[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2007 Edition]
[From the U.S. Government Printing Office]



[[Page i]]

          

          21


          Parts 1 to 99

                         Revised as of April 1, 2007


          Food and Drugs
          



________________________

          Containing a codification of documents of general 
          applicability and future effect

          As of April 1, 2007
          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 OFFICIAL EDITION NOTICE

          Legal Status and Use of Seals and Logos
          
          
          The seal of the National Archives and Records Administration 
              (NARA) authenticates the Code of Federal Regulations (CFR) as 
              the official codification of Federal regulations established 
              under the Federal Register Act. Under the provisions of 44 
              U.S.C. 1507, the contents of the CFR, a special edition of the 
              Federal Register, shall be judicially noticed. The CFR is 
              prima facie evidence of the original documents published in 
              the Federal Register (44 U.S.C. 1510).

          It is prohibited to use NARA's official seal and the stylized Code 
              of Federal Regulations logo on any republication of this 
              material without the express, written permission of the 
              Archivist of the United States or the Archivist's designee. 
              Any person using NARA's official seals and logos in a manner 
              inconsistent with the provisions of 36 CFR part 1200 is 
              subject to the penalties specified in 18 U.S.C. 506, 701, and 
              1017.

          Use of ISBN Prefix

          This is the Official U.S. Government edition of this publication 
              and is herein identified to certify its authenticity. Use of 
              the 0-16 ISBN prefix is for U.S. Government Printing Office 
              Official Editions only. The Superintendent of Documents of the 
              U.S. Government Printing Office requests that any reprinted 
              edition clearly be labeled as a copy of the authentic work 
              with a new ISBN.

              
              
          U . S . G O V E R N M E N T P R I N T I N G O F F I C E

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

          U.S. Superintendent of Documents  Washington, DC 
              20402-0001

          http://bookstore.gpo.gov

          Phone: toll-free (866) 512-1800; DC area (202) 512-1800

[[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........     461
      Table of CFR Titles and Chapters........................     463
      Alphabetical List of Agencies Appearing in the CFR......     481
      List of CFR Sections Affected...........................     491

[[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, 2007), 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, 2001, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, 1973-1985, or 1986-2000, published in 11 separate 
volumes. For the period beginning January 1, 2001, 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 202-741-6010.

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 textual 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 202-741-6000 
or write to the Director, Office of the Federal Register, National 
Archives and Records Administration, Washington, DC 20408 or e-mail 
fedreg.info@nara.gov.

SALES

    The Government Printing Office (GPO) processes all sales and 
distribution of the CFR. For payment by credit card, call toll-free, 
866-512-1800 or DC area, 202-512-1800, M-F, 8 a.m. to 4 p.m. e.s.t. or 
fax your order to 202-512-2250, 24 hours a day. For payment by check, 
write to the Superintendent of Documents, Attn: New Orders, P.O. Box 
371954, Pittsburgh, PA 15250-7954. For GPO 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.gpoaccess.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.archives.gov/federal-
register. The NARA site also contains links to GPO Access.

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

April 1, 2007.

[[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, 2007.

    For this volume, Kenneth R. Payne and Ruth Green were Chief Editors. 
The Code of Federal Regulations publication program is under the 
direction of Frances D. McDonald, assisted by Ann Worley.


[[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

[[Page 3]]



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




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


  Editorial Note: Nomenclature changes to chapter I appear at 66 FR 
56035, Nov. 6, 2001, 69 FR 13717, Mar. 24, 2004, and 69 FR 18803, Apr. 
9, 2004.

                          SUBCHAPTER A--GENERAL
Part                                                                Page
1               General enforcement regulations.............           5
2               General administrative rulings and decisions          49
3               Product jurisdiction........................          55
5               Organization................................          59
7               Enforcement policy..........................          66
10              Administrative practices and procedures.....          76
11              Electronic records; electronic signatures...         110
12              Formal evidentiary public hearing...........         114
13              Public hearing before a public board of 
                    inquiry.................................         131
14              Public hearing before a public advisory 
                    committee...............................         136
15              Public hearing before the Commissioner......         163
16              Regulatory hearing before the Food and Drug 
                    Administration..........................         165
17              Civil money penalties hearings..............         171
19              Standards of conduct and conflicts of 
                    interest................................         185
20              Public information..........................         187
21              Protection of privacy.......................         218
25              Environmental impact considerations.........         234
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..................         246
50              Protection of human subjects................         278
54              Financial disclosure by clinical 
                    investigators...........................         290
56              Institutional Review Boards.................         294
58              Good laboratory practice for nonclinical 
                    laboratory studies......................         303
60              Patent term restoration.....................         316

[[Page 4]]

70              Color additives.............................         323
71              Color additive petitions....................         331
73              Listing of color additives exempt from 
                    certification...........................         338
74              Listing of color additives subject to 
                    certification...........................         387
80              Color additive certification................         427
81              General specifications and general 
                    restrictions for provisional color 
                    additives for use in foods, drugs, and 
                    cosmetics...............................         433
82              Listing of certified provisionally listed 
                    colors and specifications...............         440
83-98           [Reserved]

99              Dissemination of information on unapproved/
                    new uses for marketed drugs, biologics, 
                    and devices.............................         445

[[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.
1.101 Notification and recordkeeping.

Subparts F-G [Reserved]

                Subpart H_Registration of Food Facilities

                           General Provisions

1.225 Who must register under this subpart?
1.226 Who does not have to register under this subpart?
1.227 What definitions apply to this subpart?

             Procedures for Registration of Food Facilities

1.230 When must you register?
1.231 How and where do you register?
1.232 What information is required in the registration?
1.233 What optional items are included in the registration form?
1.234 How and when do you update your facility's registration 
          information?
1.235 How and when do you cancel your facility's registration 
          information?

                          Additional Provisions

1.240 What other registration requirements apply?
1.241 What are the consequences of failing to register, update, or 
          cancel your registration?
1.242 What does assignment of a registration number mean?
1.243 Is food registration information available to the public?

                 Subpart I_Prior Notice of Imported Food

                           General Provisions

1.276 What definitions apply to this subpart?
1.277 What is the scope of this subpart?

          Requirements To Submit Prior Notice of Imported Food

1.278 Who is authorized to submit prior notice?
1.279 When must prior notice be submitted to FDA?
1.280 How must you submit prior notice?
1.281 What information must be in a prior notice?
1.282 What must you do if information changes after you have received 
          confirmation of a prior notice from FDA?

                              Consequences

1.283 What happens to food that is imported or offered for import 
          without adequate prior notice?
1.284 What are the other consequences of failing to submit adequate 
          prior notice or otherwise failing to comply with this subpart?
1.285 What happens to food that is imported or offered for import from 
          unregistered facilities that are required to register under 21 
          CFR part 1, subpart H?

    Subpart J_Establishment, Maintenance, and Availability of Records

                           General Provisions

1.326 Who is subject to this subpart?
1.327 Who is excluded from all or part of the regulations in this 
          subpart?
1.328 What definitions apply to this subpart?
1.329 Do other statutory provisions and regulations apply?
1.330 Can existing records satisfy the requirements of this subpart?

[[Page 6]]

 Requirements for Nontransporters To Establish and Maintain Records To 
 Identify the Nontransporter and Transporter Immediate Previous Sources 
                                 of Food

1.337 What information must nontransporters establish and maintain to 
          identify the nontransporter and transporter immediate previous 
          sources of food?

 Requirements for Nontransporters To Establish and Maintain Records To 
    Identify the Nontransporter and Transporter Immediate Subsequent 
                           Recipients of Food

1.345 What information must nontransporters establish and maintain to 
          identify the nontransporter and transporter immediate 
          subsequent recipients of food?

     Requirements for Transporters To Establish and Maintain Records

1.352 What information must transporters establish and maintain?

                          General Requirements

1.360 What are the record retention requirements?
1.361 What are the record availability requirements?
1.362 What records are excluded from this subpart?
1.363 What are the consequences of failing to establish or maintain 
          records or make them available to FDA as required by this 
          subpart?

                            Compliance Dates

1.368 What are the compliance dates for this subpart?

     Subpart K_Administrative Detention of Food for Human or Animal 
                               Consumption

                           General Provisions

1.377 What definitions apply to this subpart?
1.378 What criteria does FDA use to order a detention?
1.379 How long may FDA detain an article of food?
1.380 Where and under what conditions must the detained article of food 
          be held?
1.381 May a detained article of food be delivered to another entity or 
          transferred to another location?
1.382 What labeling or marking requirements apply to a detained article 
          of food?
1.383 What expedited procedures apply when FDA initiates a seizure 
          action against a detained perishable food?
1.384 When does a detention order terminate?

                     How does FDA order a detention?

1.391 Who approves a detention order?
1.392 Who receives a copy of the detention order?
1.393 What information must FDA include in the detention order?

            What is the appeal process for a detention order?

1.401 Who is entitled to appeal?
1.402 What are the requirements for submitting an appeal?
1.403 What requirements apply to an informal hearing?
1.404 Who serves as the presiding officer for an appeal, and for an 
          informal hearing?
1.405 When does FDA have to issue a decision on an appeal?
1.406 How will FDA handle classified information in an informal hearing?

    Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21 
U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355, 360b, 
362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262, 264.

    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 Sec. Sec. 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 
Sec. Sec. 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 
Sec. Sec. 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 Sec. Sec. 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

[[Page 7]]

of inches in declaration of net quantity in Sec. Sec. 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 Sec. Sec. 201.62(n), 701.13(p) 
and 801.62(n) of this chapter, to prohibition of certain supplemental 
net quantity statements in Sec. Sec. 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.



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

[[Page 8]]

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 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

[[Page 9]]

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, 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

[[Page 10]]

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.
    (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, 5100 Paint Branch Pkwy., College Park, MD 20740, or at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html.
    (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, 5100 Paint Branch Pkwy., College Park, MD 20740, or at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html.
    (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, 5100 Paint Branch 
Pkwy.,

[[Page 11]]

College Park, MD 20740, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
    (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\-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 Sec. Sec. 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

[[Page 12]]

wrapping is exempt from the requirements of Sec. Sec. 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 
Sec. Sec. 137.211, 137.215, and Sec. Sec. 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 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

[[Page 13]]

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; 66 FR 56035, 
Nov. 6, 2001]

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).



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

[[Page 14]]

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 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.

[[Page 15]]

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



Sec. 1.101  Notification and recordkeeping.

    (a) Scope. This section pertains to notifications and records 
required for human drug, biological product, device, animal drug, food, 
and cosmetic exports under sections 801 or 802 of the Federal Food, 
Drug, and Cosmetic Act (the act) or (21 U.S.C. 381 and 382) or section 
351 of the Public Health Service Act (42 U.S.C. 262).
    (b) Recordkeeping requirements for human drugs, biological products, 
devices, animal drugs, foods, and cosmetics exported under or subject to 
section 801(e)(1) of the act. Persons exporting an article under section 
801(e)(1) of the act or an article otherwise subject to section 
801(e)(1) of the act shall maintain records as enumerated in paragraphs 
(b)(1) through (b)(4) of this section demonstrating that the product 
meets the requirements of section 801(e)(1) of the act. Such records 
shall be maintained for the same period of time as required for records 
subject to good manufacturing practice or quality systems regulations 
applicable to the product, except that records pertaining to the export 
of foods and cosmetics under section 801(e)(1) of the act shall be kept 
for 3 years after the date of exportation. The records shall be made 
available to the Food and Drug Administration (FDA), upon request, 
during an inspection for review and copying by FDA.
    (1) Records demonstrating that the product meets the foreign 
purchaser's specifications: The records must contain sufficient 
information to match the foreign purchaser's specifications to a 
particular export;
    (2) Records demonstrating that the product does not conflict with 
the laws of the importing country: This may consist of either a letter 
from an appropriate foreign government agency, department, or other 
authorized body stating that the product has marketing approval from the 
foreign government or does not conflict with that country's laws, or a 
notarized certification by a responsible company official in the United 
States that the product does not conflict with the laws of the importing 
country and that includes a statement acknowledging that he or she is 
subject to the provisions of 18 U.S.C. 1001;

[[Page 16]]

    (3) Records demonstrating that the product is labeled on the outside 
of the shipping package that it is intended for export: This may consist 
of copies of any labels or labeling statements, such as ``For export 
only,'' that are placed on the shipping packages or, if the exported 
product does not have a shipping package or container, on shipping 
invoices or other documents accompanying the exported product; and
    (4) Records demonstrating that the product is not sold or offered 
for sale in the United States: This may consist of production and 
shipping records for the exported product and promotional materials.
    (c) Additional recordkeeping requirements for partially processed 
biological products exported under section 351(h) of the Public Health 
Service Act. In addition to the requirements in paragraph (b) of this 
section, persons exporting a partially processed biological product 
under section 351(h) of the Public Health Service Act shall maintain, 
for the same period of time as required for records subject to good 
manufacturing practice or quality systems regulations applicable to the 
product, and make available to FDA, upon request, during an inspection 
for review and copying by FDA, the following records:
    (1) Records demonstrating that the product for export is a partially 
processed biological product and not in a form applicable to the 
prevention, treatment, or cure of diseases or injuries of man;
    (2) Records demonstrating that the partially processed biological 
product was manufactured in conformity with current good manufacturing 
practice requirements;
    (3) Records demonstrating the distribution of the exported partially 
processed biological products; and
    (4) Copies of all labeling that accompanies the exported partially 
processed biological product and other records demonstrating that the 
exported partially processed biological product is intended for further 
manufacture into a final dosage form outside the United States; this may 
include a container label with the statement, ``Caution: For Further 
Manufacturing Use Only'' and any package insert.
    (d) Notification requirements for drugs, biological products, and 
devices exported under section 802 of the act. (1) Persons exporting a 
human drug, biological product, or device under section 802 of the act, 
other than a drug, biological product, or device for investigational use 
exported under section 802(c) of the act, or a drug, biological product, 
or device exported in anticipation of marketing authorization under 
section 802(d) of the act, shall provide written notification to FDA. 
The notification shall identify:
    (i) The product's trade name;
    (ii) If the product is a drug or biological product, the product's 
abbreviated or proper name or, if the product is a device, the type of 
device;
    (iii) If the product is a drug or biological product, a description 
of the product's strength and dosage form or, if the product is a 
device, the product's model number; and
    (iv) If the export is to a country not listed in section 802(b)(1) 
of the act, the country that is to receive the exported article. The 
notification may, but is not required to, identify countries listed in 
section 802(b)(1) of the act or state that the export is intended for a 
listed country without identifying the listed country.
    (2) The notification shall be sent to the following addresses:
    (i) For biological products and devices regulated by the Center for 
Biologics Evaluation and Research--Division of Case Management (HFM-
610), Office of Compliance and Biologics Quality, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, suite 200N, Rockville, MD 20852-1448.
    (ii) For human drug products, biological products, and devices 
regulated by the Center for Drug Evaluation and Research--Division of 
New Drugs and Labeling Compliance (HFD-310), Center for Drug Evaluation 
and Research, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857.
    (iii) For devices--Division of Program Operations (HFZ-305), Center 
for Devices and Radiological Health, Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850.
    (e) Recordkeeping requirements for products subject to section 
802(g) of the

[[Page 17]]

act. (1) Any person exporting a product under any provision of section 
802 of the act shall maintain records of all drugs, biological products, 
and devices exported and the countries to which the products were 
exported. In addition to the requirements in paragraph (b) of this 
section, such records include, but are not limited to, the following:
    (i) The product's trade name;
    (ii) If the product is a drug or biological product, the product's 
abbreviated or proper name or, if the product is a device, the type of 
device;
    (iii) If the product is a drug or biological product, a description 
of its strength and dosage form and the product's lot or control number 
or, if the product is a device, the product's model number;
    (iv) The consignee's name and address; and
    (v) The date on which the product was exported and the quantity of 
product exported.
    (2) These records shall be kept at the site from which the products 
were exported or manufactured, and be maintained for the same period of 
time as required for records subject to good manufacturing practice or 
quality systems regulations applicable to the product. The records shall 
be made available to FDA, upon request, during an inspection for review 
and copying by FDA.

[66 FR 65447, Dec. 19, 2001, as amended at 69 FR 48774, Aug. 11, 2004; 
70 FR 14980, Mar. 24, 2005]

Subparts F-G [Reserved]



                Subpart H_Registration of Food Facilities

    Source: 68 FR 58960, Oct. 10, 2003, unless otherwise noted.

                           General Provisions



Sec. 1.225  Who must register under this subpart?

    (a) You must register your facility under this subpart if you are 
the owner, operator, or agent in charge of either a domestic or foreign 
facility, as defined in this subpart, and your facility is engaged in 
the manufacturing/processing, packing, or holding of food for 
consumption in the United States, unless your facility qualifies for one 
of the exemptions in Sec. 1.226.
    (b) If you are an owner, operator, or agent in charge of a domestic 
facility, you must register your facility whether or not the food from 
the facility enters interstate commerce.
    (c) If you are the owner, operator, or agent in charge of a 
facility, you may authorize an individual to register your facility on 
your behalf.



Sec. 1.226  Who does not have to register under this subpart?

    This subpart does not apply to the following facilities:
    (a) A foreign facility, if food from such facility undergoes further 
manufacturing/processing (including packaging) by another facility 
outside the United States. A facility is not exempt under this provision 
if the further manufacturing/processing (including packaging) conducted 
by the subsequent facility consists of adding labeling or any similar 
activity of a de minimis nature;
    (b) Farms;
    (c) Retail food establishments;
    (d) Restaurants;
    (e) Nonprofit food establishments in which food is prepared for, or 
served directly to, the consumer;
    (f) Fishing vessels, including those that not only harvest and 
transport fish but also engage in practices such as heading, 
eviscerating, or freezing intended solely to prepare fish for holding on 
board a harvest vessel. However, those fishing vessels otherwise engaged 
in processing fish are subject to this subpart. For the purposes of this 
section, ``processing'' means handling, storing, preparing, shucking, 
changing into different market forms, manufacturing, preserving, 
packing, labeling, dockside unloading, holding, or heading, 
eviscerating, or freezing other than solely to prepare fish for holding 
on board a harvest vessel;
    (g) Facilities that are regulated exclusively, throughout the entire 
facility, by the U.S. Department of Agriculture under the Federal Meat 
Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection 
Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 
U.S.C. 1031 et seq.);

[[Page 18]]



Sec. 1.227  What definitions apply to this subpart?

    (a) The act means the Federal Food, Drug, and Cosmetic Act.
    (b) In addition, for the purposes of this subpart:
    (1) Calendar day means every day shown on the calendar.
    (2) Facility means any establishment, structure, or structures under 
one ownership at one general physical location, or, in the case of a 
mobile facility, traveling to multiple locations, that manufactures/
processes, packs, or holds food for consumption in the United States. 
Transport vehicles are not facilities if they hold food only in the 
usual course of business as carriers. A facility may consist of one or 
more contiguous structures, and a single building may house more than 
one distinct facility if the facilities are under separate ownership. 
The private residence of an individual is not a facility. Nonbottled 
water drinking water collection and distribution establishments and 
their structures are not facilities.
    (i) Domestic facility means any facility located in any State or 
Territory of the United States, the District of Columbia, or the 
Commonwealth of Puerto Rico that manufactures/processes, packs, or holds 
food for consumption in the United States.
    (ii) Foreign facility means a facility other than a domestic 
facility that manufactures/processes, packs, or holds food for 
consumption in the United States.
    (3) Farm means a facility in one general physical location devoted 
to the growing and harvesting of crops, the raising of animals 
(including seafood), or both. Washing, trimming of outer leaves of, and 
cooling produce are considered part of harvesting. The term ``farm'' 
includes:
    (i) Facilities that pack or hold food, provided that all food used 
in such activities is grown, raised, or consumed on that farm or another 
farm under the same ownership; and
    (ii) Facilities that manufacture/process food, provided that all 
food used in such activities is consumed on that farm or another farm 
under the same ownership.
    (4) Food has the meaning given in section 201(f) of the act (21 
U.S.C. 321(f)),
    (i) Except for purposes of this subpart, it does not include:
    (A) Food contact substances as defined in section 409(h)(6) of the 
act (21 U.S.C. 348(h)(6)), or
    (B) Pesticides as defined in 7 U.S.C. 136(u).
    (ii) Examples of food include fruits, vegetables, fish, dairy 
products, eggs, raw agricultural commodities for use as food or as 
components of food, animal feed (including pet food), food and feed 
ingredients, food and feed additives, dietary supplements and dietary 
ingredients, infant formula, beverages (including alcoholic beverages 
and bottled water), live food animals, bakery goods, snack foods, candy, 
and canned foods.
    (5) Holding means storage of food. Holding facilities include 
warehouses, cold storage facilities, storage silos, grain elevators, and 
liquid storage tanks.
    (6) Manufacturing/processing means making food from one or more 
ingredients, or synthesizing, preparing, treating, modifying or 
manipulating food, including food crops or ingredients. Examples of 
manufacturing/processing activities are cutting, peeling, trimming, 
washing, waxing, eviscerating, rendering, cooking, baking, freezing, 
cooling, pasteurizing, homogenizing, mixing, formulating, bottling, 
milling, grinding, extracting juice, distilling, labeling, or packaging.
    (7) Nonprofit food establishment means a charitable entity that 
prepares or serves food directly to the consumer or otherwise provides 
food or meals for consumption by humans or animals in the United States. 
The term includes central food banks, soup kitchens, and nonprofit food 
delivery services. To be considered a nonprofit food establishment, the 
establishment must meet the terms of section 501(c)(3) of the U.S. 
Internal Revenue Code (26 U.S.C. 501(c)(3)).
    (8) Packaging (when used as a verb) means placing food into a 
container that directly contacts the food and that the consumer 
receives.

[[Page 19]]

    (9) Packing means placing food into a container other than packaging 
the food.
    (10) Restaurant means a facility that prepares and sells food 
directly to consumers for immediate consumption. ``Restaurant'' does not 
include facilities that provide food to interstate conveyances, central 
kitchens, and other similar facilities that do not prepare and serve 
food directly to consumers.
    (i) Entities in which food is provided to humans, such as 
cafeterias, lunchrooms, cafes, bistros, fast food establishments, food 
stands, saloons, taverns, bars, lounges, catering facilities, hospital 
kitchens, day care kitchens, and nursing home kitchens are restaurants; 
and
    (ii) Pet shelters, kennels, and veterinary facilities in which food 
is provided to animals are restaurants.
    (11) Retail food establishment means an establishment that sells 
food products directly to consumers as its primary function. A retail 
food establishment may manufacture/process, pack, or hold food if the 
establishment's primary function is to sell from that establishment 
food, including food that it manufactures/processes, packs, or holds, 
directly to consumers. A retail food establishment's primary function is 
to sell food directly to consumers if the annual monetary value of sales 
of food products directly to consumers exceeds the annual monetary value 
of sales of food products to all other buyers. The term ``consumers'' 
does not include businesses. A ``retail food establishment'' includes 
grocery stores, convenience stores, and vending machine locations.
    (12) Trade name means the name or names under which the facility 
conducts business, or additional names by which the facility is known. A 
trade name is associated with a facility, and a brand name is associated 
with a product.
    (13) U.S. agent means a person (as defined in section 201(e) of the 
act (21 U.S.C. 321(e))) residing or maintaining a place of business in 
the United States whom a foreign facility designates as its agent for 
purposes of this subpart. A U.S. agent cannot be in the form of a 
mailbox, answering machine or service, or other place where an 
individual acting as the foreign facility's agent is not physically 
present.
    (i) The U.S. agent acts as a communications link between FDA and the 
foreign facility for both emergency and routine communications. The U.S. 
agent will be the person FDA contacts when an emergency occurs, unless 
the registration specifies under Sec. 1.233(e) another emergency 
contact.
    (ii) FDA will treat representations by the U.S. agent as those of 
the foreign facility, and will consider information or documents 
provided to the U.S. agent the equivalent of providing the information 
or documents to the foreign facility.
    (iii) Having a single U.S. agent for the purposes of this subpart 
does not preclude facilities from having multiple agents (such as 
foreign suppliers) for other business purposes. A firm's commercial 
business in the United States need not be conducted through the U.S. 
agent designated for purposes of this subpart.
    (14) You or registrant means the owner, operator, or agent in charge 
of a facility that manufactures/processes, packs, or holds food for 
consumption in the United States.

             Procedures for Registration of Food Facilities



Sec. 1.230  When must you register?

    The owner, operator, or agent in charge of a facility that 
manufactures/processes, packs or holds food for consumption in the 
United States must register the facility no later than December 12, 
2003. The owner, operator, or agent in charge of a facility that begins 
to manufacture/process, pack, or hold food for consumption in the United 
States on or after December 12, 2003, must register before the facility 
begins such activities. An owner, operator, or agent in charge of a 
facility may authorize an individual to register the facility on its 
behalf.



Sec. 1.231  How and where do you register?

    (a) Electronic registration. (1) To register electronically, you 
must register at http://www.fda.gov/furls, which is available for 
registration 24 hours a

[[Page 20]]

day, 7 days a week. This website is available from wherever the Internet 
is accessible, including libraries, copy centers, schools, and Internet 
cafes. An individual authorized by the owner, operator, or agent in 
charge of a facility may also register a facility electronically.
    (2) FDA strongly encourages electronic registration for the benefit 
of both FDA and the registrant.
    (3) Once you complete your electronic registration, FDA will 
automatically provide you with an electronic confirmation of 
registration and a permanent registration number.
    (4) You will be considered registered once FDA electronically 
transmits your confirmation and registration number.
    (b) Registration by mail or fax. If, for example, you do not have 
reasonable access to the Internet through any of the methods described 
in paragraph (a) of this section, you may register by mail or fax.
    (1) You must register using Form 3537. You may obtain a copy of this 
form by writing to the U.S. Food and Drug Administration (HFS-681), 5600 
Fishers Lane, Rockville, MD 20857 or by requesting a copy of this form 
by phone at 1-800-216-7331 or 301-575-0156.
    (2) When you receive the form, you must fill it out completely and 
legibly and either mail it to the address in paragraph (b)(1) of this 
section or fax it to 301-210-0247.
    (3) If any required information on the form is incomplete or 
illegible when FDA receives it, FDA will return the form to you for 
revision, provided that your mailing address or fax number is legible 
and valid. When returning a registration form for revision, FDA will use 
the means by which the form was received by the agency (i.e., by mail or 
fax).
    (4) FDA will enter complete and legible mailed and faxed 
registration submissions into its registration system, along with CD-ROM 
submissions, as soon as practicable, in the order FDA receives them.
    (5) FDA will then mail to the address or fax to the fax number on 
the registration form a copy of the registration as entered, 
confirmation of registration, and your registration number. When 
responding to a registration submission, FDA will use the means by which 
the registration was received by the agency (i.e., by mail or fax).
    (6) If any information you previously submitted was incorrect at the 
time of submission, you must immediately update your facility's 
registration as specified in Sec. 1.234.
    (7) Your facility is considered registered once FDA enters your 
facility's registration data into the registration system and the system 
generates a registration number.
    (c) Registration by CD-ROM for multiple submissions. If, for 
example, you do not have reasonable access to the Internet through any 
of the methods provided under paragraph (a) of this section, you may 
register by CD-ROM.
    (1) Registrants submitting their registrations in CD-ROM format must 
use ISO 9660 (CD-R or CD-RW) data format.
    (2) These files must be submitted on a portable document format 
(PDF) rendition of the registration form (Form 3537) and be accompanied 
by one signed copy of the certification statement that appears on the 
registration form (Form 3537).
    (3) Each submission on the CD-ROM must contain the same preferred 
mailing address in the appropriate block on Form 3537.
    (4) A CD-ROM may contain registrations for as many facilities as 
needed up to the CD-ROM's capacity.
    (5) The registration on the CD-ROM for each separate facility must 
have a unique file name up to 32 characters long, the first part of 
which may be used to identify the parent company.
    (6) You must mail the CD-ROM to the U.S. Food and Drug 
Administration (HFS-681), 5600 Fishers Lane, Rockville, MD 20857.
    (7) If FDA receives a CD-ROM that does not comply with these 
specifications, it will return the CD-ROM to the submitter unprocessed.
    (8) FDA will enter CD-ROM submissions that comply with these 
specifications into its registration system, along with the complete and 
legible mailed and faxed submissions, as soon as practicable, in the 
order FDA receives them.
    (9) For each facility on the CD-ROM, FDA will mail to the preferred 
mailing

[[Page 21]]

address a copy of the registration(s) as entered, confirmation of 
registration, and each facility's assigned registration number.
    (10) If any information you previously submitted was incorrect at 
the time of submission, you must immediately update your facility's 
registration as specified in Sec. 1.234.
    (11) Your facility is considered registered once FDA enters your 
facility's registration data into the registration system and the system 
generates a registration number.
    (d) Fees. No registration fee is required.
    (e) Language. You must submit all registration information in the 
English language except an individual's name, the name of a company, the 
name of a street, and a trade name may be submitted in a foreign 
language. All information, including these items, must be submitted 
using the Latin (Roman) alphabet.

[68 FR 58960, Oct. 10, 2003, as amended at 69 FR 29428, May 24, 2004]



Sec. 1.232  What information is required in the registration?

    Each registrant must submit the following information through one of 
the methods described in Sec. 1.231:
    (a) The name, full address, and phone number of the facility;
    (b) The name, address, and phone number of the parent company, if 
the facility is a subsidiary of the parent company;
    (c) For domestic and foreign facilities, the names, addresses, and 
phone numbers of the owner, operator, and agent in charge.
    (d) For a foreign facility, the name, address, phone number, and, if 
no emergency contact is designated under Sec. 1.233(e), the emergency 
contact phone number of the foreign facility's U.S. agent;
    (e) For a domestic facility, an emergency contact phone number;
    (f) All trade names the facility uses;
    (g) Applicable food product categories as identified in Sec. 170.3 
of this chapter, unless you check either ``most/all human food product 
categories,'' according to Sec. 1.233(j), or ``none of the above 
mandatory categories'' because your facility manufactures/processes, 
packs, or holds a food that is not identified in Sec. 170.3 of this 
chapter;
    (h) The name, address, and phone number for the owner, operator, or 
agent in charge;
    (i) A statement in which the owner, operator, or agent in charge 
certifies that the information submitted is true and accurate. If the 
individual submitting the form is not the owner, operator, or agent in 
charge of the facility, the registration must also include a statement 
in which the individual certifies that the information submitted is true 
and accurate, certifies that he/she is authorized to submit the 
registration, and identifies by name, address, and telephone number, the 
individual who authorized submission of the registration. Each 
registration must include the name of the individual registering the 
facility submitting the registration, and the individual's signature 
(for the paper and CD-ROM options).

