[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2018 Edition]
[From the U.S. Government Publishing Office]



[[Page i]]

          

          Title 21

Food and Drugs


________________________

Parts 1 to 99

                         Revised as of April 1, 2018

          Containing a codification of documents of general 
          applicability and future effect

          As of April 1, 2018
                    Published by the Office of the Federal Register 
                    National Archives and Records Administration as a 
                    Special Edition of the Federal Register

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                            Table of Contents



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

  Title 21:
          Chapter I--Food and Drug Administration, Department 
          of Health and Human Services                               3
  Finding Aids:
      Table of CFR Titles and Chapters........................     551
      Alphabetical List of Agencies Appearing in the CFR......     571
      List of CFR Sections Affected...........................     581

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

                     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, 2018), 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 
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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 
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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 
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PAST PROVISIONS OF THE CODE

    Provisions of the Code that are no longer in force and effect as of 
the revision date stated on the cover of each volume are not carried. 
Code users may find the text of provisions in effect on any given date 
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2001, consult the List of CFR Sections Affected compilations, published 
for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.

``[RESERVED]'' TERMINOLOGY

    The term ``[Reserved]'' is used as a place holder within the Code of 
Federal Regulations. An agency may add regulatory information at a 
``[Reserved]'' location at any time. Occasionally ``[Reserved]'' is used 
editorially to indicate that a portion of the CFR was left vacant and 
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INCORPORATION BY REFERENCE

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This material, like any other properly issued regulation, has the force 
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    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
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    (b) The matter incorporated is in fact available to the extent 
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    (c) The incorporating document is drafted and submitted for 
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alphabetical list of agencies publishing in the CFR are also included in 
this volume.

[[Page vii]]

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INQUIRIES

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    Oliver A. Potts,
    Director,
    Office of the Federal Register
    April 1, 2018







[[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 to 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, 2013.

    For this volume, Jonn V. Lilyea was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of 
Michael L. White, 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         123
3               Product jurisdiction........................         128
4               Regulation of combination products..........         133
5               Organization................................         139
7               Enforcement policy..........................         150
10              Administrative practices and procedures.....         160
11              Electronic records; electronic signatures...         197
12              Formal evidentiary public hearing...........         201
13              Public hearing before a public board of 
                    inquiry.................................         219
14              Public hearing before a public advisory 
                    committee...............................         223
15              Public hearing before the Commissioner......         251
16              Regulatory hearing before the Food and Drug 
                    Administration..........................         253
17              Civil money penalties hearings..............         260
19              Standards of conduct and conflicts of 
                    interest................................         273
20              Public information..........................         275
21              Protection of privacy.......................         306
25              Environmental impact considerations.........         323
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..................         335
50              Protection of human subjects................         365
54              Financial disclosure by clinical 
                    investigators...........................         377
56              Institutional Review Boards.................         381
58              Good laboratory practice for nonclinical 
                    laboratory studies......................         391

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60              Patent term restoration.....................         404
70              Color additives.............................         411
71              Color additive petitions....................         419
73              Listing of color additives exempt from 
                    certification...........................         426
74              Listing of color additives subject to 
                    certification...........................         479
80              Color additive certification................         517
81              General specifications and general 
                    restrictions for provisional color 
                    additives for use in foods, drugs, and 
                    cosmetics...............................         523
82              Listing of certified provisionally listed 
                    colors and specifications...............         530
83-98

[Reserved]

99              Dissemination of information on unapproved/
                    new uses for marketed drugs, biologics, 
                    and devices.............................         536

[[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.

Subpart C [Reserved]

                   Subpart D_Electronic Import Entries

1.70 Scope.
1.71 Definitions.
1.72 Data elements that must be submitted in ACE for articles regulated 
          by FDA.
1.73 Food.
1.74 Human drugs.
1.75 Animal drugs.
1.76 Medical devices.
1.77 Radiation-emitting electronic products.
1.78 Biological products, HCT/Ps, and related drugs and medical devices.
1.79 Tobacco products.
1.80 Cosmetics.
1.81 Rejection of entry.

                      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 or destruction.
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 or renew your registration?
1.231 How and where do you register or renew your registration?
1.232 What information is required in the registration?
1.233 Are there optional items 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, renew, 
          or cancel your registration?
1.242 What does assignment of a registration number mean?
1.243 Is food registration information available to the public?
1.245 Waiver request.

                 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

[[Page 6]]

          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 
          subpart H of this part?

    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?

 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?

   Subpart L_Foreign Supplier Verification Programs for Food Importers

1.500 What definitions apply to this subpart?
1.501 To what foods do the requirements in this subpart apply?
1.502 What foreign supplier verification program (FSVP) must I have?
1.503 Who must develop my FSVP and perform FSVP activities?
1.504 What hazard analysis must I conduct?
1.505 What evaluation for foreign supplier approval and verification 
          must I conduct?
1.506 What foreign supplier verification and related activities must I 
          conduct?
1.507 What requirements apply when I import a food that cannot be 
          consumed without the hazards being controlled or for which the 
          hazards are controlled after importation?

[[Page 7]]

1.508 What corrective actions must I take under my FSVP?
1.509 How must the importer be identified at entry?
1.510 How must I maintain records of my FSVP?
1.511 What FSVP must I have if I am importing a food subject to certain 
          requirements in the dietary supplement current good 
          manufacturing practice regulation?
1.512 What FSVP may I have if I am a very small importer or if I am 
          importing certain food from certain small foreign suppliers?
1.513 What FSVP may I have if I am importing certain food from a country 
          with an officially recognized or equivalent food safety 
          system?
1.514 What are some consequences of failing to comply with the 
          requirements of this subpart?

 Subpart M_Accreditation of Third-Party Certification Bodies To Conduct 
             Food Safety Audits and To Issue Certifications

1.600 What definitions apply to this subpart?
1.601 Who is subject to this subpart?

         Recognition of Accreditation Bodies Under This Subpart

1.610 Who is eligible to seek recognition?
1.611 What legal authority must an accreditation body have to qualify 
          for recognition?
1.612 What competency and capacity must an accreditation body have to 
          qualify for recognition?
1.613 What protections against conflicts of interest must an 
          accreditation body have to qualify for recognition?
1.614 What quality assurance procedures must an accreditation body have 
          to qualify for recognition?
1.615 What records procedures must an accreditation body have to qualify 
          for recognition?

 Requirements for Accreditation Bodies That Have Been Recognized Under 
                              This Subpart

1.620 How must a recognized accreditation body evaluate third-party 
          certification bodies seeking accreditation?
1.621 How must a recognized accreditation body monitor the performance 
          of third-party certification bodies it accredited?
1.622 How must a recognized accreditation body monitor its own 
          performance?
1.623 What reports and notifications must a recognized accreditation 
          body submit to FDA?
1.624 How must a recognized accreditation body protect against conflicts 
          of interest?
1.625 What records requirements must an accreditation body that has been 
          recognized meet?

  Procedures for Recognition of Accreditation Bodies Under This Subpart

1.630 How do I apply to FDA for recognition or renewal of recognition?
1.631 How will FDA review my application for recognition or renewal of 
          recognition and what happens once FDA decides on my 
          application?
1.632 What is the duration of recognition?
1.633 How will FDA monitor recognized accreditation bodies?
1.634 When will FDA revoke recognition?
1.635 What if I want to voluntarily relinquish recognition or do not 
          want to renew recognition?
1.636 How do I request reinstatement of recognition?

  Accreditation of Third-Party Certification Bodies Under This Subpart

1.640 Who is eligible to seek accreditation?
1.641 What legal authority must a third-party certification body have to 
          qualify for accreditation?
1.642 What competency and capacity must a third-party certification body 
          have to qualify for accreditation?
1.643 What protections against conflicts of interest must a third-party 
          certification body have to qualify for accreditation?
1.644 What quality assurance procedures must a third-party certification 
          body have to qualify for accreditation?
1.645 What records procedures must a third-party certification body have 
          to qualify for accreditation?

    Requirements for Third-Party Certification Bodies That Have Been 
                      Accredited Under This Subpart

1.650 How must an accredited third-party certification body ensure its 
          audit agents are competent and objective?
1.651 How must an accredited third-party certification body conduct a 
          food safety audit of an eligible entity?
1.652 What must an accredited third-party certification body include in 
          food safety audit reports?
1.653 What must an accredited third-party certification body do when 
          issuing food or facility certifications?
1.654 When must an accredited third-party certification body monitor an 
          eligible entity that it has issued a food or facility 
          certification?
1.655 How must an accredited third-party certification body monitor its 
          own performance?
1.656 What reports and notifications must an accredited third-party 
          certification body submit?

[[Page 8]]

1.657 How must an accredited third-party certification body protect 
          against conflicts of interest?
1.658 What records requirements must a third-party certification body 
          that has been accredited meet?

 Procedures for Accreditation of Third-Party Certification Bodies Under 
                              This Subpart

1.660 Where do I apply for accreditation or renewal of accreditation by 
          a recognized accreditation body and what happens once the 
          recognized accreditation body decides on my application?
1.661 What is the duration of accreditation by a recognized 
          accreditation body?
1.662 How will FDA monitor accredited third-party certification bodies?
1.663 How do I request an FDA waiver or waiver extension for the 13-
          month limit for audit agents conducting regulatory audits?
1.664 When would FDA withdraw accreditation?
1.665 What if I want to voluntarily relinquish accreditation or do not 
          want to renew accreditation?
1.666 How do I request reaccreditation?

     Additional Procedures for Direct Accreditation of Third-Party 
                 Certification Bodies Under This Subpart

1.670 How do I apply to FDA for direct accreditation or renewal of 
          direct accreditation?
1.671 How will FDA review my application for direct accreditation or 
          renewal of direct accreditation and what happens once FDA 
          decides on my application?
1.672 What is the duration of direct accreditation?

          Requirements for Eligible Entities Under This Subpart

1.680 How and when will FDA monitor eligible entities?
1.681 How frequently must eligible entities be recertified?

                  General Requirements of This Subpart

1.690 How will FDA make information about recognized accreditation 
          bodies and accredited third-party certification bodies 
          available to the public?
1.691 How do I request reconsideration of a denial by FDA of an 
          application or a waiver request?
1.692 How do I request internal agency review of a denial of an 
          application or waiver request upon reconsideration?
1.693 How do I request a regulatory hearing on a revocation of 
          recognition or withdrawal of accreditation?
1.694 Are electronic records created under this subpart subject to the 
          electronic records requirements of part 11 of this chapter?
1.695 Are the records obtained by FDA under this subpart subject to 
          public disclosure?

              Requirements for User Fees Under This Subpart

1.700 Who is subject to a user fee under this subpart?
1.705 What user fees are established under this subpart?
1.710 How will FDA notify the public about the fee schedule?
1.715 When must a user fee required by this subpart be submitted?
1.720 Are user fees under this subpart refundable?
1.725 What are the consequences of not paying a user fee under this 
          subpart on time?

Subpart N [Reserved]

       Subpart O_Sanitary Transportation of Human and Animal Food

                           General Provisions

1.900 Who is subject to this subpart?
1.902 How do the criteria and definitions in this subpart apply under 
          the Federal Food, Drug, and Cosmetic Act?
1.904 What definitions apply to this subpart?

                  Vehicles and Transportation Equipment

1.906 What requirements apply to vehicles and transportation equipment?

                        Transportation Operations

1.908 What requirements apply to transportation operations?

                                Training

1.910 What training requirements apply to carriers engaged in 
          transportation operations?

                                 Records

1.912 What record retention and other records requirements apply to 
          shippers, receivers, loaders, and carriers engaged in 
          transportation operations?

                                 Waivers

1.914 Under what circumstances will we waive a requirement of this 
          subpart?
1.916 When will we consider whether to waive a requirement of this 
          subpart?
1.918 What must be included in the Statement of Grounds in a petition 
          requesting a waiver?
1.920 What information submitted in a petition requesting a waiver or 
          submitted in

[[Page 9]]

          comments on such a petition is publicly available?
1.922 Who will respond to a petition requesting a waiver?
1.924 What process applies to a petition requesting a waiver?
1.926 Under what circumstances may we deny a petition requesting a 
          waiver?
1.928 What process will we follow when waiving a requirement of this 
          subpart on our own initiative?
1.930 When will a waiver that we grant become effective?
1.932 Under what circumstances may we modify or revoke a waiver?
1.934 What procedures apply if we determine that a waiver should be 
          modified or revoked?

Subpart P [Reserved]

Subpart Q_Administrative Detention of Drugs Intended for Human or Animal 
                                   Use

1.980 Administrative detention of drugs.

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 
1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 
350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 
373, 374, 379j-31, 381, 382, 384a, 384b, 384d, 387, 387a, 387c, 393; 42 
U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 107-188, 116 Stat. 594, 
668-69; Pub. L. 111-353, 124 Stat. 3885, 3889.

    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 
sections 201 and 900 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 and 387) 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.  101.7(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.  101.7(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.  101.7(j) and (m), 201.62(i) and (k), 
501.105(j) and (m), 701.13(j) and (m) and 801.62(i) and (k) of this 
chapter, to initial statement of inches in declaration of net quantity 
in 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.  101.7(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; 75 
FR 73953, Nov. 30, 2010; 78 FR 69543, Nov. 20, 2013; 81 FR 59131, Aug. 
29, 2016]



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.

[[Page 10]]

    (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.

    In the regulations specified in Sec.  1.1(c) of this chapter, the 
term package means any container or wrapping in which any food, drug, 
device, or cosmetic is enclosed for use in the delivery or display of 
such commodities to retail purchasers, but does not include:
    (a) Shipping containers or wrappings used solely for the 
transportation of any such commodity in bulk or in quantity to 
manufacturers, packers, processors, or wholesale or retail distributors;
    (b) Shipping containers or outer wrappings used by retailers to ship 
or deliver any such commodity to retail customers if such containers and 
wrappings bear no printed matter pertaining to any particular commodity; 
or
    (c) Containers subject to the provisions of the Act of August 3, 
1912 (37 Stat. 250, as amended; 15 U.S.C. 231-233), the Act of March 4, 
1915 (38 Stat. 1186, as amended; 15 U.S.C. 234-236), the Act of August 
31, 1916 (39 Stat. 673, as amended; 15 U.S.C. 251-256), or the Act of 
May 21, 1928 (45 Stat. 635, as amended; 15 U.S.C. 257-257i).
    (d) Containers used for tray pack displays in retail establishments.
    (e) Transparent wrappers or containers which do not bear written, 
printed, or graphic matter obscuring the label information required by 
this part.


A requirement contained in this part that any word, statement, or other 
information appear on the label shall not be considered to be complied 
with unless such word, statement, or information also appears on the 
outer container or wrapper of the retail package of the article, or, as 
stated in paragraph (e) of this section, such information is easily 
legible by virtue of the transparency of the outer wrapper or container. 
Where a consumer commodity is marketed in a multiunit retail package 
bearing the mandatory label information as required by this part and the 
unit containers are not intended to be sold separately, the net weight 
placement requirement of Sec.  101.7(f) applicable to such unit 
containers is waived if the units are in compliance with all the other 
requirements of this part.

[42 FR 15553, Mar. 22, 1977, as amended at 75 FR 73953, Nov. 30, 2010; 
78 FR 69543, Nov. 20, 2013; 81 FR 59131, Aug. 29, 2016]

[[Page 11]]



Sec.  1.21  Failure to reveal material facts.

    (a) Labeling of a food, drug, device, cosmetic, or tobacco product 
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, cosmetics, or tobacco products under 
the Federal Food, Drug, and Cosmetic 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.

[42 FR 15553, Mar. 22, 1977, as amended at 77 FR 5176, Feb. 2, 2012]



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

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



Sec.  1.24  Exemptions from required label statements.

    The following exemptions are granted from label statements required 
by this part:
    (a) Foods. (1) While held for sale, a food shall be exempt from the 
required declaration of net quantity of contents specified in this part 
if said food is received in bulk containers at a retail establishment 
and is accurately weighed, measured, or counted either within the view 
of the purchaser or in compliance with the purchaser's order.
    (2) Random food packages, as defined in Sec.  101.7(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.  101.7

[[Page 12]]

of this chapter if the accurate statement of net weight is presented 
conspicuously on the principal display panel of the package. In the case 
of food packed in random packages at one place for subsequent shipment 
and sale at another, the price sections of the label may be left blank 
provided they are filled in by the seller prior to retail sale. This 
exemption shall also apply to uniform weight packages of cheese and 
cheese products labeled in the same manner and by the same type of 
equipment as random food packages exempted by this paragraph (a)(2) 
except that the labels shall bear a declaration of price per pound and 
not price per specified number of pounds.
    (3) Individual serving-size packages of foods containing less than 
\1/2\ ounce or less than \1/2\ fluid ounce for use in restaurants, 
institutions, and passenger carriers, and not intended for sale at 
retail, shall be exempt from the required declaration of net quantity of 
contents specified in this part.
    (4) Individually wrapped pieces of penny candy and other 
confectionery of less than one-half ounce net weight per individual 
piece shall be exempt from the labeling requirements of this part when 
the container in which such confectionery is shipped is in conformance 
with the labeling requirements of this part. Similarly, when such 
confectionery items are sold in bags or boxes, such items shall be 
exempt from the labeling requirements of this part, including the 
required declaration of net quantity of contents specified in this part 
when the declaration on the bag or box meets the requirements of this 
part.
    (5)(i) Soft drinks packaged in bottles shall be exempt from the 
placement requirements for the statement of identity prescribed by Sec.  
101.3 (a) and (d) of this chapter if such statement appears 
conspicuously on the bottle closure. When such soft drinks are marketed 
in a multiunit retail package, the multiunit retail package shall be 
exempt from the statement of identity declaration requirements 
prescribed by Sec.  101.3 of this chapter if the statement of identity 
on the unit container is not obscured by the multiunit retail package.
    (ii) A multiunit retail package for soft drinks shall be exempt from 
the declaration regarding name and place of business required by Sec.  
101.5 of this chapter if the package does not obscure the declaration on 
unit containers or if it bears a statement that the declaration can be 
found on the unit containers and the declaration on the unit containers 
complies with Sec.  101.5 of this chapter. The declaration required by 
Sec.  101.5 of this chapter may appear on the top or side of the closure 
of bottled soft drinks if the statement is conspicuous and easily 
legible.
    (iii) Soft drinks packaged in bottles which display other required 
label information only on the closure shall be exempt from the placement 
requirements for the declaration of contents prescribed by Sec.  
101.7(f) of this chapter if the required content declaration is blown, 
formed, or molded into the surface of the bottle in close proximity to 
the closure.
    (iv) Where a trademark on a soft drink package also serves as, or 
is, a statement of identity, the use of such trademark on the package in 
lines not parallel to the base on which the package rests shall be 
exempted from the requirement of Sec.  101.3(d) of this chapter that the 
statement be in lines parallel to the base so long as there is also at 
least one statement of identity in lines generally parallel to the base.
    (v) A multiunit retail package for soft drinks in cans shall be 
exempt from the declaration regarding name and place of business 
required by Sec.  101.5 of this chapter if the package does not obscure 
the declaration on unit containers or if it bears a statement that the 
declaration can be found on the unit containers and the declaration on 
the unit containers complies with Sec.  101.5 of this chapter. The 
declaration required by Sec.  101.5 of this chapter may appear on the 
top of soft drinks in cans if the statement is conspicuous and easily 
legible, provided that when the declaration is embossed, it shall appear 
in type size at least one-eighth inch in height, or if it is printed, 
the type size shall not be less than one-sixteenth inch in height. The 
declaration may follow the curvature of the lid of the can and shall not 
be removed or obscured by the tab which opens the can.

[[Page 13]]

    (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.  
101.7(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, 5001 Campus Dr., 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, 5001 Campus Dr., 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.  
101.7(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, 5001 Campus Dr., 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.  101.7(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.  101.7(f) of this chapter that the 
declaration of net

[[Page 14]]

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.  101.7(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.  101.7(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.  101.7(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.  101.7(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.  
101.7(j)(1) of this chapter that such declaration be in terms of ounces 
and pounds, to permit declaration of ``1-pound'' or ``one pound''; and
    (iii) In 4-ounce, 8-ounce, and 1-pound packages with continuous 
label copy wrapping is exempt from the requirements of Sec. Sec.  101.3 
and 101.7(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.  101.7(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.  101.7(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.  101.7(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.

[[Page 15]]

    (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.  
101.7(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.  101.7(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.  
101.7(b)(2) of this chapter to the extent that net contents of 8 fluid 
ounces and 64 fluid ounces (or 2 quarts) may be expressed as \1/2\ pint 
(or half pint) and \1/2\ gallon (or half gallon), respectively.
    (14) The unit containers in a multiunit or multicomponent retail 
food package shall be exempt from regulations of section 403 (e)(1), 
(g)(2), (i)(2), (k), and (q) of the act with respect to the requirements 
for label declaration of the name and place of business of the 
manufacturer, packer, or distributor; label declaration of ingredients; 
and nutrition information when:
    (i) The multiunit or multicomponent retail food package labeling 
meets all the requirements of this part;
    (ii) The unit containers are securely enclosed within and not 
intended to be separated from the retail package under conditions of 
retail sale; and
    (iii) Each unit container is labeled with the statement ``This Unit 
Not Labeled For Retail Sale'' in type size not less than one-sixteenth 
of an inch in height. The word ``Individual'' may be used in lieu of or 
immediately preceding the word ``Retail'' in the statement.
    (b) Drugs. Liquid over-the-counter veterinary preparations intended 
for injection shall be exempt from the declaration of net quantity of 
contents in terms of the U.S. gallon of 231 cubic inches and quart, 
pint, and fluid-ounce subdivisions thereof as required by Sec.  201.62 
(b), (i), and (j) of this chapter, and from the dual declaration 
requirements of Sec.  201.62(i) of this chapter, if such declaration of 
net quantity of contents is expressed in terms of the liter and 
milliliter, or cubic centimeter, with the volume expressed at 68 [deg]F 
(20 [deg]C).
    (c) Cosmetics. Cosmetics in packages containing less than one-fourth 
ounce avoirdupois or one-eighth fluid ounce shall be exempt from 
compliance with the requirements of section 602(b)(2) of the Federal 
Food, Drug, and Cosmetic Act and section 4(a)(2) of the Fair Packaging 
and Labeling Act:
    (1) When such cosmetics are affixed to a display card labeled in 
conformance with all labeling requirements of this part; or
    (2) When such cosmetics are sold at retail as part of a cosmetic 
package consisting of an inner and outer container and the inner 
container is not for separate retail sale and the outer container is 
labeled in conformance with all labeling requirements of this part.

[42 FR 15553, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 47 
FR 32421, July 27, 1982; 49 FR 13339, Apr. 4, 1984; 54 FR 9033, Mar. 3, 
1989; 58 FR 2174, Jan. 6, 1993; 61 FR 14478, Apr. 2, 1996; 66 FR 56035, 
Nov. 6, 2001; 81 FR 49895, July 29, 2016; 81 FR 59131, Aug. 29, 2016]

Subpart C [Reserved]



                   Subpart D_Electronic Import Entries

    Source: 81 FR 85870, Nov. 29, 2016, unless otherwise noted.

[[Page 16]]



Sec.  1.70  Scope.

    This subpart specifies the data elements that are required by the 
Food and Drug Administration (FDA) to be included in an electronic 
import entry submitted in the Automated Commercial Environment (ACE) 
system or any other U.S. Customs and Border Protection (CBP)-authorized 
electronic data interchange (EDI) system, which contains an article that 
is being imported or offered for import into the United States and that 
is regulated by FDA.



Sec.  1.71  Definitions.

    For purposes of subpart D:
    ACE filer means the person who is authorized to submit an electronic 
import entry for an FDA-regulated product in the Automated Commercial 
Environment or any other CBP-authorized EDI system.
    Acidified food means acidified food, as defined in Sec.  114.3(b) of 
this chapter, and subject to the requirements in parts 108 and 114 of 
this chapter.
    Automated Commercial Environment or ACE means the automated and 
electronic system for processing commercial importations that is 
operated by U.S. Customs and Border Protection in accordance with the 
National Customs Automation Program established in Subtitle B of Title 
VI--Customs Modernization, in the North American Free Trade Agreement 
Implementation Act (Pub. L. 103-182, 107 Stat. 2057, 2170, December 8, 
1993) (Customs Modernization Act), or any other CBP-authorized EDI 
system.
    Biological product means a biological product as defined in section 
351(i)(1) of the Public Health Service Act.
    Cosmetic means a cosmetic as defined in section 201(i) of the 
Federal Food, Drug, and Cosmetic Act.
    CBP or U.S. Customs and Border Protection means the Federal Agency 
that is primarily responsible for maintaining the integrity of the 
borders and ports of entry of the United States.
    Drug means those articles meeting the definition of a drug in 
section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act.
    FDA or Agency means the U.S. Food and Drug Administration.
    Food means food as defined in section 201(f) of the Federal Food, 
Drug, and Cosmetic Act.
    Food contact substance means any substance, as defined in section 
409(h)(6) of the Federal Food, Drug, and Cosmetic Act, that is intended 
for use as a component of materials used in manufacturing, packing, 
packaging, transporting, or holding food if such use is not intended to 
have any technical effect in such food.
    HCT/Ps means human cells, tissues, or cellular or tissue-based 
products, as defined in Sec.  1271.3(d) of this chapter.
    Low-acid canned food means a thermally processed low-acid food (as 
defined in Sec.  113.3(n) of this chapter) in a hermetically sealed 
container (as defined in Sec.  113.3(j) of this chapter), and subject to 
the requirements in parts 108 and 113 of this chapter.
    Medical device means a device as defined in section 201(h) of the 
Federal Food, Drug, and Cosmetic Act, that is intended for use in 
humans.
    Radiation-emitting electronic product means an electronic product as 
defined in section 531 of the Federal Food, Drug, and Cosmetic Act.
    Tobacco product means a tobacco product as defined in section 
201(rr) of the Federal Food, Drug, and Cosmetic Act.



Sec.  1.72  Data elements that must be submitted in ACE for articles
regulated by FDA.

    General. When filing an entry in ACE, the ACE filer shall submit the 
following information for food contact substances, drugs, biological 
products, HCT/Ps, medical devices, radiation-emitting electronic 
products, cosmetics, and tobacco products.
    (a) Product identifying information for the article that is being 
imported or offered for import. This consists of:
    (1) FDA Country of Production, which is the country where the 
article was last manufactured, processed, or grown (including harvested, 
or collected and readied for shipment to the United States). The FDA 
Country of Production for an article that has undergone any 
manufacturing or processing is the country where that activity occurred 
provided that the manufacturing or

[[Page 17]]

processing had more than a minor, negligible, or insignificant effect on 
the article.
    (2) The Complete FDA Product Code, which must be consistent with the 
invoice description of the product.
    (3) The Full Intended Use Code.
    (b) Importer of record contact information, which is the telephone 
and email address of the importer of record.



Sec.  1.73  Food.

    (a) Food contact substances. An ACE filer must submit the 
information specified in Sec.  1.72 at the time of filing entry in ACE 
for food that is a food contact substance.
    (b) Low-acid canned food. For an article of food that is a low-acid 
canned food, the ACE filer must submit at the time of filing entry the 
Food Canning Establishment Number and the Submission Identifier, and can 
dimensions or volume, except that the ACE filer does not need to submit 
this information in ACE at the time of entry if the article is being 
imported or offered for import for laboratory analysis only and will not 
be taste tested or otherwise ingested.
    (c) Acidified food. For an article of food that is an acidified 
food, the ACE filer must submit at the time of filing entry the Food 
Canning Establishment Number and the Submission Identifier, and can 
dimensions or volume, except that the ACE filer does not need to submit 
this information in ACE at the time of entry if the article is being 
imported or offered for import for laboratory analysis only and will not 
be taste tested or otherwise ingested.



Sec.  1.74  Human drugs.

    In addition to the data required to be submitted in Sec.  1.72, an 
ACE filer must submit the following information at the time of filing 
entry in ACE for drugs, including biological products, intended for 
human use that are regulated by the FDA Center for Drug Evaluation and 
Research.
    (a) Registration and listing. For a drug intended for human use, the 
Drug Registration Number and the Drug Listing Number if the foreign 
establishment where the human drug was manufactured, prepared, 
propagated, compounded, or processed before being imported or offered 
for import into the United States is required to register and list the 
drug under part 207 of this chapter. For the purposes of this section, 
the Drug Registration Number that must be submitted at the time of entry 
in ACE is the unique facility identifier of the foreign establishment 
where the human drug was manufactured, prepared, propagated, compounded, 
or processed before being imported or offered for import into the United 
States. The unique facility identifier is the identifier submitted by a 
registrant in accordance with the system specified under section 510(b) 
of the Federal Food, Drug, and Cosmetic Act. For the purposes of this 
section, the Drug Listing Number is the National Drug Code number of the 
human drug article being imported or offered for import.
    (b) Drug application number. For a drug intended for human use that 
is the subject of an approved application under section 505(b) or 505(j) 
of the Federal Food, Drug, and Cosmetic Act, the number of the new drug 
application or abbreviated new drug application. For a biological 
product regulated by the FDA Center for Drug Evaluation and Research 
that is required to have an approved new drug application or an approved 
biologics license application, the number of the applicable application.
    (c) Investigational new drug application number. For a drug intended 
for human use that is the subject of an investigational new drug 
application under section 505(i) of the Federal Food, Drug, and Cosmetic 
Act, the number of the investigational new drug application.



Sec.  1.75  Animal drugs.

    In addition to the data required to be submitted in Sec.  1.72, an 
ACE filer must submit the following information at the time of filing 
entry in ACE for animal drugs:
    (a) Registration and listing. For a drug intended for animal use, 
the Drug Registration Number and the Drug Listing Number if the foreign 
establishment where the drug was manufactured, prepared, propagated, 
compounded, or processed before being imported or offered for import 
into the United States is required to register and list the drug

[[Page 18]]

under part 207 of this chapter. For the purposes of this section, the 
Drug Registration Number that must be submitted in ACE is the Unique 
Facility Identifier of the foreign establishment where the animal drug 
was manufactured, prepared, propagated, compounded, or processed before 
being imported or offered for import into the United States. The Unique 
Facility Identifier is the identifier submitted by a registrant in 
accordance with the system specified under section 510(b) of the Federal 
Food, Drug, and Cosmetic Act. For the purposes of this section, the Drug 
Listing Number is the National Drug Code number of the animal drug 
article being imported or offered for import.
    (b) New animal drug application number. For a drug intended for 
animal use that is the subject of an approved application under section 
512 of the Federal Food, Drug, and Cosmetic Act, the number of the new 
animal drug application or abbreviated new animal drug application. For 
a drug intended for animal use that is the subject of a conditionally 
approved application under section 571 of the Federal Food, Drug, and 
Cosmetic Act, the application number for the conditionally approved new 
animal drug.
    (c) Veterinary minor species index file number. For a drug intended 
for use in animals that is the subject of an Index listing under section 
572 of the Federal Food, Drug, and Cosmetic Act, the Minor Species Index 
File number of the new animal drug on the Index of Legally Marketed 
Unapproved New Animal Drugs for Minor Species.
    (d) Investigational new animal drug number. For a drug intended for 
animal use that is the subject of an investigational new animal drug or 
generic investigational new animal drug application under part 511 of 
this chapter, the number of the investigational new animal drug or 
generic investigational new animal drug file.



Sec.  1.76  Medical devices.

    In addition to the data required to be submitted in Sec.  1.72, an 
ACE filer must submit the following information at the time of filing 
entry in ACE for medical devices regulated by the FDA Center for Devices 
and Radiological Health.
    (a) Registration and listing. For a medical device, the Registration 
Number for Foreign Manufacturers, Foreign Exporters, and/or Domestic 
Manufacturers, and the Device Listing Number, required under section 510 
of the Federal Food, Drug, and Cosmetic Act and part 807 of this 
chapter.
    (b) Investigational devices. For an investigational medical device 
that has an investigational device exemption granted under section 
520(g) of the Federal Food, Drug, and Cosmetic Act, the Investigational 
Device Exemption Number. For an investigational medical device being 
imported or offered for import for use in a nonsignificant risk or 
exempt study, ``NSR'' to be entered in the Affirmation of Compliance for 
the ``investigational device exemption'' that identifies the device as 
being used in a nonsignificant risk or exempt study.
    (c) Premarket number. For a medical device that has one, the 
Premarket Number. This is the Premarket Approval Number for those 
medical devices that have received premarket approval under section 515 
of the Federal Food, Drug, and Cosmetic Act; the Product Development 
Protocol Number for those medical devices for which FDA has declared the 
product development protocol complete under section 515(f) of the 
Federal Food, Drug, and Cosmetic Act; the De Novo number for those 
medical devices granted marketing authorization under section 513(f)(2) 
of the Federal Food, Drug, and Cosmetic Act; the Premarket Notification 
Number for those medical devices that received premarket clearance under 
section 510(k) of the Federal Food, Drug, and Cosmetic Act; or the 
Humanitarian Device Exemption Number for those medical devices for which 
an exemption has been granted under section 520(m) of the Federal Food, 
Drug, and Cosmetic Act.
    (d) Component. If applicable for a medical device, an affirmation 
identifying that the article being imported or offered for import is a 
component that requires further processing or inclusion into a finished 
medical device.

[[Page 19]]

    (e) Lead wire/patient cable. For electrode lead wires and patient 
cables intended for use with a medical device, an Affirmation of 
Compliance with the applicable performance standard under Sec.  898.12 
of this chapter.
    (f) Impact resistant lens. For impact resistant lenses in eyeglasses 
and sunglasses, an Affirmation of Compliance with the applicable 
requirements of Sec.  801.410 of this chapter.
    (g) Convenience kit. If applicable for a medical device, an 
Affirmation of Compliance that the article imported or offered for 
import is a convenience kit or part of a convenience kit.



Sec.  1.77  Radiation-emitting electronic products.

    In addition to the data required to be submitted in Sec.  1.72, an 
ACE filer must submit all of the declarations required in Form FDA 2877 
electronically in ACE at the time of filing entry for products subject 
to the standards under parts 1020-1050 of this chapter.



Sec.  1.78  Biological products, HCT/Ps, and related drugs and medical
devices.

    In addition to the data required to be submitted in Sec.  1.72, an 
ACE filer must submit the following information at the time of filing 
entry in ACE for biological products, HCT/Ps, and related drugs and 
medical devices regulated by the FDA Center for Biologics Evaluation and 
Research.
    (a) Product name which identifies the article being imported or 
offered for import by the name commonly associated with that article 
including the established name, trade name, brand name, proper name, or 
product description if the article does not have an established name, 
trade name, brand name, or proper name.
    (b) HCT/P registration and affirmation. (1) For an HCT/P regulated 
solely under section 361 of the Public Health Service Act and the 
regulations in part 1271 of this chapter that is manufactured by an 
establishment that is required to be registered under part 1271 of this 
chapter, the HCT/P Registration Number; and
    (2) For an HCT/P regulated solely under section 361 of the Public 
Health Service Act and the regulations in part 1271 of this chapter, an 
Affirmation of Compliance with the applicable requirements of part 1271 
of this chapter.
    (c) Licensed biological products. For a biological product that is 
the subject of an approved biologics license application under section 
351 of the Public Health Service Act, the Submission Tracking Number of 
the biologics license application and/or the Biologics License Number.
    (d) Drug registration. For a drug intended for human use, the Drug 
Registration Number if the foreign establishment where the human drug 
was manufactured, prepared, propagated, compounded, or processed before 
being imported or offered for import into the United States is required 
to register the drug under part 207 or part 607 of this chapter as 
applicable. For the purposes of this section, the Drug Registration 
Number that must be submitted at the time of entry in ACE is the unique 
facility identifier of the foreign establishment where the human drug 
was manufactured, prepared, propagated, compounded, or processed before 
being imported or offered for import into the United States. The unique 
facility identifier is the identifier submitted by a registrant in 
accordance with the system specified under section 510(b) of the Federal 
Food, Drug, and Cosmetic Act.
    (e) Drug application number. For a drug intended for human use that 
is the subject of an approved application under section 505(b) or 505(j) 
of the Federal Food, Drug, and Cosmetic Act, the number of the new drug 
application or the abbreviated new drug application.
    (f) Investigational new drug application number. For a drug intended 
for human use that is the subject of an investigational new drug 
application under section 505(i) of the Federal Food, Drug, and Cosmetic 
Act, the number of the investigational new drug application.
    (g) Medical device registration and listing. For a medical device 
subject to the registration and listing procedures contained in part 807 
of this chapter, the Registration Number for Foreign Manufacturers, 
Foreign Exporters, and/or Domestic Manufacturers, and the Device Listing 
Number, required under section 510 of the Federal Food, Drug, and 
Cosmetic Act and part 807 of this chapter.

[[Page 20]]

    (h) Investigational devices. For an investigational medical device 
that has an investigational device exemption granted under section 
520(g) of the Federal Food, Drug, and Cosmetic Act, the Investigational 
Device Exemption Number. For an investigational medical device being 
imported or offered for import for use in a nonsignificant risk or 
exempt study, ``NSR'' to be entered in the Affirmation of Compliance for 
the ``investigational device exemption'' that identifies the device as 
being used in a nonsignificant risk or exempt study.
    (i) Medical device premarket number. For a medical device that has 
one, the Premarket Number. This is the Premarket Approval Number for 
those medical devices that have received premarket approval under 
section 515 of the Federal Food, Drug, and Cosmetic Act; the Product 
Development Protocol Number for those medical devices for which FDA has 
declared the product development protocol complete under section 515(f) 
of the Federal Food, Drug, and Cosmetic Act; the De Novo number for 
those medical devices granted marketing authorization under section 
513(f)(2) of the Federal Food, Drug, and Cosmetic Act; the Premarket 
Notification Number for those medical devices that received premarket 
clearance under section 510(k) of the Federal Food, Drug, and Cosmetic 
Act; or the Humanitarian Device Exemption Number for those medical 
devices for which an exemption has been granted under section 520(m) of 
the Federal Food, Drug, and Cosmetic Act.
    (j) Medical device component. If applicable for a medical device, an 
affirmation identifying that the article being imported or offered for 
import is a component that requires further processing or inclusion into 
a finished medical device.



Sec.  1.79  Tobacco products.

    In addition to the data required to be submitted in Sec.  1.72, an 
ACE filer must submit the following information at the time of filing 
entry in ACE.
    (a) Brand name of an article that is a tobacco product that is being 
imported or offered for import. If the article does not have a specific 
brand name, the ACE filer must submit a commercial name for the brand 
name. This data element is not applicable to those products solely 
intended either for further manufacturing or as investigational tobacco 
products.
    (b) [Reserved]



Sec.  1.80  Cosmetics.

    An ACE filer must submit the data specified in Sec.  1.72 at the 
time of filing entry in ACE.



Sec.  1.81  Rejection of entry filing.

    FDA may reject an entry filing for failure to provide complete and 
accurate information that is required pursuant to this subpart.



                      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 makes entry 
under the provisions of section 484 of the Tariff Act of 1930, as 
amended (19 U.S.C. 1484), namely, the ``importer of record.''
    (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).

[42 FR 15553, Mar. 22, 1977, as amended at 81 FR 85872, Nov. 29, 2016]



Sec.  1.90  Notice of sampling.

    When a sample of an article offered for import has been requested by 
the district director, FDA shall provide 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

[[Page 21]]

further notice from the district director or U.S. Customs and Border 
Protection of the results of examination of the sample.

[81 FR 85872, Nov. 29, 2016]



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 or destruction.

    (a) If it appears that the article may be subject to refusal of 
admission, or that the article is a drug that may be subject to 
destruction under section 801(a) of the Federal Food, Drug, and Cosmetic 
Act, the district director shall give the owner or consignee a written 
or electronic 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 or destruction of the article, and may be introduced 
orally or in writing.
    (b) If such owner or consignee submits or indicates his or her 
intention to submit an application for authorization to relabel or 
perform other action to bring the article into compliance with the 
Federal Food, Drug, and Cosmetic 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 on refusal of admission, the district director 
shall specify a time limit, reasonable in the light of the 
circumstances, for filing such application.
    (c) If the article is a drug that may be subject to destruction 
under section 801(a) of the Federal Food, Drug, and Cosmetic Act, the 
district director may give the owner or consignee a single written or 
electronic notice that provides the notice of refusal of admission and 
the notice of destruction of an article described in paragraph (a) of 
this section. The district director may also combine the hearing on 
refusal of admission with the hearing on destruction of the article 
described in paragraph (a) of this section into a single proceeding.

[80 FR 55242, Sept. 15, 2015, as amended at 81 FR 85873, Nov. 29, 2016]



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

[[Page 22]]

    (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.
    (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

[[Page 23]]

 
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, 
cosmetic, and tobacco product exports under sections 801 or 802 of the 
Federal Food, Drug, and Cosmetic 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, cosmetics, and tobacco products exported 
under or subject to section 801(e)(1) of the Federal Food, Drug, and 
Cosmetic 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;
    (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:

[[Page 24]]

    (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--Food and Drug Administration, Center 
for Biologics Evaluation and Research, Document Control Center, 10903 
New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002.
    (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, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002.
    (iii) For devices--Food and Drug Administration, Center for Devices 
and Radiological Health, Division of Program Operations, 10903 New 
Hampshire Ave., Bldg. 66, rm. 5429, Silver Spring, MD 20993-0002.
    (e) Recordkeeping requirements for products subject to section 
802(g) of the 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

[[Page 25]]

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; 74 FR 13112, Mar. 26, 2009; 75 FR 20914, 
Apr. 22, 2010; 77 FR 5176, Feb. 2, 2012; 80 FR 18090, Apr. 3, 2015]

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.);



Sec.  1.227  What definitions apply to this subpart?

