisdiction officer.

    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.



Sec. 3.7  Request for designation.

    (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;

[[Page 23]]

    (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.''



Sec. 3.8  Letter of 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 Sec. 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.



Sec. 3.9  Effect of letter of designation.

    (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.



Sec. 3.10  Stay of review time.

    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.

Subpart B  [Reserved]

[[Page 24]]



PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents




  Subpart A--Delegations of Authority to the Commissioner of Food and 
                                  Drugs

Sec.
5.10  Delegations from the Secretary, the Assistant Secretary for 
          Health, and Public Health Service Officials.
5.11  Reservation of authority.

Subpart B--Redelegations of Authority from the Commissioner of Food and 
                                  Drugs

5.20  General redelegations of authority from the Commissioner to other 
          officers of the Food and Drug Administration.
5.21  Emergency functions.
5.22  Certification of true copies and use of Department seal.
5.23  Disclosure of official records.
5.24  Authority relating to technology transfer.
5.25  Research, investigation, and testing programs and health 
          information and health promotion programs.
5.26  Service fellowships.
5.27  Patent term extensions for human drug products, medical devices, 
          and food and color additives; and due diligence 
          determinations.
5.28  Cardiac pacemaker devices and pacemaker leads.
5.29  Functions pertaining to safer vaccines.
5.30  Hearings.
5.31  Petitions under part 10.
5.32  Authority relating to determination of product classification and 
          assignment of primary jurisdiction.
5.33  Premarket approval of a product that is or contains a biologic, a 
          device, or a drug.
5.34  Authority to select temporary voting members for advisory 
          committees and authority to sign conflict of interest waivers.
5.35  Enforcement activities.
5.36  Certification following inspections.
5.37  Issuance of reports of minor violations.
5.38  Issuance of written notices concerning patent information, current 
          good manufacturing practices and false or misleading labeling 
          of new drugs, new animal drugs, and feeds bearing or 
          containing new animal drugs.
5.39  Redelegation of the Center for Biologics Evaluation and Research 
          Director's program authorities.
5.40  Issuance of Federal Register documents pertaining to the 
          determination of safe levels, notice of need for development 
          of an analytical method, notice of availability of a developed 
          analytical method, and prohibition of certain extralabel drug 
          use.
5.44  Export of unapproved drugs.
5.45  Imports and exports.
5.46  Manufacturer's resident import agents.
5.47  Detention of adulterated or misbranded medical devices.
5.49  Authorization to use alternative evidence for determination of the 
          effectiveness of medical devices.
5.50  Notification to petitioners of determinations made on petitions 
          for reclassification of medical devices.
5.51  Determination of classification of devices.
5.52  Notification to sponsors of deficiencies in petitions for 
          reclassification of medical devices.
5.53  Approval, disapproval, or withdrawal of approval of product 
          development protocols and applications for premarket approval 
          for medical devices.
5.54  Determinations that medical devices present unreasonable risk of 
          substantial harm.
5.55  Orders to repair or replace, or make refunds for, medical devices.
5.56  Recall authority.
5.57  Temporary suspension of a medical device application.
5.58  Orphan products.
5.59  Approval, disapproval, or withdrawal of approval of applications 
          for investigational device exemptions.
5.60  Required and discretionary postmarket surveillance.
5.61  Food standards, food additives, generally recognized as safe 
          (GRAS) substances, color additives, nutrient content claims, 
          and health claims.
5.62  Issuance of initial emergency permit orders and notices of 
          confirmation of effective date of final regulations on food 
          for human and animal consumption.
5.63  Detention of meat, poultry, eggs, and related products.
5.64  Establishing standards and approving accrediting bodies under the 
          National Laboratory Accreditation Program.
5.66  Approval of schools providing food-processing instruction.
5.67  Issuance of notices of opportunity for a hearing on proposals for 
          denial of approval of applications for licenses, suspension of 
          licenses, or revocation of licenses and certain notices of 
          revocation of licenses.
5.68  Issuance and revocation of licenses for the propagation or 
          manufacture and preparation of biological products.
5.69  Notification of release for distribution of biological products.
5.70  Issuance of notice implementing the provisions of the Drug 
          Amendments of 1962.
5.71  Termination of exemptions for new drugs for investigational use in 
          human beings and in animals.

[[Page 25]]

5.72  Authority to approve and to withdraw approval of a charge for 
          investigational new drugs.
5.80  Approval of new drug applications and their supplements.
5.81  Responses to Drug Enforcement Administration temporary scheduling 
          notices.
5.82  Issuance of notices relating to proposals to refuse approval or to 
          withdraw approval of new drug applications and their 
          supplements.
5.83  Approval of new animal drug applications, medicated feed mill 
          license applications and their supplements.
5.84  Issuance of notices, proposals, and orders relating to new animal 
          drugs and medicated feed mill license applications.
5.85  Authority to ensure that mammography facilities meet quality 
          standards.
5.86  Variances from performance standards for electronic products.
5.87  Exemption of electronic products from performance standards and 
          prohibited acts.
5.88  Testing programs and methods of certification and identification 
          for electronic products.
5.89  Notification of defects in, and repair or replacement of, 
          electronic products.
5.90  Manufacturers requirement to provide data to ultimate purchasers 
          of electronic products.
5.91  Dealer and distributor direction to provide data to manufacturers 
          of electronic products.
5.92  Acceptance of assistance from State and local authorities for 
          enforcement of radiation control legislation and regulations.
5.93  Submission of and effective approval dates for abbreviated new 
          drug applications and certain new drug applications.
5.94  Extensions or stays of effective dates for compliance with certain 
          labeling requirements for human prescription drugs.
5.95  Submission of and effective approval dates for abbreviated new 
          animal drug applications and certain new animal drug 
          applications.
5.98   Authority relating to medical device reporting procedures.
5.99  Issuance of notices relating to proposals and orders for debarment 
          and denial of an application to terminate debarment.

                         Subpart C--Organization

5.100  Officials authorized to make certification under 5 U.S.C. 605(b) 
          for any proposed and final rules.
5.101  Authority relating to waivers or reductions of prescription drug 
          user fees.
5.200  Headquarters.
5.205  Chief Counsel, Food and Drug Administration.
5.210  FDA Public Information Offices.
5.215  Field structure.

    Authority: 5 U.S.C. 504, 552, App. 2; 7 U.S.C. 138a, 2271; 15 U.S.C. 
638, 1261-1282, 3701-3711a; 15 U.S.C. 1451-1461; 21 U.S.C. 41-50, 61-63, 
141-149, 321-394, 467f, 679(b), 801-886, 1031-1309; 35 U.S.C. 156; 42 
U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 264, 265, 300u-300u-5, 
300aa-1; 1395y, 3246b, 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.

    Source: 42 FR 15560, Mar. 22, 1977, unless otherwise noted.



  Subpart A--Delegations of Authority to the Commissioner of Food and 
                                  Drugs



Sec. 5.10  Delegations from the Secretary, the Assistant Secretary for Health, and Public Health Service Officials.

    (a) The Assistant Secretary for Health has redelegated to the 
Commissioner of Food and Drugs, with authority to redelegate except when 
specifically prohibited, all authority delegated to the Assistant 
Secretary for Health by the Secretary of Health and Human Services, as 
follows:
    (1) Functions vested in the Secretary under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.), the Filled Milk Act (21 U.S.C. 
61-63), the Federal Import Milk Act (21 U.S.C. 141 et seq.), the Tea 
Importation Act (21 U.S.C. 41 et seq.), the Federal Caustic Poison Act 
(44 Stat. 1406), and The Fair Packaging and Labeling Act (15 U.S.C. 1451 
et seq.), pursuant to section 12 of Reorganization Plan No. IV and 
Reorganization Plan No. 1 of 1953, including authority to administer 
oaths vested in the Secretary of Agriculture by 7 U.S.C. 2217.
    (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 
(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 sections 354 through 
360F of the Public Health Service Act (42 U.S.C. 263b through 263n), as 
amended, which relate to electronic product radiation control.

[[Page 26]]

    (4) Functions vested in the Secretary under section 361 of the 
Public Health Service 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 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.
    (5) Functions vested in the Secretary under sections 351 and 352 of 
part F, subpart 1 of the Public Health Service 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.
    (6) Functions vested in the Secretary under section 302(a) of the 
Public Health Service 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.
    (7) Functions vested in the Secretary under section 303 of the 
Public Health Service 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 Pub. L. 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 Pub. L. 91-513.
    (8) Functions vested in the Secretary pertaining to section 4 of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970 (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.
    (9) 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 
determination of the qualifications and competency of practitioners 
wishing to conduct research with controlled substances listed in 
Schedule I of the Act, and the merits of the research protocol.
    (10) Functions vested in the Secretary pertaining to provisions of 
the Controlled Substances Act (21 U.S.C. 801 et seq.) which relate to 
administration of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.).
    (11) 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.
    (12) 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 of any poultry carcass, part thereof, or poultry product.
    (13) Functions vested in the Secretary under the Egg Products 
Inspection Act (21 U.S.C. 1031 et seq.).
    (14) Functions vested in the Secretary by amendments to the 
foregoing statutes subsequent to Reorganization Plan No. 1 of 1953.
    (15) Function of issuing all regulations of the Food and Drug 
Administration, except as provided in Sec. 5.11. The reservation of 
authority contained in Chapter 2-000 of the Department Organization 
Manual shall not apply.
    (16) 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 promulgated by the 
Federal Preparedness Agency of the General Services Administration; 
Office of the Secretary, HHS; and Office of the Assistant Secretary for 
Health.
    (17) Function vested in the Secretary of authorizing and approving 
miscellaneous and emergency expenses of enforcement activities.
    (18) Functions vested in the Secretary under the Federal Advisory 
Committee Act, Public Law 92-463, to make determinations that advisory 
committee meetings are concerned with matters listed in 5 U.S.C. 552(b)

[[Page 27]]

and therefore may be closed to the public for those committees under the 
administrative jurisdiction of the Commissioner of Food and Drugs. This 
authority may be redelegated to a single official who reports directly 
to the Commissioner of Food and Drugs. This authority is to be exercised 
in accordance with the requirements of the Federal Advisory Committee 
Act and only with respect to the following:
    (i) Meetings, to the extent that they directly involve review, 
discussion or consideration of records of the Department which are 
exempt from disclosure under 5 U.S.C. 552(b) (4), (6), and (7), namely, 
(a) records containing trade secrets and commercial or financial 
information obtained from a person and privileged or confidential; (b) 
personnel, medical and similar files the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy; and (c) 
investigatory files compiled for law enforcement purposes;
    (ii) Meetings to the extent that they involve the review, 
discussion, and evaluation of specific drugs and devices regulated by 
FDA which are intended to result in recommendations for regulatory 
decisions under the Federal Food, Drug, and Cosmetic Act and which are 
concerned with matters listed in 5 U.S.C. 552(b) (4), (5), and (7);
    (iii) Meetings held for the sole purpose of considering and 
formulating advice which the committee will give or any final report it 
will render, Provided:
    (a) The meetings will involve solely the internal expression of 
views and judgments of the members and it is essential to close the 
meeting or portions thereof to protect the free exchange of such views 
and avoid undue interference with agency or committee operations, and 
such views if reduced to writing would be protected from mandatory 
disclosure under 5 U.S.C. 552(b);
    (b) The meeting is closed for the shortest time necessary, 
summarizing the work of the committee during the closed session, and a 
report, prepared by the executive secretary will be made available 
promptly to the public.
    (c) When feasible, the public is given a timely opportunity to 
present relevant information and views to the committee; and
    (d) Concurrence for closing the meetings for such purpose is 
obtained from the Office of the General Counsel and the Office of Public 
Affairs.
    (19) 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 Public Health Service 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.
    (20) Functions vested in the Secretary under section 2101 of the 
Public Health Service Act (42 U.S.C. 219) 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.
    (21) Functions vested in the Secretary under section 362 of the 
Public Health Service 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.
    (22) Functions vested in the Secretary under section 1003(b)(3), 
title X, of the Public Works and Economic Development Act of 1965 (42 
U.S.C. 3246b(b)(3)) to waive any matching requirements for programs or 
projects of State and local governments funded

[[Page 28]]

under title X of that act where it is determined that State or local 
governments concerned cannot reasonably obtain any non-Federal 
contributions.
    (23) Functions vested in the Secretary under section 401(a) of the 
Lead-Based Paint Poisoning Prevention Act, as amended by Pub. L. 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.
    (24) Functions vested in the Secretary for the health information 
and health promotion program under title XVII of the Public Health 
Service Act (42 U.S.C. 300u et seq.), as amended, insofar as the 
authorities pertain to functions assigned to the Food and Drug 
Administration. The delegation includes, but is not limited to, the 
authorities under: section 1702(a) (1) and (3) and section 1704 (1), 
(2), and (6). The delegation excludes the authority to select all Senior 
Executive Service, supergrade and equivalent, and Schedule C (GS-12 and 
above) positions; promulgate regulations; and submit reports to the 
President.
    (25) 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 promulgate regulations, 
establish advisory councils and committees, appoint members to advisory 
councils and committees, and submit reports to Congress.
    (26) Functions vested in the Secretary under sections 982 and 983 of 
the Consumer-Patient Radiation Health and Safety Act of 1981 (42 U.S.C. 
10007 and 10008), as amended. The delegation excludes the authority to 
promulgate 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.
    (27) 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. 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.
    (28) Functions vested in the Secretary under section 1862(h) (1), 
(2)(A), and (3) of the Social Security Act (42 U.S.C. 1395y (h)(1), 
(2)(A), and (3)), as amended, which provides for a registry of all 
cardiac pacemaker devices and pacemaker leads for which payment was made 
under this title. The approval and issuance of regulations under that 
section are reserved to the Secretary, as provided in 21 CFR 5.11.
    (29) Functions vested in the Secretary under the Stevenson-Wydler 
Technology Innovation Act of 1980 (15 U.S.C. 3701 et seq.) (the Act), as 
amended, and under Executive Order No. 12591 of April 10, 1987, as they 
pertain to the functions of the Food and Drug Administration. The 
delegation excludes the authority to promulgate regulations and submit 
reports to Congress; under section 11(a)(2) of the Act (15 U.S.C. 
3710a(a)(2)) to approve agreements and contracts with invention 
management organizations; and under section 11(c)(3)(B) of the Act (15 
U.S.C. 3710a(c)(3)(B)) to propose necessary statutory changes regarding 
conflict of interest.
    (i) The authorities under sections 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 of Food and Drugs 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) of the Act (15 U.S.C. 3710a(b)(3)) 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)(4) of the Act (15 U.S.C. 3710a(b)(4)) to 
permit employees or former employees to participate in

[[Page 29]]

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)(29) of this section 
delegated by the Commissioner of Food and Drugs may not be further 
redelegated.
    (30) 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) which relate to pesticide monitoring and enforcement 
information, foreign pesticide information, and pesticide analytical 
methods. The delegation excludes the authority to submit reports to 
Congress.
    (31) Functions vested in the Secretary under the Government Patent 
Policy Act of 1980 as amended by the Federal Court Reorganization Act of 
1984, as they pertain to the functions of the Food and Drug 
Administration (FDA). The delegated authorities, to be exercised in 
compliance with all existing rules and regulations regarding patent and 
invention rights and responsibilities, are restricted to the extent that 
35 U.S.C. 203, as amended, may not be redelegated and that under 35 
U.S.C. 207(a), the Assistant Secretary for Health is to be notified of 
any significant invention, patent, or license, so that the Assistant 
Secretary for Health may decide whether or not documentation concerning 
any such invention, patent, or license should be submitted to the 
Assistant Secretary for Health for signature. All other authorities may 
be redelegated to officials at the level equivalent to bureau and 
institute directors.
    (i) Disposition of rights, 35 U.S.C. 202(c)(7), as amended: The 
authority to permit a nonprofit organization to assign the rights to a 
subject invention in the United States to organizations which do not 
have as one of their primary functions the management of inventions.
    (ii) Disposition of rights, 35 U.S.C. 202(d), as amended: The 
authority to permit a contractor to grant requests for retention of 
rights by the inventor.
    (iii) Disposition of rights, 35 U.S.C. 202(e), as amended: The 
authority to transfer or assign whatever rights FDA may acquire in the 
subject invention in any case when an agency employee is a coinventor of 
any invention made under a funding agreement with a nonprofit 
organization or small business firm. Such rights may be transferred or 
assigned from the FDA employee to the contractor subject to the 
conditions set forth in this chapter.
    (iv) March-in-rights, 35 U.S.C. 203, as amended: The authority to 
require the contractor to grant nonexclusive, partially exclusive, or 
exclusive licenses to responsible applicant(s), or the authority for FDA 
to grant such licenses, provided such action would be in the best 
interest of FDA, in accordance with all provisions of this section.
    (v) Preference for United States industry, 35 U.S.C. 204, as 
amended: The authority to waive the preference for U.S. industry 
requirement.
    (vi) Domestic and foreign protection of federally owned inventions, 
35 U.S.C. 207(a) as amended, the authority to:
    (A) Apply for, obtain, and maintain patents or other forms of 
protection in the United States and in foreign countries on inventions 
in which the Federal Government owns a right, title, or interest;
    (B) Grant nonexclusive, exclusive, or partially exclusive licenses 
under federally owned patent applications, patents, or other forms of 
protection obtained, royalty-free or for royalties or other 
consideration, and on such terms and conditions, including the grant to 
the licensee of the right of enforcement pursuant to the provisions of 
chapter 29 of title 35 as determined appropriate in the public interest;

[[Page 30]]

    (C) Undertake all other suitable and necessary steps to protect and 
administer rights to federally owned inventions on behalf of the Federal 
Government either directly or through contract; and
    (D) Transfer custody and administration, in whole or in part, to 
another Federal agency, of the right, title, or interest in any 
federally owned invention.
    (vii) Determination as to domestic rights and notice to employee of 
determination, 45 CFR 7.3 and 7.7, as amended, authority to:
    (A) Leave title to invention in the FDA employee inventor where the 
Government has insufficient interest in an invention to obtain the 
entire domestic right, title, and interest therein; and
    (B) Notify the FDA employee inventor of the determination in 
writing.
    (32) 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 Public Health Service 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 promulgate regulations, submit reports to the Congress, 
establish advisory committees or national commissions, and appoint 
members to such committees or commissions.
    (33) 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 Public Health Service Act (42 
U.S.C. 300ff et seq.), as amended, insofar as these authorities pertain 
to the functions assigned to the Food and Drug Administration. The 
delegations exclude the authority to promulgate regulations, submit 
reports to the Congress, establish advisory committees or national 
commissioners, and appoint members to such committees or commissions.
    (34) 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.
    (35) Functions vested in the Secretary under part C, subtitle 2 of 
title XXI of the Public Health Service Act (42 U.S.C. 300aa-25 et seq.), 
as amended, and the National Childhood Vaccine Injury Act of 1986 (42 
U.S.C. 300aa-1 note), as amended hereafter, as follows:
    (i) Section 2125 of the Public Health Service Act (42 U.S.C. 300aa-
25)--Recording and reporting of information.
    (ii) Section 2127 of the Public Health Service Act (42 U.S.C. 300aa-
27)--Mandate for safer childhood vaccines.
    (iii) Section 2128 of the Public Health Service 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.
    (v) Section 313 of the National Childhood Vaccine Injury Act of 
1986--Study of other vaccine risks.
    (vi) Section 314 of the National Childhood Vaccine Injury Act of 
1986--Review of warnings, use instructions, and precautionary 
information.
    (vii) The delegation excludes the authority to issue regulations and 
submit reports to Congress.
    (36) Functions vested in the Secretary under section 354(b) through 
(l) and (n), (o), (q), and (r) of the Public Health Service Act (section 
2 of the Mammography Quality Standards Act of 1992 (Pub. L. 102-539)), 
as amended, which deal with the certification of mammography facilities. 
The delegation excludes the authority to submit reports to Congress.
    (37) Functions vested in the Secretary under section 811(h)(4) of 
the Controlled Substances Act (Title II of

[[Page 31]]

the Comprehensive Drug Abuse Prevention and Control Act of 1970, as 
amended) to provide responses to the Drug Enforcement Administration's 
temporary scheduling notices. The delegation excludes the authority to 
submit reports to Congress.
    (38) Functions vested in the Secretary under the Safe Medical 
Devices Act of 1990 (Pub. L. 101-629), as amended. The delegation 
excludes the authority to submit reports to Congress.
    (39) 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 
(Pub. L. 104-180), as amended hereafter. The delegation excludes the 
authority to issue reports to Congress.
    (b) The Chief Counsel of the Food and Drug Administration, i.e., the 
Associate General Counsel in charge of the Food and Drug Division, has 
been authorized to report apparent violations to the Department of 
Justice for the institution of criminal proceedings, pursuant to section 
305 of the Federal Food, Drug, and Cosmetic Act, section 4 of the 
Federal Import Milk Act, and section 9(b) of the Federal Caustic Poison 
Act.
    (c) The Director, Office of Management, 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 of be affixed to 
such certifications and to agreements, awards, citations, diplomas, and 
similar documents.
    (d) The Executive Officer, Public Health Service, has redelegated to 
the Commissioner of Food and Drugs 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.
    (e) [Reserved]
    (f) The Secretary of Health and Human Services 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 procedures and 
regulations where necessary to supplement the Department's regulations, 
45 CFR part 13.

[42 FR 15560, Mar. 22, 1977]

    Editorial Note: For Federal Register citations affecting Sec. 5.10, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and on GPO Access.



Sec. 5.11  Reservation of authority.

    (a) Notwithstanding provisions of Sec. 5.10 or any previous 
delegations of authority to the contrary, the 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 
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

[[Page 32]]

approval of the Secretary are to be conclusively viewed as falling 
outside the scope of this reservation of authority.

[47 FR 16318, Apr. 16, 1982]



Subpart B--Redelegations of Authority from the Commissioner of Food and 
                                  Drugs



Sec. 5.20  General redelegations of authority from the Commissioner to other officers of the Food and Drug Administration.

    (a) Final authority of the Commissioner of Food and Drugs is 
redelegated as set forth in this subpart.
    (b) The following officials are authorized to perform all of the 
functions of the Commissioner of Food and Drugs and this authority may 
not be further redelegated:
    (1) Deputy Commissioner;
    (2) Associate Commissioner for Regulatory Affairs;
    (3) Senior Associate Commissioner;
    (4) Deputy 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) This authority may not be further redelegated. However, for a 
planned period of absence, the Commissioner of Food and Drugs (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 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 Sec. 5.10(a)(18). This authority may not be 
further redelegated.
    (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. This authority may not be 
further redelegated.
    (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. 
This authority may not be further redelegated.
    (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. This 
authority may not be further redelegated.
    (f)(1) The Senior Associate Commissioner for Policy, Planning, and 
Legislation and the Associate Commissioner for Policy are authorized to 
perform any of the functions of the Commissioner of Food and Drugs with 
respect to the issuance of Federal Register notices and proposed and 
final regulations of the Food and Drug Administration. This authority 
may not be further redelegated.
    (2) The Senior Associate Commissioner for Policy, Planning, and 
Legislation and the Associate Commissioner for Policy are authorized to 
issue responses to the following matters under part 10 of this chapter 
as follows, and this authority may not be further redelegated:
    (i) Requests for waiver, suspension, or modification of procedural 
requirements under Sec. 10.19 of this chapter;

[[Page 33]]

    (ii) Citizen petitions under Sec. 10.30 of this chapter;
    (iii) Petitions for reconsideration under Sec. 10.33 of this 
chapter;
    (iv) Petitions for stay under Sec. 10.35 of this chapter; or
    (v) Requests for advisory opinions under Sec. 10.85 of this chapter.
    (3) With respect to any matter delegated to the Senior Associate 
Commissioner for Policy, Planning, and Legislation and the Associate 
Commissioner for Policy under paragraph (f) of this section, the Senior 
Associate Commissioner for Policy, Planning, and Legislation and the 
Associate Commissioner for Policy are authorized to perform the function 
of the Commissioner of Food and Drugs under Secs. 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 Sec. 10.206(g) and (h) of this chapter. This 
authority may not be further redelegated.
    (4) The Senior Associate Commissioner for Policy, Planning, and 
Legislation and the Associate Commissioner for Policy 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. This authority may be 
further redelegated.
    (g) The following officials are authorized to perform all of the 
functions of the officials under them in their respective offices, and 
this authority may not be further redelegated:
    (1) Senior Associate Commissioner;
    (2) Deputy Commissioner for International and Constituent Relations;
    (3) Deputy 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 21 U.S.C. 379h(d)) made 
by such officers and the former Deputy User Fee Waiver Officer prior to 
July 1, 1999. This authority may not be further redelegated. (See 
Sec. 5.101 for the user fee-related redelegation to officials within the 
Center for Drug Evaluation and Research.)
    (2) The Deputy Commissioner for Management and Systems and the 
Director, Office of Financial Management are authorized to perform the 
functions of the Commissioner under 21 U.S.C. 379h(d)(1)(C), as amended, 
to waive or reduce prescription drug user fees in situations where he/
she finds that ``the fees will exceed the anticipated present and future 
costs.'' This authority may not be further redelegated.
    (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. This authority may not be further redelegated.
    (i) The Deputy Commissioner is authorized to perform the due 
diligence determinations and informal hearings functions under 35 U.S.C. 
156(d)(2)(B)(ii), as amended, relative to patent term extensions. This 
authority may not be further redelegated.
    (j) Authority delegated in the following sections of this subpart 
may not be redelegated.

[43 FR 20487, May 12, 1978, as amended at 48 FR 43300, Sept. 23, 1983; 
56 FR 36001, July 30, 1991; 57 FR 12875, Apr. 14, 1992; 58 FR 17095, 
Apr. 1, 1993; 59 FR 14549, Mar. 29, 1994; 61 FR 2414, Jan. 26, 1996; 62 
FR 923, Jan. 7, 1997; 62 FR 48757, Sept. 17, 1997; 63 FR 41960, Aug. 6, 
1998; 64 FR 59618, Nov. 3, 1999; 65 FR 34960, June 1, 2000]



Sec. 5.21  Emergency functions.

    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 region, to fully represent 
the Food and Drug Administration within his region in consonance with 
the Department of Health and Human Services regional emergency plans and 
to exercise the authority of the Commissioner for supervision of and 
direction to all Food and Drug Administration activities and use of 
resources within his region for continuity and for Federal Emergency 
Health Service operations. These same

[[Page 34]]

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.



Sec. 5.22  Certification of true copies and use of Department seal.

    (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 Deputy Commissioner for 
International and Constituent Relations, and the Deputy Commissioner for 
Management and Systems.
    (2) The Senior Associate Commissioners, the Associate and Deputy 
Associate Commissioners, and the Chief Counsel and Deputies.
    (3) The Director, Office of the Executive Secretariat, Office of the 
Senior Associate Commissioner, Office of the Commissioner.
    (4) The Executive Assistant to the Commissioner, Office of the 
Commissioner.
    (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, ORA.
    (iv) The Director, Division of Management Operations, and Chief, 
Administrative Management Branch, Office of Resource Management, ORA.
    (v) The Director, FDA History Staff, ORA.
    (6)(i) The Director, Office of Human Resources and Management 
Services, Office of Management and Systems, Office of the Commissioner.
    (ii) The Director, Division of Management Programs, Office of Human 
Resources and Management Services, Office of Management and Systems, 
Office of the Commissioner.
    (iii) The Chief, Dockets Management Branch, Division of Management 
Programs, Office of Human Resources and Management Services, Office of 
Management and Systems, Office of the Commissioner.
    (7)(i) The Associate Commissioner for Public Affairs, Office of 
Public Affairs, Office of the Senior Associate Commissioner, Office of 
the Commissioner.
    (ii) The Director, Freedom of Information Staff, Office of Public 
Affairs, Office of the Senior Associate Commissioner, Office of the 
Commissioner.
    (8)(i) The Director and Deputy Directors, Center for Biologics 
Evaluation and Research (CBER).
    (ii) The Director, Office of Management, CBER.
    (iii) The Directors and Deputy Directors of the Office of 
Compliance, CBER.
    (iv) The Director of Congressional and Public Affairs Staff, Office 
of the Center Director, CBER.
    (v) The Chief, Surveillance and Policy Branch and Consumer Safety 
Officers, Office of Compliance, CBER.
    (9)(i) The Director and Deputy Directors, Center for Food Safety and 
Applied Nutrition (CFSAN).
    (ii) The Director, Office of Policy, Planning, and Strategic 
Initiatives, 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 Beverages, CFSAN.
    (vi) The Director, Office of Seafood, CFSAN.
    (vii) The Director, Office of Special Nutritional, 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.
    (xiii) The Director, Office of Food Labeling, CFSAN.

[[Page 35]]

    (10)(i) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (ii) The Director and Deputy Director, Office of Management and 
Communications, Center for Veterinary Medicine (CVM).
    (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) Freedom of Information Officers, CDRH.
    (11)(i) The Director and Deputy Directors, 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.
    (v) The Chief, Case Guidance Branch, Division of Compliance, Office 
of Surveillance and Compliance, CVM.
    (12)(i) The Director and Deputy Director, National Center for 
Toxicological Research (NCTR).
    (ii) The Director, Office of Management, Facilities, and Research 
Support, NCTR.
    (13)(i) The Director, Deputy Center Director for Review Management, 
and Deputy Center Director for Pharmaceutical Science, 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 of the Offices of Drug Evaluation I, II, III, IV, 
and V, and the Director and Deputy Director of the Office of 
Epidemiology and 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 Chief, Freedom of Information Staff, Office of Training and 
Communications, CDER.
    (vii) The Directors of the Divisions of Labeling and Nonprescription 
Drug Compliance, Prescription Drug Compliance and Surveillance, and 
Manufacturing and Product Quality, Office of Compliance, CDER.
    (14)(i) Regional Food and Drug Directors.
    (ii) District Directors.
    (iii) The Director, St. Louis Branch.
    (iv) The Director, New York Laboratory Division, Northeast Region.
    (v) The Director, Southeast Regional Laboratory, Southeast Region.
    (vi) The Director, National Forensic Chemistry 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) The Deputy Commissioner, the Deputy Commissioner for 
International and Constituent Relations, and the Deputy Commissioner for 
Management and Systems.
    (2) The Senior Associate Commissioners, the Associate and Deputy 
Associate Commissioners, and the Chief Counsel and Deputies.
    (3) The Director, Office of Human Resources and Management Services, 
Office of Management and Systems, Office of the Commissioner.
    (c) The authorities under Sec. 5.22 (a) and (b), where appropriate, 
may be further redelegated by the Deputy Commissioners; Senior Associate 
Commissioners; Associate Commissioner for Regulatory Affairs and Deputy; 
Chief Counsel and Deputies; Center Directors and Deputies; and Executive 
Officers (i.e., Executive Assistant, Office of the Commissioner; 
Director, Office of Management, CBER; Director, Office of Management, 
CDER; Director, Office of Management and Systems, CFSAN; Director, 
Office of Systems and Management, CDRH; Director, Office of Management 
and Communications, CVM; Director, Office of Management, Facilities, and 
Research Support, NCTR; and the Director, Office of Resource Management, 
ORA).

[[Page 36]]

    (d) The Chief, Regulations Editorial Section; Regulations Policy and 
Management Staff; Office of Policy, Planning, and Legislation; Office of 
the Commissioner, and his/her alternates are authorized to certify true 
copies of Federal Register documents. The Chief, Regulations Editorial 
Section; Regulations Policy and Management Staff; Office of Policy, 
Planning, and Legislation; and the Office of the Commissioner may 
designate alternates as required.

[50 FR 4858, Feb. 4, 1985, as amended at 58 FR 17095, Apr. 1, 1993; 60 
FR 26826, May 19, 1995; 61 FR 9639, Mar. 11, 1996; 62 FR 2554, Jan. 17, 
1997; 62 FR 67270, Dec. 24, 1997; 64 FR 4965, Feb. 2, 1999; 64 FR 49383, 
Sept. 13, 1999; 65 FR 34961, June 1, 2000]



Sec. 5.23  Disclosure of official records.

    (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 paragraph (a)(1) of this 
section may disclose official records and information under Secs. 20.82 
and 20.85 of this chapter, and only officials listed in paragraph 
(a)(10) of this section may disclose information under Sec. 20.89(c) of 
this chapter.
    (1) The Deputy Commissioner, the Deputy Commissioner for 
International and Constituent Relations, the Deputy Commissioner for 
Management and Systems, Senior Associate Commissioners, Associate and 
Deputy Associate Commissioners.
    (2)(i) The Executive Assistant to the Commissioner, Office of the 
Commissioner.
    (ii) The Director, Office of the Executive Secretariat, Office of 
the Senior Associate Commissioner, Office of the Commissioner.
    (3) Executive Officer, Office of the Commissioner.
    (4)(i) The Director, Office of Human Resources and Management 
Services, Office of Management and Systems, Office of the Commissioner.
    (ii) The Director, Division of Management Programs, Office of Human 
Resources and Management Services, Office of Management and Systems, 
Office of the Commissioner.
    (iii) The Chief, Dockets Management Branch, Division of Management 
Programs; Office of Human Resources and Management Services, Office of 
Management Services, Office of the Commissioner.
    (5) Program officials at all organizational levels down to and 
including branch level for all Headquarters organizations.
    (6) Regional Food and Drug Directors and District Directors.
    (7) Director, Winchester Engineering and Analytical Center.
    (8) Chiefs of branches Field/District Offices and Centers.
    (9) Freedom of Information Officers and other employees engaged in 
Freedom of Information activities.
    (10)(i) The Associate Commissioner for Regulatory Affairs, Deputy 
Associate Commissioner for Regulatory Affairs, and Director, Office of 
Enforcement, FDA.
    (ii) The Director, Deputy Director, and Associate Director for 
Policy Coordination and Public Affairs, Center for Biologics Evaluation 
and Research (CBER), and Director, Division of Congressional and Public 
Affairs, CBER.
    (iii) The Director, Deputy Directors, and Associate Director for 
Science and Medical Affairs, Center for Drug Evaluation and Research 
(CDER).
    (iv) The Director and Deputy Director for Regulations and Policy, 
Center for Devices and Radiological Health (CDRH).
    (v) The Director, Center for Food Safety and Applied Nutrition 
(CFSAN), and Deputy Director for Systems and Support, CFSAN.
    (vi) The Director and Deputy Director, Center for Veterinary 
Medicine (CVM).
    (vii) The Director, Deputy Director, and Associate Director for 
Scientific Coordination, National Center for Toxicological Research 
(NCTR).
    (b) The Chief, Product Information Management Branch, Division of 
Database Management, Office of Management, Center for Drug Evaluation 
and Research (CDER), is authorized to sign affidavits regarding the 
presence or absence of records of Registration of Drug Establishments.
    (c) The following officials are authorized to sign affidavits 
regarding the presence or absence of medical device establishment 
registration records:

[[Page 37]]

    (1) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (2) The Director and Deputy Director, Office of Compliance, CDRH.
    (3) The Director and Deputy, Division of Program Operations, Office 
of Compliance, CDRH.
    (4) The Chief, Information Processing and Automation Branch, 
Division of Program Operations, Office of Compliance, CDRH.
    (5) The Director and Deputy Director, Office of Surveillance and 
Biometrics (OSB), CDRH, the Director and Deputy Director, Division of 
Surveillance Systems (DSS), OSB, CDRH, and the Chief Reporting Systems 
Monitoring Branch, DSS, OSB, 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.
    (e) The Director and Deputy Director, Division of Product 
Certification, Office of Biological Product Review, Center for Biologics 
Evaluation and Research, are authorized to sign affidavits regarding the 
presence or absence of records of registration of blood product 
establishments.

[43 FR 29286, July 7, 1978, as amended at 48 FR 56946, Dec. 27, 1983; 49 
FR 14932, Apr. 16, 1984; 50 FR 4859, Feb. 4, 1985; 51 FR 11428, Apr. 3, 
1986; 54 FR 8315, Feb. 28, 1989; 55 FR 47053, Nov. 9, 1990; 57 FR 40318, 
Sept. 3, 1992; 59 FR 37419, July 22, 1994; 62 FR 2554, Jan. 17, 1997; 62 
FR 67270, Dec. 24, 1997; 64 FR 4965, Feb. 2, 1999; 65 FR 34961, June 1, 
2000]



Sec. 5.24  Authority relating to technology transfer.

    (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 
sections 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 as requested by the Commissioner 
under the Stevenson-Wydler Technology Innovation Act of 1980 (15 U.S.C. 
3701 et seq.), as amended, and Executive Order 12591 of April 10, 1987, 
except to the extent that redelegation of those functions is 
specifically limited in Sec. 5.10(a)(29) of this part, as they pertain 
to the functions of their respective organizations, including the 
authority to perform the functions of laboratory directors under the Act 
as the heads of their respective Federal laboratories, subject to the 
discretion of the Commissioner of Food and Drugs to require that 
agreements entered into under section 11(a) of the Act (15 U.S.C. 
3710a(a)) include provisions in accordance with section 11(c)(5)(A) of 
the Act (15 U.S.C. 3710a(c)(5)(A):
    (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.

[53 FR 26049, July 11, 1988]



Sec. 5.25  Research, investigation, and testing programs and health information and health promotion programs.

    (a) The following officials are authorized under sections 301, 307, 
311, 1701, 1702, 1703, and 1704 of the Public Health Service Act (the 
act) 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 and Deputy Director, National Center for 
Toxicological Research.
    (2) The Director and Deputy Directors, Centers for Devices and 
Radiological Health (CDRH).

[[Page 38]]

    (3) The Director and Deputy Director, Center for Biologics 
Evaluation and Research.
    (4) The Director and Deputy Directors, Center for Food Safety and 
Applied Nutrition.
    (5) The Director and Deputy Director, Center for Veterinary 
Medicine.
    (6) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (7) The Director, Office of Orphan Products Development, Office of 
the Senior Associate Commissioner, Office of the Commissioner.
    (b) The Director and Deputy Directors, CDRH, are authorized to 
establish an electronic product radiation control program and to approve 
grants for conducting the program under section 356 of the Act.
    (c) The Deputy Commissioner for Management and Systems, Office of 
Management and Systems, Office of the Commissioner; the Director and 
Deputy Director, Office of Facilities, Acquisitions, and Central 
Services, Office of Management and Systems, Office of the Commissioner; 
the Director, Division of Contracts and Procurement Management, Office 
of Facilities, Acquisitions, and Central Services, Office of Management 
and Systems, Office of the Commissioner; and the Chief Grants Management 
Officer and the Grants Management Officer, Division of Contracts and 
Procurement Management, Office of Facilities, Acquisitions, and Central 
Services, Office of Management Systems, Office of the Commissioner 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 of the National Center for Toxicological Research 
is authorized under section 301, as amended by Pub. L. 95-622, of the 
Public Health Service Act to make available to educational institutions, 
for biomedical and behavioral research, laboratory animals bred for 
research purposes of the Center which are not required to support Center 
research programs.

[45 FR 7783, Feb. 5, 1980, as amended at 45 FR 27924, Apr. 25, 1980; 46 
FR 17758, Mar. 20, 1981; 48 FR 56946, Dec. 27, 1983; 49 FR 14932, 14936, 
Apr. 16, 1984; 50 FR 4859, Feb. 4, 1985; 54 FR 8316, Feb. 28, 1989; 57 
FR 45295, Oct. 1, 1992; 59 FR 42491, Aug. 18, 1994; 62 FR 2554, Jan. 17, 
1997; 62 FR 67270, Dec. 24, 1997; 65 FR 34962, June 1, 2000]



Sec. 5.26  Service fellowships.