[68 FR 58960, Oct. 10, 2003, as amended at 69 FR 29428, May 24, 2004]



Sec. 1.233  What optional items are included in the registration form?

    FDA encourages, but does not require, you to submit the following 
items in your facility's registration. These data will enable FDA to 
communicate more quickly with facilities that may be the target of a 
terrorist threat or attack, or otherwise affected by an outbreak of 
foodborne illness. This information includes:
    (a) Fax number and e-mail address of the facility;
    (b) Preferred mailing address, if different from that of the 
facility;
    (c) Fax number and e-mail address of the parent company, if the 
facility is a subsidiary of the parent company;
    (d) For a domestic facility, emergency contact name, title, and e-
mail address;
    (e) For a foreign facility, an emergency contact name, title, phone 
number and e-mail address. FDA will consider the facility's U.S. agent 
the facility's emergency contact unless the facility chooses to 
designate another person to serve as an emergency contact under this 
section;

[[Page 22]]

    (f) For a foreign facility, title, fax number, and e-mail address of 
the U.S. agent;
    (g) Type of activity conducted at the facility (e.g., manufacturing/
processing or holding);
    (h) Food categories not identified in Sec. 170.3 of this chapter, 
which are provided in Form 3537 sections 11a (e.g., infant formula, 
animal byproducts and extracts) and 11b (e.g., grain products, amino 
acids);
    (i) Type of storage, if the facility is primarily a holding 
facility;
    (j) A food product category of ``most/all human food product 
categories,'' if the facility manufactures/processes, packs, or holds 
foods in most or all of the categories identified in Sec. 170.3 of this 
chapter;
    (k) Approximate dates of operation, if the facility's business is 
seasonal;
    (l) The fax number and e-mail address of the owner, operator, or 
agent in charge; and
    (m) The fax number and e-mail address of the individual who 
authorized submission of the registration.



Sec. 1.234  How and when do you update your facility's registration 

information?

    (a) Update requirements. The owner, operator, or agent in charge 
must submit an update to a facility's registration within 60 calendar 
days of any change to any of the information previously submitted under 
Sec. 1.232 (e.g., change of operator, agent in charge, or U.S. agent), 
except a change of the owner. The owner, operator, or agent in charge 
may authorize an individual to update a facility's registration.
    (b) Cancellation due to ownership changes. If the reason for the 
update is that the facility has a new owner, the former owner must 
cancel the facility's registration as specified in Sec. 1.235 within 60 
calendar days of the change and the new owner must re-register the 
facility as specified in Sec. 1.231. The former owner may authorize an 
individual to cancel a facility's registration.
    (c) Electronic update. (1) To update your registration 
electronically, you must update at http://www.fda.gov/furls.
    (2) Once you complete your electronic update, FDA will automatically 
provide you with an electronic confirmation of your update.
    (3) Your registration will be considered updated once FDA transmits 
your update confirmation, unless notified otherwise.
    (d) Update by mail or fax. If, for example, you do not have 
reasonable access to the Internet through any of the methods described 
in Sec. 1.231(a)), you may update your facility's registration by mail 
or by fax:
    (1) You must update your registration using Form 3537. You may 
obtain a copy of this form by writing to the U.S. Food and Drug 
Administration (HFS-681), 5600 Fishers Lane, Rockville, MD 20857 or by 
requesting the form by phone at 1-877-FDA-3882 (1-877-332-3882).
    (2) When you receive the form, you must legibly fill out the 
sections of the form reflecting your updated information and either mail 
it to the address in paragraph (d)(1) of this section or fax it to 301-
210-0247.
    (3) If the information on the form is incomplete or illegible when 
FDA receives it, FDA will return the form to you for revision, provided 
that your mailing address or fax number is legible and valid. When 
returning a registration form for revision, FDA will use the means by 
which the registration was received by the agency (i.e., by mail or 
fax).
    (4) FDA will enter complete and legible updates into its 
registration system, along with CD-ROM submissions, as soon as 
practicable, in the order FDA receives them.
    (5) FDA will then mail to the address or fax to the fax number on 
the registration form a copy of the update as entered and confirmation 
of the update. When responding to an update submission, FDA will use the 
means by which the form was received by the agency (i.e., by mail or 
fax).
    (6) If any update information you previously submitted was incorrect 
at the time of submission, you must immediately resubmit your update.
    (7) Your registration will be considered updated once FDA enters 
your facility's update data into the registration system and the system 
generates an update confirmation.

[[Page 23]]

    (e) Update by CD-ROM for multiple submissions. If, for example, you 
do not have reasonable access to the Internet through any of the methods 
provided under Sec. 1.231(a), you may update your facilities' 
registrations by CD-ROM.
    (1) Registrants submitting their updates in CD-ROM format must use 
ISO 9660 (CD-R or CD-RW) data format.
    (2) Update files must be submitted on a PDF rendition of FDA's 
registration form (Form 3537) and be accompanied by one signed copy of 
the certification statement on the registration form (Form 3537).
    (3) Each submission on the CD-ROM must contain the same preferred 
mailing address in the appropriate block on Form 3537.
    (4) The CD-ROM may contain updates for as many facilities as needed 
up to the CD-ROM's capacity.
    (5) The update for each facility on the CD-ROM must have a unique 
file name up to 32 characters long, the first part of which may be used 
to identify the parent company.
    (6) You must mail the CD-ROM to U.S. Food and Drug Administration 
(HFS-681), 5600 Fishers Lane, Rockville, MD 20857.
    (7) If FDA receives an update CD-ROM that does not comply with these 
specifications, it will return the CD-ROM to the registrant unprocessed.
    (8) FDA will enter CD-ROM update submissions into its registration 
system, along with the complete and legible mailed and faxed update 
submissions, as soon as practicable, in the order FDA receives them.
    (9) For each facility on the CD-ROM, FDA will mail to the preferred 
mailing address a copy of the update(s) as entered and confirmation of 
the update.
    (10) If any update information you previously submitted was 
incorrect at the time of submission, you must immediately resubmit your 
update.
    (11) Your registration will be considered updated once FDA enters 
your facility's update data into the registration system and the system 
generates an update confirmation.



Sec. 1.235  How and when do you cancel your facility's registration 

information?

    (a) Notification of registration cancellation. A facility canceling 
its registration must do so within 60 calendar days of the reason for 
cancellation (e.g., facility ceases operations, ceases providing food 
for consumption in the United States, or the facility is sold to a new 
owner).
    (b) Cancellation requirements. The cancellation of a facility's 
registration must include the following information:
    (1) The facility's registration number;
    (2) Whether the facility is domestic or foreign;
    (3) The facility name and address;
    (4) The name, address, and e-mail address (if available) of the 
individual submitting the cancellation; and
    (5) A statement certifying that the information submitted is true 
and accurate, and that the person submitting the cancellation is 
authorized by the facility to cancel its registration.
    (c) Electronic cancellation. (1) To cancel your registration 
electronically, you must cancel at http://www.fda.gov/furls.
    (2) Once you complete your electronic cancellation, FDA will 
automatically provide you with an electronic confirmation of your 
cancellation.
    (3) Your registration will be considered cancelled once FDA 
transmits your cancellation confirmation.
    (d) Cancellation by mail or fax. If, for example, you do not have 
reasonable access to the Internet through any of the methods described 
in Sec. 1.231(a), you may cancel your facility's registration by mail 
or fax.
    (1) You must cancel your registration using Form 3537a. You may 
obtain a copy of this form by writing to the U.S. Food and Drug 
Administration (HFS-681), 5600 Fishers Lane, Rockville, MD 20857, or by 
requesting the form by phone at 1-877-FDA-3882 (1-877-332-3882).
    (2) When you receive the form, you must completely and legibly fill 
out the form and either mail it to the address in paragraph (d)(1) of 
this section or fax it to 301-210-0247.

[[Page 24]]

    (3) If the information on the form is incomplete or illegible when 
FDA receives it, FDA will return the form to you for revision, provided 
that your mailing address or fax number is legible and valid. When 
returning a cancellation form for revision, FDA will use the means by 
which the cancellation was received by the agency (i.e., by mail or 
fax).
    (4) FDA will enter complete and legible mailed and faxed 
cancellations into its registration system, along with CD-ROM 
cancellations, as soon as practicable, in the order FDA receives them.
    (5) FDA will then mail to the address or fax to the fax number on 
the cancellation form a copy of the cancellation as entered and 
confirmation of the cancellation. When responding to a cancellation, FDA 
will use the means by which the form was received by the agency (i.e., 
by mail or fax).
    (6) If any information you previously submitted was incorrect at the 
time of submission, you must immediately resubmit your cancellation.
    (7) Your registration will be considered cancelled once FDA enters 
your facility's cancellation data into the registration system and the 
system generates a confirmation.
    (e) Cancellation by CD-ROM for multiple submissions. If, for 
example, you do not have reasonable access to the Internet through any 
of the methods described in Sec. 1.231(a), you may cancel your 
facilities' registrations using a CD-ROM.
    (1) Registrants submitting their cancellations in CD-ROM format must 
use ISO 9660 (CD-R or CD-RW) data format.
    (2) Cancellation files must be submitted on a PDF rendition of the 
cancellation form (Form 3537a) and be accompanied by one signed copy of 
the certification statement on the cancellation form.
    (3) Each submission on the CD-ROM must contain the same preferred 
mailing address in the appropriate block on Form 3537.
    (4) The CD-ROM may contain cancellations for as many facilities as 
needed up to the CD-ROM's capacity.
    (5) The cancellation for each facility on the CD-ROM must have a 
unique file name up to 32 characters long, the first part of which may 
be used to identify the parent company.
    (6) You must mail the CD-ROM to U.S. Food and Drug Administration 
(HFS-681), 5600 Fishers Lane, Rockville, MD 20857.
    (7) If FDA receives a CD-ROM that does not comply with these 
specifications, it will return the CD-ROM to the registrant unprocessed.
    (8) FDA will enter CD-ROM submissions that meet the specifications 
into its registration system, along with complete and legible mailed and 
faxed submissions, as soon as practicable, in the order FDA receives 
them.
    (9) For each facility on the CD-ROM, FDA will mail to the preferred 
mailing address a copy of the cancellation(s) as entered and 
confirmation of the cancellation.
    (10) If any information you previously submitted was incorrect at 
the time of submission, you must immediately resubmit your cancellation.
    (11) Your registration will be considered cancelled once FDA enters 
your facility's cancellation data into the registration system and the 
system generates a confirmation.

                          Additional Provisions



Sec. 1.240  What other registration requirements apply?

    In addition to the requirements of this subpart, you must comply 
with the registration regulations found in part 108 of this chapter, 
related to emergency permit control, and any other Federal, State, or 
local registration requirements that apply to your facility.



Sec. 1.241  What are the consequences of failing to register, update, or 

cancel your registration?

    (a) Section 301 of the act (21 U.S.C. 331) prohibits the doing of 
certain acts or causing such acts to be done. Under section 302 of the 
act (21 U.S.C. 332), the United States can bring a civil action in 
Federal court to enjoin a person who commits a prohibited act. Under 
section 303 of the act (21 U.S.C. 333), the United States can bring a 
criminal action in Federal court to prosecute a person who is 
responsible for the commission of a prohibited act. Under section 306 of 
the act (21 U.S.C. 335a), FDA can seek debarment of any person who

[[Page 25]]

has been convicted of a felony relating to importation of food into the 
United States. Failure of an owner, operator, or agent in charge of a 
domestic or foreign facility to register its facility, to update 
required elements of it's facility's registration, or to cancel its 
registration in accordance with the requirements of this subpart is a 
prohibited act under section 301(dd) of the act.
    (b) FDA will cancel a registration if the agency independently 
verifies that the facility is no longer in business or has changed 
owners, and the owner, operator, or agent in charge of the facility 
fails to cancel the registration, or if FDA determines that the 
registration is for a facility that does not exist. If FDA cancels a 
facility's registration, FDA will mail a confirmation of the 
cancellation to the facility at the address provided in the facility's 
registration.
    (c) If an article of food is imported or offered for import into the 
United States and a foreign facility that manufactured/processed, 
packed, or held that article of food has not registered in accordance 
with this subpart, the disposition of the article of food shall be 
governed by the procedures set out in subpart I of this part.



Sec. 1.242  What does assignment of a registration number mean?

    Assignment of a registration number to a facility means that the 
facility is registered with FDA. Assignment of a registration number 
does not in any way convey FDA's approval or endorsement of a facility 
or its products.



Sec. 1.243  Is food registration information available to the public?

    (a) The list of registered facilities and registration documents 
submitted under this subpart are not subject to disclosure under 5 
U.S.C. 552 (the Freedom of Information Act). In addition, any 
information derived from such list or registration documents that would 
disclose the identity or location of a specific registered person, is 
not subject to disclosure under 5 U.S.C. 552 (the Freedom of Information 
Act).
    (b) Paragraph (a) of this section does not apply to any information 
obtained by other means or that has previously been disclosed to the 
public as defined in Sec. 20.81 of this chapter.



                 Subpart I_Prior Notice of Imported Food

    Source: 68 FR 59070, Oct. 10, 2003, unless otherwise noted.

                           General Provisions



Sec. 1.276  What definitions apply to this subpart?

    (a) The act means the Federal Food, Drug, and Cosmetic Act.
    (b) The definitions of terms in section 201 of the act (21 U.S.C. 
321) apply when the terms are used in this subpart, unless defined 
below.
    (1) Calendar day means every day shown on the calendar.
    (2) Country from which the article originates means FDA Country of 
Production.
    (3) Country from which the article is shipped means the country in 
which the article of food is loaded onto the conveyance that brings it 
to the United States or, in the case of food sent by international mail, 
the country from which the article is mail.
    (4) FDA Country of Production means:
    (i) For an article of food that is in its natural state, the country 
where the article of food was grown, including harvested or collected 
and readied for shipment to the United States. If an article of food is 
wild fish, including seafood that was caught or harvested outside the 
waters of the United States by a vessel that is not registered in the 
United States, the FDA Country of Production is the country in which the 
vessel is registered. If an article of food that is in its natural state 
was grown, including harvested or collected and readied for shipment, in 
a Territory, the FDA Country of Production is the United States.
    (ii) For an article of food that is no longer in its natural state, 
the country where the article was made; except that, if an article of 
food is made from wild fish, including seafood, aboard a vessel, the FDA 
Country of Production is the country in which the vessel is registered. 
If an article of food that is no longer in its natural state was made

[[Page 26]]

in a Territory, the FDA Country of Production is the United States.
    (5) Food has the meaning given in section 201(f) of the act,
    (i) Except for purposes of this subpart, it does not include:
    (A) Food contact substances as defined in section 409(h)(6) of the 
act (21 U.S.C. 348(h)(6)); or
    (B) Pesticides as defined in 7 U.S.C. 136(u).
    (ii) Examples of food include fruits, vegetables, fish, including 
seafood, dairy products, eggs, raw agricultural commodities for use as 
food or as components of food, animal feed (including pet food), food 
and feed ingredients, food and feed additives, dietary supplements and 
dietary ingredients, infant formula, beverages (including alcoholic 
beverages and bottled water), live food animals, bakery goods, snack 
foods, candy, and canned foods.
    (6) Grower means a person who engages in growing and harvesting or 
collecting crops (including botanicals), raising animals (including 
fish, which includes seafood), or both.
    (7) International mail means foreign national mail services. 
International mail does not include express carriers, express 
consignment operators, or other private delivery services.
    (8) No longer in its natural state means that an article of food has 
been made from one or more ingredients or synthesized, prepared, 
treated, modified, or manipulated. Examples of activities that render 
food no longer in its natural state are cutting, peeling, trimming, 
washing, waxing, eviscerating, rendering, cooking, baking, freezing, 
cooling, pasteurizing, homogenizing, mixing, formulating, bottling, 
milling, grinding, extracting juice, distilling, labeling, or packaging. 
Crops that have been cleaned (e.g., dusted, washed), trimmed, or cooled 
attendant to harvest or collection or treated against pests, waxed, or 
polished are still in their natural state for purposes of this subpart. 
Whole fish headed, eviscerated, or frozen attendant to harvest are still 
in their natural state for purposes of this subpart.
    (9) Port of arrival means the water, air, or land port at which the 
article of food is imported or offered for import into the United 
States, i.e., the port where the article of food first arrives in the 
United States. This port may be different than the port where 
consumption or warehouse entry or foreign trade zone admission 
documentation is presented to the United States Bureau of Customs and 
Border Protection (CBP).
    (10) Port of entry, in sections 801(m) and 801(l) of the act, means 
the port of entry as defined in 19 CFR 101.1.
    (11) Registration number refers to the registration number assigned 
by FDA under section 415 of the act (21 U.S.C. 350d) and 21 CFR part 1, 
subpart H.
    (12) Shipper means the owner or exporter of the article of food who 
consigns and ships the article from a foreign country or the person who 
sends an article of food by international mail to the United States.
    (13) United States means the Customs territory of the United States 
(i.e., the 50 states, the District of Columbia, and the Commonwealth of 
Puerto Rico), but not the Territories.
    (14) You means the person submitting the prior notice, i.e., the 
submitter, or the person transmitting prior notice information on behalf 
of the submitter, i.e., the transmitter.

[68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2004]



Sec. 1.277  What is the scope of this subpart?

    (a) This subpart applies to all food for humans and other animals 
that is imported or offered for import into the United States for use, 
storage, or distribution in the United States, including food for gifts 
and trade and quality assurance/quality control samples, food for 
transshipment through the United States to another country, food for 
future export, and food for use in a U.S. Foreign Trade Zone.
    (b) Notwithstanding paragraph (a), this subpart does not apply to:
    (1) Food for an individual's personal use when it is carried by or 
otherwise accompanies the individual when arriving in the United States;
    (2) Food that was made by an individual in his/her personal 
residence and sent by that individual as a personal gift (i.e., for non-
business reasons) to an individual in the United States;

[[Page 27]]

    (3) Food that is imported then exported without leaving the port of 
arrival until export;
    (4) Meat food products that at the time of importation are subject 
to the exclusive jurisdiction of the U.S. Department of Agriculture 
(USDA) under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);
    (5) Poultry products that at the time of importation are subject to 
the exclusive jurisdiction of USDA under the Poultry Products Inspection 
Act (21 U.S.C. 451 et seq.); and
    (6) Egg products that at the time of importation are subject to the 
exclusive jurisdiction of USDA under the Egg Products Inspection Act (21 
U.S.C. 1031 et seq.).

          Requirements To Submit Prior Notice of Imported Food



Sec. 1.278  Who is authorized to submit prior notice?

    A prior notice for an article of food may be submitted by any person 
with knowledge of the required information. This person is the 
submitter. The submitter also may use another person to transmit the 
required information on his/her behalf. The person who transmits the 
information is the transmitter. The submitter and transmitter may be the 
same person.



Sec. 1.279  When must prior notice be submitted to FDA?

    (a) Except as provided in paragraph (c) of this section, you must 
submit the prior notice to FDA and the prior notice submission must be 
confirmed by FDA for review as follows:
    (1) If the article of food is arriving by land by road, no less than 
2 hours before arriving at the port of arrival;
    (2) If the article of food is arriving by land by rail, no less than 
4 hours before arriving at the port of arrival;
    (3) If the article of food is arriving by air, no less than 4 hours 
before arriving at the port of arrival; or
    (4) If the article of food is arriving by water, no less than 8 
hours before arriving at the port of arrival.
    (b) Except in the case of an article of food imported or offered for 
import by international mail, you may not submit prior notice more than 
5 calendar days before the anticipated date of arrival of the food at 
the anticipated port of arrival.
    (c) Notwithstanding paragraphs (a) and (b) of this section, if the 
article of food is arriving by international mail, you must submit the 
prior notice before the article of food is sent to the United States.
    (d) FDA will notify you that your prior notice has been confirmed 
for review with a reply message that contains a Prior Notice (PN) 
Confirmation Number. Your prior notice will be considered submitted and 
the prior notice time will start when FDA has confirmed your prior 
notice for review.
    (e) The PN Confirmation Number must accompany any article of food 
arriving by international mail. The PN Confirmation Number must appear 
on the Customs Declaration that accompanies the package.
    (f) A copy of the confirmation, including the PN Confirmation 
Number, must accompany any article of food that is subject to this 
subpart when it is carried by or otherwise accompanies an individual 
when arriving in the United States. The copy of the confirmation must be 
provided to CBP or FDA upon arrival.
    (g) The PN Confirmation Number must accompany any article of food 
for which the prior notice was submitted through the FDA Prior Notice 
System Interface (FDA PN System Interface) when the article arrives in 
the United States and must be provided to CBP or FDA upon arrival.

[68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2004]



Sec. 1.280  How must you submit prior notice?

    (a) You must submit the prior notice electronically to FDA. You must 
submit all prior notice information in the English language, except that 
an individual's name, the name of a company, and the name of a street 
may be submitted in a foreign language. All information, including these 
items, must be submitted using the Latin (Roman) alphabet. Unless 
paragraphs (c) and (d) of this section apply, you must submit prior 
notice through:

[[Page 28]]

    (1) The CBP Automated Broker Interface of the Automated Commercial 
System (ABI/ACS); or
    (2) The FDA PN System Interface at http://www.access.fda.gov. You 
must submit prior notice through the FDA PN System Interface for 
articles of food imported or offered for import by international mail, 
other transaction types that cannot be made through ABI/ACS, and 
articles of food that have been refused under section 801(m)(1) of the 
act and this subpart.
    (b) If a custom broker's or self-filer's system is not working or if 
the ABI/ACS interface is not working, prior notice must be submitted 
through the FDA PN System Interface.
    (c) If FDA determines that FDA PN System Interface is not working, 
FDA will issue notification at http://www.access.fda.gov or http://
www.cfsan.fda.gov/furls/fisstat.html, whichever FDA determines is 
available. Once FDA issues this notification, if you intended to use the 
FDA PN System Interface to submit a prior notice, you must submit prior 
notice information by e-mail or by fax to FDA. The location for receipt 
of submission by e-mail or fax will be listed at http://
www.access.fda.gov or http://www.cfsan.fda.gov/furls/fisstat.html, 
whichever FDA determines is available.
    (d) If FDA determines that the Operational and Administration System 
for Import Support (OASIS) is not working, FDA will issue notification 
at http://www.cfsan.fda.gov/fulrs/fisstat.html, on the FDA Web site at 
http://www.fda.gov, and through messages in ABI/ACS. Once FDA issues 
this notification, all prior notices must be submitted to FDA by e-mail 
or by fax. The location for receipt of submission by e-mail or fax will 
be listed at http://www.access.fda.gov or http://www.cfsan.fda.gov/
furls;fisstat.html, whichever FDA determines is available.
    (e) Prior notice information will only be accepted at the listed e-
mail or fax locations if FDA determines that the FDA PN System Interface 
or OASIS is not working.

[68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2003; 69 FR 8330, Feb. 
24, 2004]



Sec. 1.281  What information must be in a prior notice?

    (a) General. For each article of food that is imported or offered 
for import into the United States, except by international mail, you 
must submit the information for the article that is required in this 
paragraph.
    (1) The name of the individual submitting the prior notice and his/
her business address, and phone number, fax number, and e-mail address, 
and the name and address of the submitting firm, if applicable. If a 
registration number is provided, city and country may be provided 
instead of the full address;
    (2) If different from the submitter, the name of the individual and 
firm, if applicable, transmitting the prior notice on behalf of the 
submitter and his/her business address, and phone number, fax number, 
and e-mail address. If a registration number is provided, city and 
country may be provided instead of the full address;
    (3) The entry type;
    (4) The CBP entry identifier (e.g., CBP entry number or in-bond 
number), if available;
    (5) The identity of the article of food being imported or offered 
for import, as follows:
    (i) The complete FDA product code;
    (ii) The common or usual name or market name;
    (iii) The estimated quantity of food that will be shipped, described 
from largest container to smallest package size; and
    (iv) The lot or code numbers or other identifier of the food if 
required by the act or FDA regulations, e.g., low acid canned foods, by 
21 CFR 113.60(c); acidified foods, by 21 CFR 114.80(b); and infant 
formula, by 21 CFR 106.90;
    (6) For an article of food that is no longer in its natural state, 
the name and address of the manufacturer and the registration number 
assigned to the facility that is associated with the article of food. A 
registration number is not required for a facility associated with an 
article of food if the article is imported or offered for import for 
transshipment, storage and export, or further manipulation and export. 
If the article of food is sent by an individual as a personal gift 
(i.e., for nonbusiness

[[Page 29]]

reasons) to an individual in the United States, you may provide the name 
and address of the firm that appears on the label under 21 CFR 101.5 
instead of the name, address, and registration number of the 
manufacturer. If a registration number is provided, city and country may 
be provided instead of the full address;
    (7) For an article of food that is in its natural state, the name 
and growing location address of the grower, if known. If the submitter 
does not know the identity of the grower or, if the article has been 
consolidated and the submitter does not know the identity of any of the 
growers, you may provide the name and address of the firm that has 
consolidated the articles of food from different growers or different 
growing locations;
    (8) The FDA Country of Production;
    (9) The name and address of the shipper and, if the shipper is 
required to register under 21 CFR part 1, subpart H, the registration 
number assigned to the shipper's facility that is associated with the 
article of food. A registration number is not required for a facility 
associated with an article of food if the article is imported or offered 
for import for transshipment, storage and export, or further 
manipulation and export. If a registration number is provided, city and 
country may be provided instead of the full address;
    (10) The country from which the article is shipped;
    (11) Anticipated arrival information about the article of food being 
imported or offered for import, as follows:
    (i) The anticipated port of arrival and, if the anticipated port of 
arrival has more than one border crossing, the specific anticipated 
border crossing where the food will be brought into the United States;
    (ii) The anticipated date on which the article of food will arrive 
at the anticipated port of arrival; and
    (iii) The anticipated time of that arrival;
    (12) The name and address of the importer. If a registration number 
is provided, city and country may be provided instead of the full 
address. The identity of the importer is not required for an article of 
food that is imported or offered for import for transshipment through 
the United States under a Transportation and Exportation entry;
    (13) The name and address of the owner if different from the 
importer or ultimate consignee. If a registration number is provided, 
city and country may be provided instead of the full address. The 
identity of the owner is not required for an article of food that is 
imported or offered for import for transshipment through the United 
States under a Transportation and Exportation entry;
    (14) The name and address of the ultimate consignee. If a 
registration number is provided, city and country may be provided 
instead of the full address. The identity of the ultimate consignee is 
not required for an article of food that is imported or offered for 
import for transshipment through the United States under a 
Transportation and Exportation entry;
    (15) The mode of transportation;
    (16) The Standard Carrier Abbreviation Code (SCAC) or International 
Air Transportation Association (IATA) code of the carrier which is, or 
will be, carrying the article of food from the country from which the 
article is shipped to the United States, or if codes are not applicable, 
then the name and country of the carrier;
    (17) Planned shipment information, as applicable:
    (i) The Airway Bill number(s) or Bill of Lading number(s). This 
information is not required for an article of food when carried by or 
otherwise accompanying an individual when entering the United States;
    (ii) For food arriving by ocean vessel, the vessel name and voyage 
number;
    (iii) For food arriving by air carrier, the flight number;
    (iv) For food arriving by truck, bus, or rail, the trip number;
    (v) For food arriving as containerized cargo by water, air, or land, 
the container number(s). This information is not required for an article 
of food when carried by or otherwise accompanying an individual when 
entering the United States;
    (vi) For food arriving by rail, the car number. This information is 
not required for an article of food when carried by or otherwise 
accompanying an individual;

[[Page 30]]

    (vii) For food arriving by privately owned vehicle, the license 
plate number and State or province; and
    (viii) The 6-digit Harmonized Tariff Schedule (HTS) code.
    (b) Articles arriving by international mail. For each article of 
food that is imported or offered for import into the United States by 
international mail, you must submit the information for the article that 
is required in this paragraph.
    (1) The name of the individual submitting the prior notice and his/
her business address, and phone number, fax number, and e-mail address, 
and the name and address of the submitting firm, if applicable. If a 
registration number is provided, city and country may be provided 
instead of the full address;
    (2) If different from the submitter, the name of the individual and 
firm, if applicable, transmitting the prior notice on behalf of the 
submitter and his/her business address and phone number, fax number, and 
e-mail address. If a registration number is provided, city and country 
may be provided instead of the full address;
    (3) The entry type (which will be a mail entry);
    (4) The identity of the article of food being imported or offered 
for import, as follows:
    (i) The complete FDA product code;
    (ii) The common or usual name or market name;
    (iii) The estimated quantity of food that will be shipped, described 
from largest container to smallest package size; and
    (iv) The lot or code numbers or other identifier of the food if 
required by the act or FDA regulations, e.g., low acid canned foods, by 
21 CFR 113.60(c); acidified foods, by 21 CFR 114.80(b); and infant 
formula, 21 CFR 106.90;
    (5) For an article of food that is no longer in its natural state, 
the name and address of the manufacturer and the registration number 
assigned to the facility that is associated with the article of food. A 
registration number is not required for a facility associated with an 
article of food if the article is imported or offered for import for 
transshipment, storage and export, or further manipulation and export. 
If the article of food is sent by an individual as a personal gift 
(i.e., for non-business reasons) to an individual in the United States, 
you may provide the name and address of the firm that appears on the 
label under 21 CFR 101.5 instead of the name, address, and registration 
number of the manufacturer. If a registration number is provided, city 
and country may be provided instead of the full address;
    (6) For an article of food that is in its natural state, the name 
and growing location address of the grower, if known. If the submitter 
does not know the identity of the grower or, if the article has been 
consolidated and the submitter does not know the identity of any of the 
growers, you may provide the name and address of the firm that has 
consolidated the articles of food from different growers or different 
growing locations;
    (7) The FDA Country of Production;
    (8) The name and address of the shipper and, if the shipper is 
required to register under 21 CFR part 1, subpart H, the registration 
number assigned to the shipper's facility that is associated with the 
article of food. A registration number is not required for a facility 
associated with an article of food if the article is imported or offered 
for import for transshipment, storage and export, or further 
manipulation and export. If a registration number is provided, city and 
country may be provided instead of the full address;
    (9) The country from which the article is shipped (i.e., mailed);
    (10) The anticipated date of mailing; and
    (11) The name and address of the U.S. recipient.
    (c) Refused articles. If the article of food has been refused under 
section 801(m)(1) of the act and this subpart, you must submit the 
information for the article that is required in this paragraph. However, 
if the refusal is based on Sec. 1.283(a)(1)(iii) (Untimely Prior 
Notice), you do not have to re-submit any information previously 
submitted unless it has changed or the article has been exported and the 
original prior notice was submitted through ABI/ACS. If the refusal is 
based on Sec. 1.283(a)(1)(ii), you should cancel the