    The definitions of terms in section 201 of the Federal Food, Drug, 
and Cosmetic Act apply to such terms when used in this subpart. In 
addition, for the purposes of this subpart:
    Calendar day means every day shown on the calendar.
    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.
    (1) Domestic facility means any facility located in any State or 
Territory of

[[Page 26]]

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.
    (2) Foreign facility means a facility other than a domestic facility 
that manufactures/processes, packs, or holds food for consumption in the 
United States.
    Farm means:
    (1) Primary production farm. A primary production farm is an 
operation under one management in one general (but not necessarily 
contiguous) physical location devoted to the growing of crops, the 
harvesting of crops, the raising of animals (including seafood), or any 
combination of these activities. The term ``farm'' includes operations 
that, in addition to these activities:
    (i) Pack or hold raw agricultural commodities;
    (ii) Pack or hold processed food, provided that all processed food 
used in such activities is either consumed on that farm or another farm 
under the same management, or is processed food identified in paragraph 
(1)(iii)(B)(1) of this definition; and
    (iii) Manufacture/process food, provided that:
    (A) All food used in such activities is consumed on that farm or 
another farm under the same management; or
    (B) Any manufacturing/processing of food that is not consumed on 
that farm or another farm under the same management consists only of:
    (1) Drying/dehydrating raw agricultural commodities to create a 
distinct commodity (such as drying/dehydrating grapes to produce 
raisins), and packaging and labeling such commodities, without 
additional manufacturing/processing (an example of additional 
manufacturing/processing is slicing);
    (2) Treatment to manipulate the ripening of raw agricultural 
commodities (such as by treating produce with ethylene gas), and 
packaging and labeling treated raw agricultural commodities, without 
additional manufacturing/processing; and
    (3) Packaging and labeling raw agricultural commodities, when these 
activities do not involve additional manufacturing/processing (an 
example of additional manufacturing/processing is irradiation); or
    (2) Secondary activities farm. A secondary activities farm is an 
operation, not located on a primary production farm, devoted to 
harvesting (such as hulling or shelling), packing, and/or holding of raw 
agricultural commodities, provided that the primary production farm(s) 
that grows, harvests, and/or raises the majority of the raw agricultural 
commodities harvested, packed, and/or held by the secondary activities 
farm owns, or jointly owns, a majority interest in the secondary 
activities farm. A secondary activities farm may also conduct those 
additional activities allowed on a primary production farm as described 
in paragraphs (1)(ii) and (iii) of this definition.
    Food has the meaning given in section 201(f) of the Federal Food, 
Drug, and Cosmetic Act:
    (1) Except for purposes of this subpart, it does not include:
    (i) Food contact substances as defined in section 409(h)(6) of the 
Federal Food, Drug, and Cosmetic Act; or
    (ii) Pesticides as defined in 7 U.S.C. 136(u).
    (2) 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.
    Harvesting applies to farms and farm mixed-type facilities and means 
activities that are traditionally performed on farms for the purpose of 
removing raw agricultural commodities from the place they were grown or 
raised and preparing them for use as food. Harvesting is limited to 
activities performed on raw agricultural commodities, or on processed 
foods created by drying/dehydrating a raw agricultural commodity without 
additional manufacturing/processing, on a farm. Harvesting does not 
include activities that transform a raw agricultural commodity into a 
processed food as defined in section 201(gg) of the Federal Food,

[[Page 27]]

Drug, and Cosmetic Act. Examples of harvesting include cutting (or 
otherwise separating) the edible portion of the raw agricultural 
commodity from the crop plant and removing or trimming part of the raw 
agricultural commodity (e.g., foliage, husks, roots or stems). Examples 
of harvesting also include cooling, field coring, filtering, gathering, 
hulling, shelling, sifting, threshing, trimming of outer leaves of, and 
washing raw agricultural commodities grown on a farm.
    Holding means storage of food and also includes activities performed 
incidental to storage of a food (e.g., activities performed for the safe 
or effective storage of that food, such as fumigating food during 
storage, and drying/dehydrating raw agricultural commodities when the 
drying/dehydrating does not create a distinct commodity (such as drying/
dehydrating hay or alfalfa)). Holding also includes activities performed 
as a practical necessity for the distribution of that food (such as 
blending of the same raw agricultural commodity and breaking down 
pallets), but does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities 
could 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 include: Baking, boiling, bottling, 
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw 
agricultural commodities to create a distinct commodity (such as drying/
dehydrating grapes to produce raisins), evaporating, eviscerating, 
extracting juice, formulating, freezing, grinding, homogenizing, 
irradiating, labeling, milling, mixing, packaging (including modified 
atmosphere packaging), pasteurizing, peeling, rendering, treating to 
manipulate ripening, trimming, washing, or waxing. For farms and farm 
mixed-type facilities, manufacturing/processing does not include 
activities that are part of harvesting, packing, or holding.
    Mixed-type facility means an establishment that engages in both 
activities that are exempt from registration under section 415 of the 
Federal Food, Drug, and Cosmetic Act and activities that require the 
establishment to be registered. An example of such a facility is a 
``farm mixed-type facility,'' which is an establishment that is a farm, 
but also conducts activities outside the farm definition that require 
the establishment to be registered.
    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)).
    Packaging (when used as a verb) means placing food into a container 
that directly contacts the food and that the consumer receives.
    Packing means placing food into a container other than packaging the 
food and also includes re-packing and activities performed incidental to 
packing or re-packing a food (e.g., activities performed for the safe or 
effective packing or re-packing of that food (such as sorting, culling, 
grading, and weighing or conveying incidental to packing or re-
packing)), but does not include activities that transform a raw 
agricultural commodity, as defined in section 201(r) of the Federal 
Food, Drug, and Cosmetic Act, into a processed food as defined in 
section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
    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) Entities in which food is provided to humans, such as 
cafeterias,

[[Page 28]]

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
    (2) Pet shelters, kennels, and veterinary facilities in which food 
is provided to animals are restaurants.
    Retail food establishment means an establishment that sells food 
products directly to consumers as its primary function. The term 
``retail food establishment'' includes facilities that 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. A ``retail food 
establishment'' also includes certain farm-operated businesses selling 
food directly to consumers as their primary function.
    (1) Sale of food directly to consumers from an establishment located 
on a farm includes sales by that establishment directly to consumers:
    (i) At a roadside stand (a stand situated on the side of or near a 
road or thoroughfare at which a farmer sells food from his or her farm 
directly to consumers) or farmers' market (a location where one or more 
local farmers assemble to sell food from their farms directly to 
consumers);
    (ii) Through a community supported agriculture program. Community 
supported agriculture (CSA) program means a program under which a farmer 
or group of farmers grows food for a group of shareholders (or 
subscribers) who pledge to buy a portion of the farmer's crop(s) for 
that season. This includes CSA programs in which a group of farmers 
consolidate their crops at a central location for distribution to 
shareholders or subscribers; and
    (iii) At other such direct-to-consumer sales platforms, including 
door-to-door sales; mail, catalog and Internet order, including online 
farmers markets and online grocery delivery; religious or other 
organization bazaars; and State and local fairs.
    (2) Sale of food directly to consumers by a farm-operated business 
includes the sale of food by that farm-operated business directly to 
consumers:
    (i) At a roadside stand (a stand situated on the side of or near a 
road or thoroughfare at which a farmer sells food from his or her farm 
directly to consumers) or farmers' market (a location where one or more 
local farmers assemble to sell food from their farms directly to 
consumers);
    (ii) Through a community supported agriculture program. Community 
supported agriculture (CSA) program means a program under which a farmer 
or group of farmers grows food for a group of shareholders (or 
subscribers) who pledge to buy a portion of the farmer's crop(s) for 
that season. This includes CSA programs in which a group of farmers 
consolidate their crops at a central location for distribution to 
shareholders or subscribers; and
    (iii) At other such direct-to-consumer sales platforms, including 
door-to-door sales; mail, catalog and Internet order, including online 
farmers markets and online grocery delivery; religious or other 
organization bazaars; and State and local fairs.
    (3) For the purposes of this definition, ``farm-operated business'' 
means a business that is managed by one or more farms and conducts 
manufacturing/processing not on the farm(s).
    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.
    U.S. agent means a person (as defined in section 201(e) of the 
Federal Food, Drug, and Cosmetic 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 may not be in the form of a mailbox, answering machine or service,

[[Page 29]]

or other place where an individual acting as the foreign facility's 
agent is not physically present.
    (1) 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 another emergency contact.
    (2) 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. FDA will consider the U.S. agent the equivalent 
of the registrant for purposes of sharing information and 
communications. The U.S. agent of a foreign facility may view the 
information submitted in the foreign facility's registration.
    (3) 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.
    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.

[80 FR 56141, Sept. 17, 2015, as amended at 81 FR 3715, Jan. 22, 2016; 
81 FR 45950, July 14, 2016]

             Procedures for Registration of Food Facilities



Sec.  1.230  When must you register or renew your registration?

    (a) Registration. You must register before your facility begins to 
manufacture, process, pack, or hold food for consumption in the United 
States. You may authorize an individual to register the facility on your 
behalf.
    (b) Registration renewal. You must submit a registration renewal 
containing the information required under Sec.  1.232 every other year, 
during the period beginning on October 1 and ending on December 31 of 
each even-numbered year. You may authorize an individual to renew a 
facility's registration on your behalf. If the individual submitting the 
registration renewal is not the owner, operator, or agent in charge of 
the facility, the registration renewal 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 renewal, and identifies by name, address, and telephone 
number, the individual who authorized submission of the registration 
renewal. In addition, the registration renewal must also identify the 
individual who authorized submission of the registration renewal by 
email address, unless FDA has granted a waiver under Sec.  1.245. Each 
registration renewal must include the name of the individual submitting 
the registration renewal, and the individual's signature (for the paper 
option). Each electronic registration renewal must include the name of 
the individual submitting the renewal.
    (c) Abbreviated registration renewal process. If you do not have any 
changes to the information required under Sec.  1.232 since you 
submitted the preceding registration, registration renewal, or update 
for your facility, you may use the abbreviated registration renewal 
process. If you use the abbreviated registration renewal process, you 
must confirm that no changes have been made to the information required 
under Sec.  1.232 since you submitted the preceding registration, 
registration renewal or update, and you must certify that the 
information submitted is truthful and accurate. Each abbreviated 
registration renewal must include the name of the individual submitting 
the abbreviated renewal, and the individual's signature (for the paper 
option). Each electronic abbreviated registration renewal must include 
the name of the individual submitting the abbreviated renewal. For 
abbreviated registration renewals not submitted by the owner, operator, 
or agent in charge of the facility, the abbreviated renewal must provide 
the email address of the individual who authorized submission of the 
abbreviated renewal, unless FDA has granted a waiver under Sec.  1.245. 
You must use

[[Page 30]]

Form FDA 3537 to submit abbreviated registration renewals to FDA.

[81 FR 45950, July 14, 2016]



Sec.  1.231  How and where do you register or renew your registration?

    (a) Electronic registration and registration renewal. (1) To 
register or renew a registration electronically, you must go to http://
www.fda.gov/furls, which is available for registration 24 hours a day, 7 
days a week. This Web site 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) Beginning on January 4, 2020, you must submit your registration 
or registration renewal to FDA electronically, unless FDA has granted 
you a waiver under Sec.  1.245.
    (3) After you submit your electronic registration, FDA will verify 
the accuracy of your unique facility identifier (UFI) recognized as 
acceptable by FDA and will also verify that the facility-specific 
address associated with the UFI is the same address associated with your 
registration. FDA will not confirm your registration or provide you with 
a registration number until FDA verifies the accuracy of your facility's 
UFI and verifies that the facility-specific address associated with the 
UFI is the same address associated with your registration. With respect 
to electronic registration renewals, after you submit your electronic 
registration renewal, FDA will provide you with an electronic 
confirmation of your registration renewal. When you update your 
facility's UFI as part of your electronic registration renewal, FDA will 
verify the accuracy of your facility's UFI and will also verify that the 
facility-specific address associated with the UFI is the same address 
associated with your registration. FDA will not provide you with a 
confirmation of your registration renewal until FDA verifies the 
accuracy of your UFI and verifies that the facility-specific address 
associated with the UFI is the same address associated with your 
registration.
    (4) For electronic registrations not submitted by the owner, 
operator, or agent in charge of the facility, after submission of the 
registration, FDA will verify that the individual identified as having 
authorized submission of the registration in fact authorized the 
submission on behalf of the facility. FDA will not confirm the 
registration or provide a registration number until that individual 
confirms that he or she authorized the submission. With respect to 
electronic registration renewals, after completion of the electronic 
registration renewal, FDA will provide an electronic confirmation of the 
registration renewal. For electronic registration renewals not submitted 
by the owner, operator, or agent in charge of the facility, FDA will 
verify that the individual identified as having authorized submission of 
the registration renewal in fact authorized the submission on behalf of 
the facility. FDA will not provide an electronic confirmation of the 
registration renewal until that individual confirms that he or she 
authorized the submission.
    (5) For a foreign facility, after you submit your electronic 
registration, FDA will verify that the person identified as the U.S. 
agent for your foreign facility has agreed to serve as your U.S. agent. 
FDA will not confirm your registration or provide you with a 
registration number until that person confirms that the person agreed to 
serve as your U.S. agent. With respect to electronic registration 
renewals, after you complete your electronic registration renewal, FDA 
will provide you with an electronic confirmation of your registration 
renewal. When you update information about your U.S. agent as part of 
your electronic registration renewal, FDA will verify that the person 
identified as the U.S. agent for your foreign facility has agreed to 
serve as your U.S. agent. FDA will not provide you with an electronic 
confirmation of your registration renewal until that person confirms 
that the person agreed to serve as your U.S. agent.
    (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.

[[Page 31]]

    (7) You will be considered registered once FDA electronically sends 
you your confirmation and registration number.
    (b) Registration or registration renewal by mail or fax. Beginning 
January 4, 2020, you must submit your registration or registration 
renewal to FDA electronically, unless FDA has granted you a waiver under 
Sec.  1.245. If FDA has granted you a waiver under Sec.  1.245, you may 
register or renew a registration by mail or by fax.
    (1) You must register or renew a registration (including abbreviated 
registration renewals) using Form FDA 3537. You may obtain a copy of 
this form by writing to the U.S. Food and Drug Administration, Center 
for Food Safety and Applied Nutrition, 5001 Campus Dr. (HFS-681), 
College Park, MD 20740 or by requesting the 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 301-436-2804.
    (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, as soon as 
practicable, in the order FDA receives them.
    (5) After you submit your registration, FDA will verify the accuracy 
of your facility's UFI and will also verify that the facility-specific 
address associated with the UFI is the same address associated with your 
registration. FDA will not confirm your registration or provide you with 
a registration number until FDA verifies the accuracy of your facility's 
UFI and verifies that the facility-specific address associated with the 
UFI is the same address associated with your registration. With respect 
to registration renewals, after you submit your registration renewal by 
mail or fax, FDA will provide you with a confirmation of your 
registration renewal. When you update your facility's UFI as part of 
your registration renewal, FDA will verify the accuracy of your 
facility's UFI and will also verify that the facility-specific address 
associated with the UFI is the same address associated with your 
registration. FDA will not provide you with a confirmation of your 
registration renewal until FDA verifies the accuracy of your UFI and 
verifies that the facility-specific address associated with the UFI is 
the same address associated with your registration.
    (6) For registrations not submitted by the owner, operator, or agent 
in charge of the facility, after submission of the registration by mail 
or fax, FDA will verify that the individual identified as having 
authorized submission of the registration in fact authorized the 
submission on behalf of the facility. FDA will not confirm the 
registration or provide a registration number until that individual 
confirms that he or she authorized the submission. With respect to 
registration renewals, after completion of the registration renewal by 
mail or fax, FDA will provide a confirmation of the registration 
renewal. For registration renewals not submitted by the owner, operator, 
or agent in charge of the facility, FDA will verify that the individual 
identified as having authorized submission of the registration renewal 
in fact authorized the submission on behalf of the facility. FDA will 
not provide a confirmation of the registration renewal until that 
individual confirms that he or she authorized the submission.
    (7) For a foreign facility, after you submit your registration by 
mail or fax, FDA will verify that the person identified as the U.S. 
agent for your foreign facility has agreed to serve as your U.S. agent. 
FDA will not confirm your registration or provide you with a 
registration number until that person confirms that the person agreed to 
serve as your U.S. agent. With respect to registration renewals, after 
you complete your registration renewal by mail or fax, FDA will provide 
you with a confirmation of your registration renewal. When you update 
information about your U.S. agent as part of your registration renewal, 
FDA will verify

[[Page 32]]

that the person identified as the U.S. agent for your foreign facility 
has agreed to serve as your U.S. agent. FDA will not provide you with a 
confirmation of your registration renewal until that person confirms 
that the person agreed to serve as your U.S. agent.
    (8) FDA will mail or fax you 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).
    (9) 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.
    (10) 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) Fees. No registration fee is required.
    (d) 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.

[81 FR 45950, July 14, 2016]



Sec.  1.232  What information is required in the registration?

    (a) For a domestic and foreign facility, the following information 
is required:
    (1) The name, full address, and phone number of the facility;
    (2) Beginning October 1, 2020, the facility's UFI recognized as 
acceptable by FDA;
    (3) The preferred mailing address, if different from that of the 
facility;
    (4) The name, full address, and phone number of the parent company, 
if the facility is a subsidiary of the parent company;
    (5) All trade names the facility uses;
    (6) The name, full address, and phone number of the owner, operator, 
or agent in charge of the facility. In addition, the email address of 
the owner, operator, or agent in charge is required, unless FDA has 
granted you a waiver under Sec.  1.245;
    (7) The applicable food product categories of any food manufactured/
processed, packed, or held at the facility as identified on Form FDA 
3537;
    (8) The type of activity conducted at the facility for each food 
product category identified. You may select more than one activity type 
for each food product category identified. The activity type options are 
as follows:
    (i) Ambient human food storage warehouse/holding facility;
    (ii) Refrigerated human food warehouse/holding facility;
    (iii) Frozen human food warehouse/holding facility;
    (iv) Interstate conveyance caterer/catering point;
    (v) Contract sterilizer;
    (vi) Labeler/relabeler;
    (vii) Manufacturer/processor;
    (viii) Acidified food processor;
    (ix) Low-acid food processor;
    (x) Farm mixed-type facility;
    (xi) Packer/repacker;
    (xii) Salvage operator (reconditioner);
    (xiii) Animal food warehouse/holding facility;
    (xiv) Other activity.
    (9) A statement in which the owner, operator, or agent in charge 
provides an assurance that FDA will be permitted to inspect the facility 
at the times and in the manner permitted by the Federal Food, Drug, and 
Cosmetic Act;
    (10) 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. In addition, 
the registration must identify the individual who authorized submission 
of the registration by email address, unless FDA

[[Page 33]]

has granted a waiver under Sec.  1.245. Each registration must include 
the name of the individual submitting the registration, and the 
individual's signature (for the paper option).
    (b) For a domestic facility, the following additional information is 
required:
    (1) The email address for the contact person of the facility;
    (2) An emergency contact phone number and email address if different 
from the email address for the contact person in paragraph (b)(1) of 
this section.
    (c) For a foreign facility, the following additional information is 
required:
    (1) The name, full address, phone number, and email address of the 
foreign facility's U.S. agent;
    (2) An emergency contact phone number and email address.

[81 FR 45951, July 14, 2016]



Sec.  1.233  Are there optional items included in the registration form?

    Yes. FDA encourages, but does not require, you to submit items that 
are indicated as optional on the Form FDA 3537 that you submit.

[81 FR 45952, July 14, 2016]



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

    (a) Update requirements. You must update 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. You may 
authorize an individual to update a facility's registration on your 
behalf. For updates not submitted by the owner, operator, or agent in 
charge of the facility, the update must provide the email address of the 
individual who authorized submission of the update, unless FDA has 
granted a waiver under Sec.  1.245.
    (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 submit a new 
registration for 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) After you submit your electronic update, FDA will provide you 
with an electronic confirmation of your update. When updating UFI 
information, FDA will verify the accuracy of your facility's UFI and 
will also verify that the facility-specific address associated with the 
UFI is the same address associated with your registration. FDA will not 
provide you with an electronic confirmation of your registration update 
until FDA verifies the accuracy of your facility's UFI and verifies that 
the facility-specific address associated with the UFI is the same 
address associated with your registration. For foreign facilities, when 
updating information about your U.S. agent, FDA will verify that the 
person identified as the U.S. agent for your foreign facility has agreed 
to serve as your U.S. agent. FDA will not provide you with an electronic 
confirmation of your registration update until that person confirms that 
the person agreed to serve as your U.S. agent.
    (3) For electronic updates not submitted by the owner, operator, or 
agent in charge of the facility, after submission of the electronic 
update, FDA will verify that the individual identified as having 
authorized submission of the update in fact authorized the submission on 
behalf of the facility. FDA will not confirm the update to the 
registration until that individual confirms that he or she authorized 
the submission.
    (4) Your registration will be considered updated once FDA sends you 
your update confirmation, unless notified otherwise.
    (d) Update by mail or fax. Beginning January 4, 2020, you must 
submit your update electronically, unless FDA has granted you a waiver 
under Sec.  1.245. If FDA has granted you a waiver under Sec.  1.245, 
you may update your facility's registration by mail or by fax.
    (1) You must update your registration using Form FDA 3537. You may

[[Page 34]]

obtain a copy of this form by writing to the U.S. Food and Drug 
Administration, Center for Food Safety and Applied Nutrition, 5001 
Campus Dr. (HFS-681), College Park, MD 20740 or by requesting the form 
by phone at 1-800-216-7331 or 301-575-0156.
    (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-
436-2804.
    (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 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). After you submit your update by mail or fax, FDA will verify the 
accuracy of your facility's UFI and will also verify that the facility-
specific address associated with the UFI is the same address associated 
with your registration. FDA will not provide a confirmation of your 
registration update until FDA verifies the accuracy of your facility's 
UFI and verifies that the facility-specific address associated with the 
UFI is the same address associated with your registration. For foreign 
facilities, when updating information about your U.S. agent, FDA will 
verify that the person identified as the U.S. agent for your foreign 
facility has agreed to serve as your U.S. agent. FDA will not provide 
you with a confirmation of your registration update until that person 
confirms that the person agreed to serve as your U.S. agent.
    (6) For registration updates not submitted by the owner, operator, 
or agent in charge of the facility, after submission of the registration 
update by mail or fax, FDA will verify that the individual identified as 
having authorized submission of the update in fact authorized the 
submission on behalf of the facility. FDA will not confirm the 
registration update until that individual confirms that he or she 
authorized the update.
    (7) If any update information you previously submitted was incorrect 
at the time of submission, you must immediately resubmit your update.
    (8) 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.

[81 FR 45952, July 14, 2016]



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

    (a) Notification of registration cancellation. You must cancel a 
registration within 60 calendar days of the reason for cancellation 
(e.g., your facility ceases operations, ceases providing food for 
consumption in the United States, or 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 email address (if available) of the 
individual submitting the cancellation;
    (5) For registration cancellations not submitted by the owner, 
operator, or agent in charge of the facility, the email address of the 
individual who authorized submission of the registration cancellation, 
unless FDA has granted a waiver under Sec.  1.245; and
    (6) 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.

[[Page 35]]

    (2) Once you complete your electronic cancellation, FDA will provide 
you with an electronic confirmation of your cancellation.
    (3) For registration cancellations not submitted by the owner, 
operator, or agent in charge of the facility, after submission of the 
registration cancellation, FDA will verify that the individual 
identified as having authorized submission of the cancellation in fact 
authorized the submission on behalf of the facility. FDA will not 
confirm the registration cancellation until that individual confirms 
that he or she authorized the registration cancellation.
    (4) Your registration will be considered cancelled once FDA sends 
you your cancellation confirmation.
    (d) Cancellation by mail or fax. Beginning January 4, 2020, you must 
cancel your registration electronically, unless FDA has granted you a 
waiver under Sec.  1.245. If FDA has granted a waiver under Sec.  1.245, 
you may cancel your facility's registration by mail or fax.
    (1) You must cancel your registration using Form FDA 3537a. You may 
obtain a copy of this form by writing to the U.S. Food and Drug 
Administration, Center for Food Safety and Applied Nutrition, 5001 
Campus Dr. (HFS-681), College Park, MD 20740 or by requesting the form 
by phone at 1-800-216-7331 or 301-575-0156.
    (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 301-436-2804.
    (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 as soon as practicable, in 
the order FDA receives them.
    (5) FDA will 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) For registration cancellations not submitted by the owner, 
operator, or agent in charge of the facility, after submission of the 
registration cancellation by mail or fax, FDA will verify that the 
individual identified as having authorized submission of the 
cancellation in fact authorized the submission on behalf of the 
facility. FDA will not confirm the registration cancellation until that 
individual confirms that he or she authorized the registration 
cancellation.
    (7) Your registration will be considered cancelled once FDA enters 
your facility's cancellation data into the registration system. FDA will 
send you your cancellation confirmation.

[81 FR 45952, July 14, 2016]

                          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,
renew, or cancel your registration?

    (a) Section 301 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 331) prohibits the doing of certain acts or causing such acts to 
be done. Under section 302 of the Federal Food, Drug, and Cosmetic 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 Federal Food, Drug, and Cosmetic 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 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
335a), FDA can seek debarment of any person who has been

[[Page 36]]

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, renew the registration of 
its facility, update required elements of its facility's registration, 
or cancel its registration in accordance with the requirements of this 
subpart is a prohibited act under section 301(dd) of the Federal Food, 
Drug, and Cosmetic Act.
    (b) FDA will consider a registration for a food facility to be 
expired if the registration is not renewed, as required by Sec.  
1.230(b). Thus, if you previously submitted a registration to FDA, but 
do not submit a registration renewal to FDA during the period beginning 
on October 1 and ending on December 31 of each even-numbered year, FDA 
will consider the registration for the facility to be expired. FDA will 
consider a food facility with an expired registration to have failed to 
register in accordance with section 415 of the Federal Food, Drug, and 
Cosmetic Act.
    (c) FDA will cancel a registration if FDA 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, is not required to register, or where the 
information about the facility's address was not updated in a timely 
manner in accordance with Sec.  1.234(a) or the registration was 
submitted by a person not authorized to submit the registration under 
Sec.  1.225. Also, FDA will cancel a registration if the facility's 
registration has expired because the facility has failed to renew its 
registration in accordance with Sec.  1.230(b). If FDA cancels a 
facility's registration, FDA will send a confirmation of the 
cancellation using contact information submitted by the facility in the 
registration database.
    (d) 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.

[81 FR 45953, July 14, 2016]



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.



Sec.  1.245  Waiver request.

    Under Sec. Sec.  1.231(a)(2) and (b), 1.234(d), and 1.235(d), 
beginning January 4, 2020, you must submit your registration, 
registration renewal, updates, and cancellations to FDA electronically 
unless FDA has granted a waiver from such requirement. Under Sec.  
1.232(a)(6), you must provide the email address of the owner, operator, 
or agent in charge of the facility unless FDA has granted a waiver from 
such requirement. In addition, under Sec. Sec.  1.230(b) and (c), 
1.232(a)(10), 1.234(a), and 1.235(b)(5), registration renewals, 
abbreviated registration renewals, registrations, updates, and 
cancellations not submitted by the owner, operator, or agent in charge 
must include the email address for the individual who authorized the 
submission, unless FDA has granted a waiver. To request a waiver from 
these requirements, you must submit a written request to FDA that 
explains why it is not reasonable for you to submit your registration, 
registration renewal,

[[Page 37]]

update, or cancellation to FDA electronically or to provide the email 
address of the owner, operator, or agent in charge of the facility. You 
must submit your request to: U.S. Food and Drug Administration, Center 
for Food Safety and Applied Nutrition, 5001 Campus Dr. (HFS-681), 
College Park, MD 20740.

[81 FR 45953, July 14, 2016]



                 Subpart I_Prior Notice of Imported Food

    Source: 73 FR 66402, Nov. 7, 2008, 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 in 
this section.
    (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 mailed.
    (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 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, except 
as provided in paragraph (b)(5)(i) of this section.
    (i) For purposes of this subpart, food 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) Full address means the facility's street name and number; suite/
unit number, as appropriate; city; Province or State as appropriate; 
mail code as appropriate; and country.
    (7) Grower means a person who engages in growing and harvesting or 
collecting crops (including botanicals), raising animals (including 
fish, which includes seafood), or both.
    (8) International mail means foreign national mail services. 
International mail does not include express consignment operators or 
carriers or other private delivery services unless such service is 
operating under contract as an agent or extension of a foreign mail 
service.
    (9) Manufacturer means the last facility, as that word is defined in 
Sec.  1.227, that manufactured/processed the food. A facility is 
considered the last facility even if the food undergoes further 
manufacturing/processing that consists of adding labeling or any similar 
activity

[[Page 38]]

of a de minimis nature. If the food undergoes further manufacturing/
processing that exceeds an activity of a de minimis nature, then the 
subsequent facility that performed the additional manufacturing/
processing is considered the manufacturer.
    (10) 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, 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.
    (11) 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. For an article of food arriving by water or air, this is the 
port of unloading. For an article of food arriving by land, this is the 
port where the article of food first crosses the border into the United 
States. The port of arrival may be different than the port where 
consumption or warehouse entry or foreign trade zone admission 
documentation is presented to the U.S. Customs and Border Protection 
(CBP).
    (12) Port of entry, in section 801(m) and (l) of the act (21 U.S.C. 
381(m) and (l)), means the port of entry as defined in 19 CFR 101.1.
    (13) Registration number means the registration number assigned to a 
facility by FDA under section 415 of the act (21 U.S.C. 350d) and 
subpart H of this part.
    (14) 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 or express consignment 
operators or carriers or other private delivery service to the United 
States.
    (15) 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.
    (16) You means the person submitting the prior notice, i.e., the 
submitter or the transmitter, if any.

[73 FR 66402, Nov. 7, 2008, as amended at 80 FR 56143, Sept. 17, 2015]



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) of this section, 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 
nonbusiness reasons) to an individual in the United States;
    (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.);
    (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.); and

[[Page 39]]

    (7) Articles of food subject to Article 27(3) of The Vienna 
Convention on Diplomatic Relations (1961), i.e., shipped as baggage or 
cargo constituting the diplomatic bag.

          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:
    (1) If prior notice is submitted via the Automated Broker Interface/
Automated Commercial Environment/International Trade Data System (ABI/
ACE/ITDS), you may not submit prior notice more than 30-calendar days 
before the anticipated date of arrival.
    (2) If prior notice is submitted via the FDA Prior Notice System 
Interface (FDA PNSI), you may not submit prior notice more than 15-
calendar days before the anticipated date 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 (e.g., CN22 or CN23 or U.S. equivalent) 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 U.S. Customs and Border Protection (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 PNSI when the 
article arrives in the United States and must be provided to CBP or FDA 
upon arrival.

[73 FR 66402, Nov. 7, 2008, as amended at 82 FR 15629, Mar. 30, 2017]



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 the 
items listed in the previous sentence, must be submitted using the Latin 
(Roman) alphabet. Unless paragraph (c) of this section applies, you must 
submit prior notice through:
    (1) The U.S. Customs and Border Protection (CBP) Automated Broker 
Interface/Automated Commercial Environment/International Trade Data 
System (ABI/ACE/ITDS); or

[[Page 40]]

    (2) The FDA PNSI at https://www.access.fda.gov/. You must submit 
prior notice through the FDA Prior Notice System Interface (FDA PNSI) 
for articles of food imported or offered for import by international 
mail, and other transaction types that cannot be made through ABI/ACE/
ITDS.
    (b) If a customhouse broker's or self-filer's system is not working 
or if the ABI/ACE/ITDS interface is not working, prior notice must be 
submitted through the FDA PNSI.
    (c) If FDA determines that FDA PNSI or the Operational and 
Administration System for Import Support (OASIS) is not working, FDA 
will post prominent notification and instructions at http://www.fda.gov. 
FDA will accept prior notice submissions in the format it deems 
appropriate during the system(s) outage.

[73 FR 66402, Nov. 7, 2008, as amended at 82 FR 15629, Mar. 30, 2017]



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 
paragraphs (a)(1) through (18) of this section:
    (1) The name of the individual submitting the prior notice and his/
her business address, phone number, and e-mail address, and the name and 
address of the submitting firm, if applicable. If the business address 
of the individual submitting the prior notice is a registered facility, 
then the facility's registration number, city, and country may be 
provided instead of the facility's 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, phone number, and e-mail 
address. If the business address of the individual transmitting the 
prior notice is a registered facility, then the facility's registration 
number, city, and country may be provided instead of the facility's full 
address;
    (3) The entry type;
    (4) The U.S. Customs and Border Protection (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 
Sec.  113.60(c) of this chapter; acidified foods, by Sec.  114.80(b) of 
this chapter; and infant formula, by Sec.  106.90 of this chapter;
    (6) For an article of food that is no longer in its natural state, 
the identity of the manufacturer, as follows:
    (i) The name of the manufacturer; and
    (ii) Either the registration number, city, and country of the 
manufacturer or both the full address of the manufacturer and the reason 
the registration number is not provided;
    (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) If the shipper is different from the manufacturer, the identity 
of the shipper, as follows:
    (i) The name of the shipper; and
    (ii) The full address of the shipper. If the address of the shipper 
is a registered facility, you also may submit the registration number of 
the shipper's registered facility;
    (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;

[[Page 41]]

    (ii) The anticipated date on which the article of food will arrive 
at the anticipated port of arrival;
    (iii) The anticipated time of that arrival; and
    (iv) Notwithstanding paragraphs (a)(11) introductory text and 
(a)(11)(i) through (iii) of this section, if the article of food is 
arriving by express consignment operator or carrier, the express 
consignment operator or carrier tracking number may be submitted in lieu 
of the information required in paragraphs (a)(11) introductory text and 
(a)(11)(i) through (iii) of this section.
    (12) The name and full address of the importer. If the business 
address of the importer is a registered facility, you also may submit 
the registration number of the importer's registered facility. 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 full address of the owner if different from the 
importer or ultimate consignee. If the business address of the owner is 
a registered facility, you also may submit the registration number of 
the owner's registered facility. 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 full address of the ultimate consignee. If the 
business address of the ultimate consignee is a registered facility, you 
also may submit the registration number of the ultimate consignee's 
registered facility. 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 to the port of arrival, or if 
this code is not applicable, then the name of the carrier. If the 
carrier is a privately owned vehicle, the license plate number of the 
vehicle and the State or Province that issued the license plate number;
    (17) Planned shipment information, as applicable to the mode of 
transportation and when it exists:
    (i) The Airway Bill number(s) or Bill of Lading number(s), as 
applicable. This information is not required for an article of food when 
carried by or otherwise accompanying an individual when entering the 
United States. If the article of food is arriving by express consignment 
operator or carrier, the express consignment operator or carrier 
tracking number may by submitted in lieu of the Airway Bill number(s) or 
Bill of Lading number(s), as applicable;
    (ii) For food arriving by ocean vessel, the vessel name and voyage 
number;
    (iii) For food arriving by air carrier, the flight number. If the 
article of food is arriving by express consignment operator or carrier, 
the express consignment operator or carrier tracking number may be 
submitted in lieu of 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; and
    (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.
    (18) Any country to which the article has been refused entry.
    (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 paragraphs (b)(1) through (12) of this section:
    (1) The name of the individual submitting the prior notice and his/
her business address, phone number, and e-mail address, and the name and 
address

[[Page 42]]

of the submitting firm, if applicable. If the business address of the 
individual submitting the prior notice is a registered facility, then 
the facility's registration number, city, and country may be provided 
instead of the facility's 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, phone number, and e-mail 
address. If the business address of the individual transmitting the 
prior notice is a registered facility, then the facility's registration 
number, city, and country may be provided instead of the facility's 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 
Sec.  113.60(c) of this chapter; acidified foods, by Sec.  114.80(b) of 
this chapter; and infant formula, Sec.  106.90 of this chapter;
    (5) For an article of food that is no longer in its natural state, 
the identity of the manufacturer, as follows:
    (i) The name of the manufacturer; and
    (ii) Either the registration number, city, and country of the 
manufacturer or both the full address of the manufacturer and the reason 
the registration number is not provided;
    (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) If the shipper is different from the manufacturer, the identity 
of the shipper, as follows:
    (i) The name of the shipper; and
    (ii) The full address of the shipper. If the address of the shipper 
is a registered facility, you also may submit the registration number of 
the shipper's registered facility;
    (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.
    (12) Any country to which the article has been refused entry.
    (c) Refused articles. If the article of food has been refused under 
section 801(m)(1) of the act and under this subpart, you must submit the 
information for the article that is required in paragraphs (c)(1) 
through (19) of this section. However, if the refusal is based on Sec.  
1.283(a)(1)(iii) (Untimely Prior Notice), you do not have to resubmit 
any information previously submitted unless it has changed or the 
article has been exported and the original prior notice was submitted 
through ABI/ACE/ITDS. If the refusal is based on Sec.  1.283(a)(1)(ii), 
you should cancel the previous submission per Sec.  1.282(b) and (c).
    (1) The name of the individual submitting the prior notice and his/
her business address, phone number, and e-mail address, and the name and 
address of the submitting firm, if applicable. If the business address 
of the individual submitting the prior notice is a registered facility, 
then the facility's registration number, city, and country may be 
provided instead of the facility's 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, phone number, and e-mail 
address. If the business address of the individual transmitting the 
prior notice is a registered facility, then the facility's registration 
number, city, and country may be provided instead of the facility's full 
address;
    (3) The entry type;

[[Page 43]]

    (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 
Sec.  113.60(c) of this chapter; acidified foods, by Sec.  114.80(b) of 
this chapter; and infant formula, by Sec.  106.90 of this chapter;
    (6) For an article of food that is no longer in its natural state, 
the identity of the manufacturer, as follows:
    (i) The name of the manufacturer; and
    (ii) Either the registration number, city, and country of the 
manufacturer or both the full address of the manufacturer and the reason 
the registration number is not provided;
    (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) If the shipper is different from the manufacturer, the identity 
of the shipper, as follows:
    (i) The name of the shipper; and
    (ii) The full address of the shipper. If the address of the shipper 
is a registered facility, you also may submit the registration number of 
the shipper's registered facility;
    (10) The country from which the article is shipped;
    (11) Arrival information about the article of food being imported or 
offered for import, as follows:
    (i) The port of arrival; and
    (ii) The date on which the article of food arrived at the port of 
arrival.
    (iii) Notwithstanding paragraphs (c)(11) introductory text and 
(c)(11)(i) and (ii) of this section, if the article of food arrived by 
express consignment operator or carrier, the express consignment 
operator or carrier tracking number may be submitted in lieu of the 
information required in paragraphs (c)(11) introductory text and 
(c)(11)(i) and (ii) of this section.
    (12) The name and full address of the importer. If the business 
address of the importer is a registered facility, you also may submit 
the registration number of the importer's registered facility. 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 full address of the owner, if different from the 
importer or ultimate consignee. If the business address of the owner is 
a registered facility, you also may submit the registration number of 
the importer's registered facility. 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 full address of the ultimate consignee. If the 
business address of the ultimate consignee is a registered facility, you 
also may submit the registration number of the ultimate consignee's 
registered facility. 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 SCAC or IATA code of the carrier which carried the article 
of food from the country from which the article is shipped to the United 
States to the port of arrival, or if this code is not applicable, then 
the name of the carrier. If the carrier is a privately owned vehicle, 
the license plate number of the vehicle and the State or Province that 
issued the license plate number;

[[Page 44]]

    (17) Shipment information, as applicable to the mode of 
transportation and when it exists:
    (i) The Airway Bill number(s) or Bill of Lading number(s), as 
applicable; however, this information is not required for an article of 
food when carried by or otherwise accompanying an individual when 
entering the United States. If the article of food arrived by express 
consignment operator or carrier, the express consignment operator or 
carrier tracking number may be submitted in lieu of the Airway Bill 
number(s) or Bill of Lading number(s), as applicable;
    (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. If 
the article of food arrived by express consignment operator or carrier, 
the express consignment operator or carrier tracking number may be 
submitted in lieu of 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; and
    (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;
    (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.
    (19) Any country to which the article has been refused entry.

[73 FR 66402, Nov. 7, 2008, as amended at 76 FR 25545, May 5, 2011; 82 
FR 15629, Mar. 30, 2017]



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) Section 1.281(a)(5)(iii) (quantity),
    (ii) Section 1.281(a)(11) (anticipated arrival information), or
    (iii) Section 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 PNSI, you should 
cancel the prior notice via the FDA PNSI.
    (c) If you submitted the prior notice via ABI/ACE/ITDS, you should 
cancel the prior notice via ACE by requesting that CBP cancel the entry.

[73 FR 66402, Nov. 7, 2008, as amended at 82 FR 15629, Mar. 30, 2017]

                              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 U.S. Customs and Border Protection (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

[[Page 45]]

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. 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 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, 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 
unless immediately exported under CBP supervision. If the food is to be 
held at the port, FDA must be notified of the location where the food is 
held at that port before the food is moved there. If the food is to be 
held at a secure facility outside the port, FDA must be notified of the 
location of the secure facility before the food is moved there. The 
refused food shall not be entered and shall not be delivered to any 
importer, owner, or ultimate consignee. If the food is to be held at a 
secure facility outside a port, the food must be taken directly to that 
secure facility.
    (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 or other merchandise not subject to this 
subpart, 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 paragraph (a) of this section 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 paragraph (a) of this section 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) of the act and no prior 
notice is submitted or resubmitted, no request for FDA review is 
submitted in accordance with paragraph (d) of this section, 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, 
unless otherwise agreed to by CBP and FDA, the article may only be sold 
for export or destroyed.
    (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 
prior notice (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

[[Page 46]]

food held at the port or exported, FDA or CBP may destroy the article of 
food.
    (c) Post-Refusal prior notice submissions. (1) If an article of food 
is refused under paragraph (a)(1)(i) of this section (no prior notice) 
and the food is not exported, prior notice must be submitted in 
accordance with Sec. Sec.  1.280 and 1.281(c).
    (2) If an article of food is refused under paragraph (a)(1)(ii) of 
this section (inaccurate prior notice) and the food is not exported, the 
prior notice should be canceled in accordance with Sec.  1.282 and you 
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.  1.277, or whether the 
information submitted in a prior notice is complete and 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 carrier, 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 
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.  1.277 or that the prior notice 
submission is complete and 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 marked ``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) 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 other designated 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) 
of the act. 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

[[Page 47]]

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) of the act 
does not mean that it will be granted admission under other provisions 
of the act or other U.S. laws.



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) of 
the act, 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 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 sections 301 and 303 of the act (21 U.S.C. 331 and 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 for import adulterated food that 
presents a threat of serious adverse health consequences or death to 
humans or animals.



Sec.  1.285  What happens to food that is imported or offered for import
from unregistered facilities that are required to register under subpart H 
of this part?

    (a) Consequences. If an article of food from a foreign facility that 
is not registered as required under section 415 of the act (21 U.S.C. 
350d) and subpart H of this part is imported or offered for import into 
the United States, the food is subject to being held under section 
801(l) of the act (21 U.S.C. 381(l)).
    (b) Hold. Unless CBP concurrence is obtained for export and the 
article is immediately exported from the port of arrival, if an article 
of food has been 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) of the act must be moved 
under appropriate custodial bond unless immediately exported under CBP 
supervision. If the food is to be held at the port, FDA must be notified 
of the location where the food is held at the port before the food is 
moved there. If the food is to be held at a secure facility outside the 
port, FDA must be notified of the location of the secure facility before 
the food is moved there. The food subject to hold shall not be entered 
and shall not be delivered to any importer, owner, or ultimate 
consignee. If the food is to be held at a secure facility outside a 
port, the food must be taken directly to that secure 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. 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

[[Page 48]]

hold under section 801(l) of the act and no registration number or 
request for FDA review is submitted in accordance with paragraph (j) of 
this section or export has not occurred in accordance with paragraph (f) 
of this section, the food shall be dealt with as set forth in CBP 
regulations relating to general order merchandise, except that, unless 
otherwise agreed to by CBP and FDA, the article may only be sold for 
export or destroyed.
    (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 not for personal use and 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 
and subpart H of this part, 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-hold submissions. (1) To resolve a hold, if an article of 
food is held under paragraph (b) of this section because it is from a 
foreign facility that is not registered, the facility must be registered 
and a registration number must be obtained.
    (2) The FDA Division of Food Defense Targeting 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 fax or e-mail. 
The contact information for these delivery methods is listed at http://
www.fda.gov--see Prior Notice. The notification should include the 
applicable CBP entry identifier.
    (3) 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 carrier, 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 
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 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 of the act, 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 that arrives by 
international mail is from a foreign facility that is not registered as 
required under section 415 of the act and subpart H of this part, the 
parcel will be held by CBP for 72 hours for FDA inspection and 
disposition. If the article is placed under hold under section 801(l) of 
the act and there is a return address, the parcel may be returned to 
sender marked ``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 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 marked ``No Registration--No Admission Permitted'' or, if 
there is no return address, destroy the parcel, at FDA expense.
    (l) Prohibitions on delivery and transfer. Notwithstanding section 
801(b) of the act, while an article of food is under hold under section 
801(l) of the act, it may not be delivered to the importer, owner, or 
ultimate consignee. If an article of food is no longer subject to hold 
under section 801(l) of the act,

[[Page 49]]

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) of the act does not mean that it will be granted 
admission under other provisions of the act or other U.S. laws.