    Under authority of sections 207(g) and 208(f) of the Public Health 
Service 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:
    (a) Deputy Commissioners.
    (b) The Director and Deputy Director, National Center for 
Toxicological Research (NCTR), and the Director, Office of Management, 
NCTR.
    (c) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), and the Director, Office of Systems and 
Management, CDRH.
    (d) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER), the Associate Director for Research, 
CBER, and Office Directors.
    (e) The Director and Deputy Directors, Center for Food Safety and 
Applied Nutrition (CFSAN), and Director, Office of Management Systems, 
CFSAN.
    (f) The Director and Deputy Director, Center for Veterinary Medicine 
(CVM), and the Director, Office of Management, CVM.
    (g) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER), and the Director and Deputy Director, 
Office of Management, CDER.
    (h) The Director, Office of Resource Management, Office of 
Regulatory Affairs.

[[Page 39]]

    (i) The Director, Office of Human Resources Management, Office of 
Management and Systems.

[48 FR 56946, Dec. 27, 1983, as amended at 49 FR 14932, 14936, Apr. 16, 
1984; 50 FR 4859, Feb. 4, 1985; 54 FR 8316, Feb. 28, 1989; 59 FR 5317, 
Feb. 4, 1994; 59 FR 42491, Aug. 18, 1994; 62 FR 2554, Jan. 17, 1997; 62 
FR 67270, Dec. 24, 1997]



Sec. 5.27  Patent term extensions for human drug products, medical devices, and food and color additives; and due diligence determinations.

    (a) The Director, Center for Drug Evaluation and Research (CDER) and 
the Associate Director for Policy, CDER, are authorized to perform the 
functions delegated to the Commissioner of Food and Drugs under 35 
U.S.C. 156, as amended, except for making due diligence determinations 
and holding of informal hearings under 35 U.S.C. 156(d)(2)(B).
    (b) 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 35 U.S.C. 156(d)(2)(B), as 
amended, except for holding of informal hearings under 35 U.S.C. 
156(d)(2)(B)(ii).

[65 FR 34962, June 1, 2000]



Sec. 5.28  Cardiac pacemaker devices and pacemaker leads.

    The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), are authorized to perform all the functions 
of the Commissioner of Food and Drugs with regard to a registry of all 
cardiac pacemaker devices and pacemaker leads for which payment was made 
under the Social Security Act (42 U.S.C. 1395y(h)(l), (2)(A), and (3)), 
as amended.

[62 FR 67270, Dec. 24, 1997]



Sec. 5.29  Functions pertaining to safer vaccines.

    The Director, Center for Biologics Evaluation and Research (CBER), 
and the Associate Director for Policy Coordination and Public Affairs, 
CBER, are authorized to perform the functions of the Commissioner of 
Food and Drugs under part C, subtitle 2 of title XXI of the Public 
Health Service Act (42 U.S.C. 300aa-25 et seq.), as amended, and the 
National Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1 note), 
as amended hereafter, as follows:
    (a) Section 2125 of the Public Health Service Act (42 U.S.C. 300aa-
25)--Recording and reporting of information.
    (b) Section 2127 of the Public Health Service Act (42 U.S.C. 300aa-
27)--Mandate for safer childhood vaccines.
    (c) Section 2128 of the Public Health Service Act (42 U.S.C. 300aa-
28)--Manufacturer recordkeeping and reporting.
    (d) Section 312 of the National Childhood Vaccine Injury Act of 
1986--Related studies, 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 312(d) of the 
National Childhood Vaccine Injury Act of 1986 is not redelegated by the 
Commissioner.
    (e) Section 313 of the National Childhood Vaccine Injury Act of 
1986--Study of other vaccine risks, 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.
    (f) Section 314 of the National Childhood Vaccine Injury Act of 
1986--Review of warnings, use instructions, and precautionary 
information.

[58 FR 17106, Apr. 1, 1993]



Sec. 5.30  Hearings.

    (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; section 6 of the Fair Packaging and Labeling Act; section 9(b) of 
the Federal Caustic Poison Act; 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:

[[Page 40]]

    (1) The Director and Deputy Directors, Center for Food Safety and 
Applied Nutrition (CFSAN), and the Director, Office of Policy, Planning, 
and Strategic Initiatives, CFSAN.
    (2) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for 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; and 
the Director and Deputy Director, Office of Compliance, CDER.
    (3) The Director and Deputy Director, Center for Devices and 
Radiological Health (CDRH).
    (4) The Director and Deputy Director, Center for Veterinary Medicine 
(CVM).
    (5) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER), and the Directors and Deputy Directors 
of the Offices of Biological Product Review, Biologics Research, and 
Compliance, CBER.
    (6) Regional Food and Drug Directors.
    (7) District Directors.
    (8) The Director, St. Louis Branch.
    (b) The Director and Deputy Directors, CDRH, are authorized to hold 
hearings, and to designate other officials to hold informal hearings, 
under section 360(a) of the Public Health Service 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 pursuant to 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 Sec. 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 Chief Mediator and Ombudsman, Office of the Ombudsman, 
Office of the Senior Associate Commissioner, Office of the Commissioner.
    (2) The Director and Deputy Directors, CFSAN.
    (3) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, 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, CDRH.
    (5) The Director and Deputy Director, CVM.
    (6) The Director and Deputy Director, CBER, and the Directors and 
Deputy Directors of the Offices of Biological Product Review, Biologics 
Research, and Compliance, CBER.
    (7) Regional Food and Drug Directors.
    (8) District Directors.
    (9) The Director, St. Louis Branch.
    (10) Such other FDA official as is designated by the Commissioner by 
memorandum in the proceeding.

[48 FR 8440, Mar. 1, 1983, as amended at 48 FR 56946, Dec. 27, 1983; 49 
FR 14932, 14936, Apr. 16, 1984; 51 FR 32452, Sept. 12, 1986; 54 FR 8316, 
Feb. 28, 1989; 54 FR 9034, Mar. 3, 1989; 59 FR 42491, Aug. 18, 1994; 62 
FR 2554, Jan. 17, 1997; 62 FR 67270, Dec. 24, 1997; 65 FR 34962, June 1, 
2000]



Sec. 5.31  Petitions under part 10.

    (a) For drugs assigned to their organizations, the following 
officials are authorized to grant or deny citizen petitions submitted 
under Sec. 10.30 of this chapter for a stay of an effective date in 
Sec. 201.59 of this chapter for compliance with certain labeling 
requirements for human prescription drugs.
    (1)(i) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).
    (ii) The Directors and Deputy Directors of the Offices of Biological 
Product Review and Biologics Research, CBER.
    (iii) The Directors and Deputy Directors of the divisions in the 
Offices of Biological Product Review and Biologics Research, CBER.
    (2)(i) The Director, Deputy Center Director for Review Management, 
and

[[Page 41]]

Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (ii) The 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.
    (iv) The Director and supervisory consumer safety officers, Pilot 
Drug Evaluation Staff, Office of the Center Director, CDER.
    (b) The following officials are authorized to grant or deny citizen 
petitions submitted under Sec. 10.30 of this chapter requesting in vitro 
test modifications under Sec. 331.29 of this chapter:
    (1) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for 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 Sec. 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 Sec. 211.132, Sec. 700.25, or 
Sec. 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, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, CDER.
    (2) The Director and Deputy Directors, Center for Food Safety and 
Applied Nutrition (CFSAN), and the Director, Office of Policy, Planning, 
and Strategic Initiatives, CFSAN.
    (3) The Director and Deputy Directors, Center for Devices and 
Radiological Health.
    (d) The following officials are authorized to grant or deny citizen 
petitions submitted under Sec. 10.30 of this chapter requesting 
exemption from the general pregnancy-nursing warning for over-the-
counter (OTC) drugs required under Sec. 201.63 of this chapter, 
requesting exemption from a general overdose warning required under 
Sec. 330.1(g) of this chapter, and requesting exemption from OTC drug 
administrative procedures under Sec. 330.10 of this chapter:
    (1) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for 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 Sec. 10.30(e)(2)(iii) of this chapter that relate to the assigned 
functions of that Center:
    (i) The Director and Deputy Directors, Center for Food Safety and 
Applied Nutrition (CFSAN).
    (ii) The Director, Office of Policy, Planning, and Strategic 
Initiatives, CFSAN.
    (iii) The Director, Office of Cosmetics and Colors, CFSAN.
    (iv) The Director, Office of Food Labeling, 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 Special Nutritionals, 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 Sec. 10.30(e)(2)(iii) of 
this chapter that relate to the assigned functions of that Center.
    (3) The Director and Deputy Director, CBER, are authorized to issue 
180-day tentative responses to citizen petitions on biological product 
matters under Sec. 10.30(e)(2)(iii) of this chapter that relate to the 
assigned functions of that Center.
    (4) The Director, Deputy Center Director for Review Management, and

[[Page 42]]

Deputy Center Director for Pharmaceutical Science, CDER, are authorized 
to issue 180-day tentative responses to citizen petitions on drug 
product matters under Sec. 10.30(e)(2)(iii) of this chapter that relate 
to the assigned functions of that Center.
    (5) The Director and Deputy Directors, CDRH, are authorized to issue 
180-day tentative responses to citizen petitions on medical device 
matters under Sec. 10.30(e)(2)(iii) of this chapter that relate to the 
assigned functions of that Center.
    (f)(1) The Director and Deputy Director, CBER, are authorized to 
grant or deny citizen petitions submitted under Sec. 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 part:
    (i) Section 5.68 Issuance and revocation of licenses for the 
propagation or manufacture and preparation of biological products;
    (ii) Section 5.69 Notification of release for distribution of 
biological products;
    (iii) Section 5.71 Termination of exemptions for new drugs for 
investigational use in human beings or in animals;
    (iv) Section 5.80 Approval of new drug applications and their 
supplements; and
    (v) Section 5.82 Issuance of notices relating to proposals to refuse 
approval or to withdraw approval of new drug applications and their 
supplements.
    (vi) Section 5.99 Issuance of notices relating to proposals and 
orders for debarment and denial of an application to terminate 
debarment.
    (2) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, CDER, are authorized 
to grant or deny citizen petitions submitted under Sec. 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 
part:
    (i) Section 5.70 Issuance of notices implementing the provisions of 
the Drug Amendments of 1962 (DESI);
    (ii) Section 5.71 Termination of exemptions for new drugs for 
investigational use in human beings or in animals;
    (iii)-(iv)  [Reserved]
    (v) Section 5.75 Designation of official master and working 
standards for antibiotic drugs;
    (vi) Section 5.76 Certification of antibiotic drugs;
    (vii) Section 5.78 Issuance, amendment, or repeal of regulations 
pertaining to antibiotic drugs;
    (viii) Section 5.80 Approval of new drug applications and their 
supplements; and
    (ix) Section 5.82 Issuance of notices relating to proposals to 
refuse approval or to withdraw approval of new drug applications and 
their supplements.
    (x) Section 5.99 Issuance of notices relating to proposals and 
orders for debarment and denial of an application to terminate 
debarment.
    (3) The Director and Deputy Director, Office of Generic Drugs, 
Office of Pharmaceutical Science, CDER, except for those drug products 
listed in Sec. 314.440(b) of this chapter, are authorized to issue 
responses to citizen petitions submitted under Sec. 10.30 of this 
chapter seeking a determination of the suitability of an abbreviated new 
drug application for a drug product.
    (4) The Director and Deputy Director, Office of Biological Product 
Review, CBER, for those drug products listed in Sec. 314.440(b) of this 
chapter, are authorized to issue responses to citizen petitions 
submitted under Sec. 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 Sec. 10.30 of this chapter from sponsors of an 
investigational new drug application who request approval to ship in 
interstate commerce, in accordance with Sec. 2.125(j) of this chapter, 
an investigational new drug for human use containing a 
chlorofluorocarbon.
    (i) The Director and Deputy Director, CBER.
    (ii) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, CDER.
    (6) The Director and Deputy Director, CVM, are authorized to issue 
responses to citizen petitions submitted under Sec. 10.30 of this 
chapter from sponsors of

[[Page 43]]

an investigational new animal drug application who request approval to 
ship in interstate commerce, in accordance with Sec. 21.125(j) of this 
chapter, an investigational new animal drug for animal use containing a 
chlorofluorocarbon.
    (7) The Director and Deputy Director, Office of New Animal Drug 
Evaluation, CVM, are authorized to issue responses to citizen petitions 
submitted under Sec. 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 Sec. 10.30 of this chapter 
concerning actions they are authorized to take under Sec. 5.99 Issuance 
of notices relating to proposals and orders for debarment and denial of 
an application to terminate debarment.
    (g) The Director and Deputy Directors, CDRH, and the Director, 
Office of Compliance, CDRH, are authorized to grant or deny citizen 
petitions submitted under Secs. 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) The Director and the Director of the Office of Compliance, CDER, 
are each authorized to grant or deny citizen petitions submitted under 
Sec. 10.30 of this chapter requesting an exception or alternative to any 
requirement in part 211 of this chapter pertaining to current good 
manufacturing practice for positron emission tomography 
radiopharmaceutical drug products.

[47 FR 38480, Aug. 31, 1982]

    Editorial Note: For Federal Register citations affecting Sec. 5.10, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and on GPO Access.



Sec. 5.32  Authority relating to determination of product classification and assignment of primary jurisdiction.

    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) 
respecting the classification of a product as a drug, biological 
product, device, or a combination product subject to section 503(g) of 
the act, and to assign primary responsibility respecting the 
organizational component of the Food and Drug Administration that will 
regulate the product.

[65 FR 34962, June 1, 2000]



Sec. 5.33  Premarket approval of a product that is or contains a biologic, a device, or a drug.

    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:
    (a) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER) and the Director, Office of Biological 
Product Review, CBER.
    (b) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), and the Director, Office of Device 
Evaluation, CDRH.
    (c) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for 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.

[56 FR 58759, Nov. 21, 1991, as amended at 62 FR 2555, Jan. 17, 1997; 62 
FR 67271, Dec. 24, 1997]



Sec. 5.34  Authority to select temporary voting members for advisory committees and authority to sign conflict of interest waivers.

    (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

[[Page 44]]

not available among current voting standing members of a committee or to 
comprise a quorum when, because of unforeseen circumstances, a quorum 
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 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.

[58 FR 39142, July 22, 1993, as amended at 65 FR 34962, June 1, 2000]



Sec. 5.35  Enforcement activities.

    (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); and to 
supervise compliance operations for the enforcement of the act, the Fair 
Packaging and Labeling Act, the Federal Caustic Poison Act, the Import 
Milk Act, the Filled Milk Act, the Tea Importation Act, and sections 351 
and 354 through 361 of the Public Health Service Act.
    (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 to conduct examinations, 
investigations, or inspections under the act relating to counterfeit 
drugs and issued the Food and Drug Administration Official Credential 
consisting of Form FDA-200D, Special Authority for Criminal 
Investigators, is authorized to do the following:
    (1) As set forth under section 702(e)(1) through (e)(5) of the act:
    (i) Carry firearms;
    (ii) Serve and execute search warrants and arrest warrants;
    (iii) Execute seizure by process issued pursuant to libel under 
section 304 of the act;
    (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, 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 of Food and Drugs 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 Federal 
Food, Drug, and Cosmetic Act (the act), and other

[[Page 45]]

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 promulgated under the act.
    (d) The Food and Drug Administration's official credentials referred 
to in paragraphs (a), (b), and (c) of this section are described as 
follows:
    (1) Form FDA-200A entitled ``Identification Record'' bears a color 
photograph, a description, and the signature of the holder, an 
identification number, an expiration date, the Department of Health and 
Human Services' seal with blue imprint, on the left of the photograph, 
and the Food and Drug Administration's symbol, on the right of the 
photograph.
    (2) Form FDA-200B entitled ``Specification of General Authority'' 
bears the holder's name, his or her general authority, an identification 
number, an expiration date, the Commissioner's signature, the names of 
the Department of Health and Human Services, the Public Health Service, 
and the Food and Drug Administration. The form is superimposed with the 
Department's seal with blue imprint.
    (3) Form FDA-200D, entitled ``Special Authority for Criminal 
Investigators,'' is in two parts and bears the holder's name, a color 
photograph, the signature of the holder, his or her special authority 
under 21 U.S.C. 334 and 372 and other duties as assigned by the 
Commissioner, an identification number, the Commissioner's or his 
designee's signature, the names of the Department of Health and Human 
Services, the Public Health Service, and the Food and Drug 
Administration. Part 1 of the form is superimposed with the symbol FDA 
with blue imprint, and part 2 is superimposed with the FDA criminal 
investigator's badge with blue imprint.
    (4) Form FDA-200E, entitled ``Special Authority for Criminal 
Investigative Specialists,'' is in two parts and bears the holder's 
name, a color photograph, the signature of the holder, his or her 
special authority under the act, and other duties under the law, as 
assigned by the Commissioner, an identification number, the 
Commissioner's or his designee's signature, the names of the Department 
of Health and Human Services, the Public Health Service, and the Food 
and Drug Administration. Part 1 of the form is superimposed with the 
symbol FDA with blue imprint, and part 2 is superimposed with the FDA 
criminal investigative specialist's badge with blue imprint.

[49 FR 19973, May 11, 1984, as amended at 53 FR 22293, June 15, 1988; 56 
FR 23788, May 24, 1991; 58 FR 494, Jan. 6, 1993; 58 FR 42496, Aug. 10, 
1993; 59 FR 47799, Sept. 19, 1994]



Sec. 5.36  Certification following inspections.

    Regional Food and Drug Directors and District Directors are 
authorized to issue certificates of sanitation under Sec. 1240.20 of 
this chapter.

[60 FR 15871, Mar. 28, 1995]



Sec. 5.37  Issuance of reports of minor violations.

    (a) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs under section 309 of the 
Federal Food, Drug, and Cosmetic Act regarding the issuance of written 
notices or warnings:
    (1)(i) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).
    (ii) The Director and Deputy Director, Office of Compliance, CBER.
    (2)(i) The Director and Deputy Directors, 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 Directors, Center for Food Safety and 
Applied Nutrition, (CFSAN).
    (ii) The Director, Office of Policy, Planning, and Strategic 
Initiatives, CFSAN.
    (iii) The Director, Office of Field Programs, CFSAN.

[[Page 46]]

    (iv) The Director, Division of Enforcement, 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, Deputy Center Director for Review Management, 
and Deputy Center Director for 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 Drug Evaluation I, Office of Review 
Management, 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.
    (b) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs under section 539(d) of 
the Federal Food, Drug, and Cosmetic Act regarding the issuance of 
written notices or warnings:
    (1) The Director and Deputy Directors, 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, OSB, CDRH, and the Director 
and Deputy Director, 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; and 
the Director, National Forensic Chemistry Center, when such functions 
relate to:
    (i) Assemblers of diagnostic x-ray systems, as defined in 
Sec. 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 Sec. 1040.20(b) of 
this chapter.

[48 FR 8441, Mar. 1, 1983, as amended at 48 FR 56946, Dec. 27, 1983; 49 
FR 14933, 14936, Apr. 16, 1984; 51 FR 32452, Sept. 12, 1986; 54 FR 8317, 
Feb. 28, 1989; 55 FR 47053, Nov. 9, 1990; 57 FR 40318, Sept. 3, 1992; 59 
FR 42491, Aug. 18, 1994; 60 FR 15871, Mar. 28, 1995; 62 FR 2555, Jan. 
17, 1997; 62 FR 67271, Dec. 24, 1997; 64 FR 4965, Feb. 2, 1999]



Sec. 5.38  Issuance of written notices concerning patent information, current good manufacturing practices and false or misleading labeling of new drugs, new animal drugs, and feeds bearing or containing new animal drugs.

    (a) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs under section 505(e) of 
the Federal Food, Drug, and Cosmetic Act (the act) regarding the 
issuance of written notices.
    (1) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for 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 Director and Deputy Director, Division of Scientific 
Investigations, Office of Compliance, CDER.
    (7) Regional Food and Drug Directors.

[[Page 47]]

    (8) District Directors.
    (b) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs under sections 512(e) 
and 512 (m)(4)(B)(ii) and (m)(4)(B)(iii) of the act 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.

[57 FR 18823, May 1, 1992, as amended at 62 FR 2555, Jan. 17, 1997]



Sec. 5.39  Redelegation of the Center for Biologics Evaluation and Research Director's program authorities.

    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:
    (a) Associate Directors, CBER.
    (b) Office Directors, CBER.
    (c) Division Directors, CBER.

[58 FR 18346, Apr. 9, 1993]



Sec. 5.40  Issuance of Federal Register documents pertaining to the 

determination of safe levels, notice of need for development of an 

analytical method, notice of availability of a developed analytical 

method, and prohibition of certain extralabel drug use.

    The Director and Deputy Director, Center for Veterinary Medicine 
(CVM) are authorized to issue Federal Register documents pertaining to 
the determination of safe levels, notice of need for development of an 
analytical method, notice of availability of a developed analytical 
method, and prohibition of certain extralabel drug use related to 
implementation of the Animal Medicinal Drug Use Clarification Act of 
1994 (the AMDUCA) (Pub. L. 103-396). This authority may be further 
redelegated by the Director and Deputy Director, CVM.

[62 FR 43471, Aug. 14, 1997]



Sec. 5.44  Export of unapproved drugs.

    (a) The following officials are authorized, under section 802(b) of 
the Federal Food, Drug, and Cosmetic Act, to approve or disapprove 
applications to export unapproved new drugs and biological products and 
to issue notices of receipt of such applications:
    (1) For human drugs assigned to their respective organizations:
    (i) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).
    (ii) The Director and Deputy Director, Office of Compliance, CBER.
    (iii) The Director, Deputy Center Director for Review Management, 
and Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (iv) The Director and Deputy Director, Office of Compliance, CDER.
    (2) For new animal drugs assigned to their respective organizations:
    (i) The Director and Deputy Director, Center for Veterinary Medicine 
(CVM).
    (ii) The Director and Deputy Director, Office of New Animal Drug 
Evaluation, CVM.
    (b) The following officials are authorized, under section 802(f) of 
the Federal Food, Drug, and Cosmetic Act, 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:
    (1) For human drugs assigned to their respective organizations:
    (i) The Director and Deputy Director, CBER.
    (ii) The Director and Deputy Director, Office of Compliance, CBER.
    (iii) The Director, Deputy Center Director for Review Management, 
and Deputy Center Director for Pharmaceutical Science, CDER.
    (iv) The Director and Deputy Director, Office of Compliance, CDER.
    (2) For veterinary drugs subject to their jurisdiction:
    (i) The Director and Deputy Director, CVM.
    (ii) The Director and Deputy Director, Office of New Animal Drug 
Evaluation, CVM.
    (c) The following officials are authorized, under section 351(h) of 
the Public

[[Page 48]]

Health Service Act, to approve or disapprove an application to export a 
partially processed biological product:
    (1) The Director and Deputy Director, CBER.
    (2) The Director and Deputy Director, Office of Compliance, CBER.

[52 FR 7269, Mar. 10, 1987, as amended at 54 FR 8317, Feb. 28, 1989; 62 
FR 2555, Jan. 17, 1997]



Sec. 5.45  Imports and exports.

    (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 (FFDCA), 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 
FFDCA.
    (3) Authorize relabeling or other compliance actions to bring 
articles into compliance under the FFDCA.
    (4) Supervise such compliance actions.
    (b) The Director and Deputy Directors, 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 360 of 
the Public Health Service Act (PHSA), 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 the PHSA.
    (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 the PHSA.
    (4) Refuse or grant permission and time extensions to bring 
noncomplying products into compliance with the PHSA in accordance with a 
corrective action plan approved by the Director, Office of Compliance 
and Surveillance, CDRH.
    (c) The following officials are authorized, under section 360B(b) of 
the PHSA, to exempt persons from issuing a certification, as required by 
section 358(h) of the PHSA, 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, 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 under section 362 of the 
PHSA that refers 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 of Food and Drugs pertaining to 
exportation of medical devices under section 801(e) of the FFDCA:
    (1) For medical devices assigned to their respective organization:
    (i) The Director and Deputy Directors, 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 Director, Center for Biologics 
Evaluation and Research (CBER).
    (v) The Director and Deputy Director, Office of Compliance, CBER.

[[Page 49]]

    (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 of Food and Drugs, for drugs under their 
jurisdiction, pertaining to authorizing the reimportation of 
prescription drugs under section 801(d)(2) of the FFDCA for emergency 
medical care:
    (1) The Director, Center for Biologics Evaluation and Research 
(CBER) and the Director, Office of Compliance, CBER.
    (2) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER) and the Director and Deputy Director, 
Office of Compliance, CDER.

[48 FR 8441, Mar. 1, 1983, as amended at 48 FR 56946, Dec. 27, 1983; 49 
FR 572, Jan. 5, 1984; 49 FR 14933, Apr. 16, 1984; 51 FR 32452, Sept. 12, 
1986; 54 FR 6518, Feb. 13, 1989; 54 FR 8317, Feb. 28, 1989; 54 FR 9034, 
Mar. 3, 1989; 55 FR 47053, Nov. 9, 1990; 57 FR 40318, Sept. 3, 1992; 62 
FR 2555, Jan. 17, 1997; 62 FR 67271, Dec. 24, 1997]



Sec. 5.46  Manufacturer's resident import agents.

    The Director and Deputy Directors, 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 Sec. 1005.25(b) of this chapter.

[62 FR 67271, Dec. 24, 1997]



Sec. 5.47  Detention of adulterated or misbranded medical devices.

    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 and in 
accordance with Sec. 800.55 of this chapter, of medical devices that may 
be adulterated or misbranded:
    (a) For medical devices assigned to their respective organizations:
    (1) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (2) The Director and Deputy Director, Office of Compliance, CDRH.
    (3) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).
    (4) The Director and Deputy Director, Office of Compliance, CBER.
    (b) Regional Food and Drug Directors.
    (c) District Directors.
    (d) The Director, St. Louis Branch.

[48 FR 8442, Mar. 1, 1983, as amended at 48 FR 56947, Dec. 27, 1983; 49 
FR 14933, Apr. 16, 1984; 51 FR 32452, Sept. 12, 1986; 54 FR 8317, Feb. 
28, 1989; 55 FR 47053, Nov. 9, 1990; 62 FR 67271, Dec. 24, 1997]



Sec. 5.49  Authorization to use alternative evidence for determination of the effectiveness of medical devices.

    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) 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:
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), and the Director and Deputy Directors, 
Office of Device Evaluation, CDRH.
    (b) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER), and the Director and Deputy Director, 
Office of Biological Product Review, CBER.

[48 FR 56947, Dec. 27, 1983, as amended at 49 FR 14933, Apr. 16, 1984; 
54 FR 8317, Feb. 28, 1989; 62 FR 67271, Dec. 24, 1997]



Sec. 5.50  Notification to petitioners of determinations made on petitions for reclassification of medical devices.

    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) and 
denials of petitions for reclassification of medical devices that are 
submitted under

[[Page 50]]

section 513(e) of the act (except for petitions submitted in response to 
Federal Register notices initiating standard-setting under section 
514(b) of the act or premarket approval under section 515(b) of the 
act):
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH) and the Director and Deputy Directors, Office 
of Device Evaluation.
    (b) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER), and the Director and Deputy Director, 
Office of Biological Product Review, CBER.

[48 FR 56947, Dec. 27, 1983, as amended at 49 FR 14933, Apr. 16, 1984; 
54 FR 8317, Feb. 28, 1989; 54 FR 11866, Mar. 22, 1989; 62 FR 67271, Dec. 
24, 1997]



Sec. 5.51  Determination of classification of devices.

    (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, 
pursuant to section 513(d) of the Federal Food, Drug, and Cosmetic Act 
(the act):
    (1) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH) and the Director and Deputy Directors, Office 
of Device Evaluation, CDRH.
    (2) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (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, pursuant to section 513 (f)(1)(A) of the act:
    (1) The Director and Deputy Directors, CDRH, and the Director, 
Deputy Directors, Chief of the Premarket Notification Section, Division 
and Deputy Division Directors, Associate Division Directors, and Branch 
Chiefs, Office of Device Evaluation, CDRH.
    (2) The Director and Deputy Director, CBER.

[55 FR 6974, Feb. 27, 1990, as amended at 60 FR 2014, Jan. 6, 1995; 62 
FR 67271, Dec. 24, 1997]



Sec. 5.52  Notification to sponsors of deficiencies in petitions for reclassification of medical devices.

    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:
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH) and the Director and Deputy Directors, Office 
of Device Evaluation, CDRH.
    (b) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER), and the Director and Deputy Director, 
Office of Biological Product Review, CBER.

[48 FR 56947, Dec. 27, 1983, as amended at 49 FR 14933, Apr. 16, 1984; 
54 FR 8317, Feb. 28, 1989; 62 FR 67271, Dec. 24, 1997]



Sec. 5.53  Approval, disapproval, or withdrawal of approval of product development protocols and applications for premarket approval for medical devices.

    (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):
    (1) The Director and Deputy Directors, 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 Director, Center for Biologics 
Evaluation and Research (CBER), and the Director and Deputy Director, 
Office of Biological Product Review, 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:
    (i) The Director and Deputy Directors, CDRH, the Director and Deputy

[[Page 51]]

Directors, ODE, CDRH, and the Division Directors, ODE, CDRH.
    (ii) The Director and Deputy Director, CBER, and the Director and 
Deputy Director, Office of Biological Product Review, 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, 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.

[48 FR 56947, Dec. 27, 1983, as amended at 49 FR 14933, Apr. 16, 1984; 
49 FR 21708, May 23, 1984; 50 FR 9424, Mar. 8, 1985; 54 FR 8317, Feb. 
28, 1989; 62 FR 67271, Dec. 24, 1997; 63 FR 27207, May 18, 1998]



Sec. 5.54  Determinations that medical devices present unreasonable risk of substantial harm.

    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:
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), and the Director and Deputy Director, Office 
of Compliance, CDRH.
    (b) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER), and the Director and Deputy Director, 
Office of Compliance, CBER.
    (c) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER); and the Director and Deputy Director, 
Office of Compliance, CDER.

[48 FR 56947, Dec. 27, 1983, as amended at 49 FR 14933, Apr. 16, 1984; 
57 FR 40316, Sept. 3, 1992; 62 FR 2556, Jan. 17, 1997; 62 FR 67272, Dec. 
24, 1997]



Sec. 5.55  Orders to repair or replace, or make refunds for, medical devices.

    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:
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), and the Director and Deputy Director, Office 
of Compliance, CDRH.
    (b) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER), and the Director and Deputy Director, 
Office of Compliance, CBER.
    (c) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER); and the Director and Deputy Director, 
Office of Compliance, CDER.

[48 FR 56948, Dec. 27, 1983, as amended at 49 FR 14933, Apr. 16, 1984; 
57 FR 40317, Sept. 3, 1992; 62 FR 2556, Jan. 17, 1997; 62 FR 67272, Dec. 
24, 1997]



Sec. 5.56  Recall authority.

    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, which have been delegated to the Commissioner of Food and Drugs:
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (b) The Director and Deputy Director, Office of Compliance, CDRH.
    (c) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER); and the Director and Deputy Director, 
Office of Compliance, CDER.

[[Page 52]]

    (d) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER), and the Director and Deputy Director, 
Office of Compliance, CBER.

[56 FR 51170, Oct. 10, 1991, as amended at 57 FR 40317, Sept. 3, 1992; 
62 FR 2556, Jan. 17, 1997; 62 FR 67272, Dec. 24, 1997]



Sec. 5.57  Temporary suspension of a medical device application.

    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, 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:
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (b) The Director and Deputy Director, Office of Compliance, CDRH.
    (c) The Director and Deputy Directors, Office of Device Evaluation, 
CDRH.
    (d) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for 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.
    (e) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER), and the Director and Deputy Director, 
Office of Compliance, CBER.

[56 FR 51170, Oct. 10, 1991, as amended at 57 FR 40317, Sept. 3, 1992; 
62 FR 2556, Jan. 17, 1997; 62 FR 67272, Dec. 24, 1997]



Sec. 5.58  Orphan products.

    (a) The Director, Office of Orphan Products Development, Office of 
the Senior Associate Commissioner, Office of the Commissioner, is 
authorized to issue notices, and amendments thereto, inviting 
sponsorship for orphan products (human and animal drugs, biological 
products, and medical devices) and submission of:
    (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, Office of Orphan Products Development, Office of 
the Senior Associate Commissioner, Office of the Commissioner, 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) and 
to designate such drug as a drug for a rare disease or condition under 
section 526(a) of the act.
    (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.
    (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.
    (c) The following officials are authorized to provide sponsors, 
under section 525(a) of the act, 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, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (ii) The 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

[[Page 53]]

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 Director, Center for Biologics 
Evaluation and Research (CBER).
    (ii) The Director and Deputy Director, Office of Biological Product 
Review, CBER.
    (iii) The Directors and Deputy Directors of the divisions in the 
Office of Biological Product Review, CBER.

[48 FR 40703, Sept. 9, 1983, as amended at 49 FR 14933, Apr. 16, 1984; 
49 FR 27489, July 5, 1984; 50 FR 19341, May 8, 1985; 54 FR 8318, Feb. 
28, 1989; 55 FR 51688, Dec. 17, 1990; 62 FR 2556, Jan. 17, 1997; 64 FR 
56448, Oct. 20, 1999; 65 FR 34962, June 1, 2000]



Sec. 5.59  Approval, disapproval, or withdrawal of approval of applications for investigational device exemptions.

    (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):
    (1) The Director and Deputy Directors, 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 Director, Center for Biologics 
Evaluation and Research (CBER), and the Director and Deputy Director, 
Office of Biological Product Review, 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.

[48 FR 56948, Dec. 27, 1983, as amended at 49 FR 14934, Apr. 16, 1984; 
54 FR 8318, Feb. 28, 1989; 55 FR 47053, Nov. 9, 1990; 62 FR 67272, Dec. 
24, 1997]



Sec. 5.60  Required and discretionary postmarket surveillance.

    (a) For any device (including any device that is or contains a drug 
or biologic) that was first introduced or delivered for introduction 
into interstate commerce after January 1, 1991, and that is either a 
permanent implant, the failure of which may cause serious adverse health 
consequences or death, a life-sustaining or life-supporting device, or a 
device that potentially presents a serious risk to human health, any of 
the following officials is authorized to require a manufacturer of such 
device to conduct postmarket surveillance:
    (1) The Director and Deputy Directors, 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, CDRH.
    (4) The Director and Deputy Directors, Division Directors and 
Associate Division Directors, Office of Device Evaluation, CDRH.
    (5) The Chief, Premarket Notification Section; Chief, Premarket 
Approval Section; Director, Program Operations Staff, Office of Device 
Evaluation, CDRH.
    (6) The Director and Deputy Director, Office of Compliance, CDRH.
    (7) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (8) The Directors of the Offices of Drug Evaluation I, II, III, IV, 
and V, Office of Review Management, CDER.
    (9) The Director and Deputy Director, Office of Compliance, CDER.
    (10) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).
    (11) The Director and Deputy Director, Office of Compliance, CBER.
    (12) The Director and Deputy Director, Office of Biological Product 
Review, CBER.
    (b) For any device (including any device that is or contains a drug 
or biologic), any of the following officials is

[[Page 54]]

authorized to require a manufacturer of a device to conduct postmarket 
surveillance if the official determines that postmarket surveillance of 
the device is necessary to protect the public health or provide safety 
or effectiveness data for the device:
    (1) The Director and Deputy Directors, 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, CDRH.
    (4) The Director and Deputy Directors, Office of Device Evaluation, 
CDRH.
    (5) The Director and Deputy Director, Office of Compliance, CDRH.
    (6) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, CDER.
    (7) The Directors of the Offices of Drug Evaluation I, II, III, IV, 
and V, Office of Review Management, CDER.
    (8) The Director and Deputy Director, Office of Compliance, CDER.
    (9) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).
    (10) The Director and Deputy Director, Office of Compliance, CBER.
    (11) The Director and Deputy Director, Office of Biological Product 
Review, CBER.

[57 FR 40315, Sept. 3, 1992, as amended at 62 FR 2556, Jan. 17, 1997; 62 
FR 67272, Dec. 24, 1997]



Sec. 5.61  Food standards, food additives, generally recognized as safe (GRAS) substances, color additives, nutrient content claims, and health claims.

    (a)(1) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs under section 409 and 
721 of the Federal Food, Drug, and Cosmetic Act (the act) 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 Directors, Center for Food Safety and 
Applied Nutrition (CFSAN).
    (ii) The Director, Office of Policy, Planning and Strategic 
Initiatives, CFSAN.
    (iii) The Director, Office of Premarket Approval, CFSAN.
    (iv) The Director and Deputy Director, Center for Veterinary 
Medicine (CVM).
    (2) The Director and Deputy Directors, Center for Food Safety and 
Applied Nutrition (CFSAN), and the Director, Office of Policy, Planning, 
and Strategic Initiatives, CFSAN are authorized to perform all the 
functions of the Commissioner of Food and Drugs under section 401 of the 
act 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 and Deputy Directors, CFSAN, and the Director, 
Office of Policy, Planning, and Strategic Initiatives, CFSAN are 
authorized to perform all of the functions of the Commissioner of Food 
and Drugs under sections 409 and 721 of the act regarding the approval 
of the use of food additives under section 409(e) of the act and the 
listing of color additives under section 721(d) of the act 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 of Food and Drugs under section 401 of the 
act regarding the issuance of notices of temporary permits for foods 
varying from standards of identity under Sec. 130.17 of this chapter:
    (i) The Director and Deputy Directors, CFSAN.
    (ii) The Director, Office of Policy, Planning, and Strategic 
Initiatives, CFSAN.
    (iii) The Director, Office of Food Labeling, CFSAN.
    (3) The Director and Deputy Director, CVM, are authorized to perform 
all the functions of the Commissioner of Food and Drugs regarding 
approvals of the

[[Page 55]]

use of food additives under section 409(e) of the act, 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 
or to color additive petitions under section 721(d)(1) of the act that 
relate to the assigned functions of the Center:
    (i) The Director and Deputy Directors, CFSAN.
    (ii) The Director, Office of Policy, Planning, and Strategic 
Initiatives, 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 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:
    (1) The Director and Deputy Directors, CFSAN.
    (2) The Director, Office of Policy, Planning, and Strategic 
Initiatives, 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 Sec. 130.6 of this chapter:
    (1) The Director and Deputy Directors, CFSAN.
    (2) The Director, Office of Policy, Planning, and Strategic 
Initiatives, CFSAN.
    (3) The Director, Office of Food Labeling, CFSAN.
    (f) The following officials are authorized to issue notices of 
proposed rulemaking and issue or amend regulations affirming generally 
recognized as safe (GRAS) status of food substances under Sec. 170.35 or 
Sec. 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 and Deputy Directors, CFSAN, and the Director, 
Office of Policy, Planning, and Strategic Initiatives, CFSAN.
    (2) The Director and Deputy Director, CVM.
    (g)(1) The following officials are authorized to perform all of the 
functions of the Commissioner of Food and Drugs under section 403(r)(4) 
of the act 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 Directors, CFSAN.
    (ii) The Director, Office of Policy, Planning, and Strategic 
Initiatives, CFSAN.
    (2) The following officials are authorized to perform all of the 
functions of the Commissioner of Food and Drugs under section 403(r)(4) 
of the act regarding the issuing of letters of filing in response to 
petitions for nutrient content claims and health claims:
    (i) The Director and Deputy Directors, CFSAN.
    (ii) The Director, Office of Policy, Planning, and Strategic 
Initiatives, CFSAN.
    (iii) The Director, Office of Food Labeling, CFSAN.
    (h) The following officials are authorized to issue letters 
concerning substances determined to be below the ``threshold of 
regulation'' under Sec. 170.39 of this chapter:

[[Page 56]]

    (1) The Director and Deputy Directors, Center for Food Safety and 
Applied Nutrition (CFSAN).
    (2) The Director, Office of Policy, Planning and Strategic 
Initiatives, 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 the 
functions of the Commissioner of Food and Drugs under section 409(h) of 
the act, excluding the duties set out in section 409(h)(5) of the act, 
regarding premarket notification of food-contact substances:
    (1) The Director and Deputy Director, Center for Food Safety and 
Applied Nutrition (CFSAN).
    (2) The Director, Office of Regulations and Policy, CFSAN.
    (3) The Director, Office of Premarket Approval, CFSAN.