[[Page 31]]

previous submission per Sec. 1.282(b) and (c).
    (1) The name of the individual submitting the prior notice and his/
her business address, and phone number, fax number, and e-mail address, 
and the name and address of the submitting firm, if applicable. If a 
registration number is provided, city and country may be provided 
instead of the full address;
    (2) If different from the submitter, the name of the individual and 
firm, if applicable, transmitting the prior notice on behalf of the 
submitter and his/her business address, and phone number, fax number, 
and e-mail address. If the registration number is provided, city and 
country may be provided instead of the full address;
    (3) The entry type;
    (4) The CBP entry identifier (e.g., CBP entry number or in-bond 
number), if available;
    (5) The identity of the article of food being imported or offered 
for import, as follows:
    (i) The complete FDA product code;
    (ii) The common or usual name or market name;
    (iii) The quantity of food that was shipped, described from largest 
container to smallest package size; and
    (iv) The lot or code numbers or other identifier of the food if 
required by the act or FDA regulations, e.g., low acid canned foods, by 
21 CFR 113.60(c); acidified foods, by 21 CFR 114.80(b); and infant 
formula, by 21 CFR 106.90;
    (6) For an article of food that is no longer in its natural state, 
the name and address of the manufacturer and the registration number 
assigned to the facility that is associated with the article of food. A 
registration number is not required for a facility associated with an 
article of food if the article is imported or offered for import for 
transshipment, storage and export, or further manipulation and export. 
If the article of food is sent by an individual as a personal gift 
(i.e., for non-business reasons) to an individual in the United States, 
you may provide the name and address of the firm that appears on the 
label under 21 CFR 101.5 instead of the name, address, and registration 
number of the manufacturer. If a registration number is provided, city 
and country may be provided instead of the full address;
    (7) For an article of food that is in its natural state, the name 
and growing location address of the grower, if known. If the submitter 
does not know the identity of the grower or, if the article has been 
consolidated and the submitter does not know any of the growers, you may 
provide the name and address of the firm that has consolidated the 
articles of food from different growers or different growing locations;
    (8) The FDA Country of Production;
    (9) The name and address of the shipper and, if the shipper is 
required to register under 21 CFR part 1, subpart H, the registration 
number assigned to the shipper's facility that is associated with the 
article of food. A registration number is not required for a facility 
associated with an article of food if the article is imported or offered 
for import for transshipment, storage and export, or further 
manipulation and export. If a registration number is provided, city and 
country may be provided instead of the full address;
    (10) The country from which the article is shipped;
    (11) The port of arrival;
    (12) The name and address of the importer. If a registration number 
is provided, city and country may be provided instead of the full 
address. The identity of the importer is not required for an article of 
food that is imported or offered for import for transshipment through 
the United States under a Transportation and Exportation entry;
    (13) The name and address of the owner, if different from the 
importer or ultimate consignee. If a registration number is provided, 
city and country may be provided instead of the full address. The 
identity of the importer is not required for an article of food that is 
imported or offered for import for transshipment through the United 
States under a Transportation and Exportation entry;
    (14) The name and address of the ultimate consignee. If a 
registration number is provided, city and country may be provided 
instead of the full address. The identity of the ultimate consignee is 
not required for an article of food that is imported or offered for 
import

[[Page 32]]

for transshipment through the United States under a Transportation and 
Exportation entry;
    (15) The mode of transportation;
    (16) The Standard Carrier Abbreviation Code (SCAC) or International 
Air Transportation Association (IATA) code of the carrier which carried 
the article of food from the country from which the article is shipped 
to the United States, or if codes are not applicable, then the name and 
country of the carrier;
    (17) Shipment information, as applicable:
    (i) The Airway Bill number(s) or Bill of Lading number(s); however, 
this information is not required for an article of food when carried by 
or otherwise accompanying an individual when entering the United States;
    (ii) For food that arrived by ocean vessel, the vessel name and 
voyage number;
    (iii) For food that arrived by air carrier, the flight number;
    (iv) For food that arrived by truck, bus, or rail, the trip number;
    (v) For food that arrived as containerized cargo by water, air, or 
land, the container number(s); however, this information is not required 
for an article of food when carried by or otherwise accompanying an 
individual when entering the United States;
    (vi) For food that arrived by rail, the car number; however, this 
information is not required for an article of food when carried by or 
otherwise accompanying an individual;
    (vii) For food that arrived by privately owned vehicle, the license 
plate number and State or province;
    (viii) The 6-digit HTS code; and
    (18) The location and address where the article of refused food will 
be or is being held, the date the article has arrived or will arrive at 
that location, and identification of a contact at that location.

[68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2004]



Sec. 1.282  What must you do if information changes after you have received 

confirmation of a prior notice from FDA?

    (a)(1) If any of the information required in Sec. 1.281(a) except 
the information required in:
    (i) Sec. 1.281(a)(5)(iii) (quantity),
    (ii) Sec. 1.281(a)(11) (anticipated arrival information), or
    (iii) Sec. 1.281(a)(17) (planned shipment information) changes 
after you receive notice that FDA has confirmed your prior notice 
submission for review, you must resubmit prior notice in accordance with 
this subpart unless the article of food will not be offered for import 
or imported into the United States.
    (2) If any of the information required in Sec. 1.281(b), except the 
information required in Sec. 1.281(b)(10) (the anticipated date of 
mailing), changes after you receive notice that FDA has confirmed your 
prior notice submission for review, you must resubmit prior notice in 
accordance with this subpart, unless the article of food will not be 
offered for import or imported into the United States.
    (b) If you submitted the prior notice via the FDA PN System 
Interface, you should cancel the prior notice via the FDA PN System 
Interface.
    (c) If you submitted the prior notice via ABI/ACS, you should cancel 
the prior notice via ACS by requesting that CBP delete the entry.

                              Consequences



Sec. 1.283  What happens to food that is imported or offered for import 

without adequate prior notice?

    (a) For each article of food that is imported or offered for import 
into the United States, except for food arriving by international mail 
or food carried by or otherwise accompanying an individual, the 
consequences are:
    (1) Inadequate prior notice--(i) No prior notice. If an article of 
food arrives at the port of arrival and no prior notice has been 
submitted and confirmed by FDA for review, the food is subject to 
refusal of admission under section 801(m)(1) of the act (21 U.S.C. 
381(m)(1)). If an article of food is refused for lack of prior notice, 
unless CBP concurrence

[[Page 33]]

is obtained for export and the article is immediately exported from the 
port of arrival under CBP supervision, it must be held within the port 
of entry for the article unless directed by CBP or FDA.
    (ii) Inaccurate prior notice. If prior notice has been submitted and 
confirmed by FDA for review, but upon review of the notice or 
examination of the article of food, the notice is determined to be 
inaccurate, the food is subject to refusal of admission under section 
801(m)(1) of the act (21 U.S.C. 381(m)(1)). If the article of food is 
refused due to inaccurate prior notice, unless CBP concurrence is 
obtained for export and the article is immediately exported from the 
port of arrival under CBP supervision, it must be held within the port 
of entry for the article unless directed by CBP or FDA.
    (iii) Untimely prior notice. If prior notice has been submitted and 
confirmed by FDA for review, but the full time that applies under Sec. 
1.279 of this subpart for prior notice has not elapsed when the article 
of food arrives, the food is subject to refusal of admission under 
section 801(m)(1) of the act (21 U.S.C. 381(m)(1)), unless FDA has 
already reviewed the prior notice, determined its response to the prior 
notice, and advised CBP of that response. If the article of food is 
refused due to untimely prior notice, unless CBP concurrence is obtained 
for export and the article is immediately exported from the port of 
arrival under CBP supervision, it must be held within the port of entry 
for the article unless directed by CBP or FDA.
    (2) Status and movement of refused food. (i) An article of food that 
has been refused under section 801(m)(1) of the act and paragraph (a) of 
this section shall be considered general order merchandise as described 
in section 490 of the Tariff Act of 1930, as amended, 19 U.S.C. 1490.
    (ii) Refused food must be moved under appropriate custodial bond. 
FDA must be notified of the location where the food has been or will be 
moved, within 24 hours of refusal. The refused food shall not be entered 
and shall not be delivered to any importer, owner, or ultimate 
consignee. The food must be taken directly to the designated location.
    (3) Segregation of refused foods. If an article of food that is 
refused is part of a shipment that contains articles of food that have 
not been placed under hold, the refused article of food may be 
segregated from the rest of the shipment. This segregation must take 
place where the article is held. FDA or CBP may supervise segregation. 
If FDA or CBP determines that supervision is necessary, segregation must 
not take place without supervision.
    (4) Costs. Neither FDA nor CBP are liable for transportation, 
storage, or other expenses resulting from refusal.
    (5) Export after refusal. An article of food that has been refused 
under Sec. 1.283(a) may be exported with CBP concurrence and under CBP 
supervision unless it is seized or administratively detained by FDA or 
CBP under other authority. If an article of food that has been refused 
admission under Sec. 1.283(a) is exported, the prior notice should be 
cancelled within 5 business days of exportation.
    (6) No post-refusal submission or request for review. If an article 
of food is refused under section 801(m)(1) and no prior notice is 
submitted or resubmitted, no request for FDA review is submitted in a 
timely fashion, or export has not occurred in accordance with paragraph 
(a)(5) of this section, the article of food shall be dealt with as set 
forth in CBP regulations relating to general order merchandise (19 CFR 
part 127), except that the article may only be sold for export or 
destroyed as agreed to by CBP and FDA.
    (b) Food carried by or otherwise accompanying an individual. If food 
carried by or otherwise accompanying an individual arriving in the 
United States is not for personal use and does not have adequate prior 
notice or the individual cannot provide FDA or CBP with a copy of the PN 
confirmation, the food is subject to refusal of admission under section 
801(m)(1) of the act. If before leaving the port, the individual does 
not arrange to have the food held at the port or exported, the article 
of food may be destroyed.
    (c) Post-Refusal Prior Notice Submissions. (1) If an article of food 
is refused under Sec. 1.283(a)(1)(i) (no prior notice)

[[Page 34]]

and the food is not exported, prior notice must be submitted in 
accordance with Sec. Sec. 1.280 and 1.281(c) of this subpart.
    (2) If an article of food is refused under Sec. 1.283(a)(1)(ii) 
(inaccurate prior notice) and the food is not exported, you should 
cancel the prior notice in accordance with Sec. 1.282 and must resubmit 
prior notice in accordance with Sec. Sec. 1.280 and 1.281(c).
    (3) Once the prior notice has been submitted or resubmitted and 
confirmed by FDA for review, FDA will endeavor to review and respond to 
the prior notice submission within the timeframes set out in Sec. 
1.279.
    (d) FDA Review After Refusal. (1) If an article of food has been 
refused admission under section 801(m)(1) of the act, a request may be 
submitted asking FDA to review whether the article is subject to the 
requirements of this subpart under Sec. 1.276(b)(5) or Sec. 1.277, or 
whether the information submitted in a prior notice is accurate. A 
request for review may not be used to submit prior notice or to resubmit 
an inaccurate prior notice.
    (2) A request may be submitted only by the submitter, importer, 
owner, or ultimate consignee. A request must identify which one the 
requester is.
    (3) A request must be submitted in writing to FDA and delivered by 
mail, express courier, fax, or e-mail. The location for receipt of a 
request is listed at http://www.fda.gov--see Prior Notice. A request 
must include all factual and legal information necessary for FDA to 
conduct its review. Only one request for review may be submitted for 
each refused article.
    (4) The request must be submitted within 5 calendar days of the 
refusal. FDA will review and respond within 5 calendar days of receiving 
the request.
    (5) If FDA determines that the article is not subject to the 
requirements of this subpart under Sec. 1.276(b)(5) or Sec. 1.277 or 
that the prior notice submission is accurate, it will notify the 
requester, the transmitter, and CBP that the food is no longer subject 
to refusal under section 801(m)(1) of the act.
    (e) International Mail. If an article of food arrives by 
international mail with inadequate prior notice or the PN confirmation 
number is not affixed as required, the parcel will be held by CBP for 72 
hours for FDA inspection and disposition. If FDA refuses the article 
under section 801(m)(1) of the act and there is a return address, the 
parcel may be returned to sender stamped ``No Prior Notice--FDA 
Refused.'' If the article is refused and there is no return address or 
FDA determines that the article of food in the parcel appears to present 
a hazard, FDA may dispose of or destroy the parcel at its expense. If 
FDA does not respond within 72 hours of the CBP hold, CBP may return the 
parcel to the sender or, if there is no return address, destroy the 
parcel, at FDA expense.
    (f) Prohibitions on delivery and transfer. (1) Notwithstanding 
section 801(b) of the act, an article of food refused under section 
801(m)(1) of the act may not be delivered to the importer, owner, or 
ultimate consignee until prior notice is submitted to FDA in accordance 
with this subpart, FDA has examined the prior notice, FDA has determined 
that the prior notice is adequate, and FDA has notified CBP and the 
transmitter that the article of food is no longer refused admission 
under section 801(m)(1).
    (2) During the time an article of food that has been refused under 
section 801(m)(1) of the act is held, the article may not be transferred 
by any person from the port or the secure facility until prior notice is 
submitted to FDA in accordance with this subpart, FDA has examined the 
prior notice, FDA has determined that the prior notice is adequate, and 
FDA has notified CBP and the transmitter that the article of food no 
longer is refused admission under section 801(m)(1). After this 
notification by FDA to CBP and transmitter, entry may be made in 
accordance with law and regulation.
    (g) Relationship to other admissibility decisions. A determination 
that an article of food is no longer refused under section 801(m)(1) of 
the act is different than, and may come before, determinations of 
admissibility under other provisions of the act or other U.S. laws. A 
determination that an article of food is no longer refused under section 
801(m)(1) does not mean that it will be

[[Page 35]]

granted admission under other provisions of the act or other U.S. laws.

[68 FR 59070, Oct. 10, 2003; 69 FR 4851, 4852, Feb. 2, 2004]



Sec. 1.284  What are the other consequences of failing to submit adequate 

prior notice or otherwise failing to comply with this subpart?

    (a) The importing or offering for import into the United States of 
an article of food in violation of the requirements of section 801(m), 
including the requirements of this subpart, is a prohibited act under 
section 301(ee) of the act (21 U.S.C. 331(ee)).
    (b) Section 301 of the act (21 U.S.C. 331) prohibits the doing of 
certain acts or causing such acts to be done.
    (1) Under section 302 of the act (21 U.S.C. 332), the United States 
can bring a civil action in Federal court to enjoin persons who commit a 
prohibited act.
    (2) Under section 303 of the act (21 U.S.C. 333), the United States 
can bring a criminal action in Federal court to prosecute persons who 
are responsible for the commission of a prohibited act.
    (c) Under section 306 of the act (21 U.S.C. 335a), FDA can seek 
debarment of any person who has been convicted of a felony relating to 
importation of food into the United States or any person who has engaged 
in a pattern of importing or offering adulterated food that presents a 
threat of serious adverse health consequences or death to humans or 
animals.

[68 FR 59070, Oct. 10, 2003; 69 FR 4852, Feb. 2, 2004]



Sec. 1.285  What happens to food that is imported or offered for import from 

unregistered facilities that are required to register under 21 CFR part 1, 

subpart H?

    (a) If an article of food from a foreign manufacturer that is not 
registered as required under section 415 of the act (21 U.S.C. 350d) and 
subpart H is imported or offered for import into the United States, the 
food is subject to refusal of admission under section 801(m)(1) of the 
act and Sec. 1.283 for failure to provide adequate prior notice. The 
failure to provide the correct registration number of the foreign 
manufacturer, if registration is required under section 415 of the act 
and 21 CFR part 1, subpart H, renders the identity of that facility 
incomplete for purposes of prior notice.
    (b) Unless CBP concurrence is obtained for export and the article is 
immediately exported from the port of arrival, if an article of food is 
imported or offered for import from a foreign facility that is not 
registered as required under section 415 of the act and is placed under 
hold under section 801(l) of the act, it must be held within the port of 
entry for the article unless directed by CBP or FDA.
    (c) Status and movement of held food. (1) An article of food that 
has been placed under hold under section 801(l) of the act shall be 
considered general order merchandise as described in section 490 of the 
Tariff Act of 1930, as amended (19 U.S.C. 1490).
    (2) Food under hold under section 801(l) must be moved under 
appropriate custodial bond. FDA must be notified of the location where 
the food has been or will be moved, within 24 hours of the hold. The 
food subject to hold shall not be entered and shall not be delivered to 
any importer, owner, or ultimate consignee. The food must be taken 
directly to the designated facility.
    (d) Segregation of held foods. If an article of food that has been 
placed under hold under section 801(l) of the act is part of a shipment 
that contains articles that have not been placed under hold, the food 
under hold may be segregated from the rest of the shipment. This 
segregation must take place where the article is held, if different. FDA 
or CBP may supervise segregation. If FDA or CBP determine that 
supervision is necessary, segregation must not take place without 
supervision.
    (e) Costs. Neither FDA nor CBP will be liable for transportation, 
storage, or other expenses resulting from any hold.
    (f) Export after hold. An article of food that has been placed under 
hold under section 801(l) of the act may be exported with CBP 
concurrence and under CBP supervision unless it is seized or 
administratively detained by FDA or CBP under other authority.
    (g) No Registration or Request for Review. If an article of food is 
placed under hold under section 801(l) of the act and no registration or 
request for

[[Page 36]]

FDA review is submitted in a timely fashion or export has not occurred 
in accordance with subsection (f), the food shall be dealt with as set 
forth in CBP regulations relating to general order merchandise, except 
that the article may only be sold for export or destroyed as agreed to 
by CBP and FDA.
    (h) Food carried by or otherwise accompanying an individual. If an 
article of food carried by or otherwise accompanying an individual 
arriving in the United States is placed under hold under section 801(l) 
of the act because it is from a foreign facility that is not registered 
as required under section 415 of the act, 21 U.S.C. 350d, and subpart H, 
the individual may arrange to have the food held at the port or 
exported. If such arrangements cannot be made, the article of food may 
be destroyed.
    (i) Post-refusal and post-hold submissions. (1) Post-refusal. To 
resolve the refusal if an article of food is refused under Sec. 
1.283(a) because the facility is not registered, the facility must be 
registered and after a registration number has been obtained, you should 
cancel the prior notice and must resubmit the prior notice in accordance 
with Sec. 1.283(c).
    (2) Post-hold. To resolve a hold, if an article of food is held 
under Sec. 1.285(b) because it is from a foreign facility that is not 
registered, the facility must be registered and a registration number 
must be obtained.
    (i) FDA must be notified of the applicable registration number in 
writing. The notification must provide the name and contact information 
for the person submitting the information. The notification may be 
delivered to FDA by mail, express courier, fax, or e-mail. The location 
for receipt of a notification of registration number associated with an 
article of food under hold is listed at http://www.fda.gov--see Food 
Facility Registration. The notification should include the applicable 
CBP identifier.
    (ii) If FDA determines that the article is no longer subject to 
hold, it will notify the person who provided the registration 
information and CBP that the food is no longer subject to hold under 
section 801(l) of the act.
    (j) FDA review after hold. (1) If an article of food has been placed 
under hold under section 801(l) of the act, a request may be submitted 
asking FDA to review whether the facility associated with the article is 
subject to the requirements of section 415 of the act. A request for 
review may not be submitted to obtain a registration number.
    (2) A request may be submitted only by the prior notice submitter, 
importer, owner, or ultimate consignee of the article. A request must 
identify which one the requestor is.
    (3) A request must be submitted in writing to FDA and delivered by 
mail, express courier, fax or e-mail. The location for receipt of a 
request is listed at http://www.fda.gov--see Food Facility Registration. 
A request must include all factual and legal information necessary for 
FDA to conduct its review. Only one request for review may be submitted 
for each article under hold.
    (4) The request must be submitted within 5 calendar days of the 
hold. FDA will review and respond within 5 calendar days of receiving 
the request.
    (5) If FDA determines that the article is not from a facility 
subject to the requirements of section 415, it will notify the requestor 
and CBP that the food is no longer subject to hold under section 801(l) 
of the act.
    (k) International mail. If an article of food is that arrives by 
international mail is from a foreign facility that is not registered as 
required under section 415 of the act (21 U.S.C. 350d) and subpart H, 
the parcel will be held by CBP for 72 hours for FDA inspection and 
disposition. If the article is held under section 801(1) of the act and 
there is a return address, the parcel may be returned to sender stamped 
``No Registration--No Admission Permitted.'' If the article is under 
hold and there is no return address or FDA determines that the article 
of food is in the parcel appears to present a hazard, FDA may dispose of 
or destroy the parcel at its expense. If FDA does not respond within 72 
hours of the CBP hold, CBP may return the parcel to the sender stamped 
``No Registration--No Admission Permitted'' or, if there is no return 
address, destroy the parcel, at FDA expense.

[[Page 37]]

    (l) Prohibitions on delivery and transfer. (1) Notwithstanding 
section 801(b) of the act (21 U.S.C. 381(b)), an article of food that 
has been placed under hold section 801(l) of the act may not be 
delivered to the importer, owner, or ultimate consignee until prior 
notice is submitted to FDA in accordance with this subpart, FDA has 
examined the prior notice, FDA has determined that the prior notice is 
adequate, and FDA has notified CBP and the transmitter that the article 
of food is no longer subject to hold under section 801(l) of the act.
    (2) During the time an article of food that has been refused under 
section 801(m)(1) of the act is held, the article may not be transferred 
by any person from the port or the secure facility location until prior 
notice is submitted to FDA in accordance with this subpart, FDA has 
examined the prior notice, FDA has determined that the prior notice is 
adequate, and FDA has notified CBP and the transmitter that the article 
of food is no longer refused admission under section 801(m)(1) of the 
act. After this notification by FDA to CBP and transmitter, entry may be 
made in accordance with law and regulation.
    (m) Relationship to other admissibility provisions. A determination 
that an article of food is no longer subject to hold under section 
801(l) of the act is different than, and may come before, determinations 
of admissibility under other provisions of the act or other U.S. laws. A 
determination that an article of food is no longer under hold under 
section 801(l) does not mean that it will be granted admission under 
other provisions of the act or other U.S. laws.

[68 FR 59070, Oct. 10, 2003; 69 FR 4852, Feb. 2, 2004]



    Subpart J_Establishment, Maintenance, and Availability of Records

    Source: 69 FR 71651, Dec. 9, 2004, unless otherwise noted.

                           General Provisions



Sec. 1.326  Who is subject to this subpart?

    (a) Persons who manufacture, process, pack, transport, distribute, 
receive, hold, or import food in the United States are subject to the 
regulations in this subpart, unless you qualify for one of the 
exclusions in Sec. 1.327. If you conduct more than one type of activity 
at a location, you are required to keep records with respect to those 
activities covered by this subpart, but are not required by this subpart 
to keep records with respect to activities that fall within one of the 
exclusions in Sec. 1.327.
    (b) Persons subject to the regulations in this subpart must keep 
records whether or not the food is being offered for or enters 
interstate commerce.



Sec. 1.327  Who is excluded from all or part of the regulations in this 

subpart?

    (a) Farms are excluded from all of the requirements in this subpart.
    (b) Restaurants are excluded from all of the requirements in this 
subpart. A restaurant/retail facility is excluded from all of the 
requirements in this subpart if its sales of food it prepares and sells 
to consumers for immediate consumption are more than 90 percent of its 
total food sales.
    (c) Fishing vessels, including those that not only harvest and 
transport fish but also engage in practices such as heading, 
eviscerating, or freezing intended solely to prepare fish for holding on 
board a harvest vessel, are excluded from all of the requirements in 
this subpart, except Sec. Sec. 1.361 and 1.363. However, those fishing 
vessels otherwise engaged in processing fish are subject to all of the 
requirements in this subpart. For the purposes of this section, 
``processing'' means handling, storing, preparing, shucking, changing 
into different market forms, manufacturing, preserving, packing, 
labeling, dockside unloading, holding or heading, eviscerating, or 
freezing other than solely to prepare fish for holding on board a 
harvest vessel.
    (d) Persons who distribute food directly to consumers are excluded 
from the requirements in Sec. 1.345 to establish and maintain records 
to identify the

[[Page 38]]

nontransporter and transporter immediate subsequent recipients as to 
those transactions. The term ``consumers'' does not include businesses.
    (e) Persons who operate retail food establishments that distribute 
food to persons who are not consumers are subject to all of the 
requirements in this subpart. However, the requirements in Sec. 1.345 
to establish and maintain records to identify the nontransporter and 
transporter immediate subsequent recipients that are not consumers 
applies as to those transactions only to the extent the information is 
reasonably available.
    (1) For purposes of this section, retail food establishment is 
defined to mean an establishment that sells food products directly to 
consumers as its primary function. The term ``consumers'' does not 
include businesses.
    (2) A retail food establishment may manufacture/process, pack, or 
hold food if the establishment's primary function is to sell from that 
establishment food, including food that it manufactures/processes, 
packs, or holds, directly to consumers.
    (3) A retail food establishment's primary function is to sell food 
directly to consumers if the annual monetary value of sales of food 
products directly to consumers exceeds the annual monetary value of 
sales of food products to all other buyers.
    (4) A ``retail food establishment'' includes grocery stores, 
convenience stores, and vending machine locations.
    (f) Retail food establishments that employ 10 or fewer full-time 
equivalent employees are excluded from all of the requirements in this 
subpart, except Sec. Sec. 1.361 and 1.363. The exclusion is based on 
the number of full-time equivalent employees at each retail food 
establishment and not the entire business, which may own numerous retail 
stores.
    (g) Persons who manufacture, process, pack, transport, distribute, 
receive, hold, or import food in the United States that is within the 
exclusive jurisdiction of the U.S. Department of Agriculture (USDA) 
under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the 
Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg 
Products Inspection Act (21 U.S.C. 1031 et seq.) are excluded from all 
of the requirements in this subpart with respect to that food while it 
is under the exclusive jurisdiction of USDA.
    (h) Foreign persons, except for foreign persons who transport food 
in the United States, are excluded from all of the requirements of this 
subpart.
    (i) Persons who manufacture, process, pack, transport, distribute, 
receive, hold, or import food are subject to Sec. Sec. 1.361 and 1.363 
with respect to its packaging (the outer packaging of food that bears 
the label and does not contact the food). All other persons who 
manufacture, process, pack, transport, distribute, receive, hold, or 
import packaging are excluded from all of the requirements of this 
subpart.
    (j) Persons who manufacture, process, pack, transport, distribute, 
receive, hold, or import food contact substances other than the finished 
container that directly contacts food are excluded from all of the 
requirements of this subpart, except Sec. Sec. 1.361 and 1.363.
    (k) Persons who place food directly in contact with its finished 
container are subject to all of the requirements of this subpart as to 
the finished container that directly contacts that food. All other 
persons who manufacture, process, pack, transport, distribute, receive, 
hold, or import the finished container that directly contacts the food 
are excluded from the requirements of this subpart as to the finished 
container, except Sec. Sec. 1.361 and 1.363.
    (l) Nonprofit food establishments are excluded from all of the 
requirements in this subpart, except Sec. Sec. 1.361 and 1.363.
    (m) Persons who manufacture, process, pack, transport, distribute, 
receive, hold, or import food for personal consumption are excluded from 
all of the requirements of this subpart.
    (n) Persons who receive or hold food on behalf of specific 
individual consumers and who are not also parties to the transaction and 
who are not in the business of distributing food are excluded from all 
of the requirements of this subpart.



Sec. 1.328  What definitions apply to this subpart?