[73 FR 66402, Nov. 7, 2008, as amended at 82 FR 15629, Mar. 30, 2017]



    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 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

[[Page 50]]

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 to such terms when used 
in this subpart. In addition, for the purposes of this subpart:
    Farm means:
    (1) Primary production farm. A primary production farm is an 
operation under one management in one general (but not necessarily 
contiguous) physical location devoted to the growing of crops, the 
harvesting of crops, the raising of animals (including seafood), or any 
combination of these activities. The term ``farm'' includes operations 
that, in addition to these activities:
    (i) Pack or hold raw agricultural commodities;
    (ii) Pack or hold processed food, provided that all processed food 
used in such activities is either consumed on that farm or another farm 
under the same management, or is processed food identified in paragraph 
(1)(iii)(B)(1) of this definition; and
    (iii) Manufacture/process food, provided that:
    (A) All food used in such activities is consumed on that farm or 
another farm under the same management; or
    (B) Any manufacturing/processing of food that is not consumed on 
that farm or another farm under the same management consists only of:

[[Page 51]]

    (1) Drying/dehydrating raw agricultural commodities to create a 
distinct commodity (such as drying/dehydrating grapes to produce 
raisins), and packaging and labeling such commodities, without 
additional manufacturing/processing (an example of additional 
manufacturing/processing is slicing);
    (2) Treatment to manipulate the ripening of raw agricultural 
commodities (such as by treating produce with ethylene gas), and 
packaging and labeling treated raw agricultural commodities, without 
additional manufacturing/processing; and
    (3) Packaging and labeling raw agricultural commodities, when these 
activities do not involve additional manufacturing/processing (an 
example of additional manufacturing/processing is irradiation); or
    (2) Secondary activities farm. A secondary activities farm is an 
operation, not located on a primary production farm, devoted to 
harvesting (such as hulling or shelling), packing, and/or holding of raw 
agricultural commodities, provided that the primary production farm(s) 
that grows, harvests, and/or raises the majority of the raw agricultural 
commodities harvested, packed, and/or held by the secondary activities 
farm owns, or jointly owns, a majority interest in the secondary 
activities farm. A secondary activities farm may also conduct those 
additional activities allowed on a primary production farm as described 
in paragraphs (1)(ii) and (iii) of this definition.
    Food has the meaning given in section 201(f) of the Federal Food, 
Drug, and Cosmetic 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).
    Harvesting applies to farms and farm mixed-type facilities and means 
activities that are traditionally performed on farms for the purpose of 
removing raw agricultural commodities from the place they were grown or 
raised and preparing them for use as food. Harvesting is limited to 
activities performed on raw agricultural commodities, or on processed 
foods created by drying/dehydrating a raw agricultural commodity without 
additional manufacturing/processing, on a farm. Harvesting does not 
include activities that transform a raw agricultural commodity into a 
processed food as defined in section 201(gg) of the Federal Food, Drug, 
and Cosmetic Act. Examples of harvesting include cutting (or otherwise 
separating) the edible portion of the raw agricultural commodity from 
the crop plant and removing or trimming part of the raw agricultural 
commodity (e.g., foliage, husks, roots, or stems). Examples of 
harvesting also include cooling, field coring, filtering, gathering, 
hulling, shelling, sifting, threshing, trimming of outer leaves of, and 
washing raw agricultural commodities grown on a farm.
    Holding means storage of food and also includes activities performed 
incidental to storage of a food (e.g., activities performed for the safe 
or effective storage of that food, such as fumigating food during 
storage, and drying/dehydrating raw agricultural commodities when the 
drying/dehydrating does not create a distinct commodity (such as drying/
dehydrating hay or alfalfa)). Holding also includes activities performed 
as a practical necessity for the distribution of that food (such as 
blending of the same raw agricultural commodity and breaking down 
pallets), but does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities 
could include warehouses, cold

[[Page 52]]

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 include: Baking, boiling, bottling, 
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw 
agricultural commodities to create a distinct commodity (such as drying/
dehydrating grapes to produce raisins), evaporating, eviscerating, 
extracting juice, formulating, freezing, grinding, homogenizing, 
irradiating, labeling, milling, mixing, packaging (including modified 
atmosphere packaging), pasteurizing, peeling, rendering, treating to 
manipulate ripening, trimming, washing, or waxing. For farms and farm 
mixed-type facilities, manufacturing/processing does not include 
activities that are part of harvesting, packing, or holding.
    Mixed-type facility means an establishment that engages in both 
activities that are exempt from registration under section 415 of the 
Federal Food, Drug, and Cosmetic Act and activities that require the 
establishment to be registered. An example of such a facility is a 
``farm mixed-type facility,'' which is an establishment that is a farm, 
but also conducts activities outside the farm definition that require 
the establishment to be registered.
    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 (when used as a noun) 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 Federal Food, Drug, and Cosmetic Act.
    Packaging (when used as a verb) means placing food into a container 
that directly contacts the food and that the consumer receives.
    Packing means placing food into a container other than packaging the 
food and also includes re-packing and activities performed incidental to 
packing or re-packing a food (e.g., activities performed for the safe or 
effective packing or re-packing of that food (such as sorting, culling, 
grading, and weighing or conveying incidental to packing or re-
packing)), but does not include activities that transform a raw 
agricultural commodity, as defined in section 201(r) of the Federal 
Food, Drug, and Cosmetic Act, into a processed food as defined in 
section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
    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, lunchrooms, cafes, bistros, fast food establishments, food 
stands, saloons, taverns, bars, lounges, catering facilities, hospital 
kitchens, day care kitchens,

[[Page 53]]

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.

[69 FR 71651, Dec. 9, 2004, as amended at 80 FR 56143, Sept. 17, 2015; 
81 FR 3715, Jan. 22, 2016]



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 54]]

    (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 55]]

    (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 56]]

    (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, and any 
other article of food that FDA reasonably believes is likely to be 
affected in a similar manner, is adulterated and presents a threat of 
serious adverse health consequences or death to humans or animals, or 
when FDA believes that there is a reasonable probability that the use of 
or exposure to an article of food, and any other article of food that 
FDA reasonably believes is likely to be affected in a similar manner, 
will cause 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 Federal Food, Drug, and Cosmetic 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.

[77 FR 10662, Feb. 23, 2012]



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 Federal Food, Drug, and Cosmetic 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 
Federal Food, Drug, and Cosmetic 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 Federal Food, Drug, 
and Cosmetic 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 Federal 
Food, Drug, and Cosmetic Act and this regulation is a prohibited act 
under section 301 of the Federal Food, Drug, and Cosmetic Act.

[80 FR 56144, Sept. 17, 2015

                            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]

[[Page 57]]



     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 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 
reason to believe that the article of food is adulterated or misbranded.

[76 FR 25541, May 5, 2011]



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.

[[Page 58]]

    (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 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

[[Page 59]]

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 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.

[[Page 60]]



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 reason to believe that such article of food is 
adulterated or misbranded.
    (b) The detention order must include the following information:
    (1) The detention order number;
    (2) The date and hour of the detention order;
    (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.

[69 FR 31701, June 4, 2004, as amended at 76 FR 25541, May 5, 2011]

            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.

[[Page 61]]

    (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 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, i.e., Office of Regulatory Affairs Program 
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.

[69 FR 31701, June 4, 2004, as amended at 82 FR 14144, Mar. 17, 2017]



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 Office of Regulatory Affairs Program Director or another FDA 
official senior to an FDA District Director.

[82 FR 14144, Mar. 17, 2017]

[[Page 62]]



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, 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.



   Subpart L_Foreign Supplier Verification Programs for Food Importers

    Source: 80 FR 74340, Nov. 27, 2015, unless otherwise noted.



Sec.  1.500  What definitions apply to this subpart?

    The following definitions apply to words and phrases as they are 
used in this subpart. Other definitions of these terms may apply when 
they are used in other subparts of this part.
    Adequate means that which is needed to accomplish the intended 
purpose in keeping with good public health practice.
    Audit means the systematic, independent, and documented examination 
(through observation, investigation, discussions with employees of the 
audited entity, records review, and, as appropriate, sampling and 
laboratory analysis) to assess an audited entity's food safety processes 
and procedures.
    Dietary supplement has the meaning given in section 201(ff) of the 
Federal Food, Drug, and Cosmetic Act.
    Dietary supplement component means any substance intended for use in 
the manufacture of a dietary supplement, including those that may not 
appear in the finished batch of the dietary supplement. Dietary 
supplement components include dietary ingredients (as described in 
section 201(ff) of the Federal Food, Drug, and Cosmetic Act) and other 
ingredients.

[[Page 63]]

    Environmental pathogen means a pathogen capable of surviving and 
persisting within the manufacturing, processing, packing, or holding 
environment such that food may be contaminated and may result in 
foodborne illness if that food is consumed without treatment to 
significantly minimize the environmental pathogen. Examples of 
environmental pathogens for the purposes of this part include Listeria 
monocytogenes and Salmonella spp. but do not include the spores of 
pathogenic sporeforming bacteria.
    Facility means a domestic facility or a foreign facility that is 
required to register under section 415 of the Federal Food, Drug, and 
Cosmetic Act, in accordance with the requirements of subpart H of this 
part.
    Farm means farm as defined in Sec.  1.227.
    Farm mixed-type facility means an establishment that is a farm but 
that also conducts activities outside the farm definition that require 
the establishment to be registered under section 415 of the Federal 
Food, Drug, and Cosmetic Act.
    Food has the meaning given in section 201(f) of the Federal Food, 
Drug, and Cosmetic Act, except that food does not include pesticides (as 
defined in 7 U.S.C. 136(u)).
    Food allergen means a major food allergen as defined in section 
201(qq) of the Federal Food, Drug, and Cosmetic Act.
    Foreign supplier means, for an article of food, the establishment 
that manufactures/processes the food, raises the animal, or grows the 
food that is exported to the United States without further 
manufacturing/processing by another establishment, except for further 
manufacturing/processing that consists solely of the addition of 
labeling or any similar activity of a de minimis nature.
    Good compliance standing with a foreign food safety authority means 
that the foreign supplier--
    (1) Appears on the current version of a list, issued by the food 
safety authority of the country in which the foreign supplier is located 
and which has regulatory oversight of the supplier, of food producers 
that are in good compliance standing with the food safety authority; or
    (2) Has otherwise been designated by such food safety authority as 
being in good compliance standing.
    Harvesting applies to applies to farms and farm mixed-type 
facilities and means activities that are traditionally performed on 
farms for the purpose of removing raw agricultural commodities from the 
place they were grown or raised and preparing them for use as food. 
Harvesting is limited to activities performed on raw agricultural 
commodities, or on processed foods created by drying/dehydrating a raw 
agricultural commodity without additional manufacturing/processing, on a 
farm. Harvesting does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of 
harvesting include cutting (or otherwise separating) the edible portion 
of the raw agricultural commodity from the crop plant and removing or 
trimming part of the raw agricultural commodity (e.g., foliage, husks, 
roots, or stems). Examples of harvesting also include cooling, field 
coring, filtering, gathering, hulling, shelling, sifting, threshing, 
trimming of outer leaves of, and washing raw agricultural commodities 
grown on a farm.
    Hazard means any biological, chemical (including radiological), or 
physical agent that is reasonably likely to cause illness or injury.
    Hazard requiring a control means a known or reasonably foreseeable 
hazard for which a person knowledgeable about the safe manufacturing, 
processing, packing, or holding of food would, based on the outcome of a 
hazard analysis (which includes an assessment of the probability that 
the hazard will occur in the absence of controls or measures and the 
severity of the illness or injury if the hazard were to occur), 
establish one or more controls or measures to significantly minimize or 
prevent the hazard in a food and components to manage those controls or 
measures (such as monitoring, corrections or corrective actions, 
verification, and records) as appropriate to the food, the facility, and 
the nature of the control or measure and its role in the facility's food 
safety system.

[[Page 64]]

    Holding means storage of food and also includes activities performed 
incidental to storage of a food (e.g., activities performed for the safe 
or effective storage of that food, such as fumigating food during 
storage, and drying/dehydrating raw agricultural commodities when the 
drying/dehydrating does not create a distinct commodity (such as drying/
dehydrating hay or alfalfa)). Holding also includes activities performed 
as a practical necessity for the distribution of that food (such as 
blending of the same raw agricultural commodity and breaking down 
pallets), but does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities 
could include warehouses, cold storage facilities, storage silos, grain 
elevators, and liquid storage tanks.
    Importer means the U.S. owner or consignee of an article of food 
that is being offered for import into the United States. If there is no 
U.S. owner or consignee of an article of food at the time of U.S. entry, 
the importer is the U.S. agent or representative of the foreign owner or 
consignee at the time of entry, as confirmed in a signed statement of 
consent to serve as the importer under this subpart.
    Known or reasonably foreseeable hazard means a biological, chemical 
(including radiological), or physical hazard that is known to be, or has 
the potential to be, associated with a food or the facility in which it 
is manufactured/processed.
    Lot means the food produced during a period of time and identified 
by an establishment's specific code.
    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 include: Baking, boiling, bottling, 
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw 
agricultural commodities to create a distinct commodity (such as drying/
dehydrating grapes to produce raisins), evaporating, eviscerating, 
extracting juice, extruding (of animal food), formulating, freezing, 
grinding, homogenizing, irradiating, labeling, milling, mixing, 
packaging (including modified atmosphere packaging), pasteurizing, 
peeling, pelleting (of animal food), rendering, treating to manipulate 
ripening, trimming, washing, or waxing. For farms and farm mixed-type 
facilities, manufacturing/processing does not include activities that 
are part of harvesting, packing, or holding.
    Microorganisms means yeasts, molds, bacteria, viruses, protozoa, and 
microscopic parasites and includes species that are pathogens.
    Packing means placing food into a container other than packaging the 
food and also includes re-packing and activities performed incidental to 
packing or re-packing a food (e.g., activities performed for the safe or 
effective packing or re-packing of that food (such as sorting, culling, 
grading, and weighing or conveying incidental to packing or re-
packing)), but does not include activities that transform a raw 
agricultural commodity into a processed food as defined in section 
201(gg) of the Federal Food, Drug, and Cosmetic Act.
    Pathogen means a microorganism of public health significance.
    Qualified auditor means a person who is a qualified individual as 
defined in this section and has technical expertise obtained through 
education, training, or experience (or a combination thereof) necessary 
to perform the auditing function as required by Sec.  1.506(e)(1)(i) or 
Sec.  1.511(c)(5)(i)(A). Examples of potential qualified auditors 
include:
    (1) A government employee, including a foreign government employee; 
and
    (2) An audit agent of a certification body that is accredited in 
accordance with subpart M of this part.
    Qualified individual means a person who has the education, training, 
or experience (or a combination thereof) necessary to perform an 
activity required under this subpart, and can read and understand the 
language of any records that the person must review in performing this 
activity. A qualified individual may be, but is not required to be, an 
employee of the importer. A government employee, including a foreign 
government employee, may be a qualified individual.

[[Page 65]]

    Raw agricultural commodity has the meaning given in section 201(r) 
of the Federal Food, Drug, and Cosmetic Act.
    Ready-to-eat food (RTE food) means any food that is normally eaten 
in its raw state or any food, including a processed food, for which it 
is reasonably foreseeable that the food will be eaten without further 
processing that would significantly minimize biological hazards.
    Receiving facility means a facility that is subject to subparts C 
and G of part 117 of this chapter, or subparts C and E of part 507 of 
this chapter, and that manufactures/processes a raw material or other 
ingredient that it receives from a supplier.
    U.S. owner or consignee means the person in the United States who, 
at the time of U.S. entry, either owns the food, has purchased the food, 
or has agreed in writing to purchase the food.
    Very small importer means:
    (1) With respect to the importation of human food, an importer 
(including any subsidiaries and affiliates) averaging less than $1 
million per year, adjusted for inflation, during the 3-year period 
preceding the applicable calendar year, in sales of human food combined 
with the U.S. market value of human food imported, manufactured, 
processed, packed, or held without sale (e.g., imported for a fee); and
    (2) With respect to the importation of animal food, an importer 
(including any subsidiaries and affiliates) averaging less than $2.5 
million per year, adjusted for inflation, during the 3-year period 
preceding the applicable calendar year, in sales of animal food combined 
with the U.S. market value of animal food imported, manufactured, 
processed, packed, or held without sale (e.g., imported for a fee).
    You means a person who is subject to some or all of the requirements 
in this subpart.

[80 FR 74340, Nov. 27, 2015, as amended at 81 FR 25327, Apr. 28, 2016]



Sec.  1.501  To what foods do the requirements in this subpart apply?

    (a) General. Except as specified otherwise in this section, the 
requirements in this subpart apply to all food imported or offered for 
import into the United States and to the importers of such food.
    (b) Exemptions for juice and seafood--(1) Importers of certain juice 
and seafood products. This subpart does not apply with respect to juice, 
fish, and fishery products that are imported from a foreign supplier 
that is required to comply with, and is in compliance with, the 
requirements in part 120 or part 123 of this chapter. If you import 
juice or fish and fishery products that are subject to part 120 or part 
123, respectively, you must comply with the requirements applicable to 
importers of those products under Sec.  120.14 or Sec.  123.12 of this 
chapter, respectively.
    (2) Certain importers of juice or seafood raw materials or other 
ingredients subject to part 120 or part 123 of this chapter. This 
subpart does not apply with respect to any raw materials or other 
ingredients that you import and use in manufacturing or processing juice 
subject to part 120 or fish and fishery products subject to part 123, 
provided that you are in compliance with the requirements in part 120 or 
part 123 with respect to the juice or fish or fishery product that you 
manufacture or process from the imported raw materials or other 
ingredients.
    (c) Exemption for food imported for research or evaluation. This 
subpart does not apply to food that is imported for research or 
evaluation use, provided that such food:
    (1) Is not intended for retail sale and is not sold or distributed 
to the public;
    (2) Is labeled with the statement ``Food for research or evaluation 
use'';
    (3) Is imported in a small quantity that is consistent with a 
research, analysis, or quality assurance purpose, the food is used only 
for this purpose, and any unused quantity is properly disposed of; and
    (4) Is accompanied, when filing entry with U.S. Customs and Border 
Protection, by an electronic declaration that the food will be used for 
research or evaluation purposes and will not be sold or distributed to 
the public.
    (d) Exemption for food imported for personal consumption. This 
subpart does not apply to food that is imported for personal 
consumption, provided that such food is not intended for retail sale and 
is not sold or distributed to the

[[Page 66]]

public. Food is imported for personal consumption only if it is 
purchased or otherwise acquired by a person in a small quantity that is 
consistent with a non-commercial purpose and is not sold or distributed 
to the public.
    (e) Exemption for alcoholic beverages. (1) This subpart does not 
apply with respect to alcoholic beverages that are imported from a 
foreign supplier that is a facility that meets the following two 
conditions:
    (i) Under the Federal Alcohol Administration Act (27 U.S.C. 201 et 
seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 
(26 U.S.C. 5001 et seq.), the facility is a foreign facility of a type 
that, if it were a domestic facility, would require obtaining a permit 
from, registering with, or obtaining approval of a notice or application 
from the Secretary of the Treasury as a condition of doing business in 
the United States; and
    (ii) Under section 415 of the Federal Food, Drug, and Cosmetic Act, 
the facility is required to register as a facility because it is engaged 
in manufacturing/processing one or more alcoholic beverages.
    (2) This subpart does not apply with respect to food that is not an 
alcoholic beverage that is imported from a foreign supplier described in 
paragraph (e)(1) of this section, provided such food:
    (i) Is in prepackaged form that prevents any direct human contact 
with such food; and
    (ii) Constitutes not more than 5 percent of the overall sales of the 
facility, as determined by the Secretary of the Treasury.
    (3) This subpart does not apply with respect to raw materials and 
other ingredients that are imported for use in alcoholic beverages 
provided that:
    (i) The imported raw materials and other ingredients are used in the 
manufacturing/processing, packing, or holding of alcoholic beverages;
    (ii) Such manufacturing/processing, packing, or holding is performed 
by the importer;
    (iii) The importer is required to register under section 415 of the 
Federal Food, Drug, and Cosmetic Act; and
    (iv) The importer is exempt from the regulations in part 117 of this 
chapter in accordance with Sec.  117.5(i) of this chapter.
    (f) Inapplicability to food that is transshipped or imported for 
processing and export. This subpart does not apply to food:
    (1) That is transshipped through the United States to another 
country and is not sold or distributed to the public in the United 
States; or
    (2) That is imported for processing and future export and that is 
not sold or distributed to the public in the United States.
    (g) Inapplicability to U.S. food returned. This subpart does not 
apply to food that is manufactured/processed, raised, or grown in the 
United States, exported, and returned to the United States without 
further manufacturing/processing in a foreign country.
    (h) Inapplicability to certain meat, poultry, and egg products. This 
subpart does not apply with respect to:
    (1) Meat food products that at the time of importation are subject 
to the requirements of the U.S. Department of Agriculture (USDA) under 
the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);
    (2) Poultry products that at the time of importation are subject to 
the requirements of the USDA under the Poultry Products Inspection Act 
(21 U.S.C. 451 et seq.); and
    (3) Egg products that at the time of importation are subject to the 
requirements of the USDA under the Egg Products Inspection Act (21 
U.S.C. 1031 et seq.).

[80 FR 74340, Nov. 27, 2015, as amended at 81 FR 25327, Apr. 28, 2016]



Sec.  1.502  What foreign supplier verification program (FSVP) must
I have?

    (a) General. Except as specified in paragraph (b) of this section, 
for each food you import, you must develop, maintain, and follow an FSVP 
that provides adequate assurances that your foreign supplier is 
producing the food in compliance with processes and procedures that 
provide at least the same level of public health protection as those 
required under section 418 (regarding hazard analysis and risk-based 
preventive controls for certain foods) or 419 (regarding standards for 
produce

[[Page 67]]

safety), if either is applicable, and the implementing regulations, and 
is producing the food in compliance with sections 402 (regarding 
adulteration) and 403(w) (if applicable) (regarding misbranding with 
respect to labeling for the presence of major food allergens) of the 
Federal Food, Drug, and Cosmetic Act.
    (b) Low-acid canned foods--(1) Importers of low-acid canned foods 
not subject to further manufacturing or processing. With respect to 
those microbiological hazards that are controlled by part 113 of this 
chapter, if you import a thermally processed low-acid food packaged in a 
hermetically sealed container (low-acid canned food), you must verify 
and document that the food was produced in accordance with part 113. 
With respect to all matters that are not controlled by part 113, you 
must have an FSVP as specified in paragraph (a) of this section.
    (2) Certain importers of raw materials or other ingredients subject 
to part 113 of this chapter. With respect to microbiological hazards 
that are controlled by part 113, you are not required to comply with the 
requirements of this subpart for raw materials or other ingredients that 
you import and use in the manufacturing or processing of low-acid canned 
food provided that you are in compliance with part 113 with respect to 
the low-acid canned food that you manufacture or process from the 
imported raw materials or other ingredients. With respect to all hazards 
other than microbiological hazards that are controlled by part 113, you 
must have an FSVP as specified in paragraph (a) of this section for the 
imported raw materials and other ingredients that you use in the 
manufacture or processing of low-acid canned foods.
    (c) Importers subject to section 418 of the Federal Food, Drug, and 
Cosmetic Act. You are deemed to be in compliance with the requirements 
of this subpart for a food you import, except for the requirements in 
Sec.  1.509, if you are a receiving facility as defined in Sec.  117.3 
or Sec.  507.3 of this chapter and you are in compliance with the 
following requirements of part 117 or part 507 of this chapter, as 
applicable:
    (1) You implement preventive controls for the hazards in the food in 
accordance with Sec.  117.135 or Sec.  507.34 of this chapter;
    (2) You are not required to implement a preventive control under 
Sec.  117.136 or Sec.  507.36 of this chapter with respect to the food; 
or
    (3) You have established and implemented a risk-based supply-chain 
program in compliance with subpart G of part 117 or subpart E of part 
507 of this chapter with respect to the food.



Sec.  1.503  Who must develop my FSVP and perform FSVP activities?

    (a) Qualified individual. A qualified individual must develop your 
FSVP and perform each of the activities required under this subpart. A 
qualified individual must have the education, training, or experience 
(or a combination thereof) necessary to perform their assigned 
activities and must be able to read and understand the language of any 
records that must be reviewed in performing an activity.
    (b) Qualified auditor. A qualified auditor must conduct any audit 
conducted in accordance with Sec.  1.506(e)(1)(i) or Sec.  
1.511(c)(5)(i)(A). A qualified auditor must have technical expertise 
obtained through education, training, or experience (or a combination 
thereof) necessary to perform the auditing function.



Sec.  1.504  What hazard analysis must I conduct?

    (a) Requirement for a hazard analysis. Except as specified in 
paragraph (d) of this section, you must conduct a hazard analysis to 
identify and evaluate, based on experience, illness data, scientific 
reports, and other information, known or reasonably foreseeable hazards 
for each type of food you import to determine whether there are any 
hazards requiring a control. Your hazard analysis must be written 
regardless of its outcome.
    (b) Hazard identification. (1) Your analysis of the known or 
reasonably foreseeable hazards in each food must include the following 
types of hazards:
    (i) Biological hazards, including microbiological hazards such as 
parasites, environmental pathogens, and other pathogens;
    (ii) Chemical hazards, including radiological hazards, pesticide and 
drug

[[Page 68]]

residues, natural toxins, decomposition, unapproved food or color 
additives, food allergens, and (in animal food) nutrient deficiencies or 
toxicities; and
    (iii) Physical hazards (such as stones, glass, and metal fragments).
    (2) Your analysis must include known or reasonably foreseeable 
hazards that may be present in a food for any of the following reasons:
    (i) The hazard occurs naturally;
    (ii) The hazard may be unintentionally introduced; or
    (iii) The hazard may be intentionally introduced for purposes of 
economic gain.
    (c) Hazard evaluation. (1) Your hazard analysis must include an 
evaluation of the hazards identified in paragraph (b) of this section to 
assess the probability that the hazard will occur in the absence of 
controls and the severity of the illness or injury if the hazard were to 
occur.
    (2) The hazard evaluation required by paragraph (c)(1) of this 
section must include an evaluation of environmental pathogens whenever a 
ready-to-eat food is exposed to the environment before packaging and the 
packaged food does not receive a treatment or otherwise include a 
control or measure (such as a formulation lethal to the pathogen) that 
would significantly minimize the pathogen.
    (3) Your hazard evaluation must consider the effect of the following 
on the safety of the finished food for the intended consumer:
    (i) The formulation of the food;
    (ii) The condition, function, and design of the establishment and 
equipment of a typical entity that manufactures/processes, grows, 
harvests, or raises this type of food;
    (iii) Raw materials and other ingredients;
    (iv) Transportation practices;
    (v) Harvesting, raising, manufacturing, processing, and packing 
procedures;
    (vi) Packaging and labeling activities;
    (vii) Storage and distribution;
    (viii) Intended or reasonably foreseeable use;
    (ix) Sanitation, including employee hygiene; and
    (x) Any other relevant factors, such as the temporal (e.g., weather-
related) nature of some hazards (e.g., levels of natural toxins).
    (d) Review of another entity's hazard analysis. If another entity 
(including your foreign supplier) has, using a qualified individual, 
analyzed the known or reasonably foreseeable hazards for the food to 
determine whether there are any hazards requiring a control, you may 
meet your requirement to determine whether there are any hazards 
requiring a control in a food by reviewing and assessing the hazard 
analysis conducted by that entity. You must document your review and 
assessment of that hazard analysis, including documenting that the 
hazard analysis was conducted by a qualified individual.
    (e) Hazards in raw agricultural commodities that are fruits or 
vegetables. If you are importing a raw agricultural commodity that is a 
fruit or vegetable that is ``covered produce'' as defined in Sec.  112.3 
of this chapter, you are not required to determine whether there are any 
biological hazards requiring a control in such food because the 
biological hazards in such fruits or vegetables require a control and 
compliance with the requirements in part 112 of this chapter 
significantly minimizes or prevents the biological hazards. However, you 
must determine whether there are any other types of hazards requiring a 
control in such food.
    (f) No hazards requiring a control. If you evaluate the known and 
reasonably foreseeable hazards in a food and determine that there are no 
hazards requiring a control, you are not required to conduct an 
evaluation for foreign supplier approval and verification under Sec.  
1.505 and you are not required to conduct foreign supplier verification 
activities under Sec.  1.506. This paragraph (f) does not apply if the 
food is a raw agricultural commodity that is a fruit or vegetable that 
is ``covered produce'' as defined in Sec.  112.3 of this chapter.



Sec.  1.505  What evaluation for foreign supplier approval and
verification must I conduct?

    (a) Evaluation of a foreign supplier's performance and the risk 
posed by a food. (1) Except as specified in paragraphs (d)

[[Page 69]]

and (e) of this section, in approving your foreign suppliers and 
determining the appropriate supplier verification activities that must 
be conducted for a foreign supplier of a type of food you import, you 
must consider the following:
    (i) The hazard analysis of the food conducted in accordance with 
Sec.  1.504, including the nature of the hazard requiring a control.
    (ii) The entity or entities that will be significantly minimizing or 
preventing the hazards requiring a control or verifying that such 
hazards have been significantly minimized or prevented, such as the 
foreign supplier, the foreign supplier's raw material or other 
ingredient supplier, or another entity in your supply chain.
    (iii) Foreign supplier performance, including:
    (A) The foreign supplier's procedures, processes, and practices 
related to the safety of the food;
    (B) Applicable FDA food safety regulations and information relevant 
to the foreign supplier's compliance with those regulations, including 
whether the foreign supplier is the subject of an FDA warning letter, 
import alert, or other FDA compliance action related to food safety (or, 
when applicable, the relevant laws and regulations of a country whose 
food safety system FDA has officially recognized as comparable or 
determined to be equivalent to that of the United States, and 
information relevant to the supplier's compliance with those laws and 
regulations); and
    (C) The foreign supplier's food safety history, including available 
information about results from testing foods for hazards, audit results 
relating to the safety of the food, and responsiveness of the foreign 
supplier in correcting problems.
    (iv) Any other factors as appropriate and necessary, such as storage 
and transportation practices.
    (2) You must document the evaluation you conduct under paragraph 
(a)(1) of this section.
    (b) Approval of foreign suppliers. You must approve your foreign 
suppliers on the basis of the evaluation that you conducted under 
paragraph (a) of this section or that you review and assess under 
paragraph (d) of this section, and document your approval.
    (c) Reevaluation of a foreign supplier's performance and the risk 
posed by a food. (1) Except as specified in paragraph (d) of this 
section, you must promptly reevaluate the concerns associated with the 
factors in paragraph (a)(1) of this section when you become aware of new 
information about these factors, and the reevaluation must be 
documented. If you determine that the concerns associated with importing 
a food from a foreign supplier have changed, you must promptly determine 
(and document) whether it is appropriate to continue to import the food 
from the foreign supplier and whether the supplier verification 
activities conducted under Sec.  1.506 or Sec.  1.511(c) need to be 
changed.
    (2) If at the end of any 3-year period you have not reevaluated the 
concerns associated with the factors in paragraph (a)(1) of this section 
in accordance with paragraph (c)(1) of this section, you must reevaluate 
those concerns and take other appropriate actions, if necessary, in 
accordance with paragraph (c)(1). You must document your reevaluation 
and any subsequent actions you take in accordance with paragraph (c)(1).
    (d) Review of another entity's evaluation or reevaluation of a 
foreign supplier's performance and the risk posed by a food. If an 
entity other than the foreign supplier has, using a qualified 
individual, performed the evaluation described in paragraph (a) of this 
section or the reevaluation described in paragraph (c) of this section, 
you may meet the requirements of the applicable paragraph by reviewing 
and assessing the evaluation or reevaluation conducted by that entity. 
You must document your review and assessment, including documenting that 
the evaluation or reevaluation was conducted by a qualified individual.
    (e) Inapplicability to certain circumstances. You are not required 
to conduct an evaluation under this section or to conduct foreign 
supplier verification activities under Sec.  1.506 if one of the 
circumstances described in Sec.  1.507 applies to your importation of a 
food and you are in compliance with that section.

[[Page 70]]



Sec.  1.506  What foreign supplier verification and related activities
must I conduct?

    (a) Use of approved foreign suppliers. (1) You must establish and 
follow written procedures to ensure that you import foods only from 
foreign suppliers you have approved based on the evaluation conducted 
under Sec.  1.505 (or, when necessary and appropriate, on a temporary 
basis from unapproved foreign suppliers whose foods you subject to 
adequate verification activities before importing the food). You must 
document your use of these procedures.
    (2) You may rely on an entity other than your foreign supplier to 
establish the procedures and perform and document the activities 
required under paragraph (a)(1) of this section provided that you review 
and assess that entity's documentation of the procedures and activities, 
and you document your review and assessment.
    (b) Foreign supplier verification procedures. You must establish and 
follow adequate written procedures for ensuring that appropriate foreign 
supplier verification activities are conducted with respect to the foods 
you import.
    (c) Requirement of supplier verification. The foreign supplier 
verification activities must provide assurance that the hazards 
requiring a control in the food you import have been significantly 
minimized or prevented.
    (d) Determination of appropriate foreign supplier verification 
activities--(1)(i) General. Except as provided in paragraphs (d)(2) and 
(3) of this section, before importing a food from a foreign supplier, 
you must determine and document which verification activity or 
activities listed in paragraphs (d)(1)(ii)(A) through (D) of this 
section, as well as the frequency with which the activity or activities 
must be conducted, are needed to provide adequate assurances that the 
food you obtain from the foreign supplier is produced in accordance with 
paragraph (c) of this section. Verification activities must address the 
entity or entities that are significantly minimizing or preventing the 
hazards or verifying that the hazards have been significantly minimized 
or prevented (e.g., when an entity other than the grower of produce 
subject to part 112 of this chapter harvests or packs the produce and 
significantly minimizes or prevents the hazard or verifies that the 
hazard has been significantly minimized or prevented, or when the 
foreign supplier's raw material supplier significantly minimizes or 
prevents a hazard). The determination of appropriate supplier 
verification activities must be based on the evaluation of the food and 
foreign supplier conducted under Sec.  1.505.
    (ii) Appropriate verification activities. The following are 
appropriate supplier verification activities:
    (A) Onsite audits as specified in paragraph (e)(1)(i) of this 
section;
    (B) Sampling and testing of a food as specified in paragraph 
(e)(1)(ii) of this section;
    (C) Review of the foreign supplier's relevant food safety records as 
specified in paragraph (e)(1)(iii) of this section; and
    (D) Other appropriate supplier verification activities as specified 
in paragraph (e)(1)(iv) of this section.
    (2) Verification activities for certain serious hazards. When a 
hazard in a food will be controlled by the foreign supplier and is one 
for which there is a reasonable probability that exposure to the hazard 
will result in serious adverse health consequences or death to humans or 
animals, you must conduct or obtain documentation of an onsite audit of 
the foreign supplier before initially importing the food and at least 
annually thereafter, unless you make an adequate written determination 
that, instead of such initial and annual onsite auditing, other supplier 
verification activities listed in paragraph (d)(1)(ii) of this section 
and/or less frequent onsite auditing are appropriate to provide adequate 
assurances that the foreign supplier is producing the food in accordance 
with paragraph (c) of this section, based on the determination made 
under Sec.  1.505.
    (3) Reliance on a determination by another entity. You may rely on a 
determination of appropriate foreign supplier verification activities in 
accordance with paragraph (d)(1) or (2) of this section made by an 
entity other than the foreign supplier if you review and assess whether 
the entity's determination regarding appropriate activities (including 
the frequency with which

[[Page 71]]

such activities must be conducted) is appropriate. You must document 
your review and assessment, including documenting that the determination 
of appropriate verification activities was made by a qualified 
individual.
    (e) Performance of foreign supplier verification activities--(1) 
Verification activities. Except as provided in paragraph (e)(2) of this 
section, based on the determination made in accordance with paragraph 
(d) of this section, you must conduct (and document) or obtain 
documentation of one or more of the supplier verification activities 
listed in paragraphs (e)(1)(i) through (iv) of this section for each 
foreign supplier before importing the food and periodically thereafter.
    (i) Onsite audit of the foreign supplier. (A) An onsite audit of a 
foreign supplier must be performed by a qualified auditor.
    (B) If the food is subject to one or more FDA food safety 
regulations, an onsite audit of the foreign supplier must consider such 
regulations and include a review of the supplier's written food safety 
plan, if any, and its implementation, for the hazard being controlled 
(or, when applicable, an onsite audit may consider relevant laws and 
regulations of a country whose food safety system FDA has officially 
recognized as comparable or determined to be equivalent to that of the 
United States).
    (C) If the onsite audit is conducted solely to meet the requirements 
of paragraph (e) of this section by an audit agent of a certification 
body that is accredited in accordance with subpart M of this part, the 
audit is not subject to the requirements in that subpart.
    (D) You must retain documentation of each onsite audit, including 
the audit procedures, the dates the audit was conducted, the conclusions 
of the audit, any corrective actions taken in response to significant 
deficiencies identified during the audit, and documentation that the 
audit was conducted by a qualified auditor.
    (E) The following inspection results may be substituted for an 
onsite audit, provided that the inspection was conducted within 1 year 
of the date by which the onsite audit would have been required to be 
conducted:
    (1) The written results of an appropriate inspection of the foreign 
supplier for compliance with applicable FDA food safety regulations 
conducted by FDA, representatives of other Federal Agencies (such as the 
USDA), or representatives of State, local, tribal, or territorial 
agencies; or
    (2) The written results of an inspection of the foreign supplier by 
the food safety authority of a country whose food safety system FDA has 
officially recognized as comparable or determined to be equivalent to 
that of the United States, provided that the food that is the subject of 
the onsite audit is within the scope of the official recognition or 
equivalence determination, and the foreign supplier is in, and under the 
regulatory oversight of, such country.
    (ii) Sampling and testing of the food. You must retain documentation 
of each sampling and testing of a food, including identification of the 
food tested (including lot number, as appropriate), the number of 
samples tested, the test(s) conducted (including the analytical 
method(s) used), the date(s) on which the test(s) were conducted and the 
date of the report of the testing, the results of the testing, any 
corrective actions taken in response to detection of hazards, 
information identifying the laboratory conducting the testing, and 
documentation that the testing was conducted by a qualified individual.
    (iii) Review of the foreign supplier's relevant food safety records. 
You must retain documentation of each record review, including the 
date(s) of review, the general nature of the records reviewed, the 
conclusions of the review, any corrective actions taken in response to 
significant deficiencies identified during the review, and documentation 
that the review was conducted by a qualified individual.
    (iv) Other appropriate activity. (A) You may conduct (and document) 
or obtain documentation of other supplier verification activities that 
are appropriate based on foreign supplier performance and the risk 
associated with the food.

[[Page 72]]

    (B) You must retain documentation of each activity conducted in 
accordance with paragraph (e)(1)(iv) of this section, including a 
description of the activity, the date on which it was conducted, the 
findings or results of the activity, any corrective actions taken in 
response to significant deficiencies identified, and documentation that 
the activity was conducted by a qualified individual.
    (2) Reliance upon performance of activities by other entities. (i) 
Except as specified in paragraph (e)(2)(ii) of this section, you may 
rely on supplier verification activities conducted in accordance with 
paragraph (e)(1) of this section by another entity provided that you 
review and assess the results of these activities in accordance with 
paragraph (e)(3) of this section.
    (ii) You may not rely on the foreign supplier itself or employees of 
the foreign supplier to perform supplier verification activities, except 
with respect to sampling and testing of food in accordance with 
paragraph (e)(1)(ii) of this section.
    (3) Review of results of verification activities. You must promptly 
review and assess the results of the verification activities that you 
conduct or obtain documentation of under paragraph (e)(1) of this 
section, or that are conducted by other entities in accordance with 
paragraph (e)(2) of this section. You must document your review and 
assessment of the results of verification activities. If the results do 
not provide adequate assurances that the hazards requiring a control in 
the food you obtain from the foreign supplier have been significantly 
minimized or prevented, you must take appropriate action in accordance 
with Sec.  1.508(a). You are not required to retain documentation of 
supplier verification activities conducted by other entities, provided 
that you can obtain the documentation and make it available to FDA in 
accordance with Sec.  1.510(b).
    (4) Independence of qualified individuals conducting verification 
activities. There must not be any financial conflicts of interests that 
influence the results of the verification activities set forth in 
paragraph (e)(1) of this section, and payment must not be related to the 
results of the activity.



Sec.  1.507  What requirements apply when I import a food that cannot
be consumed without the hazards being controlled or for which the hazards
are controlled after importation?