[49 FR 14936, Apr. 16, 1984, as amended at 49 FR 48183, Dec. 11, 1984; 
52 FR 5951, Feb. 27, 1987; 58 FR 2410, Jan. 6, 1993; 59 FR 42492, Aug. 
18, 1994; 60 FR 36594, July 17, 1995; 64 FR 33194, June 22, 1999]



Sec. 5.62  Issuance of initial emergency permit orders and notices of confirmation of effective date of final regulations on food for human and animal consumption.

    (a) The Director and Deputy Directors, Center for Food Safety and 
Applied Nutrition (CFSAN), the Director, Office of Field Programs, 
CFSAN, and the Director, Division of Enforcement, Office of Field 
Programs, CFSAN, are authorized to issue initial emergency permit orders 
under Sec. 108.5 of this chapter.
    (b) The following officials are authorized to issue notices of 
confirmation of effective date of final regulations on food matters 
promulgated under section 701(e) of the Federal Food, Drug, and Cosmetic 
Act:
    (1) The Director and Deputy Directors, CFSAN.
    (2) The Director, Office of Policy, Planning, and Strategic 
Initiatives, CFSAN.
    (3) The Director, Office of Food Labeling, CFSAN.
    (4) The Director, Office of Special Nutritionals, CFSAN.
    (5) The Director, Office of Plant and Dairy Foods and Beverages, 
CFSAN.
    (6) The Director, Office of Seafood, CFSAN.
    (7) The Director, Office of Field Programs, CFSAN.
    (8) The Director, Office of Premarket Approval, CFSAN.

[59 FR 42492, Aug. 18, 1994]



Sec. 5.63  Detention of meat, poultry, eggs, and related products.

    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)) which relate 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)) which relate to the detention of any poultry carcass, part 
thereof, or poultry product.
    (c) The Egg Products Inspection Act (21 U.S.C. 1031 et seq.).

[48 FR 8442, Mar. 1, 1983, as amended at 54 FR 9034, Mar. 3, 1989; 60 FR 
15871, Mar. 28, 1995]



Sec. 5.64  Establishing standards and approving accrediting bodies under the National Laboratory Accreditation Program.

    The Director and Deputy Director, 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.

[57 FR 43398, Sept. 21, 1992]

[[Page 57]]



Sec. 5.66  Approval of schools providing food-processing instruction.

    The following officials are authorized to perform all the functions 
of the Commissioner of Food and Drugs under Sec. 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:
    (a) The Director and Deputy Directors, Center for Food Safety and 
Applied Nutrition (CFSAN).
    (b) The Director, Office of Policy, Planning, and Strategic 
Initiatives, CFSAN.
    (c) The Director, Office of Plant and Dairy Foods and Beverages, 
CFSAN.

[59 FR 42492, Aug. 18, 1994]



Sec. 5.67  Issuance of notices of opportunity for a hearing on proposals for denial of approval of applications for licenses, suspension of licenses, or           revocation of licenses and certain notices of revocation of licenses.

    The Center Director and Deputy Center Directors, Center for 
Biologics Evaluation and Research are authorized to issue:
    (a) Notices of opportunity for a hearing on proposals to deny 
approval or filing of applications for biologics licenses under 
Sec. 601.4(b) of this chapter.
    (b) Notices of opportunity for a hearing on proposals to revoke 
biologics licenses under Sec. 601.5(b) of this chapter.
    (c) Notices of revocation, at the manufacturer's request, of 
biologics licenses under Secs. 601.5(a) and 601.8 of this chapter.
    (d) Notices of revocation when the manufacturer has waived the 
opportunity for hearing under Sec. 601.7(a) of this chapter.
    (e) Notice of license suspensions under Sec. 601.6 of this chapter.

[50 FR 30697, July 29, 1985, as amended at 54 FR 8318, Feb. 28, 1989; 56 
FR 25025, June 3, 1991; 64 FR 47669, Sept. 1, 1999; 64 FR 56448, Oct. 
20, 1999]



Sec. 5.68  Issuance and revocation of licenses for the propagation or manufacture and preparation of biological products.

    The following officials are authorized to issue licenses under 
section 351 of the Public Health Service Act (42 U.S.C. 262) for the 
propagation or manufacture and preparation of biological products as 
specified in the act, and to revoke such licenses at the manufacturer's 
request:
    (a) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).
    (b) The Director and Deputy Director, Office of Biological Product 
Review, CBER.

[49 FR 14934, Apr. 16, 1984, as amended at 54 FR 8318, Feb. 28, 1989]



Sec. 5.69  Notification of release for distribution of biological products.

    The following officials are authorized to issue written notices of 
release for distribution of licensed biological products under 
subchapter F (parts 600 through 699) of this chapter:
    (a) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).
    (b) The Director and Deputy Director, Office of Biological Product 
Review, CBER.
    (c) The Director and Deputy Director, Division of Product Quality 
Control, Office of Biological Product Review, CBER.

[49 FR 14934, Apr. 16, 1984, as amended at 50 FR 19341, May 8, 1985; 54 
FR 8318, Feb. 28, 1989]



Sec. 5.70  Issuance of notice implementing the provisions of the Drug Amendments of 1962.

    The Director, Deputy Center Director for Review Management, and 
Deputy Director, Center Director for Pharmaceutical Science, Center for 
Drug Evaluation and Research (CDER), 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

[[Page 58]]

provisions of section 505 of the Federal Food, Drug, and Cosmetic Act.

[62 FR 2556, Jan. 17, 1997, as amended at 64 FR 398, Jan. 5, 1999]



Sec. 5.71  Termination of exemptions for new drugs for investigational use in human beings and in animals.

    (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 Sec. 312.44 of this chapter and in animals under 
Sec. 312.160 of this chapter:
    (1) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).
    (2) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (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 
Sec. 312.44(b)(1)(viii) of this chapter:
    (1) The 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 Director and Deputy Director, Office of Biological Product 
Review, CBER.
    (4) The Director and Deputy Director, Division of Biological 
Investigational New Drugs, Office of Biological Product Review.
    (c) The following officials, for drugs under their jurisdiction, are 
authorized to make the findings set forth in Sec. 312.44(b) of this 
chapter and to notify sponsors and invite correction before termination 
action on such exemptions:
    (1) The 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 Director and Deputy Director, Office of Biological Product 
Review, CBER.
    (4) The Director and Deputy Director, Division of Biological 
Investigational New Drugs, Office of Biological Product Review.
    (d) 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 Sec. 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.

[49 FR 14934, Apr. 16, 1984, as amended at 50 FR 14094, Apr. 10, 1985; 
52 FR 7829, Mar. 13, 1987; 54 FR 8318, Feb. 28, 1989; 55 FR 51688, Dec. 
17, 1990; 62 FR 2556, Jan. 17, 1997]



Sec. 5.72  Authority to approve and to withdraw approval of a charge for investigational new drugs.

    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 Sec. 312.7(d)(1) of this chapter:
    (a) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (b) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).

[55 FR 5445, Feb. 15, 1990, as amended at 62 FR 2556, Jan. 17, 1997]



Sec. 5.80  Approval of new drug applications and their supplements.

    (a)(1) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs with regard to approval 
of new drug applications and supplements thereto on drugs for human use, 
except for those

[[Page 59]]

drugs listed in Sec. 314.440(b) of this chapter, that have been 
submitted under section 505 of the Federal Food, Drug, and Cosmetic Act:
    (i) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (ii) The 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 Director, Center for Biologics 
Evaluation and Research (CBER), for drugs listed in Sec. 314.440(b) of 
this chapter, are authorized to perform all the functions of the 
Commissioner of Food and Drugs 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 Federal Food, Drug, and Cosmetic 
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 of Food and Drugs with regard 
to approval of supplemental applications to approved new drug 
applications for drugs for human use that have been submitted under 
Sec. 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 Sec. 5.10(a) and paragraph (a) of this 
section.
    (c) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs 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 505(b)(2) applications under their 
jurisdiction. The applications to which this authorization applies may, 
in appropriate circumstances, continue to be acted upon by the officials 
so authorized in Sec. 5.10(a) and paragraph (a) of this section.
    (1) For drugs submitted under Secs. 314.50, 314.70, and 314.94 of 
this chapter, except for those drug products listed in Sec. 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)(i) For drug products listed in Sec. 314.440(b) and submitted 
under Secs. 314.50, 314.70, and 314.94 of this chapter:
    (ii) The Director and Deputy Director, Office of Biological Product 
Review, CBER.
    (d) The following officials are authorized to perform all functions 
of the Commissioner of Food and Drugs with respect to approval of 
supplemental applications to abbreviated new drug applications, 5S 
applications, or 505(b)(2) applications for drugs for human use that are 
described in Secs. 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 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 of Food and Drugs with 
respect

[[Page 60]]

to approval of supplemental applications to abbreviated new drug 
applications, 5S applications, or 505(b)(2) applications for drugs for 
human use that are described in Secs. 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 of Food and Drugs with respect to approval of 
supplemental applications to new drug applications for drugs for human 
use that are described in Secs. 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 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 Sec. 5.10(a) and paragraphs (a) and (b) of this section.

[49 FR 14935, Apr. 16, 1984, as amended at 50 FR 30697, July 29, 1985; 
50 FR 47207, Nov. 15, 1985; 52 FR 37764, Oct. 9, 1987; 54 FR 8319, Feb. 
28, 1989; 55 FR 6247, Feb. 22, 1990; 55 FR 51688, Dec. 17, 1990; 57 FR 
17980, Apr. 28, 1992; 58 FR 17094, Apr. 1, 1993; 59 FR 33431, June 29, 
1994; 60 FR 57338, Nov. 15, 1995; 62 FR 2557, Jan. 17, 1997]



Sec. 5.81  Responses to Drug Enforcement Administration temporary scheduling notices.

    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 the Controlled 
Substances Act, as amended (Title II of the Comprehensive Drug Abuse 
Prevention and Control Act of 1970, 21 U.S.C. 811(h)(4), as amended 
hereafter). The delegation excludes the authority to submit reports to 
Congress. Further redelegation may only be authorized with the 
Commissioner of Food and Drugs' approval.

[65 FR 34962, June 1, 2000]



Sec. 5.82  Issuance of notices relating to proposals to refuse approval or to withdraw approval of new drug applications and their supplements.

    (a) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for 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 Sec. 314.440(b) of this chapter, that have been submitted 
under section 505 of the Federal Food, Drug, and Cosmetic 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.
    (b) The Director and Deputy Director, Center for Biologics 
Evaluation and Research, for those drugs listed in Sec. 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 Federal Food, Drug, and Cosmetic 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.

[54 FR 8319, Feb. 28, 1989, as amended at 62 FR 2558, Jan. 17, 1997]



Sec. 5.83  Approval of new animal drug applications, medicated feed mill license applications and their supplements.

    (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 with regard to the approval of new animal drug 
applications,

[[Page 61]]

and supplements thereto, for new animal drugs submitted pursuant to 
section 512 of the Federal Food, Drug, and Cosmetic Act (the act).
    (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 pursuant to section 512 of the act:
    (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 of Food and Drugs with regard to the 
approval of supplemental applications to new animal drug applications 
that are described by Sec. 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 of Food and Drugs with regard to the 
approval of medicated feed mill license applications for the manufacture 
of animal feeds containing new animal drugs pursuant to section 512(m) 
of the act, as amended by the Animal Drug Availability Act of 1996 (Pub. 
L. 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.

[49 FR 14937, Apr. 16, 1984, as amended at 50 FR 14094, Apr. 10, 1985; 
53 FR 2225, Jan. 27, 1988; 53 FR 17186, May 16, 1988; 53 FR 40055, Oct. 
13, 1988; 63 FR 70650, Dec. 22, 1998; 64 FR 23184, Apr. 30, 1999]



Sec. 5.84  Issuance of notices, proposals, and orders relating to new animal drugs and medicated feed mill license applications.

    (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 pursuant to section 
512(m) of the Federal Food, Drug, and Cosmetic Act, as amended by the 
Animal Drug Availability Act of 1996 (Pub. L. 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 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.

[49 FR 17936, Apr. 26, 1984, as amended at 63 FR 70650, Dec. 22, 1998]



Sec. 5.85  Authority to ensure that mammography facilities meet quality standards.

    (a) The following officials are authorized to issue, renew, and 
extend certificates to mammography facilities under section 354(c) of 
the Public Health Service Act (42 U.S.C. 263b):
    (1) The Director and Deputy Director for Regulations and Policy, 
Center for

[[Page 62]]

Devices and Radiological Health (CDRH).
    (2) The Director, Office of Health and Industry Programs, CDRH.
    (3) The Director, Division of Mammography Quality and Radiation 
Programs, Office of Health and Industry Programs, CDRH.
    (b) The following officials are authorized to accept an application 
for a certificate under section 354(d)(1) of the Public Health Service 
Act:
    (1) The Director and Deputy Director for Regulations and Policy, 
CDRH.
    (2) The Director, Office of Health and Industry Programs, CDRH.
    (3) The Director, Division of Mammography Quality and Radiation 
Programs, Office of Health and Industry Programs, CDRH.
    (c) The following officials are authorized to approve accreditation 
bodies to accredit mammography facilities under section 354(e)(1)(A) of 
the Public Health Service Act:
    (1) The Director and Deputy Director for Regulations and Policy, 
CDRH.
    (2) The Director, Office of Health and Industry Programs, CDRH.
    (d) The following officials are authorized to ensure that 
accreditation bodies provide satisfactory assurances of compliance under 
section 354(e)(1)(C) of the Public Health Service Act:
    (1) The Director and Deputy Director for Regulations and Policy, 
CDRH.
    (2) The Director, Office of Health and Industry Programs, CDRH.
    (3) The Director, Division of Mammography Quality and Radiation 
Programs, Office of Health and Industry Programs, CDRH.
    (e) The Director, CDRH, is authorized to promulgate regulations 
under which the Director may withdraw approval of accreditation bodies 
under section 354(e)(2) of the Public Health Service Act.
    (f) The following officials are authorized to determine the 
applicable standards for a facility for accreditation under section 
354(e)(3) of the Public Health Service Act:
    (1) The Director and Deputy Director for Regulations and Policy, 
CDRH.
    (2) The Director, Office of Health and Industry Programs, CDRH.
    (3) The Director, Division of Mammography Quality and Radiation 
Programs, Office of Health and Industry Programs, CDRH.
    (g) The following officials are authorized to ensure that 
accreditation bodies make on site visits and to determine whether other 
measures are appropriate under section 354(e)(4)(A) and (e)(4)(B) of the 
Public Health Service Act:
    (1) The Director and Deputy Director for Regulations and Policy, 
CDRH.
    (2) The Director, Office of Health and Industry Programs, CDRH.
    (3) The Director, Division of Mammography Quality and Radiation 
Programs, Office of Health and Industry Programs, CDRH.
    (h) 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 Public Health Service Act:
    (1) The Director and Deputy Director for Regulations and Policy, 
CDRH.
    (2) The Director, Office of Health and Industry Programs, CDRH.
    (3) The Director, Division of Mammography Quality and Radiation 
Programs, Office of Health and Industry Programs, CDRH.
    (i) The following officials are authorized to determine the 
compliance of certified facilities with established standards through 
facility inspections as provided by section 354(g) of the Public Health 
Service Act:
    (1) The Director and Deputy Director for Regulations and Policy, 
CDRH.
    (2) The Director, Office of Health and Industry Programs, CDRH.
    (3) The Director, Division of Mammography Quality and Radiation 
Programs, Office of Health and Industry Programs, CDRH.
    (j) The Director and Deputy Director for Regulations and Policy, 
CDRH, are authorized to impose sanctions under section 354(h)(1) and 
(h)(2) of the Public Health Service Act.
    (k) The Director and Deputy Director for Regulations and Policy, 
CDRH, are authorized to suspend or revoke individual facility 
certificates under section 354(i)(1) and (i)(2)(A) of the Public Health 
Service Act.
    (l) The Director and Deputy Director for Regulations Policy, CDRH, 
are authorized to compile and make available

[[Page 63]]

to physicians and the general public information the Director determines 
is useful in evaluating the performance of mammography facilities as 
provided by section 354(l) of the Public Health Service Act.
    (m)(1) 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 Public Health Service Act:
    (i) The Director and Deputy Director for Regulations and Policy, 
CDRH.
    (ii) The Director, Office of Health and Industry Programs, CDRH.
    (2) The Director, CDRH, is 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 Public Health Service Act.

[60 FR 47268, Sept. 12, 1995]



Sec. 5.86  Variances from performance standards for electronic products.

    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:
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (b) The Director and Deputy Director, Office of Compliance, CDRH.

[52 FR 29664, Aug. 11, 1987, as amended at 55 FR 47053, Nov. 9, 1990; 62 
FR 67272, Dec. 24, 1997]



Sec. 5.87  Exemption of electronic products from performance standards and prohibited acts.

    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 358(a)(5) of the Public 
Health Service Act (the act) and to exempt an electronic product or 
class of products from all or part of the provisions of section 360B(a) 
of the act under section 360B(b) of that act:
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (b) The Director and Deputy Director, Office of Compliance, CDRH.

[52 FR 29664, Aug. 11, 1987, as amended at 55 FR 47053, Nov. 9, 1990; 62 
FR 67272, Dec. 24, 1997]



Sec. 5.88  Testing programs and methods of certification and identification for electronic products.

    The Director and Deputy Directors, 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 358(g) of the Public Health 
Service Act (the Act), and to approve or disapprove alternate methods of 
certification and identification and to disapprove testing programs upon 
which certification is based under section 358(h) of the Act.

[62 FR 67272, Dec. 24, 1997]



Sec. 5.89  Notification of defects in, and repair or replacement of, electronic products.

    (a) The Director and Deputy Directors, 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, relating to notification of defects in, 
noncompliance of, and repair or replacement of or refund for, electronic 
products under section 359 of the Public Health Service Act (the act) 
and under Secs. 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 
Sec. 1020.30(b) of this chapter.
    (2) Manufacturers of sunlamp products and ultraviolet lamps intended 
for use in any sunlamp product, as defined in Sec. 1040.20(b) of this 
chapter.
    (b) The Director and Deputy Director, Office of Compliance, CDRH, 
and

[[Page 64]]

the Division Directors, Office of Compliance, CDRH, are authorized to 
notify manufacturers of defects in, and noncompliance of, electronic 
products under section 359(e) of the act and under Sec. 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 
Sec. 1020.30(b) of this chapter.
    (2) Manufacturers of sunlamp products and ultraviolet lamps intended 
for use in any sunlamp products, as defined in Sec. 1040.20(b) of this 
chapter.

[48 FR 56948, Dec. 27, 1983, as amended at 51 FR 32452, Sept. 12, 1986; 
55 FR 47054, Nov. 9, 1990; 62 FR 15110, Mar. 31, 1997; 62 FR 67272, Dec. 
24, 1997]



Sec. 5.90  Manufacturers requirement to provide data to ultimate purchasers of electronic products.

    The Director and Deputy Directors, 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 360A(c) of the Public Health Service Act.

[62 FR 67273, Dec. 24, 1997]



Sec. 5.91  Dealer and distributor direction to provide data to manufacturers of electronic products.

    The Director and Deputy Directors, 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 360A(f) of the Public 
Health Service Act.

[62 FR 67273, Dec. 24, 1997]



Sec. 5.92  Acceptance of assistance from State and local authorities for enforcement of radiation control legislation and regulations.

    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 
360E of the Public Health Service Act.

[62 FR 67273, Dec. 24, 1997]



Sec. 5.93  Submission of and effective approval dates for abbreviated new drug applications and certain new drug applications.

    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) of the 
Federal Food, Drug and Cosmetic Act (the act) concerning the date of 
submission or the date or effective approval of abbreviated new drug 
applications including supplements thereto submitted under section 
505(j) of the act and of new drug applications including supplements 
thereto submitted under section 505(b)(1) of the act and described under 
section 505(b)(2) of the act:
    (a) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (b) The Director and Deputy Director, Office of Generic Drugs, 
Office of Pharmaceutical Science, CDER.

[53 FR 18274, May 23, 1988, as amended at 55 FR 6247, Feb. 22, 1990; 62 
FR 2558, Jan. 17, 1997; 64 FR 49383, Sept. 13, 1999]



Sec. 5.94  Extensions or stays of effective dates for compliance with certain labeling requirements for human prescription drugs.

    The following officials are authorized to extend or stay an 
effective date in Sec. 201.59 of this chapter for compliance with 
certain labeling requirements for human prescription drugs.
    (a) For drugs assigned to their organizations:
    (1) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).
    (2) The Director and Deputy Director, Office of Biological Product 
Review, CBER.
    (3) The Directors and Deputy Directors of the divisions in the 
Office of Biological Product Review, CBER.

[[Page 65]]

    (b) For drugs assigned to their organizations:
    (1) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (2) The Directors of the Offices of Drug Evaluation I, II, III, IV, 
and V, Office of Review Management, CDER.
    (3) 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.

[52 FR 2514, Jan. 23, 1987, as amended at 54 FR 8320, Feb. 28, 1989; 55 
FR 51688, Dec. 17, 1990; 62 FR 2558, Jan. 17, 1997]



Sec. 5.95  Submission of and effective approval dates for abbreviated new animal drug applications and certain new animal drug applications.

    The following officials are authorized to perform all the functions 
of the Commissioner of Food and Drugs 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) 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, and of new animal drug applications including supplements thereto, 
submitted under section 512(b)(1) of the act:
    (a) The Director and Deputy Director, Center for Veterinary Medicine 
(CVM).
    (b) The Director and Deputy Director, Office of New Animal Drug 
Evaluation, CVM.

[56 FR 6263, Feb. 15, 1991]



Sec. 5.98   Authority relating to medical device reporting procedures.

    (a) The Director and Deputy Directors, 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 Sec. 803.14 of this 
chapter.
    (b) The Director and Deputy Directors, 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 Sec. 803.15 of this chapter.
    (c) The Director and Deputy Directors, 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 Sec. 803.19 of this chapter.

[64 FR 4965, Feb. 2, 1999]



Sec. 5.99  Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment.

    The Director and Deputy Director, Center for Drug Evaluation and 
Research (CDER), the Director and Deputy Director, Center for Veterinary 
Medicine (CVM), and the Director and Associate Director for Policy 
Coordination and Public Relations, Center for Biologics Evaluation and 
Research (CBER) are authorized to issue the following notices under 
section 306 of the Federal Food, Drug, and Cosmetic Act (the act) which 
relate to the assigned functions of their organizations:
    (a) Notices of opportunity for hearing on proposals for mandatory or 
permissive debarment.
    (b) Notices ordering debarment when opportunity for a hearing has 
been waived.
    (c) Notices ordering debarment where the person notifies the agency 
that the person acquiesces to debarment under section 306(c)(2)(B) of 
the act.
    (d) Notices of opportunity for hearing on proposals denying an 
application to terminate debarment under section 306(d)(3) of the act.
    (e) Orders denying an application to terminate debarment under 
section 306(d)(3) of the act when opportunity for a hearing has been 
waived.

[61 FR 8215, Mar. 4, 1996; 61 FR 11545, Mar. 21, 1996; 61 FR 14375, Apr. 
1, 1996]

[[Page 66]]



                         Subpart C--Organization



Sec. 5.100  Officials authorized to make certification under 5 U.S.C. 605(b) for any proposed and final rules.

    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:
    (a) The Associate Commissioner for Regulatory Affairs (ACRA).
    (b) The Director, Center for Biologics Evaluation and Research 
(CBER).
    (c) The Director, Center for Drug Evaluation and Research (CDER).
    (d) The Director, Center for Devices and Radiological Health (CDRH).
    (e) The Director, Center for Food Safety and Applied Nutrition 
(CFSAN).
    (f) The Director, Center for Veterinary Medicine (CVM).
    (g) Other FDA Officials authorized to issue Federal Register 
documents.

[62 FR 48757, Sept. 17, 1997]



Sec. 5.101  Authority relating to waivers or reductions of prescription drug user fees.

    The Director, Center for Drug Evaluation and Research (CDER), and 
the Associate Director for Policy, CDER, are authorized to perform all 
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 l992, as originally enacted and as reauthorized by the 
FDA Modernization Act of l997, except for the functions under 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 FDA 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. 
These authorities may not be further redelegated. (See Sec. 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.)

[64 FR 59618, Nov. 3, 1999]



Sec. 5.200  Headquarters.

    The central organization of the Food and Drug Administration 
consists of the following:
    Office of the Commissioner.\1\
---------------------------------------------------------------------------

    \1\ Mailing address: 5600 Fishers Lane, Rockville, MD 20857.
---------------------------------------------------------------------------

    Office of the Chief Counsel.
    Office of Equal Opportunity.
    Office of the Administrative Law Judge.
    Office of the Senior Associate Commissioner.
    Office of Executive Secretariat.
    Office of Public Affairs.
    Office of the Ombudsman.
    Office of Orphan Products Development.
    Office of Internal Affairs.
    Office of Executive Operations.
    Office of International and Constituent Relations.
    Office of International Programs.
    Office of Consumer Affairs.
    Office of Women's Health.
    Office of Special Health Issues.
    Office of Policy, Planning, and Legislation.
    Office of Policy.
    Office of Planning.
    Office of Legislation.
    Office of Management and Systems.
    Office of Human Resources and Management Services.
    Office of Information Resources Management.
    Office of Financial Management.
    Office of Facilities, Acquisitions, and Central Services.\2\
---------------------------------------------------------------------------

    \2\ Mailing address: 5630 Fishers Lane, Rockville, MD 20852.

---------------------------------------------------------------------------

[[Page 67]]

    Center for Biologics Evaluation and Research.\3\
---------------------------------------------------------------------------

    \3\ Mailing address: 1401 Rockville Pike, Rockville, MD 20852-1448.
---------------------------------------------------------------------------

    Office of the Center Director.
    Scientific Advisors and Consultants Staff.
    Equal Employment Opportunity and Workforce Diversity Staff.
    Quality Assurance Staff.
    Regulations and Policy Staff.
    Veterinary Services Staff.
    Office of Management.
    Regulatory Information Management Staff.
    Division of Planning, Evaluation, and Budget.
    Division of Management Services.
    Office of Information Technology Management.
    Division of Information Technology Operations.
    Division of Information Technology Development.
    Division of Information Technology Infrastructure.
    Office of Compliance and Biologics Quality.
    Team Biologics Liaison Staff.
    Advertising and Promotional Labeling Staff.
    Division of Case Management.
    Division of Manufacturing and Product Quality.
    Division of Inspections and Surveillance.
    Office of Blood Research and Review.
    Human Tissue Staff.
    Policy and Publications Staff.
    Division of Emerging and Transfusion Transmitted Diseases.
    Division of Hematology.
    Division of Blood Applications.
    Office of Therapeutics Research and Review.
    Division of Cellular and Gene Therapies.
    Division of Therapeutic Proteins.
    Division of Monoclonal Antibodies.
    Division of Clinical Trial Design and Analysis.
    Division of Application Review and Policy.
    Office of Vaccines Research and Review.
    Division of Bacterial, Parasitic, and Allergenic Products.
    Division of Viral Products.
    Division of Vaccines and Related Products Applications.
    Office of Communication, Training, and Manufacturers Assistance.
    Division of Disclosure and Oversight Management.
    Division of Manufacturers Assistance and Training.
    Division of Communication and Consumer Affairs.
    Office of Biostatistics and Epidemiology.
    Division of Biostatistics.
    Division of Epidemiology.
    Center for Food Safety and Applied Nutrition.\4\
---------------------------------------------------------------------------

    \4\ Mailing address: 200 C St. SW., Washington DC 20204.
---------------------------------------------------------------------------

    Office of the Center Director.
    Food Safety Initiatives Staff.
    Senior Science Advisor's Staff.
    Office of Regulations and Policy.
    Regulations Coordination Staff.
    Office of Constituent Operations.
    Consumer Education Staff.
    International Activities Staff.
    Industry Activities Staff.
    Office of Management Systems.
    Safety Management Staff.
    Division of Information Resources Management.
    Division of Planning and Financial Resources Management.
    Division of Management Operations.
    Division of Administrative Services Management.
    Office of Operations.
    Equal Employment Opportunity Staff.
    Executive Operations Staff.
    Office of Cosmetics and Colors.
    Division of Programs and Enforcement Policy.
    Division of Science and Applied Technology.
    Office of Nutritional Products, Labeling, and Dietary Supplements.
    Clinical Research and Review Staff.
    Division of Compliance and Enforcement.
    Division of Standards and Labeling Regulations.
    Division of Nutrition Science Policy.
    Division of Research and Applied Technology.
    Office of Premarket Approval.
    Division of Product Policy.
    Division of Petition Control.

[[Page 68]]

    Division of Health Effects Evaluation.
    Division of Molecular Biological Research and Evaluation.
    Division of Product Manufacture and Use.
    Office of Plant and Dairy Foods and Beverages.
    Division of Virulence Assessment.
    Division of Pesticides and Industrial Chemicals.
    Division of Natural Products.
    Division of Food Processing and Packaging.
    Division of Plant Product Safety.
    Division of Dairy and Egg Safety.
    Division of Risk Assessment.
    Office of Seafood.
    Division of Special Programs.
    Division of Programs and Enforcement Policy.
    Division of Science and Applied Technology.
    Office of Special Research Skills.
    Division of Toxicology Research.
    Division of Microbiological Studies.
    Office of Field Programs.
    Division of Enforcement and Programs.
    Division of HACCP Programs.
    Division of Cooperative Programs.
    Office of Scientific Analysis and Support.
    Division of General Scientific Support.
    Division of Mathematics.
    Division of Market Studies.
    Center for Drug Evaluation and Research.\1\
    Office of the Center Director.
    Equal Employment Opportunity Staff.
    Executive Operations Staff.
    Regulatory Policy Staff.
    Office of Management.\1\
    Strategic Planning Staff.\5\
---------------------------------------------------------------------------

    \5\ Mailing address: 7500 Standish Pl., Rockville, MD 20855.
---------------------------------------------------------------------------

    Division of Management and Budget.\5\
    Division of Management Services.\5\
    Office of Training and Communication.\1\
    Division of Communications Management.
    Division of the Medical Library.
    Division of Training and Development.
    Division of Freedom of Information.
    Office of Compliance.\6\
---------------------------------------------------------------------------

    \6\ Mailing address 7520 Standish Pl., Rockville, MD 20855.
---------------------------------------------------------------------------

    Division of Manufacturing and Product Quality.
    Division of Prescription Drug Compliance and Surveillance.
    Division of Labeling and Non-Prescription Drug Compliance.
    Office of Information Technology.\1\
    Quality Assurance Staff.
    Technology Support Services Staff.
    Division of Data Management and Services.
    Division of Applications Development and Services.
    Division of Infrastructure Management and Services.
    Office of Medical Policy.\1\
    Division of Drug Marketing, Advertising, and Communication\1\
    Division of Scientific Investigations.\6\
    Office of Review Management.\1\
    Advisors and Consultants Staff.\2\
    Office of Drug Evaluation I.\1\
    Division of Cardio-Renal Drug Products.
    Division of Neuropharmacological Drug Products.
    Division of Oncology Drug Products.
    Office of Drug Evaluation II.\1\
    Division of Metabolic and Endocrine Drug Products.
    Division of Pulmonary and Allergy Drug Products.
    Division of Anesthetic, Critical Care, and Addiction Drug Products.
    Office of Drug Evaluation III.\1\
    Division of Gastrointestinal and Coagulation Drug Products.
    Division of Medical Imaging and Radiopharmaceutical Drug Products.
    Division of Reproductive and Urologic Drug Products.
    Office of Drug Evaluation IV.
    Division of Anti-Infective Drug Products.
    Division of Anti-Viral Drug Products.
    Division of Special Pathogen and Immunologic Drug Products. Office 
of Drug Evaluation V.
    Division of Anti-Inflammatory, Analgesic, and Opthalmologic Drug 
Products.
    Division of Dermatologic and Dental Drug Products.
    Division of Over-the-Counter Drug Products.

[[Page 69]]

    Office of Biostatistics.\1\
    Quantitative Methods Research Staff.
    Division of Biometrics I.
    Division of Biometrics II.
    Division of Biometrics III.
    Office of Post-Marketing Drug Risk Assessment.
    Extramural Programs Staff.
    Information Technology Staff.
    Division of Drug Risk Evaluation I.
    Division of Drug Risk Evaluation II.
    Office of Pharmaceutical Science.\1\
    Quality Implementation Staff.\1\
    Operations Staff.\1\
    Office of Clinical Pharmacology and Biopharmaceutics.
    Pharmacometrics Staff.
    Division of Pharmaceutical Evaluation I.\1\
    Division of Pharmaceutical Evaluation II.\1\
    Division of Pharmaceutical Evaluation III.\1\
    Office of Generic Drugs.\5\
    Division of Bioequivalence.
    Division of Chemistry I.
    Division of Chemistry II.
    Division of Labeling and Program Support.
    Office of New Drug Chemistry.\1\
    Division of New Drug Chemistry I.\1\
    Division of New Drug Chemistry II.\1\
    Division of New Drug Chemistry III.\1\
    Office of Testing and Research.\1\
    Regulatory Research and Analysis Staff.
    Laboratory of Clinical Pharmacology.\7\
---------------------------------------------------------------------------

    \7\ Mailing address: Four Research Ct., Rockville, MD 20850.
---------------------------------------------------------------------------

    Division of Applied Pharmacology Research.\8\
---------------------------------------------------------------------------

    \8\ Mailing address: 8308 Muirkirk Rd., Laurel, MD 20708.
---------------------------------------------------------------------------

    Division of Testing and Applied Analytical Development.\9\
---------------------------------------------------------------------------

    \9\ Mailing address: 1114 Market St., St. Louis, MO 63101.
---------------------------------------------------------------------------

    Division of Product Quality Research.\1\
    Office of Regulatory Affairs.\1\
    Contaminants Policy Coordination Staff.
    Equal Employment Opportunity Staff.
    Strategic Initiatives Staff.
    Office of Resource Management.
    Division of Planning, Evaluation, and Management.
    Division of Information Systems.
    Division of Human Resource Development.
    Division of Management Operations.
    Division of Personnel Operations.
    Office of Enforcement.
    Medical Products Quality Assurance Staff.
    Division of Compliance Management and Operations.
    Division of Compliance Policy.
    Office of Regional Operations.
    Division of Federal-State Relations.
    Division of Field Science.
    Division of Emergency and Investigational Operations.
    Division of Import Operations and Policy.
    Office of Criminal Investigations.
    Mid-Atlantic Area Office.\10\
---------------------------------------------------------------------------

    \10\ Mailing address: 900 U.S. Courthouse, Second Chestnut St., 
Philadelphia, PA 19106.
---------------------------------------------------------------------------

    Midwest Area Office.\11\
---------------------------------------------------------------------------

    \11\Mailing address: 901 Warrenville Rd., suite 360, Lisle, IL 
60532.
---------------------------------------------------------------------------

    Northeast Area Office.\12\
---------------------------------------------------------------------------

    \12\ Mailing address: 850 Third Ave., Brooklyn, NY 11232.
---------------------------------------------------------------------------

    Pacific Area Office.\13\
---------------------------------------------------------------------------

    \13\ Mailing address: 13301 Clay St., Oakland, CA 94512.
---------------------------------------------------------------------------

    Southeast Area Office.\14\
---------------------------------------------------------------------------

    \14\ Mailing address: 60 Eighth St. NE., Atlanta, GA 30309.
---------------------------------------------------------------------------

    Southwest Area Office.\15\
---------------------------------------------------------------------------

    \15\ Mailing address: 7920 Elmbrook Rd., Dallas, TX, 75247.
---------------------------------------------------------------------------

    Center for Veterinary Medicine.\16\
---------------------------------------------------------------------------

    \16\ Mailing address: 7500 Standish Pl., MPN-2, Rockville, MD 20855.
---------------------------------------------------------------------------

    Office of the Center Director.
    Office of Management and Communications.
    Administrative Staff.
    Communications Staff.
    Program Planning and Evaluation Staff.
    Information Resources Management Staff.
    Office of New Animal Drug Evaluation.
    Division of Therapeutic Drugs for Food Animals.
    Division of Biometrics and Production Drugs.
    Division of Therapeutic Drugs for Non-Food Animals.
    Division of Human Food Safety.

[[Page 70]]

    Division of Manufacturing Technologies.
    Office of Surveillance and Compliance.
    Division of Surveillance.
    Division of Animal Feeds.
    Division of Compliance.
    Division of Epidemiology.
    Office of Research.
    Administrative Staff.
    Division of Residue Chemistry.
    Division of Animal Research.
    Division of Animal and Food Microbiology.
    Center for Devices and Radiological Health.\17\
---------------------------------------------------------------------------

    \17\ Mailing address: 9200 Corporate Blvd., Rockville, MD 20850.
---------------------------------------------------------------------------

    Office of the Center Director.
    Equal Employment Opportunity Staff.
    Office of Systems and Management.
    Integrity Committee and Conference Management Staff.
    Division of Management Operations.
    Division of Information Dissemination.
    Division of Information Technology Management.
    Division of Planning, Analysis, and Finance.
    Office of Compliance.
    Promotion and Advertising Policy Staff.
    Division of Bioresearch Monitoring.
    Division of Program Operations.
    Division of Enforcement I.
    Division of Enforcement II.
    Division of Enforcement III.
    Office of Device Evaluation.
    Program Management Staff.
    Program Operations Staff.
    Division of Cardiovascular, Respiratory, and Neurological Devices.
    Division of Reproductive, Abdominal, Ear, Nose, Throat, and 
Radiological Devices.
    Division of General and Restorative Devices.
    Division of Clinical Laboratory Devices.
    Division of Ophthalmic Devices.
    Division of Dental, Infection Control, and General Hospital Devices.
    Office of Science and Technology.
    Division of Mechanics and Materials Science.
    Division of Life Sciences.
    Division of Physical Sciences.
    Division of Electronics and Computer Sciences.
    Division of Management Information and Support Services.
    Office of Health and Industry Programs.
    Program Operations Staff.
    Regulations Staff.
    Staff College.
    Division of Device User Programs and Systems Analysis.
    Division of Small Manufacturers Assistance.
    Division of Mammography Quality and Radiation Programs.
    Division of Communication Media.
    Office of Surveillance and Biometrics.
    Issues Management Staff.
    Division of Biostatistics.
    Division of Postmarket Surveillance.
    Division of Surveillance Systems.
    National Center for Toxicological Research.\18\
---------------------------------------------------------------------------

    \18\ Mailing address: 3900 NCTR Dr., Jefferson, AR 72079.
---------------------------------------------------------------------------

    Office of the Center Director.
    Environmental Health and Program Assurance Staff.
    Office of Research.
    Technology Advancement Staff.
    Division of Biochemical Toxicology.
    Division of Genetic and Reproductive Toxicology.
    Division of Biometry and Risk Assessment.
    Division of Microbiology.
    Division of Chemistry.
    Division of Neurotoxicology.
    Division of Veterinary Services.
    Division of Molecular Epidemiology.
    Office of Management.
    Office of Management Services.
    Contracts and Procurement Staff.
    Division of Facilities, Engineering, and Maintenance.
    Division of Administrative Services.
    Office of Planning, Finance and Information Technology.
    Division of Planning.
    Division of Financial Management.
    Division of Information Technology.