    The definitions of terms in section 201 of the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 321) apply

[[Page 39]]

to such terms when used in this subpart. In addition, for the purposes 
of this subpart:
    Act means the Federal Food, Drug, and Cosmetic Act.
    Farm means a facility in one general physical location devoted to 
the growing and harvesting of crops, the raising of animals (including 
seafood), or both. Washing, trimming of outer leaves, and cooling 
produce are considered part of harvesting. The term ``farm'' includes:
    (1) Facilities that pack or hold food, provided that all food used 
in such activities is grown, raised, or consumed on that farm or another 
farm under the same ownership; and
    (2) Facilities that manufacture/process food, provided that all food 
used in such activities is consumed on that farm or another farm under 
the same ownership.
    Food has the meaning given in section 201(f) of the act. Examples of 
food include, but are not limited to fruits; vegetables; fish; dairy 
products; eggs; raw agricultural commodities for use as food or as 
components of food; animal feed, including pet food; food and feed 
ingredients and additives, including substances that migrate into food 
from the finished container and other articles that contact food; 
dietary supplements and dietary ingredients; infant formula; beverages, 
including alcoholic beverages and bottled water; live food animals; 
bakery goods; snack foods; candy; and canned foods.
    Full-time equivalent employee means all individuals employed by the 
person claiming the exemption. The number of full-time equivalent 
employees is determined by dividing the total number of hours of salary 
or wages paid directly to employees of the person and of all of its 
affiliates by the number of hours of work in 1 year, 2,080 hours (i.e., 
40 hours x 52 weeks).
    Holding means storage of food. Holding facilities include 
warehouses, cold storage facilities, storage silos, grain elevators, and 
liquid storage tanks.
    Manufacturing/processing means making food from one or more 
ingredients, or synthesizing, preparing, treating, modifying, or 
manipulating food, including food crops or ingredients. Examples of 
manufacturing/processing activities are cutting, peeling, trimming, 
washing, waxing, eviscerating, rendering, cooking, baking, freezing, 
cooling, pasteurizing, homogenizing, mixing, formulating, bottling, 
milling, grinding, extracting juice, distilling, labeling, or packaging.
    Nonprofit food establishment means a charitable entity that prepares 
or serves food directly to the consumer or otherwise provides food or 
meals for consumption by humans or animals in the United States. The 
term includes central food banks, soup kitchens, and nonprofit food 
delivery services. To be considered a nonprofit food establishment, the 
establishment must meet the terms of section 501(c)(3) of the U.S. 
Internal Revenue Code (26 U.S.C. 501(c)(3)).
    Nontransporter means a person who owns food or who holds, 
manufactures, processes, packs, imports, receives, or distributes food 
for purposes other than transportation.
    Nontransporter immediate previous source means a person that last 
had food before transferring it to another nontransporter.
    Nontransporter immediate subsequent recipient means a nontransporter 
that acquires food from another nontransporter.
    Packaging means the outer packaging of food that bears the label and 
does not contact the food. Packaging does not include food contact 
substances as they are defined in section 409(h)(6) of the act (21 
U.S.C. 348(h)(6)).
    Person includes individual, partnership, corporation, and 
association.
    Recipe means the formula, including ingredients, quantities, and 
instructions, necessary to manufacture a food product. Because a recipe 
must have all three elements, a list of the ingredients used to 
manufacture a product without quantity information and manufacturing 
instructions is not a recipe.
    Restaurant means a facility that prepares and sells food directly to 
consumers for immediate consumption. ``Restaurant'' does not include 
facilities that provide food to interstate conveyances, central 
kitchens, and other similar facilities that do not prepare and serve 
food directly to consumers.
    (1) Facilities in which food is directly provided to humans, such as 
cafeterias,

[[Page 40]]

lunchrooms, cafes, bistros, fast food establishments, food stands, 
saloons, taverns, bars, lounges, catering facilities, hospital kitchens, 
day care kitchens, and nursing home kitchens, are restaurants.
    (2) Pet shelters, kennels, and veterinary facilities in which food 
is directly provided to animals are restaurants.
    Transporter means a person who has possession, custody, or control 
of an article of food in the United States for the sole purpose of 
transporting the food, whether by road, rail, water, or air. Transporter 
also includes a foreign person that transports food in the United 
States, regardless of whether that foreign person has possession, 
custody, or control of that food for the sole purpose of transporting 
that food.
    Transporter's immediate previous source means a person from whom a 
transporter received food. This source can be either another transporter 
or a nontransporter.
    Transporter's immediate subsequent recipient means a person to whom 
a transporter delivered food. This recipient can be either another 
transporter or a nontransporter.
    You means a person subject to this subpart under Sec. 1.326.



Sec. 1.329  Do other statutory provisions and regulations apply?

    (a) In addition to the regulations in this subpart, you must comply 
with all other applicable statutory provisions and regulations related 
to the establishment and maintenance of records for foods except as 
described in paragraph (b) of this section. For example, the regulations 
in this subpart are in addition to existing recordkeeping regulations 
for low acid canned foods, juice, seafood, infant formula, color 
additives, bottled water, animal feed, and medicated animal feed.
    (b) Records established or maintained to satisfy the requirements of 
this subpart that meet the definition of electronic records in Sec. 
11.3(b)(6) (21 CFR 11.3 (b)(6)) of this chapter are exempt from the 
requirements of part 11 of this chapter. Records that satisfy the 
requirements of this subpart but that are also required under other 
applicable statutory provisions or regulations remain subject to part 11 
of this chapter.



Sec. 1.330  Can existing records satisfy the requirements of this subpart?

    The regulations in this subpart do not require duplication of 
existing records if those records contain all of the information 
required by this subpart. If a covered person keeps records of all of 
the information as required by this subpart to comply with other 
Federal, State, or local regulations, or for any other reason, then 
those records may be used to meet these requirements. Moreover, persons 
do not have to keep all of the information required by this rule in one 
set of records. If they have records containing some of the required 
information, they may keep those existing records and keep, either 
separately or in a combined form, any new information required by this 
rule. There is no obligation to create an entirely new record or 
compilation of records containing both existing and new information, 
even if the records containing some of the required information were not 
created at the time the food was received or released.

 Requirements for Nontransporters To Establish and Maintain Records To 
 Identify the Nontransporter and Transporter Immediate Previous Sources 
                                 of Food



Sec. 1.337  What information must nontransporters establish and maintain to 

identify the nontransporter and transporter immediate previous sources of 

food?

    (a) If you are a nontransporter, you must establish and maintain the 
following records for all food you receive:
    (1) The name of the firm, address, telephone number and, if 
available, the fax number and e-mail address of the nontransporter 
immediate previous source, whether domestic or foreign;
    (2) An adequate description of the type of food received, to include 
brand name and specific variety (e.g., brand x cheddar cheese, not just 
cheese; or romaine lettuce, not just lettuce);
    (3) The date you received the food;
    (4) For persons who manufacture, process, or pack food, the lot or 
code number or other identifier of the food (to the extent this 
information exists);

[[Page 41]]

    (5) The quantity and how the food is packaged (e.g., 6 count 
bunches, 25 pound (lb) carton, 12 ounce (oz) bottle, 100 gallon (gal) 
tank); and
    (6) The name of the firm, address, telephone number, and, if 
available, the fax number and e-mail address of the transporter 
immediate previous source (the transporter who transported the food to 
you).

 Requirements for Nontransporters To Establish and Maintain Records To 
    Identify the Nontransporter and Transporter Immediate Subsequent 
                           Recipients of Food



Sec. 1.345  What information must nontransporters establish and maintain to 

identify the nontransporter and transporter immediate subsequent recipients of 

food?

    (a) If you are a nontransporter, you must establish and maintain the 
following records for food you release:
    (1) The name of the firm, address, telephone number, and, if 
available, the fax number and e-mail address of the nontransporter 
immediate subsequent recipient, whether domestic or foreign;
    (2) An adequate description of the type of food released, to include 
brand name and specific variety (e.g., brand x cheddar cheese, not just 
cheese; or romaine lettuce, not just lettuce);
    (3) The date you released the food;
    (4) For persons who manufacture, process, or pack food, the lot or 
code number or other identifier of the food (to the extent this 
information exists);
    (5) The quantity and how the food is packaged (e.g., 6 count 
bunches, 25 lb carton, 12 oz bottle, 100 gal tank);
    (6) The name of the firm, address, telephone number, and, if 
available, the fax number and e-mail address of the transporter 
immediate subsequent recipient (the transporter who transported the food 
from you); and
    (b) Your records must include information reasonably available to 
you to identify the specific source of each ingredient used to make 
every lot of finished product.

     Requirements for Transporters To Establish and Maintain Records



Sec. 1.352  What information must transporters establish and maintain?

    If you are a transporter, you must establish and maintain the 
following records for each food you transport in the United States. You 
may fulfill this requirement by either:
    (a) Establishing and maintaining the following records:
    (1) Names of the transporter's immediate previous source and 
transporter's immediate subsequent recipient;
    (2) Origin and destination points;
    (3) Date shipment received and date released;
    (4) Number of packages;
    (5) Description of freight;
    (6) Route of movement during the time you transported the food; and
    (7) Transfer point(s) through which shipment moved; or
    (b) Establishing and maintaining records containing the following 
information currently required by the Department of Transportation's 
Federal Motor Carrier Safety Administration (of roadway interstate 
transporters (49 CFR 373.101 and 373.103) as of December 9, 2004:
    (1) Names of consignor and consignee;
    (2) Origin and destination points;
    (3) Date of shipment;
    (4) Number of packages;
    (5) Description of freight;
    (6) Route of movement and name of each carrier participating in the 
transportation; and
    (7) Transfer points through which shipment moved; or
    (c) Establishing and maintaining records containing the following 
information currently required by the Department of Transportation's 
Surface Transportation Board of rail and water interstate transporters 
(49 CFR 1035.1 and 1035.2) as of December 9, 2004:
    (1) Date received;
    (2) Received from;
    (3) Consigned to;
    (4) Destination;
    (5) State of;
    (6) County of;
    (7) Route;
    (8) Delivering carrier;
    (9) Car initial;
    (10) Car no;

[[Page 42]]

    (11) Trailer initials/number;
    (12) Container initials/number;
    (13) No. packages; and
    (14) Description of articles; or
    (d) Establishing and maintaining records containing the following 
information currently required by the Warsaw Convention of international 
air transporters on air waybills:
    (1) Shipper's name and address;
    (2) Consignee's name and address;
    (3) Customs reference/status;
    (4) Airport of departure and destination;
    (5) First carrier; and
    (6) Description of goods; or
    (e) Entering into an agreement with the nontransporter immediate 
previous source located in the United States and/or the nontransporter 
immediate subsequent recipient located in the United States to 
establish, maintain, or establish and maintain, the information in Sec. 
1.352(a), (b), (c), or (d). The agreement must contain the following 
elements:
    (1) Effective date;
    (2) Printed names and signatures of authorized officials;
    (3) Description of the records to be established and/or maintained;
    (4) Provision for the records to be maintained in compliance with 
Sec. 1.360, if the agreement provides for maintenance of records;
    (5) Provision for the records to be available to FDA as required by 
Sec. 1.361, if the agreement provides for maintenance of records;
    (6) Acknowledgement that the nontransporter assumes legal 
responsibility under Sec. 1.363 for establishing and/or maintaining the 
records as required by this subpart; and
    (7) Provision that if the agreement is terminated in writing by 
either party, responsibility for compliance with the applicable 
establishment, maintenance, and access provisions of this subpart 
reverts to the transporter as of the date of termination.

                          General Requirements



Sec. 1.360  What are the record retention requirements?

    (a) You must create the required records when you receive and 
release food, except to the extent that the information is contained in 
existing records.
    (b) If you are a nontransporter, you must retain for 6 months after 
the dates you receive and release the food all required records for any 
food having a significant risk of spoilage, loss of value, or loss of 
palatability within 60 days after the date you receive or release the 
food.
    (c) If you are a nontransporter, you must retain for 1 year after 
the dates you receive and release the food all required records for any 
food for which a significant risk of spoilage, loss of value, or loss of 
palatability occurs only after a minimum of 60 days, but within 6 
months, after the date you receive or release the food.
    (d) If you are a nontransporter, you must retain for 2 years after 
the dates you receive and release the food all required records for any 
food for which a significant risk of spoilage, loss of value, or loss of 
palatability does not occur sooner than 6 months after the date you 
receive or release the food, including foods preserved by freezing, 
dehydrating, or being placed in a hermetically sealed container.
    (e) If you are a nontransporter, you must retain for 1 year after 
the dates you receive and release the food all required records for 
animal food, including pet food.
    (f) If you are a transporter or nontransporter retaining records on 
behalf of a transporter, you must retain for 6 months after the dates 
you receive and release the food all required records for any food 
having a significant risk of spoilage, loss of value, or loss of 
palatability within 60 days after the date the transporter receives or 
releases the food. If you are a transporter, or nontransporter retaining 
records on behalf of a transporter, you must retain for 1 year after the 
dates you receive and release the food, all required records for any 
food for which a significant risk of spoilage, loss of value, or loss of 
palatability occurs only after a minimum of 60 days after the date the 
transporter receives or releases the food.
    (g) You must retain all records at the establishment where the 
covered activities described in the records occurred (onsite) or at a 
reasonably accessible location.

[[Page 43]]

    (h) The maintenance of electronic records is acceptable. Electronic 
records are considered to be onsite if they are accessible from an 
onsite location.



Sec. 1.361  What are the record availability requirements?

    When FDA has a reasonable belief that an article of food is 
adulterated and presents a threat of serious adverse health consequences 
or death to humans or animals, any records and other information 
accessible to FDA under section 414 or 704(a) of the act (21 U.S.C. 350c 
and 374(a)) must be made readily available for inspection and 
photocopying or other means of reproduction. Such records and other 
information must be made available as soon as possible, not to exceed 24 
hours from the time of receipt of the official request, from an officer 
or employee duly designated by the Secretary of Health and Human 
Services who presents appropriate credentials and a written notice.



Sec. 1.362  What records are excluded from this subpart?

    The establishment and maintenance of records as required by this 
subpart does not extend to recipes for food as defined in Sec. 1.328; 
financial data, pricing data, personnel data, research data, or sales 
data (other than shipment data regarding sales).



Sec. 1.363  What are the consequences of failing to establish or maintain 

records or make them available to FDA as required by this subpart?

    (a) The failure to establish or maintain records as required by 
section 414(b) of the act and this regulation or the refusal to permit 
access to or verification or copying of any such required record is a 
prohibited act under section 301 of the act.
    (b) The failure of a nontransporter immediate previous source or a 
nontransporter immediate subsequent recipient who enters an agreement 
under Sec. 1.352(e) to establish, maintain, or establish and maintain, 
records required under Sec. 1.352(a), (b), (c), or (d), or the refusal 
to permit access to or verification or copying of any such required 
record, is a prohibited act under section 301 of the act.
    (c) The failure of any person to make records or other information 
available to FDA as required by section 414 or 704(a) of the act and 
this regulation is a prohibited act under section 301 of the act.

[69 FR 71651, Dec. 9, 2004, as amended at 70 FR 8726, Feb. 23, 2005]

                            Compliance Dates



Sec. 1.368  What are the compliance dates for this subpart?

    The compliance date for the requirements in this subpart is December 
9, 2005. However, the compliance dates for small and very small 
businesses are contained in paragraphs (a) and (b) of this section. The 
size of the business is determined using the total number of full-time 
equivalent employees in the entire business, not each individual 
location or establishment. A full-time employee counts as one full-time 
equivalent employee. Two part-time employees, each working half time, 
count as one full-time equivalent employee.
    (a) The compliance date for the requirements in this subpart is June 
9, 2006, for small businesses employing fewer that 500, but more than 10 
full-time equivalent employees.
    (b) The compliance date for the requirements in this subpart is 
December 11, 2006, for very small businesses that employ 10 or fewer 
full-time equivalent employees.

[69 FR 71651, Dec. 9, 2004, as amended at 70 FR 8727, Feb. 23, 2005]



     Subpart K_Administrative Detention of Food for Human or Animal 
                               Consumption

    Source: 69 FR 31701, June 4, 2004, unless otherwise noted.

                           General Provisions



Sec. 1.377  What definitions apply to this subpart?

    The definitions of terms that appear in section 201 of the act (21 
U.S.C. 321) apply when the terms are used in this

[[Page 44]]

subpart. In addition, for the purposes of this subpart:
    Act means the Federal Food, Drug, and Cosmetic Act.
    Authorized FDA representative means an FDA District Director in 
whose district the article of food involved is located or an FDA 
official senior to such director.
    Calendar day means every day shown on the calendar.
    Food has the meaning given in section 201(f) of the act (21 U.S.C. 
321(f)). Examples of food include, but are not limited to, fruits, 
vegetables, fish, dairy products, eggs, raw agricultural commodities for 
use as food or components of food, animal feed, including pet food, food 
and feed ingredients and additives, including substances that migrate 
into food from food packaging and other articles that contact food, 
dietary supplements and dietary ingredients, infant formula, beverages, 
including alcoholic beverages and bottled water, live food animals, 
bakery goods, snack foods, candy, and canned foods.
    Perishable food means food that is not heat-treated; not frozen; and 
not otherwise preserved in a manner so as to prevent the quality of the 
food from being adversely affected if held longer than 7 calendar days 
under normal shipping and storage conditions.
    We means the U.S. Food and Drug Administration (FDA).
    Working day means any day from Monday through Friday, excluding 
Federal holidays.
    You means any person who received the detention order or that 
person's representative.



Sec. 1.378  What criteria does FDA use to order a detention?

    An officer or qualified employee of FDA may order the detention of 
any article of food that is found during an inspection, examination, or 
investigation under the act if the officer or qualified employee has 
credible evidence or information indicating that the article of food 
presents a threat of serious adverse health consequences or death to 
humans or animals.



Sec. 1.379  How long may FDA detain an article of food?

    (a) FDA may detain an article of food for a reasonable period that 
may not exceed 20 calendar days after the detention order is issued. 
However, an article may be detained for 10 additional calendar days if a 
greater period of time is required to institute a seizure or injunction 
action. The authorized FDA representative may approve the additional 10-
calendar day detention period at the time the detention order is issued, 
or at any time within the 20-calendar day period by amending the 
detention order.
    (b) The entire detention period may not exceed 30 calendar days.
    (c) An authorized FDA representative may, in accordance with Sec. 
1.384, terminate a detention order before the expiration of the 
detention period.



Sec. 1.380  Where and under what conditions must the detained article of food 

be held?

    (a) You must hold the detained article of food in the location and 
under the conditions specified by FDA in the detention order.
    (b) If FDA determines that removal to a secure facility is 
appropriate, the article of food must be removed to a secure facility. A 
detained article of food remains under detention before, during, and 
after movement to a secure facility. FDA will also state in the 
detention order any conditions of transportation applicable to the 
detained article.
    (c) If FDA directs you to move the detained article of food to a 
secure facility, you must receive a modification of the detention order 
under Sec. 1.381(c) before you move the detained article of food to a 
secure facility.
    (d) You must ensure that any required tags or labels under Sec. 
1.382 accompany the detained article during and after movement. The tags 
or labels must remain with the article of food until FDA terminates the 
detention order or the detention period expires, whichever occurs first, 
unless otherwise permitted by the authorized FDA representative.
    (e) The movement of an article of food in violation of a detention 
order issued under Sec. 1.393 is a prohibited act

[[Page 45]]

under section 301 of the act (21 U.S.C. 331).



Sec. 1.381  May a detained article of food be delivered to another entity or 

transferred to another location?

    (a) An article of food subject to a detention order under this 
subpart may not be delivered under the execution of a bond. 
Notwithstanding section 801(b) of the act (21 U.S.C. 381(b)), while any 
article of food is subject to a detention order under section 304(h) of 
the act (21 U.S.C. 334(h)), it may not be delivered to any of its 
importers, owners, or consignees. This section does not preclude 
movement at FDA's direction of imported food to a secure facility under 
an appropriate Customs' bond when that bond is required by Customs' law 
and regulation.
    (b) Except as provided in paragraph (c) of this section, no person 
may transfer a detained article of food within or from the place where 
it has been ordered detained, or from the place to which it was removed, 
until an authorized FDA representative releases the article of food 
under Sec. 1.384 or the detention period expires under Sec. 1.379, 
whichever occurs first.
    (c) The authorized FDA representative may approve, in writing, a 
request to modify a detention order to permit movement of a detained 
article of food for any of the following purposes:
    (1) To destroy the article of food,
    (2) To move the detained article of food to a secure facility under 
the terms of a detention order,
    (3) To maintain or preserve the integrity or quality of the article 
of food, or
    (4) For any other purpose that the authorized FDA representative 
believes is appropriate in the case.
    (d) You must submit your request for modification of the detention 
order in writing to the authorized FDA representative who approved the 
detention order. You must state in your request the reasons for 
movement; the exact address of and location in the new facility (or the 
new location within the same facility) where the detained article of 
food will be transferred; an explanation of how the new address and 
location will be secure, if FDA has directed that the article be 
detained in a secure facility; and how the article will be held under 
any applicable conditions described in the detention order. If you are 
requesting modification of a detention order for the purpose of 
destroying the detained article of food, you also must submit a verified 
statement identifying the ownership or proprietary interest you have in 
the detained article of food, in accordance with Supplemental Rule C to 
the ``Federal Rules of Civil Procedure.''
    (e) If FDA approves a request for modification of a detention order, 
the article may be transferred but remains under detention before, 
during, and after the transfer. FDA will state any conditions of 
transportation applicable to the detained article. You may not transfer 
a detained article of food without FDA supervision unless FDA has 
declined in writing to supervise the transfer. If FDA has declined in 
writing to supervise the transfer of a detained article, you must 
immediately notify in writing the authorized FDA representative who 
approved the modification of the detention order that the article of 
food has reached its new location, and the specific location of the 
detained article within the new location. Such written notification may 
be in the form of a fax, e-mail, or other form as agreed to by the 
authorized FDA representative.
    (f) You must ensure that any required tags or labels under Sec. 
1.382 accompany the detained article during and after movement. The tags 
or labels must remain with the article of food until FDA terminates the 
detention order or the detention period expires, whichever occurs first, 
unless otherwise permitted by the authorized FDA representative who 
approves the modification of a detention order under this section.
    (g) The transfer of an article of food in violation of a detention 
order issued under Sec. 1.393 is a prohibited act under section 301 of 
the act.



Sec. 1.382  What labeling or marking requirements apply to a detained article 

of food?

    The officer or qualified employee of FDA issuing a detention order 
under Sec. 1.393 may label or mark the detained article of food with 
official FDA tags

[[Page 46]]

or labels that include the following information:
    (a) A statement that the article of food is detained by FDA in 
accordance with section 304(h) of the act;
    (b) A statement that the article of food must not be consumed, 
moved, altered, or tampered with in any manner for the period shown, 
without the written permission of an authorized FDA representative;
    (c) A statement that the violation of a detention order or the 
removal or alteration of the tag or label is a prohibited act, 
punishable by fine or imprisonment or both; and
    (d) The detention order number, the date and hour of the detention 
order, the detention period, and the name of the officer or qualified 
employee of FDA who issued the detention order.



Sec. 1.383  What expedited procedures apply when FDA initiates a seizure 

action against a detained perishable food?

    If FDA initiates a seizure action under section 304(a) of the act 
against a perishable food subject to a detention order under this 
subpart, FDA will send the seizure recommendation to the Department of 
Justice (DOJ) within 4 calendar days after the detention order is 
issued, unless extenuating circumstances exist. If the fourth calendar 
day is not a working day, FDA will advise the DOJ of its plans to 
recommend a seizure action on the last working day before the fourth 
calendar day and send the recommendation as soon as practicable on the 
first working day that follows. For purposes of this section, an 
extenuating circumstance includes, but is not limited to, instances when 
the results of confirmatory testing or other evidentiary development 
requires more than 4 calendar days to complete.



Sec. 1.384  When does a detention order terminate?

    If FDA terminates a detention order or the detention period expires, 
an authorized FDA representative will issue a detention termination 
notice releasing the article of food to any person who received the 
detention order or that person's representative and will remove, or 
authorize in writing the removal of, the required labels or tags. If FDA 
fails to issue a detention termination notice and the detention period 
expires, the detention is deemed to be terminated.

                     How Does FDA Order a Detention?



Sec. 1.391  Who approves a detention order?

    An authorized FDA representative, i.e., the FDA District Director in 
whose district the article of food involved is located or an FDA 
official senior to such director, must approve a detention order. If 
prior written approval is not feasible, prior oral approval must be 
obtained and confirmed in writing as soon as possible.



Sec. 1.392  Who receives a copy of the detention order?

    (a) FDA must issue the detention order to the owner, operator, or 
agent in charge of the place where the article of food is located. If 
the owner of the article of food is different from the owner, operator, 
or agent in charge of the place where the article is detained, FDA must 
provide a copy of the detention order to the owner of the article of 
food if the owner's identity can be determined readily.
    (b) If FDA issues a detention order for an article of food located 
in a vehicle or other carrier used to transport the detained article of 
food, FDA also must provide a copy of the detention order to the shipper 
of record and the owner and operator of the vehicle or other carrier, if 
their identities can be determined readily.



Sec. 1.393  What information must FDA include in the detention order?

    (a) FDA must issue the detention order in writing, in the form of a 
detention notice, signed and dated by the officer or qualified employee 
of FDA who has credible evidence or information indicating that such 
article of food presents a threat of serious adverse health consequences 
or death to humans or animals.
    (b) The detention order must include the following information:
    (1) The detention order number;
    (2) The date and hour of the detention order;

[[Page 47]]

    (3) Identification of the detained article of food;
    (4) The period of the detention;
    (5) A statement that the article of food identified in the order is 
detained for the period shown;
    (6) A brief, general statement of the reasons for the detention;
    (7) The address and location where the article of food is to be 
detained and the appropriate storage conditions;
    (8) Any applicable conditions of transportation of the detained 
article of food;
    (9) A statement that the article of food is not to be consumed, 
moved, altered, or tampered with in any manner during the detention 
period, unless the detention order is first modified under Sec. 
1.381(c);
    (10) The text of section 304(h) of the act and Sec. Sec. 1.401 and 
1.402;
    (11) A statement that any informal hearing on an appeal of a 
detention order must be conducted as a regulatory hearing under part 16 
of this chapter, with certain exceptions described in Sec. 1.403;
    (12) The mailing address, telephone number, e-mail address, and fax 
number of the FDA district office and the name of the FDA District 
Director in whose district the detained article of food is located;
    (13) A statement indicating the manner in which approval of the 
detention order was obtained, i.e., verbally or in writing; and
    (14) The name and the title of the authorized FDA representative who 
approved the detention order.

            What Is the Appeal Process for a Detention Order?



Sec. 1.401  Who is entitled to appeal?

    Any person who would be entitled to be a claimant for the article of 
food, if seized under section 304(a) of the act, may appeal a detention 
order as specified in Sec. 1.402. Procedures for establishing 
entitlement to be a claimant for purposes of section 304(a) of the act 
are governed by Supplemental Rule C to the ``Federal Rules of Civil 
Procedure.''



Sec. 1.402  What are the requirements for submitting an appeal?

    (a) If you want to appeal a detention order, you must submit your 
appeal in writing to the FDA District Director, in whose district the 
detained article of food is located, at the mailing address, e-mail 
address, or fax number identified in the detention order according to 
the following applicable timeframes:
    (1) Perishable food: If the detained article is a perishable food, 
as defined in Sec. 1.377, you must file an appeal within 2 calendar 
days of receipt of the detention order.
    (2) Nonperishable food: If the detained article is not a perishable 
food, as defined in Sec. 1.377, you must file a notice of an intent to 
request a hearing within 4 calendar days of receipt of the detention 
order. If the notice of intent is not filed within 4 calendar days, you 
will not be granted a hearing. If you have not filed a timely notice of 
intent to request a hearing, you may file an appeal without a hearing 
request. Whether or not it includes a request for hearing, your appeal 
must be filed within 10 calendar days of receipt of the detention order.
    (b) Your request for appeal must include a verified statement 
identifying your ownership or proprietary interest in the detained 
article of food, in accordance with Supplemental Rule C to the ``Federal 
Rules of Civil Procedure.''
    (c) The process for the appeal of a detention order under this 
section terminates if FDA institutes either a seizure action under 
section 304(a) of the act or an injunction under section 302 of the act 
(21 U.S.C. 276) regarding the article of food involved in the detention 
order.
    (d) As part of the appeals process, you may request an informal 
hearing. Your request for a hearing must be in writing and must be 
included in your request for an appeal specified in paragraph (a) of 
this section. If you request an informal hearing, and FDA grants your 
request, the hearing will be held within 2 calendar days after the date 
the appeal is filed.



Sec. 1.403  What requirements apply to an informal hearing?

    If FDA grants a request for an informal hearing on an appeal of a 
detention order, FDA must conduct the

[[Page 48]]

hearing in accordance with part 16 of this chapter, except that:
    (a) The detention order under Sec. 1.393, rather than the notice 
under Sec. 16.22(a) of this chapter, provides notice of opportunity for 
a hearing under this section and is part of the administrative record of 
the regulatory hearing under Sec. 16.80(a) of this chapter;
    (b) A request for a hearing under this section must be addressed to 
the FDA District Director in whose district the article of food involved 
is located;
    (c) The provision in Sec. 16.22(b) of this chapter, providing that 
a person not be given less than 3 working days after receipt of notice 
to request a hearing, does not apply to a hearing under this subpart;
    (d) The provision in Sec. 16.24(e) of this chapter, stating that a 
hearing may not be required to be held at a time less than 2 working 
days after receipt of the request for a hearing, does not apply to a 
hearing under this subpart;
    (e) Section 1.406, rather than Sec. 16.24(f) of this chapter, 
describes the statement that will be provided to an appellant where a 
detention order is based on classified information;
    (f) Section 1.404, rather than Sec. 16.42(a) of this chapter, 
describes the FDA employees, e.g., Regional Food and Drug Directors or 
other officials senior to a District Director, who preside at hearings 
under this subpart;
    (g) The presiding officer may require that a hearing conducted under 
this section be completed within 1 calendar day, as appropriate;
    (h) Section 16.60(e) and (f) of this chapter does not apply to a 
hearing under this subpart. The presiding officer must prepare a written 
report of the hearing. All written material presented at the hearing 
will be attached to the report. The presiding officer must 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 must include a proposed decision, with a statement 
of reasons. The hearing participant may review and comment on the 
presiding officer's report within 4 hours of issuance of the report. The 
presiding officer will then issue the final agency decision.
    (i) Section 16.80(a)(4) of this chapter does not apply to a 
regulatory hearing under this subpart. The presiding officer's report of 
the hearing and any comments on the report by the hearing participant 
under Sec. 1.403(h) are part of the administrative record.
    (j) No party shall have the right, under Sec. 16.119 of this 
chapter to petition the Commissioner of Food and Drugs for 
reconsideration or a stay of the presiding officer's final agency 
decision.
    (k) If FDA grants a request for an informal hearing on an appeal of 
a detention order, the hearing must be conducted as a regulatory hearing 
pursuant to regulation in accordance with part 16 of this chapter, 
except that Sec. 16.95(b) does not apply to a hearing under this 
subpart. With respect to a regulatory hearing under this subpart, the 
administrative record of the hearing specified in Sec. Sec. 
16.80(a)(1), (a)(2), (a)(3), and (a)(5), and 1.403(i) constitutes the 
exclusive record for the presiding officer's final decision on an 
administrative detention. For purposes of judicial review under Sec. 
10.45 of this chapter, the record of the administrative proceeding 
consists of the record of the hearing and the presiding officer's final 
decision.