    (a) Circumstances. You are not required to conduct an evaluation of 
a food and foreign supplier under Sec.  1.505 or supplier verification 
activities under Sec.  1.506 when you identify a hazard requiring a 
control (identified hazard) in a food and any of the following 
circumstances apply:
    (1) You determine and document that the type of food (e.g., raw 
agricultural commodities such as cocoa beans and coffee beans) could not 
be consumed without application of an appropriate control;
    (2) You rely on your customer who is subject to the requirements for 
hazard analysis and risk-based preventive controls in subpart C of part 
117 or subpart C of part 507 of this chapter to ensure that the 
identified hazard will be significantly minimized or prevented and you:
    (i) Disclose in documents accompanying the food, in accordance with 
the practice of the trade, that the food is ``not processed to control 
[identified hazard]''; and
    (ii) Annually obtain from your customer written assurance, subject 
to the requirements of paragraph (c) of this section, that the customer 
has established and is following procedures (identified in the written 
assurance) that will significantly minimize or prevent the identified 
hazard;
    (3) You rely on your customer who is not subject to the requirements 
for hazard analysis and risk-based preventive controls in subpart C of 
part 117 or subpart C of part 507 of this chapter to provide assurance 
it is manufacturing, processing, or preparing the food in accordance 
with the applicable food safety requirements and you:
    (i) Disclose in documents accompanying the food, in accordance with 
the practice of the trade, that the food is ``not processed to control 
[identified hazard]''; and
    (ii) Annually obtain from your customer written assurance that it is

[[Page 73]]

manufacturing, processing, or preparing the food in accordance with 
applicable food safety requirements;
    (4) You rely on your customer to provide assurance that the food 
will be processed to control the identified hazard by an entity in the 
distribution chain subsequent to the customer and you:
    (i) Disclose in documents accompanying the food, in accordance with 
the practice of the trade, that the food is ``not processed to control 
[identified hazard]''; and
    (ii) Annually obtain from your customer written assurance, subject 
to the requirements of paragraph (c) of this section, that your 
customer:
    (A) Will disclose in documents accompanying the food, in accordance 
with the practice of the trade, that the food is ``not processed to 
control [identified hazard]''; and
    (B) Will only sell the food to another entity that agrees, in 
writing, it will:
    (1) Follow procedures (identified in a written assurance) that will 
significantly minimize or prevent the identified hazard (if the entity 
is subject to the requirements for hazard analysis and risk-based 
preventive controls in subpart C of part 117 or subpart C of part 507 of 
this chapter) or manufacture, process, or prepare the food in accordance 
with applicable food safety requirements (if the entity is not subject 
to the requirements for hazard analysis and risk-based preventive 
controls in subpart C of part 117 or subpart C of part 507); or
    (2) Obtain a similar written assurance from the entity's customer, 
subject to the requirements of paragraph (c) of this section, as in 
paragraphs (a)(4)(ii)(A) and (B) of this section, as appropriate; or
    (5) You have established, documented, and implemented a system that 
ensures control, at a subsequent distribution step, of the hazards in 
the food you distribute and you document your implementation of that 
system.
    (b) Written assurances. Any written assurances required under this 
section must contain the following:
    (1) Effective date;
    (2) Printed names and signatures of authorized officials; and
    (3) The assurance specified in the applicable paragraph.
    (c) Provision of assurances. The customer or other subsequent entity 
in the distribution chain for a food that provides a written assurance 
under paragraph (a)(2), (3), or (4) of this section must act 
consistently with the assurance and document its actions taken to 
satisfy the written assurance.



Sec.  1.508  What corrective actions must I take under my FSVP?

    (a) You must promptly take appropriate corrective actions if you 
determine that a foreign supplier of food you import does not produce 
the food in compliance with processes and procedures that provide at 
least the same level of public health protection as those required under 
section 418 or 419 of the Federal Food, Drug, and Cosmetic Act, if 
either is applicable, and the implementing regulations, or produces food 
that is adulterated under section 402 or misbranded under section 403(w) 
(if applicable) of the Federal Food, Drug, and Cosmetic Act. This 
determination could be based on a review of consumer, customer, or other 
complaints related to food safety, the verification activities conducted 
under Sec.  1.506 or Sec.  1.511(c), a reevaluation of the risks posed 
by the food and the foreign supplier's performance conducted under Sec.  
1.505(c) or (d), or any other relevant information you obtain. The 
appropriate corrective actions will depend on the circumstances but 
could include discontinuing use of the foreign supplier until the cause 
or causes of noncompliance, adulteration, or misbranding have been 
adequately addressed. You must document any corrective actions you take 
in accordance with this paragraph.
    (b) If you determine, by means other than the verification 
activities conducted under Sec.  1.506 or Sec.  1.511(c) or a 
reevaluation conducted under Sec.  1.505(c) or (d), that a foreign 
supplier of food that you import does not produce food in compliance 
with processes and procedures that provide at least the same level of 
public health protection as those required under section 418 or 419 of 
the Federal Food, Drug, and Cosmetic Act, if either is applicable, and

[[Page 74]]

the implementing regulations, or produces food that is adulterated under 
section 402 or misbranded under section 403(w) (if applicable) of the 
Federal Food, Drug, and Cosmetic Act, you must promptly investigate to 
determine whether your FSVP is adequate and, when appropriate, modify 
your FSVP. You must document any investigations, corrective actions, and 
changes to your FSVP that you undertake in accordance with this 
paragraph.
    (c) This section does not limit your obligations with respect to 
other laws enforced by FDA, such as those relating to product recalls.



Sec.  1.509  How must the importer be identified at entry?

    (a) You must ensure that, for each line entry of food product 
offered for importation into the United States, your name, electronic 
mail address, and unique facility identifier recognized as acceptable by 
FDA, identifying you as the importer of the food, are provided 
electronically when filing entry with U.S. Customs and Border 
Protection.
    (b) Before an article of food is imported or offered for import into 
the United States, the foreign owner or consignee of the food (if there 
is no U.S. owner or consignee) must designate a U.S. agent or 
representative as the importer of the food for the purposes of the 
definition of ``importer'' in Sec.  1.500.



Sec.  1.510  How must I maintain records of my FSVP?

    (a) General requirements for records. (1) You must keep records as 
original records, true copies (such as photocopies, pictures, scanned 
copies, microfilm, microfiche, or other accurate reproductions of the 
original records), or electronic records.
    (2) You must sign and date records concerning your FSVP upon initial 
completion and upon any modification of the FSVP.
    (3) All records must be legible and stored to prevent deterioration 
or loss.
    (b) Record availability. (1) You must make all records required 
under this subpart available promptly to an authorized FDA 
representative, upon request, for inspection and copying. Upon FDA 
request, you must provide within a reasonable time an English 
translation of records maintained in a language other than English.
    (2) Offsite storage of records, including records maintained by 
other entities in accordance with Sec.  1.504, Sec.  1.505, or Sec.  
1.506, is permitted if such records can be retrieved and provided onsite 
within 24 hours of request for official review. Electronic records are 
considered to be onsite if they are accessible from an onsite location.
    (3) If requested in writing by FDA, you must send records to the 
Agency electronically, or through another means that delivers the 
records promptly, rather than making the records available for review at 
your place of business.
    (c) Record retention. (1) Except as specified in paragraph (c)(2) of 
this section, you must retain records referenced in this subpart until 
at least 2 years after you created or obtained the records.
    (2) You must retain records that relate to your processes and 
procedures, including the results of evaluations and determinations you 
conduct, for at least 2 years after their use is discontinued (e.g., 
because you no longer import a particular food, you no longer use a 
particular foreign supplier, you have reevaluated the risks associated 
with a food and the foreign supplier, or you have changed your supplier 
verification activities for a particular food and foreign supplier).
    (d) Electronic records. Records that are established or maintained 
to satisfy the requirements of this subpart and that meet the definition 
of electronic records in Sec.  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 also are required under other 
applicable statutory provisions or regulations, remain subject to part 
11.
    (e) Use of existing records. (1) You do not need to duplicate 
existing records you have (e.g., records that you maintain to comply 
with other Federal, State, or local regulations) if they contain all of 
the information required by this subpart. You may supplement any

[[Page 75]]

such existing records as necessary to include all of the information 
required by this subpart.
    (2) You do not need to maintain the information required by this 
subpart in one set of records. If existing records you have contain some 
of the required information, you may maintain any new information 
required by this subpart either separately or combined with the existing 
records.
    (f) Public disclosure. Records obtained by FDA in accordance with 
this subpart are subject to the disclosure requirements under part 20 of 
this chapter.



Sec.  1.511   What FSVP must I have if I am importing a food subject
to certain requirements in the dietary supplement current good
manufacturing practice regulation?

    (a) Importers subject to certain requirements in the dietary 
supplement current good manufacturing practice regulation. If you are 
required to establish specifications under Sec.  111.70(b) or (d) of 
this chapter with respect to a food that is a dietary supplement or 
dietary supplement component you import for further manufacturing, 
processing, or packaging as a dietary supplement, and you are in 
compliance with the requirements in Sec. Sec.  111.73 and 111.75 of this 
chapter applicable to determining whether the specifications you 
established are met for such food, then for that food you must comply 
with the requirements in Sec. Sec.  1.503 and 1.509, but you are not 
required to comply with the requirements in Sec.  1.502, Sec. Sec.  
1.504 through 1.508, or Sec.  1.510. This requirement does not limit 
your obligations with respect to part 111 of this chapter or any other 
laws enforced by FDA.
    (b) Importers whose customer is subject to certain requirements in 
the dietary supplement current good manufacturing practice regulation. 
If your customer is required to establish specifications under Sec.  
111.70(b) or (d) of this chapter with respect to a food that is a 
dietary supplement or dietary supplement component you import for 
further manufacturing, processing, or packaging as a dietary supplement, 
your customer is in compliance with the requirements of Sec. Sec.  
111.73 and 111.75 of this chapter applicable to determining whether the 
specifications it established are met for such food, and you annually 
obtain from your customer written assurance that it is in compliance 
with those requirements, then for that food you must comply with the 
requirements in Sec. Sec.  1.503, 1.509, and 1.510, but you are not 
required to comply with the requirements in Sec.  1.502 or Sec. Sec.  
1.504 through 1.508.
    (c) Other importers of dietary supplements--(1) General. If the food 
you import is a dietary supplement and neither paragraph (a) or (b) of 
this section is applicable, you must comply with paragraph (c) of this 
section and the requirements in Sec. Sec.  1.503, 1.505(a)(1)(ii) 
through (iv), (a)(2), and (b) through (d), and 1.508 through 1.510, but 
you are not required to comply with the requirements in Sec. Sec.  
1.504, 1.505(a)(1)(i), 1.506, and 1.507. This requirement does not limit 
your obligations with respect to part 111 of this chapter or any other 
laws enforced by FDA.
    (2) Use of approved foreign suppliers. (i) You must establish and 
follow written procedures to ensure that you import foods only from 
foreign suppliers that you have approved based on the evaluation 
conducted under Sec.  1.505 (or, when necessary and appropriate, on a 
temporary basis from unapproved foreign suppliers whose foods you 
subject to adequate verification activities before importing the food). 
You must document your use of these procedures.
    (ii) You may rely on an entity other than the foreign supplier to 
establish the procedures and perform and document the activities 
required under paragraph (c)(2)(i) of this section provided that you 
review and assess that entity's documentation of the procedures and 
activities, and you document your review and assessment.
    (3) Foreign supplier verification procedures. You must establish and 
follow adequate written procedures for ensuring that appropriate foreign 
supplier verification activities are conducted with respect to the foods 
you import.
    (4) Determination of appropriate foreign supplier verification 
activities--(i) General. Except as provided in paragraph (c)(4)(iii) of 
this section, before importing a dietary supplement from a foreign 
supplier, you must determine and document which verification activity or 
activities listed in paragraphs

[[Page 76]]

(c)(4)(ii)(A) through (D) of this section, as well as the frequency with 
which the activity or activities must be conducted, are needed to 
provide adequate assurances that the foreign supplier is producing the 
dietary supplement in accordance with processes and procedures that 
provide the same level of public health protection as those required 
under part 111 of this chapter. This determination must be based on the 
evaluation conducted under Sec.  1.505.
    (ii) Appropriate verification activities. The following are 
appropriate supplier verification activities:
    (A) Onsite audits as specified in paragraph (c)(5)(i)(A) of this 
section;
    (B) Sampling and testing of a food as specified in paragraph 
(c)(5)(i)(B) of this section;
    (C) Review of the foreign supplier's relevant food safety records as 
specified in paragraph (c)(5)(i)(C) of this section; and
    (D) Other appropriate supplier verification activities as specified 
in paragraph (c)(5)(i)(D) of this section.
    (iii) Reliance upon determination by other entity. You may rely on a 
determination of appropriate foreign supplier verification activities in 
accordance with paragraph (c)(4)(i) of this section made by an entity 
other than the foreign supplier if you review and assess whether the 
entity's determination regarding appropriate activities (including the 
frequency with which such activities must be conducted) is appropriate 
based on the evaluation conducted in accordance with Sec.  1.505. You 
must document your review and assessment, including documenting that the 
determination of appropriate verification activities was made by a 
qualified individual.
    (5) Performance of foreign supplier verification activities. (i) 
Except as provided in paragraph (c)(5)(ii) of this section, for each 
dietary supplement you import under paragraph (c) of this section, you 
must conduct (and document) or obtain documentation of one or more of 
the verification activities listed in paragraphs (c)(5)(i)(A) through 
(D) of this section before importing the dietary supplement and 
periodically thereafter.
    (A) Onsite auditing. You conduct (and document) or obtain 
documentation of a periodic onsite audit of your foreign supplier.
    (1) An onsite audit of a foreign supplier must be performed by a 
qualified auditor.
    (2) The onsite audit must consider the applicable requirements of 
part 111 of this chapter and include a review of the foreign supplier's 
written food safety plan, if any, and its implementation (or, when 
applicable, an onsite audit may consider relevant laws and regulations 
of a country whose food safety system FDA has officially recognized as 
comparable or determined to be equivalent to that of the United States).
    (3) If the onsite audit is conducted solely to meet the requirements 
of paragraph (c)(5) of this section by an audit agent of a certification 
body that is accredited in accordance with subpart M of this part, the 
audit is not subject to the requirements in that subpart.
    (4) You must retain documentation of each onsite audit, including 
the audit procedures, the dates the audit was conducted, the conclusions 
of the audit, any corrective actions taken in response to significant 
deficiencies identified during the audit, and documentation that the 
audit was conducted by a qualified auditor.
    (5) The following inspection results may be substituted for an 
onsite audit, provided that the inspection was conducted within 1 year 
of the date by which the onsite audit would have been required to be 
conducted:
    (i) The written results of appropriate inspection of the foreign 
supplier for compliance with the applicable requirements in part 111 of 
this chapter conducted by FDA, representatives of other Federal Agencies 
(such as the USDA), or representatives of State, local, tribal, or 
territorial agencies; or
    (ii) The written results of an inspection by the food safety 
authority of a country whose food safety system FDA has officially 
recognized as comparable or determined to be equivalent to that of the 
United States, provided that the food that is the subject of the onsite 
audit is within the scope of the official recognition or equivalence 
determination, and the foreign supplier is in, and

[[Page 77]]

under the regulatory oversight of, such country.
    (B) Sampling and testing of the food. You must retain documentation 
of each sampling and testing of a dietary supplement, including 
identification of the food tested (including lot number, as 
appropriate), the number of samples tested, the test(s) conducted 
(including the analytical method(s) used), the date(s) on which the 
test(s) were conducted and the date of the report of the testing, the 
results of the testing, any corrective actions taken in response to 
detection of hazards, information identifying the laboratory conducting 
the testing, and documentation that the testing was conducted by a 
qualified individual.
    (C) Review of the foreign supplier's food safety records. You must 
retain documentation of each record review, including the date(s) of 
review, the general nature of the records reviewed, the conclusions of 
the review, any corrective actions taken in response to significant 
deficiencies identified during the review, and documentation that the 
review was conducted by a qualified individual.
    (D) Other appropriate activity. (1) You may conduct (and document) 
or obtain documentation of other supplier verification activities that 
are appropriate based on foreign supplier performance and the risk 
associated with the food.
    (2) You must retain documentation of each activity conducted in 
accordance with paragraph (c)(5)(i)(D)(1) of this section, including a 
description of the activity, the date on which it was conducted, the 
findings or results of the activity, any corrective actions taken in 
response to significant deficiencies identified, and documentation that 
the activity was conducted by a qualified individual.
    (ii) Reliance upon performance of activities by other entities. (A) 
Except as specified in paragraph (c)(5)(ii)(B) of this section, you may 
rely on supplier verification activities conducted in accordance with 
paragraph (c)(5)(i) by another entity provided that you review and 
assess the results of these activities in accordance with paragraph 
(c)(5)(iii) of this section.
    (B) You may not rely on the foreign supplier or employees of the 
foreign supplier to perform supplier verification activities, except 
with respect to sampling and testing of food in accordance with 
paragraph (c)(5)(i)(B) of this section.
    (iii) Review of results of verification activities. You must 
promptly review and assess the results of the verification activities 
that you conduct or obtain documentation of under paragraph (c)(5)(i) of 
this section, or that are conducted by other entities in accordance with 
paragraph (c)(5)(ii) of this section. You must document your review and 
assessment of the results of verification activities. If the results 
show that the foreign supplier is not producing the dietary supplement 
in accordance with processes and procedures that provide the same level 
of public health protection as those required under part 111 of this 
chapter, you must take appropriate action in accordance with Sec.  
1.508(a). You are not required to retain documentation of supplier 
verification activities conducted by other entities, provided that you 
can obtain the documentation and make it available to FDA in accordance 
with Sec.  1.510(b).
    (iv) Independence of qualified individuals conducting verification 
activities. There must not be any financial conflicts of interest that 
influence the results of the verification activities set forth in 
paragraph (c)(5)(i) of this section, and payment must not be related to 
the results of the activity.

[80 FR 74340, Nov. 27, 2015, as amended at 81 FR 25327, Apr. 28, 2016]



Sec.  1.512  What FSVP may I have if I am a very small importer or
I am importing certain food from certain small foreign suppliers?

    (a) Eligibility. This section applies only if:
    (1) You are a very small importer; or
    (2) You are importing certain food from certain small foreign 
suppliers as follows:
    (i) The foreign supplier is a qualified facility as defined by Sec.  
117.3 or Sec.  507.3 of this chapter;
    (ii) You are importing produce from a foreign supplier that is a 
farm that grows produce and is not a covered

[[Page 78]]

farm under part 112 of this chapter in accordance with Sec.  112.4(a) of 
this chapter, or in accordance with Sec. Sec.  112.4(b) and 112.5 of 
this chapter; or
    (iii) You are importing shell eggs from a foreign supplier that is 
not subject to the requirements of part 118 of this chapter because it 
has fewer than 3,000 laying hens.
    (b) Applicable requirements--(1) Documentation of eligibility--(i) 
Very small importer status. (A) If you are a very small importer and you 
choose to comply with the requirements in this section, you must 
document that you meet the definition of very small importer in Sec.  
1.500 with respect to human food and/or animal food before initially 
importing food as a very small importer and thereafter on an annual 
basis by December 31 of each calendar year.
    (B) For the purpose of determining whether you satisfy the 
definition of very small importer with respect to human food and/or 
animal food for a given calendar year, the relevant 3-year period of 
sales (and U.S. market value of human or animal food, as appropriate) is 
the period ending 1 year before the calendar year for which you intend 
to import food as a very small importer. The baseline year for 
calculating the adjustment for inflation is 2011. If you conduct any 
food sales in currency other than U.S. dollars, you must use the 
relevant currency exchange rate in effect on December 31 of the year in 
which sales occurred to calculate the value of these sales.
    (ii) Small foreign supplier status. If you are a importing food from 
a small foreign supplier as specified in paragraph (a)(2) of this 
section and you choose to comply with the requirements in this section, 
you must obtain written assurance that your foreign supplier meets the 
criteria in paragraph (a)(2)(i), (ii), or (iii) of this section before 
first approving the supplier for an applicable calendar year and 
thereafter on an annual basis by December 31 of each calendar year, for 
the following calendar year.
    (2) Additional requirements. If this section applies and you choose 
to comply with the requirements in paragraph (b) of this section, you 
also are required to comply with the requirements in Sec. Sec.  1.502, 
1.503, and 1.509, but you are not required to comply with the 
requirements in Sec. Sec.  1.504 through 1.508 or Sec.  1.510.
    (3) Foreign supplier verification activities. (i) If you are a very 
small importer, for each food you import, you must obtain written 
assurance, before importing the food and at least every 2 years 
thereafter, that your foreign supplier is producing the food in 
compliance with processes and procedures that provide at least the same 
level of public health protection as those required under section 418 or 
419 of the Federal Food, Drug, and Cosmetic Act, if either is 
applicable, and the implementing regulations, and is producing the food 
in compliance with sections 402 and 403(w) (if applicable) of the 
Federal Food, Drug, and Cosmetic Act.
    (ii) If your foreign supplier is a qualified facility as defined by 
Sec.  117.3 or Sec.  507.3 of this chapter and you choose to comply with 
the requirements in this section, you must obtain written assurance, 
before importing the food and at least every 2 years thereafter, that 
the foreign supplier is producing the food in compliance with applicable 
FDA food safety regulations (or, when applicable, relevant laws and 
regulations of a country whose food safety system FDA has officially 
recognized as comparable or determined to be equivalent to that of the 
United States). The written assurance must include either:
    (A) A brief description of the preventive controls that the supplier 
is implementing to control the applicable hazard in the food; or
    (B) A statement that the supplier is in compliance with State, 
local, county, tribal, or other applicable non-Federal food safety law, 
including relevant laws and regulations of foreign countries.
    (iii) If your foreign supplier is a farm that grows produce and is 
not a covered farm under part 112 of this chapter in accordance with 
Sec.  112.4(a) of this chapter, or in accordance with Sec. Sec.  
112.4(b) and 112.5 of this chapter, and you choose to comply with the 
requirements in this section, you must obtain written assurance, before 
importing the produce and at least every 2 years thereafter, that the 
farm acknowledges that its food is subject to section 402 of the Federal 
Food, Drug, and Cosmetic Act (or, when applicable, that its food

[[Page 79]]

is subject to relevant laws and regulations of a country whose food 
safety system FDA has officially recognized as comparable or determined 
to be equivalent to that of the United States).
    (iv) If your foreign supplier is a shell egg producer that is not 
subject to the requirements of part 118 of this chapter because it has 
fewer than 3,000 laying hens and you choose to comply with the 
requirements in this section, you must obtain written assurance, before 
importing the shell eggs and at least every 2 years thereafter, that the 
shell egg producer acknowledges that its food is subject to section 402 
of the Federal Food, Drug, and Cosmetic Act (or, when applicable, that 
its food is subject to relevant laws and regulations of a country whose 
food safety system FDA has officially recognized as comparable or 
determined to be equivalent to that of the United States).
    (4) Corrective actions. You must promptly take appropriate 
corrective actions if you determine that a foreign supplier of food you 
import does not produce the food consistent with the assurance provided 
in accordance with Sec.  1.512(b)(3)(i) through (iv). The appropriate 
corrective actions will depend on the circumstances but could include 
discontinuing use of the foreign supplier until the cause or causes of 
noncompliance, adulteration, or misbranding have been adequately 
addressed. You must document any corrective actions you take in 
accordance with this paragraph (b)(4). This paragraph (b)(4) does not 
limit your obligations with respect to other laws enforced by FDA, such 
as those relating to product recalls.
    (5) Records--(i) General requirements for records. (A) You must keep 
records as original records, true copies (such as photocopies, pictures, 
scanned copies, microfilm, microfiche, or other accurate reproductions 
of the original records), or electronic records.
    (B) You must sign and date records concerning your FSVP upon initial 
completion and upon any modification of the FSVP.
    (C) All records must be legible and stored to prevent deterioration 
or loss.
    (ii) Availability. (A) You must make all records required under this 
subpart available promptly to an authorized FDA representative, upon 
request, for inspection and copying. Upon FDA request, you must provide 
within a reasonable time an English translation of records maintained in 
a language other than English.
    (B) Offsite storage of records, including records retained by other 
entities in accordance with paragraph (c) of this section, is permitted 
if such records can be retrieved and provided onsite within 24 hours of 
request for official review. Electronic records are considered to be 
onsite if they are accessible from an onsite location.
    (C) If requested in writing by FDA, you must send records to the 
Agency electronically or through another means that delivers the records 
promptly, rather than making the records available for review at your 
place of business.
    (iii) Record retention. (A) Except as specified in paragraph 
(b)(5)(iii)(B) or (C) of this section, you must retain records required 
under this subpart for a period of at least 2 years after you created or 
obtained the records.
    (B) If you are subject to paragraph (c) of this section, you must 
retain records that relate to your processes and procedures, including 
the results of evaluations of foreign suppliers and procedures to ensure 
the use of approved suppliers, for at least 2 years after their use is 
discontinued (e.g., because you have reevaluated a foreign supplier's 
compliance history or changed your procedures to ensure the use of 
approved suppliers).
    (C) You must retain for at least 3 years records that you rely on 
during the 3-year period preceding the applicable calendar year to 
support your status as a very small importer.
    (iv) Electronic records. Records that are established or maintained 
to satisfy the requirements of this subpart and that meet the definition 
of electronic records in Sec.  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 part, but that also are required

[[Page 80]]

under other applicable statutory provisions or regulations, remain 
subject to part 11.
    (v) Use of existing records. (A) You do not need to duplicate 
existing records you have (e.g., records that you maintain to comply 
with other Federal, State, or local regulations) if they contain all of 
the information required by this subpart. You may supplement any such 
existing records as necessary to include all of the information required 
by this subpart.
    (B) You do not need to maintain the information required by this 
subpart in one set of records. If existing records you have contain some 
of the required information, you may maintain any new information 
required by this subpart either separately or combined with the existing 
records.
    (vi) Public disclosure. Records obtained by FDA in accordance with 
this subpart are subject to the disclosure requirements under part 20 of 
this chapter.
    (c) Requirements for importers of food from certain small foreign 
suppliers. The following additional requirements apply if you are 
importing food from certain small foreign suppliers as specified in 
paragraph (a)(2) of this section and you are not a very small importer:
    (1) Evaluation of foreign supplier compliance history--(i) Initial 
evaluation. Except as specified in paragraph (c)(1)(iii) of this 
section, in approving your foreign suppliers, you must evaluate the 
applicable FDA food safety regulations and information relevant to the 
foreign supplier's compliance with those regulations, including whether 
the foreign supplier is the subject of an FDA warning letter, import 
alert, or other FDA compliance action related to food safety, and 
document the evaluation. You may also consider other factors relevant to 
a foreign supplier's performance, including those specified in Sec.  
1.505(a)(1)(iii)(A) and (C).
    (ii) Reevaluation of foreign supplier compliance history. (A) Except 
as specified in paragraph (c)(1)(iii) of this section, you must promptly 
reevaluate the concerns associated with the foreign supplier's 
compliance history when you become aware of new information about the 
matters in paragraph (c)(1)(i) of this section, and the reevaluation 
must be documented. If you determine that the concerns associated with 
importing a food from a foreign supplier have changed, you must promptly 
determine (and document) whether it is appropriate to continue to import 
the food from the foreign supplier.
    (B) If at the end of any 3-year period you have not reevaluated the 
concerns associated with the foreign supplier's compliance history in 
accordance with paragraph (c)(1)(ii)(A) of this section, you must 
reevaluate those concerns and take other appropriate actions, if 
necessary, in accordance with paragraph (c)(1)(ii)(A). You must document 
your reevaluation and any subsequent actions you take in accordance with 
paragraph (c)(1)(ii)(A).
    (iii) Review of another entity's evaluation or reevaluation of 
foreign supplier compliance history. If an entity other than the foreign 
supplier has, using a qualified individual, performed the evaluation 
described in paragraph (c)(1)(i) of this section or the reevaluation 
described in paragraph (c)(1)(ii), you may meet the requirements of the 
applicable paragraph by reviewing and assessing the evaluation or 
reevaluation conducted by that entity. You must document your review and 
assessment, including documenting that the evaluation or reevaluation 
was conducted by a qualified individual.
    (2) Approval of foreign supplier. You must approve your foreign 
suppliers on the basis of the evaluation you conducted under paragraph 
(c)(1)(i) of this section or that you review and assess under paragraph 
(c)(1)(iii) of this section, and document your approval.
    (3) Use of approved foreign suppliers. (i) You must establish and 
follow written procedures to ensure that you import foods only from 
foreign suppliers you have approved based on the evaluation conducted 
under paragraph (c)(1)(i) of this section (or, when necessary and 
appropriate, on a temporary basis from unapproved foreign suppliers 
whose foods you subject to adequate verification activities before 
importing the food). You must document your use of these procedures.
    (ii) You may rely on an entity other than the foreign supplier to 
establish

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the procedures and perform and document the activities required under 
paragraph (c)(3)(i) of this section provided that you review and assess 
that entity's documentation of the procedures and activities, and you 
document your review and assessment.

[80 FR 74340, Nov. 27, 2015, as amended at 81 FR 25327, Apr. 28, 2016]



Sec.  1.513  What FSVP may I have if I am importing certain food from
a country with an officially recognized or equivalent food safety system?

    (a) General. (1) If you meet the conditions and requirements of 
paragraph (b) of this section for a food of the type specified in 
paragraph (a)(2) of this section that you are importing, then you are 
not required to comply with the requirements in Sec. Sec.  1.504 through 
1.508. You would still be required to comply with the requirements in 
Sec. Sec.  1.503, 1.509, and 1.510.
    (2) This section applies to food that is not intended for further 
manufacturing/processing, including packaged food products and raw 
agricultural commodities that will not be commercially processed further 
before consumption.
    (b) Conditions and requirements. (1) Before importing a food from 
the foreign supplier and annually thereafter, you must document that the 
foreign supplier is in, and under the regulatory oversight of, a country 
whose food safety system FDA has officially recognized as comparable or 
determined to be equivalent to that of the United States, and that the 
food is within the scope of that official recognition or equivalency 
determination.
    (2) Before importing a food from the foreign supplier, you must 
determine and document whether the foreign supplier of the food is in 
good compliance standing with the food safety authority of the country 
in which the foreign supplier is located. You must continue to monitor 
whether the foreign supplier is in good compliance standing and promptly 
review any information obtained. If the information indicates that food 
safety hazards associated with the food are not being significantly 
minimized or prevented, you must take prompt corrective action. The 
appropriate corrective action will depend on the circumstances but could 
include discontinuing use of the foreign supplier. You must document any 
corrective actions that you undertake in accordance with this paragraph 
(b)(2).



Sec.  1.514  What are some consequences of failing to comply with the
requirements of this subpart?

    (a) Refusal of admission. An article of food is subject to refusal 
of admission under section 801(a)(3) of the Federal Food, Drug, and 
Cosmetic Act if it appears that the importer of that food fails to 
comply with this subpart with respect to that food. If there is no U.S. 
owner or consignee of an article of food at the time the food is offered 
for entry into the United States, the article of food may not be 
imported into the United States unless the foreign owner or consignee 
has appropriately designated a U.S. agent or representative as the 
importer in accordance with Sec.  1.500.
    (b) Prohibited act. The importation or offering for importation into 
the United States of an article of food without the importer having an 
FSVP that meets the requirements of section 805 of the Federal Food, 
Drug, and Cosmetic Act, including the requirements of this subpart, is 
prohibited under section 301(zz) of the Federal Food, Drug, and Cosmetic 
Act.



 Subpart M_Accreditation of Third-Party Certification Bodies To Conduct 
             Food Safety Audits and To Issue Certifications

    Source: 80 FR 74650, Nov. 27, 2015, unless otherwise noted.



Sec.  1.600  What definitions apply to this subpart?

    (a) The FD&C Act means the Federal Food, Drug, and Cosmetic Act.
    (b) Except as otherwise defined in paragraph (c) of this section, 
the definitions of terms in section 201 of the FD&C Act apply when the 
terms are used in this subpart.
    (c) In addition, for the purposes of this subpart:
    Accreditation means a determination by a recognized accreditation 
body (or, in the case of direct accreditation, by

[[Page 82]]

FDA) that a third-party certification body meets the applicable 
requirements of this subpart.
    Accreditation body means an authority that performs accreditation of 
third-party certification bodies.
    Accredited third-party certification body means a third-party 
certification body that a recognized accreditation body (or, in the case 
of direct accreditation, FDA) has determined meets the applicable 
requirements of this subpart and is accredited to conduct food safety 
audits and to issue food or facility certifications to eligible 
entities. An accredited third-party certification body has the same 
meaning as accredited third-party auditor as defined in section 
808(a)(4) of the FD&C Act.
    Assessment means:
    (i) With respect to an accreditation body, an evaluation by FDA of 
the competency and capacity of the accreditation body under the 
applicable requirements of this subpart for the defined scope of 
recognition. An assessment of the competency and capacity of the 
accreditation body involves evaluating the competency and capacity of 
the operations of the accreditation body that are relevant to decisions 
on recognition and, if recognized, an evaluation of its performance and 
the validity of its accreditation decisions under the applicable 
requirements of this subpart.
    (ii) With respect to a third-party certification body, an evaluation 
by a recognized accreditation body (or, in the case of direct 
accreditation, FDA) of the competency and capacity of a third-party 
certification body under the applicable requirements of this subpart for 
the defined scope of accreditation. An assessment of the competency and 
capacity of the third-party certification body involves evaluating the 
competency and capacity of the operations of the third-party 
certification body that are relevant to decisions on accreditation and, 
if accredited, an evaluation of its performance and the validity of its 
audit results and certification decisions under the applicable 
requirements of this subpart.
    Audit means the systematic and functionally independent examination 
of an eligible entity under this subpart by an accredited third-party 
certification body or by FDA. An audit conducted under this subpart is 
not considered an inspection under section 704 of the FD&C Act.
    Audit agent means an individual who is an employee or other agent of 
an accredited third-party certification body who, although not 
individually accredited, is qualified to conduct food safety audits on 
behalf of an accredited third-party certification body. An audit agent 
includes a contractor of the accredited third-party certification body 
but excludes subcontractors or other agents under outsourcing 
arrangements for conducting food safety audits without direct control by 
the accredited third-party certification body.
    Consultative audit means an audit of an eligible entity:
    (i) To determine whether such entity is in compliance with the 
applicable food safety requirements of the FD&C Act, FDA regulations, 
and industry standards and practices;
    (ii) The results of which are for internal purposes only; and
    (iii) That is conducted in preparation for a regulatory audit; only 
the results of a regulatory audit may form the basis for issuance of a 
food or facility certification under this subpart.
    Direct accreditation means accreditation of a third-party 
certification body by FDA.
    Eligible entity means a foreign entity in the import supply chain of 
food for consumption in the United States that chooses to be subject to 
a food safety audit under this subpart conducted by an accredited third-
party certification body. Eligible entities include foreign facilities 
required to be registered under subpart H of this part.
    Facility means any structure, or structures of an eligible entity 
under one ownership at one general physical location, or, in the case of 
a mobile facility, traveling to multiple locations, that manufactures/
processes, packs, holds, grows, harvests, or raises animals for 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

[[Page 83]]

separate ownership. The private residence of an individual is not a 
facility. Non-bottled water drinking water collection and distribution 
establishments and their structures are not facilities. Facilities for 
the purposes of this subpart are not limited to facilities required to 
be registered under subpart H of this part.
    Facility certification means an attestation, issued for purposes of 
section 801(q) or 806 of the FD&C Act by an accredited third-party 
certification body, after conducting a regulatory audit and any other 
activities necessary to establish whether a facility complies with the 
applicable food safety requirements of the FD&C Act and FDA regulations.
    Food has the meaning given in section 201(f) of the FD&C Act, except 
that food does not include pesticides (as defined in 7 U.S.C. 136(u)).
    Food certification means an attestation, issued for purposes of 
section 801(q) of the FD&C Act by an accredited third-party 
certification body, after conducting a regulatory audit and any other 
activities necessary to establish whether a food of an eligible entity 
complies with the applicable food safety requirements of the FD&C Act 
and FDA regulations.
    Food safety audit means a regulatory audit or a consultative audit 
that is conducted to determine compliance with the applicable food 
safety requirements of the FD&C Act, FDA regulations, and for 
consultative audits, also includes conformance with industry standards 
and practices. An eligible entity must declare that an audit is to be 
conducted as a regulatory audit or consultative audit at the time of 
audit planning and the audit will be conducted on an unannounced basis 
under this subpart.
    Foreign cooperative means an autonomous association of persons, 
identified as members, who are united through a jointly owned enterprise 
to aggregate food from member growers or processors that is intended for 
export to the United States.
    Recognized accreditation body means an accreditation body that FDA 
has determined meets the applicable requirements of this subpart and is 
authorized to accredit third-party certification bodies under this 
subpart.
    Regulatory audit means an audit of an eligible entity:
    (i) To determine whether such entity is in compliance with the 
applicable food safety requirements of the FD&C Act and FDA regulations; 
and
    (ii) The results of which are used in determining eligibility for 
certification under section 801(q) or under section 806 of the FD&C Act.
    Relinquishment means:
    (i) With respect to an accreditation body, a decision to cede 
voluntarily its authority to accredit third-party certification bodies 
as a recognized accreditation body prior to expiration of its 
recognition under this subpart; and
    (ii) With respect to a third-party certification body, a decision to 
cede voluntarily its authority to conduct food safety audits and to 
issue food and facility certifications to eligible entities as an 
accredited third-party certification body prior to expiration of its 
accreditation under this subpart.
    Self-assessment means an evaluation conducted by a recognized 
accreditation body or by an accredited third-party certification body of 
its competency and capacity under the applicable requirements of this 
subpart for the defined scope of recognition or accreditation. For 
recognized accreditation bodies this involves evaluating the competency 
and capacity of the entire operations of the accreditation body and the 
validity of its accreditation decisions under the applicable 
requirements of this subpart. For accredited third-party certification 
bodies this involves evaluating the competency and capacity of the 
entire operations of the third-party certification body and the validity 
of its audit results under the applicable requirements of this subpart.
    Third-party certification body has the same meaning as third-party 
auditor as that term is defined in section 808(a)(3) of the FD&C Act and 
means a foreign government, agency of a foreign government, foreign 
cooperative, or any other third party that is eligible to be considered 
for accreditation to conduct food safety audits and to certify that 
eligible entities meet the applicable food safety requirements of the 
FD&C

[[Page 84]]

Act and FDA regulations. A third-party certification body may be a 
single individual or an organization. Once accredited, a third-party 
certification body may use audit agents to conduct food safety audits.



Sec.  1.601  Who is subject to this subpart?

    (a) Accreditation bodies. Any accreditation body seeking recognition 
from FDA to accredit third-party certification bodies to conduct food 
safety audits and to issue food and facility certifications under this 
subpart.
    (b) Third-party certification bodies. Any third-party certification 
body seeking accreditation from a recognized accreditation body or 
direct accreditation by FDA for:
    (1) Conducting food safety audits; and
    (2) Issuing certifications that may be used in satisfying a 
condition of admissibility of an article of food under section 801(q) of 
the FD&C Act; or issuing a facility certification for meeting the 
eligibility requirements for the Voluntary Qualified Importer Program 
under section 806 of the FD&C Act.
    (c) Eligible entities. Any eligible entity seeking a food safety 
audit or a food or facility certification from an accredited third-party 
certification body under this subpart.
    (d) Limited exemptions from section 801(q) of the FD&C Act--(1) 
Alcoholic beverages. (i) Any certification required under section 801(q) 
of the FD&C Act does not apply with respect to alcoholic beverages from 
an eligible entity that is a facility that meets the following two 
conditions:
    (A) Under the Federal Alcohol Administration Act (27 U.S.C. 201 et 
seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 
(26 U.S.C. 5001 et seq.), the facility is a foreign facility of a type 
that, if it were a domestic facility, would require obtaining a permit 
from, registering with, or obtaining approval of a notice or application 
from the Secretary of the Treasury as a condition of doing business in 
the United States; and
    (B) Under section 415 of the FD&C Act, the facility is required to 
register as a facility because it is engaged in manufacturing/processing 
one or more alcoholic beverages.
    (ii) Any certification required under section 801(q) of the FD&C Act 
does not apply with respect to food that is not an alcoholic beverage 
that is received and distributed by a facility described in paragraph 
(d)(1)(i) of this section, provided such food:
    (A) Is received and distributed in prepackaged form that prevents 
any direct human contact with such food; and
    (B) Constitutes not more than 5 percent of the overall sales of the 
facility, as determined by the Secretary of the Treasury.
    (iii) Any certification required under section 801(q) of the FD&C 
Act does not apply with respect to raw materials or other ingredients 
that are imported for use in alcoholic beverages provided that:
    (A) The imported raw materials or other ingredients are used in the 
manufacturing/processing, packing, or holding of alcoholic beverages;
    (B) Such manufacturing/processing, packing, or holding is performed 
by the importer;
    (C) The importer is required to register under section 415 of the 
Federal Food, Drug, and Cosmetic Act; and
    (D) The importer is exempt from the regulations in part 117 of this 
chapter in accordance with Sec.  117.5(i).
    (2) Certain meat, poultry, and egg products. Any certification 
required under section 801(q) of the FD&C Act does not apply with 
respect to:
    (i) Meat food products that at the time of importation are subject 
to the requirements of the United States Department of Agriculture 
(USDA) under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);
    (ii) Poultry products that at the time of importation are subject to 
the requirements of the USDA under the Poultry Products Inspection Act 
(21 U.S.C. 451 et seq.); and
    (iii) Egg products that at the time of importation are subject to 
the requirements of the USDA under the Egg Products Inspection Act (21 
U.S.C. 1031 et seq.).

[[Page 85]]

         Recognition of Accreditation Bodies Under This Subpart



Sec.  1.610  Who is eligible to seek recognition?

    An accreditation body is eligible to seek recognition by FDA if it 
can demonstrate that it meets the requirements of Sec. Sec.  1.611 
through 1.615. The accreditation body may use documentation of 
conformance with International Organization for Standardization/
International Electrotechnical Commission (ISO/IEC) 17011:2004, 
supplemented as necessary, in meeting the applicable requirements of 
this subpart.



Sec.  1.611  What legal authority must an accreditation body have to
qualify for recognition?

    (a) An accreditation body seeking recognition must demonstrate that 
it has the authority (as a governmental entity or as a legal entity with 
contractual rights) to perform assessments of a third-party 
certification body as are necessary to determine its capability to 
conduct audits and certify food facilities and food, including authority 
to:
    (1) Review any relevant records;
    (2) Conduct onsite assessments of the performance of third-party 
certification bodies, such as by witnessing the performance of a 
representative sample of its agents (or, in the case of a third-party 
certification body that is an individual, such individual) conducting a 
representative sample of audits;
    (3) Perform any reassessments or surveillance necessary to monitor 
compliance of accredited third-party certification bodies; and
    (4) Suspend, withdraw, or reduce the scope of accreditation for 
failure to comply with the requirements of accreditation.
    (b) An accreditation body seeking recognition must demonstrate that 
it is capable of exerting the authority (as a governmental entity or as 
a legal entity with contractual rights) necessary to meet the applicable 
requirements of this subpart, if recognized.



Sec.  1.612  What competency and capacity must an accreditation body have
to qualify for recognition?

    An accreditation body seeking recognition must demonstrate that it 
has:
    (a) The resources required to adequately implement its accreditation 
program, including:
    (1) Adequate numbers of employees and other agents with relevant 
knowledge, skills, and experience to effectively evaluate the 
qualifications of third-party certification bodies seeking accreditation 
and to effectively monitor the performance of accredited third-party 
certification bodies; and
    (2) Adequate financial resources for its operations; and
    (b) The capability to meet the applicable assessment and monitoring 
requirements, the reporting and notification requirements, and the 
procedures of this subpart, if recognized.



Sec.  1.613  What protections against conflicts of interest must an
accreditation body have to qualify for recognition?

    An accreditation body must demonstrate that it has:
    (a) Implemented written measures to protect against conflicts of 
interest between the accreditation body (and its officers, employees, 
and other agents involved in accreditation activities) and any third-
party certification body (and its officers, employees, and other agents 
involved in auditing and certification activities) seeking accreditation 
from, or accredited by, such accreditation body; and
    (b) The capability to meet the applicable conflict of interest 
requirements of this subpart, if recognized.