[65 FR 19830, Apr. 13, 2000]



Sec. 5.205  Chief Counsel, Food and Drug Administration.

    The Chief Counsel to the Commissioner of Food and Drugs is the 
Associate General Counsel, Food and Drug

[[Page 71]]

Division, Office of the General Counsel, Department of Health and Human 
Services, Room 6-57, 5600 Fishers Lane, Rockville, MD 20857.

[46 FR 8455, Jan. 27, 1981, as amended at 56 FR 8709, Mar. 1, 1991. 
Redesignated at 62 FR 13824, Mar. 24, 1997]



Sec. 5.210  FDA Public Information Offices.

    (a) Dockets Management Branch (HFA-305). The Dockets Management 
Branch Public Room is located in rm. 1061, 5630 Fishers Lane, Rockville, 
MD 20852. Telephone: 301-827-6860.
    (b) Freedom of Information Staff (HFI-35). The Freedom of 
Information Public Room is located in rm. 12A-30, Parklawn Bldg., 5600 
Fishers Lane, Rockville, MD 20857. Telephone: 301-827-6567.
    (c) Press Relations Staff (HFI-40). The Press Offices are located in 
rm. 15-05, Parklawn Bldg., 5600 Fisher Lane, Rockville, MD 20857. 
Telephone: 301-827-6242; and in rm. 3807, FB-8, 200 C St. SW., 
Washington, DC 20204. Telephone 202-205-4144.

[65 FR 19832, Apr. 13, 2000]



Sec. 5.215  Field structure.

                            NORTHEAST REGION

    Regional Field Office: 850 Third Ave., Brooklyn, NY 11232.
    Northeast Regional Laboratory: 850 Third Ave., Brooklyn, NY 11232-
1593.
    New York District Office: 850 Third Ave., Brooklyn, NY 11232-1593.
    New England District Office: One Montvale Ave., Stoneham, MA 02180.
    Winchester Engineering and Analytical Center: 109 Holton St., 
Winchester, MA 01890.

                             CENTRAL REGION

    Regional Field Office: U.S. Customhouse, Second and Chestnut Sts., 
rm. 900, Philadelphia, PA 19106.
    Philadelphia District Office: U.S. Customhouse, Second and Chestnut 
Sts., rm. 900, Philadelphia, PA 19106.
    Baltimore District Office: 900 Madison Ave., Baltimore, MD 21201-
2199.
    Cincinnati District Office: 6751 Steger Dr., Cincinnati, OH 45237-
3097.
    Forensic Chemistry Center: 1141 Central Pkwy., Cincinnati, OH 45202-
1097.
    New Jersey District Office: Waterview Corporate Center, 10 Waterview 
Blvd., 3d Floor, Parsippany, NJ 07054.
    Chicago District Office: 300 South Riverside Plaza, suite 550, South 
Chicago, IL 60606.
    Detroit District Office: 1560 East Jefferson Ave., Detroit, MI 
48207-3179.
    Minneapolis District Office: 240 Hennepin Ave., Minneapolis, MN 
55401-1912.

                            SOUTHEAST REGION

    Regional Field Office: 60 Eighth St. NE., Atlanta, GA 30309.
    Southeast Regional Laboratory: 60 Eighth St. NE., Atlanta, GA 30309.
    Atlanta District Office: 60 Eighth St. NE., Atlanta, GA 30309.
    Nashville District Office: 297 Plus Park Blvd., Nashville, TN 37217.
    New Orleans District Office: 4298 Elysian Fields Ave., New Orleans, 
LA 70122.
    Florida District Office: 555 Winderley, suite 200, Maitland, FL 
32751.
    San Juan District Office: 466 Fernandez Juncos Ave., San Juan, PR 
00901-3223.

                            SOUTHWEST REGION

    Regional Field Office: 7920 Elmwood Rd., suite 102, Dallas, TX 
75247-4982.
    Dallas District Office: 3310 Live Oak St., Dallas, TX 75204.
    Denver District Office: Bldg. 20, Denver Federal Center, Sixth and 
Kipling Sts., P.O. Box 25087, Denver, CO 80225-0087.
    Kansas City District Office: 11630 West 80th St., Lenexa, KS 66214-
3338.
    St. Louis Branch:12 Sunnen Dr., suite 122, St. Louis, MO 63143-3800.
    Arkansas Regional Laboratory: 3900 NCTR Rd., Bldg. 14-T, rm. 104, 
Jefferson, AR 72079-9502.

                             PACIFIC REGION

    Regional Field Office: 1301 Clay St., suite 1180-N, Oakland, CA 
94612-5217.
    San Francisco District Office: 1431 Harbor Bay Pkwy., Alameda, CA 
94502-7070.
    Los Angeles District Office: 19900 MacArthur Blvd., suite 300, 
Irvine, CA 92715.
    Seattle District Office: P.O. Box 3012, Bothell, WA 98021-3012.
    Pacific Regional Laboratory, SW.: 1521 West Pico Blvd., Los Angeles, 
CA 90015-2488.

[[Page 72]]

    Pacific Regional Laboratory, NW.: 22201 23d Dr. SE., Bothell, WA 
98021-4421.

[65 FR 19832, Apr. 13, 2000]



PART 7--ENFORCEMENT POLICY--Table of Contents




                      Subpart A--General Provisions

Sec.
7.1  Scope.
7.3  Definitions.
7.12  Guaranty.
7.13  Suggested forms of guaranty.

Subpart B  [Reserved]

Subpart C--Recalls (Including Product Corrections)--Guidance on Policy, 
                Procedures, and Industry Responsibilities

7.40  Recall policy.
7.41  Health hazard evaluation and recall classification.
7.42  Recall strategy.
7.45  Food and Drug Administration-requested recall.
7.46  Firm-initiated recall.
7.49  Recall communications.
7.50  Public notification of recall.
7.53  Recall status reports.
7.55  Termination of a recall.
7.59  General industry guidance.

Subpart D  [Reserved]

                     Subpart E--Criminal Violations

7.84  Opportunity for presentation of views before report of criminal 
          violation.
7.85  Conduct of a presentation of views before report of criminal 
          violation.
7.87  Records related to opportunities for presentation of views 
          conducted before report of criminal violation.

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 241, 262, 263b-263n, 264.

    Source: 42 FR 15567, Mar. 22, 1977, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 7.1  Scope.

    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 et seq.) and other laws that it administers. This part also 
provides guidance for manufacturers and distributors to follow with 
respect to their voluntary removal or correction of marketed violative 
products. This part is promulgated to clarify and explain the regulatory 
practices and procedures of the Food and Drug Administration, enhance 
public understanding, improve consumer protection, and assure uniform 
and consistent application of practices and procedures throughout the 
agency.

[43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19, 2000]



Sec. 7.3  Definitions.

    (a) Agency means the Food and Drug Administration.
    (b) Citation or cite means a document and any attachments thereto 
that provide notice to a person against whom criminal prosecution is 
contemplated of the opportunity to present views to the agency regarding 
an alleged violation.
    (c) Respondent means a person named in a notice who presents views 
concerning an alleged violation either in person, by designated 
representative, or in writing.
    (d) Responsible individual includes those in positions of power or 
authority to detect, prevent, or correct violations of the Federal Food, 
Drug, and Cosmetic Act.
    (e) [Reserved]
    (f) Product means an article subject to the jurisdiction of the Food 
and Drug Administration, including any food, drug, and device intended 
for human or animal use, any cosmetic and biologic intended for human 
use, and any item subject to a quarantine regulation under part 1240 of 
this chapter. Product does not include an electronic product that emits 
radiation and is subject to parts 1003 and 1004 of this chapter.
    (g) Recall means a firm's removal or correction of a marketed 
product that the Food and Drug Administration considers to be in 
violation of the laws it administers and against which the agency would 
initiate legal action, e.g., seizure. Recall does not include a market 
withdrawal or a stock recovery.
    (h) Correction means repair, modification, adjustment, relabeling, 
destruction, or inspection (including patient monitoring) of a product 
without its physical removal to some other location.

[[Page 73]]

    (i) Recalling firm means the firm that initiates a recall or, in the 
case of a Food and Drug Administration-requested recall, the firm that 
has primary responsibility for the manufacture and marketing of the 
product to be recalled.
    (j) Market withdrawal means a firm's removal or correction of a 
distributed product which involves a minor violation that would not be 
subject to legal action by the Food and Drug Administration or which 
involves no violation, e.g., normal stock rotation practices, routine 
equipment adjustments and repairs, etc.
    (k) Stock recovery means a firm's removal or correction of a product 
that has not been marketed or that has not left the direct control of 
the firm, i.e., the product is located on premises owned by, or under 
the control of, the firm and no portion of the lot has been released for 
sale or use.
    (l) Recall strategy means a planned specific course of action to be 
taken in conducting a specific recall, which addresses the depth of 
recall, need for public warnings, and extent of effectiveness checks for 
the recall.
    (m) Recall classification means the numerical designation, i.e., I, 
II, or III, assigned by the Food and Drug Administration to a particular 
product recall to indicate the relative degree of health hazard 
presented by the product being recalled.
    (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) Consignee means anyone who received, purchased, or used the 
product being recalled.

[42 FR 15567, Mar. 22, 1977, as amended at 43 FR 26218, June 16, 1978; 
44 FR 12167, Mar. 6, 1979]



Sec. 7.12  Guaranty.

    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.



Sec. 7.13  Suggested forms of guaranty.

    (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

[[Page 74]]

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.

Subpart B  [Reserved]



Subpart C--Recalls (Including Product Corrections)--Guidance on Policy, 
                Procedures, and Industry Responsibilities

    Source: 43 FR 26218, June 16, 1978, unless otherwise noted.



Sec. 7.40  Recall policy.

    (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 
Secs. 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

[[Page 75]]

ineffective, or discovers that a violation is continuing.

[43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19, 2000]



Sec. 7.41  Health hazard evaluation and recall classification.

    (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 possible by scientific 
documentation and/or statements that the conclusion is the opinion of 
the individual(s) making the health hazard determination.
    (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.



Sec. 7.42  Recall strategy.

    (a) General. (1) A recall strategy that takes into account the 
following factors will be developed by the agency for a Food and Drug 
Administration-requested recall and by the recalling firm for a firm-
initiated recall to suit the individual circumstances of the particular 
recall:
    (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) Elements of a recall strategy. A recall strategy will address 
the following elements regarding the conduct of the recall:
    (1) Depth of recall. Depending on the product's degree of hazard and 
extent of distribution, the recall strategy will specify the level in 
the distribution chain to which the recall is to extend, as follows:
    (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) Public warning. The purpose of a public warning is to alert the 
public that a product being recalled presents a serious hazard to 
health. It is reserved for urgent situations where other means for 
preventing use of the recalled product appear inadequate. The Food and 
Drug Administration in consultation with the recalling firm will 
ordinarily issue such publicity. The recalling firm that decides to 
issue its own public warning is requested to submit its proposed public 
warning and plan for distribution of the warning for review and comment 
by the Food and Drug Administration. The recall strategy will specify 
whether a public warning is needed and whether it will issue as:

[[Page 76]]

    (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) Effectiveness checks. The purpose of effectiveness checks is to 
verify that all consignees at the recall depth specified by the strategy 
have received notification about the recall and have taken appropriate 
action. The method for contacting consignees may be accomplished by 
personal visits, telephone calls, letters, or a combination thereof. A 
guide entitled ``Methods for Conducting Recall Effectiveness Checks'' 
that describes the use of these different methods is available upon 
request from the Dockets Management Branch (HFA-305), Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. The 
recalling firm will ordinarily be responsible for conducting 
effectiveness checks, but the Food and Drug Administration will assist 
in this task where necessary and appropriate. The recall strategy will 
specify the method(s) to be used for and the level of effectiveness 
checks that will be conducted, as follows:
    (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.

[43 FR 26218, June 16, 1978, as amended at 46 FR 8455, Jan. 27, 1981; 59 
FR 14363, Mar. 28, 1994]



Sec. 7.45  Food and Drug Administration-requested recall.

    (a) The Commissioner of Food and Drugs or his designee under 
Sec. 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 Sec. 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.



Sec. 7.46  Firm-initiated recall.

    (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 Sec. 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

[[Page 77]]

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.



Sec. 7.49  Recall communications.

    (a) General. A recalling firm is responsible for promptly notifying 
each of its affected direct accounts about the recall. The format, 
content, and extent of a recall communication should be commensurate 
with the hazard of the product being recalled and the strategy developed 
for that recall. In general terms, the purpose of a recall communication 
is to convey:
    (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) Implementation. A recall communication can be accomplished by 
telegrams, mailgrams, or first class letters conspicuously marked, 
preferably in bold red type, on the letter and the envelope: ``drug [or 
food, biologic, etc.] recall [or correction]''. The letter and the 
envelope should be also marked: ``urgent'' for class I and class II 
recalls and, when appropriate, for class III recalls. Telephone calls or 
other personal contacts should ordinarily be confirmed by one of the 
above methods and/or documented in an appropriate manner.
    (c) Contents. (1) A recall communication should be written in 
accordance with the following guidelines:
    (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

[[Page 78]]

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) Responsibility of recipient. Consignees that receive a recall 
communication should immediately carry out the instructions set forth by 
the recalling firm and, where necessary, extend the recall to its 
consignees in accordance with paragraphs (b) and (c) of this section.



Sec. 7.50  Public notification of recall.

    The Food and Drug Administration will promptly make available to the 
public in the weekly FDA Enforcement Report a descriptive listing of 
each new recall according to its classification, whether it was Food and 
Drug Administration-requested or firm-initiated, and the specific action 
being taken by the recalling firm. The Food and Drug Administration will 
intentionally delay public notification of recalls of certain drugs and 
devices where the agency determines that public notification may cause 
unnecessary and harmful anxiety in patients and that initial 
consultation between patients and their physicians is essential. The 
report will not include a firm's product removals or corrections which 
the agency determines to be market withdrawals or stock recoveries. The 
report, which also includes other Food and Drug Administration 
regulatory actions, e.g., seizures that were effected and injunctions 
and prosecutions that were filed, is available upon request from the 
Office of Public Affairs (HFI-1), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857.



Sec. 7.53  Recall status reports.

    (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.



Sec. 7.55  Termination of a recall.

    (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

[[Page 79]]

and a description of the disposition of the recalled product.



Sec. 7.59  General industry guidance.

    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 Secs. 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.

Subpart D  [Reserved]



                     Subpart E--Criminal Violations



Sec. 7.84  Opportunity for presentation of views before report of criminal violation.

    (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

[[Page 80]]

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 verified by telephone or other 
appropriate means.

[44 FR 12167, Mar. 6, 1979]



Sec. 7.85  Conduct of a presentation of views before report of criminal violation.

    (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

[[Page 81]]

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 United States attorney has already done so.

[44 FR 12168, Mar. 6, 1979]



Sec. 7.87  Records related to opportunities for presentation of views conducted before report of criminal violation.

    (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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 
Sec. 20.32 of this chapter.

[44 FR 12168, Mar. 6, 1979]



PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES--Table of Contents




                      Subpart A--General Provisions

Sec.
10.1  Scope.
10.3  Definitions.
10.10  Summaries of administrative practices and procedures.
10.19  Waiver, suspension, or modification of procedural requirements.

              Subpart B--General Administrative Procedures

10.20  Submission of documents to Dockets Management Branch; computation 
          of time; availability for public disclosure.

[[Page 82]]

10.25  Initiation of administrative proceedings.
10.30  Citizen petition.
10.33  Administrative reconsideration of action.
10.35  Administrative stay of action.
10.40  Promulgation of regulations for the efficient enforcement of the 
          law.
10.45  Court review of final administrative action; exhaustion of 
          administrative remedies.
10.50  Promulgation of regulations and orders after an opportunity for a 
          formal evidentiary public hearing.
10.55  Separation of functions; ex parte communications.
10.60  Referral by court.
10.65  Meetings and correspondence.
10.65a  Meetings and correspondence.
10.70  Documentation of significant decisions in administrative file.
10.75  Internal agency review of decisions.
10.80  Dissemination of draft Federal Register notices and regulations.
10.85  Advisory opinions.
10.90  Food and Drug Administration regulations, recommendations, and 
          agreements.
10.95  Participation in outside standard-setting activities.
10.100  Public calendar.
10.100a  Public calendars.
10.105  Representation by an organization.
10.110  Settlement proposals.
10.115  Good guidance practices.

     Subpart C--Electronic Media Coverage of Public Administrative 
             Proceedings; Guideline on Policy and Procedures

10.200  Scope.
10.203  Definitions.
10.204  General.
10.205  Electronic media coverage of public administrative proceedings.
10.206  Procedures for electronic media coverage of agency public 
          administrative proceedings.

    Authority: 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.

    Source: 44 FR 22323, Apr. 13, 1979, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 10.1  Scope.

    (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 Sec. 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 
publication, or to the day or date of publication, or use of the phrase 
to publish, refer to publication in the Federal Register unless 
otherwise noted.

[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989]



Sec. 10.3  Definitions.

    (a) The following definitions apply in this part and parts 12, 13, 
14, 15, 16, and 19:
    Act means the Federal Food, Drug, and Cosmetic Act unless otherwise 
indicated.
    Administrative action includes every act, including the refusal or 
failure to act, involved in the administration of any law by the 
Commissioner, except that it does not include the referral of apparent 
violations to U.S. attorneys for the institution of civil or criminal 
proceedings or an act in preparation of a referral.
    Administrative file means the file or files containing all documents 
pertaining to a particular administrative action, including internal 
working memoranda, and recommendations.
    Administrative record means the documents in the administrative file 
of a particular administrative action on which the Commissioner relies 
to support the action.
    Agency means the Food and Drug Administration.
    Chief Counsel means the Chief Counsel of the Food and Drug 
Administration.
    Commissioner means the Commissioner of Food and Drugs, Food and Drug 
Administration, U.S. Department of Health and Human Services, or the 
Commissioner's designee.

[[Page 83]]

    Department means the U.S. Department of Health and Human Services.
    Dockets Management Branch means the Dockets Management Branch, 
Office of Management and Operations of the Food and Drug Administration, 
U.S. Department of Health and Human Services, rm. 1-23, 12420 Parklawn 
Dr., Rockville, MD 20857.
    Ex parte communication means an oral or written communication not on 
the public record for which reasonable prior notice to all parties is 
not given, but does not include requests for status reports on a matter.
    FDA means the Food and Drug Administration.
    Food and Drug Administration employee or Food and Drug 
Administration representative includes members of the Food and Drug 
Division of the office of the General Counsel of the Department of 
Health and Human Services.
    Formal evidentiary public hearing means a hearing conducted under 
part 12.
    Interested person or any person who will be adversely affected means 
a person who submits a petition or comment or objection or otherwise 
asks to participate in an informal or formal administrative proceeding 
or court action.
    Meeting means any oral discussion, whether by telephone or in 
person.
    Office of the Commissioner includes the offices of the Associate 
Commissioners but not the centers or the regional or district offices.
    Order means the final agency disposition, other than the issuance of 
a regulation, in a proceeding concerning any matter and includes action 
on a new drug application, new animal drug application, or biological 
license.
    Participant means any person participating in any proceeding, 
including each party and any other interested person.
    Party means the center of the Food and Drug Administration 
responsible for a matter involved and every person who either has 
exercised a right to request or has been granted the right by the 
Commissioner to have a hearing under part 12 or part 16 or who has 
waived the right to a hearing to obtain the establishment of a Public 
Board of Inquiry under part 13 and as a result of whose action a hearing 
or a Public Board of Inquiry has been established.
    Person includes an individual, partnership, corporation, 
association, or other legal entity.
    Petition means a petition, application, or other document requesting 
the Commissioner to establish, amend, or revoke a regulation or order, 
or to take or not to take any other form of administrative action, under 
the laws administered by the Food and Drug Administration.
    Presiding officer means the Commissioner or the Commissioner's 
designee or an administrative law judge appointed as provided in 5 
U.S.C. 3105.
    Proceeding and administrative proceeding means any undertaking to 
issue, amend, or revoke a regulation or order, or to take or refrain 
from taking any other form of administrative action.
    Public advisory committee or advisory committee means any committee, 
board, commission, council, conference, panel, task force, or other 
similar group, or any subcommittee or other subgroup of an advisory 
committee, that is not composed wholly of full-time employees of the 
Federal Government and is established or utilized by the Food and Drug 
Administration to obtain advice or recommendations.
    Public Board of Inquiry or Board means an administrative law 
tribunal constituted under part 13.
    Public hearing before a public advisory committee means a hearing 
conducted under part 14.
    Public hearing before a Public Board of Inquiry means a hearing 
conducted under part 13.
    Public hearing before the Commissioner means a hearing conducted 
under part 15.
    Regulations means an agency rule of general or particular 
applicability and future effect issued under a law administered by the 
Commissioner or relating to administrative practices and procedures. In 
accordance with Sec. 10.90(a), each agency regulation will be published 
in the Federal Register and codified in the Code of Federal Regulations.
    Regulatory hearing before the Food and Drug Administration means a 
hearing conducted under part 16.

[[Page 84]]

    Secretary means the Secretary of Health and Human Services.
    The laws administered by the Commissioner or the laws administered 
by the Food and Drug Administration means all the laws that the 
Commissioner is authorized to administer under Sec. 5.10.
    (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 has delegated the specific function involved.

[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 50 
FR 8994, Mar. 6, 1985; 54 FR 6886, Feb. 15, 1989; 54 FR 9034, Mar. 3, 
1989; 59 FR 14363, Mar. 28, 1994]



Sec. 10.10  Summaries of administrative practices and procedures.

    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.



Sec. 10.19  Waiver, suspension, or modification of procedural requirements.

    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.



              Subpart B--General Administrative Procedures



Sec. 10.20  Submission of documents to Dockets Management Branch; computation of time; availability for public disclosure.

    (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 Federal Register notice or in another section of 
this chapter. The Dockets Management Branch is the agency custodian of 
these documents.
    (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 
Sec. 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 Sec. 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.

[[Page 85]]

    (6) The failure to comply with the requirements of this part or with 
Sec. 12.80 or Sec. 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 Branch does not make decisions regarding the 
confidentiality of submitted documents. Persons wishing to voluntarily 
submit information considered confidential shall follow the 
presubmission review requirements of Sec. 20.44.
    (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 Federal Register notice, 
or an order issued by an administrative law judge specifically states 
that the documents must be received by a specified date, e.g., 
Sec. 10.33(g) relating to a petition for reconsideration, in which case 
they will be considered submitted on the date received.
    (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, except that a submission which is 
required to be received by the Branch by a specified date may be 
delivered in person to the FDA building in Washington (Room 6819, 200 C 
Street SW., Washington, DC 20204) and will be considered as received by 
the Branch on the date on which it is delivered.
    (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., Sec. 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 Federal 
Register, and on similar public documents.
    (iii) Objections and requests for hearings filed under part 12.
    (iv) Material submitted at a hearing under Sec. 12.32(a)(2) and 
parts 12, 13, and 15.
    (v) Material placed on public display under the regulations in this 
chapter,

[[Page 86]]

e.g., agency guidance documents developed under Sec. 10.115.
    (2)(i) Material prohibited from public disclosure under Sec. 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 Sec. 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:
    (a) Safety and effectiveness information, which includes all studies 
and tests of an ingredient or product on animals and humans and all 
studies and tests on the ingredient or product for identity, stability, 
purity, potency, bioavailability, performance, and usefulness.
    (b) A protocol for a test or study.
    (c) Manufacturing methods or processes, including quality control 
procedures.
    (d) Production, sales distribution, and similar information, except 
any compilation of information aggregated and prepared in a way that 
does not reveal confidential information.
    (e) Quantitative or semiquantitative formulas.
    (f) Information on product design or construction.
    (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 Sec. 20.46.
    (3) Material listed in paragraph (j)(2)(i) (a) and (b) of this 
section may be disclosed under a protective order issued by the 
administrative law judge or other presiding officer at a hearing 
referenced in paragraph (j)(2)(i). The administrative law judge or 
presiding officer shall permit disclosure of the data only in camera and 
only to the extent necessary for the proper conduct of the hearing. The 
administrative law judge or presiding officer shall direct to whom the 
information is to be made available (e.g., to parties or participants, 
or only to counsel for parties or participants), and persons not 
specifically permitted access to the data will be excluded from the in 
camera part of the proceeding. The administrative law judge or other 
presiding officer may impose other conditions or safeguards. The limited 
availability of material under this paragraph does not constitute prior 
disclosure to the public as defined in Sec. 20.81, and no information 
subject to a particular order is to be submitted to or received or 
considered by FDA in support of a petition or other request from any 
other person.

[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 49 
FR 7363, Feb. 29, 1984; 54 FR 9034, Mar. 3, 1989; 59 FR 14363, Mar. 28, 
1994; 64 FR 69190, Dec. 10, 1999; 65 FR 56477, Sept. 19, 2000]



Sec. 10.25  Initiation of administrative proceedings.

    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 Sec. 71.1, for a food 
additive petition in Sec. 171.1, for a new drug application in 
Sec. 314.50, for a new animal drug application in Sec. 514.1, or (2) in 
the form for a citizen petition in Sec. 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

[[Page 87]]

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 any matter to 
the agency for an administrative determination and the Commissioner 
concludes that an administrative determination is feasible within agency 
priorities and resources.

[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989]



Sec. 10.30  Citizen petition.

    (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 Sec. 10.20 and in the following form:

(Date)__________________________________________________________________

    Dockets Management Branch, Food and Drug Administration, Department 
of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville, 
MD 20857.

                            Citizen Petition

    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).

                           A. Action requested

    ((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.)

                         B. Statement of grounds

    (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.)

                         C. Environmental impact

    (A) Claim for categorical exclusion under Secs. 25.30, 25.31, 25.32, 
25.33, or Sec. 25.34 of this chapter or an environmental assessment 
under Sec. 25.40 of this chapter.)

                           D. Economic impact

    (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.)

                            E. Certification

    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.
(Signature)_____________________________________________________________
(Name of petitioner)____________________________________________________
(Mailing address)_______________________________________________________
(Telephone number)______________________________________________________

    (c) A petition which appears to meet the requirements of paragraph 
(b) of this section and Sec. 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

[[Page 88]]

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 in whole or in part. A 
request for alternative or different administrative action must be 
submitted as a separate 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 Federal 
Register notice) implementing the approval;
    (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 Federal Register.
    (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 Sec. 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, Sec. 10.40 or 
Sec. 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 
Sec. 10.65.
    (2) A hearing under parts 12, 13, 14, 15, or 16.
    (3) A Federal Register notice requesting information and views.
    (4) A proposal to issue, amend, or revoke a regulation, in 
accordance with Sec. 10.40 or Sec. 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 Sec. 10.40(g).
    (4) The record, consisting of any transcripts, minutes of meetings, 
reports, Federal Register notices, and

[[Page 89]]

other documents resulting from the optional procedures specified in 
paragraph (h) of this section, except a transcript of a closed portion 
of a public advisory committee meeting.
    (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 
Sec. 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 Sec. 10.33(k) or Sec. 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 
Sec. 10.33 or a petition for stay of action under Sec. 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 Sec. 10.45.
    (l) The Dockets Management Branch will maintain a chronological list 
of each petition filed under this section and Sec. 10.85, but not of 
petitions submitted elsewhere in the agency under Sec. 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.

[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 50 
16656, Apr. 26, 1985; 54 FR 9034, Mar. 3, 1989; 57 FR 17980, Apr. 28, 
1992; 59 FR 14364, Mar. 28, 1994; 62 FR 40592, July 29, 1997; 66 FR 
6467, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001]

    Effective Date Note: At 66 FR 12848, Mar. 1, 2001, Sec. 10.30 was 
amended in paragraph (i)(6) by removing ``Sec.  10.65(f)'' and by adding 
in its place ``Sec. 10.65(h)'', effective Jan. 22, 2001, to Apr. 22, 
2001.



Sec. 10.33  Administrative reconsideration of action.

    (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 
Sec. 10.25. Each request for reconsideration must be submitted in 
accordance with Sec. 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 Federal Register, the day of publication is 
the day of decision.

(Date)__________________________________________________________________

    Dockets Management Branch, Food and Drug Administration, Department 
of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville, 
MD 20857.

                      Petition for Reconsideration

                              [Docket No.]

    The undersigned submits this petition for reconsideration of the 
decision of the Commissioner of Food and Drugs in Docket No. ____.

                          A. Decision involved

    (A concise statement of the decision of the Commissioner which the 
petitioner wishes to have reconsidered.)

                           B. Action requested

    (The decision which the petitioner requests the Commissioner to make 
upon reconsideration of the matter.)

[[Page 90]]

                         C. Statement of grounds

    (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.)

(Signature)_____________________________________________________________
(Name of petitioner)____________________________________________________
(Mailing address)_______________________________________________________
(Telephone number)______________________________________________________

    (c) A petition for reconsideration relating to a petition submitted 
under Sec. 10.25(a)(2) is subject to the requirements of Sec. 10.30 (c) 
and (d), except that it is filed in the same docket file as the petition 
to which it relates.
    (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 
Sec. 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 Federal Register if 
the Commissioner's original decision was so published. Any other 
determination to grant or deny reconsideration may also be published in 
the Federal Register.
    (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 Sec. 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 Sec. 10.25(a)(2) is subject to Sec. 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 Sec. 10.30(i).
    (2) The petition for reconsideration, including all information on 
which it relies, filed by the Dockets Management Branch.

[[Page 91]]

    (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 Federal Register notices or other documents resulting from 
the petition.
    (6) All documents filed with the Dockets Management Branch under 
Sec. 10.65(h).
    (7) If the Commissioner reconsiders the matter, the administrative 
record relating to reconsideration specified in Sec. 10.30(i).

[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 59 
FR 14364, Mar. 28, 1994; 66 FR 6467, Jan. 22, 2001; 66 FR 12848, Mar. 1, 
2001]

    Effective Date Note: At 66 FR 12848, Mar. 1, 2001, Sec. 10.33 was 
amended in paragraph (k)(6) by removing ``Sec. 10.65(f)'' and by adding 
in its place ``Sec. 10.65(h)'', effective Jan. 22, 2001, to Apr. 22, 
2001.



Sec. 10.35  Administrative stay of action.

    (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 Sec. 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 Federal 
Register, the day of publication is the date of decision.

(Date)__________________________________________________________________

    Dockets Management Branch, Food and Drug Administration, Department 
of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville, 
MD 20857.

                       Petition for Stay of Action

    The undersigned submits this petition requesting that the 
Commissioner of Food and Drugs stay the effective date of the following 
matter.

                          A. Decision involved

    (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.)

                           B. Action requested

    (The length of time for which the stay is requested, which may be 
for a specific or indefinite time period.)

                         C. Statement of grounds

    (A full statement, in a well-organized format, of the factual and 
legal grounds upon which the petitioner relies for the stay.)

(Signature)_____________________________________________________________
(Name of petitioner)____________________________________________________
(Mailing address)_______________________________________________________
(Telephone number)______________________________________________________

    (c) A petition for stay of action relating to a petition submitted 
under Sec. 10.25(a)(2) is subject to the requirements of Sec. 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 Sec. 10.30 or a 
petition for reconsideration under Sec. 10.33 or a request for an 
advisory opinion under Sec. 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

[[Page 92]]

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 Federal Register if the 
Commissioner's original decision was so published. Any other 
determination to grant or to deny a stay may also be published in the 
Federal Register.
    (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 Federal Register notices or other documents resulting from 
the petition.
    (6) All documents filed with the Dockets Management Branch under 
Sec. 10.65(h).

[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 54 
FR 9034, Mar. 3, 1989; 59 FR 14364, Mar. 28, 1994; 66 FR 6468, Jan. 22, 
2001; 66 FR 12848, Mar. 1, 2001]

    Effective Date Note: At 66 FR 12848, Mar. 1, 2001, Sec. 10.35 was 
amended in paragraph (h)(6) by removing ``Sec. 10.65(f)'' and by adding 
in its place ``Sec. 10.65(h)'', effective Jan. 22, 2001, to Apr. 22, 
2001.



Sec. 10.40  Promulgation of regulations for the efficient enforcement of the law.

    (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 Sec. 10.25.
    (1) This section applies to any regulation: (i) Not subject to 
Sec. 10.50 and part 12, or (ii) if it is subject to Sec. 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 Sec. 10.25(a) will be published in the Federal Register 
as a proposal if:
    (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 Sec. 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 Federal Register. (1) The notice will contain:
    (i) The name of the agency;
    (ii) The nature of the action, e.g., proposed rule, or notice;

[[Page 93]]

    (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 Sec. 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 Sec. 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 Federal Register and will be applicable to all interested 
persons. A comment time extension of less than 30 days will be the 
subject either of a letter or memorandum filed with the Dockets 
Management Branch or of a notice published in the Federal Register.
    (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 Federal 
Register, will terminate the proceeding, issue a new proposal, or 
promulgate a final regulation.
    (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 Federal Register will have a 
preamble stating: (i) The name of the agency, (ii) the nature of the 
action e.g., final rule, notice, (iii) a summary

[[Page 94]]

first paragraph describing the substance of the document in easily 
understandable terms, (iv) relevant dates, e.g., the rule's effective 
date and comment closing date, if an opportunity for comment is 
provided, (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 the submission of written comments when 
they are permitted, (vii) supplementary information about the regulation 
in the body of the preamble that contains references to prior notices 
relating to the same matter and a summary of each type of comment 
submitted on the proposal and the Commissioner's conclusions with 
respect to each. The preamble is to contain a thorough and 
comprehensible explanation of the reasons for the Commissioner's 
decision on each issue.
    (4) The effective date of a final regulation may not be less than 30 
days after the date of publication in the Federal Register, except for:
    (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 Sec. 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 Federal 
Register, to the following additional procedures:
    (1) Conferences, meetings, discussions, and correspondence under 
Sec. 10.65.
    (2) A hearing under parts 12, 13, 14, or 15.
    (3) A notice published in the Federal Register requesting 
information and views before the Commissioner determines whether to 
propose a regulation.
    (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 Federal Register 
stating that the document is available and specifying the time within 
which comments on the draft proposal may be submitted orally or in 
writing.
    (5) A revised proposal published in the Federal Register, which 
proposal is subject to all the provisions in this section relating to 
proposed regulations.
    (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 Federal Register. If the tentative regulation is placed 
on display only, the Commissioner shall publish an appropriate notice in 
the Federal Register stating that the document is available and 
specifying the time within which comments may be submitted orally or in 
writing on the tentative final regulation. The Commissioner shall mail a 
copy of the tentative final regulation and the Federal Register notice 
to each person who submitted comments on the proposed regulation if one 
has been published.

[[Page 95]]

    (7) A final regulation published in the Federal Register that 
provides an opportunity for the submission of further comments, in 
accordance with paragraph (e)(1) of this section.
    (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 Sec. 10.30(i).
    (2) If a petition for reconsideration or for a stay of action is 
filed, the administrative record specified in Secs. 10.33(k) and 
10.35(h).
    (3) The proposed rule published in the Federal Register, including 
all information identified or filed by the Commissioner with the Dockets 
Management Branch on the proposal.
    (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 as part of the administrative record of the final 
regulation.
    (6) The transcripts, minutes of meetings, reports, Federal Register 
notices, and other documents resulting from the procedures specified in 
paragraph (f) of this section, but not the transcript of a closed 
portion of a public advisory committee meeting.
    (7) All documents submitted to the Dockets Management Branch under 
Sec. 10.65(h).
    (h) The record of the administrative proceeding closes on the date 
of publication of the final regulation in the Federal Register unless 
some other date is specified. Thereafter, any interested person may 
submit a petition for reconsideration under Sec. 10.33 or a petition for 
stay of action under Sec. 10.35. A person who wishes to rely upon 
information or views not included in the administrative record shall 
submit it to the Commissioner with a new petition to modify the final 
regulation.
    (i) The Dockets Management Branch shall maintain a chronological 
list of all regulations proposed and promulgated under this section and 
Sec. 10.50 (which list will not include regulations resulting from 
petitions filed and assigned a docket number under Sec. 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.

[44 FR 22323, Apr. 13, 1979, as amended at 52 FR 36401, Sept. 29, 1987; 
54 FR 9034, Mar. 3, 1989; 56 FR 13758, Apr. 4, 1991; 62 FR 40592, July 
29, 1997; 66 FR 6468, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001]

    Effective Date Note: At 66 FR 12848, Mar. 1, 2001, Sec. 10.40 was 
amended in paragraph (g)(7) by removing ``Sec. 10.65(f)'' and by adding 
in its place ``Sec. 10.65(h)'', effective Jan. 22, 2001, to Apr. 22, 
2001.



Sec. 10.45  Court review of final administrative action; exhaustion of administrative remedies.

    (a) This section applies to court review of final administrative 
action taken by the Commissioner, including action taken under 
Secs. 10.25 through 10.40 and Sec. 16.1(b), except action subject to 
Sec. 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 
Sec. 10.25(a) or, where applicable, a hearing under Sec. 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 
Sec. 10.25(a) or, where applicable, a hearing under Sec. 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 et seq., and the lack of an actual 
controversy as required by 28 U.S.C. 2201.
    (c) A request that administrative action be stayed must first be the 
subject of an administrative decision based

[[Page 96]]

upon a petition for stay of action submitted under Sec. 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 
Sec. 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 et seq., and the lack of an actual 
controversy as required by 28 U.S.C. 2201. If a court action is filed 
requesting a stay of administrative action after a petition for a stay 
of action is denied because it was submitted after expiration of the 
time period provided under Sec. 10.35, or after the time for submitting 
such a petition has expired, the Commissioner will request dismissal of 
the court action on the ground of a failure to exhaust administrative 
remedies.
    (d) The Commissioner's final decision constitutes final agency 
action (reviewable in the courts under 5 U.S.C. 701 et seq. and, where 
appropriate, 28 U.S.C. 2201) on a petition submitted under 
Sec. 10.25(a), on a petition for reconsideration submitted under 
Sec. 10.33, on a petition for stay of action submitted under Sec. 10.35, 
on an advisory opinion issued under Sec. 10.85, on a matter involving 
administrative action which is the subject of an opportunity for a 
hearing under Sec. 16.1(b) of this chapter, or on the issuance of a 
final regulation published in accordance with Sec. 10.40, except that 
the agency's response to a petition filed under section 505(j)(2)(C) of 
the act and Sec. 314.93 of this chapter will not constitute final agency 
action until any petition for reconsideration submitted by the 
petitioner is acted on by the Commissioner.
    (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 Sec. 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 et seq., whether or not it includes a 
request for a declaratory judgment under 28 U.S.C. 2201, or in any other 
case in which the validity of administrative action is properly 
challenged, that the validity of the action must be determined solely on 
the basis of the administrative record specified in Secs. 10.30(i), 
10.33(k), 10.35(h), 10.40(g), and 16.80(a) or the administrative record 
applicable to any decision or action under the regulations referenced in 
Sec. 16.1(b), and that additional information or views may not be 
considered. An interested 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 action under 
Sec. 10.25(a).
    (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

[[Page 97]]

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 U.S.C. 2112(a) be clearly identified in a cover letter.
    (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.

[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 6886, Feb. 15, 1989; 54 
FR 9034, Mar. 3, 1989; 57 FR 17980, Apr. 28, 1992; 65 FR 56477, Sept. 
19, 2000]

[[Page 98]]



Sec. 10.50  Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.

    (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 Secs. 12.20 through 12.22 and other applicable provisions in 
this chapter, e.g., Secs. 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 Sec. 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) Section 502(d) on regulations designating habit forming drugs.
    (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.