Sec. 1.404  Who serves as the presiding officer for an appeal, and for an 

informal hearing?

    The presiding officer for an appeal, and for an informal hearing, 
must be an FDA Regional Food and Drug Director or another FDA official 
senior to an FDA District Director.



Sec. 1.405  When does FDA have to issue a decision on an appeal?

    (a) The presiding officer must issue a written report that includes 
a proposed decision confirming or revoking the detention by noon on the 
fifth calendar day after the appeal is filed; after your 4 hour 
opportunity for submitting comments under Sec. 1.403(h), the presiding 
officer must issue a final decision within the 5-calendar day period 
after the appeal is filed. If FDA either fails to provide you with an 
opportunity to request an informal hearing, or fails to confirm or 
terminate the detention order within the 5-calendar day period,

[[Page 49]]

the detention order is deemed terminated.
    (b) If you appeal the detention order, but do not request an 
informal hearing, the presiding officer must issue a decision on the 
appeal confirming or revoking the detention within 5 calendar days after 
the date the appeal is filed. If the presiding officer fails to confirm 
or terminate the detention order during such 5-calendar day period, the 
detention order is deemed terminated.
    (c) If you appeal the detention order and request an informal 
hearing and your hearing request is denied, the presiding officer must 
issue a decision on the appeal confirming or revoking the detention 
within 5 calendar days after the date the appeal is filed. If the 
presiding officer fails to confirm or terminate the detention order 
during such 5-calendar day period, the detention order is deemed 
terminated.
    (d) If the presiding officer confirms a detention order, the article 
of food continues to be detained until we terminate the detention under 
Sec. 1.384 or the detention period expires under Sec. 1.379, whichever 
occurs first.
    (e) If the presiding officer terminates a detention order, or the 
detention period expires, FDA must terminate the detention order as 
specified under Sec. 1.384.
    (f) Confirmation of a detention order by the presiding officer is 
considered a final agency action for purposes of 5 U.S.C. 702.



Sec. 1.406  How will FDA handle classified information in an informal 

hearing?

    Where the credible evidence or information supporting the detention 
order is classified under the applicable Executive order as requiring 
protection from unauthorized disclosure in the interest of national 
security (``classified information''), FDA will not provide you with 
this information. The presiding officer will give you notice of the 
general nature of the information and an opportunity to offer opposing 
evidence or information, if he or she may do so consistently with 
safeguarding the information and its source. If classified information 
was used to support the detention, then any confirmation of such 
detention will state whether it is based in whole or in part on that 
classified information.



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 ozone-depleting substances in foods, drugs, devices, or 
          cosmetics.

    Authority: 15 U.S.C. 402, 409; 21 U.S.C. 321, 331, 335, 342, 343, 
346a, 348, 351, 352, 355, 360b, 361, 362, 371, 372, 374; 42 U.S.C. 7671 
et seq.

    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

[[Page 50]]

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 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

[[Page 51]]

sample. When two or more requests for parts of the same sample are 
received the requests shall be complied with in the order in which they 
were received so long as any part of the sample remains available 
therefor.
    (d) When an official sample of food, drug, or cosmetic is the basis 
of a notice given under section 305 of the act, or of a case under the 
act, and the person to whom the notice was given, or any person who is a 
party to the case, has no right under paragraph (c) of this section to a 
part of the sample, such person or his attorney or agent may obtain a 
part of the sample upon request accompanied by a written waiver of right 
under such paragraph (c) from each person named on the label of the 
article and owner thereof, who has not exercised his right under such 
paragraph (c). The operation of this paragraph shall be subject to the 
exceptions, terms, and conditions prescribed in paragraph (c) of this 
section.
    (e) The Food and Drug Administration is authorized to destroy:
    (1) Any official sample when it determines that no analysis of such 
sample will be made;
    (2) Any official sample or part thereof when it determines that no 
notice under section 305 of the act, and no case under the act, is or 
will be based on such sample;
    (3) Any official sample or part thereof when the sample was the 
basis of a notice under section 305 of the act, and when, after 
opportunity for presentation of views following such notice, it 
determines that no other such notice, and no case under the act, is or 
will be based on such sample;
    (4) Any official sample or part thereof when the sample was the 
basis of a case under the act which has gone to final judgment, and when 
it determines that no other such case is or will be based on such 
sample;
    (5) Any official sample or part thereof if the article is 
perishable;
    (6) Any official sample or part thereof when, after collection, such 
sample or part has become decomposed or otherwise unfit for analysis;
    (7) That part of any official sample which is in excess of three 
times the quantity it estimates to be sufficient for analysis.

[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 AOAC INTERNATIONAL 
(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 AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html. 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; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 
2005]

[[Page 52]]



                    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 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.

[[Page 53]]

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 ozone-depleting substances in foods, drugs, devices, or 

cosmetics.

    (a) As used in this section, ozone-depleting substance (ODS) means 
any class I substance as defined in 40 CFR part 82, appendix A to 
subpart A, or class II substance as defined in 40 CFR part 82, appendix 
B to subpart A.
    (b) Except as provided in paragraph (c) of this section, any food, 
drug, device, or cosmetic that is, consists in part of, or is contained 
in an aerosol product or other pressurized dispenser that releases an 
ODS is not an essential use of the ODS under the Clean Air Act.
    (c) A food, drug, device, or cosmetic that is, consists in part of, 
or is contained in an aerosol product or other pressurized dispenser 
that releases an ODS is an essential use of the ODS under the Clean Air 
Act if paragraph (e) of this section specifies the use of that product 
as essential. For drugs, including biologics and animal drugs, and for 
devices, an investigational application or an approved marketing 
application must be in effect, as applicable.
    (d) [Reserved]
    (e) The use of ODSs in the following products is essential:
    (1) Metered-dose corticosteroid human drugs for oral inhalation. 
Oral pressurized metered-dose inhalers containing the following active 
moieties:
    (i) Beclomethasone.
    (ii) Dexamethasone.
    (iii) Flunisolide.
    (iv) Fluticasone.
    (v) Triamcinolone.
    (2) Metered-dose short-acting adrenergic bronchodilator human drugs 
for oral inhalation. Oral pressurized metered-dose inhalers containing 
the following active moieties:
    (i) Albuterol.
    (ii) Bitolterol.
    (iii) Metaproterenol.
    (iv) Pirbuterol.
    (v) Epinephrine.
    (3) [Reserved]
    (4) Other essential uses. (i) Metered-dose salmeterol drug products 
administered by oral inhalation for use in humans.
    (ii) Metered-dose ergotamine tartrate drug products administered by 
oral inhalation for use in humans.
    (iii) Anesthetic drugs for topical use on accessible mucous 
membranes of humans where a cannula is used for application.
    (iv) Metered-dose cromolyn sodium human drugs administered by oral 
inhalation.
    (v) Metered-dose ipratropium bromide for oral inhalation.
    (vi) Metered-dose atropine sulfate aerosol human drugs administered 
by oral inhalation.
    (vii) Metered-dose nedocromil sodium human drugs administered by 
oral inhalation.

[[Page 54]]

    (viii) Metered-dose ipratropium bromide and albuterol sulfate, in 
combination, administered by oral inhalation for human use.
    (ix) Sterile aerosol talc administered intrapleurally by 
thoracoscopy for human use.
    (f) Any person may file a petition under part 10 of this chapter to 
request that FDA initiate rulemaking to amend paragraph (e) of this 
section to add an essential use. FDA may initiate notice-and-comment 
rulemaking to add an essential use on its own initiative or in response 
to a petition, if granted.
    (1) If the petition is to add use of a noninvestigational product, 
the petitioner must submit compelling evidence that:
    (i) Substantial technical barriers exist to formulating the product 
without ODSs;
    (ii) The product will provide an unavailable important public health 
benefit; and
    (iii) Use of the product does not release cumulatively significant 
amounts of ODSs into the atmosphere or the release is warranted in view 
of the unavailable important public health benefit.
    (2) If the petition is to add use of an investigational product, the 
petitioner must submit compelling evidence that:
    (i) Substantial technical barriers exist to formulating the 
investigational product without ODSs;
    (ii) A high probability exists that the investigational product will 
provide an unavailable important public health benefit; and
    (iii) Use of the investigational product does not release 
cumulatively significant amounts of ODSs into the atmosphere or the 
release is warranted in view of the high probability of an unavailable 
important public health benefit.
    (g) Any person may file a petition under part 10 of this chapter to 
request that FDA initiate rulemaking to amend paragraph (e) of this 
section to remove an essential use. FDA may initiate notice-and-comment 
rulemaking to remove an essential use on its own initiative or in 
response to a petition, if granted. If the petition is to remove an 
essential use from paragraph (e) of this section, the petitioner must 
submit compelling evidence of any one of the following criteria:
    (1) The product using an ODS is no longer being marketed; or
    (2) After January 1, 2005, FDA determines that the product using an 
ODS no longer meets the criteria in paragraph (f) of this section after 
consultation with a relevant advisory committee(s) and after an open 
public meeting; or
    (3) For individual active moieties marketed as ODS products and 
represented by one new drug application (NDA):
    (i) At least one non-ODS product with the same active moiety is 
marketed with the same route of administration, for the same indication, 
and with approximately the same level of convenience of use as the ODS 
product containing that active moiety;
    (ii) Supplies and production capacity for the non-ODS product(s) 
exist or will exist at levels sufficient to meet patient need;
    (iii) Adequate U.S. postmarketing use data is available for the non-
ODS product(s); and
    (iv) Patients who medically required the ODS product are adequately 
served by the non-ODS product(s) containing that active moiety and other 
available products; or
    (4) For individual active moieties marketed as ODS products and 
represented by two or more NDAs:
    (i) At least two non-ODS products that contain the same active 
moiety are being marketed with the same route of delivery, for the same 
indication, and with approximately the same level of convenience of use 
as the ODS products; and
    (ii) The requirements of paragraphs (g)(3)(ii), (g)(3)(iii), and 
(g)(3)(iv) of this section are met.

[67 FR 48384, July 24, 2002]

    Effective Date Notes: 1. At 70 FR 17192, Apr. 4, 2005, Sec. 2.125 
was amended by removing paragraph (e)(2)(i), effective December 31, 
2008.
    2. At 71 FR 70873, Dec. 7, 2006, Sec. 2.125 was amended by removing 
and reserving paragraphs (e)(1)(i), (e)(1)(ii), (e)(1)(iv), (e)(2)(ii), 
(e)(4)(i), (e)(4)(ii), and (e)(4)(v), effective Apr. 23, 2007, except 
for Sec. 2.125(e)(4)(v) which is effective Aug. 1, 2007.

[[Page 55]]



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, 353, 355, 360, 360c-360f, 360h-360j, 
360gg-360ss, 360bbb-2, 371(a), 379e, 381, 394; 42 U.S.C. 216, 262, 264.

    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 (Public 
Law 101-629) and amended by section 204 of the Medical Device User Fee 
and Modernization Act of 2002 (Public Law 107-250), 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.

[56 FR 58756, Nov. 21, 1991, as amended by 68 FR 37077, June 23, 2003]



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, the Center for 
Drug Evaluation and Research, or alternative organizational component of 
the agency.
    (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 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,

[[Page 56]]

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) Mode of action is the means by which a product achieves an 
intended therapeutic effect or action. For purposes of this definition, 
``therapeutic'' action or effect includes any effect or action of the 
combination product intended to diagnose, cure, mitigate, treat, or 
prevent disease, or affect the structure or any function of the body. 
When making assignments of combination products under this part, the 
agency will consider three types of mode of action: The actions provided 
by a biological product, a device, and a drug. Because combination 
products are comprised of more than one type of regulated article 
(biological product, device, or drug), and each constituent part 
contributes a biological product, device, or drug mode of action, 
combination products will typically have more than one identifiable mode 
of action.
    (1) A constituent part has a biological product mode of action if it 
acts by means of a virus, therapeutic serum, toxin, antitoxin, vaccine, 
blood, blood component or derivative, allergenic product, or analogous 
product applicable to the prevention, treatment, or cure of a disease or 
condition of human beings, as described in section 351(i) of the Public 
Health Service Act.
    (2) A constituent part has a device mode of action if it meets the 
definition of device contained in section 201(h)(1) to (h)(3) of the 
act, it does not have a biological product mode of action, and it does 
not achieve its primary intended purposes through chemical action within 
or on the body of man or other animals and is not dependent upon being 
metabolized for the achievement of its primary intended purposes.
    (3) A constituent part has a drug mode of action if it meets the 
definition of drug contained in section 201(g)(1) of the act and it does 
not have a biological product or device mode of action.
    (l) 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).
    (m) Primary mode of action is the single mode of action of a 
combination product that provides the most important therapeutic action 
of the combination product. The most important therapeutic action is the 
mode of action expected to make the greatest contribution to the overall 
intended therapeutic effects of the combination product.
    (n) 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)).
    (o) 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.

[[Page 57]]

    (p) 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; 68 FR 37077, June 23, 2003; 70 FR 49861, Aug. 25, 
2005]



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) In some situations, it is not possible to determine, with 
reasonable certainty, which one mode of action will provide a greater 
contribution than any other mode of action to the overall therapeutic 
effects of the combination product. In such a case, the agency will 
assign the combination product to the agency component that regulates 
other combination products that present similar questions of safety and 
effectiveness with regard to the combination product as a whole. When 
there are no other combination products that present similar questions 
of safety and effectiveness with regard to the combination product as a 
whole, the agency will assign the combination product to the agency 
component with the most expertise related to the most significant safety 
and effectiveness questions presented by the combination product.
    (c) 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.

[56 FR 58756, Nov. 21, 1991, as amended at 70 FR 49861, Aug. 25, 2005]



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 clarifying product 
jurisdictional issues. These guidance documents are on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 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

[[Page 58]]

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.

[56 FR 58756, Nov. 21, 1991, as amended at 68 FR 24879, May 9, 2003]



Sec. 3.6  Product jurisdiction officer.

    The Office of Combination Products (HFG-3), Food and Drug 
Administration, 15800 Crabbs Branch Way, suite 200, Rockville, MD 20855, 
301-427-1934, e-mail: combination@fda.gov, is the designated product 
jurisdiction officer.

[68 FR 37077, June 23, 2003, as amended at 71 FR 16033, Mar. 30, 2006]



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 single mode of action that provides the most 
important therapeutic action of the product, and the basis for that 
determination.
    (x) Schedule and duration of use;
    (xi) Dose and route of administration of drug or biologic;
    (xii) Description of related products, including the regulatory 
status of those related products; and
    (xiii) Any other relevant information.
    (3) The sponsor's recommendation as to which agency component should 
have primary jurisdiction based on the mode of action that provides the 
most important therapeutic action of the combination product. If the 
sponsor cannot determine with reasonable certainty which mode of action 
provides the most important therapeutic action of the combination 
product, the sponsor's recommendation must be based on the assignment 
algorithm set forth in Sec. 3.4(b) and an assessment of the assignment 
of other combination products the sponsor wishes FDA to consider during 
the assignment of its combination product.
    (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.'' Concurrent submissions of electronic

[[Page 59]]

copies of Requests for Designation may be addressed to 
combination@fda.gov.

[56 FR 58756, Nov. 21, 1991, as amended at 68 FR 37077, June 23, 2003; 
70 FR 49861, Aug. 25, 2005]



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 Principal 
Associate Commissioner.

[56 FR 58756, Nov. 21, 1991, as amended at 68 FR 37077, June 23, 2003]



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]



PART 5_ORGANIZATION--Table of Contents




Subparts A-L [Reserved]

                         Subpart M_Organization

Sec.
5.1100 Headquarters.
5.1105 Chief Counsel, Food and Drug Administration.
5.1110 FDA Public Information Offices.
5.1115 Field structure.

    Authority: 5 U.S.C. 552; 21 U.S.C. 301-397.

    Source: 69 FR 17286, Apr. 2, 2004, unless otherwise noted.

Subparts A-L [Reserved]

[[Page 60]]



                         Subpart M_Organization



Sec. 5.1100  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.\2\
---------------------------------------------------------------------------

    \2\ The Office of the Chief Counsel (also known as the Food and Drug 
Division, Office of the General Counsel, Department of Health and Human 
Services), while administratively within the Office of the Commissioner, 
is part of the Office of the General Counsel of the Department of Health 
and Human Services.

---------------------------------------------------------------------------
Office of Equal Employment Opportunity and Diversity.

Office of the Administrative Law Judge.

Office of External Relations.

Office of Executive Secretariat.

Office of Public Affairs.

Office of the Ombudsman.

Office of Special Health Issues.

Office of Policy and Planning.

Office of Policy.

Office of Planning.

Office of Management.

Office of the Chief Information Officer.

Office of Financial Management.

Office of Shared Services.\3\
---------------------------------------------------------------------------

    \3\ Mailing address: 5630 Fishers Lane, Rockville, MD 20852.

---------------------------------------------------------------------------
Office of Management Programs.

Office of Executive Operations.

Office of Science and Health Coordination.

Office of Orphan Products Development.

Office of Women's Health.

Office of International Activities and Strategic Initiatives.

Office of International Programs.

Office of Pediatric Therapeutics.

Office of Combination Products.

Office of Legislation.

Office of Crisis Management.

Office of Emergency Operations.

Office of Security Operations, Policy and Planning.

Center for Biologics Evaluation and Research\4\
---------------------------------------------------------------------------

    \4\ 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 Compliance and Biologics Quality.

Division of Case Management.

Division of Manufacturing and Product Quality.

Division of Inspections and Surveillance.

Office of Blood Research and Review.

Policy and Publications Staff.

Division of Emerging and Transfusion Transmitted Diseases.

Division of Hematology.

Division of Blood Applications.

Office of Vaccines Research and Review.

Analytical Chemistry Staff.

Standards and Testing Staff.

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.

Office of Information Management.

[[Page 61]]


Division of Information Operations.

Division of Information Development.

Office of Cellular, Tissue, and Gene Therapies.

Division of Cell and Gene Therapies.

Division of Clinical Evaluation and Pharmacology/Toxicology Review.

Division of Human Tissues.

Center for Food Safety and Applied Nutrition\5\
---------------------------------------------------------------------------

    \5\ Mailing address: 5100 Paint Branch Pkwy., College Park, MD 
20740-3835.

---------------------------------------------------------------------------
Office of the Center Director.

Food Safety Staff.

Office of Science.

Quality Assurance Staff.

CFSAN Staff College.

Microbial Research and Risk Assessment Staff.

JIFSAN Liaison Staff.

CFSAN Food Advisory Committee Staff.

Office of Applied Research and Safety Assessment.

Muirkirk Technical Operations Staff.

Division of Molecular Biology.

Division of Virulence Assessment.

Division of Toxicology.

Office of Regulations and Policy.

Regulations Management 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 Program Support Services.

Office of Operations.

Equal Employment Opportunity Staff.

Executive Operations Staff.

Office of Cosmetics and Colors.

Division of Color Certification and Technology.

Division of Cosmetics and Compliance.

Office of Nutritional Products, Labeling and Dietary Supplements.

Infant Formula and Medical Foods Staff.

Division of Dietary Supplement Programs and Compliance.

Division of Food Labeling, Standards and Compliance.

Division of Nutrition Programs and Labeling.

Division of Research and Applied Technology.

Office of Food Additive Safety.

Division of Petition Review.

Division of Chemistry Research and Environmental Review.

Division of Food Contact Notifications.

Division of Biotechnology and GRAS Notice Review.

Office of Plant and Dairy Foods and Beverages.

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.

Division of Microbiological Studies.

Office of Seafood.

Division of Programs and Enforcement Policy.

Division of Science and Applied Technology.

Office of Compliance.

Emergency Coordination and Response Staff.

Division of Enforcement.

Division of Field Programs.

Division of Cooperative Programs.

Office of Scientific Analysis and Support.

CFSAN Adverse Events Reporting System Staff.

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.

Controlled Substance Staff.

Office of Regulatory Policy.

[[Page 62]]


Division of Regulatory Policy I.

Division of Regulatory Policy II.

Division of Information Disclosure Policy.

Office of Management.\1\

Division of Management and Budget.\1\

Division of Management Services.\1\

Office of Training and Communication.\1\

Division of Training and Development.

Division of Public Affairs.

Division of Drug Information.

Division of Library and Information Services.

Office of Compliance.\1\

Division of New Drugs and Labeling Compliance (HFD-310).

Division of Manufacturing and Product Quality (HFD-320).

Division of Compliance Risk Management and Surveillance (HFD-330).

Office of Information Technology.\1\

Quality Assurance Staff.

Technology Support Services Staff.

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\
---------------------------------------------------------------------------

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

---------------------------------------------------------------------------
Office of Pharmacoepidemiology and Statistical Science.

Office of Drug Safety.

Division of Surveillance, Research and Communication Support.

Division of Medication Errors and Technical Support.

Division of Drug Risk Evaluation.

Office of Biostatistics.

Quantitative Methods and Research Staff.

Division of Biometrics I.

Division of Biometrics II.

Division of Biometrics III.

Office of Executive Programs.

Executive Operations Staff.

Quality Assurance Staff.

Advisors and Consultants Staff.\2\

Office of Counter-Terrorism and Pediatric Drug Development.

Division of Counter-Terrorism.

Division of Pediatric Drug Development.

Office of Information Management.

Business Information Staff.

Review Technology Staff.

Division of Records Management.

Office of New Drugs.\1\

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. \1\

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 Ophthalmologic Drug 
Products.

Division of Dermatologic and Dental Drug Products.

Division of Over-The-Counter Drug Products.

Office of Drug Evaluation VI.

Division of Therapeutic Biological Oncology Products.

Division of Therapeutic Biological Internal Medicine Products.

Division of Review Management and Policy.

Office of Pharmaceutical Science.\1\

[[Page 63]]


Quality Implementation Staff.\1\

Operations Staff.\1\

Informatics and Computational Safety Analysis Staff.

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.\6\

Division of Bioequivalence.

Division of Chemistry I.

Division of Chemistry II.

Division of Labeling and Program Support.

Division of Chemistry III.

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\

Laboratory of Clinical Pharmacology.\7\
---------------------------------------------------------------------------

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

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

    \8\ Mailing address: 8301 Muirkirk Rd., Laurel, MD 20708.

Division of Pharmaceutical Analysis.\9\
---------------------------------------------------------------------------

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

---------------------------------------------------------------------------
Division of Product Quality Research.\1\

Office of Biotechnology Products.

Division of Monoclonal Antibodies.

Division of Therapeutic Protein.

Office of Regulatory Affairs\1\

Equal Employment Opportunity Staff.

Office of Resource Management.

Strategic Initiatives Staff.

Division of Planning, Evaluation, and Management.

Division of Human Resource Development.

Division of Management Operations.

Division of Personnel Operations.

Office of Information Technology.

Office of Enforcement.

Division of Compliance Management and Operations.

Division of Compliance Policy.

Division of Compliance Information and Quality Assurance.

Office of Regional Operations.

Division of Federal-State Relations.

Division of Field Science.

Division of Import Operations and Policy.

Division of Field Investigations.

Office of Criminal Investigations.

Office of Internal Affairs.

Mid-Atlantic Area Office.\10\
---------------------------------------------------------------------------

    \10\ Mailing address: 900 U.S. Customhouse, 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.

Management Services 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.

Division of Manufacturing Technologies.

Office of Surveillance and Compliance.

Division of Surveillance.

Division of Animal Feeds.

Division of Compliance.

[[Page 64]]


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.

Division of Ethics and Management Operations.

Division of Information Technology.

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 A.

Division of Enforcement B.

Office of Device Evaluation.

Program Management Staff.

Program Operations Staff.

Division of Cardiovascular Devices.

Division of Reproductive, Abdominal, and Radiological Devices.

Division of General, Restorative, and Neurological Devices.

Division of Ophthalmic, and Ear, Nose and Throat Devices.

Division of Anesthesiology, General Hospital, Infection Control, and 
Dental 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.

Office of In Vitro Diagnostic Device Evaluation and Safety.

Division of Chemistry and Toxicology Devices.

Division of Immunology and Hematology Devices.

Division of Microbiology.

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.

Division of Facilities, Engineering and Maintenance.

Division of Administrative Services.

Division of Contracts and Acquisitions.

Office of Planning, Finance and Information Technology.

Division of Planning.

Division of Financial Management.

[[Page 65]]


Division of Information Technology.

[69 FR 17286, Apr. 2, 2004, as amended at 69 FR 52600, Aug. 27, 2004]



Sec. 5.1105  Chief Counsel, Food and Drug Administration.

    The Office of the Chief Counsel's mailing address is 5600 Fishers 
Lane, rm. 6-05, Rockville, MD 20857.\1\
---------------------------------------------------------------------------

    \1\ The Office of the Chief Counsel (also known as the Food and Drug 
Division, Office of the General Counsel, Department of Health and Human 
Services), while administratively within the Office of the Commissioner, 
is part of the Office of the General Counsel of the Department of Health 
and Human Services.
---------------------------------------------------------------------------



Sec. 5.1110  FDA public information offices.

    (a) Division of Dockets Management (HFA-305). The Division of 
Dockets Management public room is located in rm. 1061, 5630 Fishers 
Lane, Rockville, MD 20852. Telephone: 301-827-6860.
    (b) Division of Freedom of Information (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). Press offices are located in rm. 
15-A07, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857. 
Telephone: 301-827-6242; and at 5100 Paint Branch Pkwy., College Park, 
MD 20740. Telephone: 301-436-2335.



Sec. 5.1115  Field structure.

                            Northeast Region

Regional Field Office: 158-15 Liberty Ave., Jamaica, NY 11433.

Northeast Regional Laboratory: 158-15 Liberty Ave., Jamaica, NY 11433.

New York District Office: 158-15 Liberty Ave., Jamaica, NY 11433.

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: 6000 Metro Dr., suite 101, Baltimore, MD 
21215.

Cincinnati District Office: 6751 Steger Dr., Cincinnati, OH 45237-3097.

Forensic Chemistry Center: 6751 Steger Dr., Cincinnati, OH 45237-3097.

New Jersey District Office: Waterview Corporate Center, 10 Waterview 
Blvd., 3d floor, Parsippany, NJ 07054.

Chicago District Office: 550 West Jackson Blvd., suite 1500, South 
Chicago, IL 60661.

Detroit District Office: 300 River Pl., suite 5900, Detroit, MI 48207.

Minneapolis District Office: 212 Third Ave. South, Minneapolis, MN 
55401.

                            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.

New Orleans District Office: 6600 Plaza Dr., suite 400, 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: 4040 North Central Expressway, suite 900, Dallas, 
TX 75204.

Dallas District Office: 4040 North Central Expressway, suite 300, 
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. 26, Jefferson, AR 
72079-9502.

[[Page 66]]


Southwest Import District Office: 4040 North Central Expressway, suite 
300, Dallas, TX 75204.

                             Pacific Region

Regional Field Office: 1301 Clay St., suite 1180-N, Oakland, CA 94512-
5217.

San Francisco District Office: 1431 Harbor Bay Pkwy., Alameda, CA 94502-
7070.

Los Angeles District Office: 19701 Fairchild, Irvine, CA 92612.

Seattle District Office: 22201 23rd Dr. SE., Bothell, WA 98021-4421.

Pacific Regional Laboratory, SW: 19701 Fairchild, Irvine, CA 92612.

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



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.

[[Page 67]]

    (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.
    (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,

[[Page 68]]

as of the date of such shipment or delivery, to be, on such date, not 
adulterated or misbranded within the meaning of the Federal Food, Drug, 
and Cosmetic Act, and not an article which may not, under the provisions 
of section 404, 505, or 512 of the act, be introduced into interstate 
commerce.
    (Signature and post-office address of person giving the guaranty of 
undertaking.)

    (c) The application of a guaranty or undertaking referred to in 
section 303(c)(2) of the act to any shipment or other delivery of an 
article shall expire when such article, after shipment or delivery by 
the person who gave such guaranty or undertaking, becomes adulterated or 
misbranded within the meaning of the act, or becomes an article which 
may not, under the provisions of section 404, 505, or 512 of the act, be 
introduced into interstate commerce.
    (d) A guaranty or undertaking referred to in section 303(c)(3) of 
the act shall state that the shipment or other delivery of the color 
additive covered thereby was manufactured by a signer thereof. It may be 
a part of or attached to the invoice or bill of sale covering such 
color. If such shipment or delivery is from a foreign manufacturer, such 
guaranty or undertaking shall be signed by such manufacturer and by an 
agent of such manufacturer who resides in the United States.
    (e) The following are suggested forms of guaranty or undertaking 
under section 303(c)(3) of the act:
    (1) For domestic manufacturers:

    (Name of manufacturer) hereby guarantees that all color additives 
listed herein were manufactured by him, and (where color additive 
regulations require certification) are from batches certified in 
accordance with the applicable regulations promulgated under the Federal 
Food, Drug, and Cosmetic Act.
    (Signature and post-office address of manufacturer.)

    (2) For foreign manufacturers:

    (Name of manufacturer and agent) hereby severally guarantee that all 
color additives listed herein were manufactured by (name of 
manufacturer), and (where color additive regulations require 
certification) are from batches certified in accordance with the 
applicable regulations promulgated under the Federal Food, Drug, and 
Cosmetic Act.
    (Signature and post-office address of manufacturer.)
    (Signature and post-office address of agent.)

    (f) For the purpose of a guaranty or undertaking under section 
303(c)(3) of the act the manufacturer of a shipment or other delivery of 
a color additive is the person who packaged such color.
    (g) A guaranty or undertaking, if signed by two or more persons, 
shall state that such persons severally guarantee the article to which 
it applies.
    (h) No representation or suggestion that an article is guaranteed 
under the act shall be made in labeling.