Sec.  1.614  What quality assurance procedures must an accreditation
body have to qualify for recognition?

    An accreditation body seeking recognition must demonstrate that it 
has:
    (a) Implemented a written program for monitoring and evaluating the 
performance of its officers, employees, and other agents and its 
accreditation program, including procedures to:
    (1) Identify areas in its accreditation program or performance where 
deficiencies exist; and

[[Page 86]]

    (2) Quickly execute corrective actions that effectively address 
deficiencies when identified; and
    (b) The capability to meet the applicable quality assurance 
requirements of this subpart, if recognized.



Sec.  1.615  What records procedures must an accreditation body have
to qualify for recognition?

    An accreditation body seeking recognition must demonstrate that it 
has:
    (a) Implemented written procedures to establish, control, and retain 
records (including documents and data) for the period of time necessary 
to meet its contractual and legal obligations pertaining to this subpart 
and to provide an adequate basis for evaluating its program and 
performance; and
    (b) The capability to meet the applicable reporting and notification 
requirements of this subpart, if recognized.

 Requirements for Accreditation Bodies That Have Been Recognized Under 
                              This Subpart



Sec.  1.620  How must a recognized accreditation body evaluate 
third-party certification bodies seeking accreditation?

    (a) Prior to accrediting a third-party certification body under this 
subpart, a recognized accreditation body must perform, at a minimum, the 
following:
    (1) In the case of a foreign government or an agency of a foreign 
government, such reviews and audits of the government's or agency's food 
safety programs, systems, and standards as are necessary to determine 
that it meets the eligibility requirements of Sec.  1.640(b).
    (2) In the case of a foreign cooperative or any other third-party 
seeking accreditation as a third-party certification body, such reviews 
and audits of the training and qualifications of agents conducting 
audits for such cooperative or other third party (or in the case of a 
third-party certification body that is an individual, such individual) 
and such reviews of internal systems and any other investigation of the 
cooperative or other third party necessary to determine that it meets 
the eligibility requirements of Sec.  1.640(c).
    (3) In conducting a review and audit under paragraph (a)(1) or (2) 
of this section, an observation of a representative sample of onsite 
audits examining compliance with the applicable food safety requirements 
of the FD&C Act and FDA regulations as conducted by the third-party 
certification body or its agents (or, in the case of a third-party 
certification body that is an individual, such individual).
    (b) A recognized accreditation body must require a third-party 
certification body, as a condition of accreditation under this subpart, 
to comply with the reports and notification requirements of Sec. Sec.  
1.652 and 1.656 and to agree to submit to FDA, electronically and in 
English, any food or facility certifications it issues for purposes of 
sections 801(q) or 806 of the FD&C Act.
    (c) A recognized accreditation body must maintain records on any 
denial of accreditation (in whole or in part) and on any withdrawal, 
suspension, or reduction in scope of accreditation of a third-party 
certification body under this subpart. The records must include the name 
and contact information for the third-party certification body; the date 
of the action; the scope of accreditation denied, withdrawn, suspended, 
or reduced; and the basis for such action.
    (d) A recognized accreditation body must notify any third-party 
certification body of an adverse decision associated with its 
accreditation under this subpart, including denial of accreditation or 
the withdrawal, suspension, or reduction in the scope of its 
accreditation. The recognized accreditation body must establish and 
implement written procedures for receiving and addressing appeals from 
any third-party certification body challenging such an adverse decision 
and for investigating and deciding on appeals in a fair and meaningful 
manner. The appeals procedures must provide similar protections to those 
offered by FDA under Sec. Sec.  1.692 and 1.693, and include 
requirements to:
    (1) Make the appeals procedures publicly available;
    (2) Use competent persons, who may or may not be external to the 
recognized accreditation body, who are free from bias or prejudice and 
have not

[[Page 87]]

participated in the accreditation decision or be subordinate to a person 
who has participated in the accreditation decision to investigate and 
decide appeals;
    (3) Advise third-party certification bodies of the final decisions 
on their appeals; and
    (4) Maintain records under Sec.  1.625 of appeals, final decisions 
on appeals, and the bases for such decisions.



Sec.  1.621  How must a recognized accreditation body monitor the
performance of third-party certification bodies it accredited?

    (a) A recognized accreditation body must annually conduct a 
comprehensive assessment of the performance of each third-party 
certification body it accredited under this subpart by reviewing the 
accredited third-party certification body's self-assessments (including 
information on compliance with the conflict of interest requirements of 
Sec. Sec.  1.643 and 1.657); its regulatory audit reports and 
notifications submitted to FDA under Sec.  1.656; and any other 
information reasonably available to the recognized accreditation body 
regarding the compliance history of eligible entities the accredited 
third-party certification body certified under this subpart; or that is 
otherwise relevant to a determination whether the accredited third-party 
certification body is in compliance with this subpart.
    (b) No later than 1 year after the initial date of accreditation of 
the third-party certification body and every 2 years thereafter for 
duration of its accreditation under this subpart, a recognized 
accreditation body must conduct onsite observations of a representative 
sample of regulatory audits performed by the third-party certification 
body (or its audit agents) (or, in the case of a third-party 
certification body that is an individual, such individual) accredited 
under this subpart and must visit the accredited third-party 
certification body's headquarters (or other location that manages audit 
agents conducting food safety audits under this subpart, if different 
than its headquarters). The recognized accreditation body will consider 
the results of such observations and visits in the annual assessment of 
the accredited third-party certification body required by paragraph (a) 
of this section.



Sec.  1.622  How must a recognized accreditation body monitor its
own performance?

    (a) A recognized accreditation body must annually, and as required 
under Sec.  1.664(g), conduct a self-assessment that includes evaluation 
of compliance with this subpart, including:
    (1) The performance of its officers, employees, or other agents 
involved in accreditation activities and the degree of consistency in 
conducting accreditation activities;
    (2) The compliance of the recognized accreditation body and its 
officers, employees, and other agents involved in accreditation 
activities, with the conflict of interest requirements of Sec.  1.624; 
and
    (3) If requested by FDA, any other aspects of its performance 
relevant to a determination whether the recognized accreditation body is 
in compliance with this subpart.
    (b) As a means to evaluate the recognized accreditation body's 
performance, the self-assessment must include onsite observation of 
regulatory audits of a representative sample of third-party 
certification bodies it accredited under this subpart. In meeting this 
requirement, the recognized accreditation body may use the results of 
onsite observations performed under Sec.  1.621(b).
    (c) Based on the evaluations conducted under paragraphs (a) and (b) 
of this section, the recognized accreditation body must:
    (1) Identify any area(s) where deficiencies exist;
    (2) Quickly implement corrective action(s) that effectively address 
those deficiencies; and
    (3) Establish and maintain records of any such corrective action(s) 
under Sec.  1.625.
    (d) The recognized accreditation body must prepare, and as required 
by Sec.  1.623(b) submit, a written report of the results of its self-
assessment that includes the following elements. Documentation of 
conformance to ISO/IEC 17011:2004 may be used, supplemented as 
necessary, in meeting the requirements of this paragraph.

[[Page 88]]

    (1) A description of any corrective actions taken under paragraph 
(c) of this section;
    (2) A statement disclosing the extent to which the recognized 
accreditation body, and its officers, employees, and other agents 
involved in accreditation activities, complied with the conflict of 
interest requirements in Sec.  1.624; and
    (3) A statement attesting to the extent to which the recognized 
accreditation body complied with applicable requirements of this 
subpart.



Sec.  1.623  What reports and notifications must a recognized
accreditation body submit to FDA?

    (a) Reporting results of assessments of accredited third-party 
certification body performance. A recognized accreditation body must 
submit to FDA electronically, in English, a report of the results of any 
assessment conducted under Sec.  1.621, no later than 45 days after 
completing such assessment. The report must include an up-to-date list 
of any audit agents used by the accredited third-party certification 
body to conduct food safety audits under this subpart.
    (b) Reporting results of recognized accreditation body self-
assessments. A recognized accreditation body must submit to FDA 
electronically, in English:
    (1) A report of the results of an annual self-assessment required 
under Sec.  1.622, no later than 45 days after completing such self-
assessment; and
    (2) For a recognized accreditation body subject to Sec.  
1.664(g)(1), a report of such self-assessment to FDA within 60 days of 
the third-party certification body's withdrawal. A recognized 
accreditation body may use a report prepared for conformance to ISO/IEC 
17011:2004, supplemented as necessary, in meeting the requirements this 
section.
    (c) Immediate notification to FDA. A recognized accreditation body 
must notify FDA electronically, in English, immediately upon:
    (1) Granting (including expanding the scope of) accreditation to a 
third-party certification body under this subpart, and include:
    (i) The name, address, telephone number, and email address of the 
accredited third-party certification body;
    (ii) The name of one or more officers of the accredited third-party 
certification body;
    (iii) A list of the accredited third-party certification body's 
audit agents; and
    (iv) The scope of accreditation, the date on which it was granted, 
and its expiration date.
    (2) Withdrawing, suspending, or reducing the scope of an 
accreditation under this subpart, and include:
    (i) The basis for such action; and
    (ii) Any additional changes to accreditation information previously 
submitted to FDA under paragraph (c)(1) of this section.
    (3) Determining that a third-party certification body it accredited 
failed to comply with Sec.  1.653 in issuing a food or facility 
certification under this subpart, and include:
    (i) The basis for such determination; and
    (ii) Any changes to accreditation information previously submitted 
to FDA under paragraph (c)(1) of this section.
    (d) Other notification to FDA. A recognized accreditation body must 
notify FDA electronically, in English, within 30 days after:
    (1) Denying accreditation (in whole or in part) under this subpart 
and include:
    (i) The name, address, telephone number, and email address of the 
third-party certification body;
    (ii) The name of one or more officers of the third-party 
certification body;
    (iii) The scope of accreditation requested; and
    (iv) The scope and basis for such denial.
    (2) Making any significant change that would affect the manner in 
which it complies with the applicable requirements of this subpart and 
include:
    (i) A description of the change; and
    (ii) An explanation for the purpose of the change.



Sec.  1.624  How must a recognized accreditation body protect against
conflicts of interest?

    (a) A recognized accreditation body must implement a written program 
to protect against conflicts of interest between the recognized 
accreditation

[[Page 89]]

body (and its officers, employees, and other agents involved in 
accreditation activities) and any third-party certification body (and 
its officers, employees, and other agents involved in auditing and 
certification activities) seeking accreditation from, or accredited by, 
such recognized accreditation body, including the following:
    (1) Ensuring that the recognized accreditation body (and its 
officers, employees, or other agents involved in accreditation 
activities) does not own or have a financial interest in, manage, or 
otherwise control the third-party certification body (or any affiliate, 
parent, or subsidiary); and
    (2) Prohibiting officers, employees, or other agents involved in 
accreditation activities of the recognized accreditation body from 
accepting any money, gift, gratuity, or item of value from the third-
party certification body.
    (3) The items specified in paragraph (a)(2) of this section do not 
include:
    (i) Money representing payment of fees for accreditation services 
and reimbursement of direct costs associated with an onsite assessment 
of the third-party certification body; or
    (ii) Lunch of de minimis value provided during the course of an 
assessment and on the premises where the assessment is conducted, if 
necessary to facilitate the efficient conduct of the assessment.
    (b) A recognized accreditation body may accept the payment of fees 
for accreditation services and the reimbursement of direct costs 
associated with assessment of a certification body only after the date 
on which the report of such assessment was completed or the date of 
which the accreditation was issued, whichever comes later. Such payment 
is not considered a conflict of interest for purposes of paragraph (a) 
of this section.
    (c) The financial interests of the spouses and children younger than 
18 years of age of a recognized accreditation body's officers, 
employees, and other agents involved in accreditation activities will be 
considered the financial interests of such officers, employees, and 
other agents involved in accreditation activities.
    (d) A recognized accreditation body must maintain on its Web site an 
up-to-date list of the third-party certification bodies it accredited 
under this subpart and must identify the duration and scope of each 
accreditation and the date(s) on which the accredited third-party 
certification body paid any fee or reimbursement associated with such 
accreditation. If the accreditation of a certification body is 
suspended, withdrawn, or reduced in scope, this list must also include 
the date of suspension, withdrawal, or reduction in scope and maintain 
that information for the duration of accreditation or until the 
suspension is lifted, the certification body is reaccredited, or the 
scope of accreditation is reinstated, whichever comes first.



Sec.  1.625  What records requirements must an accreditation body
that has been recognized meet?

    (a) An accreditation body that has been recognized must maintain 
electronically for 5 years records created while it is recognized 
(including documents and data) demonstrating its compliance with this 
subpart, including records relating to:
    (1) Applications for accreditation and renewal of accreditation 
under Sec.  1.660;
    (2) Decisions to grant, deny, suspend, withdraw, or expand or reduce 
the scope of an accreditation;
    (3) Challenges to adverse accreditation decisions under Sec.  
1.620(c);
    (4) Its monitoring of accredited third-party certification bodies 
under Sec.  1.621;
    (5) Self-assessments and corrective actions under Sec.  1.622;
    (6) Regulatory audit reports, including any supporting information, 
that an accredited third-party certification body may have submitted;
    (7) Any reports or notifications to FDA under Sec.  1.623, including 
any supporting information; and
    (8) Records of fee payments and reimbursement of direct costs.
    (b) An accreditation body that has been recognized must make records 
required by paragraph (a) of this section available for inspection and 
copying promptly upon written request of an authorized FDA officer or 
employee at the place of business of the accreditation body or at a 
reasonably accessible location. If the records required by

[[Page 90]]

paragraph (a) of this section are requested by FDA electronically, the 
records must be submitted to FDA electronically not later than 10 
business days after the date of the request. Additionally, if the 
requested records are maintained in a language other than English, the 
accreditation body must electronically submit an English translation 
within a reasonable time.
    (c) An accreditation body that has been recognized must not prevent 
or interfere with FDA's access to its accredited third-party 
certification bodies and the accredited third-party certification body 
records required by Sec.  1.658.

  Procedures for Recognition of Accreditation Bodies Under This Subpart



Sec.  1.630  How do I apply to FDA for recognition or renewal of
recognition?

    (a) Applicant for recognition. An accreditation body seeking 
recognition must submit an application demonstrating that it meets the 
eligibility requirements in Sec.  1.610.
    (b) Applicant for renewal of recognition. An accreditation body 
seeking renewal of its accreditation must submit a renewal application 
demonstrating that it continues to meet the requirements of this 
subpart.
    (c) Submission. Recognition and renewal applications and any 
documents provided as part of the application process must be submitted 
electronically, in English. An applicant must provide any translation 
and interpretation services needed by FDA during the processing of the 
application, including during onsite assessments of the applicant by 
FDA.
    (d) Signature. Recognition and renewal applications must be signed 
in the manner designated by FDA, by an individual authorized to act on 
behalf of the applicant for purposes of seeking recognition or renewal 
of recognition.



Sec.  1.631  How will FDA review my application for recognition or
renewal of recognition and what happens once FDA decides on my 
application?

    (a) Review of recognition or renewal application. FDA will examine 
an accreditation body's recognition or renewal application for 
completeness and notify the applicant of any deficiencies. FDA will 
review an accreditation body's recognition or renewal application on a 
first in, first out basis according to the date on which the completed 
application was submitted; however, FDA may prioritize the review of 
specific applications to meet the needs of the program.
    (b) Evaluation of recognition or renewal. FDA will evaluate any 
completed recognition or renewal application to determine whether the 
applicant meets the applicable requirements of this subpart. Such 
evaluation may include an onsite assessment of the accreditation body. 
FDA will notify the applicant, in writing, regarding whether the 
application has been approved or denied. FDA may make such notification 
electronically. If FDA does not reach a final decision on a renewal 
application before an accreditation body's recognition terminates by 
expiration, FDA may extend such recognition for a specified period of 
time or until the Agency reaches a final decision on the renewal 
application.
    (c) Issuance of recognition. FDA will notify an applicant that its 
recognition or renewal application has been approved through issuance of 
recognition that will list any limitations associated with the 
recognition.
    (d) Issuance of denial of recognition or renewal application. FDA 
will notify an applicant that its recognition or renewal application has 
been denied through issuance of a denial of recognition or denial of a 
renewal application that will state the basis for such denial and 
provide the procedures for requesting reconsideration of the application 
under Sec.  1.691.
    (e) Notice of records custodian after denial of an application for 
renewal of recognition. An applicant whose renewal application was 
denied must notify FDA electronically, in English, within 10 business 
days of the date of issuance of a denial of a renewal application, of 
the name and contact information of the custodian who will maintain the 
records required by Sec.  1.625(a) and make them available to FDA as 
required by Sec.  1.625(b). The contact information for

[[Page 91]]

the custodian must include, at a minimum, an email address and the 
physical address where the records required by Sec.  1.625(a) will be 
located.
    (f) Effect of denial of an application for renewal of recognition of 
an accreditation body on accredited third-party certification bodies. 
(1) FDA will issue a notice of the denial of a recognition renewal to 
any third-party certification bodies accredited by the accreditation 
body whose renewal application was denied. The third-party certification 
body's accreditation will remain in effect so long as the third-party 
certification body:
    (i) No later than 60 days after FDA's issuance of the notice of the 
denial of recognition renewal, conducts a self-assessment under Sec.  
1.655 and reports the results of the self-assessment to FDA under Sec.  
1.656(b); and
    (ii) No later than 1 year after issuance of the notice of denial of 
recognition renewal or the original date of the expiration of the 
accreditation, whichever comes first, becomes accredited by another 
recognized accreditation body or by FDA through direct accreditation.
    (2) FDA may withdraw the accreditation of a third-party 
certification body whenever FDA determines there is good cause for 
withdrawal of accreditation under Sec.  1.664(c).
    (g) Effect of denial of an application for renewal of recognition of 
an accreditation body on food or facility certifications issued to 
eligible entities. A food or facility certification issued by a third-
party certification body accredited by a recognized accreditation body 
prior to issuance of a denial of the renewal application will remain in 
effect until the certification expires. If FDA has reason to believe 
that a certification issued for purposes of section 801(q) or 806 of the 
FD&C Act is not valid or reliable, FDA may refuse to consider the 
certification in determining the admissibility of the article of food 
for which the certification was offered or in determining the importer's 
eligibility for participation in the voluntary qualified importer 
program (VQIP).
    (h) Public notice of denial of an application for renewal of 
recognition of an accreditation body. FDA will provide notice on the Web 
site described in Sec.  1.690 of the date of issuance of a denial of a 
renewal application and will describe the basis for the denial.



Sec.  1.632  What is the duration of recognition?

    FDA may grant recognition of an accreditation body for a period not 
to exceed 5 years from the date of recognition.



Sec.  1.633  How will FDA monitor recognized accreditation bodies?

    (a) FDA will evaluate the performance of each recognized 
accreditation body to determine its compliance with the applicable 
requirements of this subpart. Such assessment must occur by at least 4 
years after the date of recognition for a 5-year recognition period, or 
by no later than the mid-term point for a recognition period of less 
than 5 years. FDA may conduct additional assessments of a recognized 
accreditation body at any time.
    (b) An FDA assessment of a recognized accreditation body may include 
onsite assessments of a representative sample of third-party 
certification bodies the recognized accreditation body accredited and 
onsite audits of a representative sample of eligible entities certified 
by such third-party certification bodies under this subpart. These may 
be conducted at any time and, as FDA determines necessary or 
appropriate, may occur without the recognized accreditation body or, in 
the case of an audit of an eligible entity, the accredited third-party 
certification body present.



Sec.  1.634  When will FDA revoke recognition?

    (a) Grounds for revocation of recognition. FDA will revoke the 
recognition of an accreditation body found not to be in compliance with 
the requirements of this subpart, including for any one or more of the 
following:
    (1) Refusal by the accreditation body to allow FDA to access records 
required by Sec.  1.625, or to conduct an assessment or investigation of 
the accreditation body or of a third-party certification body it 
accredited to ensure the accreditation body's continued compliance with 
the requirements of this subpart.

[[Page 92]]

    (2) Failure to take timely and necessary corrective action when:
    (i) The accreditation of a third-party certification body it 
accredited is withdrawn by FDA under Sec.  1.664(a);
    (ii) A significant deficiency is identified through self-assessment 
under Sec.  1.622, monitoring under Sec.  1.621, or self-assessment by 
one or more of its accredited third-party certification bodies under 
Sec.  1.655; or
    (iii) Directed to do so by FDA to ensure compliance with this 
subpart.
    (3) A determination by FDA that the accreditation body has committed 
fraud or has submitted material false statements to the Agency.
    (4) A determination by FDA that there is otherwise good cause for 
revocation, including:
    (i) Demonstrated bias or lack of objectivity when conducting 
activities under this subpart; or
    (ii) Failure to adequately support one or more decisions to grant 
accreditation under this subpart.
    (iii) Failure to pay the annual user fee within 90 days of the 
payment due date, as specified in Sec.  1.725(b)(3).
    (b) Records request associated with revocation. To assist in 
determining whether revocation is warranted under paragraph (a) of this 
section, FDA may request records of the accreditation body required by 
Sec.  1.625 or the records, required by Sec.  1.658, of one or more of 
the third-party certification bodies it accredited under this subpart.
    (c) Issuance of revocation of recognition. (1) FDA will notify an 
accreditation body that its recognition has been revoked through 
issuance of a revocation that will state the grounds for revocation, the 
procedures for requesting a regulatory hearing under Sec.  1.693 on the 
revocation, and the procedures for requesting reinstatement of 
recognition under Sec.  1.636.
    (2) Within 10 business days of the date of issuance of the 
revocation, the accreditation body must notify FDA electronically, in 
English, of the name of the custodian who will maintain the records and 
make them available to FDA as required by Sec.  1.625. The contact 
information for the custodian must provide, at a minimum, an email 
address and the physical address where the records will be located.
    (d) Effect of revocation of recognition of an accreditation body on 
accredited third-party certification bodies. (1) FDA will issue a notice 
of the revocation of recognition to any accredited third-party 
certification body accredited by the accreditation body whose 
recognition was revoked. The third-party certification body's 
accreditation will remain in effect if the third-party certification 
body:
    (i) No later than 60 days after FDA's issuance of the notice of 
revocation, conducts a self-assessment under Sec.  1.655 and reports the 
results of the self-assessment to FDA under Sec.  1.656(b); and
    (ii) No later than 1 year after issuance of the notice of the 
revocation, or the original date of expiration of the accreditation, 
whichever comes first, becomes accredited by another recognized 
accreditation body or by FDA through direct accreditation.
    (2) FDA may withdraw the accreditation of a third-party 
certification body whenever FDA determines there is good cause for 
withdrawal of accreditation under Sec.  1.664(c).
    (e) Effect of revocation of recognition of an accreditation body on 
food or facility certifications issued to eligible entities. A food or 
facility certification issued by a third-party certification body 
accredited by a recognized accreditation body prior to issuance of the 
revocation of recognition will remain in effect until the certificate 
terminates by expiration. If FDA has reason to believe that a 
certification issued for purposes of section 801(q) or 806 of the FD&C 
Act is not valid or reliable, FDA may refuse to consider the 
certification in determining the admissibility of the article of food 
for which the certification was offered or in determining the importer's 
eligibility for participation in VQIP.
    (f) Public notice of revocation of recognition. FDA will provide 
notice on the Web site described in Sec.  1.690 of the issuance of the 
revocation of recognition of an accreditation body and will describe the 
basis for revocation.

[80 FR 74650, Nov. 27, 2015, as amended at 81 FR 90193, Dec. 14, 2016]

[[Page 93]]



Sec.  1.635  What if I want to voluntarily relinquish recognition or
do not want to renew recognition?

    (a) Notice to FDA of intent to relinquish or not to renew 
recognition. A recognized accreditation body must notify FDA 
electronically, in English, at least 60 days before voluntarily 
relinquishing recognition or before allowing recognition to expire 
without seeking renewal. The recognized accreditation body must provide 
the name and contact information of the custodian who will maintain the 
records required under Sec.  1.625(a) after the date of relinquishment 
or the date recognition expires, as applicable, and make them available 
to FDA as required by Sec.  1.625(b). The contact information for the 
custodian must include, at a minimum, an email address and the physical 
address where the records required by Sec.  1.625(a) will be located.
    (b) Notice to accredited third-party certification bodies of intent 
to relinquish or not to renew recognition. No later than 15 business 
days after notifying FDA under paragraph (a) of this section, the 
recognized accreditation body must notify any currently accredited 
third-party certification body that it intends to relinquish recognition 
or to allow its recognition to expire, specifying the date on which 
relinquishment or expiration will occur. The recognized accreditation 
body must establish and maintain records of such notification under 
Sec.  1.625.
    (c)(1) Effect of voluntary relinquishment or expiration of 
recognition on third-party certification bodies. The accreditation of a 
third-party certification body issued prior to the relinquishment or 
expiration of its accreditation body's recognition will remain in 
effect, so long as the third-party certification body:
    (i) No later than 60 days after the date of relinquishment or the 
date of expiration of the recognition, conducts a self-assessment under 
Sec.  1.655 and reports the results of the self-assessment to FDA under 
Sec.  1.656(b); and
    (ii) No later than 1 year after the date of relinquishment or the 
date of expiration of recognition, or the original date of the 
expiration of the accreditation, whichever comes first, becomes 
accredited by another recognized accreditation body or by FDA through 
direct accreditation.
    (2) FDA may withdraw the accreditation of a third-party 
certification body whenever FDA determines there is good cause for 
withdrawal of accreditation under Sec.  1.664(c).
    (d) Effect of voluntary relinquishment or expiration of recognition 
of an accreditation body on food or facility certifications issued to 
eligible entities. A food or facility certification issued by a third-
party certification body accredited by a recognized accreditation body 
prior to relinquishment or expiration of its recognition will remain in 
effect until the certification expires. If FDA has reason to believe 
that a certification issued for purposes of section 801(q) or 806 of the 
FD&C Act is not valid or reliable, FDA may refuse to consider the 
certification in determining the admissibility of the article of food 
for which the certification was offered or in determining the importer's 
eligibility for participation in VQIP.
    (e) Public notice of voluntary relinquishment or expiration of 
recognition. FDA will provide notice on the Web site described in Sec.  
1.690 of the voluntary relinquishment or expiration of recognition of an 
accreditation body under this subpart.



Sec.  1.636  How do I request reinstatement of recognition?

    (a) Application following revocation. An accreditation body that has 
had its recognition revoked may seek reinstatement by submitting a new 
application for recognition under Sec.  1.630. The accreditation body 
must submit evidence that the grounds for revocation have been resolved, 
including evidence addressing the cause or conditions that were the 
basis for revocation and identifying measures that have been implemented 
to help ensure that such cause(s) or condition(s) are unlikely to recur.
    (b) Application following relinquishment. An accreditation body that 
previously relinquished its recognition under Sec.  1.635 may seek 
recognition by submitting a new application for recognition under Sec.  
1.630.

[[Page 94]]

  Accreditation of Third-Party Certification Bodies Under This Subpart



Sec.  1.640  Who is eligible to seek accreditation?

    (a) A foreign government, agency of a foreign government, foreign 
cooperative, or any other third party may seek accreditation from a 
recognized accreditation body (or, where direct accreditation is 
appropriate, FDA) to conduct food safety audits and to issue food and 
facility certifications to eligible entities under this subpart. An 
accredited third-party certification body may use documentation of 
conformance with ISO/IEC 17021: 2011 or ISO/IEC 17065: 2012, 
supplemented as necessary, in meeting the applicable requirements of 
this subpart.
    (b) A foreign government or an agency of a foreign government is 
eligible for accreditation if it can demonstrate that its food safety 
programs, systems, and standards meet the requirements of Sec. Sec.  
1.641 through 1.645.
    (c) A foreign cooperative or other third party is eligible for 
accreditation if it can demonstrate that the training and qualifications 
of its agents used to conduct audits (or, in the case of a third-party 
certification body that is an individual, such individual) and its 
internal systems and standards meet the requirements of Sec. Sec.  1.641 
through 1.645.



Sec.  1.641  What legal authority must a third-party certification body
have to qualify for accreditation?

    (a) A third-party certification body seeking accreditation from a 
recognized accreditation body or from FDA must demonstrate that it has 
the authority (as a governmental entity or as a legal entity with 
contractual rights) to perform such examinations of facilities, their 
process(es), and food(s) as are necessary to determine compliance with 
the applicable food safety requirements of the FD&C Act and FDA 
regulations, and conformance with applicable industry standards and 
practices and to issue certifications where appropriate based on a 
review of the findings of such examinations. This includes authority to:
    (1) Review any relevant records;
    (2) Conduct onsite audits of an eligible entity; and
    (3) Suspend or withdraw certification for failure to comply with 
applicable requirements.
    (b) A third-party certification body seeking accreditation must 
demonstrate that it is capable of exerting the authority (as a 
governmental entity or as legal entity with contractual rights) 
necessary to meet the applicable requirements of accreditation under 
this subpart if accredited.



Sec.  1.642  What competency and capacity must a third-party certification
body have to qualify for accreditation?

    A third-party certification body seeking accreditation must 
demonstrate that it has:
    (a) The resources necessary to fully implement its certification 
program, including:
    (1) Adequate numbers of employees and other agents with relevant 
knowledge, skills, and experience to effectively examine for compliance 
with applicable FDA food safety requirements of the FD&C Act and FDA 
regulations, conformance with applicable industry standards and 
practices, and issuance of valid and reliable certifications; and
    (2) Adequate financial resources for its operations; and
    (b) The competency and capacity to meet the applicable requirements 
of this subpart, if accredited.



Sec.  1.643  What protections against conflicts of interest must a 
third-party certification body have to qualify for accreditation?

    A third-party certification body must demonstrate that it has:
    (a) Implemented written measures to protect against conflicts of 
interest between the third-party certification body (and its officers, 
employees, and other agents involved in auditing and certification 
activities) and clients seeking examinations or certification from, or 
audited or certified by, such third-party certification body; and
    (b) The capability to meet the conflict of interest requirements in 
Sec.  1.657, if accredited.

[[Page 95]]



Sec.  1.644  What quality assurance procedures must a third-party
certification body have to qualify for accreditation?

    A third-party certification body seeking accreditation must 
demonstrate that it has:
    (a) Implemented a written program for monitoring and evaluating the 
performance of its officers, employees, and other agents involved in 
auditing and certification activities, including procedures to:
    (1) Identify deficiencies in its auditing and certification program 
or performance; and
    (2) Quickly execute corrective actions that effectively address any 
identified deficiencies; and
    (b) The capability to meet the quality assurance requirements of 
Sec.  1.655, if accredited.



Sec.  1.645  What records procedures must a third-party certification 
body have to qualify for accreditation?

    A third-party certification body seeking accreditation must 
demonstrate that it:
    (a) Implemented written procedures to establish, control, and retain 
records (including documents and data) for a period of time necessary to 
meet its contractual and legal obligations and to provide an adequate 
basis for evaluating its program and performance; and
    (b) Is capable of meeting the reporting, notification, and records 
requirements of this subpart, if accredited.

    Requirements for Third-Party Certification Bodies That Have Been 
                      Accredited Under This Subpart



Sec.  1.650  How must an accredited third-party certification body
ensure its audit agents are competent and objective?

    (a) An accredited third-party certification body that uses audit 
agents to conduct food safety audits must ensure that each such audit 
agent meets the following requirements with respect to the scope of its 
accreditation under this subpart. If the accredited third-party 
certification body is an individual, that individual is also subject to 
the following requirements, as applicable:
    (1) Has relevant knowledge and experience that provides an adequate 
basis for the audit agent to evaluate compliance with applicable food 
safety requirements of the FD&C Act and FDA regulations and, for 
consultative audits, also includes conformance with applicable industry 
standards and practices;
    (2) Has been determined by the accredited third-party certification 
body, through observations of a representative sample of audits, to be 
competent to conduct food safety audits under this subpart relevant to 
the audits they will be assigned to perform;
    (3) Has completed annual food safety training that is relevant to 
activities conducted under this subpart;
    (4) Is in compliance with the conflict of interest requirements of 
Sec.  1.657 and has no other conflicts of interest with the eligible 
entity to be audited that might impair the audit agent's objectivity; 
and
    (5) Agrees to notify its accredited third-party certification body 
immediately upon discovering, during a food safety audit, any condition 
that could cause or contribute to a serious risk to the public health.
    (b) In assigning an audit agent to conduct a food safety audit at a 
particular eligible entity, an accredited third-party certification body 
must determine that the audit agent is qualified to conduct such audit 
under the criteria established in paragraph (a) of this section and 
based on the scope and purpose of the audit and the type of facility, 
its process(es), and food.
    (c) An accredited third-party certification body cannot use an audit 
agent to conduct a regulatory audit at an eligible entity if such audit 
agent conducted a consultative audit or regulatory audit for the same 
eligible entity in the preceding 13 months, except that such limitation 
may be waived if the accredited third-party certification body 
demonstrates to FDA, under Sec.  1.663, there is insufficient access to 
audit agents in the country or region where the eligible entity is 
located. If the accredited third-party certification body is an 
individual, that individual is also subject to such limitations.

[[Page 96]]



Sec.  1.651  How must an accredited third-party certification body
conduct a food safety audit of an eligible entity?

    (a) Audit planning. Before beginning to conduct a food safety audit 
under this subpart, an accredited third-party certification body must:
    (1) Require the eligible entity seeking a food safety audit to:
    (i) Identify the scope and purpose of the food safety audit, 
including the facility, process(es), or food to be audited; whether the 
food safety audit is to be conducted as a consultative or regulatory 
audit subject to the requirements of this subpart, and if a regulatory 
audit, the type(s) of certification(s) sought; and
    (ii) Provide a 30-day operating schedule for such facility that 
includes information relevant to the scope and purpose of the audit; and
    (2) Determine whether the requested audit is within its scope of 
accreditation.
    (b) Authority to audit. In arranging a food safety audit with an 
eligible entity under this subpart, an accredited third-party 
certification body must ensure it has authority, whether contractual or 
otherwise, to:
    (1) Conduct an unannounced audit to determine whether the facility, 
process(es), and food of the eligible entity (within the scope of the 
audit) comply with the applicable food safety requirements of the FD&C 
Act and FDA regulations and, for consultative audits, also includes 
conformance with applicable industry standards and practices;
    (2) Access any records and any area of the facility, process(es), 
and food of the eligible entity relevant to the scope and purpose of 
such audit;
    (3) When, for a regulatory audit, sampling and analysis is 
conducted, the accredited third-party certification body must use a 
laboratory that is accredited in accordance with:
    (i) ISO/IEC 17025:2005; or
    (ii) Another laboratory accreditation standard that provides at 
least a similar level of assurance in the validity and reliability of 
sampling methodologies, analytical methodologies, and analytical 
results.
    (4) Notify FDA immediately if, at any time during a food safety 
audit, the accredited third-party certification body (or its audit 
agent, where applicable) discovers a condition that could cause or 
contribute to a serious risk to the public health and provide 
information required by Sec.  1.656(c);
    (5) Prepare reports of audits conducted under this subpart as 
follows:
    (i) For consultative audits, prepare reports that contain the 
elements specified in Sec.  1.652(a) and maintain such records, subject 
to FDA access in accordance with section 414 of the FD&C Act; and
    (ii) For regulatory audits, prepare reports that contain the 
elements specified in Sec.  1.652(b) and submit them to FDA and to its 
recognized accreditation body (where applicable) under Sec.  1.656(a); 
and
    (6) Allow FDA and the recognized accreditation body that accredited 
such third-party certification body, if any, to observe any food safety 
audit conducted under this subpart for purposes of evaluating the 
accredited third-party certification body's performance under Sec. Sec.  
1.621 and 1.662 or, where appropriate, the recognized accreditation 
body's performance under Sec. Sec.  1.622 and 1.633.
    (c) Audit protocols. An accredited third-party certification body 
(or its audit agent, where applicable) must conduct a food safety audit 
in a manner consistent with the identified scope and purpose of the 
audit and within the scope of its accreditation.
    (1) With the exception of records review, which may be scheduled, 
the audit must be conducted without announcement during the 30-day 
timeframe identified under paragraph (a)(1)(ii) of this section and must 
be focused on determining whether the facility, its process(es), and 
food are in compliance with applicable food safety requirements of the 
FD&C Act and FDA regulations, and, for consultative audits, also 
includes conformance with applicable industry standards and practices 
that are within the scope of the audit.
    (2) The audit must include records review prior to the onsite 
examination; an onsite examination of the facility, its process(es), and 
the food that results from such process(es); and where appropriate or 
when required by FDA,

[[Page 97]]

environmental or product sampling and analysis. When, for a regulatory 
audit, sampling and analysis is conducted, the accredited third-party 
certification body must use a laboratory that is accredited in 
accordance with paragraph (b)(3) of this section. The audit may include 
any other activities necessary to determine compliance with applicable 
food safety requirements of the FD&C Act and FDA regulations, and, for 
consultative audits, also includes conformance with applicable industry 
standards and practices.
    (3) The audit must be sufficiently rigorous to allow the accredited 
third-party certification body to determine whether the eligible entity 
is in compliance with the applicable food safety requirements of the 
FD&C Act and FDA regulations, and for consultative audits, also includes 
conformance with applicable industry standards and practices, at the 
time of the audit; and for a regulatory audit, whether the eligible 
entity, given its food safety system and practices would be likely to 
remain in compliance with the applicable food safety requirements of the 
FD&C Act and FDA regulations for the duration of any certification 
issued under this subpart. An accredited third-party certification body 
(or its audit agent, where applicable) that identifies a deficiency 
requiring corrective action may verify the effectiveness of a corrective 
action once implemented by the eligible entity but must not recommend or 
provide input to the eligible entity in identifying, selecting, or 
implementing the corrective action.
    (4) Audit observations and other data and information from the 
examination, including information on corrective actions, must be 
documented and must be used to support the findings contained in the 
audit report required by Sec.  1.652 and maintained as a record under 
Sec.  1.658.



Sec.  1.652  What must an accredited third-party certification body
include in food safety audit reports?

    (a) Consultative audits. An accredited third-party certification 
body must prepare a report of a consultative audit not later than 45 
days after completing such audit and must provide a copy of such report 
to the eligible entity and must maintain such report under Sec.  1.658, 
subject to FDA access in accordance with the requirements of section 414 
of the FD&C Act. A consultative audit report must include:
    (1) The identity of the site or location where the consultative 
audit was conducted, including:
    (i) The name, address and the FDA Establishment Identifier of the 
facility subject to the consultative audit and a unique facility 
identifier, if designated by FDA; and
    (ii) Where applicable, the FDA registration number assigned to the 
facility under subpart H of this part;
    (2) The identity of the eligible entity, if different from the 
facility, including the name, address, the FDA Establishment Identifier 
and unique facility identifier, if designated by FDA, and, where 
applicable, registration number under subpart H of this part;
    (3) The name(s) and telephone number(s) of the person(s) responsible 
for compliance with the applicable food safety requirements of the FD&C 
Act and FDA regulations
    (4) The dates and scope of the consultative audit;
    (5) The process(es) and food(s) observed during such consultative 
audit; and
    (6) Any deficiencies observed that relate to or may influence a 
determination of compliance with the applicable food safety requirements 
of the FD&C Act and FDA regulations that require corrective action, the 
corrective action plan, and the date on which such corrective actions 
were completed. Such consultative audit report must be maintained as a 
record under Sec.  1.658 and must be made available to FDA in accordance 
with section 414 of the FD&C Act.
    (b) Regulatory audits. An accredited third-party certification body 
must, no later than 45 days after completing a regulatory audit, prepare 
and submit electronically, in English, to FDA and to its recognized 
accreditation body (or, in the case of direct accreditation, only to 
FDA) and must provide to the eligible entity a report of such regulatory 
audit that includes the following information:

[[Page 98]]

    (1) The identity of the site or location where the regulatory audit 
was conducted, including:
    (i) The name, address, and FDA Establishment Identifier of the 
facility subject to the regulatory audit and a unique facility 
identifier, if designated by FDA; and
    (ii) Where applicable, the FDA registration number assigned to the 
facility under subpart H of this part;
    (2) The identity of the eligible entity, if different from the 
facility, including the name, address, FDA Establishment Identifier, and 
unique facility identifier, if designated by FDA, and, where applicable, 
registration number under subpart H of this part;
    (3) The dates and scope of the regulatory audit;
    (4) The process(es) and food(s) observed during such regulatory 
audit;
    (5) The name(s) and telephone number(s) of the person(s) responsible 
for the facility's compliance with the applicable food safety 
requirements of the FD&C Act and FDA regulations;
    (6) Any deficiencies observed during the regulatory audit that 
present a reasonable probability that the use of or exposure to a 
violative product:
    (i) Will cause serious adverse health consequences or death to 
humans and animals; or
    (ii) May cause temporary or medically reversible adverse health 
consequences or where the probability of serious adverse health 
consequences or death to humans or animals is remote;
    (7) The corrective action plan for addressing each deficiency 
identified under paragraph (b)(6) of this section, unless corrective 
action was implemented immediately and verified onsite by the accredited 
third-party certification body (or its audit agent, where applicable);
    (8) Whether any sampling and laboratory analysis (e.g., under a 
microbiological sampling plan) is performed in or used by the facility; 
and
    (9) Whether the eligible entity has made significant changes to the 
facility, its process(es), or food products during the 2 years preceding 
the regulatory audit.
    (c) Submission of regulatory audit report. An accredited third-party 
certification body must submit a completed regulatory audit report as 
required by paragraph (b) of this section, regardless of whether the 
certification body issued a food or facility certification to the 
eligible entity.
    (d) Notice and appeals of adverse regulatory audit results. An 
accredited third-party certification body must notify an eligible entity 
of a denial of certification and must establish and implement written 
procedures for receiving and addressing appeals from eligible entities 
challenging such adverse regulatory audit results and for investigating 
and deciding on appeals in a fair and meaningful manner. The appeals 
procedures must provide similar protections to those offered by FDA 
under Sec. Sec.  1.692 and 1.693, including requirements to:
    (1) Make the appeals procedures publicly available;
    (2) Use competent persons, who may or may not be external to the 
accredited third-party certification body, who are free from bias or 
prejudice and have not participated in the certification decision or be 
subordinate to a person who has participated in the certification 
decision, to investigate and decide appeals;
    (3) Advise the eligible entity of the final decision on its appeal; 
and
    (4) Maintain records under Sec.  1.658 of the appeal, the final 
decision, and the basis for such decision.



Sec.  1.653  What must an accredited third-party certification body
do when issuing food or facility certifications?