[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989; 58 
FR 49190, Sept. 22, 1993; 60 FR 38626, July 27, 1995; 63 FR 26697, May 
13, 1998; 64 FR 398, Jan. 5, 1999; 64 FR 56448, Oct. 20, 1999]



Sec. 10.55  Separation of functions; ex parte communications.

    (a) This section applies to any matter subject by statute to an 
opportunity for a formal evidentiary public hearing, as listed in 
Sec. 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 Sec. 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 Sec. 10.65 
apply to the meetings and correspondence; and
    (2) Upon publication of a notice announcing a formal evidentiary 
public

[[Page 99]]

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 office of General Counsel designated to 
advise the center may not participate or advise in any decision of the 
Commissioner except as counsel in public proceedings. The designation is 
to be in the form of a memorandum filed with the Dockets Management 
Branch and made a part of the administrative record in the proceeding. 
There may be no other communication between those members of the office 
of General Counsel designated to advise the office of the Commissioner 
and any other persons in the office of General Counsel or in the 
involved center with respect to the matter prior to the decision of the 
Commissioner. The Chief Counsel may assign new attorneys to advise 
either the center or the office of the Commissioner at any stage of the 
proceedings. The Chief Counsel will ordinarily advise and participate 
with the office of the Commissioner in its functions relating to the 
hearing and the final decision.
    (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 Sec. 10.50(c) (11) and (16) through (19), 
the provisions relating to separation of functions set forth in 
Secs. 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

[[Page 100]]

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.

[44 FR 22323, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54 
FR 9035, Mar. 3, 1989; 64 FR 398, Jan. 5, 1999]



Sec. 10.60  Referral by court.

    (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 Sec. 10.25(c) or Sec. 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 
Sec. 10.65.
    (2) A hearing under parts 12, 13, 14, 15, or 16.
    (3) A notice published in the Federal Register requesting 
information and views.
    (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 Sec. 10.40 or Sec. 10.50 also apply.



Sec. 10.65  Meetings and correspondence.

    (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 Sec. 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

[[Page 101]]

meaning of Sec. 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 that would be in the public interest. The agency representative may 
decline to participate in a meeting held as a private meeting if that 
will best serve the public interest.
    (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.

[66 FR 6468, Jan. 22, 2001]

    Effective Date Note: At 66 FR 12848, Mar. 1, 2001, Sec. 10.65 was 
stayed from Jan. 22, 2001, to Apr. 22, 2001.



Sec. 10.65a  Meetings and correspondence.

    (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 Sec. 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, at which any interested person may 
participate.
    (1) The Commissioner shall give public notice through the public 
calendar described in Sec. 10.100(a) of the time and place of the 
meeting and of the matters to be discussed, and may also publish notice 
of the meeting.
    (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.
    (3) No official transcript or recording of the meeting will be made 
unless it appears to the agency that it will be

[[Page 102]]

useful. A written memorandum summarizing the substance of the meeting 
will be prepared by an FDA representative in all cases.
    (c) A meeting with a person outside the Department, including a 
person in the executive or legislative branch of the Federal Government, 
concerning a pending court case, administrative hearing, or other 
regulatory action or decision, which involves more than a brief 
description of the matter, is to be summarized in a written memorandum, 
which is filed in the administrative file on the matter.
    (d) Every person outside the Federal Government may request and 
obtain a private meeting with a representative of FDA in agency offices 
to discuss a matter.
    (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 Sec. 20.81(a). 
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) Whenever appropriate (e.g., the meeting involves a matter 
covered by paragraph (c) of this section or other important matter, a 
decision on an issue, or statements or advice or conclusions to which 
future reference may be desirable), a written memorandum summarizing the 
substance of the meeting will be prepared by an FDA representative.
    (4) A person who wishes to attend a private meeting, but who either 
is not permitted to attend by the person requesting the meeting or by 
FDA or who cannot attend because the meeting is conducted by telephone, 
may obtain a separate meeting with FDA to discuss the same matter or an 
additional matter.
    (e) 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 that would be in the public interest. The agency representative may 
decline to participate in a meeting held as a private meeting if that 
will best serve the public interest.
    (3) An agency representative may not knowingly participate in a 
meeting which is closed on the basis of sex, race, or religion.
    (4) A meeting, whether open or closed, is subject to paragraph 
(d)(3) of this section with respect to memoranda summarizing the 
substance of the meeting.
    (f) Representatives of FDA may initiate a meeting or correspondence 
with any person outside the Federal Government on any matter concerning 
the laws administered by the Commissioner.
    (1) A meeting initiated by FDA representatives which involves a 
small number of interested persons, for example, a meeting with a 
petitioner or with two manufacturers of a particular product which 
requires additional testing or with a trade association employee to 
discuss an industry labeling problem, may be a private meeting. A 
meeting initiated by FDA representatives which involves a large number 
of interested persons, for example, 10 manufacturers of an ingredient in 
a discussion of appropriate testing or labeling, must be held as an open 
conference or meeting under paragraph (b) of this section.

[[Page 103]]

    (2) Whenever appropriate (e.g., the meeting involves a matter 
covered by paragraph (c) of this section or another important matter, a 
decision on an issue, or statements or advice or conclusions to which 
future reference may be desirable), a written memorandum summarizing the 
substance of the meeting will be prepared by an FDA representative.
    (g) A person who participates in a meeting described in paragraphs 
(b) through (f) of this section may also prepare and submit to FDA for 
inclusion in the administrative file a written memorandum summarizing 
the substance of the meeting.
    (h) Memoranda of meetings prepared by an FDA representative or by 
any other person and all correspondence which relate to a matter pending 
before the agency will promptly be filed in the administrative file of 
the proceeding.
    (i) A meeting with a representative of Congress relating to a 
pending or potential investigation, inquiry, or hearing by a 
congressional committee or a Member of Congress will be summarized in a 
written memorandum which is to be forwarded to the Food and Drug 
Administration, Office of Legislative Affairs. This provision does not 
restrict the right of an agency employee to participate in the meeting.
    (j) A meeting of an advisory committee is subject to the 
requirements of part 14.
    (k) Under 42 U.S.C. 2631(a)(8), a log or summary is to be made of 
all meetings between representatives of FDA and industry and other 
interested parties to implement the Radiation Control for Health and 
Safety Act of 1968.

[66 FR 12848, Mar. 1, 2001]

    Effective Date Note: At 66 FR 12848, Mar. 1, 2001, Sec. 10.65a was 
added, effective Jan. 22, 2001, to Apr. 22, 2001.



Sec. 10.70  Documentation of significant decisions in administrative file.

    (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

[[Page 104]]

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.



Sec. 10.75  Internal agency review of decisions.

    (a) A decision of an FDA employee, other than the Commissioner, on a 
matter, is subject to review by the employee's supervisor under the 
following circumstances:
    (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.

[44 FR 22323, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 63 
FR 63982, Nov. 18, 1998]



Sec. 10.80  Dissemination of draft Federal Register notices and regulations.

    (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) Notices and proposed regulations. (1) Once it is determined that 
a notice or proposed regulation will be prepared, the general concepts 
may be discussed by a representative of FDA with an interested person. 
Details of a draft of a notice or proposed regulation may be discussed 
with a person outside the executive branch only with the specific 
permission of the Commissioner. The permission must be in writing and 
filed with the Dockets Management Branch.
    (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 Federal Register. A draft of a notice or 
proposed regulation made available in this manner may, without the prior 
permission of the

[[Page 105]]

Commissioner, be discussed with an interested person to clarify and 
resolve questions raised and concerns expressed about the draft.
    (c) After publication of a notice or proposed regulation in the 
Federal Register, and before preparation of a draft of the final notice 
or regulation, a representative of FDA may discuss the proposal with an 
interested person as provided in paragraph (b)(2) of this section.
    (d) Final notices and regulations. (1) Details of a draft of a final 
notice or regulation may be discussed with an interested person outside 
the executive branch only with the specific permission of the 
Commissioner. The permission must be in writing and filed with the 
Dockets Management Branch.
    (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 Federal Register, except as otherwise 
provided in paragraphs (g) and (j) of this section. A draft of a final 
notice or regulation made available to an interested person in this 
manner may, without the prior permission of the Commissioner, be 
discussed as provided in paragraph (b)(2) of this section.
    (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:
    (a) The scheduling of an open public meeting under Sec. 10.65(b) at 
which interested persons may participate in review of and comment on the 
draft document; or
    (b) The preparation of a tentative final regulation or tentative 
revised final regulation under Sec. 10.40(f)(6), on which interested 
persons will be given an additional period of time for oral and written 
comment.
    (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 Sec. 10.55 apply to the promulgation of a regulation subject to 
Sec. 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 Sec. 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 Federal Register an announcement when 
a proposed or final performance standard, including any amendment, is 
being considered for an electronic product, and any draft of any 
proposed or final standard will be furnished to an interested person 
upon request and may be discussed in detail.
    (i) The provisions of Sec. 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 Secs. 20.83 through 20.89.

[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64 
FR 398, Jan. 5, 1999]

[[Page 106]]



Sec. 10.85  Advisory opinions.

    (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 Sec. 10.20, is subject to the provisions of Sec. 10.30 
(c) through (l), and must be in the following form:

(Date)__________________________________________________________________

    Dockets Management Branch, Food and Drug Administration, Department 
of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville, 
MD 20857.

                      Request for Advisory Opinion

    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. Issues involved.
    (A concise statement of the issues and questions on which an opinion 
is requested.)
    B. Statement of facts and law.
    (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.

(Signature)_____________________________________________________________
(Person making request)_________________________________________________
(Mailing address)_______________________________________________________
(Telephone number)______________________________________________________

    (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 Federal Register notice other than the text of 
a proposed or final regulation, e.g., a notice to manufacturers or a 
preamble to a proposed or final regulation.
    (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 Federal Register, and will be placed on public display as part 
of the file on the matter in the office of the Dockets Management 
Branch. The Dockets

[[Page 107]]

Management Branch shall maintain a separate chronological index of all 
advisory opinions filed. The index will specify the date of the request 
for the advisory opinion, the date of the opinion, and identification of 
the appropriate file.
    (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 does not remain acceptable, and any transition 
period that may be applicable.
    (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 Sec. 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.

[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 59 
FR 14364, Mar. 28, 1994; 65 FR 56477, Sept. 19, 2000]



Sec. 10.90  Food and Drug Administration regulations, recommendations, and agreements.

    (a) Regulations. FDA regulations are promulgated in the Federal 
Register under Sec. 10.40 or Sec. 10.50 and codified in the Code of 
Federal Regulations. Regulations may contain provisions that will be 
enforced as legal requirements, or which are intended only as guidelines 
and recommendations, or both. The dissemination of draft notices and 
regulations is subject to Sec. 10.80.
    (b) [Reserved]
    (c) Recommendations. In addition to the guidelines subject to 
paragraph (b) of this section, FDA often formulates and disseminates 
recommendations about matters which are authorized by, but do not 
involve direct regulatory action under, the laws administered by the 
Commissioner, e.g., model State and local ordinances, or personnel 
practices for reducing radiation exposure, issued under 42 U.S.C. 243 
and 263d(b). These recommendations may, in the discretion of the 
Commissioner, be handled under the procedures established in paragraph 
(b) of this section, except that the recommendations will be included in 
a separate public file of recommendations established by the Dockets 
Management Branch and will be separated from the guidelines in the 
notice of availability published in the Federal Register, or be 
published in the Federal Register as regulations under paragraph (a) of 
this section.
    (d) Agreements. Formal agreements, memoranda of understanding, or 
other similar written documents executed by FDA and another person will 
be included in the public file on agreements established by the Freedom 
of Information Staff (HFI-35) under Sec. 20.108. A document not included 
in the public file is deemed to be rescinded and has no force or effect 
whatever.

[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 65 
FR 56477, Sept. 19, 2000]



Sec. 10.95  Participation in outside standard-setting activities.

    (a) General. This section applies to participation by FDA employees 
in standard-setting activities outside the

[[Page 108]]

agency. Standard-setting activities include matters such as the 
development of performance characteristics, testing methodology, 
manufacturing practices, product standards, scientific protocols, 
compliance criteria, ingredient specifications, labeling, or other 
technical or policy criteria. FDA encourages employee participation in 
outside standard-setting activities that are in the public interest.
    (b) Standard-setting activities by other Federal Government 
agencies. (1) An FDA employee may participate in these activities after 
approval of the activity under procedures specified in the current 
agency Staff Manual Guide.
    (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) Standard-setting activities by State and local government 
agencies and by United Nations organizations and other international 
organizations and foreign governments pursuant to treaty. (1) An FDA 
employee may participate in these activities after approval of the 
activity under procedures specified in the current agency Staff Manual 
Guide.
    (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) Standard-setting activities by private groups and organizations. 
(1) An FDA employee may engage in these activities after approval of the 
activity under procedures specified in the current agency Staff Manual 
Guide. A request for official participation must be made by the group or 
organization in writing, must describe the scope of the activity, and 
must demonstrate that the minimum standards set out in paragraph (d)(5) 
of this section are met. Except as provided in paragraph (d)(7) of this 
section, a request that is granted will be the subject of a letter from 
the Commissioner or the center director to the organization stating--
    (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.

[[Page 109]]

    (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 an interested person will have 
an opportunity to provide information and views on the activity and 
standards involved, without the payment of fees, and the information and 
views will be considered. How this is accomplished, including whether 
the presentation will be in person or in writing, will be decided by the 
group or organization responsible for the activity.
    (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).

[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 52 
FR 35064, Sept. 17, 1987; 54 FR 9035, Mar. 3, 1989]

[[Page 110]]



Sec. 10.100  Public calendar.

    (a) Public calendar. A public calendar will be prepared and made 
publicly available by FDA each week showing, to the extent feasible, 
significant events of the previous week, including significant meetings 
with persons outside the executive branch, that involve the 
representatives of FDA designated under paragraph (c) of this section.
    (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) Calendar entries. The calendar will specify for each entry the 
date, person(s), and subject matter involved. If a large number of 
persons are in attendance, the name of each individual need not be 
specified. When more than one FDA representative is in attendance, the 
most senior agency official will report the meeting on the public 
calendar.
    (c) Affected persons. The following FDA representatives are subject 
to the requirements of this section:
    (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) Public display. The public calendar will be placed on public 
display at the following locations:
    (1) Dockets Management Branch.
    (2) Office of the Associate Commissioner for Public Affairs.
    (3) The FDA home page, to the extent feasible.

[66 FR 6468, Jan. 22, 2001]

    Effective Date Note: At 66 FR 12849, Mar. 1, 2001, Sec. 10.100 was 
stayed from Jan. 22, 2001, to Apr. 22, 2001.



Sec. 10.100a  Public calendars.

    (a) Prospective public calendar of public proceedings. (1) A public 
calendar will be prepared and made publicly available each week showing, 
to the extent feasible, for the following 4 weeks, the public meetings, 
conferences, hearings, advisory committee meetings, seminars, and other 
public proceedings of FDA, and other significant public events involving 
FDA, e.g., congressional hearings.
    (2) A copy of this public calendar will be placed on public display 
in the following places:
    (i) Dockets Management Branch.
    (ii) Office of the Associate Commissioner for Public Affairs.
    (iii) A central place in each center.
    (iv) A central place in each field office.
    (v) A central place at the National Center for Toxicological 
Research.
    (b) Retrospective public calendar of meetings. (1) A public calendar 
will be prepared and made publicly available each week showing for the 
previous week meetings with persons outside the executive branch and 
other significant events involving the representatives of FDA designated 
under paragraph (b)(3) of this section, but telephone conversations will 
be included on an optional basis and meetings with the working press, 
except for ``house organs'' (i.e., publications of firms that 
manufacture or distribute regulated products, or industry associations), 
and with on-site contractors will not be included. Meetings with members 
of the judiciary, representatives of Congress, or staffs of 
congressional committees will be included when the meeting relates to a 
pending court case, administrative hearing, or other regulatory action 
or decision and involves more than a brief description of the matter.
    (2) The calendar will include all meetings, conferences, seminars, 
social events sponsored by the regulated industry, and speeches. The 
calendar will specify the date and the person and

[[Page 111]]

subject matter involved. When more than one FDA representative is in 
attendance, only the presiding or head representative will report the 
meeting on the public calendar. If a large number of persons is 
involved, the name of each need not be specified. 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 in FDA) will not be reported.
    (3) The following FDA representatives and their deputies are subject 
to the requirements of paragraphs (b)(1) and (2) of this section:
    (i) Commissioner of Food and Drugs.
    (ii) Deputy Commissioner.
    (iii) Associate Commissioners.
    (iv) Executive and Special Assistants to the Commissioner.
    (v) [Reserved]
    (vi) Director, National Center for Toxicological Research.
    (vii) Center Directors.
    (viii) Chief Counsel for the Food and Drug Administration, or any 
representative of that office attending on behalf of the Chief Counsel.
    (4) A copy of the public calendar will be placed on public display 
in the following places:
    (i) Dockets Management Branch.
    (ii) Office of the Associate Commissioner for Public Affairs.
    (iii) A central place in each center.
    (iv) A central place in each field office.
    (v) A central place at the National Center for Toxicological 
Research.

[66 FR 12849, Mar. 1, 2001]

    Effective Date Note: At 66 FR 12849, Mar. 1, 2001, Sec. 10.100a was 
added, effective Jan. 22, 2001, to Apr. 22, 2001.



Sec. 10.105  Representation by an organization.

    (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 Secs. 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.



Sec. 10.110  Settlement proposals.

    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.



Sec. 10.115  Good guidance practices.

    (a) What are good guidance practices? Good guidance practices 
(GGP's) are FDA's policies and procedures for developing, issuing, and 
using guidance documents.

[[Page 112]]

    (b) What is a guidance document?
    (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) What other terms have a special meaning?
    (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) Are you or FDA required to follow a guidance document?
    (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 
supervisory concurrence.
    (e) Can FDA use means other than a guidance document to communicate 
new agency policy or a new regulatory approach to a broad public 
audience? The agency may not use documents or other means of 
communication that are excluded from the definition of guidance document 
to informally communicate new or different regulatory expectations to a 
broad public audience for the first time. These GGP's must be followed 
whenever regulatory expectations that are not readily apparent from the 
statute or regulations are first communicated to a broad public 
audience.
    (f) How can you participate in the development and issuance of 
guidance documents?
    (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 to 
consider. 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 Federal Register and 
on the Internet, a list of possible topics for future guidance document 
development or revision during the next year. You can comment on this 
list (e.g., by

[[Page 113]]

suggesting alternatives or making recommendations on the topics that FDA 
is considering).
    (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) What are FDA's procedures for developing and issuing guidance 
documents?
    (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 Federal Register announcing that the 
draft guidance document is available;
    (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 Federal Register announcing that the 
guidance document is available;
    (C) Post the guidance document on the Internet and make it available 
in 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 Federal Register announcing that the 
guidance document is available;
    (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.

[[Page 114]]

    (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) How should you submit comments on a guidance document?
    (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 Sec. 10.20(j).
    (i) What standard elements must FDA include in a guidance document?
    (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) Who, within FDA, can approve issuance of guidance documents? 
Each center and office must have written procedures for the approval of 
guidance documents. Those procedures must ensure that issuance of all 
documents is approved by appropriate senior FDA officials.
    (k) How will FDA review and revise existing guidance documents?
    (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 any 
time suggest that FDA revise a guidance document.
    (l) How will FDA ensure that FDA staff are following GGP's?
    (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) How can you get copies of FDA's guidance documents? FDA will 
make copies available in hard copy and, as feasible, through the 
Internet.
    (n) How will FDA keep you informed of the guidance documents that 
are available?
    (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 Federal Register its 
comprehensive list of guidance documents. The comprehensive list will 
identify documents that have been added to the list or withdrawn from 
the list since the previous comprehensive list.

[[Page 115]]

    (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.

[65 FR 56477, Sept. 19, 2000]



     Subpart C--Electronic Media Coverage of Public Administrative 
             Proceedings; Guideline on Policy and Procedures

    Source: 49 FR 14726, Apr. 13, 1984, unless otherwise noted.



Sec. 10.200  Scope.

    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.



Sec. 10.203  Definitions.

    (a) Public administrative proceeding as used in this guideline means 
any FDA proceeding which the public has a right to attend. This includes 
a formal evidentiary public hearing as set forth in part 12, a public 
hearing before a Public Board of Inquiry as set forth in part 13, a 
public hearing before a Public Advisory Committee as set forth in part 
14, a public hearing before the Commissioner as set forth in part 15, a 
regulatory hearing before FDA as set forth in part 16, consumer exchange 
meetings, and Commissioner's public meetings with health professionals.
    (b) Advance notice as used in this guideline means written or 
telephone notification to FDA's Office of Public Affairs (Press 
Relations Staff) of intent to electronically record an agency public 
administrative proceeding.
    (c) Electronic recording as used in this guideline means any visual 
or audio recording made by videotape recording equipment or moving film 
camera, and/or other electronic recording equipment.

[49 FR 14726, Apr. 13, 1984, as amended at 54 FR 9035, Mar. 3, 1989]



Sec. 10.204  General.

    (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 Federal Register. Thus, all parties to a 
proceeding will be on notice that the proceeding may be recorded 
electronically and any person interested in videotaping or otherwise 
recording the proceeding will be notified that there are established 
procedures to be followed.
    (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

[[Page 116]]

of the proceeding over which he or she presides. The responsibilities of 
the presiding officer, established elsewhere in parts 10 through 16, 
include an obligation to be concerned with the timely conduct of a 
hearing, the limited availability of certain witnesses, and reducing 
disruptions to the proceeding which may occur. Each proceeding varies, 
and the presiding officer cannot anticipate all that might occur. 
Discretionary authority to regulate conduct at a proceeding has 
traditionally been granted to presiding officers to enable them to 
fulfill their responsibility to maintain a fair and orderly hearing 
conducted in an expeditious manner.
    (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.

[[Page 117]]

    (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.



Sec. 10.205  Electronic media coverage of public administrative proceedings.

    (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 
Sec. 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.



Sec. 10.206  Procedures for electronic media coverage of agency public administrative proceedings.

    (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) Off the record portions of a proceeding may not be videotaped.
    (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

[[Page 118]]

less restrictive than those stated in this guideline, except that the 
presiding officer shall observe the agency's presumption of openness of 
its public proceedings to the electronic media. Only a substantial and 
clear threat to the agency's interests in order, fairness, and 
timeliness authorizes the presiding officer to impose additional 
restrictions. This threat must outweigh the public interest in 
electronic media coverage of agency proceedings. Additional restrictions 
shall be narrowly drawn to the particular circumstances. The following 
factors are listed to assist presiding officers in determining whether 
the agency's interest is sufficiently compelling to call for the unusual 
step of imposing additional restrictions. Generally this step is 
justified when one of the following factors is met:
    (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

[[Page 119]]

expeditiously as possible so as to preserve, to the extent possible, the 
reporters' opportunity to record the proceedings.

[49 FR 14726, Apr. 13, 1984, as amended at 54 FR 9035, Mar. 3, 1989]



PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES--Table of Contents




                      Subpart A--General Provisions

Sec.
11.1  Scope.
11.2  Implementation.
11.3  Definitions.

                      Subpart B--Electronic Records

11.10  Controls for closed systems.
11.30  Controls for open systems.
11.50  Signature manifestations.
11.70  Signature/record linking.

                    Subpart C--Electronic Signatures

11.100  General requirements.
11.200  Electronic signature components and controls.
11.300  Controls for identification codes/passwords.

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.

    Source: 62 FR 13464, Mar. 20, 1997, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 11.1  Scope.

    (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 Sec. 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.



Sec. 11.2  Implementation.

    (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

[[Page 120]]

considered as official and must accompany any electronic records. 
Persons are expected to consult with the intended agency receiving unit 
for details on how (e.g., method of transmission, media, file formats, 
and technical protocols) and whether to proceed with the electronic 
submission.



Sec. 11.3  Definitions.

    (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) Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-
903 (21 U.S.C. 321-393)).
    (2) Agency means the Food and Drug Administration.
    (3) Biometrics means a method of verifying an individual's identity 
based on measurement of the individual's physical feature(s) or 
repeatable action(s) where those features and/or actions are both unique 
to that individual and measurable.
    (4) Closed system means an environment in which system access is 
controlled by persons who are responsible for the content of electronic 
records that are on the system.
    (5) Digital signature means an electronic signature based upon 
cryptographic methods of originator authentication, computed by using a 
set of rules and a set of parameters such that the identity of the 
signer and the integrity of the data can be verified.
    (6) Electronic record means any combination of text, graphics, data, 
audio, pictorial, or other information representation in digital form 
that is created, modified, maintained, archived, retrieved, or 
distributed by a computer system.
    (7) Electronic signature means a computer data compilation of any 
symbol or series of symbols executed, adopted, or authorized by an 
individual to be the legally binding equivalent of the individual's 
handwritten signature.
    (8) Handwritten signature means the scripted name or legal mark of 
an individual handwritten by that individual and executed or adopted 
with the present intention to authenticate a writing in a permanent 
form. The act of signing with a writing or marking instrument such as a 
pen or stylus is preserved. The scripted name or legal mark, while 
conventionally applied to paper, may also be applied to other devices 
that capture the name or mark.
    (9) Open system means an environment in which system access is not 
controlled by persons who are responsible for the content of electronic 
records that are on the system.



                      Subpart B--Electronic Records



Sec. 11.10  Controls for closed systems.

    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.

[[Page 121]]

    (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.



Sec. 11.30  Controls for open systems.

    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 Sec. 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.



Sec. 11.50  Signature manifestations.

    (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).



Sec. 11.70  Signature/record linking.

    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.



                    Subpart C--Electronic Signatures



Sec. 11.100  General requirements.

    (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.

[[Page 122]]



Sec. 11.200  Electronic signature components and controls.

    (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.



Sec. 11.300  Controls for identification codes/passwords.

    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.



PART 12--FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents




                      Subpart A--General Provisions

Sec.
12.1  Scope.

                  Subpart B--Initiation of Proceedings

12.20  Initiation of a hearing involving the issuance, amendment, or 
          revocation of a regulation.
12.21  Initiation of a hearing involving the issuance, amendment, or 
          revocation of an order.
12.22  Filing objections and requests for a hearing on a regulation or 
          order.
12.23  Notice of filing of objections.
12.24  Ruling on objections and requests for hearing.
12.26  Modification or revocation of regulation or order.
12.28  Denial of hearing in whole or in part.
12.30  Judicial review after waiver of hearing on a regulation.
12.32  Request for alternative form of hearing.
12.35  Notice of hearing; stay of action.
12.37  Effective date of a regulation.
12.38  Effective date of an order.

                 Subpart C--Appearance and Participation

12.40  Appearance.
12.45  Notice of participation.
12.50  Advice on public participation in hearings.

                      Subpart D--Presiding Officer

12.60  Presiding officer.
12.62  Commencement of functions.
12.70  Authority of presiding officer.
12.75  Disqualification of presiding officer.
12.78  Unavailability of presiding officer.

[[Page 123]]

                      Subpart E--Hearing Procedures

12.80  Filing and service of submissions.
12.82  Petition to participate in forma pauperis.
12.83  Advisory opinions.
12.85  Disclosure of data and information by the participants.
12.87  Purpose; oral and written testimony; burden of proof.
12.89  Participation of nonparties.
12.90  Conduct at oral hearings or conferences.
12.91  Time and place of prehearing conference.
12.92  Prehearing conference procedure.
12.93  Summary decisions.
12.94  Receipt of evidence.
12.95  Official notice.
12.96  Briefs and argument.
12.97  Interlocutory appeal from ruling of presiding officer.
12.98  Official transcript.
12.99  Motions.

                    Subpart F--Administrative Record

12.100  Administrative record of a hearing.
12.105  Examination of record.

                 Subpart G--Initial and Final Decisions

12.120  Initial decision.
12.125  Appeal from or review of initial decision.
12.130  Decision by Commissioner on appeal or review of initial 
          decision.
12.139  Reconsideration and stay of action.

                       Subpart H--Judicial Review

12.140  Review by the courts.
12.159  Copies of petitions for judicial review.

    Authority: 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.

    Source: 44 FR 22339, Apr. 13, 1979, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 12.1  Scope.

    The procedures in this part apply when--
    (a) A person has a right to an opportunity for a hearing under the 
laws specified in Sec. 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.



                  Subpart B--Initiation of Proceedings



Sec. 12.20  Initiation of a hearing involving the issuance, amendment, or revocation of a regulation.

    (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 Sec. 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 Sec. 71.1; or
    (ii) If no form is specified, by a petition under Sec. 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 Sec. 10.40 (b) through 
(f);
    (2) If it involves a color additive or food additive, and meets the 
requirements for filing in Secs. 71.1 and 71.2, or in Secs. 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 Sec. 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

[[Page 124]]

requests for a hearing may be submitted on or before the 30th day after 
the date on which the order confirming or modifying the Commissioner's 
previous order is published.

[44 FR 22339, Apr. 13, 1979, as amended at 64 FR 399, Jan. 5, 1999]



Sec. 12.21  Initiation of a hearing involving the issuance, amendment, or revocation of an order.

    (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., Sec. 314.50 for new drug applications, Sec. 514.1 for new animal 
drug applications, Sec. 514.2 for applications for animal feeds, or 
Sec. 601.3 for licenses for biologic products; or
    (3) By a petition under Sec. 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 
Sec. 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.

[44 FR 22339, Apr. 13, 1979, as amended at 47 FR 25734, June 15, 1982; 
54 FR 9035, Mar. 3, 1989]



Sec. 12.22  Filing objections and requests for a hearing on a regulation or order.

    (a) Objections and requests for a hearing under Sec. 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 Sec. 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 Sec. 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--
    (a) An FDA document that is routinely publicly available; or
    (b) A recognized medical or scientific textbook that is readily 
available to the agency.
    (ii) A summary of the nondocumentary testimony to be presented by 
any witnesses relied upon must be submitted.
    (b) Requests for hearing submitted under Sec. 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 Secs. 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

[[Page 125]]

with. A deficient objection or request for a hearing may be supplemented 
and subsequently filed if submitted within the 30-day time period 
specified in Sec. 12.20(e) or Sec. 12.21(b).
    (d) If another person objects to a regulation issued in response to 
a petition submitted under Sec. 12.20(a)(2), the petitioner may submit a 
written reply to the Dockets Management Branch.

[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64 
FR 69190, Dec. 10, 1999]



Sec. 12.23  Notice of filing of objections.

    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 Federal Register specifying those parts of the regulation that have 
been stayed by the filing of proper objections and, if no objections 
have been filed, stating that fact. The notice does not constitute a 
determination that a hearing is justified on any objections or requests 
for hearing that have been filed. When to do so will cause no undue 
delay, the notice required by this section may be combined with the 
notices described in Secs. 12.28 and 12.35.



Sec. 12.24  Ruling on objections and requests for hearing.

    (a) As soon as possible the Commissioner will review all objections 
and requests for hearing filed under Sec. 12.22 and determine--
    (1) Whether the regulation should be modified or revoked under 
Sec. 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., 
Secs. 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 
Sec. 10.30(h) or in other applicable regulations, e.g., Secs. 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

[[Page 126]]

summary decision against the person requesting a hearing should be 
considered, the Commissioner may serve upon the person by registered 
mail a proposed order denying a hearing. The person has 30 days after 
receipt of the proposed order to demonstrate that the submission 
justifies a hearing.

[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64 
FR 399, Jan. 5, 1999]



Sec. 12.26  Modification or revocation of regulation or order.

    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 Federal Register. Further objections to or requests for hearing on 
the modification or revocation may be submitted under Secs. 12.20 
through 12.22 but no further issue may be taken with other provisions in 
the regulation or order. Objections and requests for hearing that are 
not affected by the modification or revocation will remain on file and 
be acted upon in due course.



Sec. 12.28  Denial of hearing in whole or in part.

    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 Sec. 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 Sec. 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, Federal 
Register notices, and other documents constituting the record of any of 
the optional procedures specified in Sec. 12.24(c) used by the 
Commissioner, but not the transcript of a closed portion of a public 
advisory committee meeting; and
    (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 Sec. 10.33 or a petition for stay of 
action under Sec. 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 Sec. 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 Federal Register.
    (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 
Sec. 10.35.

[[Page 127]]

    (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 Federal Register, (i) When an objection or issues 
relates to a regulation, if a hearing is denied on all objections and 
issues concerning a part of the proposal the effectiveness of which has 
not been deferred pending a hearing on other parts of the proposal; or 
(ii) when an issue relates to an order, if a hearing is denied on all 
issues relating to a particular new drug application, new animal drug 
application, device premarket approval application or product 
development protocol, or biologics license. The failure to file a 
petition for judicial review within the period established in the 
statutory provision governing the matter involved constitutes a waiver 
of the right to judicial review of the objection or issue, regardless 
whether a hearing has been granted on other objections and issues.



Sec. 12.30  Judicial review after waiver of hearing on a regulation.

    (a) A person with a right to submit objections and a request for 
hearing under Sec. 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 Secs. 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 
Sec. 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.



Sec. 12.32  Request for alternative form of hearing.

    (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 
Sec. 10.30 before publication of a notice of hearing under Sec. 12.35 or 
a denial of hearing under Sec. 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.

[[Page 128]]

    (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 
Sec. 13.10(b);
    (ii) A notice of participation under Sec. 12.45 should be filed; and
    (iii) Participants should submit written information under 
Sec. 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 Sec. 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 Sec. 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 Sec. 12.120 (b) 
and (c).
    (3) Thereafter, the participants in the proceeding may pursue the 
administrative and court remedies specified in Secs. 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 
Sec. 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.



Sec. 12.35  Notice of hearing; stay of action.

    (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 Sec. 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 Sec. 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 
Sec. 12.45(a).
    (9) The time within which participants should submit written 
information and views under Sec. 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 
Sec. 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

[[Page 129]]

eliminate an issue on which a hearing has been granted.
    (c) A hearing is deemed to begin on the date of publication of the 
notice of hearing.

[44 FR 22339, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982]



Sec. 12.37  Effective date of a regulation.

    (a) If no objections are filed and no hearing is requested on a 
regulation under Sec. 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 Federal Register document confirming the 
effective date of the regulation may extend the time for compliance with 
the regulation.



Sec. 12.38  Effective date of an order.

    (a) If a person who is subject to a notice of opportunity for 
hearing under Sec. 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 Sec. 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.



                 Subpart C--Appearance and Participation



Sec. 12.40  Appearance.

    (a) A person who has filed a notice of participation under 
Sec. 12.45 may appear in person or by counsel or other representative in 
any hearing and, subject to Sec. 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 Sec. 12.90.



Sec. 12.45  Notice of participation.

    (a) Within 30 days after publication of the notice of hearing under 
Sec. 12.35, a person desiring to participate in a hearing is to file 
with the Dockets Management Branch under Sec. 10.20 a notice of 
participation in the following form:

      (Date)

    Dockets Management Branch, Food and Drug Administration, Department 
of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville, 
MD 20857.

                         Notice of Participation

                             Docket No. ____

    Under 21 CFR part 12, please enter the participation of:

      (Name)____________________________________________________________
      (Street address)__________________________________________________
      (City and State)__________________________________________________
      (Telephone number)________________________________________________

    Service on the above will be accepted by:

      (Name)____________________________________________________________
      (Street address)__________________________________________________
      (City and State)__________________________________________________
      (Telephone number)________________________________________________

    The following statements are made as part of this notice of 
participation:
    A. Specific interests. (A statement of the specific interest of the 
person in the proceeding, including the specific issues of fact 
concerning which the person desires to be heard. This part need not be 
completed by a party to the proceeding.)
    B. Commitment to participate. (A statement that the person will 
present documentary evidence or testimony at the hearing and will comply 
with the requirements of 21 CFR 12.85, or, in the case of a hearing 
before a Public Board of Inquiry, with the requirements of 21 CFR 
13.25.)

      (Signed)__________________________________________________________

    (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.

[[Page 130]]

    (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 Sec. 12.85 or the prehearing order issued under Sec. 12.92. Any 
person whose participation is stricken may petition the Commissioner for 
interlocutory review.

[44 FR 22339, Apr. 13, 1979, as amended at 46 FR 8456, Jan. 27, 1981; 59 
FR 14364, Mar. 28, 1994]



Sec. 12.50  Advice on public participation in hearings.

    (a) Designated agency contact. All inquiries from the public about 
scheduling, location, and general procedures should be addressed to the 
Deputy Commissioner for Policy (HF-22), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, or telephone 301-443-3480. The 
staff of the Associate Commissioner for Regulatory Affairs will attempt 
to respond promptly to all inquiries from members of the public, as well 
as to simple requests for information from participants in hearings.
    (b) Hearing schedule changes. Requests by hearing participants for 
changes in the schedule of a hearing or for filing documents, briefs, or 
other pleadings should be made in writing directly to the Administrative 
Law Judge (HF-3), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857.
    (c) Legal advice to individuals. FDA does not have the resources to 
provide legal advice to members of the public concerning participation 
in hearings. Furthermore, to do so would compromise the independence of 
the Commissioner's office and invite charges of improper interference in 
the hearing process. Accordingly, the Deputy Commissioner for Policy 
(HF-22) will not answer questions about the strengths or weaknesses of a 
party's position at a hearing, litigation strategy, or similar matters.
    (d) Role of the office of the Chief Counsel. Under no circumstances 
will the office of the Chief Counsel of FDA directly provide advice 
about a hearing to any person who is participating or may participate in 
the hearing. In every hearing, certain attorneys in the office are 
designated to represent the center or centers whose action is the 
subject of the hearing. Other members of the office, including 
ordinarily the Chief Counsel, are designated to advise the Commissioner 
on a final decision in the matter. It is not compatible with these 
functions, nor would it be professionally responsible, for the attorneys 
in the office of the Chief Counsel also to advise other participants in 
a hearing, or for any attorney who may be called on to advise the 
Commissioner to respond to inquiries from other participants in the 
hearing, for such participants may be urging views contrary to those of 
the center involved or to what may ultimately be the final conclusions 
of the Commissioner. Accordingly, members of the office of the Chief 
Counsel, other than the attorneys responsible for representing the 
center whose action is the subject of the hearing, will not answer 
questions about the hearing from any participant or potential 
participant.
    (e) Communication between participants and attorneys. Participants 
in a hearing may communicate with the attorneys responsible for 
representing the center whose action is the subject of the hearing, in 
the same way that they may communicate with counsel for any other party 
in interest about the presentation of matters at the hearing. It would 
be inappropriate to bar discussion of such matters as stipulations of 
fact, joint presentation of witnesses, or possible settlement of hearing 
issues. Members of the public, including participants at hearings, are 
advised, however, that all such communications, including those by 
telephone, will be recorded in memoranda that can be filed with the 
Dockets Management Branch.

[44 FR 22329, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54 
FR 9035, Mar. 3, 1989; 58 FR 17096, Apr. 1, 1993]



                      Subpart D--Presiding Officer



Sec. 12.60  Presiding officer.

    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

[[Page 131]]

has been delegated, or an administrative law judge qualified under 5 
U.S.C. 3105.



Sec. 12.62  Commencement of functions.

    The functions of the presiding officer begin upon designation and 
end upon the filing of the initial decision.



Sec. 12.70  Authority of presiding officer.

    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 Sec. 12.92(b) and to rule on the need 
for oral testimony and cross-examination under Sec. 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 Sec. 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 
Sec. 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 Sec. 12.45(e) or 
exclude any person from the hearing under Sec. 12.90, or take other 
reasonable disciplinary action; and
    (o) Take any action for the fair, expeditious, and orderly conduct 
of the hearing.



Sec. 12.75  Disqualification of presiding officer.

    (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 Sec. 12.97(b).
    (b) A presiding officer who is aware of grounds for disqualification 
shall withdraw from the proceeding.



Sec. 12.78  Unavailability of presiding officer.