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 
Sec. Sec. 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

[[Page 69]]

and is to be directed to the firm that has primary responsibility for 
the manufacture and marketing of the product that is to be recalled.
    (c) Recall is generally more appropriate and affords better 
protection for consumers than seizure, when many lots of product have 
been widely distributed. Seizure, multiple seizure, or other court 
action is indicated when a firm refuses to undertake a recall requested 
by the Food and Drug Administration, or where the agency has reason to 
believe that a recall would not be effective, determines that a recall 
is ineffective, or discovers that a violation is continuing.

[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

[[Page 70]]

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:
    (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 Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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; 68 FR 24879, May 9, 2003]



Sec. 7.45  Food and Drug Administration-requested recall.

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

[43 FR 26218, June 16, 1978, as amended at 69 FR 17290, Apr. 2, 2004]



Sec. 7.46  Firm-initiated recall.

    (a) A firm may decide of its own volition and under any 
circumstances to

[[Page 71]]

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 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:

[[Page 72]]

    (i) Be brief and to the point;
    (ii) Identify clearly the product, size, lot number(s), code(s) or 
serial number(s) and any other pertinent descriptive information to 
enable accurate and immediate identification of the product;
    (iii) Explain concisely the reason for the recall and the hazard 
involved, if any;
    (iv) Provide specific instructions on what should be done with 
respect to the recalled products; and
    (v) Provide a ready means for the recipient of the communication to 
report to the recalling firm whether it has any of the product, e.g., by 
sending a postage-paid, self-addressed postcard or by allowing the 
recipient to place a collect call to the recalling firm.
    (2) The recall communication should not contain irrelevant 
qualifications, promotional materials, or any other statement that may 
detract from the message. Where necessary, followup communications 
should be sent to those who fail to respond to the initial recall 
communication.
    (d) 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

[[Page 73]]

to assume that the product subject to the recall has been removed and 
proper disposition or correction has been made commensurate with the 
degree of hazard of the recalled product. Written notification that a 
recall is terminated will be issued by the appropriate Food and Drug 
Administration district office to the recalling firm.
    (b) A recalling firm may request termination of its recall by 
submitting a written request to the appropriate Food and Drug 
Adminstration district office stating that the recall is effective in 
accordance with the criteria set forth in paragraph (a) of this section, 
and by accompanying the request with the most current recall status 
report and a description of the disposition of the recalled product.



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 Sec. Sec. 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

[[Page 74]]

    (5) Furnish a form on which the legal status of any person named in 
the notice may be designated.
    (e) If more than one person is named in a notice, a separate 
opportunity for presentation of views shall be scheduled on request. 
Otherwise, the time and place specified in a notice may be changed only 
upon a showing of reasonable grounds. A request for any change shall be 
addressed to the Food and Drug Administration office that issued the 
notice and shall be received in that office at least 3 working days 
before the date set in the notice.
    (f) A person who has received a notice is under no legal obligation 
to appear or answer in any manner. A person choosing to respond may 
appear personally, with or without a representative, or may designate a 
representative to appear for him or her. Alternatively, a person may 
respond in writing. If a person elects not to respond on or before the 
time scheduled, the Commissioner will, without further notice, decide 
whether to recommend criminal prosecution to a United States attorney on 
the basis of the information available.
    (g) If a respondent chooses to appear solely by designated 
representative, that representative shall present a signed statement of 
authorization. If a representative appears for more than one respondent, 
the representative shall submit independent documentation of authority 
to act for each respondent. If a representative appears without written 
authorization, the opportunity to present views with respect to that 
respondent may be provided at that time only if the authenticity of the 
representative's authority is first 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

[[Page 75]]

be considered before a final decision as to whether or not to recommend 
prosecution. Any materials received after the supplemental response 
period generally will be considered only if the final agency decision 
has not yet been made.
    (h)(1) When consideration of a criminal prosecution recommendation 
involving the same violations is closed by the Commissioner with respect 
to all persons named in the notice, the Commissioner will so notify each 
person in writing.
    (2) When it is determined that a person named in a notice will not 
be included in the Commissioner's recommendation for criminal 
prosecution, the Commissioner will so notify that person, if and when 
the Commissioner concludes that notification will not prejudice the 
prosecution of any other person.
    (3) When a United States attorney informs the agency that no persons 
recommended will be prosecuted, the Commissioner will so notify each 
person in writing, unless the United States attorney has already done 
so.
    (4) When a United States attorney informs the agency of intent to 
prosecute some, but not all, persons who had been provided an 
opportunity to present views and were subsequently named in the 
Commissioner's recommendation for criminal prosecution, the 
Commissioner, after being advised by the United States attorney that the 
notification will not prejudice the prosecution of any other person, 
will so notify those persons eliminated from further consideration, 
unless the 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

[[Page 76]]

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 Division of Dockets Management; 
          computation of time; availability for public disclosure.
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.
10.70 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.
10.105 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.

    Editorial Note: Nomenclature changes to part 10 appear at 68 FR 
24879, May 9, 2003.



                      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 which the 
Commissioner of Food and Drugs administers.
    (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; 69 
FR 17290, Apr. 2, 2004]



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

[[Page 77]]

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.
    Department means the U.S. Department of Health and Human Services.
    Division of Dockets Management means the Division of Dockets 
Management, Office of Management and Operations of the Food and Drug 
Administration, U.S. Department of Health and Human Services, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.
    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.

[[Page 78]]

    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.
    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.
    (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; 69 FR 17290, Apr. 2, 2004]



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 Division of Dockets Management; 

computation of time; availability for public disclosure.

    (a) A submission to the Division of Dockets Management 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 Division of Dockets Management 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

[[Page 79]]

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 Division of Dockets Management 
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 Division of Dockets 
Management.
    (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 
Division of Dockets Management, the Division of Dockets Management 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 Division of Dockets Management does not make decisions 
regarding the confidentiality of submitted documents.
    (d) The filing of a submission means only that the Division of 
Dockets Management 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 Division of Dockets Management 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 
Division of Dockets Management, Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.
    (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 Division of Dockets Management 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 Division of Dockets Management 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:

[[Page 80]]

    (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, 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. 20.48.
    (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; 66 FR 
56035, Nov. 6, 2001; 66 FR 66742, Dec. 27, 2001; 68 FR 25285, May 12, 
2003]



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.

[[Page 81]]

    (b) The Commissioner may initiate a proceeding to issue, amend, or 
revoke a regulation or order or take or refrain from taking any other 
form of administrative action. FDA has primary jurisdiction to make the 
initial determination on issues within its statutory mandate, and will 
request a court to dismiss, or to hold in abeyance its determination of 
or refer to the agency for administrative determination, any issue which 
has not previously been determined by the agency or which, if it has 
previously been determined, the agency concluded should be reconsidered 
and subject to a new administrative determination. The Commissioner may 
utilize any of the procedures established in this part in reviewing and 
making a determination on any matter initiated under this paragraph.
    (c) The Commissioner will institute a proceeding to determine 
whether to issue, amend, or revoke a regulation or order, or take or 
refrain from taking any other form of administrative action whenever any 
court, on its own initiative, holds in abeyance or refers 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)__________________________________________________________________

    Division of Dockets Management, Food and Drug Administration, 
Department of Health and Human Services, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

                            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 Sec. Sec. 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)______________________________________________________


[[Page 82]]

________________________________________________________________________
    (c) A petition which appears to meet the requirements of paragraph 
(b) of this section and Sec. 10.20 will be filed by the Division of 
Dockets Management, stamped with the date of filing, and assigned a 
docket number. The docket number identifies the file established by the 
Division of Dockets Management for all submissions relating to the 
petition, as provided in this part. Subsequent submissions relating to 
the matter must refer to the docket number and will be filed in the 
docket file. Related petitions may be filed together and given the same 
docket number. The Division of Dockets Management 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 Division 
of Dockets Management 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 Division of Dockets Management 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:

[[Page 83]]

    (1) The petition, including all information on which it relies, 
filed by the Division of Dockets Management.
    (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 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 Division of 
Dockets Management as part of the record supporting the decision.
    (6) All documents filed with the Division of Dockets Management 
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 Division of Dockets Management 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 Division of Dockets 
Management;
    (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]



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)__________________________________________________________________

    Division of Dockets Management, Food and Drug Administration, 
Department of Health and Human Services, rm. 1-23, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

                      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. ----.

[[Page 84]]

                          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.)

                         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 Division of Dockets Management. 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 Division of Dockets Management.
    (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

[[Page 85]]

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 Division of Dockets Management.
    (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 Division of Dockets Management 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 Division of Dockets Management 
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]



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)__________________________________________________________________

    Division of Dockets Management, Food and Drug Administration, 
Department of Health and Human Services, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

                       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

[[Page 86]]

other action as is warranted by the petition. The Commissioner may grant 
a stay in any proceeding if it is in the public interest and in the 
interest of justice. The Commissioner shall grant a stay in any 
proceeding if all of the following apply:
    (1) The petitioner will otherwise suffer irreparable injury.
    (2) The petitioner's case is not frivolous and is being pursued in 
good faith.
    (3) The petitioner has demonstrated sound public policy grounds 
supporting the stay.
    (4) The delay resulting from the stay is not outweighted by public 
health or other public interests.
    (f) The Commissioner's decision on a petition for stay of action is 
to be in writing and placed on public display as part of the file on the 
matter in the office of the Division of Dockets Management. 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 Division of Dockets Management.
    (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 Division of Dockets Management.
    (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 Division of Dockets Management 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 Division of Dockets Management 
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]



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;
    (iii) A summary in the first paragraph describing the substance of 
the

[[Page 87]]

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 Division of 
Dockets Management), 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 Division of Dockets Management 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 
Division of Dockets Management 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 Division of 
Dockets Management 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 Division of Dockets Management, 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 first paragraph 
describing the substance of the document in easily understandable terms, 
(iv) relevant dates,

[[Page 88]]

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 Division of Dockets Management. 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 Division of 
Dockets Management 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.
    (7) A final regulation published in the Federal Register that 
provides an opportunity for the submission of further

[[Page 89]]

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 Sec. Sec. 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 
Division of Dockets Management 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 Division of 
Dockets Management 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 Division of Dockets Management 
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 Division of Dockets Management 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]



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 
Sec. Sec. 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 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

[[Page 90]]

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) Unless otherwise provided, 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 (21 U.S.C. 355(j)(2)(C)) 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 Sec. Sec. 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 Commissioner will 
take appropriate action to prevent a multiplicity of suits in various 
jurisdictions, such as:

[[Page 91]]

    (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; 69 FR 31705, June 4, 2004]



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

[[Page 92]]

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 Sec. Sec. 12.20 through 12.22 and other applicable 
provisions in this chapter, e.g., Sec. Sec. 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) [Reserved]
    (8) Section 502(h) on regulations designating requirements for drugs 
liable to deterioration.
    (9) Section 502(n) on prescription drug advertising regulations.
    (10)-(11) [Reserved]
    (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; 67 FR 
4906, Feb. 1, 2002]



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 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

[[Page 93]]

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 Division 
of Dockets Management 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 Division of Dockets 
Management 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 
Sec. Sec. 314.200(f), 514.200, and 601.7(a) are applicable before 
publication of a notice announcing a formal evidentiary public hearing 
or a hearing before a Public Board of Inquiry. Following publication of 
the notice of hearing, the rules in paragraph (b)(2) of this section 
apply.
    (d) Except as provided in paragraph (e) of this section, between the 
date that separation of functions applies under paragraph (b) or (c) of 
this section and the date of the Commissioner's decision on the matter, 
communication concerning the matter involved in the hearing will be 
restricted as follows:
    (1) No person outside the agency may have an ex parte communication 
with the presiding officer or any person representing the office of the 
Commissioner concerning the matter in the hearing. Neither the presiding 
officer nor any person representing the office of the Commissioner may 
have any ex parte communication with a person outside the agency 
concerning the matter in the hearing. All communications are to be 
public communications, as witness or counsel, under the applicable 
provisions of this part.
    (2) A participant in the hearing may submit a written communication 
to the office of the Commissioner with respect to a proposal for 
settlement. These communications are to be in the form of pleadings, 
served on all other participants, and filed with the Division of Dockets 
Management like any other pleading.
    (3) A written communication contrary to this section must be 
immediately served on all other participants and filed with the Division 
of Dockets Management 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

[[Page 94]]

other participants and filed with the Division of Dockets Management. 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 Division of Dockets Management.
    (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 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

[[Page 95]]

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]



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);

[[Page 96]]

    (5) If it records the views, analyses, recommendations, or decisions 
of an agency employee in addition to the author, be given to the other 
employees; and
    (6) Once completed (i.e., typed in final form, dated, and signed) 
not be altered or removed. Later additions to or revisions of the 
document must be made in a new document.
    (d) Memoranda or other documents that are prepared by agency 
employees and are not in the administrative file have no status or 
effect.
    (e) FDA employees working on a matter have access to the 
administrative file on that matter, as appropriate for the conduct of 
their work. FDA employees who have worked on a matter have access to the 
administrative file on that matter so long as attention to their 
assignments is not impeded. Reasonable restrictions may be placed upon 
access to assure proper cataloging and storage of documents, the 
availability of the file to others, and the completeness of the file for 
review.



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

[[Page 97]]

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 Division of Dockets 
Management.
    (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 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 
Division of Dockets Management.
    (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 Division of Dockets Management 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 Division of Dockets 
Management 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,

[[Page 98]]

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 Sec. Sec. 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]



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)__________________________________________________________________

    Division of Dockets Management, Food and Drug Administration, 
Department of Health and Human Services, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

                      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 Division of Dockets Management 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

[[Page 99]]

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 Division of Dockets 
Management. The Division of Dockets Management 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 Division of Dockets Management 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 Division of 
Dockets Management 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

[[Page 100]]

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 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

[[Page 101]]

the public file on standard-setting activities established by the 
Freedom of Information Staff (HFI-35).
    (3) The availability for public disclosure of records relating to 
the activities will be governed by part 20.
    (4) An FDA employee appointed as the liaison representative to an 
activity shall refer all requests for information about or participation 
in the activity to the group or organization responsible for the 
activity.
    (5) The following minimum standards apply to an outside private 
standard-setting activity in which FDA employees participate:
    (i) The activity will be based upon consideration of sound 
scientific and technological information, will permit revision on the 
basis of new information, and will be designed to protect the public 
against unsafe, ineffective, or deceptive products or practices.
    (ii) The activity and resulting standards will not be designed for 
the economic benefit of any company, group, or organization, will not be 
used for such antitrust violations as fixing prices or hindering 
competition, and will not involve establishment of certification or 
specific approval of individual products or services.
    (iii) The group or organization responsible for the standard-setting 
activity must have a procedure by which 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) AOAC INTERNATIONAL (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).

[[Page 102]]

    (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; 70 FR 40880, July 
15, 2005; 70 FR 67651, Nov. 8, 2005]



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) Division of Dockets Management.
    (2) Office of the Associate Commissioner for Public Affairs.
    (3) The FDA home page, to the extent feasible.

[66 FR 6468, Jan. 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 Division of Dockets 
Management 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 Sec. Sec. 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

[[Page 103]]

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.
    (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

[[Page 104]]

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 Division of Dockets Management 
(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 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:

[[Page 105]]

    (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.
    (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 Division of Dockets 
Management (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 Division of Dockets 
Management 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.

[[Page 106]]

    (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.
    (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

[[Page 107]]

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 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

[[Page 108]]

before commencement of the proceeding. For example, the network pool 
representatives might agree to record a portion of the proceeding up to 
a break in the proceeding, at which time, while the network 
representative is disassembling equipment, another media representative 
might set up to continue recording. If an agreement cannot be reached 
before the proceeding, the agency will use the time of receipt of any 
advance notice to determine the representation for each category of 
media, e.g., one network reporter, one independent reporter. The agency 
recommends that parties intending to videotape provide as much advance 
notice as possible, so that the agency may best respond to the needs of 
the electronic media.
    (g) To ensure the timely conduct of agency hearings and to prevent 
disruptions, equipment is to be stationary during a proceeding and 
should be set up and taken down when the proceeding is not in progress. 
As noted previously, the presiding officer may, at his or her 
discretion, be less restrictive if appropriate.
    (h) The agency recognizes that electronic media representatives may 
desire only short footage of a proceeding, a facsimile of the 
proceeding, and/or interview opportunities and may be unnecessarily 
restricted by requirements for setting up before a proceeding and then 
waiting until a break in the proceeding before being permitted to take 
down their equipment. To accommodate this possibility, FDA's Press 
Relations Staff will attempt to make arrangements to respond to such 
needs by, for example, requesting that the presiding officer provide a 
break shortly after commencement of the proceeding to permit take down 
of equipment.
    (i) The agency is making a full commitment to allowing, whenever 
possible, electronic coverage of its public administrative proceedings 
subject to the limited restrictions established in this guideline.



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

[[Page 109]]

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 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

[[Page 110]]

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 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.
    (f) This part does not apply to records required to be established 
or maintained by Sec. Sec. 1.326 through 1.368 of this chapter. Records 
that satisfy the requirements of part 1, subpart J of this chapter, but 
that also are required under other applicable statutory provisions or 
regulations, remain subject to this part.

[62 FR 13464, Mar. 20, 1997, as amended at 69 FR 71655, Dec. 9, 2004]

[[Page 111]]



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 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

[[Page 112]]

signed record as not genuine. Such procedures and controls shall include 
the following:
    (a) Validation of systems to ensure accuracy, reliability, 
consistent intended performance, and the ability to discern invalid or 
altered records.
    (b) The ability to generate accurate and complete copies of records 
in both human readable and electronic form suitable for inspection, 
review, and copying by the agency. Persons should contact the agency if 
there are any questions regarding the ability of the agency to perform 
such review and copying of the electronic records.
    (c) Protection of records to enable their accurate and ready 
retrieval throughout the records retention period.
    (d) Limiting system access to authorized individuals.
    (e) Use of secure, computer-generated, time-stamped audit trails to 
independently record the date and time of operator entries and actions 
that create, modify, or delete electronic records. Record changes shall 
not obscure previously recorded information. Such audit trail 
documentation shall be retained for a period at least as long as that 
required for the subject electronic records and shall be available for 
agency review and copying.
    (f) Use of operational system checks to enforce permitted sequencing 
of steps and events, as appropriate.
    (g) Use of authority checks to ensure that only authorized 
individuals can use the system, electronically sign a record, access the 
operation or computer system input or output device, alter a record, or 
perform the operation at hand.
    (h) Use of device (e.g., terminal) checks to determine, as 
appropriate, the validity of the source of data input or operational 
instruction.
    (i) Determination that persons who develop, maintain, or use 
electronic record/electronic signature systems have the education, 
training, and experience to perform their assigned tasks.
    (j) The establishment of, and adherence to, written policies that 
hold individuals accountable and responsible for actions initiated under 
their electronic signatures, in order to deter record and signature 
falsification.
    (k) Use of appropriate controls over systems documentation 
including:
    (1) Adequate controls over the distribution of, access to, and use 
of documentation for system operation and maintenance.
    (2) Revision and change control procedures to maintain an audit 
trail that documents time-sequenced development and modification of 
systems documentation.



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.

[[Page 113]]



                     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.



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.

[[Page 114]]



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.

                      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

[[Page 115]]

    (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 Sec. Sec. 71.1 and 71.2, or in Sec. Sec. 
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 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 Division of Dockets Management 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.

[[Page 116]]

    (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 Division of Dockets Management 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 Sec. Sec. 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 
Division of Dockets Management, the Division of Dockets Management shall 
return it with a copy of the applicable regulations, indicating those 
provisions not complied 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 Division of Dockets Management.

[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 Sec. Sec. 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

[[Page 117]]

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., 
Sec. Sec. 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., Sec. Sec. 
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 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 Sec. Sec. 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 Division 
of Dockets Management;
    (iii) If the proceeding involves a color additive regulation 
referred to an advisory committee in accordance with

[[Page 118]]

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 Division of Dockets 
Management;
    (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.
    (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 Sec. Sec. 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--

[[Page 119]]

    (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.
    (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 Division of Dockets Management 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 Sec. Sec. 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 Division of Dockets Management, 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.

[[Page 120]]

    (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 Division of Dockets Management 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 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 Division of Dockets Management under Sec. 10.20 a

[[Page 121]]

notice of participation in the following form:

 (Date)

    Division of Dockets Management, Food and Drug Administration, 
Department of Health and Human Services, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

                         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 Division of Dockets Management and served on all participants.
    (c) No person may participate in a hearing who has not filed a 
written notice of participation or whose participation has been stricken 
under paragraph (e) of this section.
    (d) The presiding officer may permit the late filing of a notice of 
participation upon a showing of good cause.
    (e) The presiding officer may strike the participation of a person 
for nonparticipation in the hearing or failure to comply with any 
requirement of this subpart, e.g., disclosure of information as required 
by 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; 68 FR 24879, May 9, 2003]



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

[[Page 122]]

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 
Division of Dockets Management.

[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 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/

[[Page 123]]

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 Division of Dockets Management 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 Division of Dockets Management. 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 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 Division of Dockets Management. The Division of Dockets 
Management 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 Division of Dockets 
Management:
    (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.

[[Page 124]]

    (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 Division 
of Dockets Management 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 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

[[Page 125]]

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--
    (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

[[Page 126]]

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 Division of 
Dockets Management 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 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.

[[Page 127]]

    (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 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 Division of Dockets Management, 
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--

[[Page 128]]

    (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).



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 
Sec. Sec. 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,

[[Page 129]]

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 Division of Dockets Management 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.



                     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 Division of 
Dockets Management under Sec. Sec. 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 
Division of Dockets Management 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 Division of Dockets 
Management promptly upon receipt in that office.

[[Page 130]]



                  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 Division of Dockets 
Management and served upon all participants. Once the initial decision 
is filed with the Division of Dockets Management, the presiding officer 
has no further jurisdiction over the matter, and any motions or requests 
filed with the Division of Dockets Management 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 Division of Dockets Management 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 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 Division of Dockets Management, 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 Division of Dockets 
Management (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 Division of Dockets Management, 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]

[[Page 131]]



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.



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.

[[Page 132]]



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 Division of 
Dockets Management 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 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 
Division of Dockets Management 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 Division of Dockets Management on 
whether the nominees of the other persons meet the criteria established 
in paragraph (a) of this section. A person submitting comments to the 
Division of Dockets Management 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 Division of Dockets Management 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.

[[Page 133]]

    (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.
    (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 Division of Dockets 
Management 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 Sec. Sec. 
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 Sec. Sec. 
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 Division of Dockets Management--
    (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

[[Page 134]]

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 Division of 
Dockets Management 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 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

[[Page 135]]

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.
    (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

[[Page 136]]

placed on public display in the office of the Division of Dockets 
Management 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.

             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.


[[Page 137]]


    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; Pub. L. 107-109; Pub. L. 108-155.

    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;
    (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

[[Page 138]]

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.
    (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,

[[Page 139]]

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 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 Division of Dockets Management 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 Division of 
Dockets Management and placed on public display. The extent to which the 
committee maintains minutes of closed sessions is in the discretion of 
the committee.

[[Page 140]]

    (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;
    (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.

[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]



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

[[Page 141]]

Commissioner receives and approves a written request from the advisory 
committee for a different location. A different location may be approved 
when one or more of the following applies:
    (1) The total cost of the meeting to the Government will be reduced.
    (2) A substantial number of the committee members will be at the 
location at no expense to FDA for other reasons, e.g., for a meeting of 
a professional association.
    (3) It is a central location more readily accessible to committee 
members.
    (4) There is a need for increased participation available at that 
location.
    (5) The committee wishes to review work or facilities in a specific 
location.
    (6) The committee is concerned with matters that functionally or 
historically occur in some other location, e.g., the Board of Tea 
Experts and the Science Advisory Board of the National Center for 
Toxicological Research will generally hold meetings in Brooklyn, NY, and 
in the Little Rock, AR, vicinity, respectively.
    (c) Advisory committee members may, with the approval of FDA, 
conduct onsite visits relevant to their work.
    (d) Unless the committee charter provides otherwise, a quorum for an 
advisory committee is a majority of the current voting members of the 
committee, except as provided in 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 Sec. Sec. 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

[[Page 142]]

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.
    (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.

[[Page 143]]

    (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 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.

[[Page 144]]

    (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.
    (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

[[Page 145]]

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 Sec. Sec. 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, 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 Division of Dockets Management.
    (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

[[Page 146]]

concerning the product during a regularly scheduled meeting of the 
committee. The request may be for an oral presentation or for a concise, 
well-organized written summary of pertinent information for review by 
the committee members before the meeting, or both. Unless specified 
otherwise, one copy of the written summary along with a proposed agenda 
outlining the topics to be covered and identifying the participating 
industry staff members or consultants that will present each topic is to 
be submitted to the executive secretary or other designated agency 
employee at least 3 weeks before the meeting.
    (d) An interested person may submit to a committee written 
information or views on any matter being reviewed. Voluminous data is to 
be accompanied by a summary. A submission is to be made to the executive 
secretary and not directly to a committee member.
    (1) FDA will distribute submissions to each member, either by mail 
or at the next meeting. Submissions will be considered by the committee 
in its review of the matter.
    (2) A committee may establish, and give public notice of, a cutoff 
date after which submissions about a matter will no longer be received 
or considered.
    (e) The Commissioner will provide the committee all information the 
Commissioner deems relevant. A member will, upon request, also be 
provided any material available to FDA which the member believes 
appropriate for an independent judgment on the matter, e.g., raw data 
underlying a summary or report, or a briefing on the legal aspects of 
the matter.



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

[[Page 147]]

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]



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

[[Page 148]]

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 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. 20.45. 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. 20.53.
    (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.

[44 FR 22351, Apr. 13, 1979, as amended at 68 FR 25285, May 12, 2003]



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

[[Page 149]]

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.



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.

[[Page 150]]

    (c) The Division of Dockets Management (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]



                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 Sec. Sec. 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).

[[Page 151]]

    (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 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.

[[Page 152]]

    (4) The executive secretary, or other designated agency employee, 
will review the list of nominees and select three to five qualified 
nominees to be placed on a ballot. Names not selected will remain on a 
list of eligible nominees and be reviewed periodically by the Office of 
Consumer Affairs to determine continued interest. Upon selection of the 
nominees to be placed on the ballot, the curriculum vitae for each of 
the nominees will be sent to each of the organizations on the list 
complied under paragraph (c)(3) of this section, together with a ballot 
to be filled out and returned within 30 days. After the time for return 
of the ballots has expired, the ballots will be counted and the nominee 
who has received the highest number of votes will be selected as the 
nonvoting member representing consumer interests for that particular 
advisory committee or subcommittee. In the event of a tie, the 
Commissioner will select the winner by lot from among those tied for the 
highest number of votes.
    (5) If a member representing consumer interests resigns or is 
removed before termination of the committee on which the member is 
serving, the following procedures will be used to appoint a replacement 
to serve out the term of the former member:
    (i) The Commissioner will appoint the runner-up, in order of number 
of ballots received, on the original ballot submitted under paragraph 
(c)(4) of this section to fill the vacancy. If the runner-up is no 
longer willing to serve as a member, then the next runner-up will be 
appointed.
    (ii) If none of the nominees on the original ballot is willing to 
serve, or if there was only one nominee on the original ballot, the 
Office of Consumer Affairs will contact by telephone eligible 
individuals whose names have been submitted in the past as candidates 
for membership as representatives of consumer interests. A list of 
persons who are interested in serving on an advisory committee will then 
be prepared. The curricula vitae of these persons, together with a 
ballot, will be sent to 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

[[Page 153]]

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).
    (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 Sec. Sec. 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

[[Page 154]]

Standards Committee (TEPRSSC) are not appointed as special Government 
employees. Any member of TEPRSSC who is not a Federal employee or member 
of the uniformed services, including the Commissioned Corps of the 
Public Health Service, shall receive a consultant fee and be reimbursed 
for travel expenses, including per diem in lieu of subsistence, unless 
such compensation and reimbursement are waived.
    (3) Voting and nonvoting advisory committee members who are members 
of the uniformed services, including the Commissioned Corps of the 
Public Health Service, provide service on Food and Drug Administration 
advisory committees as part of their assigned functions, are not 
appointed as special government employees, but are reimbursed by the 
Food and Drug Administration for travel expenses.
    (b) Notwithstanding the member's primary residence, an advisory 
committee member, while attending meetings of the full committee or a 
subcommittee, will be paid whether the meetings are held in the 
Washington, DC, area or elsewhere.
    (c) A committee member who participates in any agency-directed 
assignment will be paid at an hourly rate when doing assigned work at 
home, a place of business, or in an FDA facility located within the 
member's commuting area, and at a daily rate when required to travel 
outside of that commuting area to perform the assignment. A committee 
member will not be paid for time spent on normal preparation for a 
committee meeting.
    (1) An agency-directed assignment is an assignment that meets the 
following criteria:
    (i) An activity that requires undertaking a definitive study. The 
activity must produce a tangible end product, usually a written report. 
Examples are:
    (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.