    (a) Basis for issuance of a food or facility certification. (1) 
Prior to issuing a food or facility certification to an eligible entity, 
an accredited third-party certification body (or, where applicable, an 
audit agent on its behalf) must complete a regulatory audit that meets 
the requirements of Sec.  1.651 and any other activities that may be 
necessary to determine compliance with the applicable food safety 
requirements of the FD&C Act and FDA regulations.
    (2) If, as a result of an observation during a regulatory audit, an 
eligible entity must implement a corrective action plan to address a 
deficiency, an accredited third-party certification body

[[Page 99]]

may not issue a food or facility certification to such entity until 
after the accredited third-party certification body verifies that 
eligible entity has implemented the corrective action plan through 
methods that reliably verify the corrective action was taken and as a 
result the identified deficiency is unlikely to recur, except onsite 
verification is required for corrective actions required to address 
deficiencies that are the subject of a notification under Sec.  
1.656(c).
    (3) An accredited third-party certification body must consider each 
observation and the data and other information from a regulatory audit 
and other activities conducted under Sec.  1.651 to determine whether 
the entity was in compliance with the applicable food safety 
requirements of the FD&C Act and FDA regulations at the time of the 
audit and whether the eligible entity, given its food safety system and 
practices, would be likely to remain in compliance for the duration of 
any certification issued under this subpart.
    (4) A single regulatory audit may result in issuance of one or more 
food or facility certifications under this subpart, provided that the 
requirements of issuance are met as to each such certification.
    (5) Where an accredited third-party certification body uses an audit 
agent to conduct a regulatory audit of an eligible entity under this 
subpart, the accredited third-party certification body (and not the 
audit agent) must make the determination whether to issue a food or 
facility certification based on the results of such regulatory audit.
    (b) Issuance of a food or facility certification and submission to 
FDA. (1) Any food or facility certification issued under this subpart 
must be submitted to FDA electronically and in English. The accredited 
third-party certification body may issue a food or facility 
certification under this subpart for a term of up to 12 months.
    (2) A food or facility certification must contain, at a minimum, the 
following elements:
    (i) The name and address of the accredited third-party certification 
body and the scope and date of its accreditation under this subpart;
    (ii) The name, address, FDA Establishment Identifier, and unique 
facility identifier, if designated by FDA, of the eligible entity to 
which the food or facility certification was issued;
    (iii) The name, address, FDA Establishment Identifier, and unique 
facility identifier, if designated by FDA, of the facility where the 
regulatory audit was conducted, if different than the eligible entity;
    (iv) The scope and date(s) of the regulatory audit and the 
certification number;
    (v) The name of the audit agent(s) (where applicable) conducting the 
regulatory audit; and
    (vi) The scope of the food or facility certification, date of 
issuance, and date of expiration.
    (3) FDA may refuse to accept any certification for purposes of 
section 801(q) or 806 of the FD&C Act, if FDA determines, that such food 
or facility certification is not valid or reliable because, for example:
    (i) The certification is offered in support of the admissibility of 
a food that was not within the scope of the certification;
    (ii) The certification was issued by an accredited third-party 
certification body acting outside the scope of its accreditation under 
this subpart; or
    (iii) The certification was issued without reliable demonstration 
that the requirements of paragraph (a) of this section were met.



Sec.  1.654  When must an accredited third-party certification body
monitor an eligible entity that it has issued a food or facility
certification?

    If an accredited third-party certification body has reason to 
believe that an eligible entity to which it issued a food or facility 
certification may no longer be in compliance with the applicable food 
safety requirements of the FD&C Act and FDA regulations, the accredited 
third-party certification body must conduct any monitoring (including an 
onsite audit) of such eligible entity necessary to determine whether the 
entity is in compliance with such requirements. The accredited third-
party certification body must immediately notify FDA, under Sec.  
1.656(d), if

[[Page 100]]

it withdraws or suspends a food or facility certification because it 
determines that the entity is no longer in compliance with the 
applicable food safety requirements of the FD&C Act and FDA regulations. 
The accredited third-party certification body must maintain records of 
such monitoring under Sec.  1.658.



Sec.  1.655  How must an accredited third-party certification body 
monitor its own performance?

    (a) An accredited third-party certification body must annually, upon 
FDA request made for cause, or as required under Sec.  1.631(f)(1)(i), 
Sec.  1.634(d)(1)(i), or Sec.  1.635(c)(1)(i), conduct a self-assessment 
that includes evaluation of compliance with this subpart, including:
    (1) The performance of its officers, employees, or other agents 
involved in auditing and certification activities, including the 
performance of audit agents in examining facilities, process(es), and 
food using the applicable food safety requirements of the FD&C Act and 
FDA regulations;
    (2) The degree of consistency among its officers, employees, or 
other agents involved in auditing and certification activities, 
including evaluating whether its audit agents interpreted audit 
protocols in a consistent manner;
    (3) The compliance of the accredited third-party certification body 
and its officers, employees, and other agents involved in auditing and 
certification activities, with the conflict of interest requirements of 
Sec.  1.657;
    (4) Actions taken in response to the results of any assessments 
conducted by FDA or, where applicable, the recognized accreditation body 
under Sec.  1.621; and
    (5) As requested by FDA, any other aspects of its performance 
relevant to a determination of whether the accredited third-party 
certification body is in compliance with this subpart.
    (b) As a means to assess its performance, the accredited third-party 
certification body may evaluate the compliance of one or more of 
eligible entities to which a food or facility certification was issued 
under this subpart.
    (c) Based on the assessments and evaluations conducted under 
paragraphs (a) and (b) of this section, the accredited third-party 
certification body must:
    (1) Identify any deficiencies in complying with the requirements of 
this subpart;
    (2) Quickly implement corrective action(s) that effectively address 
the identified deficiencies; and
    (3) Under Sec.  1.658, establish and maintain records of such 
corrective action(s).
    (d) The accredited third-party certification body must prepare a 
written report of the results of its self-assessment that includes:
    (1) A description of any corrective action(s) taken under paragraph 
(c) of this section;
    (2) A statement disclosing the extent to which the accredited third-
party certification body, and its officers, employees, and other agents 
involved in auditing and certification activities, complied with the 
conflict of interest requirements in Sec.  1.657; and
    (3) A statement attesting to the extent to which the accredited 
third-party certification body complied with the applicable requirements 
of this subpart.
    (e) An accredited third-party certification body may use a report, 
supplemented as necessary, on its conformance to ISO/IEC 17021: 2011 or 
ISO/IEC 17065: 2012 in meeting the requirements of this section.



Sec.  1.656  What reports and notifications must an accredited
third-party certification body submit?

    (a) Reporting results of regulatory audits. An accredited third-
party certification body must submit a regulatory audit report, as 
described in Sec.  1.652(b), electronically, in English, to FDA and to 
the recognized accreditation body that granted its accreditation (where 
applicable), no later than 45 days after completing such audit.
    (b) Reporting results of accredited third-party certification body 
self-assessments. An accredited third-party certification body must 
submit the report of its annual self-assessment required by Sec.  1.655 
electronically to its recognized accreditation body (or, in the case of 
direct accreditation, electronically and in English, to FDA), within 45 
days of the anniversary date of its accreditation

[[Page 101]]

under this subpart. For an accredited third-party certification body 
subject to an FDA request for cause, or Sec.  1.631(f)(1)(i), Sec.  
1.634(d)(1)(i), or Sec.  1.635(c)(1)(i), the report of its self-
assessment must be submitted to FDA electronically, in English, within 
60 days of the FDA request, denial of renewal, revocation, or 
relinquishment of recognition of the accreditation body that granted its 
accreditation. Such report must include an up-to-date list of any audit 
agents it uses to conduct audits under this subpart.
    (c) Notification to FDA of a serious risk to public health. An 
accredited third-party certification body must immediately notify FDA 
electronically, in English, if during a regulatory or consultative 
audit, any of its audit agents or the accredited third-party 
certification body itself discovers a condition that could cause or 
contribute to a serious risk to the public health, providing the 
following information:
    (1) The name, physical address, and unique facility identifier, if 
designated by FDA, of the eligible entity subject to the audit, and, 
where applicable, the registration number under subpart H of this part;
    (2) The name, physical address, and unique facility identifier, if 
designated by FDA, of the facility where the condition was discovered 
(if different from that of the eligible entity) and, where applicable, 
the registration number assigned to the facility under subpart H of this 
part; and
    (3) The condition for which notification is submitted.
    (d) Immediate notification to FDA of withdrawal or suspension of a 
food or facility certification. An accredited third-party certification 
body must notify FDA electronically, in English, immediately upon 
withdrawing or suspending any food or facility certification of an 
eligible entity and the basis for such action.
    (e) Notification to its recognized accreditation body or an eligible 
entity. (1) After notifying FDA under paragraph (c) of this section, an 
accredited third-party certification body must immediately notify the 
eligible entity of such condition and must immediately thereafter notify 
the recognized accreditation body that granted its accreditation, except 
for third-party certification bodies directly accredited by FDA. Where 
feasible and reliable, the accredited third-party certification body may 
contemporaneously notify its recognized accreditation body and/or the 
eligible entity when notifying FDA.
    (2) An accredited third-party certification body must notify its 
recognized accreditation body (or, in the case of direct accreditation, 
FDA) electronically, in English, within 30 days after making any 
significant change that would affect the manner in which it complies 
with the requirements of this subpart and must include with such 
notification the following information:
    (i) A description of the change; and
    (ii) An explanation for the purpose of the change.



Sec.  1.657  How must an accredited third-party certification body
protect against conflicts of interest?

    (a) An accredited third-party certification body must implement a 
written program to protect against conflicts of interest between the 
accredited third-party certification body (and its officers, employees, 
and other agents involved in auditing and certification activities) and 
an eligible entity seeking a food safety audit or food or facility 
certification from, or audited or certified by, such accredited third-
party certification body, including the following:
    (1) Ensuring that the accredited third-party certification body and 
its officers, employees, or other agents involved in auditing and 
certification activities do not own, operate, have a financial interest 
in, manage, or otherwise control an eligible entity to be certified, or 
any affiliate, parent, or subsidiary of the entity;
    (2) Ensuring that the accredited third-party certification body and, 
its officers, employees, or other agents involved in auditing and 
certification activities are not owned, managed, or controlled by any 
person that owns or operates an eligible entity to be certified;
    (3) Ensuring that an audit agent of the accredited third-party 
certification

[[Page 102]]

body does not own, operate, have a financial interest in, manage, or 
otherwise control an eligible entity or any affiliate, parent, or 
subsidiary of the entity that is subject to a consultative or regulatory 
audit by the audit agent; and
    (4) Prohibiting an accredited third-party certification body's 
officer, employee, or other agent involved in auditing and certification 
activities from accepting any money, gift, gratuity, or other item of 
value from the eligible entity to be audited or certified under this 
subpart.
    (5) The items specified in paragraph (a)(4) of this section do not 
include:
    (i) Money representing payment of fees for auditing and 
certification services and reimbursement of direct costs associated with 
an onsite audit by the third-party certification body; or
    (ii) Lunch of de minimis value provided during the course of an 
audit and on the premises where the audit is conducted, if necessary to 
facilitate the efficient conduct of the audit.
    (b) An accredited third-party certification body may accept the 
payment of fees for auditing and certification services and the 
reimbursement of direct costs associated with an audit of an eligible 
entity only after the date on which the report of such audit was 
completed or the date a food or facility certification was issued, 
whichever is later. Such payment is not considered a conflict of 
interest for purposes of paragraph (a) of this section.
    (c) The financial interests of the spouses and children younger than 
18 years of age of accredited third-party certification body's officers, 
employees, and other agents involved in auditing and certification 
activities will be considered the financial interests of such officers, 
employees, and other agents involved in auditing and certification 
activities.
    (d) An accredited third-party certification body must maintain on 
its Web site an up-to-date list of the eligible entities to which it has 
issued food or facility certifications under this subpart. For each such 
eligible entity, the Web site also must identify the duration and scope 
of the food or facility certification and date(s) on which the eligible 
entity paid the accredited third-party certification body any fee or 
reimbursement associated with such audit or certification.



Sec.  1.658  What records requirements must a third-party 
certification body that has been accredited meet?

    (a) A third-party certification body that has been accredited must 
maintain electronically for 4 years records created during its period of 
accreditation (including documents and data) that document compliance 
with this subpart, including:
    (1) Any audit report and other documents resulting from a 
consultative audit conducted under this subpart, including the audit 
agent's observations, correspondence with the eligible entity, 
verification of any corrective action(s) taken to address deficiencies 
identified during the audit;
    (2) Any request for a regulatory audit from an eligible entity;
    (3) Any audit report and other documents resulting from a regulatory 
audit conducted under this subpart, including the audit agent's 
observations, correspondence with the eligible entity, verification of 
any corrective action(s) taken to address deficiencies identified during 
the audit, and, when sampling and analysis is conducted, laboratory 
testing records and results from a laboratory that is accredited in 
accordance with Sec.  1.651(b)(3), and documentation demonstrating such 
laboratory is accredited in accordance with Sec.  1.651(b)(3);
    (4) Any notification submitted by an audit agent to the accredited 
third-party certification body in accordance with Sec.  1.650(a)(5);
    (5) Any challenge to an adverse regulatory audit decision and the 
disposition of the challenge;
    (6) Any monitoring it conducted of an eligible entity to which food 
or facility certification was issued;
    (7) Its self-assessments and corrective actions taken to address any 
deficiencies identified during a self-assessment; and
    (8) Significant changes to its auditing or certification program 
that might affect compliance with this subpart.

[[Page 103]]

    (b) An accredited third-party certification body must make the 
records of a consultative audit required by paragraph (a)(1) of this 
section available to FDA in accordance with section 414 of the FD&C Act.
    (c) An accredited third-party certification body must make the 
records required by paragraphs (a)(2) through (8) of this section 
available for inspection and copying promptly upon written request of an 
authorized FDA officer or employee at the place of business of the 
accredited third-party certification body or at a reasonably accessible 
location. If such records are requested by FDA electronically, the 
records must be submitted electronically not later than 10 business days 
after the date of the request. Additionally, if the records are 
maintained in a language other than English, an accredited third-party 
certification body must electronically submit an English translation 
within a reasonable time.

 Procedures for Accreditation of Third-Party Certification Bodies Under 
                              This Subpart



Sec.  1.660  Where do I apply for accreditation or renewal of
accreditation by a recognized accreditation body and what happens
once the recognized accreditation body decides on my application?

    (a) Submission of accreditation or renewal application to a 
recognized accreditation body. A third-party certification body seeking 
accreditation must submit its request for accreditation or renewal of 
accreditation by a recognized accreditation body identified on the Web 
site described in Sec.  1.690.
    (b) Notice of records custodian after denial of application for 
renewal of accreditation. An applicant whose renewal application was 
denied by a recognized accreditation body must notify FDA 
electronically, in English, within 10 business days of the date of 
issuance of a denial of accreditation or denial of the renewal 
application, of the name and contact information of the custodian who 
will maintain the records required by Sec.  1.658(a) and make them 
available to FDA as required by Sec.  1.658(b) and (c). The contact 
information for the custodian must include, at a minimum, an email 
address and the physical address where the records required by Sec.  
1.658(a) will be located.
    (c) Effect of denial of an application for renewal of accreditation 
on food or facility certifications issued to eligible entities. A food 
or facility certification issued by an accredited third-party 
certification body prior to issuance of the denial of its renewal 
application l will remain in effect until the certification expires. If 
FDA has reason to believe that a certification issued for purposes of 
section 801(q) or 806 of the FD&C Act is not valid or reliable, FDA may 
refuse to consider the certification in determining the admissibility of 
the article of food for which the certification was offered or in 
determining the importer's eligibility for participation in VQIP.
    (d) Public notice of denial of an application for renewal of 
accreditation. FDA will provide notice on the Web site described in 
Sec.  1.690 of the date of issuance of a denial of renewal of 
accreditation of a third-party certification body that had previous been 
accredited.



Sec.  1.661  What is the duration of accreditation by a recognized
accreditation body?

    A recognized accreditation body may grant accreditation to a third-
party certification body under this subpart for a period not to exceed 4 
years.



Sec.  1.662  How will FDA monitor accredited third-party
certification bodies?

    (a) FDA will periodically evaluate the performance of each 
accredited third-party certification body to determine whether the 
accredited third-party certification body continues to comply with the 
applicable requirements of this subpart and whether there are 
deficiencies in the performance of the accredited third-party 
certification body that, if not corrected, would warrant withdrawal of 
its accreditation under Sec.  1.664. FDA will evaluate each directly 
accredited third-party certification body annually. For a third-party 
certification body accredited by a recognized accreditation body, FDA 
will evaluate an accredited third-party certification body not later 
than 3 years after the date of

[[Page 104]]

accreditation for a 4-year term of accreditation, or by no later than 
the mid-term point for accreditation granted for less than 4 years. FDA 
may conduct additional performance assessments of an accredited third-
party certification body at any time.
    (b) In evaluating the performance of an accredited third-party 
certification body under paragraph (a) of this section, FDA may review 
any one or more of the following:
    (1) Regulatory audit reports and food and facility certifications;
    (2) The accredited third-party certification body's self-assessments 
under Sec.  1.655;
    (3) Reports of assessments by a recognized accreditation body under 
Sec.  1.621;
    (4) Documents and other information relevant to a determination of 
the accredited third-party certification body's compliance with the 
applicable requirements of this subpart; and
    (5) Information obtained by FDA, including during inspections, 
audits, onsite observations, or investigations, of one or more eligible 
entities to which a food or facility certification was issued by such 
accredited third-party certification body.
    (c) FDA may conduct its evaluation of an accredited third-party 
certification body through a site visit to an accredited third-party 
certification body's headquarters (or other location that manages audit 
agents conducting food safety audits under this subpart, if different 
than its headquarters), through onsite observation of an accredited 
third party certification body's performance during a food safety audit 
of an eligible entity, or through document review.



Sec.  1.663  How do I request an FDA waiver or waiver extension for
the 13-month limit for audit agents conducting regulatory audits?

    (a) An accredited third-party certification body may submit a 
request to FDA to waive the requirements of Sec.  1.650(c) preventing an 
audit agent from conducting a regulatory audit of an eligible entity if 
the audit agent (or, in the case that the third-party certification body 
is an individual, the third-party certification body) has conducted a 
food safety audit of such entity during the previous 13 months. The 
accredited third-party certification body seeking a waiver or waiver 
extension must demonstrate there is insufficient access to audit agents 
and any third-party certification bodies that are comprised of an 
individual in the country or region where the eligible entity is 
located.
    (b) Requests for a waiver or waiver extension and all documents 
provided in support of the request must be submitted to FDA 
electronically, in English. The requestor must provide such translation 
and interpretation services as are needed by FDA to process the request.
    (c) The request must be signed by the requestor or by any individual 
authorized to act on behalf of the requestor for purposes of seeking 
such waiver or waiver extension.
    (d) FDA will review requests for waivers and waiver extensions on a 
first in, first out basis according to the date on which the completed 
submission is received; however, FDA may prioritize the review of 
specific requests to meet the needs of the program. FDA will evaluate 
any completed waiver request to determine whether the criteria for 
waiver have been met.
    (e) FDA will notify the requestor whether the request for a waiver 
or waiver extension is approved or denied.
    (f) If FDA approves the request, issuance of the waiver will state 
the duration of the waiver and list any limitations associated with it. 
If FDA denies the request, the issuance of a denial of a waiver request 
will state the basis for denial and will provide the address and 
procedures for requesting reconsideration of the request under Sec.  
1.691.
    (g) Unless FDA notifies a requestor that its waiver request has been 
approved, an accredited third-party certification body must not use the 
audit agent to conduct a regulatory audit of such eligible entity until 
the 13-month limit in Sec.  1.650(c) has elapsed.



Sec.  1.664  When would FDA withdraw accreditation?

    (a) Mandatory withdrawal. FDA will withdraw accreditation from a 
third-party certification body:

[[Page 105]]

    (1) Except as provided in paragraph (b) of this section, if the food 
or facility certified under this subpart is linked to an outbreak of 
foodborne illness or chemical or physical hazard that has a reasonable 
probability of causing serious adverse health consequences or death in 
humans or animals;
    (2) Following an evaluation and finding by FDA that the third-party 
certification body no longer complies with the applicable requirements 
of this subpart; or
    (3) Following its refusal to allow FDA to access records under Sec.  
1.658 or to conduct an audit, assessment, or investigation necessary to 
ensure continued compliance with this subpart.
    (4) If payment of the third-party certification body's annual fee is 
not received within 90 days of the payment due date, as specified in 
Sec.  1.725(c)(3).
    (b) Exception. FDA may waive mandatory withdrawal under paragraph 
(a)(1) of this section, if FDA:
    (1) Conducts an investigation of the material facts related to the 
outbreak of human or animal illness;
    (2) Reviews the relevant audit records and the actions taken by the 
accredited third-party certification body in support of its decision to 
certify; and
    (3) Determines that the accredited third-party certification body 
satisfied the requirements for issuance of certification under this 
subpart.
    (c) Discretionary withdrawal. FDA may withdraw accreditation, in 
whole or in part, from a third-party certification body when such third-
party certification body is accredited by an accreditation body for 
which recognition is revoked under Sec.  1.634, if FDA determines there 
is good cause for withdrawal, including:
    (1) Demonstrated bias or lack of objectivity when conducting 
activities under this subpart; or
    (2) Performance that calls into question the validity or reliability 
of its food safety audits or certifications.
    (d) Records access. FDA may request records of the accredited third-
party certification body under Sec.  1.658 and, where applicable, may 
request records under Sec.  1.625 of an accreditation body that has been 
recognized under Sec.  1.625, when considering withdrawal under 
paragraph (a)(1), (a)(2), or (c) of this section.
    (e) Notice to the third-party certification body of withdrawal of 
accreditation. (1) FDA will notify a third-party certification body of 
the withdrawal of its accreditation through issuance of a withdrawal 
that will state the grounds for withdrawal, the procedures for 
requesting a regulatory hearing under Sec.  1.693 on the withdrawal, and 
the procedures for requesting reaccreditation under Sec.  1.666.
    (2) Within 10 business days of the date of issuance of the 
withdrawal, the third-party certification body must notify FDA 
electronically, in English, of the name of the custodian who will 
maintain the records required by Sec.  1.658, and provide contact 
information for the custodian, which will at least include an email 
address, and the street address where the records will be located.
    (f) Effect of withdrawal of accreditation on eligible entities. A 
food or facility certification issued by a third-party certification 
body prior to withdrawal will remain in effect until the certification 
terminates by expiration. If FDA has reason to believe that a 
certification issued for purposes of section 801(q) or 806 of the FD&C 
Act is not valid or reliable, FDA may refuse to consider the 
certification in determining the admissibility of the article of food 
for which the certification was offered or in determining the importer's 
eligibility for participation in VQIP.
    (g) Effect of withdrawal of accreditation on recognized 
accreditation bodies. (1) FDA will notify a recognized accreditation 
body if the accreditation of a third-party certification body it 
accredited is withdrawn by FDA. Such accreditation body's recognition 
will remain in effect if, no later than 60 days after withdrawal, the 
accreditation body conducts a self-assessment under Sec.  1.622 and 
reports the results of the self-assessment to FDA as required by Sec.  
1.623(b).
    (2) FDA may revoke the recognition of an accreditation body whenever 
FDA determines there is good cause for revocation of recognition under 
Sec.  1.634.

[[Page 106]]

    (h) Public notice of withdrawal accreditation. FDA will provide 
notice on the Web site described in Sec.  1.690 of its withdrawal of 
accreditation of a third-party certification body and provide a 
description of the basis for withdrawal.

[80 FR 74650, Nov. 27, 2015, as amended at 81 FR 90193, Dec. 14, 2016]



Sec.  1.665  What if I want to voluntarily relinquish accreditation
or do not want to renew accreditation?

    (a) Notice to FDA of intent to relinquish or not to renew 
accreditation. A third-party certification body must notify FDA 
electronically, in English, at least 60 days before voluntarily 
relinquishing accreditation or before allowing accreditation to expire 
without seeking renewal. The certification body must provide the name 
and contact information of the custodian who will maintain the records 
required under Sec.  1.658(a) after the date of relinquishment or the 
date accreditation expires, as applicable, and make them available to 
FDA as required by Sec.  1.658(b) and (c). The contact information for 
the custodian must include, at a minimum, an email address and the 
physical address where the records required by Sec.  1.658(a) will be 
located.
    (b) Notice to recognized accreditation body and eligible entities of 
intent to relinquish or not to renew accreditation. No later than 15 
business days after notifying FDA under paragraph (a) of this section, 
the certification body must notify its recognized accreditation body and 
any eligible entity with current certifications that it intends to 
relinquish accreditation or to allow its accreditation to expire, 
specifying the date on which relinquishment or expiration will occur. 
The recognized accreditation body must establish and maintain records of 
such notification under Sec.  1.625(a).
    (c) Effect of voluntary relinquishment or expiration of 
accreditation on food or facility certifications issued to eligible 
entities. A food or facility certification issued by a third-party 
certification body prior to relinquishment or expiration of its 
accreditation will remain in effect until the certification expires. If 
FDA has reason to believe that a certification issued for purposes of 
section 801(q) or 806 of the FD&C Act is not valid or reliable, FDA may 
refuse to consider the certification in determining the admissibility of 
the article of food for which the certification was offered or in 
determining the importer's eligibility for participation in VQIP.
    (d) Public notice of voluntary relinquishment or expiration of 
accreditation. FDA will provide notice on the Web site described in 
Sec.  1.690 of the voluntary relinquishment or expiration of 
accreditation of a certification body under this subpart.



Sec.  1.666  How do I request reaccreditation?

    (a) Application following withdrawal. FDA will reinstate the 
accreditation of a third-party certification body for which it has 
withdrawn accreditation:
    (1) If, in the case of direct accreditation, FDA determines, based 
on evidence presented by the third-party certification body, that the 
third-party certification body satisfies the applicable requirements of 
this subpart and adequate grounds for withdrawal no longer exist; or
    (2) In the case of a third-party certification body accredited by an 
accreditation body for which recognition has been revoked under Sec.  
1.634:
    (i) If the third-party certification body becomes accredited by 
another recognized accreditation body or by FDA through direct 
accreditation no later than 1 year after withdrawal of accreditation, or 
the original date of the expiration of accreditation, whichever comes 
first; or
    (ii) Under such conditions as FDA may impose in withdrawing 
accreditation.
    (b) Application following voluntary relinquishment. A third-party 
certification body that previously relinquished its accreditation under 
Sec.  1.665 may seek accreditation by submitting a new application for 
accreditation under Sec.  1.660 or, where applicable, Sec.  1.670.

[[Page 107]]

     Additional Procedures for Direct Accreditation of Third-Party 
                 Certification Bodies Under This Subpart



Sec.  1.670  How do I apply to FDA for direct accreditation or renewal
of direct accreditation?

    (a) Eligibility. (1) FDA will accept applications from third-party 
certification bodies for direct accreditation or renewal of direct 
accreditation only if FDA determines that it has not identified and 
recognized an accreditation body to meet the requirements of section 808 
of the FD&C Act within 2 years after establishing the accredited third-
party audits and certification program. Such FDA determination may 
apply, as appropriate, to specific types of third-party certification 
bodies, types of expertise, or geographic location; or through 
identification by FDA of any requirements of section 808 of the FD&C Act 
not otherwise met by previously recognized accreditation bodies. FDA 
will only accept applications for direct accreditation and renewal 
applications that are within the scope of the determination.
    (2) FDA may revoke or modify a determination under paragraph (a)(1) 
of this section if FDA subsequently identifies and recognizes an 
accreditation body that affects such determination.
    (3) FDA will provide notice on the Web site described in Sec.  1.690 
of a determination under paragraph (a)(1) of this section and of a 
revocation or modification of the determination under paragraph (a)(1) 
of this section, as described in paragraph (a)(2) of this section.
    (b) Application for direct accreditation or renewal of direct 
accreditation. (1) A third-party certification body seeking direct 
accreditation or renewal of direct accreditation must submit an 
application to FDA, demonstrating that it is within the scope of the 
determination issued under paragraph (a)(1) of this section, and it 
meets the eligibility requirements of Sec.  1.640.
    (2) Applications and all documents provided as part of the 
application process must be submitted electronically, in English. An 
applicant must provide such translation and interpretation services as 
are needed by FDA to process the application, including during an onsite 
audit of the applicant.
    (3) The application must be signed in the manner designated by FDA 
by an individual authorized to act on behalf of the applicant for 
purposes of seeking or renewing direct accreditation.



Sec.  1.671  How will FDA review my application for direct accreditation 
or renewal of direct accreditation and what happens once FDA decides on
my application?

    (a) Review of a direct accreditation or renewal application. FDA 
will examine a third-party certification body's direct accreditation or 
renewal application for completeness and notify the applicant of any 
deficiencies. FDA will review applications for direct accreditation and 
for renewal of direct accreditation on a first in, first out basis 
according to the date the completed submission is received; however, FDA 
may prioritize the review of specific applications to meet the needs of 
the program.
    (b) Evaluation of a direct accreditation or renewal application. FDA 
will evaluate any completed application to determine whether the 
applicant meets the requirements for direct accreditation under this 
subpart. If FDA does not reach a final decision on a renewal application 
before the expiration of the direct accreditation, FDA may extend the 
duration of such direct accreditation for a specified period of time or 
until the Agency reaches a final decision on the renewal application.
    (c) Notice of approval or denial. FDA will notify the applicant that 
its direct accreditation or renewal application has been approved 
through issuance of or denied.
    (d) Issuance of direct accreditation. If an application has been 
approved, the issuance of the direct accreditation that will list any 
limitations associated with the accreditation.
    (e) Issuance of denial of direct accreditation. If FDA issues a 
denial of direct accreditation or denial of a renewal application, the 
issuance of the denial of direct accreditation will state the basis for 
such denial and provide the procedures for requesting reconsideration of 
the application under Sec.  1.691.
    (f) Notice of records custodian after denial of application for 
renewal of direct

[[Page 108]]

accreditation. An applicant whose renewal application was denied must 
notify FDA electronically, in English, within 10 business days of the 
date of issuance of a denial of a renewal application, of the name and 
contact information of the custodian who will maintain the records 
required by Sec.  1.658(a) and make them available to FDA as required by 
Sec.  1.658(b) and (c). The contact information for the custodian must 
include, at a minimum, an email address and the physical address where 
the records required by Sec.  1.658(b) will be located.
    (g) Effect of denial of renewal of direct accreditation on food or 
facility certifications issued to eligible entities. A food or facility 
certification issued by an accredited third-party certification body 
prior to issuance of the denial of its renewal application will remain 
in effect until the certification expires. If FDA has reason to believe 
that a certification issued for purposes of section 801(q) or 806 of the 
FD&C Act is not valid or reliable, FDA may refuse to consider the 
certification in determining the admissibility of the article of food 
for which the certification was offered or in determining the importer's 
eligibility for participation in VQIP.
    (h) Public notice of denial of renewal of direct accreditation. FDA 
will provide notice on the Web site described in Sec.  1.690 of the 
issuance of a denial of renewal application for direct accreditation 
under this subpart.



Sec.  1.672  What is the duration of direct accreditation?

    FDA will grant direct accreditation of a third-party certification 
body for a period not to exceed 4 years.

          Requirements for Eligible Entities Under This Subpart



Sec.  1.680  How and when will FDA monitor eligible entities?

    FDA may, at any time, conduct an onsite audit of an eligible entity 
that has received food or facility certification from an accredited 
third-party certification body under this subpart. Where FDA determines 
necessary or appropriate, the unannounced audit may be conducted with or 
without the accredited third-party certification body or the recognized 
accreditation body (where applicable) present. An FDA audit conducted 
under this section will be conducted on an unannounced basis and may be 
preceded by a request for a 30-day operating schedule.



Sec.  1.681  How frequently must eligible entities be recertified?

    An eligible entity seeking recertification of a food or facility 
certification under this subpart must apply for recertification prior to 
the expiration of its certification. For certifications used in meeting 
the requirements of section 801(q) or 806 of the FD&C Act, FDA may 
require an eligible entity to apply for recertification at any time FDA 
determines appropriate under such section.

                  General Requirements of This Subpart



Sec.  1.690  How will FDA make information about recognized accreditation
bodies and accredited third-party certification bodies available to the
public?

    FDA will place on its Web site a registry of recognized 
accreditation bodies and accredited third-party certification bodies, 
including the name, contact information, and scope and duration of 
recognition or accreditation. The registry may provide information on 
third-party certification bodies accredited by recognized accreditation 
bodies through links to the Web sites of such recognized accreditation 
bodies. FDA will also place on its Web site a list of accreditation 
bodies for which it has denied renewal of recognition, for which FDA has 
revoked recognition, and that have relinquished their recognition or 
have allowed their recognition to expire. FDA will also place in its Web 
site a list of certification bodies whose renewal of accreditation has 
been denied, for which FDA has withdrawn accreditation, and that have 
relinquished their accreditations or have allowed their accreditations 
to expire. FDA will place on its Web site determinations under Sec.  
1.670(a)(1) and modifications of such determinations under Sec.  
1.670(a)(2).

[[Page 109]]



Sec.  1.691  How do I request reconsideration of a denial by FDA of an
application or a waiver request?

    (a) An accreditation body may seek reconsideration of the denial of 
an application for recognition, renewal of recognition, or reinstatement 
of recognition no later than 10 business days after the date of the 
issuance of such denial.
    (b) A third-party certification body may seek reconsideration of the 
denial of an application for direct accreditation, renewal of direct 
accreditation, reaccreditation of directly accredited third-party 
certification body, a request for a waiver of the conflict of interest 
requirement in Sec.  1.650(b), or a waiver extension no later than 10 
business days after the date of the issuance of such denial.
    (c) A request to reconsider an application or waiver request under 
paragraph (a) or (b) of this section must be signed by the requestor or 
by an individual authorized to act on its behalf in submitting the 
request for reconsideration. The request must be submitted 
electronically in English and must comply with the procedures described 
in the notice.
    (d) After completing its review and evaluation of the request for 
reconsideration, FDA will notify the requestor through the issuance of 
the recognition, direct accreditation, or waiver upon reconsideration or 
through the issuance of a denial of the application or waiver request 
under paragraph (a) or (b) of this section upon reconsideration.



Sec.  1.692  How do I request internal agency review of a denial of
an application or waiver request upon reconsideration?

    (a) No later than 10 business days after the date of issuance of a 
denial of an application or waiver request upon reconsideration under 
Sec.  1.691, the requestor may seek internal agency review of such 
denial under Sec.  10.75(c)(1) of this chapter.
    (b) The request for internal agency review under paragraph (a) of 
this section must be signed by the requestor or by an individual 
authorized to act on its behalf in submitting the request for internal 
review. The request must be submitted electronically in English to the 
address specified in the denial upon reconsideration and must comply 
with procedures it describes.
    (c) Under Sec.  10.75(d) of this chapter, internal agency review of 
such denial must be based on the information in the administrative file, 
which will include any supporting information submitted under Sec.  
1.691(c).
    (d) After completing the review and evaluation of the administrative 
file, FDA will notify the requestor of its decision to overturn the 
denial and grant the application or waiver request through issuance of 
an application or waiver request upon reconsideration or to affirm the 
denial of the application or waiver request upon reconsideration through 
issuance of a denial of an application or waiver request upon 
reconsideration.
    (e) Issuance by FDA of a denial of an application or waiver request 
upon reconsideration constitutes final agency action under 5 U.S.C. 702.



Sec.  1.693  How do I request a regulatory hearing on a revocation of
recognition or withdrawal of accreditation?

    (a) Request for hearing on revocation. No later than 10 business 
days after the date of issuance of a revocation of recognition of an 
accreditation body under Sec.  1.634, an individual authorized to act on 
the accreditation body's behalf may submit a request for a regulatory 
hearing on the revocation under part 16 of this chapter. The issuance of 
revocation issued under Sec.  1.634 will contain all of the elements 
required by Sec.  16.22 of this chapter and will thereby constitute the 
notice of an opportunity for hearing under part 16 of this chapter.
    (b) Request for hearing on withdrawal. No later than 10 business 
days after the date of issuance of a withdrawal of accreditation of a 
third-party certification body under Sec.  1.664, an individual 
authorized to act on the third-party certification body's behalf may 
submit a request for a regulatory hearing on the withdrawal under part 
16 of this chapter. The issuance of withdrawal under Sec.  1.664 will 
contain all of the elements required by Sec.  16.22 of this chapter and 
will thereby constitute the notice

[[Page 110]]

of opportunity of hearing under part 16 of this chapter.
    (c) Submission of request for regulatory hearing. The request for a 
regulatory hearing under paragraph (a) or (b) of this section must be 
submitted with a written appeal that responds to the basis for the FDA 
decision, as described in the issuance of revocation or withdrawal, as 
appropriate, and includes any supporting information upon which the 
requestor is relying. The request, appeal, and supporting information 
must be submitted in English to the address specified in the notice and 
must comply with the procedures it describes.
    (d) Effect of submission of request on FDA decision. The submission 
of a request for a regulatory hearing under paragraph (a) or (b) of this 
section will not operate to delay or stay the effect of a decision by 
FDA to revoke recognition of an accreditation body or to withdraw 
accreditation of a third-party certification body unless FDA determines 
that a delay or a stay is in the public interest.
    (e) Presiding officer. The presiding officer for a regulatory 
hearing for a revocation or withdrawal under this subpart will be 
designated after a request for a regulatory hearing is submitted to FDA.
    (f) Denial of a request for regulatory hearing. The presiding 
officer may deny a request for regulatory hearing for a revocation or 
withdrawal under Sec.  16.26(a) of this chapter when no genuine or 
substantial issue of fact has been raised.
    (g) Conduct of regulatory hearing. (1) If the presiding officer 
grants a request for a regulatory hearing for a revocation or 
withdrawal, the hearing will be held within 10 business days after the 
date the request was filed or, if applicable, within a timeframe agreed 
upon in writing by requestor, the presiding officer, and FDA.
    (2) The presiding officer must conduct the regulatory hearing for 
revocation or withdrawal under part 16 of this chapter, except that, 
under Sec.  16.5(b) of this chapter, such procedures apply only to the 
extent that the procedures are supplementary and do not conflict with 
the procedures specified for regulatory hearings under this subpart. 
Accordingly, the following requirements of part 16 are inapplicable to 
regulatory hearings under this subpart: Sec.  16.22 (Initiation of a 
regulatory hearing); Sec.  16.24(e) (timing) and (f) (contents of 
notice); Sec.  16.40 (Commissioner); Sec.  16.60(a) (public process); 
Sec.  16.95(b) (administrative decision and record for decision); and 
Sec.  16.119 (Reconsideration and stay of action).
    (3) A decision by the presiding officer to affirm the revocation of 
recognition or the withdrawal of accreditation is considered a final 
agency action under 5 U.S.C. 702.



Sec.  1.694  Are electronic records created under this subpart subject
to the electronic records requirements of part 11 of this chapter?

    Records that are established or maintained to satisfy the 
requirements of this subpart and that meet the definition of electronic 
records in Sec.  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 also are required under other 
applicable statutory provisions or regulations, remain subject to part 
11 of this chapter.



Sec.  1.695  Are the records obtained by FDA under this subpart 
subject to public disclosure?

    Records obtained by FDA under this subpart are subject to the 
disclosure requirements under part 20 of this chapter.

              Requirements for User Fees Under This Subpart

    Source: Sections 1.700 through 1.725 appear at 81 FR 90193, Dec. 14, 
2016, unless otherwise noted.



Sec.  1.700  Who is subject to a user fee under this subpart?

    (a) Accreditation bodies submitting applications or renewal 
applications for recognition in the third-party certification program;
    (b) Recognized accreditation bodies participating in the third-party 
certification program;
    (c) Third-party certification bodies submitting applications or 
renewal applications for direct accreditation; and

[[Page 111]]

    (d) Accredited third-party certification bodies (whether accredited 
by recognized accreditation bodies or by FDA through direct 
accreditation) participating in the third-party certification program.



Sec.  1.705  What user fees are established under this subpart?

    (a) The following application fees:
    (1) Accreditation bodies applying for recognition are subject to an 
application fee for the estimated average cost of the work FDA performs 
in reviewing and evaluating applications for recognition of 
accreditation bodies.
    (2) Recognized accreditation bodies submitting renewal applications 
are subject to a renewal application fee for the estimated average cost 
of the work FDA performs in reviewing and evaluating renewal 
applications for recognition of accreditation bodies.
    (3) Third-party certification bodies applying for direct 
accreditation are subject to an application fee for the estimated 
average cost of the work FDA performs in reviewing and evaluating 
applications for direct accreditation.
    (4) Accredited third-party certification bodies applying for renewal 
of direct accreditation are subject to an application fee for the 
estimated average cost of the work FDA performs in reviewing and 
evaluating renewal applications for direct accreditation.
    (b) The following annual fees:
    (1) Recognized accreditation bodies are subject to an annual fee for 
the estimated average cost of the work FDA performs to monitor 
performance of recognized accreditation bodies under Sec.  1.633.
    (2) Third-party certification bodies directly accredited by FDA are 
subject to an annual fee for the estimated average cost of the work FDA 
performs to monitor directly accredited third-party certification bodies 
under Sec.  1.662.
    (3) Third-party certification bodies accredited by recognized 
accreditation bodies are subject to an annual fee for the estimated 
average cost of the work FDA performs to monitor third-party 
certification bodies that are accredited by a recognized accreditation 
body under Sec.  1.662.



Sec.  1.710  How will FDA notify the public about the fee schedule?

    FDA will notify the public of the fee schedule annually. The fee 
notice will be made publicly available prior to the beginning of the 
fiscal year for which the fees apply, except for the first fiscal year 
in which this regulation is effective. Each new fee schedule will be 
adjusted for inflation and improvements in the estimates of the cost to 
FDA of performing relevant work for the upcoming year.



Sec.  1.715  When must a user fee required by this subpart be submitted?

    (a) Accreditation bodies applying for recognition and third-party 
certification bodies applying for direct accreditation must submit a fee 
concurrently with submitting an application or a renewal application.
    (b) Accreditation bodies and third-party certification bodies 
subject to an annual fee must submit payment within 30 days of receiving 
billing for the fee.



Sec.  1.720  Are user fees under this subpart refundable?

    User fees accompanying completed applications and annual fees under 
this subpart are not refundable.



Sec.  1.725  What are the consequences of not paying a user fee under
this subpart on time?

    (a) An application for recognition or renewal of recognition will 
not be considered complete for the purposes of Sec.  1.631(a) until the 
date that FDA receives the application fee. An application for direct 
accreditation or for renewal of direct accreditation will not be 
considered complete for the purposes of Sec.  1.671(a) until FDA 
receives the application fee.
    (b) A recognized accreditation body that fails to submit its annual 
user fee within 30 days of the due date will have its recognition 
suspended.
    (1) FDA will notify the accreditation body electronically that its 
recognition is suspended. FDA will notify the public of the suspension 
on the Web site described in Sec.  1.690.
    (2) While an accreditation body's recognition is suspended, the 
accreditation body will not be able to accredit

[[Page 112]]

additional third-party certification bodies. The accreditation of third-
party certification bodies that occurred prior to an accreditation 
body's suspension, as well as food or facility certifications issued by 
such third-party certification bodies, would remain in effect.
    (3) If payment is not received within 90 days of the payment due 
date, FDA will revoke the accreditation body's recognition under Sec.  
1.634(a)(4)(iii), and provide notice of such revocation in accordance 
with Sec.  1.634.
    (c) An accredited third-party certification body that fails to 
submit its annual fee within 30 days of the due date will have its 
accreditation suspended.
    (1) FDA will notify the third-party certification body that its 
accreditation is suspended, electronically and in English. FDA will 
notify a recognized accreditation body, electronically and in English, 
if the accreditation of one if its third-party certification bodies is 
suspended. FDA will notify the public of the suspension on the Web site 
described in Sec.  1.690.
    (2) While a third-party certification body's accreditation is 
suspended, the third-party certification body will not be able to issue 
food or facility certifications. A food or facility certification issued 
by a third-party certification body prior to the suspension of the 
auditor/certification body accreditation will remain in effect.
    (3) If payment is not received within 90 days of the payment due 
date, FDA will withdraw the third-party certification body's 
accreditation under Sec.  1.664(a)(4), and provide notice of such 
withdrawal in accordance with Sec.  1.664.