    (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.



                      Subpart E--Hearing Procedures



Sec. 12.80  Filing and service of submissions.

    (a) Submissions, including pleadings in a hearing, are to be filed 
with the Dockets Management Branch under Sec. 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

[[Page 132]]

in the notice of participation or by personal delivery.
    (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 Sec. 12.105.



Sec. 12.82  Petition to participate in forma pauperis.

    (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 Sec. 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.



Sec. 12.83  Advisory opinions.

    Before or during a hearing, a person may, under Sec. 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.



Sec. 12.85  Disclosure of data and information by the participants.

    (a) Before the notice of hearing is published under Sec. 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. Files 
means the principal files in the center in which documents relating to 
the issues in the hearing are ordinarily kept, e.g., the food additive 
master file and the food additive petition in the case of issues 
concerning a food additive, or the new drug application in the case of 
issues concerning a new drug. Internal memoranda reflecting the 
deliberative process, and attorney work product and material prepared 
specifically for use in connection with the hearing, are not required to 
be submitted.
    (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

[[Page 133]]

when the submission was made or that the relevance of the material 
contained in the supplement could not reasonably have been forseen.
    (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.

[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]



Sec. 12.87  Purpose; oral and written testimony; burden of proof.

    (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.

[44 FR 22339, Apr. 13, 1979 as amended at 64 FR 399, Jan. 5, 1999]



Sec. 12.89  Participation of nonparties.

    (a) A nonparty participant may--

[[Page 134]]

    (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.

[44 FR 22339, Apr. 13, 1979, as amended at 48 FR 51770, Nov. 14, 1983]



Sec. 12.90  Conduct at oral hearings or conferences.

    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.



Sec. 12.91  Time and place of prehearing conference.

    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.



Sec. 12.92  Prehearing conference procedure.

    (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 Sec. 12.45.
    (2) Participants shall bring to the prehearing conference the 
following specific information, which will be filed with the Dockets 
Management Branch under Sec. 12.80:
    (i) Any additional information to supplement the submission filed 
under Sec. 12.85, which may be filed if approved under Sec. 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

[[Page 135]]

or transcription of an oral statement made, by persons identified as 
witnesses if--
    (a) The statement is available without making request of the witness 
or any other person;
    (b) The statement relates to the subject matter of the witness' 
testimony; and
    (c) The statement either was made before the time the person agreed 
to become a witness or has been made publicly available by the person.
    (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 Sec. 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.



Sec. 12.93  Summary decisions.

    (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

[[Page 136]]

evidence to be obtained, or issue other just order.
    (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.



Sec. 12.94  Receipt of evidence.

    (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 Sec. 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 Sec. 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 Sec. 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 
Sec. 10.20(j)(2)(i) (a) and (b). Such closed proceedings will be 
conducted in accordance with Sec. 10.20(j)(3). Participation in closed 
proceedings will be limited to the witness, the witness' counsel, and 
Federal Government executive branch employees and special government 
employees. Closed proceedings will be permitted only for, and will be 
limited to, oral testimony directly relating to matters specified in 
Sec. 10.20(j)(3).

[[Page 137]]



Sec. 12.95  Official notice.

    (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.



Sec. 12.96  Briefs and arguments.

    (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 Sec. 10.20(j)(2)(i)(a) and (b), except as specifically 
authorized in a protective order issued under Sec. 10.20(j)(3).



Sec. 12.97  Interlocutory appeal from ruling of presiding officer.

    (a) Except as provided in paragraph (b) of this section and in 
Secs. 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.



Sec. 12.98  Official transcript.

    (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 Sec. 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.



Sec. 12.99  Motions.

    (a) A motion on any matter relating to the proceeding is to be filed 
under Sec. 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.

[[Page 138]]



                    Subpart F--Administrative Record



Sec. 12.100  Administrative record of a hearing.

    (a) The record of a hearing consists  of--
    (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 Secs. 12.20 through 12.22;
    (3) The notice of hearing published under Sec. 12.35;
    (4) All notices of participation filed under Sec. 12.45;
    (5) All Federal Register notices pertinent to the proceeding;
    (6) All submissions filed under Sec. 12.82, e.g., the submissions 
required by Sec. 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 Sec. 12.92;
    (8) All documents relating to any motion for summary decision under 
Sec. 12.93;
    (9) All documents of which official notice is taken under 
Sec. 12.95;
    (10) All pleadings filed under Sec. 12.96;
    (11) All documents relating to any interlocutory appeal under 
Sec. 12.97;
    (12) All transcripts prepared under Sec. 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 
Sec. 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.



Sec. 12.105  Examination of record.

    Documents in the record will be publicly available in accordance 
with Sec. 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.



                 Subpart G--Initial and Final Decisions



Sec. 12.120  Initial decision.

    (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 Sec. 10.20(j)(2)(i) (a) and (b), except 
as specifically authorized in a protective order issued pursuant to 
Sec. 10.20(j)(3).
    (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 Sec. 12.125(a) or the 
Commissioner files a notice of review under Sec. 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

[[Page 139]]

the Federal Register, or the Commissioner may publish the decision when 
it is of widespread interest.



Sec. 12.125  Appeal from or review of initial decision.

    (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.

[44 FR 22339, Apr. 13, 1979, as amended at 53 FR 29453, Aug. 5, 1988]



Sec. 12.130  Decision by Commissioner on appeal or review of initial decision.

    (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 Sec. 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 
Federal Register, or the Commissioner may publish the decision when it 
is of widespread interest.



Sec. 12.139  Reconsideration and stay of action.

    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 Sec. 10.33 or may petition for a stay 
of the decision under Sec. 10.35.



                       Subpart H--Judicial Review



Sec. 12.140  Review by the courts.

    (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 Sec. 10.35.
    (b) Under 28 U.S.C. 2112(a), FDA will request consolidation of all 
petitions related to a particular matter.

[[Page 140]]



Sec. 12.159  Copies of petitions for judicial review.

    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.



PART 13--PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY--Table of Contents




                      Subpart A--General Provisions

Sec.
13.1  Scope.
13.5  Notice of a hearing before a Board.
13.10  Members of a Board.
13.15  Separation of functions; ex parte communications; administrative 
          support.

                      Subpart B--Hearing Procedures

13.20  Submissions to a Board.
13.25  Disclosure of data and information by the participants.
13.30  Proceedings of a Board.

             Subpart C--Records of a Hearing Before a Board

13.40  Administrative record of a Board.
13.45  Examination of administrative record.
13.50  Record for administrative decision.

    Authority: 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.

    Source: 44 FR 22348, Apr. 13, 1979, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 13.1  Scope.

    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 (Board) with respect to any matter before FDA;
    (b) Under specific sections of this chapter a matter before FDA is 
subject to a hearing before a Board; or
    (c) Under Sec. 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.



Sec. 13.5  Notice of a hearing before a Board.

    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 Federal Register setting forth the following information:
    (a) If the hearing is under Sec. 13.1 (a) or (b), all applicable 
information described in Sec. 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 Federal 
Register or state that the document is available from the Dockets 
Management Branch or an agency employee designated in the notice.
    (2) For purposes of a hearing under Sec. 13.1 (a) or (b), all 
participants who file a notice of participation under 
Sec. 12.32(e)(6)(ii) are deemed to be parties and entitled to 
participate in selection of the Board under Sec. 13.15(b).
    (b) If the hearing is in lieu of a formal evidentiary hearing, as 
provided in Sec. 13.1(c), all of the information described in 
Sec. 12.32(e).

[44 FR 22348, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982]



Sec. 13.10  Members of a Board.

    (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

[[Page 141]]

matter before a Board, the other parties to the proceeding, and any 
person whose petition was granted and is the subject of the hearing, 
shall each submit to the Dockets Management Branch the names and full 
curricula vitae of five nominees for members of the Board. Nominations 
are to state that the nominee is aware of the nomination, is interested 
in becoming a member of the Board, and appears to have no conflict of 
interest.
    (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 Sec. 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 Sec. 12.70.

[44 FR 22348, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985]



Sec. 13.15  Separation of functions; ex parte communications; administrative support.

    (a) The proceeding of a Board are subject to the provisions of 
Sec. 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.

[[Page 142]]

    (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.

[44 FR 22348, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]



                      Subpart B--Hearing Procedures



Sec. 13.20  Submissions to a Board.

    (a) Submissions are to be filed with the Dockets Management Branch 
under Sec. 10.20.
    (b) The person making a submission shall serve copies of it on each 
participant in the proceeding, except as provided in Secs. 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 
Secs. 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 Sec. 12.82.



Sec. 13.25  Disclosure of data and information by the participants.

    (a) Before the notice of hearing is published under Sec. 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. Files 
means the principal files in the center in which documents relating to 
the issues in the hearing are ordinarily kept, e.g., the food additive 
master file and the food additive petition in the case of issues 
concerning a food additive, or the new drug application in the case of 
issues concerning a new drug. Internal memoranda reflecting the 
deliberative process, and attorney work product and material prepared 
specifically for use in connection with the hearing, are not required to 
be submitted;
    (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 Sec. 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

[[Page 143]]

the case of a party constitutes a waiver of the right to a hearing.
    (e) The Chairman rules on questions relating to this section. Any 
participant dissatisfied with a ruling may petition the Commissioner for 
interlocutory review.

[44 FR 22348, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54 
FR 9035, Mar. 3, 1989]



Sec. 13.30  Proceedings of a Board.

    (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 Sec. 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 Sec. 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 Sec. 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.

[[Page 144]]

    (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.



             Subpart C--Records of a Hearing Before a Board



Sec. 13.40  Administrative record of a Board.

    (a) The administrative record of a hearing before a Board consists 
of the following:
    (1) All relevant Federal Register notices.
    (2) All written submissions under Sec. 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 Sec. 13.30(i); and
    (2) Relevant to pleadings, at the time specified in Sec. 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.



Sec. 13.45  Examination of administrative record.

    (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 Sec. 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 
Sec. 13.10(b)(3) are not subject to disclosure unless they become an 
issue in a court proceeding.



Sec. 13.50  Record for administrative decision.

    The administrative record of the hearing specified in Sec. 13.40(a) 
constitutes the exclusive record for decision.



PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE--Table of Contents




                     Subpart A--General Provisions.

Sec.
14.1  Scope.
14.5  Purpose of proceedings before an advisory committee.
14.7  Administrative remedies.
14.10  Applicability to Congress.
14.15  Committees working under a contract with FDA.

                      Subpart B--Meeting Procedures

14.20  Notice of hearing before an advisory committee.
14.22  Meetings of an advisory committee.
14.25  Portions of advisory committee meetings.
14.27  Determination to close portions of advisory committee meetings.
14.29  Conduct of a hearing before an advisory committee.
14.30  Chairman of an advisory committee.
14.31  Consultation by an advisory committee with other persons.
14.33  Compilation of materials for members of an advisory committee.
14.35  Written submissions to an advisory committee.
14.39  Additional rules for a particular advisory committee.

[[Page 145]]

             Subpart C--Establishment of Advisory Committees

14.40  Establishment and renewal of advisory committees.
14.55  Termination of advisory committees.

 Subpart D--Records of Meetings and Hearings Before Advisory Committees

14.60  Minutes and reports of advisory committee meetings.
14.61  Transcripts of advisory committee meetings.
14.65  Public inquiries and requests for advisory committee records.
14.70  Administrative record of a public hearing before an advisory 
          committee.
14.75  Examination of administrative record and other advisory committee 
          records.

                Subpart E--Members of Advisory Committees

14.80  Qualifications for members of standing policy and technical 
          advisory committees.
14.82  Nominations of voting members of standing advisory committees.
14.84  Nominations and selection of nonvoting members of standing 
          technical advisory committees.
14.86  Rights and responsibilities of nonvoting members of advisory 
          committees.
14.90  Ad hoc advisory committee members.
14.95  Compensation of advisory committee members.

                 Subpart F--Standing Advisory Committees

14.100  List of standing advisory committees.

  Subpart G--Technical Electronic Products Radiation Safety Standards 
                                Committee

14.120  Establishment of the Technical Electronic Product Radiation 
          Safety Standards Committee (TEPRSSC).
14.122  Functions of TEPRSSC.
14.125  Procedures of TEPRSSC.
14.127  Membership of TEPRSSC.
14.130  Conduct of TEPRSSC meetings; availability of TEPRSSC records.

              Subpart H--Color Additive Advisory Committees

14.140  Establishment of a color additive advisory committee.
14.142  Functions of a color additive advisory committee.
14.145  Procedures of a color additive advisory committee.
14.147  Membership of a color additive advisory committee.
14.155  Fees and compensation pertaining to a color additive advisory 
          committee.

       Subpart I--Advisory Committees for Human Prescription Drugs

14.160  Establishment of standing technical advisory committees for 
          human prescription drugs.
14.171  Utilization of an advisory committee on the initiative of FDA.
14.172  Utilization of an advisory committee at the request of an 
          interested person.
14.174  Advice and recommendations in writing.

    Authority: 5 U.S.C. App. 2; 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, 
264.

    Effective Date Note: At 66 FR 1259, Jan. 8, 2001, the authority to 
part 14 was revised, effective May 23, 2001. For the convenience of the 
user, the revised text is set forth as follows:
    Authority: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.

    Source: 44 FR 22351, Apr. 13, 1979, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 14.1  Scope.

    (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 (advisory committee or committee) to hold a 
public hearing and to review and make recommendations on any matter 
before FDA and for interested persons to present information and views 
at an oral public hearing before the 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;

[[Page 146]]

    (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 Sec. 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 public advisory committee as 
defined in Sec. 10.3(a) and thus subject to this part and to the Federal 
advisory Committee Act, the following guidelines will be used:
    (1) An advisory committee may be a standing advisory committee or an 
ad hoc advisory committee. All standing advisory committees are listed 
in Sec. 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 utilized when FDA requests advice or recommendations from 
the committee on a specific matter in order to obtain an independent 
review and consideration of the matter, and not when FDA is merely 
seeking the comments of all interested persons or of persons who have a 
specific interest in the matter.
    (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.

[[Page 147]]

    (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 example, a monthly meeting with consumer representatives, does 
not make that group or committee an advisory committee. Thus, this 
subpart does not apply to routine meetings, discussions, and other 
dealings, including exchanges of views, between FDA and any committee 
representing or advocating the particular interests of consumers, 
industry, professional organizations, or others.
    (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 
Sec. 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 Sec. 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.

[44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]



Sec. 14.5  Purpose of proceedings before an advisory committee.

    (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.



Sec. 14.7  Administrative remedies.

    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 Sec. 10.30. The provisions of Sec. 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

[[Page 148]]

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 for the first time on the 
day of the meeting, the matter may be handled by an oral petition in 
lieu of a written petition.
    (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.

[44 FR 22351, Apr. 13, 1979, as amended at 55 FR 1404, Jan. 16, 1990]



Sec. 14.10  Applicability to Congress.

    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 Sec. 20.87.



Sec. 14.15  Committees working under a contract with FDA.

    (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 Sec. 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 Federal Register or 
disseminated by other reasonable means. It is in any event to be filed 
with the Dockets Management Branch not less than 15 days before the 
meeting. The time for oral presentations and the extent to which the 
committee meets in open session other than for such oral presentations 
is in the discretion of the committee.
    (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.



                      Subpart B--Meeting Procedures



Sec. 14.20  Notice of hearing before an advisory committee.

    (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 Federal 
Register of all advisory committee meetings to be held during the month. 
Any advisory committee meetings for that month called after the 
publication of the general monthly notice are to be announced in the 
Federal Register on an individual basis at least 15 days in advance. The 
Commissioner may authorize an exception to these notice requirements in 
an emergency or for other reasons requiring an immediate meeting of an 
advisory committee, in which case public notice will be given at the 
earliest time and in the most accessible form feasible including, 
whenever possible, publication in the Federal Register.
    (b) The Federal Register notice will include--
    (1) The name of the committee;

[[Page 149]]

    (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 Sec. 14.35(d)(2);
    (10) When a notice is published in the Federal Register less than 15 
days before a meeting, an explanation for the lateness of the notice; 
and
    (c) If a public hearing before an advisory committee is used in lieu 
of a formal evidentiary public hearing under Sec. 14.1(a)(3), an initial 
notice of hearing is to be published separately in the Federal Register 
containing all the information described in Sec. 12.32(e). This 
procedure may be used for any other hearing before an advisory committee 
when the Commissioner concludes, as a matter of discretion, that it 
would be informative to the public.
    (d) A list of advisory committee meetings will be distributed to the 
press by the Associate Commissioner for Public Affairs.
    (e) All advisory committee meetings are to be included on the public 
calendar described in Sec. 10.100(a).

[44 FR 22351, Apr. 13, 1979, as amended at 47 FR 26375, June 1, 1982; 54 
FR 9035, Mar. 3, 1989; 66 FR 6469, Jan. 22, 2001; 66 FR 12850, Mar. 1, 
2001]

    Effective Date Note: At 66 FR 12850, Mar. 1, 2001, Sec. 14.20 was 
amended by adding paragraph (e), effective Jan. 22, 2001, to Apr. 22, 
2001.



Sec. 14.22  Meetings of an advisory committee.

    (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 Federal Register under Sec. 14.20(b)(4), an attempt is to be made to 
inform persons known to be interested in the matter, and the change is 
to be announced at the beginning of the open portion of the meeting.
    (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.

[[Page 150]]

    (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 Sec. 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 Secs. 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 Sec. 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 Sec. 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.

[44 FR 22351, Apr. 13, 1979; 48 FR 40887, Sept. 12, 1983, as amended at 
54 FR 9035, Mar. 3, 1989]



Sec. 14.25  Portions of advisory committee meetings.

    An advisory committee meeting has the following portions:
    (a) The open public hearing. Every committee meeting includes an 
open portion, which constitutes a public hearing during which interested 
persons may present relevant information or views orally or in writing. 
The hearing is conducted in accordance with Sec. 14.29.
    (b) The open committee discussion. A committee discusses any matter 
pending before it in an open portion of its meeting unless the meeting 
has been closed for that matter under Sec. 14.27. To the maximum extent 
feasible, consistent with the policy expressed in Sec. 14.27, a 
committee conducts its discussion of pending matters in an open portion. 
No public participation is permissible during this portion of the 
meeting except with the consent of the committee chairman.

[[Page 151]]

    (c) The closed presentation of data. Information prohibited from 
public disclosure under part 20 and the regulations referenced therein 
is presented to the committee in a closed portion of its meeting. 
However, if information is in the form of a summary that is not 
prohibited from public disclosure, the presentation is to be made in an 
open portion of a meeting.
    (d) The closed committee deliberations. Deliberations about matters 
before an advisory committee may be held in a closed portion of a 
meeting only upon an appropriate determination by the Commissioner under 
Sec. 14.27.



Sec. 14.27  Determination to close portions of advisory committee meetings.

    (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 
Federal Register notice of the meeting under Sec. 14.20 in accordance 
with the following rules:
    (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 Sec. 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 Sec. 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

[[Page 152]]

under Sec. 14.25(c), for presentation of information prohibited from 
public disclosure. A person making a presentation described in 
Sec. 14.25(c) may be accompanied by a reasonable number of employees, 
consultants, or other persons in a commercial arrangement within the 
meaning of Sec. 20.81(a).
    (2) A portion of a meeting that has been closed for consideration of 
existing internal agency documents falling within Sec. 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 Sec. 20.63; or investigatory records compiled for law enforcement 
purposes as defined in Sec. 20.64 may be attended only by committee 
members (voting and nonvoting), the executive secretary of the 
committee, a transcriber, and other regular employees of FDA (including 
members of the Office of the Chief Counsel) whom the chairman of the 
committee may invite. Consultants, individuals performing personal 
service contracts, employees of other Federal agencies, and the general 
public may not attend such portions.
    (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 Sec. 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.

[44 FR 22351, Apr. 13, 1979, as amended at 65 FR 56479, Sept. 19, 2000]



Sec. 14.29  Conduct of a hearing before an advisory committee.

    (a) For each meeting, the open portion for public participation, 
which constitutes a public hearing under Sec. 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 Federal Register notice 
published under Sec. 14.20 will designate the time specifically reserved 
for the hearing, which is ordinarily the first portion of the meeting. 
Further public participation in any open portion of the meeting under 
Sec. 14.25(b) is solely at the discretion of the chairman.
    (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 Sec. 14.30 and be accompanied by other committee 
members, who serve as a panel in conducting the hearing portion of the 
meeting.

[[Page 153]]

    (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 
Sec. 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 person's presentation. No other person, however, may question the 
person. The chairman may allot additional time when it is in the public 
interest, but may not reduce the time allotted without consent of the 
person.
    (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.



Sec. 14.30  Chairman of an advisory committee.

    (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 designated Federal employee who is assigned to the advisory 
committee. The designated Federal employee is also authorized to adjourn 
a hearing or meeting if the employee determines adjournment to be in the 
public interest.



Sec. 14.31  Consultation by an advisory committee with other persons.

    (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 Sec. 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 
Secs. 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 
Sec. 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,

[[Page 154]]

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 Sec. 14.70.

[44 FR 22351, Apr. 13, 1979, as amended at 55 FR 42703, Oct. 23, 1990]



Sec. 14.33  Compilation of materials for members of an advisory committee.

    The Commissioner shall prepare and provide to all committee members 
a compilation of materials bearing upon members' duties and 
responsibilities, including--
    (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, Federal Register 
notices, curricula vitae, rules adopted by the advisory committee, and 
other material relating to the formation, composition, and operation of 
the advisory committee, and a summary of their principal provisions;
    (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.

[44 FR 22351, Apr. 13, 1979, as amended at 65 FR 56479, Sept. 19, 2000]



Sec. 14.35  Written submissions to an advisory committee.

    (a) Ten copies of written submissions to a committee are to be sent 
to the executive secretary unless an applicable Federal Register notice 
or other regulations in this chapter specify otherwise. Submissions are 
subject to the provisions of Sec. 10.20, except that it is not necessary 
to send copies to the Dockets Management Branch.
    (b) At the request of a committee, or on the Commissioner's own 
initiative, the Commissioner may issue in the Federal Register a notice 
requesting the submission to the committee of written information and 
views pertinent to a matter being reviewed by the committee. The notice 
may specify the manner in which the submission should be made.
    (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.

[[Page 155]]

    (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.



Sec. 14.39  Additional rules for a particular advisory committee.

    (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 Sec. 14.33 and 
will be available for public disclosure under Sec. 14.65(c).



             Subpart C--Establishment of Advisory Committees



Sec. 14.40  Establishment and renewal of advisory committees.

    (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 Federal Register notice certifying that the 
establishment or renewal is in the public interest and stating the 
structure, function, and purposes of the committee and, if it is a 
standing advisory committee, shall amend Sec. 14.100 to add it to the 
list of standing advisory committees. A notice of establishment will be 
published at least 15 days before the filing of the advisory committee 
charter under paragraph (c) of this section. A notice of renewal does 
not require the 15-day notice.
    (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.

[44 FR 22351, Apr. 13, 1979, as amended at 55 FR 42703, Oct. 23, 1990]

[[Page 156]]



Sec. 14.55  Termination of advisory committees.

    (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 Sec. 14.40 also apply to its renewal.
    (b) FDA will issue a Federal Register notice announcing the reasons 
for terminating a committee and, if it is a standing committee, amending 
Sec. 14.100 to delete it from the list.
    (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 Sec. 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 Sec. 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.



 Subpart D--Records of Meetings and Hearings Before Advisory Committees



Sec. 14.60  Minutes and reports of advisory committee meetings.

    (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 Sec. 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 Sec. 14.25 (a) and (b), any closed 
portion during which a presentation is made under Sec. 14.25(c), and any 
closed deliberative portion under Sec. 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 
Sec. 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

[[Page 157]]

disclosure under Sec. 14.75(a)(6)(i), or (2) if under 
Sec. 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 meeting prepared under paragraph (c) of this section.

[44 FR 22351, Apr. 13, 1979, as amended at 45 FR 85725, Dec. 30, 1980]



Sec. 14.61  Transcripts of advisory committee meetings.

    (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 Sec. 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 Sec. 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.



Sec. 14.65  Public inquiries and requests for advisory committee records.

    (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 Federal 
Register notices published under Sec. 14.20.
    (c) Requests for public advisory committee records, including 
minutes, are to be made, to FDA's Freedom of Information Staff (HFI-35) 
under Sec. 20.40 and the related provisions of part 20.

[44 FR 22351, Apr. 13, 1979, as amended at 46 FR 8456, Jan. 27, 1981]



Sec. 14.70  Administrative record of a public hearing before an advisory committee.

    (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 Sec. 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 Sec. 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.

[[Page 158]]



Sec. 14.75  Examination of administrative record and other advisory committee records.

    (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 Sec. 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 
Sec. 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 
Sec. 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 
Sec. 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 Sec. 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.

[44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]

    Effective Date Note: At 66 FR 1259, Jan. 8, 2001, Sec. 14.75 was 
amended by revising paragraph (a)(1), effective May 23, 2001. For the 
convenience of the user, the revised text is set forth as follows:

Sec. 14.75  Examination of administrative record and other advisory 
          committee records.

    (a) *  *  *
    (1) The written information for consideration by the committee at 
any meeting: Whenever practicable, before or at the time of the meeting.

                                * * * * *

[[Page 159]]



                Subpart E--Members of Advisory Committees



Sec. 14.80  Qualifications for members of standing policy and technical advisory committees.

    (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) Technical advisory committee.(1) Voting members of technical 
advisory committees--
    (i) Shall have expertise in the subject matter with which the 
committee is concerned and have diverse professional education, 
training, and experience so that the committee will reflect a balanced 
composition of sufficient scientific expertise to handle the problems 
that come before it; and
    (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 Sec. 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 Sec. 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 Secs. 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 Sec. 14.86(c).
    (g) Consultants appointed under Sec. 14.31(e) are not members of 
advisory committees.

[44 FR 22351, Apr. 13, 1979, as amended at 53 FR 50949, Dec. 19, 1988; 
54 FR 9035, Mar. 3, 1989]



Sec. 14.82  Nominations of voting members of standing advisory committees.

    (a) The Commissioner will publish one or more notices in the Federal 
Register each year requesting nominations for voting members of all 
existing standing advisory committees. The notice will invite the 
submission of

[[Page 160]]

nominations for voting members from both individuals and organizations.
    (b) The notice announcing the establishment of a new committee under 
Sec. 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.



Sec. 14.84  Nominations and selection of nonvoting members of standing technical advisory committees.

    (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 are normally limited to 
one person selected by consumer groups and organizations and one person 
selected by industry groups and organizations.
    (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 Federal Register requesting nominations for 
each specific committee, or subcommittee, for which nonvoting members 
are to be appointed.
    (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

[[Page 161]]

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 a representative number of consumer 
organizations that have been determined to be eligible to vote for 
consumer representatives in accordance with paragraph (c)(3) of this 
section. After 4 days have elapsed, the Office of Consumer Affairs will 
contact the consumer organizations by telephone and elicit their votes. 
The candidate who has received the highest number of votes will be 
selected. In the event of a tie, the Commissioner will select the winner 
by lot from among those tied for the highest number of votes.
    (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.

[44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]



Sec. 14.86  Rights and responsibilities of nonvoting members of advisory committees.

    (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 Sec. 14.39(a), approval of minutes under 
Sec. 14.60(a), decisions on transcripts under Sec. 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 
Sec. 20.61 only if the person has been appointed as a special Government 
employee under Sec. 14.80(b).

[[Page 162]]

    (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 committee. The nonvoting member takes the initiative in 
contacting interested persons whom the member represents to seek out 
relevant information and views and to relate the progress of the 
advisory committee.
    (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 Sec. 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 
Sec. 14.80(f).



Sec. 14.90  Ad hoc advisory committee members.

    In selecting members of an ad hoc advisory committee, the 
Commissioner may use the procedures in Secs. 14.82 and 14.84 or any 
other procedure deemed appropriate.



Sec. 14.95  Compensation of advisory committee members.

    (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

[[Page 163]]

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:
    (a) An analysis of the risks and benefits of the use of a class of 
drugs or a report on a specific problem generated by an IND or NDA;
    (b) The performance of similar investigations or analysis of complex 
industry submissions to support advisory committee deliberations other 
than normal meeting preparation;
    (c) The preparation of a statistical analysis leading to an estimate 
of toxicologically safe dose levels; and
    (d) The design or analysis of animal studies of toxicity, 
mutagenicity, teratogenicity, or carcinogenicity.
    (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.

[44 FR 22351, Apr. 13, 1979, as amended at 53 FR 50949, Dec. 19, 1988]



                 Subpart F--Standing Advisory Committees



Sec. 14.100  List of standing advisory committees.

    Standing advisory committees and the dates of their establishment 
are as follows:
    (a) Office of the Commissioner--(1) Board of Tea Experts.
    (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) Science Board to the Food and Drug Administration.
    (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.

[[Page 164]]

    (b) Center for Biologics Evaluation and Research--(1) Allergenic 
Products Advisory Committee.
    (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) Biological Response Modifiers Advisory Committee.
    (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) Blood Products Advisory Committee.
    (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) Vaccines and Related Biological Products Advisory Committee.
    (i) Date established: December 31, 1979.
    (ii) Function: Reviews and evaluates data on the safety and 
effectiveness of vaccines intended for use in the diagnosis, prevention, 
or treatment of human diseases.
    (6) Transmissible Spongiform Encephalopathies Advisory Committee.
    (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) Center for Drug Evaluation and Research--(1) Anesthetic and Life 
Support Drugs Advisory Committee.
    (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) Anti-Infective Drugs Advisory Committee.
    (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) Antiviral Drugs Advisory Committee.
    (i) Date established: February 15, 1989.
    (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) Arthritis Advisory Committee.
    (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) Cardiovascular and Renal Drugs Advisory Committee.
    (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) Dermatologic and Ophthalmic Drugs Advisory Committee.
    (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) Drug Abuse Advisory Committee.
    (i) Date established: May 31, 1978.
    (ii) Function: Advises on the scientific and medical evaluation of 
information gathered by the Department of Health and Human Services and 
the Department of Justice on the safety, efficacy, and abuse potential 
of drugs and recommends actions to be taken on the marketing, 
investigation, and control of such drugs.
    (8) Endocrinologic and Metabolic Drugs Advisory Committee.
    (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.

[[Page 165]]

    (9) Advisory Committee for Reproductive Health Drugs.
    (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) Gastrointestinal Drugs Advisory Committee.
    (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) Oncologic Drugs Advisory Committee.
    (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) Peripheral and Central Nervous System Drugs Advisory Committee.
    (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) Psychopharmacologic Drugs Advisory Committee.
    (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) Pulmonary-Allergy Drugs Advisory Committee.
    (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) Medical Imaging Drugs Advisory Committee.
    (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) Advisory Committe for Pharmaceutical Science.
    (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) Nonprescription Drugs Advisory Committee.
    (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) Pharmacy Compounding Advisory Committee.
    (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) Center for Devices and Radiological Health--(1) Medical Devices 
Advisory Committee.
    (i) Date established: October 27, 1990.
    (ii) Function: Reviews and evaluates data on the safety and 
effectiveness of marketed and investigational devices and makes 
recommendations for their regulation.
    (2) Device Good Manufacturing Practice Advisory Committee.
    (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) Technical Electronic Product Radiation Safety Standards 
Committee.
    (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).

[[Page 166]]

    (4) National Mammography Quality Assurance Advisory Committee.
    (i) Date established: July 6, 1993.
    (ii) Function: Advises on developing appropriate quality standards 
and regulations for the use of mammography facilities.
    (e) National Center for Toxicological Research--Science Advisory 
Board.
    (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) Center for Veterinary Medicine--Veterinary Medicine Advisory 
Committee.
    (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) Center for Food Safety and Applied Nutrition--Food Advisory 
Committee.
    (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.

[54 FR 9036, Mar. 3, 1989]

    Editorial Note: For Federal Register citations affecting Sec. 5.10, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and on GPO Access.



  Subpart G--Technical Electronic Products Radiation Safety Standards 
                                Committee



Sec. 14.120  Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

    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.



Sec. 14.122  Functions of TEPRSSC.

    (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.



Sec. 14.125  Procedures 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 Federal 
Register the Commissioner will submit to TEPRSSC the proposed standard 
or amendment under consideration, together with other relevant 
information to aid TEPRSSC in its deliberations.
    (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 
Sec. 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.

[[Page 167]]

    (e) Sections 14.1 through 14.7 apply to TEPRSSC, except where other 
provisions are specifically included in Secs. 14.120 through 14.130.

[44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989]



Sec. 14.127  Membership of TEPRSSC.

    (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 adequate notice, the executive secretary may appoint a 
committee member as temporary chairman pending appointment of a new 
chairman by the Commissioner.
    (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 Sec. 14.95, in 
accordance with 42 U.S.C. 210(c).



Sec. 14.130  Conduct of TEPRSSC meeting; availability of TEPRSSC records.

    (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 Sec. 14.27, that a portion of a meeting may be 
closed.



              Subpart H--Color Additive Advisory Committees



Sec. 14.140  Establishment of a color additive advisory committee.

    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,

[[Page 168]]

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 Sec. 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 color additive advisory 
committee that the matter is premature or that it does not involve an 
issue arising under section 721(b)(5)(B) of the act or that there is no 
genuine and substantial issue of fact requiring scientific judgment, or 
for any other reason a color additive advisory committee is not 
justified, the Commissioner may deny the establishment of a color 
additive advisory committee.
    (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 Sec. 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.



Sec. 14.142  Functions of a color additive advisory committee.

    (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.



Sec. 14.145  Procedures of 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

[[Page 169]]

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.



Sec. 14.147  Membership of a color additive advisory committee.

    (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 Sec. 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 an interested person, it shall be established 
under the following requirements:
    (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 Sec. 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.



Sec. 14.155  Fees and compensation pertaining to a color additive advisory committee.

    (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

[[Page 170]]

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 Sec. 10.30 to waive or 
refund the fees.



       Subpart I--Advisory Committees for Human Prescription Drugs



Sec. 14.160  Establishment of standing technical advisory committees for human prescription drugs.

    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 the 
advisory committee and on the scientific standards appropriate for a 
determination of safety and effectiveness in that class of drugs.
    (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.



Sec. 14.171  Utilization of an advisory committee on the initiative of FDA.

    (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

[[Page 171]]

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 
Sec. 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 disclosure, or not 
in any way discussed or disclosed in open session or otherwise disclosed 
to the public.

[44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989]



Sec. 14.172  Utilization of an advisory committee at the request of an interested person.

    Any interested person may request, under Sec. 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.



Sec. 14.174  Advice and recommendations in writing.

    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.



PART 15--PUBLIC HEARING BEFORE THE COMMISSIONER--Table of Contents




                      Subpart A--General Provisions

Sec.
15.1  Scope.

    Subpart B--Procedures for Public Hearing Before the Commissioner

15.20  Notice of a public hearing before the Commissioner.
15.21  Notice of participation; schedule for hearing.
15.25  Written submissions.
15.30  Conduct of a public hearing before the Commissioner.

     Subpart C--Records of a Public Hearing Before the Commissioner

15.40  Administrative record.
15.45  Examination of administrative record.

    Authority: 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.

    Source: 44 FR 22366, Apr. 13, 1979, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 15.1  Scope.

    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., Sec. 330.10(a)(8) relating to 
over-the-

[[Page 172]]

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 
Sec. 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 Sec. 12.32 a public hearing before the 
Commissioner, and the Commissioner, as a matter of discretion, accepts 
the request.



    Subpart B--Procedures for Public Hearing Before the Commissioner



Sec. 15.20  Notice of a public hearing before the Commissioner.

    (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 Federal Register setting forth the following information:
    (1) If the hearing is under Sec. 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 Federal Register, or the 
notice will state that the document is available from an agency office 
identified in the notice.
    (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 Sec. 15.1(c), all of the information described in Sec. 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., Sec. 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 
Sec. 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.

[44 FR 22366, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982]



Sec. 15.21  Notice of participation; schedule for hearing.

    (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

[[Page 173]]

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.



Sec. 15.25  Written submissions.

    A person may submit information or views on the subject of the 
hearing in writing to the Dockets Management Branch, under Sec. 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.



Sec. 15.30  Conduct of a public hearing before the Commissioner.

    (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 Sec. 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 Sec. 15.21(e), by which 
participants must be present.
    (h) The Commissioner or the presiding officer may, under Sec. 10.19, 
suspend, modify, or waive any provision of this part.



     Subpart C--Records of a Public Hearing Before the Commissioner



Sec. 15.40  Administrative record.

    (a) The administrative record of a public hearing before the 
Commissioner consists of the following:
    (1) All relevant Federal Register notices, including any documents 
to which they refer.
    (2) All written submissions under Sec. 15.25.
    (3) The transcript of the oral hearing.
    (b) The record of the administrative proceeding will be closed at 
the time specified in Sec. 15.25.



Sec. 15.45  Examination of administrative record.

    Section 10.20(j) governs the availability for public examination and

[[Page 174]]

copying of each document in the administrative record of the hearing



PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents




                      Subpart A--General Provisions

Sec.
16.1  Scope.
16.5  Inapplicability and limited applicability.

                  Subpart B--Initiation of Proceedings

16.22  Initiation of regulatory hearing.
16.24  Regulatory hearing required by the act or a regulation.
16.26  Denial of hearing and summary decision.

              Subpart C--Commissioner and Presiding Officer

16.40  Commissioner.
16.42  Presiding officer.
16.44  Communication to presiding officer and Commissioner.

              Subpart D--Procedures for Regulatory Hearing

16.60  Hearing procedure.
16.62  Right to counsel.

              Subpart E--Administrative Record and Decision

16.80  Administrative record of a regulatory hearing.
16.85  Examination of administrative record.
16.95  Administrative decision and record for decision.

                   Subpart F--Reconsideration and Stay

16.119  Reconsideration and stay of action.

                       Subpart G--Judicial Review

16.120  Judicial review.

    Authority: 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.

    Source: 44 FR 22367, Apr. 13, 1979, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 16.1  Scope.

    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:

Section 304(g) of the act relating to the administrative detention of 
devices (see Sec. 800.55(g) of this chapter).
Section 515(e)(1) of the act relating to the proposed withdrawal of 
approval of a device premarket approval application.
Section 515(e)(3) of the act relating to the temporary suspension of 
approval of a premarket approval application.
Section 515(f)(6) of the act relating to a proposed order revoking a 
device product development protocol or declaring a protocol not 
completed.
Section 515(f)(7) of the act relating to revocation of a notice of 
completion of a product development protocol.
Section 516 of the act relating to a proposed banned device regulations 
(see Sec. 895.21(d) of this chapter).
Section 518(b) of the act relating to a determination that a device is 
subject to a repair, replacement, or refund order or that a correction 
plan, or revised correction plan, submitted by a manufacturer, importer, 
or distributor is inadequate.
Section 518(e) of the act relating to a cease distribution and 
notification order or mandatory recall order concerning a medical device 
for human use.
Section 520(f)(2)(D) of the act relating to exemptions or variances from 
device current good manufacturing practice requirements (see 
Sec. 820.1(d)).
Section 520(g)(4) and (g)(5) of the act relating to disapproval and 
withdrawal of approval of an application from an investigational device 
exemption (see Secs. 812.19(c), 812.30(c), 813.30(d), and 813.35(c) of 
this chapter).