[[Page 155]]

    (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.
    (3) Pediatric Advisory Committee.
    (i) Date established: June 18, 2004.
    (ii) Function: Advises on pediatric therapeutics, pediatric 
research, and other matters involving pediatrics for which the Food and 
Drug Administration has regulatory responsibility.
    (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) Cellular, Tissue and Gene Therapies Advisory Committee.
    (i) Date established: October 28, 1988.
    (ii) Function: Reviews and evaluates available data relating to the 
safety, effectiveness, and appropriate use of human cells, human 
tissues, gene transfer therapies and xenotransplantation products which 
are intended for transplantation, implantation, infusion, and transfer 
in the prevention and treatment of a broad spectrum of human diseases 
and in the reconstruction, repair or replacement of tissues for various 
conditions. The Committee also considers the quality and relevance of 
FDA's research program which provides scientific support for the 
regulation of these products, and makes appropriate recommendations to 
the Commissioner of Food and Drugs.
    (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

[[Page 156]]

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 Safety and Risk Management Advisory Committee.
    (i) Date established: May 31, 1978.
    (ii) Function: Reviews and evaluates data on risk management plans, 
provides active surveillance methodologies, trademark studies, 
methodologies for risk management communication, and related issues.
    (8) 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.
    (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 Committee for Pharmaceutical Science and Clinical 
Pharmacology.
    (i) Date established: January 22, 1990.
    (ii) Function: The committee shall provide advice on scientific, 
clinical and technical issues related to safety and effectiveness of 
drug products for use in the treatment of a broad spectrum of human 
diseases, the quality characteristics which such drugs purport or are 
represented to have and as required, any other product for which the 
Food and Drug Administration has regulatory responsibility, and make 
appropriate recommendations to the Commissioner of Food and Drugs. The 
Committee may also review agency sponsored intramural and extramural

[[Page 157]]

biomedical research programs in support of FDA's drug regulatory 
responsibilities and its critical path initiatives related to improving 
the efficacy and safety of drugs and improving the efficiency of drug 
development.
    (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).
    (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. 
14.100, 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--

[[Page 158]]

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

[[Page 159]]

    (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, 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

[[Page 160]]

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 Division of 
Dockets Management.
    (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 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

[[Page 161]]

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 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

[[Page 162]]

human prescription drugs. The Commissioner's determinations on the 
agenda of the committee are based upon the priorities of the various 
matters pending before the agency which fall within the pharmacologic 
class covered by that committee.
    (b) High priority for such hearing and review by the appropriate 
standing technical advisory committee for human prescription drugs are 
given to the following types of human prescription drugs:
    (1) Investigational drugs which are potential therapeutic advances 
over currently marketed products from the standpoint of safety or 
effectiveness, or which pose significant safety hazards, or which 
present narrow benefit-risk considerations requiring a close judgmental 
decision on approval for marketing, or which have a novel delivery 
system or formulation, or which are the subject of major scientific or 
public controversy, or which may be subject to special regulatory 
requirements such as a limitation on clinical trials, a patient followup 
requirement, postmarketing Phase IV studies, distributional controls, or 
boxed warnings.
    (2) Marketed drugs for which an important new use has been 
discovered or which pose newly discovered safety hazards, or which are 
the subject of major scientific or public controversy, or which may be 
subject to important regulatory actions such as withdrawal of approval 
for marketing, boxed warnings, distributional controls, or newly 
required scientific studies.
    (c) The committee may request the Commissioner for an opportunity to 
hold a public hearing and to review any matter involving a human 
prescription drug which falls within the pharmacologic class covered by 
the committee. The Commissioner may, after consulting with the 
committtee on such request, grant or deny the request in light of the 
priorities of the other matters pending before the committee. Whenever 
feasible, consistent with the other work of the committee, the request 
will be granted.
    (d) For a drug that meets any of the criteria established in 
paragraph (b) of this section, one or more members of or consultants to 
the appropriate advisory committee may be selected for more detailed 
monitoring of the matter and consultation with FDA on behalf of the 
committee. The member or consultant may be invited to attend appropriate 
meetings and shall assist the center in any briefing of the committee on 
that matter.
    (e) An advisory committee may obtain advice and recommendations from 
other agency advisory committees, consultants, and experts which the 
advisory committee and the center conclude would facilitate the work of 
the advisory committee.
    (f) Presentation of all relevant information about the matter will 
be made in open session unless it relates to an IND the existence of 
which has not previously been disclosed to the public as defined in 
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

[[Page 163]]

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-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

[[Page 164]]

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 Division of Dockets 
Management within a specified period of time containing the information 
specified in the notice, e.g., name of participant, address, phone 
number, affiliation, if any, topic of presentation and approximate 
amount of time requested for the presentation. If the public interest 
requires, e.g., a hearing is to be conducted within a short period of 
time or is to be primarily attended by individuals without an 
organizational affiliation, the notice may name a specific FDA employee 
and telephone number to whom an oral notice of participation may be 
given or provide for submitting notices of participation at the time of 
the hearing. A written or oral notice of participation must be received 
by the designated person by the close of business of the day specified 
in the notice.
    (b) Promptly after expiration of the time for filing a notice, the 
Commissioner will determine the amount of time allotted to each person 
and the approximate time that oral presentation is scheduled to begin. 
If more than one hearing is held on the same subject, a person will 
ordinarily be allotted time for a presentation at only one hearing.
    (c) Individuals and organizations with common interests are urged to 
consolidate or coordinate their presentations and to request time for a 
joint presentation. The Commissioner may require joint presentations by 
persons with common interests.
    (d) The Commissioner will prepare a hearing schedule showing the 
persons making oral presentations and the time alloted to each person, 
which will be filed with the Division of Dockets Management 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 Division of Dockets Management, 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

[[Page 165]]

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 
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

[[Page 166]]

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 304(h) of the act relating to the administrative detention of 
food for human or animal consumption (see part 1, subpart k 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 Sec. Sec. 812.19(c), 812.30(c), 813.30(d), and 813.35(c) 
of this chapter).

    (2) Regulatory provisions:

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. 900.25, relating to approval or withdrawal of approval of 
certification agencies.
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. 1240.63(c)(3), relating to a written order to cause an animal to 
be placed in quarantine or to cause an animal to be destroyed.
Sec. 1270.15(e), relating to the retention, recall, and destruction of 
human tissue.
Sec. 1271.440(e) relating to the retention, recall, and destruction of 
human cells, tissues, and cellular and tissue-based products (HCT/Ps), 
and/or the cessation of manufacturing HCT/Ps.

[44 FR 22367, Apr. 13, 1979]

[[Page 167]]


    Editorial Note: For Federal Register citations affecting Sec. 16.1 
see the List of CFR Sections Affected, which appears in the Finding Aids 
sections of the printed volume and on GPO Access.



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.
    (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 Sec. Sec. 101.17(h) and 115.50 of this chapter.
    (b) If a regulation provides a person with an opportunity for 
hearing and specifies some procedures for the hearing but not a 
comprehensive set of procedures, the procedures in this part apply to 
the extent that they are supplementary and not in conflict with the 
other procedures specified for the hearing. Thus, the procedures in 
subpart A of part 108 relating to emergency permit control are 
supplemented by the nonconflicting procedures in this part, e.g., the 
right to counsel, public notice of the hearing, reconsideration and 
stay, and judicial review.

[44 FR 22367, Apr. 13, 1979, as amended at 57 FR 58403, Dec. 10, 1992; 
65 FR 76110, Dec. 5, 2000]



                   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.

[[Page 168]]

    (b) [Reserved]
    (c) The notice will state whether any action concerning the matter 
that is the subject of the opportunity for hearing is or is not being 
taken pending the hearing under paragraph (d) of this section.
    (d) The Commissioner may take such action pending a hearing under 
this section as the Commissioner concludes is necessary to protect the 
public health, except where expressly prohibited by statute or 
regulation. A hearing to consider action already taken, and not stayed 
by the Commissioner, will be conducted on an expedited basis.
    (e) The hearing may not be required to be held at a time less than 2 
working days after receipt of the request for hearing.
    (f) Before the hearing, FDA will give to the party requesting the 
hearing reasonable notice of the matters to be considered at the 
hearing, including a comprehensive statement of the basis for the 
decision or action taken or proposed that is the subject of the hearing 
and a general summary of the information that will be presented by FDA 
at the hearing in support of the decision or action. This information 
may be given orally or in writing, in the discretion of FDA.
    (g) FDA and the party requesting the hearing will, if feasible, at 
least 1 day before the hearing provide to each other written notice of 
any published articles or written information to be presented at or 
relied on at the hearing. A copy will also be provided in advance if the 
other participant could not reasonably be expected to have or be able to 
obtain a copy. If written notice or a copy is not provided, the 
presiding officer may, if time permits, allow the party who did not 
receive the notice or copy additional time after the close of the 
hearing to make a submission concerning the article or information.

[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 authority is delegated to 
make the final decision on the matter 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, as amended at 69 FR 17290, Apr. 2, 2004]



              Subpart C_Commissioner and Presiding Officer



Sec. 16.40  Commissioner.

    Whenever the Commissioner has delegated authority 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.

[69 FR 17290, Apr. 2, 2004]



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, or, consistent with 5 CFR 930.209(b) 
or (c), an administrative law judge to whom such authority is delegated, 
may serve as the presiding officer and conduct a regulatory hearing 
under this part.

[[Page 169]]

    (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 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; 67 
FR 53306, Aug. 15, 2002]



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.
    (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

[[Page 170]]

which is the subject of the hearing, together with the information and 
reasons supporting it, and may present any oral or written information 
relevant to the hearing. The party requesting the hearing may then 
present any oral or written information relevant to the hearing. All 
parties may confront and conduct reasonable cross-examination of any 
person (except for the presiding officer and counsel for the parties) 
who makes any statement on the matter at the hearing.
    (c) The hearing is informal in nature, and the rules of evidence do 
not apply. No motions or objections relating to the admissibility of 
information and views will be made or considered, but any other party 
may comment upon or rebut all such data, information, and views.
    (d) The presiding officer may order the hearing to be transcribed. 
The party requesting the hearing may have the hearing transcribed, at 
the party's expense, in which case a copy of the transcript is to be 
furnished to FDA. Any transcript of the hearing will be included with 
the presiding officer's report of the hearing.
    (e) The presiding officer shall prepare a written report of the 
hearing. All written material presented at the hearing will be attached 
to the report. Whenever time permits, the parties to the hearing will be 
given the opportunity to review and comment on the presiding officer's 
report of the hearing.
    (f) The presiding officer shall include as part of the report of the 
hearing a finding on the credibility of witnesses (other than expert 
witnesses) whenever credibility is a material issue, and shall include a 
recommended decision, with a statement of reasons, unless the 
Commissioner directs otherwise.
    (g) The presiding officer has the power to take such actions and 
make such rulings as are necessary or appropriate to maintain order and 
to conduct a fair, expeditious, and impartial hearing, and to enforce 
the requirements of this part concerning the conduct of hearings. The 
presiding officer may direct that the hearing be conducted in any 
suitable manner permitted by law and these regulations.
    (h) The Commissioner or the presiding officer has the power under 
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]



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

[[Page 171]]

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 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.
17.2 Maximum penalty amounts.
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.

    Editorial Note: Nomenclature changes to part 17 appear at 68 FR 
24879, May 9, 2003.



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 authorize civil 
money penalties that are governed by these procedures.
    (a) Section 303(b)(2) and (b)(3) 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(f)(1) of the act authorizing civil money penalties 
for certain violations of the act that relate to medical devices and 
section 303(f)(2) of the act authorizing civil money penalties for 
certain violations of the act that relate to pesticide residues.

[[Page 172]]

    (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 539(b)(1) of the act authorizing civil money penalties 
for certain violations of the act that relate to electronic products.
    (e) Section 351(d)(2) of the Public Health Service Act (the PHS Act) 
authorizing civil money penalties for violations of biologic recall 
orders.
    (f) Section 354(h)(3) of the PHS Act, as amended by the Mammography 
Quality Standards Act of 1992 and the Mammography Quality Standards Act 
of 1998, authorizing civil money penalties for failure to obtain a 
certificate and failure to comply with established standards, among 
other things.
    (g) Section 2128(b)(1) 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 under section 2128 of the PHS Act.

[60 FR 38626, July 27, 1995, as amended at 69 FR 43301, July 20, 2004]



Sec. 17.2  Maximum penalty amounts.

    The following table shows maximum civil monetary penalties 
associated with the statutory provisions authorizing civil monetary 
penalties under the act or the Public Service Act.

          Civil Monetary Penalties Authorities Administered by FDA and Adjusted Maximum Penalty Amounts
----------------------------------------------------------------------------------------------------------------
                                              Former Maximum                        Date of     Adjusted Maximum
   U.S.C. Section        Description of       Penalty Amount   Assessment Method      Last       Penalty Amount
                            Violation          (in dollars)                         Penalty       (in dollars)
----------------------------------------------------------------------------------------------------------------
(a) 21 U.S.C.
----------------------------------------------------------------------------------------------------------------
  (1) 333(b)(2)(A)    Violation of certain       50,000        For each of the           2004       55,000
                       requirements of the                      first two
                       Prescription Drug                        violations in
                       Marketing Act                            any 10-year
                       (PDMA)                                   period
----------------------------------------------------------------------------------------------------------------
  (2) 333(b)(2)(B)    Violation of certain    1,000,000        For each                  2004    1,100,000
                       requirements of the                      violation after
                       PDMA                                     the second
                                                                conviction in
                                                                any 10-year
                                                                period
----------------------------------------------------------------------------------------------------------------
  (3) 333(b)(3)       Violation of certain      100,000        Per violation             2004      110,000
                       requirements of the
                       PDMA
----------------------------------------------------------------------------------------------------------------
  (4) 333(f)(1)(A)    Violation of certain       15,000        Per violation             2004       16,500
                       requirements of the
                       Safe Medical
                       Devices Act (SMDA)
----------------------------------------------------------------------------------------------------------------
  (5) 333(f)(1)(A)    Violation of certain    1,000,000        For the aggregate         2004    1,100,000
                       requirements of the                      of violations
                       SMDA
----------------------------------------------------------------------------------------------------------------
  (6) 333(f)(2)(A)    Violation of certain       50,000        Per individual            2004       55,000
                       requirements of the
                       Food Quality
                       Protection Act of
                       1996 (FQPA)
----------------------------------------------------------------------------------------------------------------
  (7) 333(f)(2)(A)    Violation of certain      250,000        Per ``any other           2004      275,000
                       requirements of the                      person''
                       FQPA
----------------------------------------------------------------------------------------------------------------

[[Page 173]]

 
  (8) 333(f)(2)(A)    Violation of certain      500,000        For all                   2004      550,000
                       requirements of the                      violations
                       FQPA                                     adjudicated in a
                                                                single
                                                                proceeding
----------------------------------------------------------------------------------------------------------------
  (9) 335b(a)         Violation of certain      250,000        Per violation for         2004      275,000
                       requirements of the                      an individual
                       Generic Drug
                       Enforcement Act of
                       1992 (GDEA)
----------------------------------------------------------------------------------------------------------------
  (10) 335b(a)        Violation of certain    1,000,000        Per violation for         2004    1,100,000
                       requirements of the                      ``any other
                       GDEA                                     person''
----------------------------------------------------------------------------------------------------------------
  (11) 360pp(b)(1)    Violation of certain        1,000        Per violation per         2004        1,100
                       requirements of the                      person
                       Radiation Control
                       for Health and
                       Safety Act of 1968
                       (RCHSA)
----------------------------------------------------------------------------------------------------------------
  (12) 360pp(b)(1)    Violation of certain      300,000        For any related           2004      330,000
                       requirements of the                      series of
                       RCHSA                                    violations
----------------------------------------------------------------------------------------------------------------
(b) 42 U.S.C.
----------------------------------------------------------------------------------------------------------------
  (1) 263b(h)(3)      Violation of certain       10,000        Per violation             2004       11,000
                       requirements of the
                       Mammography Quality
                       Standards Act of
                       1992 and the
                       Mammography Quality
                       Standards Act of
                       1998
----------------------------------------------------------------------------------------------------------------
  (2) 300aa-28(b)(1)  Violation of certain      100,000        Per occurrence            2004      110,000
                       requirements of the
                       National Childhood
                       Vaccine Injury Act
                       of 1986
----------------------------------------------------------------------------------------------------------------


[69 FR 43301, July 20, 2004; 69 FR 49807, Aug. 12, 2004]



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.
    (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,

[[Page 174]]

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 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    (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
    (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 Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 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;

[[Page 175]]

    (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;
    (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

[[Page 176]]

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 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

[[Page 177]]

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;
    (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

[[Page 178]]

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 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

[[Page 179]]

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.
    (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 Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852, 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

[[Page 180]]

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 Division of Dockets Management.
    (b) Service. A party filing a document with the Division of Dockets 
Management 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 Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852, 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.



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

[[Page 181]]

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.
    (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

[[Page 182]]

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 Division of 
Dockets Management at a cost not to exceed the actual cost of 
duplication.
    (b) The transcript of testimony, exhibits, and other evidence 
admitted at the hearing and all papers and requests filed in the 
proceeding constitute the administrative record for the decision by the 
presiding officer and the entity designated by the Commissioner of Food 
and Drugs to decide the appeal, currently the DAB.
    (c) The administrative record may be inspected and copied (upon 
payment of a reasonable fee) by anyone unless otherwise ordered by the 
presiding officer, who shall upon motion of any party order otherwise 
when necessary to protect trade secrets or confidential commercial 
information, as defined in 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

[[Page 183]]

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, Appellate Division MS6127, 
Departmental Appeals Board, United States Department of Health and Human 
Services, 330 Independence Ave. SW., Cohen Bldg., rm. G-644, Washington, 
DC 20201, and the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
in accordance with this section.
    (b)(1) A notice of appeal may be filed at any time within 30 days 
after the presiding officer issues an initial decision or decision 
granting summary decision.
    (2) The Commissioner or the entity designated by the Commissioner to 
hear appeals may, within his or her discretion, extend the initial 30-
day period for an additional period of time if the Center or any 
respondent files a request for an extension within the initial 30-day 
period and shows good cause.
    (c) A notice of appeal shall be accompanied by a written brief of no 
greater length than that allowed for the posthearing brief. The notice 
must identify specific exceptions to the initial decision, must support 
each exception with citations to the record, and must explain the basis 
for each exception.

[[Page 184]]

    (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 Division of Dockets Management 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.

[60 FR 38626, July 27, 1995, as amended at 71 FR 5979, Feb. 6, 2006]



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 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

[[Page 185]]

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.
    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.

[[Page 186]]

    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.
    (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]

[[Page 187]]



                  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.
20.33 Form or format of response.
20.34 Search for records.

                      Subpart C_Procedures and Fees

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

                          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.

[[Page 188]]

20.65 National defense and foreign policy.
20.66 Internal personnel rules and practices.
20.67 Records exempted by other statutes.

                   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.
20.120 Records available in Feed and Drug Administration Public Reading 
          Rooms.

    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 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

[[Page 189]]

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.
    (e) ``Record'' and any other term used in this section in reference 
to information includes any information that would be an agency record 
subject to the requirements of this part when maintained by the agency 
in any format, including an electronic format.

[42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25285, May 12, 2003]



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 190]]

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.

    (a) 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.
    (b)(1) Whenever information is deleted from a record that contains 
both disclosable and nondisclosable information, the amount of 
information deleted shall be indicated on the portion of the record that 
is made available, unless including that indication would harm an 
interest protected by an exemption under the Freedom of Information Act.
    (2) When technically feasible, the amount of information deleted 
shall be indicated at the place in the record where the deletion is 
made.

[42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25285, May 12, 2003]



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.

[[Page 191]]



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.
    (4) Records that have been released to any person in response to a 
Freedom of Information request and that the agency has determined have 
become, or are likely to become, the subject of subsequent requests for 
substantially the same records.
    (b) Each such index will be made available through the Internet at 
http://www.fda.gov. A printed copy of each index is available by writing 
to the Freedom of Information Staff (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, or 
by visiting the Freedom of Information Public Reading Room in rm. 12A-30 
at the same address.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 68 
FR 25285, May 12, 2003]



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 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.

[42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25285, May 12, 2003]



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.

[42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25285, May 12, 2003]



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

Administration files.

    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.

[42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25285, May 12, 2003]



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.

[[Page 192]]

    (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.



Sec. 20.33  Form or format of response.

    (a) The Food and Drug Administration shall make reasonable efforts 
to provide a record in any requested form or format if the record is 
readily reproducible by the agency in that form or format.
    (b) If the agency determines that a record is not readily 
reproducible in the requested form or format, the agency may notify the 
requester of alternative forms and formats that are available. If the 
requester does not express a preference for an alternative in response 
to such notification, the agency may provide its response in the form 
and format of the agency's choice.

[68 FR 25285, May 12, 2003]



Sec. 20.34  Search for records.

    (a) In responding to a request for records, the Food and Drug 
Administration shall make reasonable efforts to search for records kept 
in electronic form or format, except when such efforts would 
significantly interfere with the operation of the agency's automated 
information systems.
    (b) The term ``search'' means to review, manually or by automated 
means, agency records for the purpose of locating those records that are 
responsive to the request.

[68 FR 25285, May 12, 2003]



                      Subpart C_Procedures and Fees



Sec. 20.40  Filing a request for records.

    (a) All requests for Food and Drug Administration records shall be 
made in writing by mailing or delivering the request to the Freedom of 
Information Staff (HFI-35), Food and Drug Administration, rm. 12A-16, 
5600 Fishers Lane, Rockville, MD 20857, or by faxing it to 301-443-1726. 
All requests must contain the postal address and telephone number of the 
requester and the name of the person responsible for payment of any fees 
that may be charged.
    (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

[[Page 193]]

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; 68 
FR 25285, May 12, 2003]



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 20 working days (excluding Saturdays, Sundays, and legal 
public holidays) after a request for records is logged in at the Freedom 
of Information Staff, the agency shall send a letter to the requester 
providing the agency's determination as to whether, or the extent to 
which, the agency will comply with the request, and, if any records are 
denied, the reasons for the denial.
    (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. 20.47, the letter shall state the 
extent to which the records involved shall be disclosed pursuant to the 
rules established in this part.
    (3)(i) In unusual circumstances, the agency may extend the time for 
sending the letter for an additional period.
    (A) The agency may provide for an extension of up to 10 working days 
by providing written notice to the requester setting out the reasons for 
the extension and the date by which a determination is expected to be 
sent.
    (B) The agency may provide for an extension of more than 10 working 
days by providing written notice to the requester setting out the 
reasons for the extension. The notice also will give the requester an 
opportunity to limit the scope of the request so that it may be 
processed in a shorter time and/or an opportunity to agree on a 
timeframe longer than the 10 extra working days for processing the 
request.
    (ii) Unusual circumstances may exist under any of the following 
conditions:
    (A) There is a need to search for and collect the requested records 
from field facilities or other components that are separate from the 
agency component responsible for processing the request;
    (B) There is a need to search for, collect, and appropriately 
examine a voluminous amount of separate and distinct records that are 
demanded in a single request; or
    (C) There is need for consultation, which shall be conducted with 
all practicable speed, with another agency having a substantial interest 
in the determination of the request, or among two or more components of 
the Food and Drug Administration having substantial subject-matter 
interest in the determination.
    (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.
    (c) The Food and Drug Administration shall provide a determination 
of whether to provide expedited processing within 10 calendar days of 
receipt by the Freedom of Information Staff of the request and the 
required documentation of compelling need in accordance with Sec. 
20.44(b).

[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; 68 FR 25285, May 12, 
2003]

[[Page 194]]



Sec. 20.42  Aggregation of certain requests.

    The Food and Drug Administration may aggregate certain requests by 
the same requester, or by a group of requesters acting in concert, if 
the requests involve clearly related matters and the agency reasonably 
believes that such requests actually constitute a single request which 
would otherwise satisfy the unusual circumstances specified in Sec. 
20.41(b)(3)(ii)(B). FDA may extend the time for processing aggregated 
requests in accordance with the unusual circumstances provisions of 
Sec. 20.41.

[68 FR 25286, May 12, 2003]



Sec. 20.43  Multitrack processing.

    (a) Each Food and Drug Administration component is responsible for 
determining whether to use a multitrack system to process requests for 
records maintained by that component. A multitrack system provides two 
or more tracks for processing requests, based on the amount of work and/
or time required for a request to be processed. The availability of 
multitrack processing does not affect expedited processing in accordance 
with Sec. 20.44.
    (b) If multitrack processing is not adopted by a particular agency 
component, that component will process all requests in a single track, 
ordinarily on a first-in, first-out basis.
    (c) If a multitrack processing system is established by a particular 
agency component, that component may determine how many tracks to 
establish and the specific criteria for assigning requests to each 
track. Multiple tracks may be established for requests based on the 
amount of work and/or time required for a request to be processed.
    (d) Requests assigned to a given track will ordinarily be processed 
on a first-in, first-out basis within that track.
    (e) If a request does not qualify for the fastest processing track, 
the requester may be provided an opportunity to limit the scope of the 
request in order to qualify for faster processing.

[68 FR 25286, May 12, 2003]



Sec. 20.44  Expedited processing.

    (a) The Food and Drug Administration will provide expedited 
processing of a request for records when the requester demonstrates a 
compelling need, or in other cases as determined by the agency. A 
compelling need exists when:
    (1) A failure to obtain requested records on an expedited basis 
could reasonably be expected to pose an imminent threat to the life or 
physical safety of an individual; or
    (2) With respect to a request made by a person primarily engaged in 
disseminating information, there is a demonstrated urgency to inform the 
public concerning actual or alleged Federal Government activity.
    (b) A request for expedited processing made under paragraph (a)(1) 
of this section must be made by the specific individual who is subject 
to an imminent threat, or by a family member, medical or health care 
professional, or other authorized representative of the individual, and 
must demonstrate a reasonable basis for concluding that failure to 
obtain the requested records on an expedited basis could reasonably be 
expected to pose a specific and identifiable imminent threat to the life 
or safety of the individual.
    (c) A request for expedited processing made under paragraph (a)(2) 
of this section must demonstrate that:
    (1) The requester is primarily engaged in disseminating information 
to the general public and not merely to a narrow interest group;
    (2) There is an urgent need for the requested information and that 
it has a particular value that will be lost if not obtained and 
disseminated quickly; however, a news media publication or broadcast 
deadline alone does not qualify as an urgent need, nor does a request 
for historical information; and
    (3) The request for records specifically concerns identifiable 
operations or activities of the Federal Government.
    (d) All requests for expedited processing shall be filed in writing 
as provided by Sec. 20.40. Each such request shall include information 
that demonstrates a reasonable basis for concluding that a compelling 
need exists within the

[[Page 195]]

meaning of paragraph (a) of this section and a certification that the 
information provided in the request is true and correct to the best of 
the requester's knowledge and belief. Any statements made in support of 
a request for expedited processing are subject to the False Reports to 
the Government Act (18 U.S.C. 1001).
    (e) The Assistant Commissioner for Public Affairs (or delegatee) 
will determine whether to grant a request for expedited processing 
within 10 days of receipt by the Freedom of Information Staff of all 
information required to make a decision.
    (f) If the agency grants a request for expedited processing, the 
agency shall process the request as soon as practicable.
    (g) If the agency denies a request for expedited processing, the 
agency shall process the request with other nonexpedited requests.
    (h) If the agency denies a request for expedited processing, the 
requester may appeal the agency's decision by writing to the official 
identified in the denial letter.

[68 FR 25286, May 12, 2003]



Sec. 20.45  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. 
20.46 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,

[[Page 196]]

and in taking actions to encourage payment.
    (c) Fee schedule. The Food and Drug Administration charges the 
following fees in accordance with the regulations of the Department of 
Health and Human Services at 45 CFR part 5.
    (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 hourly rate for the specified grade 
and step, adding 16 percent of that rate to cover benefits, and rounding 
to the nearest whole dollar. 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 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, the requester 
will be required to directly pay, or be directly charged by, the 
courier. The agency will not agree to any special delivery method that 
does not permit the requester to directly pay or be directly charged for 
the service.
    (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

[[Page 197]]

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. Redesignated and amended at 68 FR 25286, May 
12, 2003]



Sec. 20.46  Waiver or reduction of fees.

    (a) Standard. The Assistant Commissioner for Public Affairs (or 
delegatee) will waive or 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

[[Page 198]]

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 the Associate Commissioner's decision that 
are set forth in the denial letter.

[59 FR 534, Jan. 5, 1994. Redesignated and amended at 68 FR 25286, 
25287, May 12, 2003]



Sec. 20.47  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.

[42 FR 15616, Mar. 22, 1977. Redesignated at 68 FR 25286, May 12, 2003]



Sec. 20.48  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. 
20.47, and rejects the person's request that part or all of the records 
not be made available for public disclosure, the decision constitutes 
final agency action that is subject to judicial review pursuant to 5 
U.S.C. chapter 7. The person affected will be permitted 5 days after 
receipt of notification of such decision within which to institute suit 
in a United States District Court to enjoin release of the records 
involved. If suit is brought, the Food and Drug Administration will not 
disclose the records involved until the matter and all related appeals 
have been concluded.

[42 FR 15616, Mar. 22, 1977. Redesignated and amended at 68 FR 25286, 
25287, May 12, 2003]



Sec. 20.49  Denial of a request for records.

    (a) A denial of a request for records, in whole or in part, shall be 
signed by the Assistant Commissioner for Public Affairs (or delegatee).
    (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 Deputy Assistant Secretary for Public Affairs 
(Media), Department of Health and Human Services. The agency will also 
make a reasonable effort to include in the letter an estimate of the 
volume of the records denied, unless providing such an estimate would 
harm an interest protected by an exemption under the Freedom of 
Information Act. This estimate will ordinarily be provided in terms of 
the approximate number of pages or some other reasonable measure. This 
estimate will not be provided if the volume of records denied is 
otherwise indicated through deletions on records disclosed in part.
    (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. Redesignated and amended at 68 FR 25286, 25287, 
May 12, 2003]



Sec. 20.50  Nonspecific and overly burdensome requests.

    The Food and Drug Administration will make every reasonable effort 
to

[[Page 199]]

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.

[42 FR 15616, Mar. 22, 1977. Redesignated at 68 FR 25286, May 12, 2003]



Sec. 20.51  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.

[42 FR 15616, Mar. 22, 1977. Redesignated at 68 FR 25286, May 12, 2003]



Sec. 20.52  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. 
Redesignated at 68 FR 25286, May 12, 2003]



Sec. 20.53  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 charge the person requesting the records for all of 
the fees involved pursuant to Sec. 20.45.

[42 FR 15616, Mar. 22, 1977. Redesignated and amended at 68 FR 25286, 
25287, May 12, 2003]



Sec. 20.54  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.

[42 FR 15616, Mar. 22, 1977. Redesignated at 68 FR 25286, May 12, 2003]



Sec. 20.55  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

[[Page 200]]

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. 
Redesignated at 68 FR 25286, May 12, 2003]



                          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.
    (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.

[[Page 201]]

    (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;
    (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.

[[Page 202]]



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 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

[[Page 203]]

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 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]

[[Page 204]]



Sec. 20.65  National defense and foreign policy.