Subpart N [Reserved]



       Subpart O_Sanitary Transportation of Human and Animal Food

    Source: 81 FR 20166, Apr. 6, 2016, unless otherwise noted.

                           General Provisions



Sec.  1.900  Who is subject to this subpart?

    (a) Except for non-covered businesses as defined in Sec.  1.904 and 
as provided for in paragraph (b) of this section, the requirements of 
this subpart apply to shippers, receivers, loaders, and carriers engaged 
in transportation operations whether or not the food is being offered 
for or enters interstate commerce. The requirements of this subpart 
apply in addition to any other requirements of this chapter that are 
applicable to the transportation of food, e.g., in 21 CFR parts 1, 117, 
118, 225, 507, and 589.
    (b) The requirements of this subpart do not apply to shippers, 
receivers, loaders, or carriers when they are engaged in transportation 
operations:
    (1) Of food that is transshipped through the United States to 
another country; or
    (2) Of food that is imported for future export, in accordance with 
section 801(d)(3) of the Federal Food, Drug, and Cosmetic Act, and that 
is neither consumed nor distributed in the United States; or
    (3) Of food when it is located in food facilities as defined in 
Sec.  1.227 of this chapter, 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.).



Sec.  1.902  How do the criteria and definitions in this subpart apply
under the Federal Food, Drug, and Cosmetic Act?

    (a) The criteria and definitions of this subpart apply in 
determining whether food is adulterated within the meaning of section 
402(i) of the Federal Food, Drug, and Cosmetic Act in that the food has 
been transported or offered for transport by a shipper, carrier by motor 
vehicle or rail vehicle, loader, or receiver engaged in transportation 
operations under conditions that are not in compliance with this 
subpart.
    (b) The failure by a shipper, carrier by motor vehicle or rail 
vehicle, loader, or receiver engaged in transportation operations to 
comply with the requirements of this subpart is a prohibited act under 
section 301(hh) of the Federal Food, Drug, and Cosmetic Act.

[[Page 113]]



Sec.  1.904  What definitions apply to this subpart?

    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act are applicable to such terms when 
used in this part. The following definitions also apply:
    Adequate means that which is needed to accomplish the intended 
purpose in keeping with good public health practice.
    Animal food means food for animals other than man, and includes pet 
food, animal feed, and raw materials and ingredients.
    Bulk vehicle means a tank truck, hopper truck, rail tank car, hopper 
car, cargo tank, portable tank, freight container, or hopper bin, or any 
other vehicle in which food is shipped in bulk, with the food coming 
into direct contact with the vehicle.
    Carrier means a person who physically moves food by rail or motor 
vehicle in commerce within the United States. The term carrier does not 
include any person who transports food while operating as a parcel 
delivery service.
    Cross-contact means the unintentional incorporation of a food 
allergen as defined in section 201(qq) of the Federal Food, Drug, and 
Cosmetic Act into food, except animal food.
    Farm has the meaning given in Sec.  1.227 of this chapter.
    Food not completely enclosed by a container means any food that is 
placed into a container in such a manner that it is partially open to 
the surrounding environment. Examples of such containers include an open 
wooden basket or crate, an open cardboard box, a vented cardboard box 
with a top, or a vented plastic bag. This term does not include food 
transported in a bulk vehicle as defined in this subpart.
    Full-time equivalent employee is a term used to represent the number 
of employees of a business entity for the purpose of determining whether 
the business is a small business. 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 business entity and of all of 
its affiliates and subsidiaries by the number of hours of work in 1 
year, 2,080 hours (i.e., 40 hours x 52 weeks). If the result is not a 
whole number, round down to the next lowest whole number.
    Loader means a person that loads food onto a motor or rail vehicle 
during transportation operations.
    Non-covered business means a shipper, loader, receiver, or carrier 
engaged in transportation operations that has less than $500,000, as 
adjusted for inflation, in average annual revenues, calculated on a 
rolling basis, during the 3-year period preceding the applicable 
calendar year. For the purpose of determining an entity's 3-year average 
revenue threshold as adjusted for inflation, the baseline year for 
calculating the adjustment for inflation is 2011.
    Operating temperature means a temperature sufficient to ensure that 
under foreseeable circumstances of temperature variation during 
transport, e.g., seasonal conditions, refrigeration unit defrosting, 
multiple vehicle loading and unloading stops, the operation will meet 
the requirements of Sec.  1.908(a)(3).
    Pest means any objectionable animals or insects including birds, 
rodents, flies, and larvae.
    Receiver means any person who receives food at a point in the United 
States after transportation, whether or not that person represents the 
final point of receipt for the food.
    Shipper means a person, e.g., the manufacturer or a freight broker, 
who arranges for the transportation of food in the United States by a 
carrier or multiple carriers sequentially.
    Small business means a business employing fewer than 500 full-time 
equivalent employees except that for carriers by motor vehicle that are 
not also shippers and/or receivers, this term would mean a business 
subject to Sec.  1.900(a) having less than $27,500,000 in annual 
receipts.
    Transportation means any movement of food in by motor vehicle or 
rail vehicle in commerce within the United States.
    Transportation equipment means equipment used in food transportation 
operations, e.g., bulk and non-bulk containers, bins, totes, pallets, 
pumps, fittings, hoses, gaskets, loading systems, and unloading systems. 
Transportation

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equipment also includes a railcar not attached to a locomotive or a 
trailer not attached to a tractor.
    Transportation operations means all activities associated with food 
transportation that may affect the sanitary condition of food including 
cleaning, inspection, maintenance, loading and unloading, and operation 
of vehicles and transportation equipment. Transportation operations do 
not include any activities associated with the transportation of food 
that is completely enclosed by a container except a food that requires 
temperature control for safety, compressed food gases, food contact 
substances as defined in section 409(h)(6) of the Federal Food, Drug, 
and Cosmetic Act, human food byproducts transported for use as animal 
food without further processing, or live food animals except molluscan 
shellfish. In addition, transportation operations do not include any 
transportation activities that are performed by a farm.
    Vehicle means a land conveyance that is motorized, e.g., a motor 
vehicle, or that moves on rails, e.g., a railcar, which is used in 
transportation operations.

                  Vehicles and Transportation Equipment



Sec.  1.906  What requirements apply to vehicles and transportation
equipment?

    (a) Vehicles and transportation equipment used in transportation 
operations must be so designed and of such material and workmanship as 
to be suitable and adequately cleanable for their intended use to 
prevent the food they transport from becoming unsafe, i.e., adulterated 
within the meaning of section 402(a)(1), (2), and (4) of the Federal 
Food, Drug, and Cosmetic Act during transportation operations.
    (b) Vehicles and transportation equipment must be maintained in such 
a sanitary condition for their intended use as to prevent the food they 
transport from becoming unsafe during transportation operations.
    (c) Vehicles and transportation equipment used in transportation 
operations for food requiring temperature control for safety must be 
designed, maintained, and equipped as necessary to provide adequate 
temperature control to prevent the food from becoming unsafe during 
transportation operations.
    (d) Vehicles and transportation equipment must be stored in a manner 
that prevents it from harboring pests or becoming contaminated in any 
other manner that could result in food for which it will be used 
becoming unsafe during transportation operations.

                        Transportation Operations



Sec.  1.908  What requirements apply to transportation operations?

    (a) General requirements. (1) Unless stated otherwise in this 
section, the requirements of this section apply to all shippers, 
carriers, loaders, and receivers engaged in transportation operations. A 
person may be subject to these requirements in multiple capacities, 
e.g., the shipper may also be the loader and the carrier, if the person 
also performs the functions of those respective persons as defined in 
this subpart. An entity subject to this subpart (shipper, loader, 
carrier, or receiver) may reassign, in a written agreement, its 
responsibilities under this subpart to another party subject to this 
subpart. The written agreement is subject to the records requirements of 
Sec.  1.912(d).
    (2) Responsibility for ensuring that transportation operations are 
carried out in compliance with all requirements in this subpart must be 
assigned to competent supervisory personnel.
    (3) All transportation operations must be conducted under such 
conditions and controls necessary to prevent the food from becoming 
unsafe during transportation operations including:
    (i) Taking effective measures such as segregation, isolation, or the 
use of packaging to protect food from contamination by raw foods and 
nonfood items in the same load.
    (ii) Taking effective measures such as segregation, isolation, or 
other protective measures, such as hand washing, to protect food 
transported in bulk vehicles or food not completely enclosed by a 
container from contamination and cross-contact during transportation 
operations.

[[Page 115]]

    (iii) Taking effective measures to ensure that food that requires 
temperature control for safety is transported under adequate temperature 
control.
    (4) The type of food, e.g., animal feed, pet food, human food, and 
its production stage, e.g., raw material, ingredient or finished food, 
must be considered in determining the necessary conditions and controls 
for the transportation operation.
    (5) Shippers, receivers, loaders, and carriers, which are under the 
ownership or operational control of a single legal entity, as an 
alternative to meeting the requirements of paragraphs (b), (d), and (e) 
of this section may conduct transportation operations in conformance 
with common, integrated written procedures that ensure the sanitary 
transportation of food consistent with the requirements of this section. 
The written procedures are subject to the records requirements of Sec.  
1.912(e).
    (6) If a shipper, loader, receiver, or carrier becomes aware of an 
indication of a possible material failure of temperature control or 
other conditions that may render the food unsafe during transportation, 
the food shall not be sold or otherwise distributed, and these persons 
must take appropriate action including, as necessary, communication with 
other parties to ensure that the food is not sold or otherwise 
distributed unless a determination is made by a qualified individual 
that the temperature deviation or other condition did not render the 
food unsafe.
    (b) Requirements applicable to shippers engaged in transportation 
operations. (1) Unless the shipper takes other measures in accordance 
with paragraph (b)(3) of this section to ensure that vehicles and 
equipment used in its transportation operations are in appropriate 
sanitary condition for the transportation of the food, i.e., that will 
prevent the food from becoming unsafe, the shipper must specify to the 
carrier and, when necessary, the loader, in writing, all necessary 
sanitary specifications for the carrier's vehicle and transportation 
equipment to achieve this purpose, including any specific design 
specifications and cleaning procedures. One-time notification shall be 
sufficient unless the design requirements and cleaning procedures 
required for sanitary transport change based upon the type of food being 
transported, in which case the shipper shall so notify the carrier in 
writing before the shipment. The information submitted by the shipper to 
the carrier is subject to the records requirements in Sec.  1.912(a).
    (2) Unless the shipper takes other measures in accordance with 
paragraph (b)(5) of this section to ensure that adequate temperature 
control is provided during the transportation of food that requires 
temperature control for safety under the conditions of shipment, a 
shipper of such food must specify in writing to the carrier, except a 
carrier who transports the food in a thermally insulated tank, and, when 
necessary, the loader, an operating temperature for the transportation 
operation including, if necessary, the pre-cooling phase. One-time 
notification shall be sufficient unless a factor, e.g., the conditions 
of shipment, changes, necessitating a change in the operating 
temperature, in which case the shipper shall so notify the carrier in 
writing before the shipment. The information submitted by the shipper to 
the carrier is subject to the records requirements in Sec.  1.912(a).
    (3) A shipper must develop and implement written procedures, subject 
to the records requirements of Sec.  1.912(a), adequate to ensure that 
vehicles and equipment used in its transportation operations are in 
appropriate sanitary condition for the transportation of the food, i.e., 
will prevent the food from becoming unsafe during the transportation 
operation. Measures to implement these procedures may be accomplished by 
the shipper or by the carrier or another party covered by this subpart 
under a written agreement subject to the records requirements of Sec.  
1.912(a).
    (4) A shipper of food transported in bulk must develop and implement 
written procedures, subject to the records requirements of Sec.  
1.912(a), adequate to ensure that a previous cargo does not make the 
food unsafe. Measures to ensure the safety of the food may be 
accomplished by the shipper or by the carrier or another party covered 
by this subpart under a written agreement

[[Page 116]]

subject to the records requirements of Sec.  1.912(a).
    (5) The shipper of food that requires temperature control for safety 
under the conditions of shipment must develop and implement written 
procedures, subject to the records requirements of Sec.  1.912(a), to 
ensure that the food is transported under adequate temperature control. 
Measures to ensure the safety of the food may be accomplished by the 
shipper or by the carrier or another party covered by this subpart under 
a written agreement subject to the records requirements of Sec.  
1.912(a) and must include measures equivalent to those specified for 
carriers under paragraphs (e)(1) through (3) of this section.
    (c) Requirements applicable to loaders engaged in transportation 
operations. (1) Before loading food not completely enclosed by a 
container onto a vehicle or into transportation equipment the loader 
must determine, considering, as appropriate, specifications provided by 
the shipper in accordance with paragraph (b)(1) of this section, that 
the vehicle or transportation equipment is in appropriate sanitary 
condition for the transport of the food, e.g., it is in adequate 
physical condition, and free of visible evidence of pest infestation and 
previous cargo that could cause the food to become unsafe during 
transportation. This may be accomplished by any appropriate means.
    (2) Before loading food that requires temperature control for 
safety, the loader must verify, considering, as appropriate, 
specifications provided by the shipper in accordance with paragraph 
(b)(2) of this section, that each mechanically refrigerated cold storage 
compartment or container is adequately prepared for the transportation 
of such food, including that it has been properly pre-cooled, if 
necessary, and meets other sanitary conditions for food transportation.
    (d) Requirements applicable to receivers engaged in transportation 
operations. Upon receipt of food that requires temperature control for 
safety under the conditions of shipment, the receiver must take steps to 
adequately assess that the food was not subjected to significant 
temperature abuse, such as determining the food's temperature, the 
ambient temperature of the vehicle and its temperature setting, and 
conducting a sensory inspection, e.g., for off-odors.
    (e) Requirements applicable to carriers engaged in transportation 
operations. When the carrier and shipper have a written agreement that 
the carrier is responsible, in whole or in part, for sanitary conditions 
during the transportation operation, the carrier is responsible for the 
following functions as applicable per the agreement:
    (1) A carrier must ensure that vehicles and transportation equipment 
meet the shipper's specifications and are otherwise appropriate to 
prevent the food from becoming unsafe during the transportation 
operation.
    (2) A carrier must, once the transportation operation is complete 
and if requested by the receiver, provide the operating temperature 
specified by the shipper in accordance with paragraph (b)(2) of this 
section and, if requested by the shipper or receiver, demonstrate that 
it has maintained temperature conditions during the transportation 
operation consistent with the operating temperature specified by the 
shipper in accordance with paragraph (b)(2) of this section. Such 
demonstration may be accomplished by any appropriate means agreeable to 
the carrier and shipper, such as the carrier presenting measurements of 
the ambient temperature upon loading and unloading or time/temperature 
data taken during the shipment.
    (3) Before offering a vehicle or transportation equipment with an 
auxiliary refrigeration unit for use for the transportation of food that 
requires temperature control for safety under the conditions of the 
shipment during transportation, a carrier must pre-cool each 
mechanically refrigerated cold storage compartment as specified by the 
shipper in accordance with paragraph (b)(2) of this section.
    (4) If requested by the shipper, a carrier that offers a bulk 
vehicle for food transportation must provide information to the shipper 
that identifies the previous cargo transported in the vehicle.
    (5) If requested by the shipper, a carrier that offers a bulk 
vehicle for food

[[Page 117]]

transportation must provide information to the shipper that describes 
the most recent cleaning of the bulk vehicle.
    (6) A carrier must develop and implement written procedures subject 
to the records requirements of Sec.  1.912(b) that:
    (i) Specify practices for cleaning, sanitizing if necessary, and 
inspecting vehicles and transportation equipment that the carrier 
provides for use in the transportation of food to maintain the vehicles 
and the transportation equipment in appropriate sanitary condition as 
required by Sec.  1.906(b);
    (ii) Describe how it will comply with the provisions for temperature 
control in paragraph (e)(2) of this section, and;
    (iii) Describe how it will comply with the provisions for the use of 
bulk vehicles in paragraphs (e)(4) and (5) of this section.

                                 Training



Sec.  1.910  What training requirements apply to carriers engaged in
transportation operations?

    (a) When the carrier and shipper have agreed in a written contract 
that the carrier is responsible, in whole or in part, for the sanitary 
conditions during transportation operations, the carrier must provide 
adequate training to personnel engaged in transportation operations that 
provides an awareness of potential food safety problems that may occur 
during food transportation, basic sanitary transportation practices to 
address those potential problems, and the responsibilities of the 
carrier under this part. The training must be provided upon hiring and 
as needed thereafter.
    (b) Carriers must establish and maintain records documenting the 
training described in paragraph (a) of this section. Such records must 
include the date of the training, the type of training, and the 
person(s) trained. These records are subject to the records requirements 
of Sec.  1.912(c).

                                 Records



Sec.  1.912  What record retention and other records requirements apply
to shippers, receivers, loaders, and carriers engaged in transportation
operations?

    (a) Shippers must retain records:
    (1) That demonstrate that they provide specifications and operating 
temperatures to carriers as required by Sec.  1.908(b)(1) and (2) as a 
regular part of their transportation operations for a period of 12 
months beyond the termination of the agreements with the carriers.
    (2) Of written agreements and the written procedures required by 
Sec.  1.908(b)(3), (4), and (5), for a period of 12 months beyond when 
the agreements and procedures are in use in their transportation 
operations.
    (b) Carriers must retain records of the written procedures required 
by Sec.  1.908(e)(6) for a period of 12 months beyond when the 
agreements and procedures are in use in their transportation operations.
    (c) Carriers must retain training records required by Sec.  1.910(b) 
for a period of 12 months beyond when the person identified in any such 
records stops performing the duties for which the training was provided.
    (d) Any person subject to this subpart must retain any other written 
agreements assigning tasks in compliance with this subpart for a period 
of 12 months beyond the termination of the agreements.
    (e) Shippers, receivers, loaders, and carriers, which operate under 
the ownership or control of a single legal entity in accordance with the 
provisions of Sec.  1.908(a)(5), must retain records of the written 
procedures for a period of 12 months beyond when the procedures are in 
use in their transportation operations.
    (f) Shippers, receivers, loaders, and carriers must make all records 
required by this subpart available to a duly authorized individual 
promptly upon oral or written request.
    (g) All records required by this subpart must be kept as original 
records, true copies (such as photocopies, pictures, scanned copies, 
microfilm,

[[Page 118]]

microfiche, or other accurate reproductions of the original records), or 
electronic records.
    (h) Records that are established or maintained to satisfy the 
requirements of this subpart and that meet the definition of electronic 
records in Sec.  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 also are required under other 
applicable statutory provisions or regulations, remain subject to part 
11 of this chapter.
    (i) Except for the written procedures required by Sec.  
1.908(e)(6)(i), offsite storage of records is permitted if such records 
can be retrieved and provided onsite within 24 hours of request for 
official review. The written procedures required by Sec.  1.908(e)(6)(i) 
must remain onsite as long as the procedures are in use in 
transportation operations. Electronic records are considered to be 
onsite if they are accessible from an onsite location.
    (j) All records required by this subpart are subject to the 
disclosure requirements under part 20 of this chapter.

                                 Waivers



Sec.  1.914  Under what circumstances will we waive a requirement of
this subpart?

    We will waive any requirement of this subpart with respect to any 
class of persons, vehicles, food, or nonfood products, when we determine 
that:
    (a) The waiver will not result in the transportation of food under 
conditions that would be unsafe for human or animal health; and
    (b) The waiver will not be contrary to the public interest.



Sec.  1.916  When will we consider whether to waive a requirement of
this subpart?

    We will consider whether to waive a requirement of this subpart on 
our own initiative or on the petition submitted under Sec.  10.30 of 
this chapter by any person who is subject to the requirements of this 
subpart with respect to any class of persons, vehicles, food, or nonfood 
products.



Sec.  1.918  What must be included in the Statement of Grounds in a
petition requesting a waiver?

    In addition to the requirements set forth in Sec.  10.30 of this 
chapter, the Statement of Grounds in a petition requesting a waiver 
must:
    (a) Describe with particularity the waiver requested, including the 
persons, vehicles, food, or nonfood product(s) to which the waiver would 
apply and the requirement(s) of this subpart to which the waiver would 
apply; and
    (b) Present information demonstrating that the waiver will not 
result in the transportation of food under conditions that would be 
unsafe for human or animal health and will not be contrary to the public 
interest.



Sec.  1.920  What information submitted in a petition requesting a 
waiver or submitted in comments on such a petition is publicly 
available?

    We will presume that information submitted in a petition requesting 
a waiver and comments submitted on such a petition does not contain 
information exempt from public disclosure under part 20 of this chapter 
and would be made public as part of the docket associated with this 
request.



Sec.  1.922  Who will respond to a petition requesting a waiver?

    The Director or Deputy Directors of the Center for Food Safety and 
Applied Nutrition (CFSAN) or the Center for Veterinary Medicine (CVM), 
or the Director, Office of Compliance, CFSAN, or the Director, Office of 
Surveillance and Compliance, CVM, will respond to a petition requesting 
a waiver.



Sec.  1.924  What process applies to a petition requesting a waiver?

    (a) In general, the procedures set forth in Sec.  10.30 of this 
chapter govern our response to a petition requesting a waiver.
    (b) Under Sec.  10.30(h)(3) of this chapter, we will publish a 
notice in the Federal Register, requesting information and views on a 
filed petition, including information and views from persons who could 
be affected by the waiver if the petition were to be granted.

[[Page 119]]

    (c) Under Sec.  10.30(e)(3) of this chapter, we will respond to the 
petitioner in writing.
    (1) If we grant the petition, either in whole or in part, we will 
publish a notice in the Federal Register setting forth any waiver and 
the reasons for such waiver.
    (2) If we deny the petition (including partial denials), our written 
response to the petitioner will explain the reason(s) for the denial.
    (d) We will make readily accessible to the public, and periodically 
update, a list of filed petitions requesting waivers, including the 
status of each petition (for example, pending, granted, or denied).



Sec.  1.926  Under what circumstances may we deny a petition requesting
a waiver?

    We may deny a petition requesting a waiver if the petition does not 
provide the information required under Sec.  1.918 (including the 
requirements of Sec.  10.30 of this chapter), or if we determine that 
the waiver could result in the transportation of food under conditions 
that would be unsafe for human or animal health, or that the waiver 
could be contrary to the public interest.



Sec.  1.928  What process will we follow when waiving a requirement
of this subpart on our own initiative?

    If we, on our own initiative, determine that a waiver is 
appropriate, we will publish a notice in the Federal Register setting 
forth the waiver and the reasons for such waiver.



Sec.  1.930  When will a waiver that we grant become effective?

    Any waiver that we grant will become effective on the date that 
notice of the waiver is published in the Federal Register.



Sec.  1.932  Under what circumstances may we modify or revoke a waiver?

    We may modify or revoke a waiver if we determine that the waiver 
could result in the transportation of food under conditions that would 
be unsafe for human or animal health or that the waiver could be 
contrary to the public interest.



Sec.  1.934  What procedures apply if we determine that a waiver should
be modified or revoked?

    (a) We will provide the following notifications:
    (1) We will notify the entity that initially requested the waiver, 
in writing at the address identified in its petition, if we determine 
that a waiver granted in response to its petition should be modified or 
revoked.
    (2) We will publish a notice of our determination that a waiver 
should be modified or revoked in the Federal Register. This notice will 
establish a public docket so that interested parties may submit written 
submissions on our determination.
    (b) We will consider timely written submissions submitted to the 
public docket from interested parties.
    (c) We will publish a notice of our decision in the Federal 
Register. The effective date of the decision will be the date of 
publication of the notice.

Subpart P [Reserved]



Subpart Q_Administrative Detention of Drugs Intended for Human or Animal 
                                   Use



Sec.  1.980  Administrative detention of drugs.

    (a) General. This section sets forth the procedures for detention of 
drugs believed to be adulterated or misbranded. Administrative detention 
is intended to protect the public by preventing distribution or use of 
drugs encountered during inspections that may be adulterated or 
misbranded, until the Food and Drug Administration (FDA) has had time to 
consider what action it should take concerning the drugs, and to 
initiate legal action, if appropriate. Drugs that FDA orders detained 
may not be used, moved, altered, or tampered with in any manner by any 
person during the detention period, except as authorized under paragraph 
(h) of this section, until FDA terminates the detention order under 
paragraph (j) of this section, or the detention period expires, 
whichever occurs first.
    (b) Criteria for ordering detention. Administrative detention of 
drugs may be ordered in accordance with this section

[[Page 120]]

when an authorized FDA representative, during an inspection under 
section 704 of the Federal Food, Drug, and Cosmetic Act, has reason to 
believe that a drug, as defined in section 201(g) of the Federal Food, 
Drug, and Cosmetic Act, is adulterated or misbranded.
    (c) Detention period. The detention is to be for a reasonable period 
that may not exceed 20 calendar days after the detention order is 
issued, unless the FDA District Director in whose district the drugs are 
located determines that a greater period is required to seize the drugs, 
to institute injunction proceedings, or to evaluate the need for legal 
action, in which case the District Director may authorize detention for 
10 additional calendar days. The additional 10-calendar-day detention 
period may be ordered at the time the detention order is issued or at 
any time thereafter. The entire detention period may not exceed 30 
calendar days, except when the detention period is extended under 
paragraph (g)(6) of this section. An authorized FDA representative may, 
in accordance with paragraph (j) of this section, terminate a detention 
before the expiration of the detention period.
    (d) Issuance of detention order. (1) The detention order must be 
issued in writing, in the form of a detention notice, signed by the 
authorized FDA representative who has reason to believe that the drugs 
are adulterated or misbranded, and issued to the owner, operator, or 
agent in charge of the place where the drugs are located. If the owner 
or the user of the drugs is different from the owner, operator, or agent 
in charge of the place where the drugs are detained, a copy of the 
detention order must be provided to the owner or user of the drugs if 
the owner's or user's identity can be readily determined.
    (2) If detention of drugs in a vehicle or other carrier is ordered, 
a copy of the detention order must be provided to the shipper of record 
and the owner of the vehicle or other carrier, if their identities can 
be readily determined.
    (3) The detention order must include the following information:
    (i) A statement that the drugs identified in the order are detained 
for the period shown;
    (ii) A brief, general statement of the reasons for the detention;
    (iii) The location of the drugs;
    (iv) A statement that these drugs are not to be used, moved, 
altered, or tampered with in any manner during that period, except as 
permitted under paragraph (h) of this section, without the written 
permission of an authorized FDA representative;
    (v) Identification of the detained drugs;
    (vi) The detention order number;
    (vii) The date and hour of the detention order;
    (viii) The period of the detention;
    (ix) The text of section 304(g) of the Federal Food, Drug, and 
Cosmetic Act and paragraphs (g)(1) and (g)(2) of this section;
    (x) 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 paragraph (g)(3) 
of this section; and
    (xi) The location and telephone number of the FDA district office 
and the name of the FDA District Director.
    (e) Approval of detention order. A detention order, before issuance, 
must be approved by the FDA District Director in whose district the 
drugs are located. If prior written approval is not feasible, prior oral 
approval must be obtained and confirmed by written memorandum within FDA 
as soon as possible.
    (f) Labeling or marking a detained drug. An FDA representative 
issuing a detention order under paragraph (d) of this section must label 
or mark the drugs with official FDA tags that include the following 
information:
    (1) A statement that the drugs are detained by the U.S. Government 
in accordance with section 304(g) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 334(g)).

[[Page 121]]

    (2) A statement that the drugs must not be used, moved, altered, or 
tampered with in any manner for the period shown, without the written 
permission of an authorized FDA representative, except as authorized in 
paragraph (h) of this section.
    (3) A statement that the violation of a detention order or the 
removal or alteration of the tag is punishable by fine or imprisonment 
or both (section 303 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 333)).
    (4) The detention order number, the date and hour of the detention 
order, the detention period, and the name of the FDA representative who 
issued the detention order.
    (g) Appeal of a detention order. (1) A person who would be entitled 
to claim the drugs, if seized, may appeal a detention order. Any appeal 
must be submitted in writing to the FDA District Director in whose 
district the drugs are located within 5 working days of receipt of a 
detention order. If the appeal includes a request for an informal 
hearing, as defined in section 201(x) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(x)), the appellant must request either that 
a hearing be held within 5 working days after the appeal is filed or 
that the hearing be held at a later date, which must not be later than 
20 calendar days after receipt of a detention order.
    (2) The appellant of a detention order must state the ownership or 
proprietary interest the appellant has in the detained drugs. If the 
detained drugs are located at a place other than an establishment owned 
or operated by the appellant, the appellant must include documents 
showing that the appellant would have legitimate authority to claim the 
drugs if seized.
    (3) Any informal hearing on an appeal of a detention order must be 
conducted as a regulatory hearing under regulation in accordance with 
part 16 of this chapter, except that:
    (i) The detention order under paragraph (d) of this section, 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;
    (ii) A request for a hearing under this section should be addressed 
to the FDA District Director;
    (iii) The last sentence of 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 section;
    (iv) Paragraph (g)(4) of this section, rather than Sec.  16.42(a) of 
this chapter, describes the FDA employees, i.e., Office of Regulatory 
Affairs Program Directors or other FDA officials senior to an FDA 
District Director, who preside at hearings under this section.
    (4) The presiding officer of a regulatory hearing on an appeal of a 
detention order, who also must decide the appeal, must be an Office of 
Regulatory Affairs Program Director or another FDA official senior to an 
FDA District Director who is permitted by Sec.  16.42(a) of this chapter 
to preside over the hearing.
    (5) If the appellant requests a regulatory hearing and requests that 
the hearing be held within 5 working days after the appeal is filed, the 
presiding officer must, within 5 working days, hold the hearing and 
render a decision affirming or revoking the detention.
    (6) If the appellant requests a regulatory hearing and requests that 
the hearing be held at a date later than within 5 working days after the 
appeal is filed, but not later than 20 calendar days after receipt of a 
detention order, the presiding officer must hold the hearing at a date 
agreed upon by FDA and the appellant. The presiding officer must decide 
whether to affirm or revoke the detention within 5 working days after 
the conclusion of the hearing. The detention period extends to the date 
of the decision even if the 5-working-day period for making the decision 
extends beyond the otherwise applicable 20-calendar-day or 30-calendar-
day detention period.
    (7) If the appellant appeals the detention order but does not 
request a regulatory hearing, the presiding officer must render a 
decision on the appeal, affirming or revoking the detention within 5 
working days after the filing of the appeal.

[[Page 122]]

    (8) If the presiding officer affirms a detention order, the drugs 
continue to be detained until FDA terminates the detention under 
paragraph (j) of this section or the detention period expires, whichever 
occurs first.
    (9) If the presiding officer revokes a detention order, FDA must 
terminate the detention under paragraph (j) of this section.
    (h) Movement of detained drugs. (1) Except as provided in this 
paragraph, no person may move detained drugs within or from the place 
where they have been ordered detained until FDA terminates the detention 
under paragraph (j) of this section or the detention period expires, 
whichever occurs first.
    (2) If detained drugs are not in final form for shipment, the 
manufacturer may move them within the establishment where they are 
detained to complete the work needed to put them in final form. As soon 
as the drugs are moved for this purpose, the individual responsible for 
their movement must orally notify the FDA representative who issued the 
detention order, or another responsible district office official, of the 
movement of the drugs. As soon as the drugs are put in final form, they 
must be segregated from other drugs, and the individual responsible for 
their movement must orally notify the FDA representative who issued the 
detention order, or another responsible district office official, of 
their new location. The drugs put in final form must not be moved 
further without FDA approval.
    (3) The FDA representative who issued the detention order, or 
another responsible district office official, may approve, in writing, 
the movement of detained drugs for any of the following purposes:
    (i) To prevent interference with an establishment's operations or 
harm to the drugs;
    (ii) To destroy the drugs;
    (iii) To bring the drugs into compliance;
    (iv) For any other purpose that the FDA representative who issued 
the detention order, or other responsible district office official, 
believes is appropriate in the case.
    (4) If an FDA representative approves the movement of detained drugs 
under paragraph (h)(3) of this section, the detained drugs must remain 
segregated from other drugs and the person responsible for their 
movement must immediately orally notify the official who approved the 
movement of the drugs, or another responsible FDA district office 
official, of the new location of the detained drugs.
    (5) Unless otherwise permitted by the FDA representative who is 
notified of, or who approves, the movement of drugs under this 
paragraph, the required tags must accompany the drugs during and after 
movement and must remain with the drugs until FDA terminates the 
detention or the detention period expires, whichever occurs first.
    (i) Actions involving adulterated or misbranded drugs. If FDA 
determines that the detained drugs, including any that have been put in 
final form, are adulterated or misbranded, or both, it may initiate 
legal action against the drugs or the responsible individuals, or both, 
or request that the drugs be destroyed or otherwise brought into 
compliance with the Federal Food, Drug, and Cosmetic Act under FDA's 
supervision.
    (j) Detention termination. If FDA decides to terminate a detention 
or when the detention period expires, whichever occurs first, an FDA 
representative authorized to terminate a detention will issue a 
detention termination notice releasing the drugs to any person who 
received the original detention order or that person's representative 
and will remove, or authorize in writing the removal of, the required 
labels or tags.
    (k) Recordkeeping requirements. (1) After issuance of a detention 
order under paragraph (d) of this section, the owner, operator, or agent 
in charge of any factory, warehouse, other establishment, or consulting 
laboratory where detained drugs are manufactured, processed, packed, or 
held, must have, or establish, and maintain adequate records relating to 
how the detained drugs may have become adulterated or misbranded, 
records on any distribution of the drugs before and after the detention 
period, records on the correlation of any in-process detained drugs that 
are put in final form under paragraph (h) of this section to the 
completed drugs, records of any changes in, or processing of, the drugs

[[Page 123]]

permitted under the detention order, and records of any other movement 
under paragraph (h) of this section. Records required under this 
paragraph must be provided to FDA on request for review and copying. Any 
FDA request for access to records required under this paragraph must be 
made at a reasonable time, must state the reason or purpose for the 
request, and must identify to the fullest extent practicable the 
information or type of information sought in the records to which access 
is requested.
    (2) Records required under this paragraph must be maintained for a 
maximum period of 2 years after the issuance of the detention order or 
for such other shorter period as FDA directs. When FDA terminates the 
detention or when the detention period expires, whichever occurs first, 
FDA will advise all persons required under this paragraph to keep 
records concerning that detention whether further recordkeeping is 
required for the remainder of the 2-year, or shorter, period. FDA 
ordinarily will not require further recordkeeping if the Agency 
determines that the drugs are not adulterated or misbranded or that 
recordkeeping is not necessary to protect the public health, unless the 
records are required under other regulations in this chapter (e.g., the 
good manufacturing practice regulation in part 211 of this chapter).

[79 FR 30719, May 29, 2014, as amended at 82 FR 14144, Mar. 17, 2017]



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 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

[[Page 124]]

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 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

[[Page 125]]

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]



                    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

[[Page 126]]

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. 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]

[[Page 127]]



                        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)-(v) [Reserved]
    (2) Metered-dose short-acting adrenergic bronchodilator human drugs 
for oral inhalation. Oral pressurized metered-dose inhalers containing 
the following active moieties:
    (i)-(v) [Reserved]
    (3) [Reserved]
    (4) Other essential uses. (i)-(ii) [Reserved]
    (iii) Anesthetic drugs for topical use on accessible mucous 
membranes of humans where a cannula is used for application.
    (iv)-(ix) [Reserved]
    (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

[[Page 128]]

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, as amended at 71 FR 70873, Dec. 7, 2006; 70 
FR 17192, Apr. 4, 2005; 75 FR 19241, Apr. 14, 2010; 73 FR 69552, Nov. 
19, 2008; 75 FR 19241, Apr. 14, 2010; 81 FR 74302, Oct. 26, 2016]



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

[[Page 129]]

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 at 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, 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

[[Page 130]]

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.
    (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.

[[Page 131]]

    (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 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 (Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD 20993-
0002, 301-796-8930,, e-mail: [email protected], is the designated 
product jurisdiction officer.

[68 FR 37077, June 23, 2003, as amended at 71 FR 16033, Mar. 30, 2006; 
75 FR 13678, Mar. 23, 2010]



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;

[[Page 132]]

    (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 copies of Requests 
for Designation may be addressed to [email protected].

[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.

[[Page 133]]

    (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 4_REGULATION OF COMBINATION PRODUCTS--Table of Contents



     Subpart A_Current Good Manufacturing Practice Requirements for 
                          Combination Products

Sec.
4.1 What is the scope of this subpart?
4.2 How does FDA define key terms and phrases in this subpart?
4.3 What current good manufacturing practice requirements apply to my 
          combination product?
4.4 How can I comply with these current good manufacturing practice 
          requirements for a co-packaged or single-entity combination 
          product?

    Subpart B_Postmarketing Safety Reporting for Combination Products

4.100 What is the scope of this subpart?
4.101 How does FDA define key terms and phrases in this subpart?
4.102 What reports must you submit to FDA for your combination product 
          or constituent part?
4.103 What information must you share with other constituent part 
          applicants for the combination product?
4.104 How and where must you submit postmarketing safety reports for 
          your combination product or constituent part?
4.105 What are the postmarketing safety reporting recordkeeping 
          requirements for your combination product or constituent part?

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360b-360f, 
360h-360j, 360l, 360hh-360ss, 360aaa-360bbb, 371(a), 372-374, 379e, 381, 
383, 394; 42 U.S.C. 216, 262, 263a, 264, 271.

    Source: 78 FR 4321, Jan. 22, 2013, unless otherwise noted.



     Subpart A_Current Good Manufacturing Practice Requirements for 
                          Combination Products



Sec.  4.1  What is the scope of this subpart?

    This subpart applies to combination products. It establishes which 
current good manufacturing practice requirements apply to these 
products. This subpart clarifies the application of current good 
manufacturing practice regulations to combination products, and provides 
a regulatory framework for designing and implementing the current good 
manufacturing practice operating system at facilities that manufacture 
co-packaged or single-entity combination products.



Sec.  4.2  How does FDA define key terms and phrases in this subpart?

    The terms listed in this section have the following meanings for 
purposes of this subpart:
    Biological product has the meaning set forth in Sec.  3.2(d) of this 
chapter. A biological product also meets the definitions of either a 
drug or device as these terms are defined under this section.
    Combination product has the meaning set forth in Sec.  3.2(e) of 
this chapter.
    Constituent part is a drug, device, or biological product that is 
part of a combination product.

[[Page 134]]

    Co-packaged combination product has the meaning set forth in Sec.  
3.2(e)(2) of this chapter.
    Current good manufacturing practice operating system means the 
operating system within an establishment that is designed and 
implemented to address and meet the current good manufacturing practice 
requirements for a combination product.
    Current good manufacturing practice requirements means the 
requirements set forth under Sec.  4.3(a) through (d).
    Device has the meaning set forth in Sec.  3.2(f) of this chapter. A 
device that is a constituent part of a combination product is considered 
a finished device within the meaning of the QS regulation.
    Drug has the meaning set forth in Sec.  3.2(g) of this chapter. A 
drug that is a constituent part of a combination product is considered a 
drug product within the meaning of the drug CGMPs.
    Drug CGMPs refers to the current good manufacturing practice 
regulations set forth in parts 210 and 211 of this chapter.
    HCT/Ps refers to human cell, tissue, and cellular and tissue-based 
products, as defined in Sec.  1271.3(d) of this chapter. An HCT/P that 
is not solely regulated under section 361 of the Public Health Service 
Act may be a constituent part of a combination product. Such an HCT/P is 
subject to part 1271 of this chapter and is also regulated as a drug, 
device, and/or biological product.
    Manufacture includes, but is not limited to, designing, fabricating, 
assembling, filling, processing, testing, labeling, packaging, 
repackaging, holding, and storage.
    QS regulation refers to the quality system regulation in part 820 of 
this chapter.
    Single-entity combination product has the meaning set forth in Sec.  
3.2(e)(1) of this chapter.
    Type of constituent part refers to the category of the constituent 
part, which can be either a biological product, a device, or a drug, as 
these terms are defined under this section.



Sec.  4.3  What current good manufacturing practice requirements apply
to my combination product?

    If you manufacture a combination product, the requirements listed in 
this section apply as follows:
    (a) The current good manufacturing practice requirements in parts 
210 and 211 of this chapter apply to a combination product that includes 
a drug constituent part;
    (b) The current good manufacturing practice requirements in part 820 
of this chapter apply to a combination product that includes a device 
constituent part;
    (c) The current good manufacturing practice requirements among the 
requirements (including standards) for biological products in parts 600 
through 680 of this chapter apply to a combination product that includes 
a biological product constituent part to which those requirements would 
apply if that constituent part were not part of a combination product; 
and
    (d) The current good tissue practice requirements including donor 
eligibility requirements for HCT/Ps in part 1271 of this chapter apply 
to a combination product that includes an HCT/P.



Sec.  4.4  How can I comply with these current good manufacturing
practice requirements for a co-packaged or single-entity combination
product?