    (2) Regulatory provisions:


[[Page 175]]


Sec. 56.121(a), relating to disqualifying an institutional review board 
or an institution.
Sec. 71.37(a), relating to use of food containing a color additive.
Sec. 80.31(b), relating to refusal to certify a batch of a color 
additive.
Sec. 80.34(b), relating to suspension of certification service for a 
color additive.
Sec. 99.401(c), relating to a due diligence determination concerning the 
conduct of studies necessary for a supplemental application for a new 
use of a drug or device.
Sec. 130.17(1), relating to a temporary permit to vary from a food 
standard.
Sec. 170.17(b), relating to use of food containing an investigational 
food additive.
Sec. 202.1(j)(5), relating to approval of prescription drug 
advertisements.
Sec. 312.70, relating to whether an investigator is entitled to receive 
investigational new drugs.
Sec. 312.70(d) and 312.44, relating to termination of an IND for a 
sponsor.
Sec. 312.160(b), relating to termination of an IND for tests in vitro 
and in laboratory research animals for a sponsor.
Sec. 511.1(b)(5), relating to use of food containing an investigational 
new animal drug.
Sec. 511.1(c)(1), relating to termination of an INAD for an 
investigator.
Sec. 511.1(c) (4) and (d), relating to termination of an INAD for a 
sponsor.
Sec. 814.46(c) relating to withdrawal of approval of a device premarket 
approval application.
Sec. 900.7, relating to approval, reapproval, or withdrawal of approval 
of mammography accreditation bodies or rejection of a proposed fee for 
accreditation.
Sec. 900.14, relating to suspension or revocation of a mammography 
certificate.
Sec. 1003.11(a)(3), relating to the failure of an electronic product to 
comply with an applicable standard or to a defect in an electronic 
product.
Sec. 1003.31(d), relating to denial of an exemption from notification 
requirements for an electronic product which fails to comply with an 
applicable standard or has a defect.
Sec. 1004.6, relating to plan for repurchase, repair, or replacement of 
an electronic product.
Sec. 1210.30, relating to denial, suspension, or revocation of a permit 
under the Federal Import Milk Act.
Sec. 1270.15(e), relating to the retention, recall, and destruction of 
human tissue.

[44 FR 22367, Apr. 13, 1979, as amended at 45 FR 3750, Jan 18, 1980; 45 
FR 10332, Feb. 15, 1980; 46 FR 8975, Jan. 27, 1981; 46 FR 14340, Feb. 
27, 1981; 51 FR 26364, July 22, 1986; 54 FR 9037, Mar. 3, 1989; 57 FR 
58403, Dec. 10, 1992; 58 FR 65520, Dec. 14, 1993; 62 FR 40444, July 29, 
1997; 62 FR 55976, Oct. 28, 1997; 63 FR 26697, May 13, 1998; 63 FR 
64581, Nov. 20, 1998]



Sec. 16.5  Inapplicability and limited applicability.

    (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 Sec. 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 Sec. 1.94, or of an 
electronic product under section 360(a) of the Public Health Service Act 
and Sec. 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.
    (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.

[44 FR 22367, Apr. 13, 1979, as amended at 57 FR 58403, Dec. 10, 1992]

    Effective Date Note: At 65 FR 76110, Dec. 5, 2000, Sec. 16.5 was 
amended by adding paragraph (a)(4), effective Sept. 4, 2001. For the 
convenience of the user, the added text is set forth as follows:

[[Page 176]]

Sec. 16.5  Inapplicability and limited applicability.

    (a) * * *
    (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 Secs. 101.17(h) and 115.50 of this chapter.

                                * * * * *



                  Subpart B--Initiation of Proceedings



Sec. 16.22  Initiation of regulatory hearing.

    (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, and 
the presiding officer or, if agreement cannot be reached, at a 
reasonable time and location designated by the presiding officer.
    (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.

[44 FR 22367, Apr. 13, 1979, as amended at 49 FR 32173, Aug. 13, 1984]



Sec. 16.24  Regulatory hearing required by the act or a regulation.

    (a) A regulatory hearing required by the act or a regulation under 
Sec. 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

[[Page 177]]

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.

[44 FR 22367, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982; 
54 FR 9037, Mar. 3, 1989]



Sec. 16.26  Denial of hearing and summary decision.

    (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 Sec. 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.

[53 FR 4615, Feb. 17, 1988]



              Subpart C--Commissioner and Presiding Officer



Sec. 16.40  Commissioner.

    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.

[44 FR 22367, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989]



Sec. 16.42  Presiding officer.

    (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, 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 Sec. 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 Sec. 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

[[Page 178]]

designated under Sec. 16.22 without notice to the parties.

[44 FR 22367, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989]



Sec. 16.44  Communication to presiding officer and Commissioner.

    (a) Regulatory hearings are not subject to the separation of 
functions rules in Sec. 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 Sec. 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.



              Subpart D--Procedures for Regulatory Hearing



Sec. 16.60  Hearing procedure.

    (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 trade secret or confidential commercial or financial 
information that is not available for public disclosure under 
Sec. 20.61; or to protect investigatory records complied for law 
enforcement purposes that are not available for public disclosure under 
Sec. 20.64.
    (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 Sec. 20.81(a) and FDA representatives with a direct 
professional interest in the subject matter of the proceeding are 
entitled to attend.
    (3) If the hearing is a public hearing, it will be announced on the 
public calendar described in Sec. 10.100(a) whenever feasible, and any 
interested person who attends the hearing may participate to the extent 
of presenting relevant information.
    (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

[[Page 179]]

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 
Sec. 10.19 to suspend, modify, or waive any provision of this part.

[44 FR 22367, Apr. 13, 1979, as amended at 66 FR 6469, Jan. 22, 2001; 66 
FR 12850, Mar. 1, 2001]

    Effective Date Note: At 66 FR 12850, Mar. 1, 2001, Sec. 16.60 was 
amended by adding paragraph (a)(3), effective Jan. 22, 2001, to Apr. 22, 
2001.



Sec. 16.62  Right to counsel.

    Any party to a hearing under this part has the right at all times to 
be advised and accompanied by counsel.



              Subpart E--Administrative Record and Decision



Sec. 16.80  Administrative record of a regulatory hearing.

    (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 Sec. 16.60(e).
    (5) All letters and memoranda of meetings or communications between 
participants and the presiding officer or the Commissioner referred to 
in Sec. 16.44(c).
    (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.



Sec. 16.85  Examination of administrative record.

    Part 20 governs the availability for public disclosure of each 
document that is a part of the administrative record of a regulatory 
hearing.



Sec. 16.95  Administrative decision and record for decision.

    (a) With respect to a regulatory hearing at the Commissioner's 
initiative under Sec. 16.1(a), the Commissioner shall consider the 
administrative record of the hearing specified in Sec. 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 Sec. 16.1(b)--
    (1) The administrative record of the hearing specified in 
Sec. 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 Sec. 10.45, the record of 
the administrative proceeding consists of the record of the hearing and 
the Commissioner's decision.



                   Subpart F--Reconsideration and Stay



Sec. 16.119  Reconsideration and stay of action.

    After any final administrative action that is the subject of a 
hearing under this part, any party may petition the Commissioner for 
reconsideration of

[[Page 180]]

any part or all of the decision or action under Sec. 10.33 or may 
petition for a stay of the decision or action under Sec. 10.35.

[44 FR 22367, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989]



                       Subpart G--Judicial Review



Sec. 16.120  Judicial review.

    Section 10.45 governs the availability of judicial review concerning 
any regulatory action which is the subject of a hearing under this part



PART 17--CIVIL MONEY PENALTIES HEARINGS--Table of Contents




Sec.
17.1  Scope.
17.3  Definitions.
17.5  Complaint.
17.7  Service of complaint.
17.9  Answer.
17.11  Default upon failure to file an answer.
17.13  Notice of hearing.
17.15  Parties to the hearing.
17.17  Summary decisions.
17.18  Interlocutory appeal from ruling of presiding officer.
17.19  Authority of the presiding officer.
17.20  Ex parte contacts.
17.21  Prehearing conferences.
17.23  Discovery.
17.25  Exchange of witness lists, witness statements, and exhibits.
17.27  Hearing subpoenas.
17.28  Protective order.
17.29  Fees.
17.30  Computation of time.
17.31  Form, filing, and service of papers.
17.32  Motions.
17.33  The hearing and burden of proof.
17.34  Determining the amount of penalties and assessments.
17.35  Sanctions.
17.37  Witnesses.
17.39  Evidence.
17.41  The administrative record.
17.43  Posthearing briefs.
17.45  Initial decision.
17.47  Appeals.
17.48  Harmless error.
17.51  Judicial review.
17.54  Deposit in the Treasury of the United States.

    Authority: 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.

    Source: 60 FR 38626, July 27, 1995, unless otherwise noted.



Sec. 17.1  Scope.

    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.



Sec. 17.3  Definitions.

    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) Significant departure, for the purpose of interpreting 21 U.S.C. 
333(g)(1)(B)(i), means a departure from requirements that is either a 
single major incident or a series of incidents that collectively are 
consequential.

[[Page 181]]

    (2) Knowing departure, for the purposes of interpreting 21 U.S.C. 
333(g)(1)(B)(i), means a departure from a requirement taken: (a) With 
actual knowledge that the action is such a departure, or (b) in 
deliberate ignorance of a requirement, or (c) in reckless disregard of a 
requirement.
    (3) Minor violations, for the purposes of interpreting 21 U.S.C. 
333(g)(1)(B)(ii), means departures from requirements that do not rise to 
a level of a single major incident or a series of incidents that are 
collectively consequential.
    (4) Defective, for the purposes of interpreting 21 U.S.C. 
333(g)(1)(B)(iii), includes any defect in performance, manufacture, 
construction, components, materials, specifications, design, 
installation, maintenance, or service of a device, or any defect in 
mechanical, physical, or chemical properties of a device.
    (b) Person or respondent includes an individual, partnership, 
corporation, association, scientific or academic establishment, 
government agency or organizational unit thereof, or other legal entity, 
or as may be defined in the act or regulation pertinent to the civil 
penalty action being brought.
    (c) Presiding officer means an administrative law judge qualified 
under 5 U.S.C. 3105.
    (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) Departmental Appeals Board (DAB) means the Departmental Appeals 
Board of the Department of Health and Human Services.



Sec. 17.5  Complaint.

    (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 the Center and by filing a copy of the complaint with the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.
    (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 Sec. 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.



Sec. 17.7  Service of complaint.

    (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

[[Page 182]]

    (3) Written acknowledgment of receipt by the respondent or by the 
respondent's counsel or authorized representative or agent.



Sec. 17.9  Answer.

    (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.



Sec. 17.11  Default upon failure to file an answer.

    (a) If the respondent does not file an answer within the time 
prescribed in Sec. 17.9 and if service has been effected as provided in 
Sec. 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 issue an initial decision 
within 30 days of the time the answer was due, imposing:
    (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 
Sec. 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.



Sec. 17.13  Notice of hearing.

    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;

[[Page 183]]

    (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.



Sec. 17.15  Parties to the hearing.

    (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.



Sec. 17.17  Summary decisions.

    (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 that the affiant is 
competent to testify to the matters stated. When a motion for summary 
decision is made and supported as provided in this regulation, a party 
opposing the motion may not rest on 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 material fact for the hearing.
    (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 Sec. 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 Sec. 17.47.



Sec. 17.18  Interlocutory appeal from ruling of presiding officer.

    (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

[[Page 184]]

entity deciding the appeal (currently the DAB). The deadline for filing 
an interlocutory appeal is subject to the discretion of the presiding 
officer.



Sec. 17.19  Authority 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 
Sec. 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 determines that no party will be prejudiced, the ends 
of justice will be served, and the action is in accordance with law;
    (18) Issue protective orders pursuant to Sec. 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.



Sec. 17.20  Ex parte contacts.

    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.



Sec. 17.21  Prehearing conferences.

    (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;

[[Page 185]]

    (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.



Sec. 17.23  Discovery.

    (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 documents includes 
information, reports, answers, records, accounts, papers and other data 
and documentary evidence. Nothing contained in this section may be 
interpreted to require the creation of a document, except that requested 
data stored in an electronic data storage system must be produced in a 
form readily accessible to the requesting party.
    (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.



Sec. 17.25  Exchange of witness lists, witness statements, and exhibits.

    (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

[[Page 186]]

exchanged in accordance with paragraph (a) of this section will be 
deemed to be authentic for the purpose of admissibility at the hearing.



Sec. 17.27  Hearing subpoenas.

    (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 Sec. 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.



Sec. 17.28  Protective order.

    (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 Sec. 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.



Sec. 17.29  Fees.

    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.



Sec. 17.30  Computation of time.

    (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.

[[Page 187]]

    (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.



Sec. 17.31  Form, filing, and service of papers.

    (a) Form. (1) Documents filed with the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857, shall include an original and two copies.
    (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) Service. A party filing a document with the Dockets Management 
Branch under this part shall, no later than the time of filing, serve a 
copy of such document on every other party. Service upon any party of 
any document, other than service of a complaint, shall be made by 
delivering a copy personally or by placing a copy of the document in the 
United States mail or express delivery service, postage prepaid and 
addressed, to the party's last known address. When a party is 
represented by counsel, service shall be made on such counsel in lieu of 
the actual party.
    (c) Proof of service. A certificate of the individual serving the 
document by personal delivery or by mail, setting forth the time and 
manner of service, shall be proof of service.



Sec. 17.32  Motions.

    (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 with the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, delivered to the presiding 
officer, and served on all other parties.
    (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.



Sec. 17.33  The hearing and burden of proof.

    (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 Sec. 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.

[[Page 188]]



Sec. 17.34  Determining the amount of penalties and assessments.

    (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.



Sec. 17.35  Sanctions.

    (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 legal counsel, party, or witness who refuses to obey an 
order of the presiding officer. In the case of repeated refusal, the 
presiding officer may grant judgment to the opposing party.
    (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 Sec. 17.18(b), provided that no such 
appeal will stay or delay a proceeding.



Sec. 17.37  Witnesses.

    (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 
Sec. 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.

[[Page 189]]

    (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.



Sec. 17.39  Evidence.

    (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 Sec. 17.28.



Sec. 17.41  The administrative record.

    (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

[[Page 190]]

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 Sec. 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.



Sec. 17.43  Posthearing briefs.

    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.



Sec. 17.45  Initial decision.

    (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.



Sec. 17.47  Appeals.

    (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.

[[Page 191]]

    (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 the failure to adduce such evidence at the 
hearing, the entity deciding the appeal may remand the matter to the 
presiding officer for consideration of the additional evidence.
    (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.



Sec. 17.48  Harmless error.

    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

[[Page 192]]

any error or defect in the proceeding that does not affect the 
substantial rights of the parties.



Sec. 17.51  Judicial review.

    (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 
Sec. 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.



Sec. 17.54  Deposit in the Treasury of the United States.

    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.



PART 19--STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST--Table of Contents




                      Subpart A--General Provisions

Sec.
19.1  Scope.
19.5  Reference to Department regulations.
19.6  Code of ethics for government service.
19.10  Food and Drug Administration Conflict of Interest Review Board.

                   Subpart B--Reporting of Violations

19.21  Duty to report violations.

                 Subpart C--Disqualification Conditions

19.45  Temporary disqualification of former employees.
19.55  Permanent disqualification of former employees.

    Authority: 21 U.S.C. 371.

    Source: 42 FR 15615, Mar. 22, 1977, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 19.1  Scope.

    This part governs the standards of conduct for, and establishes 
regulations to prevent conflicts of interest by, all Food and Drug 
Administration employees.



Sec. 19.5  Reference to Department regulations.

    (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.



Sec. 19.6  Code of ethics for government service.

    The following code of ethics, adopted by Congress on July 11, 1958, 
shall apply to all Food and Drug Administration employees:

                  Code of Ethics for Government Service

    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.

[[Page 193]]

    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.



Sec. 19.10  Food and Drug Administration Conflict of Interest Review Board.

    (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 Sec. 19.21.
    (c) All general policy relating to conflicts of interest shall be 
established in guidance documents pursuant to the provisions of 
Sec. 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 
Sec. 20.63 of this chapter.

[42 FR 15615, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 50 
FR 52278, Dec. 23, 1985; 55 FR 1404, Jan. 16, 1990; 65 FR 56479, Sept. 
19, 2000]



                   Subpart B--Reporting of Violations



Sec. 19.21  Duty to report violations.

    (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.

[[Page 194]]

    (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.

[42 FR 15615, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 50 
FR 52278, Dec. 23, 1985; 60 FR 47478, Sept. 13, 1995]



                 Subpart C--Disqualification Conditions



Sec. 19.45  Temporary disqualification of former employees.

    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 official responsibility 
means the direct administrative or operating authority, whether 
intermediate or final, and either exercisable alone or with others, and 
either personally or through subordinates, to approve, disapprove, or 
otherwise direct government action.



Sec. 19.55  Permanent disqualification of former employees.

    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 of advice, investigation, or 
otherwise as a Food and Drug Administration employee.



PART 20--PUBLIC INFORMATION--Table of Contents




              Subpart A--Official Testimony and Information

Sec.
20.1  Testimony by Food and Drug Administration employees.
20.2  Production of records by Food and Drug Administration employees.
20.3  Certification and authentication of Food and Drug Administration 
          records.

                        Subpart B--General Policy

20.20  Policy on disclosure of Food and Drug Administration records.
20.21  Uniform access to records.
20.22  Partial disclosure of records.
20.23  Request for existing records.
20.24  Preparation of new records.
20.25  Retroactive application of regulations.
20.26  Indexes of certain records.
20.27  Submission of records marked as confidential.
20.28  Food and Drug Administration determinations of confidentiality.
20.29  Prohibition on withdrawal of records from Food and Drug 
          Administration files.
20.30  Food and Drug Administration Freedom of Information Staff.
20.31  Retention schedule of requests for Food and Drug Administration 
          records.
20.32  Disclosure of Food and Drug Administration employee names.

                     Subpart C--Procedures and Fees

20.40  Filing a request for records.
20.41  Time limitations.
20.42  Fees to be charged.
20.43  Waiver or reduction of fees.
20.44  Presubmission review of request for confidentiality of 
          voluntarily submitted data or information.
20.45  Situations in which confidentiality is uncertain.
20.46  Judicial review of proposed disclosure.
20.47  Denial of a request for records.
20.48  Nonspecific and overly burdensome requests.
20.49  Referral to primary source of records.
20.50  Availability of records at National Technical Information 
          Service.
20.51  Use of private contractor for copying.
20.52  Request for review without copying.
20.53  Indexing trade secrets and confidential commercial or financial 
          information.

[[Page 195]]

                          Subpart D--Exemptions

20.60  Applicability of exemptions.
20.61  Trade secrets and commercial or financial information which is 
          privileged or confidential.
20.62  Inter- or intra-agency memoranda or letters.
20.63  Personnel, medical, and similar files, disclosure of which 
          constitutes a clearly unwarranted invasion of personal 
          privacy.
20.64  Records or information compiled for law enforcement purposes.

                  Subpart E--Limitations on Exemptions

20.80  Applicability of limitations on exemptions.
20.81  Data and information previously disclosed to the public.
20.82  Discretionary disclosure by the Commissioner.
20.83  Disclosure required by court order.
20.84  Disclosure to consultants, advisory committees, State and local 
          government officials commissioned pursuant to 21 U.S.C. 
          372(a), and other special government employees.
20.85  Disclosure to other Federal government departments and agencies.
20.86  Disclosure in administrative or court proceedings.
20.87  Disclosure to Congress.
20.88  Communications with State and local government officials.
20.89  Communications with foreign government officials.
20.90  Disclosure to contractors.
20.91  Use of data or information for administrative or court 
          enforcement action.

        Subpart F--Availability of Specific Categories of Records

20.100  Applicability; cross-reference to other regulations.
20.101  Administrative enforcement records.
20.102  Court enforcement records.
20.103  Correspondence.
20.104  Summaries of oral discussions.
20.105  Testing and research conducted by or with funds provided by the 
          Food and Drug Administration.
20.106  Studies and reports prepared by or with funds provided by the 
          Food and Drug Administration.
20.107  Food and Drug Administration manuals.
20.108  Agreements between the Food and Drug Administration and other 
          departments, agencies, and organizations.
20.109  Data and information obtained by contract.
20.110  Data and information about Food and Drug Administration 
          employees.
20.111  Data and information submitted voluntarily to the Food and Drug 
          Administration.
20.112  Voluntary drug experience reports submitted by physicians and 
          hospitals.
20.113  Voluntary product defect reports.
20.114  Data and information submitted pursuant to cooperative quality 
          assurance agreements.
20.115  Product codes for manufacturing or sales dates.
20.116  Drug and device listing information.
20.117  New drug information.
20.118  Advisory committee records.
20.119  Lists of names and addresses.

    Authority: 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.

    Source: 42 FR 15616, Mar. 22, 1977, unless otherwise noted.



              Subpart A--Official Testimony and Information



Sec. 20.1  Testimony by Food and Drug Administration employees.

    (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

[[Page 196]]

the event of compliance with such request: Provided, That a written 
request therefor made by a health, food, or drug officer, prosecuting 
attorney, or member of the judiciary of any State, Territory, or 
political subdivision thereof, acting in his official capacity, need not 
be verified by oath. If it is determined by the Commissioner, or any 
other officer or employee of the Food and Drug Administration whom he 
may designate to act on his behalf for the purpose, that such testimony 
will be in the public interest and will promote the objectives of the 
act and the agency, the request may be granted. Where a request for 
testimony is granted, one or more employees of the Food and Drug 
Administration may be designated to appear, in response to a subpoena, 
and testify with respect thereto.



Sec. 20.2  Production of records by Food and Drug Administration employees.

    (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 Sec. 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.



Sec. 20.3  Certification and authentication of Food and Drug Administration records.

    (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 of Information Staff 
(HFI-35), Food and Drug Administration, Room 12A-16, 5600 Fishers Lane, 
Rockville, MD 20857.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981]



                        Subpart B--General Policy



Sec. 20.20  Policy on disclosure of Food and Drug Administration records.

    (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 Sec. 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 Sec. 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.



Sec. 20.21  Uniform access to records.

    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 
Sec. 20.61 for

[[Page 197]]

trade secrets and confidential commercial or financial information, and 
in Sec. 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 Sec. 7.87(c) of 
this chapter for section 305 hearing records, in Sec. 20.80(b) regarding 
certain limitations on exemptions, in Sec. 20.103(b) for certain 
correspondence, and in Sec. 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 
Sec. 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 Sec. 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.

[42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9037, Mar. 3, 1989]



Sec. 20.22  Partial disclosure of records.

    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.



Sec. 20.23  Request for existing records.

    (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 not be applicable to such requests except when the supply of such 
material is exhausted and it is necessary to reproduce individual copies 
upon specific request.
    (c) All existing Food and Drug Administration records are subject to 
routine destruction according to standard record retention schedules.



Sec. 20.24  Preparation of new records.

    (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.



Sec. 20.25  Retroactive application of regulations.

    The provisions of this part apply to all records in Food and Drug 
Administration files.



Sec. 20.26  Indexes of certain records.

    (a) Indexes shall be maintained, and revised at least quarterly, for 
the following Food and Drug Administration records:
    (1) Final orders published in the Federal Register with respect to 
every denial or withdrawal of approval of a new drug application or a 
new animal drug application for which a public hearing has been 
requested.
    (2) Statements of policy and interpretation adopted by the agency 
and still in force and not published in the Federal Register.
    (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

[[Page 198]]

Administration, Room 12A-16, 5600 Fishers Lane, Rockville, MD 20857.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981]



Sec. 20.27  Submission of records marked as confidential.

    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 Sec. 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.



Sec. 20.28  Food and Drug Administration determinations of confidentiality.

    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 Sec. 20.44.



Sec. 20.29  Prohibition on withdrawal of records from Food and Drug Administration files.

    Except pursuant to the procedure established in Sec. 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.



Sec. 20.30  Food and Drug Administration Freedom of Information Staff.

    (a) The Office responsible for agency compliance with the Freedom of 
Information Act and this part is:

Freedom of Information Staff (HFI-35), Food and Drug Administration, 
Room 12A-16, 5600 Fishers Lane, Rockville, MD 20857.

    (b) All requests for agency records shall be sent in writing to this 
office.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981]



Sec. 20.31  Retention schedule of requests for Food and Drug Administration records.

    (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.

[47 FR 24277, June 4, 1982]



Sec. 20.32  Disclosure of Food and Drug Administration employee names.

    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.



                     Subpart C--Procedures and Fees



Sec. 20.40  Filing a request for records.

    (a) All requests for Food and Drug Administration records shall be 
filed in

[[Page 199]]

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 Sec. 20.41(b), and the date(s) any 
records are subsequently furnished.
    (d) A request by an individual, as defined in Sec. 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 Sec. 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.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981]



Sec. 20.41  Time limitations.

    (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 Sec. 20.40(c). An oral request 
for records shall not begin any time requirement. A written request for 
records sent elsewhere within the agency shall not begin any time 
requirement until it is redirected to the Freedom of Information Staff 
and is logged in there in accordance with Sec. 20.40(c).
    (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 Sec. 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

[[Page 200]]

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.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 55 
FR 1405, Jan. 16, 1990; 59 FR 533, Jan. 5, 1994]



Sec. 20.42  Fees to be charged.

    (a) Categories of requests. Paragraphs (a) (1) through (3) of this 
section state, for each category of request, the type of fees that the 
Food and Drug Administration will generally charge. However, for each of 
these categories, the fees may be limited, waived, or reduced for the 
reasons given in paragraphs (b) and (c) of this section and in 
Sec. 20.43 or for other reasons.
    (1) Commercial use request. If the request is for a commercial use, 
the Food and Drug Administration will charge for the costs of search, 
review, and duplication.
    (2) Educational and scientific institutions and news media. If the 
request is from an educational institution or a noncommercial scientific 
institution, operated primarily for scholarly or scientific research, or 
a representative of the news media, and the request is not for a 
commercial use, the Food and Drug Administration will charge only for 
the duplication of documents. Also, the Food and Drug Administration 
will not charge the copying costs for the first 100 pages of 
duplication.
    (3) Other requests. If the request is not the kind described in 
paragraph (a)(1) or (a)(2) of this section, then the Food and Drug 
Administration will charge only for the search and the duplication. 
Also, the Food and Drug Administration will not charge for the first 2 
hours of search time or for the copying costs of the first 100 pages of 
duplication.
    (b) General provisions. (1) The Food and Drug Administration may 
charge search fees even if the records found are exempt from disclosure 
or if no records are found.
    (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. If the operator spends less than 2 hours on 
the search, the total search fees will be reduced by the average hourly 
rate for the operator's time, multiplied by 2.
    (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) Fee schedule. The Food and Drug Administration charges the 
following fees:
    (1) Manual searching for or reviewing of records. When the search or 
review is performed by employees at grade GS-1 through GS-8, an hourly 
rate based on the salary of a GS-5, step 7, employee; when done by a GS-
9 through GS-14, an hourly rate based on the salary of a GS-12, step 4, 
employee; and when done by a GS-15 or above, an hourly rate based on the 
salary of a GS-15, step 7, employee. In each case, the hourly rate will 
be computed by taking the current

[[Page 201]]

hourly rate for the specified grade and step, adding 16 percent of that 
rate to cover benefits, and rounding to the nearest whole dollar. As of 
January 1, 1993, these rates were $12, $24, and $43 respectively. When a 
search involves employees at more than one of these levels, the Food and 
Drug Administration will charge the rate appropriate for each.
    (2) Computer searching and printing. The actual cost of operating 
the computer plus charges for the time spent by the operator, at the 
rates given in paragraph (c)(1) of this section.
    (3) Photocopying standard size pages. $0.10 per page. Freedom of 
Information Officers may charge lower fees for particular documents 
where:
    (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) Photocopying odd-size documents (such as punchcards or 
blueprints), or reproducing other records (such as tapes). The actual 
costs of operating the machine, plus the actual cost of the materials 
used, plus charges for the time spent by the operator, at the rates 
given in paragraph (c)(1) of this section.
    (5) Certifying that records are true copies. This service is not 
required by the Freedom of Information Act. If the Food and Drug 
Administration agrees to provide certification, there is a $10 charge 
per certification.
    (6) Sending records by express mail, certified mail, or other 
special methods. This service is not required by the Freedom of 
Information Act. If the Food and Drug Administration agrees to provide 
this service, actual costs will be charged.
    (7) Performing any other special service in connection with a 
request to which the Food and Drug Administration has agreed. Actual 
costs of operating any machinery, plus actual cost of any materials 
used, plus charges for the time of the Food and Drug Administration's 
employees, at the rates given in paragraph (c)(1) of this section.
    (d) Procedures for assessing and collecting fees--(1) Agreement to 
pay. The Food and Drug Administration generally assumes that a requester 
is willing to pay the fees charged for services associated with the 
request. The requester may specify a limit on the amount to be spent. If 
it appears that the fees will exceed the limit, the Food and Drug 
Administration will consult the requester to determine whether to 
proceed with the search.
    (2) Advance payment. If a requester has failed to pay previous bills 
in a timely fashion, or if the Food and Drug Administration's initial 
review of the request indicates that the charges will exceed $250, the 
requester will be required to pay past due fees and/or the estimated 
fees, or a deposit, before the search for the requested records begins. 
In such cases, the requester will be notified promptly upon receipt of 
the request, and the administrative time limits prescribed in Sec. 20.41 
will begin only after there is an agreement with the requester over 
payment of fees, or a decision that fee waiver or reduction is 
appropriate.
    (3) Billing and payment. Ordinarily, the requester will be required 
to pay all fees before the Food and Drug Administration will furnish the 
records. At its discretion, the Food and Drug Administration may send 
the requester a bill along with or following the records. For example, 
the Food and Drug Administration may do this if the requester has a 
history of prompt payment. The Food and Drug Administration may also, at 
its discretion, aggregate the charges for certain time periods in order 
to avoid sending numerous small bills to frequent requesters, or to 
businesses or agents representing requesters. For example, the Food and 
Drug Administration might send a bill to such a requester once a month. 
Fees should be paid in accordance with the instructions furnished by the 
person who responds to the request.

[59 FR 533, Jan. 5, 1994]



Sec. 20.43  Waiver or reduction of fees.

    (a) Standard. The Associate Commissioner for Public Affairs will 
waive or

[[Page 202]]

reduce the fees that would otherwise be charged if disclosure of the 
information meets both of the following tests:
    (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) Public interest. Disclosure of information satisfies the first 
test only if it furthers the specific public interest of being likely to 
contribute significantly to public understanding of Government 
operations or activities, regardless of any other public interest it may 
further. In analyzing this question, the Food and Drug Administration 
will consider the following factors:
    (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) Not primarily in the requester's commercial interest. If 
disclosure passes the test of furthering the specific public interest 
described in paragraph (b) of this section, the Food and Drug 
Administration will determine whether disclosure also furthers the 
requester's commercial interest and, if so, whether this effect 
outweighs the advancement of that public interest. In applying this 
second test, the Food and Drug Administration will consider the 
following factors:
    (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) Deciding between waiver and reduction. If the disclosure of the 
information requested passes both tests described in paragraphs (b) and 
(c) of this section, the Food and Drug Administration will normally 
waive fees. However, in some cases the Food and Drug Administration may 
decide only to reduce the fees. For example, the Food and Drug 
Administration may do this when disclosure of some but not all of the 
requested records passes the tests.
    (e) Procedure for requesting a waiver or reduction. A requester must 
request a waiver or reduction of fees at the same time as the request 
for records. The requester should explain why a waiver or reduction is 
proper under the factors set forth in paragraphs (a) through (d) of this 
section. Only the Associate Commissioner for Public Affairs may make the 
decision whether to waive or reduce the fees. If the Food and Drug 
Administration does not completely grant the request for a waiver or 
reduction, the denial letter will designate a review official. The 
requester may appeal the denial to that official. The appeal letter 
should address reasons for

[[Page 203]]

the Associate Commissioner's decision that are set forth in the denial 
letter.

[59 FR 534, Jan. 5, 1994]



Sec. 20.44  Presubmission review of request for confidentiality of voluntarily submitted data or information.

    (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 Sec. 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 Sec. 20.111 or by any 
other regulation published or cross-referenced in this part.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 50 
FR 8995, Mar. 6, 1985]



Sec. 20.45  Situations in which confidentiality is uncertain.

    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.



Sec. 20.46  Judicial review of proposed 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 
Sec. 20.45, and rejects the person's request that part or all of the 
records

[[Page 204]]

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.



Sec. 20.47  Denial of a request for records.

    (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.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 55 
FR 1405, Jan. 16, 1990]



Sec. 20.48  Nonspecific and overly burdensome requests.

    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 made after balancing the public benefit to be gained by the 
disclosure against the public loss that will result from diverting 
agency personnel from their other responsibilities. In any situation in 
which it is determined that a request for voluminous records would 
unduly burden and interfere with the operations of the Food and Drug 
Administration, the person making the request will be asked to be more 
specific and to narrow the request, and to agree on an orderly procedure 
for the production of the requested records, in order to satisfy the 
request without disproportionate adverse effects on agency operations.



Sec. 20.49  Referral to primary source of records.

    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.



Sec. 20.50  Availability of records at National Technical Information Service.

    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.

[42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989]



Sec. 20.51  Use of private contractor for copying.

    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

[[Page 205]]

charge the person requesting the records for all of the fees involved 
pursuant to Sec. 20.42.



Sec. 20.52  Request for review without copying.

    (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.



Sec. 20.53  Indexing trade secrets and confidential commercial or financial information.

    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 Sec. 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 make the records available for public disclosure.

[42 FR 15616, Mar. 22, 1977, as amended at 59 FR 535, Jan. 5, 1994]



                          Subpart D--Exemptions



Sec. 20.60  Applicability of exemptions.

    (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 Sec. 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 Sec. 20.103 
is not disclosable to the extent that it contains trade secrets exempt 
from disclosure under Sec. 20.61 and is not subject to discretionary 
release under Sec. 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 Sec. 20.22 shall apply.



Sec. 20.61  Trade secrets and commercial or financial information which is privileged or confidential.

    (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.

[[Page 206]]

    (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 Drug Administration decides to disclose the records, the Food 
and Drug Administration will notify the submitter in writing. This 
notice will briefly explain why the agency did not sustain the 
submitter's objections. The Food and Drug Administration will include 
with the notice a copy of the records about which the submitter 
objected, as the agency proposes to disclose them. The notice will state 
that the Food and Drug Administration intends to disclose the records 5 
working days after the submitter receives the notice unless a U.S. 
District Court orders the agency not to release them.
    (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;

[[Page 207]]

    (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.

[42 FR 15616, Mar. 22, 1977, as amended at 59 FR 535, Jan. 5, 1994]



Sec. 20.62  Inter- or intra-agency memoranda or letters.

    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 Sec. 20.22 is available for public disclosure.



Sec. 20.63  Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy.

    (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 
secrets and confidential commercial or financial information under 
Sec. 20.61.
    (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) Exceptions. (i) Identities may be disclosed if both the 
voluntary reporter and the person identified in an adverse event report 
or that person's legal representative consent in writing to disclosure, 
but neither FDA nor any manufacturer in possession of such reports shall 
be required to seek consent for disclosure from the voluntary reporter 
or the person identified in the adverse event report or that person's 
legal representative; or
    (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

[[Page 208]]

report, excluding the identities of any other individuals, shall be 
disclosed to the person who is the subject of the report upon request.
    (2) Preemption. No State or local governing entity shall establish 
or continue in effect any law, rule, regulation, or other requirement 
that permits or requires disclosure of the identities of the voluntary 
reporter or other person identified in an adverse event report except as 
provided in this section.

[42 FR 15616, Mar. 22, 1977, as amended at 60 FR 16968, Apr. 3, 1995]



Sec. 20.64  Records or information compiled for law enforcement purposes.

    (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 court action, which have not 
been disclosed to any member of the public, including any person who is 
the subject of the investigation.
    (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 Sec. 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 Sec. 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 Sec. 20.82. The Commissioner will 
exercise his discretion to disclose records relating to possible 
criminal prosecution pursuant to Sec. 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

[[Page 209]]

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 Sec. 20.32.

[42 FR 15616, Mar. 22, 1977, as amended at 59 FR 536, Jan. 5, 1994]



                  Subpart E--Limitations on Exemptions



Sec. 20.80  Applicability of limitations on exemptions.

    (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 Sec. 20.64 is disclosable to Congress in 
accordance with the provisions of Sec. 20.87.
    (b) Disclosure of a record to any member of the public pursuant to 
the provisions in Sec. 20.81, data and information previously disclosed 
to the public, in Sec. 20.82, discretionary disclosure by the 
Commissioner, and in Sec. 20.83, disclosure pursuant to a court order, 
shall involve the rule established in Sec. 20.21 that the record shall 
be made available for disclosure to all members of the public who 
request it. Disclosure of a record only to the limited categories of 
persons and under the conditions specified in Sec. 20.84, special 
government employees, in Sec. 20.85, other Federal government 
departments and agencies, in Sec. 20.86, in camera disclosure in 
administrative or court proceedings, in Sec. 20.87(b), Congress, in 
Sec. 20.88, State and local government officials, in Sec. 20.89, foreign 
government officials, and in Sec. 20.90, contractors, which does not 
result in disclosure of the record to any member of the public in an 
authorized manner, shall not invoke the rule established in Sec. 20.21.
    (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 Sec. 21.3(c) of this chapter:
    (1) The availability to an individual, as defined in Sec. 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 Sec. 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.

[[Page 210]]



Sec. 20.81  Data and information previously disclosed to the public.

    (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 Sec. 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.

[42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989; 59 
FR 536, Jan. 5, 1994]



Sec. 20.82  Discretionary disclosure by the Commissioner.

    (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 Sec. 20.61.
    (2) Exempt from public disclosure pursuant to Sec. 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 Sec. 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.



Sec. 20.83  Disclosure required by court order.

    (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

[[Page 211]]

established in Sec. 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 Sec. 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.



Sec. 20.84  Disclosure to consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other special 
          government employees.

    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.



Sec. 20.85  Disclosure to other Federal government departments and agencies.

    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 further disclosed by the other department or agency except with 
the written permission of the Food and Drug Administration.

[47 FR 10804, Mar. 12, 1982, as amended at 59 FR 536, Jan. 5, 1994]



Sec. 20.86  Disclosure in administrative or court proceedings.

    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.

[42 FR 15616, Mar. 22, 1977, as amended at 60 FR 38633, July 27, 1995]



Sec. 20.87  Disclosure to Congress.

    (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.

[42 FR 15616, Mar. 22, 1977, as amended at 59 FR 536, Jan. 5, 1994]



Sec. 20.88  Communications with State and local government officials.

    (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

[[Page 212]]

rules for public disclosure established in Sec. 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 Secs. 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 
Sec. 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 law enforcement or 
regulatory efforts, provided that:
    (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 Sec. 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

[[Page 213]]

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 Sec. 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 International and Constituent 
Relations or their designee makes the determination that the exchange is 
reasonably necessary to improve Federal-State uniformity, cooperative 
regulatory activities, or implementation of Federal-State agreements.
    (2) Any exchange under this section of nonpublic documents does not 
invoke the rule established at Sec. 20.21 that such records shall be 
made available to all members of the public.
    (3) For purposes of this paragraph, the term official of a State 
government agency includes, but is not limited to, an agent contracted 
by the State government, and an employee of an organization of State 
officials having responsibility to facilitate harmonization of State 
standards and requirements in FDA's areas of responsibility. For such 
officials, the statement and commitment required by paragraph (e)(1)(i) 
of this section shall be provided by both the organization and the 
individual.

[42 FR 15616, Mar. 22, 1977, as amended at 60 FR 63381, Dec. 8, 1995; 65 
FR 11887, Mar. 7, 2000]



Sec. 20.89  Communications with foreign government officials.

    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 Secs. 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

[[Page 214]]

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 Sec. 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 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 foreign scientist to 
sign a written commitment to protect the confidentiality of the 
information, and the 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 
Sec. 14.80(b)(1) of this chapter. Subject to all of the foregoing 
conditions, visiting foreign scientists may have access to trade secret 
information, entitled to protection under section 301(j) of the Federal 
Food, Drug, and Cosmetic Act (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 (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 Sec. 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

[[Page 215]]

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 Sec. 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.