    (a) Records or information may be withheld from public disclosure if 
they are:
    (1) Specifically authorized under criteria established by an 
Executive order to be kept secret in the interest of national defense or 
foreign policy; and
    (2) In fact properly classified under such Executive order.
    (b) [Reserved]

[70 FR 41958, July 21, 2005]



Sec. 20.66  Internal personnel rules and practices.

    Records or information may be withheld from public disclosure if 
they are related solely to the internal personnel rules and practices of 
the Food and Drug Administration (FDA). Under this exemption, FDA may 
withhold records or information about routine internal agency practices 
and procedures. Under this exemption, the agency may also withhold 
internal records whose release would help some persons circumvent the 
law.

[70 FR 41958, July 21, 2005]



Sec. 20.67  Records exempted by other statutes.

    Records or information may be withheld from public disclosure if a 
statute specifically allows the Food and Drug Administration (FDA) to 
withhold them. FDA may use another statute to justify withholding 
records and information only if it absolutely prohibits disclosure, sets 
forth criteria to guide our decision on releasing material, or 
identifies particular types of matters to be withheld.

[70 FR 41958, July 21, 2005]



                   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.

[[Page 205]]

    (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.



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 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; 68 FR 25287, May 12, 2003]



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 under statute.
    (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.

[42 FR 15616, Mar. 22, 1977, as amended at 70 FR 41958, July 21, 2005]

[[Page 206]]



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, in 
the form of a regulation published or cross-referenced in this part, 
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.

[42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25287, May 12, 2003]



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

[[Page 207]]

Drug Administration records as any special government employee.
    (b) Communications with State and local government officials with 
respect to law enforcement activities undertaken pursuant to a contract 
between the Food and Drug Administration and such officials shall be 
subject to the rules for public disclosure established in 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 Sec. Sec. 
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

[[Page 208]]

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 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 Sec. Sec. 20.61 and 
20.64, as if they had been prepared by or submitted directly to Food and 
Drug Administration employees, except that investigatory

[[Page 209]]

records shall be exempt from disclosure for a longer period of time if 
the foreign government officials so require as a condition of their 
furnishing the information to the Food and Drug Administration.
    (b) Disclosure of investigatory records compiled for law enforcement 
purposes by the Food and Drug Administration to foreign government 
officials who perform counterpart functions to the Food and Drug 
Administration in a foreign country as part of cooperative law 
enforcement efforts does not invoke the rule established in 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

[[Page 210]]

disclosure to, or receipt from, an official of a foreign government 
agency of nonpublic, predecisional documents concerning the Food and 
Drug Administration's or the other government agency's regulations or 
other regulatory requirements, or other nonpublic information relevant 
to either agency's activities, as part of cooperative efforts to 
facilitate global harmonization of regulatory requirements, cooperative 
regulatory activities, or implementation of international agreements, 
provided that:
    (i) The foreign government agency has the authority to protect such 
nonpublic documents from public disclosure and will not disclose any 
such documents provided without the written confirmation by the Food and 
Drug Administration that the documents no longer have nonpublic status; 
and
    (ii) The Senior Associate Commissioner for Policy, Planning, and 
Legislation or the Deputy Commissioner for International and Constituent 
Relations or their designee makes the determination that the exchange is 
reasonably necessary to facilitate global harmonization of regulatory 
requirements, cooperative regulatory activities, or implementation of 
international agreements.
    (2) Any exchange under this section of nonpublic documents does not 
invoke the rule established in 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,

[[Page 211]]

as the basis for taking any administrative or court enforcement action 
within its jurisdiction. Data and information otherwise exempt from 
public disclosure are nevertheless available for public disclosure to 
the extent necessary to effectuate such action, e.g., the brand name, 
code designation, and distribution information are released when a 
product is recalled.



        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 Sec. Sec. 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 Sec. Sec. 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.

[[Page 212]]

    (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.
    (28) Device premarket notification submissions, in Sec. 807.95 of 
this chapter.
    (29) Electronic product information, in Sec. Sec. 1002.4 and 
1002.42 of this chapter.
    (30) Data and information submitted to the Commissioner or to 
classification panels in connection with the classification or 
reclassification of devices intended for human use, in Sec. 860.5 of 
this chapter.
    (31) Data and information submitted in offers to develop a proposed 
performance standard for medical devices, in Sec. 861.26 of this 
chapter.
    (32) Investigational device exemptions in Sec. 812.38 of this 
chapter.
    (33) Health claims petitions, in Sec. 101.70 of this chapter.
    (34) Premarket approval application, in Sec. 814.9 of this chapter.
    (35) Report of certain adverse experiences with a medical device, in 
Sec. 803.9 of this chapter.
    (36) Disqualification determination of an institutional review 
board, in Sec. 56.122 of this chapter.
    (37) Disqualification determination of a nonclinical laboratory, in 
Sec. 58.213 of this chapter.
    (38) Minutes or records regarding a public advisory committee, in 
Sec. 14.65(c) of this chapter.
    (39) Data submitted regarding persons receiving an implanted 
pacemaker device or lead, in Sec. 805.25 of this chapter.
    (40) Humanitarian device exemption application, in Sec. 814.122 of 
this chapter.
    (41) Premarket notifications for food contact substances, in Sec. 
170.102 of this chapter.
    (42) Registration of food facilities, in Sec. 1.243 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; 67 FR 
13717, Mar. 26, 2002; 67 FR 35729, May 21, 2002; 68 FR 58965, Oct. 10, 
2003]



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

[[Page 213]]

for public disclosure. Prior to disclosure of any record specifically 
reflecting consideration of possible criminal prosecution of any 
individual, all names and other information that would identify an 
individual who was considered for criminal prosecution but who was not 
prosecuted shall be deleted unless the Commissioner concludes that there 
is a compelling public interest in the disclosure of such names.



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

[[Page 214]]

sampling numbers or sizes shall be deleted until implementation of the 
program is completed.
    (7) Work plans prepared by Food and Drug Administration centers, 
field offices, and other components, except that names of specific 
firms, the location of specific activities, and details about sampling 
numbers or sizes shall be deleted until implementation of the plan is 
completed.
    (b) The following types of reports and studies prepared by or with 
funds provided by the Food and Drug Administration are not available for 
public disclosure:
    (1) Internal audits of agency needs and performance.
    (2) Records relating to the internal planning and budget process.
    (3) Legislative proposals or comments prior to submission to 
Congress.

[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) Food and Drug Administration administrative staff manuals and 
instructions that affect a member of the public are available for public 
disclosure. An index of all such manuals is available by writing to the 
Freedom of Information Staff (HFI-35), Food and Drug Administration, rm. 
12A-16, 5600 Fishers Lane, Rockville, MD 20857, or by visiting the 
Freedom of Information Public Reading Room, located in rm. 12A-30 at the 
same address. The index and all manuals created by the agency on or 
after November 1, 1996, will be made available through the Internet at 
http://www.fda.gov.
    (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; 68 FR 25287, May 12, 2003]



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

[[Page 215]]

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).
    (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.
    (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:

[[Page 216]]

    (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 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.
    (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.

[42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25287, May 12, 2003]



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

[[Page 217]]

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 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 Sec. Sec. 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 Sec. Sec. 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 218]]



Sec. 20.120  Records available in Food and Drug Administration Public Reading Rooms.

    (a) The Food and Drug Administration operates two public reading 
rooms. The Freedom of Information Staff's Public Reading Room is located 
in rm. 12A-30, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857, 
the phone number is 301-827-6500. The Division of Dockets Management's 
Public Reading Room is located in rm. 1061, 5630 Fishers Lane, 
Rockville, MD 20852; the phone number is 301-827-6860. Both public 
reading rooms are open from 9 a.m. to 4 p.m., Monday through Friday, 
excluding legal public holidays.
    (b) The following records are available at the Freedom of 
Information Staff's Public Reading Room:
    (1) A guide for making requests for records or information from the 
Food and Drug Administration;
    (2) Administrative staff manuals and instructions to staff that 
affect a member of the public;
    (3) Food and Drug Administration records which have been released to 
any person in response to a Freedom of Information request and which the 
agency has determined have become or are likely to become the subject of 
subsequent requests for substantially the same records;
    (4) Indexes of records maintained in the Freedom of Information 
Staff's Public Reading Room; and
    (5) Such other records and information as the agency determines are 
appropriate for inclusion in the public reading room.
    (c) The following records are available in the Division of Dockets 
Management's Public Reading Room:
    (1) Final opinions, including concurring and dissenting opinions, as 
well as orders, made in the adjudication of cases;
    (2) Statements of policy and interpretation adopted by the agency 
that are still in force and not published in the Federal Register;
    (3) Indexes of records maintained in the Division of Dockets 
Management's Public Reading Room; and
    (4) Such other records and information as the agency determines are 
appropriate for inclusion in the public reading room.
    (d) The agency will make reading room records created by the Food 
and Drug Administration on or after November 1, 1996, available 
electronically through the Internet at the agency's World Wide Web site 
which can be found at http://www.fda.gov. At the agency's discretion, 
the Food and Drug Administration may also make available through the 
Internet such additional records and information it believes will be 
useful to the public.

[68 FR 25287, May 12, 2003; 68 FR 65392, Nov. 20, 2003]



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.

[[Page 219]]

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.
    (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

[[Page 220]]

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 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),

[[Page 221]]

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 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.

[[Page 222]]

    (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 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]

[[Page 223]]



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 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 Sec. Sec. 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

[[Page 224]]

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).



   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

[[Page 225]]

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 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

[[Page 226]]

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
    (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 then 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

[[Page 227]]

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 part 5, subpart M of this 
chapter, or at another location or time upon which the Food and Drug 
Administration and the individual agree. Arrangement for such review can 
be made by consultation between the FDA Privacy Act Coordinator and the 
individual. An individual seeking to review records in person shall 
generally be permitted access to the file copy, except that where the 
records include nondisclosable information, a copy shall be made of that 
portion of the records, with the nondisclosable information blocked out. 
Where the individual is not given a copy of the record to retain, no 
charge shall be made for the cost of copying a record to make it 
available to an individual who reviews a record in person under this 
paragraph.
    (b) An individual may request that a record be disclosed to or 
discussed in the presence of another individual, such as an attorney. 
The individual may be required to furnish a written statement 
authorizing the disclosure or discussion in such other individual's 
presence.
    (c) The Food and Drug Administration will make every reasonable 
effort to assure that records made available under this section can be 
understood by the individual, such as by providing an oral or written 
explanation of the records.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8458, Jan. 27, 1981; 69 
FR 17290, Apr. 2, 2004]



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

[[Page 228]]

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]



       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

[[Page 229]]

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 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

[[Page 230]]

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.



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

[[Page 231]]

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 Sec. Sec. 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 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 Sec. Sec. 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

[[Page 232]]

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 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

[[Page 233]]

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 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

[[Page 234]]

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.



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.

[[Page 235]]

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 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

[[Page 236]]

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 the delegated authority for the underlying actions.
    (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; 69 
FR 17291, Apr. 2, 2004]



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 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

[[Page 237]]

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 Sec. Sec. 
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 
Sec. Sec. 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 Sec. Sec. 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 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 Sec. Sec. 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 Sec. Sec. 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 Sec. Sec. 
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 Sec. Sec. 
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).

[[Page 238]]

    (h) Withdrawal of existing approvals of FDA-approved articles, 
unless categorically excluded in Sec. Sec. 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 
Sec. Sec. 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 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 Sec. Sec. 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

[[Page 239]]

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 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.

[[Page 240]]

    (f) Testing and release by the Food and Drug Administration 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; 70 FR 14980, Mar. 24, 2005]



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 
Sec. Sec. 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 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.

[[Page 241]]

    (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(b)(3), (b)(4), or (c)(3) 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.
    (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.

[62 FR 40592, July 29, 1997, as amended at 71 FR 74782, Dec. 13, 2006]



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.

[[Page 242]]

    (b) Classification or reclassification of a device under part 860 of 
this chapter, including the establishment of special controls, if the 
action will not result in increases in the existing levels of use of the 
device or changes in the intended use of the device or its substitutes.
    (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.
    (i) Approval of humanitarian device exemption under subpart H of 
part 814 of this chapter.

[62 FR 40592, July 29, 1997, as amended at 70 FR 69277, Nov. 15, 2005]



            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 Sec. Sec. 25.30, 25.31, 25.32, 25.33, or 
25.34. The EA shall focus on relevant environmental issues relating to 
the use and disposal from use of FDA-regulated articles and shall be a 
concise, objective, and well-balanced document that allows the public to 
understand the agency's decision. If potentially adverse environmental 
impacts are identified for an action or a group of related actions, the 
EA shall discuss any reasonable alternative course of action that offers 
less environmental risk or that is environmentally preferable to the 
proposed action. The use of a scientifically justified tiered testing 
approach, in which testing may be stopped when the results suggest that 
no significant impact will occur, is an acceptable approach.
    (b) Generally, FDA requires an applicant to prepare an EA and make 
necessary corrections to it. Ultimately, FDA is responsible for the 
scope and content of EA's and may include additional information in 
environmental documents when warranted.
    (c) Information concerning the nature and scope of information that 
an applicant or petitioner shall submit in an EA may be obtained from 
the center or other office of the agency having responsibility for the 
action that is the subject of the environmental evaluation. Applicants 
and petitioners are encouraged to submit proposed protocols for 
environmental studies for technical review by agency staff. Applicants 
and petitioners also are encouraged to consult applicable FDA EA 
guidance documents, which provide additional advice on how to comply 
with FDA regulations.
    (d) Consistent with 40 CFR 1500.4(j) and 1502.21, EA's may 
incorporate by reference information presented in other documents that 
are available to FDA and to the public.
    (e) The agency evaluates the information contained in an EA and any 
public input to determine whether it is accurate and objective, whether 
the

[[Page 243]]

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 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.

[62 FR 40592, July 29, 1997, as amended at 69 FR 17291, Apr. 2, 2004]



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 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 responsible agency official prepares the environmental 
documents or ensures 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

[[Page 244]]

reflected in the agency's record of formal decisionmaking as required by 
40 CFR 1505.2.

[62 FR 40592, July 29, 1997, as amended at 69 FR 17291, Apr. 2, 2004]



    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, Sec. Sec. 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 Division of Dockets 
Management. 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 are available upon request and filed in FDA's Division 
of Dockets Management.
    (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.

[[Page 245]]



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, 
Sec. Sec. 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 Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

[62 FR 40592, July 29, 1997, as amended at 68 FR 24879, May 9, 2003]



                      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;
    (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.

[[Page 246]]



   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--List of Applicable Laws, Regulations, and 
          Administrative Provisions.
Appendix B to Subpart A--List of Authorities.
Appendix C to Subpart A--Indicative List of Products Covered by Subpart 
          A.
Appendix D to Subpart A--Criteria for Assessing Equivalence for Post- 
          and Preapproval.
Appendix E to Subpart A--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--Relevant Legislation, Regulations, and 
          Procedures.
Appendix B to Subpart B--Scope of Product Coverage.
Appendixes C-F to Subpart B [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.
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.

[[Page 247]]



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/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.

[[Page 248]]

    (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 or Center 
for Drug 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.

[63 FR 60141, Nov. 6, 1998, as amended at 70 FR 14980, Mar. 24, 2005]



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 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

[[Page 249]]

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 accordance with these 
criteria. A list of authorities determined as equivalent shall be agreed 
to by the Joint Sectoral Committee at the end of the transition period, 
with reference to any limitation in terms of inspection type (e.g., 
postapproval or preapproval) or product classes or processes.
    (b) The parties will document insufficient evidence of equivalence, 
lack of opportunity to assess equivalence or a determination of 
nonequivalence, in sufficient detail to allow the authority being 
assessed to know how to attain equivalence.



Sec. 26.10  Regulatory authorities not listed as currently equivalent.

    Authorities not currently listed as equivalent, or not equivalent 
for certain types of inspections, product classes or processes may apply 
for reconsideration of their status once the necessary corrective 
measures have been taken or additional experience is gained.



Sec. 26.11  Start of operational period.

    (a) The operational period shall start at the end of the transition 
period and its provisions apply to inspection reports generated by 
authorities listed as equivalent for the inspections performed in their 
territory.
    (b) In addition, when an authority is not listed as equivalent based 
on adequate experience gained during the transition period, the Food and 
Drug Administration (FDA) will accept for normal endorsement (as 
provided in Sec. 26.12) inspection reports generated as a result of 
inspections conducted jointly by that authority on its territory and 
another authority listed as equivalent, provided that the authority of 
the Member State in which the inspection is performed can guarantee 
enforcement of the findings of the inspection report and require that 
corrective measures be taken when necessary. FDA has the option to 
participate in these inspections, and based on experience gained during 
the transition period, the parties will agree on procedures for 
exercising this option.
    (c) In the European Community (EC), the qualified person will be 
relieved of responsibility for carrying the controls laid down in 
Article 22 paragraph 1(b) of Council Directive 75/319/EEC (see Appendix 
A of this subpart) provided that these controls have been carried out in 
the United States and that each batch/lot is accompanied by a batch 
certificate (in accordance with the World Health Organization 
Certification Scheme on the Quality of Medicinal Products) issued by the 
manufacturer certifying that the product complies with requirements of 
the marketing authorization and signed by the person responsible for 
releasing the batch/lot.



Sec. 26.12  Nature of recognition of inspection reports.

    (a) Inspection reports (containing information as established under 
Sec. 26.8), including a good manufacturing practice (GMP) compliance 
assessment, prepared by authorities listed as equivalent, will be 
provided to the authority of the importing party. Based on the 
determination of equivalence in light of the experience gained, these 
inspection reports will normally be endorsed by the authority of the 
importing party, except under specific and delineated circumstances. 
Examples of such circumstances include indications of

[[Page 250]]

material inconsistencies or inadequacies in an inspection report, 
quality defects identified in the postmarket surveillance or other 
specific evidence of serious concern in relation to product quality or 
consumer safety. In such cases, the authority of the importing party may 
request clarification from the authority of the exporting party which 
may lead to a request for reinspection. The authorities will endeavor to 
respond to requests for clarification in a timely manner.
    (b) Where divergence is not clarified in this process, an authority 
of the importing country may carry out an inspection of the production 
facility.



Sec. 26.13  Transmission of postapproval inspection reports.

    Postapproval good manufacturing practice (GMP) inspection reports 
concerning products covered by this subpart will be transmitted to the 
authority of the importing country within 60-calendar days of the 
request. Should a new inspection be needed, the inspection report will 
be transmitted within 90-calendar days of the request.



Sec. 26.14  Transmission of preapproval inspection reports.

    (a) A preliminary notification that an inspection may have to take 
place will be made as soon as possible.
    (b) Within 15-calendar days, the relevant authority will acknowledge 
receipt of the request and confirm its ability to carry out the 
inspection. In the European Community (EC), requests will be sent 
directly to the relevant authority, with a copy to the European Agency 
for the Evaluation of Medicinal Products (EMEA). If the authority 
receiving the request cannot carry out the inspection as requested, the 
requesting authority shall have the right to conduct the inspection.
    (c) Reports of preapproval inspections will be sent within 45-
calendar days of the request that transmitted the appropriate 
information and detailed the precise issues to be addressed during the 
inspection. A shorter time may be necessary in exceptional cases and 
these will be described in the request.



Sec. 26.15  Monitoring continued equivalence.

    Monitoring activities for the purpose of maintaining equivalence 
shall include review of the exchange of inspection reports and their 
quality and timeliness; performance of a limited number of joint 
inspections; and the conduct of common training sessions.



Sec. 26.16  Suspension.

    (a) Each party has the right to contest the equivalence of a 
regulatory authority. This right will be exercised in an objective and 
reasoned manner in writing to the other party.
    (b) The issue shall be discussed in the Joint Sectoral Committee 
promptly upon such notification. Where the Joint Sectoral Committee 
determines that verification of equivalence is required, it may be 
carried out jointly by the parties in a timely manner, under Sec. 26.6.
    (c) Efforts will be made by the Joint Sectoral Committee to reach 
unanimous consent on the appropriate action. If agreement to suspend is 
reached in the Joint Sectoral Committee, an authority may be suspended 
immediately thereafter. If no agreement is reached in the Joint Sectoral 
Committee, the matter is referred to the Joint Committee as described in 
Sec. 26.73. If no unanimous consent is reached within 30 days after 
such notification, the contested authority will be suspended.
    (d) Upon the suspension of authority previously listed as 
equivalent, a party is no longer obligated to normally endorse the 
inspection reports of the suspended authority. A party shall continue to 
normally endorse the inspection reports of that authority prior to 
suspension, unless the authority of the receiving party decides 
otherwise based on health or safety considerations. The suspension will 
remain in effect until unanimous consent has been reached by the parties 
on the future status of that authority.



Sec. 26.17  Role and composition of the Joint Sectoral Committee.

    (a) A Joint Sectoral Committee is set up to monitor the activities 
under both the transitional and operational phases of this subpart.

[[Page 251]]

    (b) The Joint Sectoral Committee will be cochaired by a 
representative of the Food and Drug Administration (FDA) for the United 
States and a representative of the European Community (EC) who each will 
have one vote. Decisions will be taken by unanimous consent.
    (c) The Joint Sectoral Committee's functions will include:
    (1) Making a joint assessment, which must be agreed by both parties, 
of the equivalence of the respective authorities;
    (2) Developing and maintaining the list of equivalent authorities, 
including any limitation in terms of inspecting type or products, and 
communicating the list to all authorities and the Joint Committee;
    (3) Providing a forum to discuss issues relating to this subpart, 
including concerns that an authority may be no longer equivalent and 
opportunity to review product coverage; and
    (4) Consideration of the issue of suspension.
    (d) The Joint Sectoral Committee shall meet at the request of either 
party and, unless the cochairs otherwise agree, at least once each year. 
The Joint Committee will be kept informed of the agenda and conclusions 
of meetings of the Joint Sectoral Committee.



Sec. 26.18  Regulatory collaboration.

    (a) The parties and authorities shall inform and consult one 
another, as permitted by law, on proposals to introduce new controls or 
to change existing technical regulations or inspection procedures and to 
provide the opportunity to comment on such proposals.
    (b) The parties shall notify each other in writing of any changes to 
Appendix B of this subpart.



Sec. 26.19  Information relating to quality aspects.

    The authorities will establish an appropriate means of exchanging 
information on any confirmed problem reports, corrective actions, 
recalls, rejected import consignments, and other regulatory and 
enforcement problems for products subject to this subpart.



Sec. 26.20  Alert system.

    (a) The details of an alert system will be developed during the 
transitional period. The system will be maintained in place at all 
times. Elements to be considered in developing such a system are 
described in Appendix E of this subpart.
    (b) Contact points will be agreed between both parties to permit 
authorities to be made aware with the appropriate speed in case of 
quality defect, recalls, counterfeiting, and other problems concerning 
quality, which could necessitate additional controls or suspension of 
the distribution of the product.



Sec. 26.21  Safeguard clause.

    Each party recognizes that the importing country has a right to 
fulfill its legal responsibilities by taking actions necessary to ensure 
the protection of human and animal health at the level of protection it 
deems appropriate. This includes the suspension of the distribution, 
product detention at the border of the importing country, withdrawal of 
the batches and any request for additional information or inspection as 
provided in Sec. 26.12.

      Appendix A to Subpart A of Part 26--List of Applicable Laws, 
               Regulations, and Administrative Provisions

                   1. For the European Community (EC):

    [Copies of EC documents may be obtained from the European Document 
Research, 1100 17th St. NW., suite 301, Washington, DC 20036. EC 
documents may be viewed on the European Commission Pharmaceuticals Units 
web site at http://dg3.eudra.org.]
Council Directive 65/65/EEC of 26 January 1965 on the approximation of 
provisions laid down by law, regulation, or administrative action 
relating to proprietary medicinal products as extended, widened, and 
amended.
Council Directive 75/319/EEC of 20 May 1975 on the approximation of 
provisions laid down by law, regulation or administrative action 
relating to proprietary medicinal products as extended, widened and 
amended.
Council Directive 81/851/EEC of 28 September 1981 on the approximation 
of the laws of the Member States relating to veterinary medicinal 
products, as widened and amended.
Commission Directive 91/356/EEC of 13 June 1991 laying down the 
principles and guidelines of good manufacturing practice for medicinal 
products for human use.

[[Page 252]]

Commission Directive 91/412/EEC of 23 July 1991 laying down the 
principles and guidelines of good manufacturing practice for veterinary 
medicinal products.
Council Regulation EEC No 2309/93 of 22 July 1993 laying down Community 
procedures for the authorization and supervision of medicinal products 
for human and veterinary use and establishing a European Agency for the 
Evaluation of Medicinal Products.
Council Directive 92/25/EEC of 31 March 1992 on the wholesale 
distribution of medicinal products for human use.
Guide to Good Distribution Practice (94/C 63/03).
Current version of the Guide to Good Manufacturing Practice, Rules 
Governing Medicinal Products in the European Community, Volume IV.

                        2. For the United States:

    [Copies of FDA documents may be obtained from the Government 
Printing Office, 1510 H St. NW., Washington, DC 20005. FDA documents, 
except the FDA Compliance Program Guidance Manual, may be viewed on 
FDA's Internet web site at http://www.fda.gov.]
Relevant sections of the United States Federal Food, Drug, and Cosmetic 
Act and the United States Public Health Service Act.
Relevant sections of Title 21, United States Code of Federal Regulations 
(CFR) Parts 1-99, Parts 200-299, Parts 500-599, and Parts 600-799.
Relevant sections of the FDA Investigations Operations Manual, the FDA 
Regulatory Procedures Manual, the FDA Compliance Policy Guidance Manual, 
the FDA Compliance Program Guidance Manual, and other FDA guidances.

         Appendix B to Subpart A of Part 26--List of Authorities

1. For the United States: In the United States, the regulatory authority 
                  is the Food and Drug Administration.

2. For the European Community: In the European Community, the regulatory 
                     authorities are the following:

Belgium: Inspection g[eacute]n[eacute]rale de la Pharmacie, Algemene 
Farmaceutische Inspectie.
Denmark: Laegemiddelstyrelsen.
Germany: Bundesministerium f[uuml]r Gesundheit for immunologicals: Paul-
Ehrlich-Institut, Federal Agency for Sera and Vaccines.
Greece: [Egr][theta][nu][iota][kappa][omega][sigmav] 
[Omega][rho][gamma][alpha][nu][iota][sigma][mu][omega][sigmav] 
[Phi][alpha][rho][mu][alpha][kappa][omega][ugr], Ministry of Health and 
Welfare, National Drug Organization (E.O.F).
Spain: For medicinal products for human use: Ministerio de Sanidad y 
Consumo, Subdirecci[oacute]n General de Control Farmac[eacute]utico. For 
medicinal products for veterinary use: Ministerio de Agricultura, Pesca 
y Alimentaci[oacute]n (MAPA), Direcci[oacute]n General de la 
Producci[oacute]n Agraria.
France: For medicinal products for human use: Agence du 
M[eacute]dicament. For veterinary medicinal products: Agence Nationale 
du M[eacute]dicament V[eacute]t[eacute]rinaire.
Ireland: Irish Medicines Board.
Italy: For medicinal products for human use: Ministero della 
Sanit[agrave], Dipartimento Farmaci e Farmacovigilanza. For medicinal 
products for veterinary use: Ministero della Sanit[agrave], Dipartimento 
alimenti e nutrizione e sanit[agrave] pubblica veterinaria-Div. IX.
Luxembourg: Division de la Pharmacie et des M[eacute]dicaments.
Netherlands: Staat der Nederlanden.
Austria: Bundesministerium f[uuml]r Arbeit, Gesundheit und Soziales.
Portugal: Instituto da Farm[aacute]cia e do Medicamento (INFARMED).
Finland: L[auml][auml]kelaitos/L[auml]kemedelsverket (National Agency 
for Medicines).
Sweden: L[auml]kemedelsverket-Medical Products Agency.
United Kingdom: For human use and veterinary (non-immunologicals): 
Medicines Control Agency. For veterinary immunologicals: Veterinary 
Medicines Directorate.
European Community: Commission of the European Communities. European 
Agency for the Evaluation of Medicinal Products (EMEA).

Appendix C to Subpart A of Part 26--Indicative List of Products Covered 
                              by Subpart A

Recognizing that precise definition of medicinal products and drugs are 
to be found in the legislation referred to above, an indicative list of 
products covered by this arrangement is given below:
    --human medicinal products including prescription and 
nonprescription drugs;
    --human biologicals including vaccines, and immunologicals;
    --veterinary pharmaceuticals, including prescription and 
nonprescription drugs, with the exclusion of veterinary immunologicals 
(Under 9 CFR 101.2 ``veterinary immunologicals'' are referred to as 
``veterinary biologicals'');
    --premixes for the preparation of veterinary medicated feeds (EC), 
Type A medicated articles for the preparation of veterinary medicated 
feeds (United States);
    --intermediate products and active pharmaceutical ingredients or 
bulk pharmaceuticals (United States)/starting materials (EC).

[[Page 253]]

 Appendix D to Subpart A of Part 26--Criteria for Assessing Equivalence 
                        for Post- and Preapproval

 I. Legal/Regulatory authority and structures and procedures providing 
                       for post- and preapproval:

A. Appropriate statutory mandate and jurisdiction.
B. Ability to issue and update binding requirements on GMP's and 
guidance documents.
C. Authority to make inspections, review and copy documents, and to take 
samples and collect other evidence.
D. Ability to enforce requirements and to remove products found in 
violation of such requirements from the market.
E. Substantive current good manufacturing requirements.
F. Accountability of the regulatory authority.
G. Inventory of current products and manufacturers.
H. System for maintaining or accessing inspection reports, samples and 
other analytical data, and other firm/product information relating to 
matters covered by subpart A of this part.

II. Mechanisms in place to assure appropriate professional standards and 
                   avoidance of conflicts of interest.

            III. Administration of the regulatory authority:

A. Standards of education/qualification and training.
B. Effective quality assurance systems measures to ensure adequate job 
performance.
C. Appropriate staffing and resources to enforce laws