[42 FR 15616, Mar. 22, 1977, as amended at 58 FR 61603, Nov. 19, 1993; 
60 FR 63382, Dec. 8, 1995; 65 FR 11888, Mar. 7, 2000]



Sec. 20.90  Disclosure to contractors.

    (a) Data and information otherwise exempt from public disclosure may 
be disclosed to contractors with the Food and Drug Administration and 
their employees for use only in their work for the Food and Drug 
Administration. Contractors and their employees are thereafter subject 
to the same legal restrictions and penalties with respect to the 
disclosure of such data and information as Food and Drug Administration 
employees.
    (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.



Sec. 20.91  Use of data or information for administrative or court enforcement action.

    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.,

[[Page 216]]

the brand name, code designation, and distribution information are 
released when a product is recalled.



        Subpart F--Availability of Specific Categories of Records



Sec. 20.100  Applicability; cross-reference to other regulations.

    (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 Secs. 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 Sec. 7.87(c) of this chapter.
    (2) Flavor ingredient records and notes, in Sec. 101.22(i)(4)(iv) of 
this chapter.
    (3) Environmental assessments; finding of no significant impact, in 
Sec. 25.51 of this chapter, or draft and final environmental impact 
statements, in Sec. 25.52 of this chapter.
    (4) Color additive petitions, in Sec. 71.15 of this chapter.
    (5) Food standard temporary permits, in Sec. 130.17(k) of this 
chapter.
    (6) Information on thermal processing of low-acid foods packaged in 
hermetically sealed containers, in Sec. 108.35(l) of this chapter.
    (7) Food additive petitions, in Secs. 171.1(h) and 571.1(h) of this 
chapter.
    (8) Action levels for natural and unavoidable defects in food for 
human use, in Sec. 110.110(e) of this chapter.
    (9) Drug establishment registrations and drug listings, in 
Sec. 207.37 of this chapter.
    (10) Investigational new animal drug notices, in Sec. 514.12 of this 
chapter.
    (11) New animal drug application files, in Sec. 514.11 of this 
chapter.
    (12) Investigational new animal drug notice and a new animal drug 
application file for an antibiotic drug, in Sec. 514.10 of this chapter.
    (13) Methadone patient records, in Sec. 291.505(g) of this chapter.
    (14) Investigational new drug notice, in Sec. 312.130 of this 
chapter.
    (15) Labeling for and lists of approved new drug applications, in 
Sec. 314.430 of this chapter.
    (16) Master file for a new drug application, in Sec. 312.420 of this 
chapter.
    (17) New drug application file, in Sec. 314.430 of this chapter.
    (18) Data and information submitted for in vitro diagnostic 
products, in Sec. 809.4 of this chapter.
    (19) Data and information submitted for OTC drug review, in 
Sec. 330.10(a)(2) of this chapter.
    (20) Investigational new drug notice for an antibiotic drug, in 
Sec. 431.70 of this chapter.
    (21) Antibiotic drug file, in Sec. 314.430 of this chapter.
    (22) Data and information submitted for biologics review, in 
Sec. 601.25(b)(2) of this chapter.
    (23) Investigational new drug notice for a biological product, in 
Sec. 601.50 of this chapter.
    (24) Applications for biologics licenses for biological products, in 
Sec. 601.51 of this chapter.
    (25) Cosmetic establishment registrations, in Sec. 710.7 of this 
chapter.
    (26) Cosmetic product ingredient and cosmetic raw material 
composition statements, Sec. 720.8 of this chapter.
    (27) Cosmetic product experience reports, in Sec. 730.7 of this 
chapter.

[[Page 217]]

    (28) Device premarket notification submissions, in Sec. 807.95 of 
this chapter.
    (29) Electronic product information, in Secs. 1002.4 and 1002.42 of 
this chapter.
    (30) Investigational device exemptions in Sec. 813.38 of this 
chapter.
    (31) 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 Sec. 860.5 of 
this chapter.
    (32) Data and information submitted in offers to develop a proposed 
performance standard for medical devices, in Sec. 861.26 of this 
chapter.
    (33) Investigational device exemptions in Sec. 812.38 of this 
chapter.
    (34) Health claims petitions, in Sec. 101.70 of this chapter.
    (35) Premarket approval application, in Sec. 814.9 of this chapter.
    (36) Report of certain adverse experiences with a medical device, in 
Sec. 803.9 of this chapter.
    (37) Disqualification determination of an institutional review 
board, in Sec. 56.122 of this chapter.
    (38) Disqualification determination of a nonclinical laboratory, in 
Sec. 58.213 of this chapter.
    (39) Minutes or records regarding a public advisory committee, in 
Sec. 14.65(c) of this chapter.
    (40) Data submitted regarding persons receiving an implanted 
pacemaker device or lead, in Sec. 805.25 of this chapter.
    (41) Humanitarian device exemption application, in Sec. 814.122 of 
this chapter.

[42 FR 15616, Mar. 22, 1977, as amended at 42 FR 19989, Apr. 15, 1977; 
42 FR 42526, Aug. 28, 1977; 42 FR 58889, Nov. 11, 1977; 43 FR 32993, 
July 28, 1978; 51 FR 22475, June 19, 1986; 54 FR 9038, Mar. 3, 1989; 58 
FR 2533, Jan. 6, 1993; 59 FR 536, Jan. 5, 1994; 61 FR 33244, June 26, 
1996; 62 FR 40592, July 29, 1997; 64 FR 56448, Oct. 20, 1999]



Sec. 20.101  Administrative enforcement records.

    (a) All Food and Drug Administration records relating to 
administrative enforcement action disclosed to any member of the public, 
including the person who is the subject of such action, are available 
for public disclosure at the time such disclosure is first made. Such 
records include correspondence with companies following factory 
inspection, recall or detention requests, notice of refusal of admission 
of an imported product, regulatory letters, information letters, Forms 
FD-483 and FD-2275 furnished to companies after factory inspection, and 
similar records.
    (b) To the extent that any of such records fall within the exemption 
for investigatory records established in Sec. 20.64, the Commissioner 
determines that they are subject to discretionary release pursuant to 
Sec. 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 
Sec. 20.64. For example, an establishment inspection report is an 
investigatory record and thus subject to Sec. 20.64 except insofar as 
the Commissioner exercises his discretion to release it pursuant to 
Sec. 20.82.



Sec. 20.102  Court enforcement records.

    (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

[[Page 218]]

interest in the disclosure of such names.



Sec. 20.103  Correspondence.

    (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 Sec. 314.430 of this chapter.

[42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989]



Sec. 20.104  Summaries of oral discussions.

    (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 Sec. 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.



Sec. 20.105  Testing and research conducted by or with funds provided by the Food and Drug Administration.

    (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.



Sec. 20.106  Studies and reports prepared by or with funds provided by the Food and Drug Administration.

    (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

[[Page 219]]

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.

[42 FR FR 15616, Mar. 22, 1977, as amended at 50 FR 8995, Mar. 6, 1985]



Sec. 20.107  Food and Drug Administration manuals.

    (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 Sec. 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 Sec. 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.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 46 
FR 14340, Feb. 27, 1981]



Sec. 20.108  Agreements between the Food and Drug Administration and other departments, agencies, and organizations.

    (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 
Federal Register, except those agreements and memoranda of understanding 
between FDA and State or local government agencies that are cooperative 
work-sharing agreements. In lieu of publication of the complete text of 
these agreements and understandings, FDA will publish in the Federal 
Register periodically, but not less than once every 2 years, a notice 
listing all such agreements and memoranda of understanding currently in 
effect between FDA and State or local government agencies.
    (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 
Federal Register, these agreements will be available for disclosure in 
response to a request from the public after deletion of information that 
would disclose confidential investigative techniques or procedures, or 
information that would disclose guidelines for law enforcement 
investigations if such disclosure could reasonably be expected to risk 
circumvention of the law.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 58 
FR 48794, 48796, Sept. 20, 1993]



Sec. 20.109  Data and information obtained by contract.

    (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 Sec. 20.88(b).

[[Page 220]]

    (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 Sec. 20.61.



Sec. 20.110  Data and information about Food and Drug Administration employees.

    (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.



Sec. 20.111  Data and information submitted voluntarily to the Food and Drug Administration.

    (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 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 Sec. 20.44.
    (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 
Sec. 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 Sec. 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:
    (a) Names and any information that would identify the person using 
the product.
    (b) Names and any information that would identify any third party 
involved with the report, such as a physician or hospital or other 
institution.
    (c) Names and any other information that would identify the 
manufacturer or the brand designation of the product, but not the type 
of product or its ingredients.
    (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:
    (a) Names and any information that would identify the person using 
the product.
    (b) Names and any information that would identify any third party 
involved with the report, such as a physician or hospital or other 
institution.
    (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

[[Page 221]]

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 Sec. 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 Sec. 20.44 that the ingredient or 
ingredients fall within the exemption established in Sec. 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 Sec. 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 
Sec. 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 Sec. 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 Sec. 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.



Sec. 20.112  Voluntary drug experience reports submitted by physicians and hospitals.

    (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 Sec. 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.

[42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989; 62 
FR 52249, Oct. 7, 1997]



Sec. 20.113  Voluntary product defect reports.

    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 
Sec. 20.61 for trade secrets and confidential commercial or financial 
information and in Sec. 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

[[Page 222]]

information falling within the exemption established in Sec. 20.63 for 
personal privacy.



Sec. 20.114  Data and information submitted pursuant to cooperative quality assurance agreements.

    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 Sec. 20.111.



Sec. 20.115  Product codes for manufacturing or sales dates.

    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.



Sec. 20.116  Drug and device listing information.

    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 Secs. 207.37 and 807.37 of this 
chapter.

[42 FR 42526, Aug. 23, 1977]



Sec. 20.117  New drug information.

    (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 Secs. 20.61, 312.130, and 314.430 of 
this chapter.

[42 FR 15616, Mar. 22, 1977, as amended at 45 FR 72608, Oct. 31, 1980; 
46 FR 8457, Jan. 27, 1981; 54 FR 9038, Mar. 3, 1989; 64 FR 399, Jan. 5, 
1999]



Sec. 20.118  Advisory committee records.

    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.



Sec. 20.119  Lists of names and addresses.

    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 
Sec. 20.110.

[[Page 223]]



PART 21--PROTECTION OF PRIVACY--Table of Contents




                      Subpart A--General Provisions

Sec.
21.1  Scope.
21.3  Definitions.
21.10  Policy concerning records about individuals.

   Subpart B--Food and Drug Administration Privacy Act Record Systems

21.20  Procedures for notice of Food and Drug Administration Privacy Act 
          Record Systems.
21.21  Changes in systems and new systems.

       Subpart C--Requirements for Specific Categories of Records

21.30  Records of contractors.
21.31  Records stored by the National Archives and Records 
          Administration.
21.32  Personnel records.
21.33  Medical records.

   Subpart D--Procedures for Notification of and Access to Records in 
                       Privacy Act Record Systems

21.40  Procedures for submitting requests for notification and access.
21.41  Processing of requests.
21.42  Responses to requests.
21.43  Access to requested records.
21.44  Verification of identity.
21.45  Fees.

       Subpart E--Procedures for Requests for Amendment of Records

21.50  Procedures for submitting requests for amendment of records.
21.51  Responses to requests for amendment of records.
21.52  Administrative appeals of refusals to amend records.
21.53  Notation and disclosure of disputed records.
21.54  Amended or disputed records received from other agencies.

                          Subpart F--Exemptions

21.60  Policy.
21.61  Exempt systems.
21.65  Access to records in exempt systems.

   Subpart G--Disclosure of Records in Privacy Act Record Systems to 
                Persons Other Than the Subject Individual

21.70  Disclosure and intra-agency use of records in Privacy Act Record 
          Systems; no accounting required.
21.71  Disclosure of records in Privacy Act Record Systems; accounting 
          required.
21.72  Individual consent to disclosure of records to other persons.
21.73  Accuracy, completeness, timeliness, and relevance of records 
          disclosed from Privacy Act Record Systems.
21.74  Providing notice that a record is disputed.
21.75  Rights of legal guardians.

    Authority: 21 U.S.C. 371; 5 U.S.C. 552, 552a.

    Source: 42 FR 15626, Mar. 22, 1977, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 21.1  Scope.

    (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 Sec. 21.43, (iii) persons provided records pursuant to 
individual consent under Sec. 21.72, or (iv) persons acting on behalf of 
such individuals as legal guardians under Sec. 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.

[[Page 224]]

    (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 Sec. 21.32. Such records are subject to regulations of the Office of 
Personnel Management in 5 CFR parts 293, 294, and 297.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 50 
FR 52278, Dec. 23, 1985]



Sec. 21.3  Definitions.

    As used in this part:
    (a) Individual means a natural living person who is a citizen of the 
United States or an alien lawfully admitted for permanent residence. 
Individual does not include sole proprietorships, partnerships, or 
corporations engaged in the production or distribution of products 
regulated by the Food and Drug Administration or with which the Food and 
Drug Administration has business dealings. Any such business enterprise 
that is identified by the name of one or more individuals is not an 
individual within the meaning of this part. Employees of regulated 
business enterprises are considered individuals. Accordingly, physicians 
and other health professionals who are engaged in business as 
proprietors of establishments regulated by the Food and Drug 
Administration are not considered individuals; however, physicians and 
other health professionals who are engaged in clinical investigations, 
employed by regulated enterprises, or the subjects of records concerning 
their own health, e.g., exposure to excessive radiation, are considered 
individuals. Food and Drug Administration employees, consultants, and 
advisory committee members, State and local officials, and consumers are 
considered individuals.
    (b) Records about individuals means items, collections, or groupings 
of information about individuals contained in Privacy Act Record 
Systems, including, but not limited to education, financial 
transactions, medical history, criminal history, or employment history, 
that contain names or personal identifiers.
    (c) Privacy Act Record System means a system of records about 
individuals under the control of the Food and Drug Administration from 
which information is retrieved by individual names or other personal 
identifiers. The term includes such a system of records whether subject 
to a notice published by the Food and Drug Administration, the 
Department, or another agency. Where records are retrieved only by 
personal identifiers other than individual names, a system of records is 
not a Privacy Act Record System if the Food and Drug Administration 
cannot, by reference to information under its control, or by reference 
to records of contractors that are subject to this part under 
Sec. 21.30, ascertain the identity of individuals who are the subjects 
of the records.
    (d) Personal identifiers includes individual names, identifying 
numbers, symbols, or other identifying designations assigned to 
individuals. Personal identifiers does not include names, numbers, 
symbols, or other identifying designations that identify products, 
establishments, or actions.
    (e) Personnel records means any personal information maintained in a 
Privacy Act Record System that is needed for personnel management 
programs or processes such as staffing, employee development, 
retirement, and grievances and appeals.
    (f) Department means Department of Health and Human Services.



Sec. 21.10  Policy concerning records about individuals.

    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

[[Page 225]]

agency, and administrative and program management needs.



   Subpart B--Food and Drug Administration Privacy Act Record Systems



Sec. 21.20  Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

    (a) The Food and Drug Administration shall issue in the Federal 
Register on or before August 30 of each year a notice concerning each 
Privacy Act Record System as defined in Sec. 21.3(c) that is not covered 
by a notice published by the Department, the Office of Personnel 
Management, or another agency.
    (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 Sec. 21.61, a reference to this exemption.
    (11) The categories of sources of records in the system.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981]



Sec. 21.21  Changes in systems and new systems.

    (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 Sec. 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 Sec. 21.20(b).
    (d) Notices under paragraphs (b) and (c) of this section shall be 
published in the Federal Register for comment at

[[Page 226]]

least 30 days prior to implementation of the proposed changes or 
establishment of new systems. Interested persons shall have the 
opportunity to submit written data, views, or arguments on such proposed 
new uses or systems.



       Subpart C--Requirements for Specific Categories of Records



Sec. 21.30  Records of contractors.

    (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 Sec. 21.71 or for maintenance of a system of records 
without notice as required in Sec. 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 Sec. 21.21, the Food and Drug 
Administration shall comply with the requirements of Sec. 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

[[Page 227]]

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.



Sec. 21.31  Records stored by the National Archives and Records Administration.

    (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.

[42 FR 15626, Mar. 22, 1977, as amended at 50 FR 52278, Dec. 23, 1985]



Sec. 21.32  Personnel records.

    (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 Sec. 21.33 and 
subparts D through F of this part, govern systems of personnel records 
about Food and Drug Administration employees that are subject to notice 
published by the Office of Personnel Management, i.e., systems that:
    (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

[[Page 228]]

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 Secs. 21.40 through 21.43.
    (2) Employee identity may be verified, if necessary, by an FDA ID 
card rather than in accordance with Sec. 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 Sec. 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 Sec. 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 be made to the Commissioner of Food and Drugs, except where 
the Associate Commissioner for Management and Operations or his or her 
designate indicates with his or her refusal that the appeal should be 
made to the Office of Personnel Management.
    (7) Disclosures of records subject to this paragraph are subject to 
subpart G of this part.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 50 
FR 52278, Dec. 23, 1985]



Sec. 21.33  Medical records.

    (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 Sec. 21.41(f).

[[Page 229]]



   Subpart D--Procedures for Notification of and Access to Records in 
                       Privacy Act Record Systems



Sec. 21.40  Procedures for submitting requests for notification and access.

    (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 
verification of the identity of the individual shall be required.
    (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 
Sec. 21.43(a)(1), which may involve a fee under Sec. 21.45, including 
information to verify his identity under Sec. 21.44 or (2) to use the 
procedures for access in person under Sec. 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 Sec. 21.61, as indicated in the notice for the system. An 
individual seeking access to records under Sec. 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 Sec. 21.61, and access to the requested 
records is not granted under Sec. 21.65, the request shall be handled 
under the provisions of part 20 of this chapter (the public information 
regulations).

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8458, Jan. 27, 1981; 50 
FR 52278, Dec. 23, 1985]



Sec. 21.41  Processing of requests.

    (a) An individual or his guardian under Sec. 21.75 shall not be 
required to show any justification or need to obtain notification under 
Sec. 21.42 or access to a record under Sec. 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

[[Page 230]]

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 Sec. 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 
Sec. 21.41 shall apply. In any case, access to available records shall 
be provided as promptly as possible.
    (f) Except as provided in Sec. 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 Sec. 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 for purposes of the 
annual report to Congress under the Privacy Act. These temporary 
administrative management records shall not be considered to be Privacy 
Act Record Systems. All records required to be kept under this paragraph 
shall only include requesting individuals' names or personal identifiers 
for so long as any request for notification, access, or amendment is 
pending. The identity of individuals making request under this subpart 
shall be regarded as confidential and shall not be disclosed under part 
20 of this chapter (the public information regulations) to any other 
person or agency except as is necessary for the processing of requests 
under this subpart.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8458, Jan. 27, 1981]



Sec. 21.42  Responses to requests.

    (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 Sec. 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 
Sec. 21.61, or the system is exempt but access is allowed or required 
under Sec. 21.65, the letter shall inform him that the records exist and 
shall either:
    (i) Enclose a copy of the records under Sec. 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 Sec. 21.44 
and the fees under Sec. 21.45 do not exceed $25, or

[[Page 231]]

    (ii) Inform the individual of the procedures to obtain access to the 
records by mail or in person under Sec. 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 Sec. 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 Sec. 21.61 and access is not allowed or required under Sec. 21.65, 
the letter should inform him that the records are exempted from access 
and contest by Sec. 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 Sec. 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 Sec. 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 the right of the individual to appeal to 
the Commissioner of Food and Drugs.
    (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.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8458, Jan. 27, 1981]



Sec. 21.43  Access to requested records.

    (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 Sec. 20.30 of this chapter, or at any Food and Drug 
Administration field office listed in Sec. 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

[[Page 232]]

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.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8458, Jan. 27, 1981]



Sec. 21.44  Verification of identity.

    (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 Sec. 21.75, a parent of a minor child 
or legal guardian of an incompetent individual may be required to verify 
his relationship to the minor child or the incompetent individual, in 
addition to verifying his own identity, by providing a copy of the 
minor's birth certificate, a court order, or other evidence of 
guardianship.
    (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.



Sec. 21.45  Fees.

    (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 Sec. 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.

[42 FR 15626, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989]

[[Page 233]]



       Subpart E--Procedures for Requests for Amendment of Records



Sec. 21.50  Procedures for submitting requests for amendment of records.

    (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 Sec. 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 amendment. An edited copy of the 
record showing the described amendment may be included. Verification of 
identity should be provided in accordance with Sec. 21.44.
    (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.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8459, Jan. 27, 1981]



Sec. 21.51  Responses to requests for amendment of records.

    (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 Sec. 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

[[Page 234]]

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 Sec. 21.71(d) of a disclosure of 
the record under Sec. 21.71(a), provide a copy of the record as amended, 
to all previous recipients of the record.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8459, Jan. 27, 1981]



Sec. 21.52  Administrative appeals of refusals to amend records.

    (a) If an individual disagrees with a refusal under Sec. 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 person to whom the record is subsequently disclosed together 
with, in the discretion of the Food and Drug Administration, a brief 
statement summarizing its reasons for refusing to amend the record. Any 
individual who includes false information in the statement of 
disagreement filed with the Food and Drug Administration may be subject 
to penalties under 18 U.S.C. 1001, the False Reports to the Government 
Act.
    (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 Sec. 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.

[42 FR 15626, Mar. 22, 1977, as amended at 50 FR 52278, Dec. 23, 1985]



Sec. 21.53  Notation and disclosure of disputed records.

    When an individual has filed a statement of disagreement under 
Sec. 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 Sec. 21.70 or Sec. 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 Sec. 21.50.
    (c) If an accounting was made under Sec. 21.71(d) and (e) of a 
disclosure of the record under Sec. 21.71(a), provide to all previous 
recipients of the record a copy of the statement of disagreement and the 
agency statement, if any.

[[Page 235]]



Sec. 21.54  Amended or disputed records received from other agencies.

    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 Sec. 21.71 (d) and (e) of the 
disclosure of the record under Sec. 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.



                          Subpart F--Exemptions



Sec. 21.60  Policy.

    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.



Sec. 21.61  Exempt systems.

    (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 
Sec. 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 
Sec. 21.65(a)(2), (such records are exempt from 5 U.S.C. 552a(d)(1) 
through (4) and (f)) and Secs. 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 
Sec. 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

[[Page 236]]

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.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8459, Jan. 27, 1981; 50 
FR 52278, Dec. 23, 1985]



Sec. 21.65  Access to records in exempt systems.

    (a) Where a Privacy Act Record System is exempt and the requested 
records are unavailable under Sec. 21.61, an individual may nevertheless 
make a request under Sec. 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 Secs. 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 
confidentiality, which must be an express promise if the information was 
furnished on or after September 27, 1975. Any individual refused access 
to a record that would reveal a confidential source shall be advised in 
a general way that the record contains information that would reveal a 
confidential source.
    (c) The Commissioner shall not make available any record that is 
prohibited from public disclosure under Sec. 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 Sec. 21.61.



   Subpart G--Disclosure of Records in Privacy Act Record Systems to 
                Persons Other Than the Subject Individual



Sec. 21.70  Disclosure and intra-agency use of records in Privacy Act Record Systems; no accounting required.

    (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 Sec. 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 Sec. 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

[[Page 237]]

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 
Sec. 21.30.
    (b) No accounting is required for any disclosure or use under 
paragraph (a) of this section.



Sec. 21.71  Disclosure of records in Privacy Act Record Systems; accounting required.

    (a) Except as provided in Sec. 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. Government, or to the 
Archivist of the United States or his or her designee for evaluation to 
determine whether the record has such value;
    (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.


Under 5 U.S.C. 552a(i)(3), any person who knowingly or willfully 
requests or

[[Page 238]]

obtains any record concerning an individual from an agency under false 
pretenses shall be guilty of a misdemeanor and fined not more than 
$5,000. Such person may also be subject to prosecution under the False 
Reports to the Government Act, 18 U.S.C. 1001.
    (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 Sec. 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 Sec. 21.51(d)(3), Sec. 21.53(c), or Sec. 21.54(c).
    (4) Except when the record is exempt from individual access and 
contest under Sec. 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.

[42 FR 15626, Mar. 22, 1977, as amended at 50 FR 52278, Dec. 23, 1985; 
54 FR 9038, Mar. 3, 1989]



Sec. 21.72  Individual consent to disclosure of records to other persons.

    (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 
Sec. 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 Sec. 21.71(e)(2).



Sec. 21.73  Accuracy, completeness, timeliness, and relevance of records disclosed from Privacy Act Record Systems.

    (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 Sec. 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.

[[Page 239]]



Sec. 21.74  Providing notice that a record is disputed.

    Whenever an individual has filed a statement of disagreement with 
the Food and Drug Administration concerning a refusal to amend a record 
under Sec. 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.



Sec. 21.75  Rights of legal guardians.

    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.



PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS--Table of Contents




                      Subpart A--General Provisions

Sec.
25.1  Purpose.
25.5  Terminology.
25.10  Policies and NEPA planning.

     Subpart B--Agency Actions Requiring Environmental Consideration

25.15  General procedures.
25.16  Public health and safety emergencies.
25.20  Actions requiring preparation of an environmental assessment.
25.21  Extraordinary circumstances.
25.22  Actions requiring the preparation of an environmental impact 
          statement.

                    Subpart C--Categorical Exclusions

25.30  General.
25.31  Human drugs and biologics.
25.32  Foods, food additives, and color additives.
25.33  Animal drugs.
25.34  Devices and electronic products.

            Subpart D--Preparation of Environmental Documents

25.40  Environmental assessments.
25.41  Findings of no significant impact.
25.42  Environmental impact statements.
25.43  Records of decision.
25.44  Lead and cooperating agencies.
25.45  Responsible agency official.

   Subpart E--Public Participation and Notification of Environmental 
                                Documents

25.50  General information.
25.51  Environmental assessments and findings of no significant impact.
25.52  Environmental impact statements.

                      Subpart F--Other Requirements

25.60  Environmental effects abroad of major agency actions.

    Authority: 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.

    Source: 62 FR 40592, July 29, 1997, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 25.1  Purpose.

    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).



Sec. 25.5  Terminology.

    (a) Definitions that apply to the terms used in this part are set 
forth in the CEQ regulations under 40 CFR part

[[Page 240]]

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) Abbreviated application applies to an abbreviated new drug 
application and an abbreviated new animal drug application.
    (2) Active moiety means the molecule or ion, excluding those 
appended portions of the molecule that cause the drug to be an ester, 
salt (including a salt with hydrogen or coordination bonds), or other 
noncovalent derivative (such as a complex chelate or clathrate) of the 
molecule responsible for the physiological or pharmacological action of 
the drug substance.
    (3) Agency means the Food and Drug Administration (FDA).
    (4) Increased use of a drug or biologic product may occur if the 
drug will be administered at higher dosage levels, for longer duration 
or for different indications than were previously in effect, or if the 
drug is a new molecular entity. The term ``use'' also encompasses 
disposal of FDA-regulated articles by consumers.
    (5) Responsible agency official means the agency decisionmaker 
designated in part 5 of this chapter.
    (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.

[62 FR 40592, July 29, 1997, as amended at 64 FR 399, Jan. 5, 1999]



Sec. 25.10  Policies and NEPA planning.

    (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

[[Page 241]]

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.



     Subpart B--Agency Actions Requiring Environmental Consideration



Sec. 25.15  General procedures.

    (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 Sec. 25.20, unless the agency can 
determine that the action qualifies for exclusion under Secs. 25.30, 
25.31, 25.32, 25.33, or 25.34, is sufficient grounds for FDA to refuse 
to file or approve the application or petition. An EA adequate for 
filing is one that addresses the relevant environmental issues. An EA 
adequate for approval is one that contains sufficient information to 
enable the agency to determine whether the proposed action may 
significantly affect the quality of the human environment.
    (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 Sec. 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 
Secs. 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 Secs. 25.30, 25.31, 25.32, 25.33, or 
25.34, or proposing to dispose of an article as provided in 
Sec. 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.



Sec. 25.16  Public health and safety emergencies.

    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

[[Page 242]]

time does not permit prior consultation with CEQ.



Sec. 25.20  Actions requiring preparation of an environmental assessment.

    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 Secs. 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 Secs. 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 
Secs. 25.30(d) or 25.32(h).
    (d) Disposition of FDA laboratory waste materials, unless 
categorically excluded in Sec. 25.30(m).
    (e) Intramural and extramural research supported in whole or in part 
through contracts, other agreements, or grants, unless categorically 
excluded in Sec. 25.30 (e) or (f).
    (f) Establishment by regulation of labeling requirements, a 
standard, or a monograph, unless categorically excluded in 
Secs. 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 Sec. 25.30 (h), (i), or (j), or Sec. 25.32 (e), (g), (n), or 
(p).
    (h) Withdrawal of existing approvals of FDA-approved articles, 
unless categorically excluded in Secs. 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 under Sec. 170.39 of this chapter, and 
allowing notifications submitted under 21 U.S.C. 348(h) to become 
effective, unless categorically excluded in Sec. 25.32(b), (c), (i), 
(j), (k), (l), (o), (q), or (r).
    (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 
Secs. 170.3(l) and 181.5(a) of this chapter, unless categorically 
excluded in Sec. 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 
Sec. 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 Sec. 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 Sec. 25.34.

[62 FR 40592, July 29, 1997, as amended at 65 FR 30355, May 11, 2000]



Sec. 25.21  Extraordinary circumstances.

    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

[[Page 243]]

protection under some other Federal law.



Sec. 25.22  Actions requiring the preparation of an environmental impact statement.

    (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.



                    Subpart C--Categorical Exclusions



Sec. 25.30  General.

    The classes of actions listed in this section and Secs. 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 
substance and, therefore, will not result in the introduction of any 
substance into the environment.
    (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

[[Page 244]]

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.

[62 FR 40592, July 29, 1997, as amended at 65 FR 56479, Sept. 19, 2000]



Sec. 25.31  Human drugs and biologics.

    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.

[62 FR 40592, July 29, 1997, as amended at 63 FR 26697, May 13, 1998; 64 
FR 399, Jan. 5, 1999]



Sec. 25.32  Foods, food additives, and color additives.

    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 
Secs. 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 Sec. 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

[[Page 245]]

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 Sec. 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 Sec. 101.12(h) of this 
chapter, a nutrient content claim petition as described in Sec. 101.69 
of this chapter, a health claim petition as described in Sec. 101.70 of 
this chapter, or a petition pertaining to the label declaration of 
ingredients as described in Sec. 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 Sec. 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.

[62 FR 40592, July 29, 1997, as amended at 65 FR 30355, May 11, 2000]



Sec. 25.33  Animal drugs.

    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 Sec. 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 Sec. 510.455 of this chapter or as a liquid feed 
supplement under Sec. 558.5 of this chapter; or
    (7) Approval of a drug for use in animal feeds if such drug has been 
approved under Sec. 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.

[[Page 246]]

    (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.



Sec. 25.34  Devices and electronic products.

    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.



            Subpart D--Preparation of Environmental Documents



Sec. 25.40  Environmental assessments.

    (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 Secs. 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

[[Page 247]]

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.



Sec. 25.41  Findings of no significant impact.

    (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.



Sec. 25.42  Environmental impact statements.

    (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.



Sec. 25.43  Records of decision.

    (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.



Sec. 25.44  Lead and cooperating agencies.

    For actions requiring the preparation of an EIS, FDA and other 
affected Federal agencies will agree which will be

[[Page 248]]

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.



Sec. 25.45  Responsible agency official.

    (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.



   Subpart E--Public Participation and Notification of Environmental 
                                Documents



Sec. 25.50  General information.

    (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 the act. These 
actions are also protected from disclosure under FDA's regulations 
including part 20, Secs. 312.130(a), 314.430(b), 514.11(b), 514.12(a), 
601.50(a), 601.51(a), 807.95(b), 812.38(a), and 814.9(b) of this 
chapter. Even the existence of applications for human drugs, animal 
drugs, biologic products, and devices is protected from disclosure under 
these regulations. Therefore, unless the existence of applications for 
human drugs, animal drugs, biologic products, or premarket notification 
for devices has been made publicly available, the release of the 
environmental document before approval of human drugs, animal drugs, 
biologic products, and devices is inconsistent with statutory 
requirements imposed on FDA. Appropriate environmental documents, 
comments, and responses will be included in the administrative record to 
the extent allowed by applicable laws.



Sec. 25.51  Environmental assessments and findings of no significant impact.

    (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 Federal Register, the 
notice shall state that no EIS is necessary and that the FONSI and the 
EA are available for public inspection at FDA's Dockets Management 
Branch. If the responsible agency official is unable to complete 
environmental consideration of the proposed action before a notice of 
filing of a food or color additive petition is required to be published 
under the act, and if the subsequent environmental analysis leads to the 
conclusion that no EIS is necessary, the final regulation rather than 
the notice of filing shall state that no EIS is necessary and that the 
FONSI and the EA

[[Page 249]]

are available upon request and filed in FDA's Dockets Management Branch.
    (2) For actions for which notice is not published in the Federal 
Register, the FONSI and the EA shall be made available to the public 
upon request according to the procedures in 40 CFR 1506.6.
    (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.



Sec. 25.52  Environmental impact statements.

    (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 the action, the agency 
will make diligent effort (40 CFR 1506.6) to involve the public in 
preparing and implementing the NEPA procedures for EIS's while following 
its own disclosure requirements including those listed in part 20, 
Secs. 312.130(b), 314.430(d), 514.11(d), 514.12(b), 601.51(d), 
807.95(e), 812.38(b), and 814.9(d) of this chapter.
    (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.



                      Subpart F--Other Requirements



Sec. 25.60  Environmental effects abroad of major agency actions.

    (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;

[[Page 250]]

    (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.



   PART 26--MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY--Table of Contents




Sec.
26.0  General.

     Subpart A--Specific Sector Provisions for Pharmaceutical Good 
                         Manufacturing Practices

26.1  Definitions.
26.2  Purpose.
26.3  Scope.
26.4  Product coverage.
26.5  Length of transition period.
26.6  Equivalence assessment.
26.7  Participation in the equivalence assessment and determination.
26.8  Other transition activities.
26.9  Equivalence determination.
26.10  Regulatory authorities not listed as currently equivalent.
26.11  Start of operational period.
26.12  Nature of recognition of inspection reports.
26.13  Transmission of postapproval inspection reports.
26.14  Transmission of preapproval inspection reports.
26.15  Monitoring continued equivalence.
26.16  Suspension.
26.17  Role and composition of the Joint Sectoral Committee.
26.18  Regulatory collaboration.
26.19   Information relating to quality aspects.
26.20  Alert system.
26.21  Safeguard clause.

Appendix A to Subpart A of Part 26--List of Applicable Laws, 
          Regulations, and Administrative Provisions.
Appendix B to Subpart A of Part 26--List of Authorities.
Appendix C to Subpart A of Part 26--Indicative List of Products Covered 
          by Subpart A.
Appendix D to Subpart A of Part 26--Criteria for Assessing Equivalence 
          for Post- and Preapproval.
Appendix E to Subpart A of Part 26--Elements to be Considered in 
          Developing a Two-Way Alert System.

        Subpart B--Specific Sector Provisions for Medical Devices

26.31  Purpose.
26.32  Scope.
26.33  Product coverage.
26.34  Regulatory authorities.
26.35  Length and purpose of transition period.
26.36  Listing of CAB's.
26.37  Confidence building activities.
26.38  Other transition period activities.
26.39  Equivalence assessment.
26.40  Start of the operational period.
26.41  Exchange and endorsement of quality system evaluation reports.
26.42  Exchange and endorsement of product evaluation reports.
26.43  Transmission of quality system evaluation reports.
26.44  Transmission of product evaluation reports.
26.45  Monitoring continued equivalence.
26.46  Listing of additional CAB's.
26.47  Role and composition of the Joint Sectoral Committee.
26.48  Harmonization.
26.49  Regulatory cooperation.
26.50  Alert system and exchange of postmarket vigilance reports.

Appendix A to Subpart B of Part 26--Relevant Legislation, Regulations, 
          and Procedures.
Appendix B to Subpart B of Part 26--Scope of Product Coverage.
Appendices C-F to Subpart B of Part 26  [Reserved]

                   Subpart C--``Framework'' Provisions

26.60   Definitions.
26.61   Purpose of this part.
26.62   General obligations.
26.63   General coverage of this part.
26.64   Transitional arrangements.
26.65   Designating authorities.
26.66   Designation and listing procedures.
26.67   Suspension of listed conformity assessment bodies.
26.68   Withdrawal of listed conformity assessment bodies.

[[Page 251]]

26.69   Monitoring of conformity assessment bodies.
26.70   Conformity assessment bodies.
26.71   Exchange of information.
26.72  Sectoral contact points.
26.73   Joint Committee.
26.74   Preservation of regulatory authority.
26.75   Suspension of recognition obligations.
26.76   Confidentiality.
26.77   Fees.
26.78   Agreements with other countries.
26.79   Territorial application.
26.80   Entry into force, amendment, and termination.
26.81   Final provisions.

    Authority: 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.

    Source: 63 FR 60141, Nov. 6, 1998, unless otherwise noted.



Sec. 26.0   General.

    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 this 
part, the terms ``party'' or ``parties,'' where relevant to FDA's 
implementation of the MRA, should be considered as referring to FDA 
only. If the parties to the MRA subsequently amend or terminate the MRA, 
FDA will modify this part accordingly, using appropriate administrative 
procedures.



     Subpart A--Specific Sector Provisions for Pharmaceutical Good 
                         Manufacturing Practices



Sec. 26.1   Definitions.

    (a) Enforcement means action taken by an authority to protect the 
public from products of suspect quality, safety, and effectiveness or to 
assure that products are manufactured in compliance with appropriate 
laws, regulations, standards, and commitments made as part of the 
approval to market a product.
    (b) Equivalence of the regulatory systems means that the systems are 
sufficiently comparable to assure that the process of inspection and the 
ensuing inspection reports will provide adequate information to 
determine whether respective statutory and regulatory requirements of 
the authorities have been fulfilled. Equivalence does not require that 
the respective regulatory systems have identical procedures.
    (c) Good Manufacturing Practices (GMP's). [The United States has 
clarified its interpretation that under the MRA, paragraph (c)(1) of 
this section has to be understood as the U.S. definition and paragraph 
(c)(2) as the EC definition.]
    (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/

[[Page 252]]

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) Inspection means an onsite evaluation of a manufacturing 
facility to determine whether such manufacturing facility is operating 
in compliance with GMP's and/or commitments made as part of the approval 
to market a product.
    (e) Inspection report means the written observations and GMP's 
compliance assessment completed by an authority listed in Appendix B of 
this subpart.
    (f) Regulatory system means the body of legal requirements for 
GMP's, inspections, and enforcements that ensure public health 
protection and legal authority to assure adherence to these 
requirements.

[63 FR 60141, Nov. 6, 1998; 64 FR 16348, Apr. 5, 1999]



Sec. 26.2   Purpose.

    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.



Sec. 26.3   Scope.

    (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.



Sec. 26.4   Product coverage.

    (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.



Sec. 26.5   Length of transition period.

    A 3-year transition period will start immediately after the 
effective date described in Sec. 26.80(a).



Sec. 26.6   Equivalence assessment.

    (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

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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 Sec. 26.80(a) will be 
conducted as described in this subpart, as soon as practicable.



Sec. 26.7   Participation in the equivalence assessment and determination.

    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.



Sec. 26.8   Other transition activities.

    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).



Sec. 26.9   Equivalence determination.

    (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 acc