    (a) Under this subpart, for single entity or co-packaged combination 
products, compliance with all applicable current good manufacturing 
practice requirements for the combination product shall be achieved 
through the design and implementation of a current good manufacturing 
practice operating system that is demonstrated to comply with:
    (1) The specifics of each set of current good manufacturing practice 
regulations listed under Sec.  4.3 as they apply to each constituent 
part included in the combination product; or
    (2) Paragraph (b) of this section.
    (b) If you elect to establish a current good manufacturing practice 
operating system in accordance with paragraph (b) of this section, the 
following requirements apply:
    (1) If the combination product includes a device constituent part 
and a

[[Page 135]]

drug constituent part, and the current good manufacturing practice 
operating system has been shown to comply with the drug CGMPs, the 
following provisions of the QS regulation must also be shown to have 
been satisfied; upon demonstration that these requirements have been 
satisfied, no additional showing of compliance with respect to the QS 
regulation need be made:
    (i) Section 820.20 of this chapter. Management responsibility.
    (ii) Section 820.30 of this chapter. Design controls.
    (iii) Section 820.50 of this chapter. Purchasing controls.
    (iv) Section 820.100 of this chapter. Corrective and preventive 
action.
    (v) Section 820.170 of this chapter. Installation.
    (vi) Section 820.200 of this chapter. Servicing.
    (2) If the combination product includes a device constituent part 
and a drug constituent part, and the current good manufacturing practice 
operating system has been shown to comply with the QS regulation, the 
following provisions of the drug CGMPs must also be shown to have been 
satisfied; upon demonstration that these requirements have been 
satisfied, no additional showing of compliance with respect to the drug 
CGMPs need be made:
    (i) Section 211.84 of this chapter. Testing and approval or 
rejection of components, drug product containers, and closures.
    (ii) Section 211.103 of this chapter. Calculation of yield.
    (iii) Section 211.132 of this chapter. Tamper-evident packaging 
requirements for over-the-counter (OTC) human drug products.
    (iv) Section 211.137 of this chapter. Expiration dating.
    (v) Section 211.165 of this chapter. Testing and release for 
distribution.
    (vi) Section 211.166 of this chapter. Stability testing.
    (vii) Section 211.167 of this chapter. Special testing requirements.
    (viii) Section 211.170 of this chapter. Reserve samples.
    (3) In addition to being shown to comply with the other applicable 
manufacturing requirements listed under Sec.  4.3, if the combination 
product includes a biological product constituent part, the current good 
manufacturing practice operating system must also be shown to implement 
and comply with all manufacturing requirements identified under Sec.  
4.3(c) that would apply to that biological product if that constituent 
part were not part of a combination product.
    (4) In addition to being shown to comply with the other applicable 
current good manufacturing practice requirements listed under Sec.  4.3, 
if the combination product includes an HCT/P, the current good 
manufacturing practice operating system must also be shown to implement 
and comply with all current good tissue practice requirements identified 
under Sec.  4.3(d) that would apply to that HCT/P if it were not part of 
a combination product.
    (c) During any period in which the manufacture of a constituent part 
to be included in a co-packaged or single entity combination product 
occurs at a separate facility from the other constituent part(s) to be 
included in that single-entity or co-packaged combination product, the 
current good manufacturing practice operating system for that 
constituent part at that facility must be demonstrated to comply with 
all current good manufacturing practice requirements applicable to that 
type of constituent part.
    (d) When two or more types of constituent parts to be included in a 
single-entity or co-packaged combination product have arrived at the 
same facility, or the manufacture of these constituent parts is 
proceeding at the same facility, application of a current good 
manufacturing process operating system that complies with paragraph (b) 
of this section may begin.
    (e) The requirements set forth in this subpart and in parts 210, 
211, 820, 600 through 680, and 1271 of this chapter listed in Sec.  4.3, 
supplement, and do not supersede, each other unless the regulations 
explicitly provide otherwise. In the event of a conflict between 
regulations applicable under this subpart to combination products, 
including their constituent parts, the regulations most specifically 
applicable to the constituent part in question shall supersede the more 
general.

[[Page 136]]



    Subpart B_Postmarketing Safety Reporting for Combination Products

    Source: 81 FR 92624, Dec. 20, 2016, unless otherwise noted.



Sec.  4.100  What is the scope of this subpart?

    (a) This subpart identifies postmarketing safety reporting 
requirements for combination product applicants and constituent part 
applicants.
    (b) This subpart does not apply to investigational combination 
products, combination products that have not received marketing 
authorization, or to persons other than combination product applicants 
and constituent part applicants.
    (c) This subpart supplements and does not supersede other provisions 
of this chapter, including the provisions in parts 314, 600, 606, 803, 
and 806 of this chapter, unless a regulation explicitly provides 
otherwise.



Sec.  4.101  How does the FDA define key terms and phrases in this 
subpart?

    Abbreviated new drug application (ANDA) has the same meaning given 
the term ``abbreviated application'' in Sec.  314.3(b) of this chapter.
    Agency or we means Food and Drug Administration.
    Applicant means, for the purposes of this subpart, a person holding 
an application under which a combination product or constituent part of 
a combination product has received marketing authorization (such as 
approval, licensure, or clearance). For the purposes of this subpart, 
applicant is used interchangeably with the term ``you.''
    Application means, for purposes of this subpart, a BLA, an NDA, an 
ANDA, or a device application, including all amendments and supplements 
to them.
    Biological product has the meaning given the term in section 351 of 
the Public Health Service Act (42 U.S.C. 262).
    Biological product deviation report (BPDR) is a report as described 
in Sec. Sec.  600.14 and 606.171 of this chapter.
    Biologics license application (BLA) has the meaning given the term 
in section 351 of the Public Health Service Act (42 U.S.C. 262) and 
Sec.  601.2 of this chapter.
    Combination product has the meaning given the term in Sec.  3.2(e) 
of this chapter.
    Combination product applicant means an applicant that holds the 
application(s) for a combination product.
    Constituent part has the meaning given the term in Sec.  4.2.
    Constituent part applicant means the applicant for a constituent 
part of a combination product the constituent parts of which are 
marketed under applications held by different applicants.
    Correction or removal report is a report as described in Sec.  
806.10 of this chapter.
    De novo classification request is a submission requesting de novo 
classification under section 513(f)(2) of the Federal Food, Drug, and 
Cosmetic Act.
    Device has the meaning given the term in section 201(h) of the 
Federal Food, Drug, and Cosmetic Act.
    Device application means a PMA, PDP, premarket notification 
submission, de novo classification request, or HDE.
    Drug has the meaning given the term in section 201(g)(1) of the 
Federal Food, Drug, and Cosmetic Act.
    Field alert report is a report as described in Sec.  314.81 of this 
chapter.
    Fifteen-day report is a report required to be submitted within 15 
days as described in Sec.  314.80 of this chapter or Sec.  600.80 of 
this chapter, as well as followup reports to such a report.
    Five-day report is a report as described in Sec. Sec.  803.3 and 
803.53 of this chapter, as well as supplemental or followup reports to 
such a report as described in Sec.  803.56 of this chapter.
    Humanitarian device exemption (HDE) has the meaning given the term 
in Sec.  814.3 of this chapter.
    Malfunction report is a report as described in Sec.  803.50 of this 
chapter as well as supplemental or followup reports to such a report as 
described in Sec.  803.56 of this chapter.
    New drug application (NDA) has the meaning given the term 
``application'' in Sec.  314.3(b) of this chapter.
    Premarket approval application (PMA) has the meaning given the term 
in Sec.  814.3 of this chapter.

[[Page 137]]

    Premarket notification submission is a submission as described in 
Sec.  807.87 of this chapter.
    Product Development Protocol (PDP) is a submission as set forth in 
section 515(f) of the Federal Food, Drug, and Cosmetic Act.



Sec.  4.102  What reports must you submit to FDA for your combination
product or constituent part?

    (a) In general. If you are a constituent part applicant, the 
reporting requirements applicable to you that are identified in this 
section apply to your constituent part, and if you are a combination 
product applicant, the reporting requirements applicable to you that are 
identified in this section apply to your combination product as a whole.
    (b) Reporting requirements applicable to both combination product 
applicants and constituent part applicants. If you are a combination 
product applicant or constituent part applicant, you must comply with 
the reporting requirements identified in paragraphs (b)(1), (b)(2), or 
(b)(3) of this section for your product based on its application type. 
If you are a combination product applicant, you are required to submit a 
report as specified in this paragraph unless you have already submitted 
a report in accordance with paragraph (c) of this section for the same 
event that: Includes the information required under the applicable 
regulations identified in this paragraph, is required to be submitted in 
the same manner under Sec.  4.104, and meets the deadlines under the 
applicable regulations identified in this paragraph.
    (1) If your combination product or device constituent part received 
marketing authorization under a device application, you must comply with 
the requirements for postmarketing safety reporting described in parts 
803 and 806 of this chapter with respect to your product.
    (2) If your combination product or drug constituent part received 
marketing authorization under an NDA or ANDA, you must comply with the 
requirements for postmarketing safety reporting described in part 314 of 
this chapter with respect to your product.
    (3) If your combination product or biological product constituent 
part received marketing authorization under a BLA, you must comply with 
the requirements for postmarketing safety reporting described in parts 
600 and 606 of this chapter with respect to your product.
    (c) Reporting requirements applicable only to combination product 
applicants. If you are a combination product applicant, in addition to 
compliance with paragraph (a) of this section, you must also comply with 
the reporting requirements identified under this paragraph as applicable 
to your product based on its constituent parts. If you are a combination 
product applicant, you are required to submit a report as specified in 
this paragraph unless you have already submitted a report in accordance 
with paragraph (b) of this section for the same event that: Includes the 
information required under the applicable regulations for the report 
identified in this paragraph; is required to be submitted in the same 
manner under Sec.  4.104 of this chapter; and, unless otherwise 
specified in this paragraph, meets the deadlines under the applicable 
regulations for the report identified in this paragraph.
    (1) If your combination product contains a device constituent part, 
you must submit:
    (i) Five-day reports;
    (ii) Malfunction reports; and
    (iii) Correction or removal reports, and maintain records as 
described in Sec.  806.20 of this chapter for corrections and removals 
not required to be reported.
    (2) If your combination product contains a drug constituent part, 
you must submit:
    (i) Field alert reports; and
    (ii) Fifteen-day reports as described in Sec.  314.80 of this 
chapter, which must be submitted within 30 calendar days instead of 15 
calendar days if your combination product received marketing 
authorization under a device application.
    (3) If your combination product contains a biological product 
constituent part, you must submit:
    (i) Biological product deviation reports; and

[[Page 138]]

    (ii) Fifteen-day reports as described in Sec.  600.80 of this 
chapter, which must be submitted within 30 calendar days instead of 15 
calendar days if your combination product received marketing 
authorization under a device application.
    (d) Other reporting requirements for combination product applicants. 
(1) If you are the combination product applicant for a combination 
product that contains a device constituent part and that received 
marketing authorization under an NDA, ANDA, or BLA, in addition to the 
information otherwise required in the periodic safety reports you submit 
under Sec.  314.80 or Sec.  600.80 of this chapter, your periodic safety 
reports must also include a summary and analysis of the reports 
identified in paragraphs (c)(1)(i) and (ii) of this section that were 
submitted during the report interval.
    (2) If you are the combination product applicant for a combination 
product that received marketing authorization under a device 
application, in addition to the reports required under paragraphs (b) 
and (c) of this section, you must submit reports regarding postmarketing 
safety events if notified by the Agency in writing that the Agency 
requires additional information. We will specify what safety information 
is needed and will require such information if we determine that 
protection of the public health requires additional or clarifying safety 
information for the combination product. In any request under this 
section, we will state the reason or purpose for the safety information 
request, specify the due date for submitting the information, and 
clearly identify the reported event(s) related to our request.



Sec.  4.103  What information must you share with other constituent
part applicants for the combination product?

    (a) When you receive information regarding an event that involves a 
death or serious injury as described in Sec.  803.3 of this chapter, or 
an adverse experience as described in Sec.  314.80(a) of this chapter or 
Sec.  600.80(a) of this chapter, associated with the use of the 
combination product, you must provide the information to the other 
constituent part applicant(s) for the combination product no later than 
5 calendar days of your receipt of the information.
    (b) With regard to information you must provide to the other 
constituent part applicant(s) for the combination product, you must 
maintain records that include:
    (1) A copy of the information you provided,
    (2) The date the information was received by you,
    (3) The date the information was provided to the other constituent 
part applicant(s), and
    (4) The name and address of the other constituent part applicant(s) 
to whom you provided the information.



Sec.  4.104  How and where must you submit postmarketing safety reports 
for your combination product or constituent part?

    (a) If you are a constituent part applicant, you must submit 
postmarketing safety reports in accordance with the regulations 
identified in Sec.  4.102(b) that are applicable to your product based 
on its application type.
    (b) If you are a combination product applicant, you must submit 
postmarketing safety reports required under Sec.  4.102 in the manner 
specified in the regulation applicable to the type of report, with the 
following exceptions:
    (1) You must submit the postmarketing safety reports identified in 
Sec.  4.102(c)(1)(i) and (ii) in accordance with Sec.  314.80(g) of this 
chapter if your combination product received marketing authorization 
under an NDA or ANDA or in accordance with Sec.  600.80(h) of this 
chapter if your combination product received marketing authorization 
under a BLA.
    (2) You must submit the postmarketing safety reports identified in 
Sec.  4.102(c)(2)(ii) and (c)(3)(ii) in accordance with Sec.  803.12(a) 
of this chapter if your combination product received marketing 
authorization under a device application.



Sec.  4.105  What are the postmarketing safety reporting recordkeeping 
requirements for your combination product or constituent part?

    (a) If you are a constituent part applicant:

[[Page 139]]

    (1) You must maintain records in accordance with the recordkeeping 
requirements in the applicable regulation(s) described in Sec.  
4.102(b).
    (2) You must maintain records required under Sec.  4.103(b) for the 
longest time period required for records under the postmarketing safety 
reporting regulations applicable to your product under Sec.  4.102(b).
    (b) If you are a combination product applicant, you must maintain 
records in accordance with the longest time period required for records 
under the regulations applicable to your product under Sec.  4.102.



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.

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

    Source: 77 FR 15962, Mar. 19, 2012, unless otherwise noted.

Subparts A-L [Reserved]



                         Subpart M_Organization



Sec.  5.1100  Headquarters.

Office of the Commissioner.\1\
---------------------------------------------------------------------------

    \1\ Mailing address: 10903 New Hampshire Ave., Silver Spring, MD 
20993.
---------------------------------------------------------------------------

Office of the Chief Counsel.
Office of the Executive Secretariat.
    Freedom of Information Staff.
    Dockets Management Staff.
Office of the Chief Scientist.\1\
Office of Counter-Terrorism and Emerging Threats.
Office of Scientific Integrity.
Office of Regulatory Science and Innovation.
    Division of Science Innovation and Critical Path.
    Division of Scientific Computing and Medical Information.
Office of Scientific Professional Development.
Office of Health Informatics.
Office of Women's Health.
Office of External Affairs.
    Office of Media Affairs.
    Office of Communications.
    Office of Health and Constituent Affairs.
Office of Minority Health.
National Center for Toxicological Research.\2\
---------------------------------------------------------------------------

    \2\ Mailing address: Food and Drug Administration, 3900 NCTR Rd., 
Jefferson, AR 72079.
---------------------------------------------------------------------------

    Office of the Center Director.
    Office of Management.
    Office of Research.
    Division of Biochemical Toxicology.
    Division of Genetic and Molecular Toxicology.
    Division of Microbiology.
    Division of Systems Biology.
    Division of Neurotoxicology.
    Division of Bioinformatics and Biostatistics.
    Office of Scientific Coordination.
Office of Foods and Veterinary Medicine.\3\
---------------------------------------------------------------------------

    \3\ Mailing address: Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993.
---------------------------------------------------------------------------

    Communications and Public Engagement Staff.
    Executive Secretariat Staff.
Office of Resource Planning and Strategic Management.
    Strategic Planning and Budget Formulation Staff.
    Risk Analytics Staff.
Office of Coordinated Outbreak Response and Evaluation Network.\4\
---------------------------------------------------------------------------

    \4\ Mailing address: 4300 River Rd., University Station (HFS-015), 
College Park, MD 20740.
---------------------------------------------------------------------------

    Prevention Staff.
    Response Staff.
Center for Food Safety and Applied Nutrition.\5\
---------------------------------------------------------------------------

    \5\ Mailing address: Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740.
---------------------------------------------------------------------------

Office of the Center Director.
    International Affairs Staff.
    Executive Operations Staff.
Office of Management.
    Safety Staff.
    Division of Budget & Planning.
    Division of Program Services.
Office of Analytics and Outreach.
    Food Defense and Emergency Coordination Staff.
    Biostatistics and Bioinformatics Staff.
    Division of Education, Outreach and Information.
    Education and Outreach Branch.
    Information Center Branch.
    Web Branch.
    Division of Public Health Informatics and Analytics.
    Epidemiology and Surveillance Branch.
    Signals Management Branch.
    Consumers Studies Branch.
    Division of Risk and Decision Analysis.
    Risk Analysis Branch.
    Contaminant Assessment Branch.
    Exposure Assessment Branch.
Office of Food Safety.

[[Page 140]]

    Retail Food Production Staff.
    Multi-Commodity Foods Staff.
    Division of Seafood Science and Technology.
    Chemical Hazard Science Branch.
    Microbiological Hazards Science Branch.
    Division of Food Processing Science & Technology.
    Process Engineering Branch.
    Food Technology Branch.
    Division of Plant and Dairy Food Safety.
    Plant Products Branch.
    Dairy and Egg Branch.
    Division of Seafood Safety.
    Shellfish and Aquaculture Policy Branch.
    Seafood Processing and Technology Policy Branch.
    Division of Produce Safety.
    Fresh Produce Branch.
    Processed Produce Branch.
    Division of Dairy, Egg, and Meat Products.
    Milk and Milk Products Branch.
    Egg and Meat Products Branch.
    Division of Plant Products and Beverages.
    Plant Products Branch.
    Beverages Branch.
Office of Cosmetics and Colors.
    Division of Color Certification and Technology.
    Division of Cosmetics.
Office of Regulatory Science.
    Division of Analytical Chemistry.
    Methods Development Branch.
    Spectroscopy and Mass Spectrometry Branch.
    Division of Microbiology.
    Microbial Methods and Development Branch.
    Molecular Methods and Subtyping Branch.
    Division of Bioanalytical Chemistry.
    Chemical Contaminants Branch.
    Bioanalytical Methods Branch.
Office of Food Additive Safety.
    Division of Food Contract Notifications.
    Division of Biotechnology and GRAS Notice Review.
    Division of Petition Review.
Office of Compliance.
    Division of Enforcement.
    Division of Field Programs and Guidance.
Office of Applied Research and Safety Assessment.
    Division of Molecular Biology.
    Division of Virulence Assessment.
    Virulence Mechanisms Branch.
    Immunobiology Branch.
    Division of Toxicology.
Office of Regulations, Policy and Social Sciences.
    Regulations and Special Government Employee Management Staff.
    Division of Social Sciences.
Office of Nutrition and Food Labeling.
    Food Labeling and Standards Staff.
    Nutrition Programs Staff.
Office of Dietary Supplement Program.
    Evaluation and Research Staff.
    Regulatory Implementation Staff.
    Center for Veterinary Medicine.\6\
---------------------------------------------------------------------------

    \6\ Mailing address: Food and Drug Administration, 7519 Standish 
Pl., Rockville MD 20855.
---------------------------------------------------------------------------

Office of the Center Director.
Office of Management.
    Program and Resources Management Staff.
    Human Capital Management Staff.
    Talent Development Staff.
    Management Logistics Staff.
    Budget Planning and Evaluation Staff.
Office of New Animal Drug Evaluation.
    Division of Therapeutic Drugs for Food Animals.
    Division of Production Drugs.
    Division of Therapeutic Drugs for Non-Food Animals.
    Division of Human Food Safety.
    Division of Manufacturing Technologies.
    Division of Scientific Support.
    Division of Generic Animal Drugs.
    Division of Business Information Science and Management.
Office of Surveillance and Compliance.
    Division of Surveillance.
    Division of Animal Feeds.
    Division of Compliance.
    Division of Veterinary Product Safety.
Office of Research.
    Division of Residue Chemistry.
    Division of Applied Veterinary Research.
    Division of Animal and Food Microbiology.
Office of Minor Use and Minor Species Animal Drug Development.
OFFICE OF MEDICAL PRODUCTS AND TOBACCO
Office of Medical Products and Tobacco--Immediate Office.\7\
---------------------------------------------------------------------------

    \7\ Mailing address: 10903 New Hampshire Ave., Bldg. 1, Silver 
Spring, MD 20993.
---------------------------------------------------------------------------

    Office of Special Medical Programs--Immediate Office.\8\
---------------------------------------------------------------------------

    \8\ Mailing address: 10903 New Hampshire Ave., Bldg. 32, Silver 
Spring, MD 20993.
---------------------------------------------------------------------------

    Advisory Committee Oversight and Management Staff.
    Good Clinical Practice Staff.
    Office of Pediatric Therapeutics.
    Office of Orphan Products Development.
    Office of Combination Products.
Center for Biologics Evaluation and Research.\9\
---------------------------------------------------------------------------

    \9\ Mailing address: 10903 New Hampshire Ave., Bldg. 71, Silver 
Spring, MD 20993.
---------------------------------------------------------------------------

    Office of the Center Director.
    Executive Operations Staff.
    Regulatory Information Management Staff.
    Regulations and Policy Staff.
    Records Management Staff.
    Bioinformatics Support Staff.
    Business Operations Staff.
Office of Management.
    Planning and Performance Management Staff.

[[Page 141]]

    Division of Program Services.
    Program Operations Branch.
    Program Services Branch.
    Division of Budget and Resource Management.
    Budget Analysis and Formulation Branch.
    Resource Management Branch.
    Division of Program Services.
    Building Operations Staff.
    Program Management Services Branch.
    Program Operations Branch.
    Division of Scientific Advisors and Consultants.
    Division of Veterinary Services.
Office of Compliance and Biologics Quality.
    Division of Case Management.
    Blood and Tissue Compliance Branch.
    Advertising and Promotional Labeling Branch.
    Biological Drug and Device Compliance Branch.
    Division of Manufacturing and Product Quality.
    Product Release Branch.
    Manufacturing Review Branch I.
    Manufacturing Review Branch II.
    Applications Review Branch.
    Division of Inspections and Surveillance.
    Program Surveillance Branch.
    Bioresearch Monitoring Branch.
    Division of Biological Standards and Quality Control.
    Laboratory of Analytical Chemistry and Blood Related Products.
    Quality Assurance Branch.
    Laboratory of Microbiology, In-vivo Testing and Standards.
Office of Blood Research and Review.
    Administrative Staff.
    Policy and Publication Staff.
    Regulatory Project Management Staff.
    Division of Emerging and Transfusion Transmitted Diseases.
    Laboratory of Molecular Virology.
    Laboratory of Emerging Pathogens.
    Laboratory of Bacterial and Transmissible Spongiform Encephalopathy 
Agents.
    Product Review Branch.
    Division of Hematology Clinical Review.
    Hematology Product Review Branch.
    Clinical Review Branch.
    Division of Blood Components and Devices.
    Blood and Plasma Branch.
    Devices and Review Branch.
    Division of Hematology Research and Review.
    Laboratory of Cellular Hematology.
    Laboratory of Hemostasis.
    Laboratory of Plasma Derivatives.
    Laboratory of Biochemistry and Vascular Biology.
Office of Vaccine Research and Review.
    Program Operations Staff.
    Division of Bacterial, Parasitic, and Allergenic Products.
    Laboratory of Immunobiochemistry.
    Laboratory of Respiratory and Special Pathogens.
    Laboratory of Bacterial Polysaccharides.
    Laboratory of Mucosal Pathogens and Cellular Immunology.
    Division of Viral Products.
    Laboratory of Pediatric and Respiratory Viral Diseases.
    Laboratory of Hepatitis Viruses.
    Laboratory of Retroviruses.
    Laboratory of DNA Viruses.
    Laboratory of Vector-Borne Diseases.
    Laboratory of Method Development.
    Laboratory of Immunoregulation.
    Division of Vaccines and Related Products Applications.
    Clinical Review Branch 1.
    Clinical Review Branch 2.
    CMC Review Branch 1.
    CMC Review Branch 2.
    CMC Review Branch 3.
    Review Management Support Branch.
Office of Communication, Outreach, and Development.
    Division of Disclosure and Oversight Management.
    Congressional and Oversight Branch.
    Access Litigation and Freedom of Information Branch.
    Division of Manufacturers Assistance and Training.
    Career Development and Directed Training Branch.
    Manufacturers Assistance and Technical Training Branch.
    Division of Communication and Consumer Affairs.
    Communication Technology Branch.
    Consumer Affairs Branch.
Office of Biostatistics and Epidemiology.
    Division of Biostatistics.
    Vaccine Evaluation Branch.
    Therapeutics Evaluation Branch.
    Division of Epidemiology.
    Pharmacovigilance Branch.
    Analytic Epidemiology Branch.
Office of Cellular, Tissue and Gene Therapies.
    Regulatory Management Staff.
    Division of Cellular and Gene Therapies.
    Cell Therapies Branch.
    Gene Therapies Branch.
    Gene Transfer and Immunogencity Branch.
    Tumor Vaccine and Biotechnology Branch.
    Cellular and Tissue Therapy Branch.
    Division of Clinical Evaluation and Pharmacological Toxicology 
Review.
    General Medicine Branch.
    Pharmacology/Toxicology Branch.
    Oncology Branch.
    Division of Human Tissues.
    Human Tissue and Reproduction Branch.
Center for Tobacco Products.\10\
---------------------------------------------------------------------------

    \10\ Mailing address: 10903 New Hampshire Ave., Bldg. 75, Silver 
Spring, MD 20993.
---------------------------------------------------------------------------

    Office of the Center Director.

[[Page 142]]

    Office of Management.
    Acquisitions and Assistance Staff.
    Information and Technology Staff.
    Management and Logistics Staff.
    Division of Financial Management.
    Division of Human Capital.
    Office of Regulations.
    Office of Science.
    Regulatory Science and Management Staff.
    Research Staff.
    Division of Regulatory Project Management.
    Regulatory Project Management Branch I.
    Regulatory Project Management Branch II.
    Regulatory Project Management Branch III.
    Regulatory Project Management Branch IV.
    Division of Regulatory Science Informatics.
    Division of Product Science.
    Division of Individual Health Science.
    Division of Population Health Science.
    Division of Non-Clinical Science.
    Office of Health Communication and Education.
    Division of Public Health Education.
    Division of Health, Scientific, and Regulatory Communication.
    Office of Compliance and Enforcement.
    Division of Enforcement and Manufacturing.
    Division of Promotion, Advertising and Labeling.
    Division of State Programs.
    Division of Business Operations.
Center for Drug Evaluation and Research.\11\
---------------------------------------------------------------------------

    \11\ Mailing address: 10903 New Hampshire Ave., Bldg. 51, Silver 
Spring, MD 20993.
---------------------------------------------------------------------------

Office of the Center Director.
    Controlled Substance Staff.
    Professional Affairs and Stakeholder Engagement Staff.
    Counter-Terrorism and Emergency Coordination Staff.
    Drug Shortages Staff.
Office of Regulatory Policy.
    Division of Regulatory Policy I.
    Division of Regulatory Policy II.
    Division of Regulatory Policy III.
    Division of Regulatory Policy IV.
    Division of Information Disclosure Policy.
    Proactive Disclosure Branch.
    Freedom of Information Branch.
Office of Management.
    Strategic Programs and Initiatives Staff.
    Ethics Liaison Staff.
    Division of Budget Execution and Resource Management.
    Budget Execution Branch.
    Acquisitions Support Branch.
    Financial Accountability Branch.
    Division of Management Services.
    Human Capital Management Branch.
    Human Capital Programs Branch.
    Facilities Operations Branch.
    Property and Travel Services Branch.
    Leave and Performance Management Branch.
    Division of User Fee Management and Budget Formulation.
    Generics Branch.
    Policy and Operations Branch.
    Brands Branch.
Office of Communications.
    Division of Online Communications.
    Division of Health Communications.
    Division of Drug Information.
Office of Compliance.
    Program Management and Analysis Staff.
Office of Manufacturing Quality.
    Manufacturing Guidance and Policy Staff.
    Division of Drug Quality I.
    Global Compliance Branch I.
    Global Compliance Branch II.
    Division of Drug Quality II.
    Global Compliance Branch III.
    Global Compliance Branch IV.
Office of Unapproved Drugs and Labeling Compliance.
    Division of Prescription Drugs.
    Prescription Drugs Branch.
    Compounding and Pharmacy Practices Branch.
    Division of Non-Prescription Drugs and Health Fraud.
    Over-the-Counter Drugs Branch.
    Health Fraud Branch.
Office of Scientific Investigations.
    Policy Staff.
    Division of Enforcement and Postmarket Safety.
    Compliance Enforcement Branch.
    Postmarketing Safety Branch.
    Division of Clinical Compliance Evaluation.
    Good Clinical Practice Compliance Oversight Branch.
    Good Clinical Practice Assessment Branch.
Office of Drug Security, Integrity and Response.
    Division of Import Exports and Recalls.
    Recalls and Shortages Branch.
    Import Export Compliance Branch.
    Division of Supply Chain Integrity.
    Supply Chain Strategy and Policy Branch.
    Supply Chain Response and Enforcement Branch.
Office of Program and Regulatory Operations.
    Project Management and Coordination Staff I.
    Project Management and Coordination Staff II.
    Drug Registration and Listing Staff.
Office of Medical Policy.
    Office of Prescription Drug Promotion.
    Division of Consumer Drug Promotion.
    Division of Professional Drug Promotion.
Office of Medical Policy Initiatives.
    Division of Medical Policy Development.
    Division of Medical Policy Programs.

[[Page 143]]

    Division of Clinical Trial Quality.
Office of Translational Science.
    Program Management and Analysis Staff.
Office of Biostatistics.
    Division of Biometrics I.
    Division of Biometrics II.
    Division of Biometrics III.
    Division of Biometrics IV.
    Division of Biometrics V.
    Division of Biometrics VI.
    Division of Biometrics VII.
    Division of Biometrics VIII.
Office of Clinical Pharmacology.
    Division of Clinical Pharmacology I.
    Division of Clinical Pharmacology II.
    Division of Clinical Pharmacology III.
    Division of Clinical Pharmacology IV.
    Division of Clinical Pharmacology V.
    Division of Pharmacometrics.
    Division of Applied Regulatory Science.
Office of Computational Science.
Office of Study Integrity and Surveillance.
    Division of New Drug Bioequivalence Evaluation.
    Division of Generic Drug Bioequivalence Evaluation.
Office of Executive Programs.
    Division of Learning and Organizational Development.
    Scientific and Regulatory Education Branch.
    Training Design and Delivery Branch.
    Leadership and Organizational Development Branch.
    Division of Executive Operations.
    Division of Advisory Committee and Consultant Management.
Office of Surveillance and Epidemiology.
    Regulatory Science Staff.
    Regulatory Affairs Staff.
    Program Management and Analysis Staff.
    Project Management Staff.
Office of Medication Error Prevention and Risk Management.
    Division of Medication Error Prevention and Analysis.
    Division of Risk Management.
Office of Pharmacovigilance and Epidemiology.
    Division of Epidemiology I.
    Division of Epidemiology II.
    Division of Pharmacovigilance I.
    Division of Pharmacovigilance II.
Office of New Drugs.
    Program Management and Analysis Staff.
    Pharmacology/Toxicology Staff.
    Regulatory Affairs Staff.
Office of Drug Evaluation I.
    Division of Cardiovascular and Renal Products.
    Division of Neurology Products.
    Division of Psychiatry Products.
Office of Drug Evaluation II.
    Division of Metabolism and Endocrinology Products.
    Division of Pulmonary, Allergy, and Rheumatology Products.
    Division of Anesthesia, Analgesia, and Addiction Products.
Office of Drug Evaluation III.
    Division of Gastroenterology and Inborn Effects Products.
    Division of Bone, Reproductive and Urologic Products.
    Division of Dermatology and Dental Products.
Office of Antimicrobial Products.
    Division of Anti-Infective Products.
    Division of Anti-Viral Products.
    Division of Transplant and Ophthalmology Products.
Office of Drug Evaluation IV.
    Division of Nonprescription Drug Products.
    Division of Medical Imaging Products.
    Division of Pediatrics and Maternal Health.
Office of Hematology and Oncology Drug Products.
    Division of Oncology Products I.
    Division of Oncology Products II.
    Division of Hematology Products.
    Division of Hematology Oncology Toxicology.
Office of Strategic Programs.
Office of Program and Strategic Analysis.
    Program Evaluation and Implementation Staff.
    Economics Staff.
    Performance Analysis and Data Services Staff.
    Lean Management Staff.
Office of Business Informatics.
    Division of Regulatory Review and Drug Safety Services and 
Solutions.
    Division of Business Management Services and Solutions.
    Division of Data Management Services and Solutions.
    Division of Drug Quality and Compliance Services and Solutions.
Office of Generic Drugs.
    Clinical Safety Surveillance Staff.
    Program Management and Analysis Staff.
    Communications Staff.
Office of Research and Standards.
    Division of Therapeutic Performance.
    Division of Quantitative Methods and Modeling.
Office of Bioequivalence.
    Division of Bioequivalence I.
    Division of Bioequivalence II.
    Division of Bioequivalence III.
    Division of Clinical Review.
Office of Generic Drug Policy.
    Division of Legal and Regulatory Support.
    Division of Policy Development.
Office of Regulatory Operations.
    Division of Labeling Review.
    Division of Filing Review.
    Division of Project Management.
    Division of Quality Management Systems.
Office of Pharmaceutical Quality.
    Scientific Staff.
    Program Management and Analysis Staff.

[[Page 144]]

Office of Biotechnology Products.
    Division of Biotechnology Review and Research I.
    Division of Biotechnology Review and Research II.
    Division of Biotechnology Review and Research III.
    Division of Biotechnology Review and Research IV.
Office of New Drug Products.
    Division of Life Cycle API.
    Life Cycle Branch I.
    Life Cycle Branch II.
    Life Cycle Branch III.
    Division of New Drug API.
    New Drug Branch I.
    New Drug Branch II.
    Division of New Drug Products I.
    New Drug Products Branch I.
    New Drug Products Branch II.
    New Drug Products Branch III.
    Division of New Drug Products II.
    New Drug Products Branch IV.
    New Drug Products Branch V.
    New Drug Products Branch VI.
    Division of Biopharmaceutics.
    Biopharmaceutics Branch I.
    Biopharmaceutics Branch II.
    Biopharmaceutics Branch III.
Office of Policy for Pharmaceutical Quality.
    Division of Regulations, Guidance and Standards.
    Policy Development and Evaluation Branch I.
    Policy Development and Evaluation Branch II.
    Compendial Operations and Standards Branch.
    Division of Internal Policies and Programs.
    Policy Development and Evaluation Branch I.
    Policy Development and Evaluation Branch II.
Office of Process and Facilities.
    Division of Process Assessment I.
    Process Assessment Branch I.
    Process Assessment Branch II.
    Process Assessment Branch III.
    Division of Process Assessment II.
    Process Assessment Branch IV.
    Process Assessment Branch V.
    Process Assessment Branch VI.
    Division of Process Assessment III.
    Process Assessment Branch VII.
    Process Assessment Branch VIII.
    Process Assessment Branch IX.
Division of Microbiology Assessment.
    Microbiology Assessment Branch I.
    Microbiology Assessment Branch II.
    Microbiology Assessment Branch III.
    Microbiology Assessment Branch IV.
Division of Inspectional Assessment.
    Inspectional Assessment Branch I.
    Inspectional Assessment Branch II.
    Inspectional Assessment Branch III.
Office of Surveillance.
    Division of Quality Intelligence, Risk Analysis, and Modeling.
    Data Integrity Branch.
    Quality Intelligence Branch.
    Analysis and Modeling Branch.
    Division of Quality Surveillance Assessment.
    Quality Deviation and Assessment Branch.
    Inspection Assessment Branch.
Office of Testing and Research.
    Division of Product Quality Research.
    Product Quality Branch I.
    Product Quality Branch II.
    Division of Pharmaceutical Analysis.
    Pharmaceutical Analysis Branch I.
    Pharmaceutical Analysis Branch II.
Office of Program and Regulatory Operations.
    Division of Regulatory and Business Process Management I.
    Regulatory and Business Process Management Branch I.
    Regulatory and Business Process Management Branch II.
    Division of Regulatory and Business Process Management II.
    Regulatory and Business Process Management Branch III.
    Regulatory and Business Process Management Branch IV.
    Division of Operational Excellence, Learning, and Professional 
Development.
    Learning and Professional Development Branch.
    Organizational Excellence Branch.
Office of Lifecycle Drug Products.
    Division of Immediate Release Products I.
    Immediate Release Branch I.
    Immediate Release Branch II.
    Immediate Release Branch III.
    Division of Immediate Release Products II.
    Immediate Release Branch IV.
    Immediate Release Branch V.
    Immediate Release Branch VI.
    Division of Modified Release Products.
    Modified Release Branch I.
    Modified Release Branch II.
    Modified Release Branch III.
    Division of Liquid-Based Products.
    Liquid-Based Branch I.
    Liquid-Based Branch II.
    Liquid-Based Branch III.
    Division of Post-Marketing Activities I.
    Post-Marketing Branch I.
    Post-Marketing Branch II.
    Division of Post-Marketing Activities II.
    Post-Marketing Branch III.
    Post-Marketing Branch IV.
    Post-Marketing Branch V.
Center for Devices and Radiological Health. \12\
---------------------------------------------------------------------------

    \12\ Mailing address: 10903 New Hampshire Ave., Bldg. 66, Silver 
Spring, MD 20993.
---------------------------------------------------------------------------

Office of the Center Director.
    Regulations Staff.
Office of Management Operations.
    Division of Ethics and Management Operations.

[[Page 145]]

    Human Resources and Administrative Management Branch.
    Integrity, Conference and Committee Management Branch.
    Division of Planning, Analysis and Finance and Property.
    Planning Branch.
    Financial Management Branch.
Office of Compliance.
    Program Management Staff.
    Division of Bioresearch Monitoring.
    Bioresearch Compliance Branch I.
    Bioresearch Compliance Branch II.
    Division of Analysis and Program Operations.
    Quality Management System and Executive Secretary Staff.
    Field Inspections Support Branch.
    Recall Branch.
    Registration and Risk Branch.
    Allegations of Regulatory Misconduct Branch.
    Division of Manufacturing and Quality.
    Physical Medicine, Orthopedic, Neurology, and Dental Devices Branch.
    Cardiovascular Devices Branch.
    Abdominal and Surgical Devices Branch.
    Respiratory, Ear/Nose/Throat, General Hospital, and Ophthalmic 
Devices Branch.
    Division of Premarket and Labeling Compliance.
    Surveillance and Enforcement Branch I.
    Surveillance and Enforcement Branch II
    Division of International Compliance Operations.
    Foreign Enforcement Branch.
    Imports Branch.
    Exports Branch.
Office of Device Evaluation.
    Program Management Staff.
    Program Operations Staff.
    Pre-Market Approval Staff.
    Investigational Device Exemption Staff.
    Pre-Market Notification Section.
    Division of Cardiovascular Devices.
    Circulatory Support Devices Branch.
    Cardiac Diagnostics Devices Branch.
    Implantable Electrophysiology Devices Branch.
    Vascular Surgery Devices Branch.
    Structural Heart Devices Branch.
    Interventional Cardiology Devices Branch.
    Cardiac Electrophysiology Devices Branch.
    Peripheral Interventional Devices Branch.
    Division of Reproductive, Gastro-Renal, and Urological Devices.
    Obstetrics/Gynecology Devices Branch.
    Urology and Lithotripsy Devices Branch.
    Renal Devices Branch.
    Gastroenterology Devices Branch.
    Division of Orthopedic Devices.
    Restorative and Repair Devices Branch.
    Joint and Fixation Branch I.
    Joint and Fixation Branch II.
    Anterior Spine Devices Branch.
    Posterior Spine Devices Branch.
    Division of Ophthalmic and Ear, Nose, and Throat Devices.
    Intraocular and Corneal Implant Devices Branch.
    Diagnostic and Surgical Devices Branch.
    Contact Lenses and Retinal Devices Branch.
    Ear, Nose and Throat Devices Branch.
    Division of Anesthesiology, General Hospital, Respiratory Infection 
Control, and Dental Devices.
    General Hospital Devices Branch.
    Infection Control Devices Branch.
    Dental Devices Branch.
    Anesthesiology Devices Branch.
    Respiratory Devices Branch.
    Division of Neurological and Physical Medicine Devices.
    Neurostimulation Devices Branch.
    Neurodiagnostic and Neurosurgical Devices Branch.
    Physical Medicine Devices Branch.
    Division of Surgical Devices.
    General Surgery Devices Branch I.
    General Surgery Devices Branch II.
    Plastic and Reconstructive Surgery Devices Branch I.
    Plastic and Reconstructive Surgery Devices Branch II.
Office of Science and Engineering Laboratories.
    Division of Biology, Chemistry, and Materials Science.
    Division of Biomedical Physics.
    Division of Imaging, Diagnostics, and Software Reliability.
    Division of Applied Mechanics.
    Division of Administrative and Laboratory Support.
Office of Communication and Education.
    Program Management Operations Staff.
    Digital Communication Media Staff.
    Division of Health Communication.
    Web Communication Branch.
    Strategic Communication Branch.
    Division of Industry and Consumer Education.
    Postmarket and Consumer Branch.
    Premarket Programs Branch.
    Division of Information Disclosure.
    Freedom of Information Branch A.
    Freedom of Information Branch B.
    Division of Employee Training and Development.
    Employee Development Branch.
    Technology and Learning Management Branch.
Office of Surveillance and Biometrics.
    Program Management Staff.
    Informatics Staff.
    Signal Management Staff.
    Division of Biostatistics.
    Therapeutic Statistics Branch I.
    Therapeutic Statistics Branch II.
    Therapeutic Statistics Branch III.
    Diagnostic Statistics Branch I.
    Diagnostic Statistics Branch II.
    Division of Postmarket Surveillance.

[[Page 146]]

    Product Evaluation Branch I.
    Product Evaluation Branch II.
    Product Evaluation Branch III.
    Information Analysis Branch.
    MDR Policy Branch.
    Division of Patient Safety Partnership.
    Clinical Outreach Branch I.
    Clinical Outreach Branch II.
    Division of Epidemiology.
    Epidemiologic Evaluation and Research Branch I.
    Epidemiologic Evaluation and Research Branch II.
    Epidemiologic Evaluation and Research Branch III.
Office of In Vitro Diagnostics and Radiological Health.
    Division of Chemistry and Toxicology Devices.
    Chemistry Branch.
    Diabetes Branch.
    Toxicology Branch.
    Cardio-Renal Diagnostics Branch.
    Division of Immunology and Hematology Devices.
    Hematology Branch.
    Immunology and Flow Cytometry Branch.
    Division of Microbiology Devices.
    Viral Respiratory and HPV Branch.
    General Viral and Hepatitis Branch.
    General Bacterial and Antimicrobial Susceptibility Branch.
    Bacterial Respiratory and Medical Countermeasures Branch.
    Division of Radiological Health.
    Magnetic Resonance and Electronic Products Branch.
    Diagnostic X-Ray Systems Branch.
    Nuclear Medicine and Radiation Therapy Branch.
    Mammography, Ultrasound and Imaging Software Branch.
    Division of Mammography Quality Standards.
    Program Management Branch.
    Information Management Branch.
    Division of Program Operations and Management.
    Division of Molecular Genetics and Pathology.
    Molecular Pathology and Cytology Branch.
    Molecular Genetics Branch.
Office of Global Regulatory Operations and Policy. \13\
---------------------------------------------------------------------------

    \13\ Mailing address: 10903 New Hampshire Ave., Bldg. 1, Silver 
Spring, MD 20993.
---------------------------------------------------------------------------

Office of International Programs.\14\
---------------------------------------------------------------------------

    \14\ Mailing address: 12420 Parklawn Dr., Element Building, 
Rockville, MD 20857.
---------------------------------------------------------------------------

Office of Regulatory Affairs.\15\
---------------------------------------------------------------------------

    \15\ Mailing address: 10903 New Hampshire Ave., Bldg. 31, Silver 
Spring, MD 20993.
---------------------------------------------------------------------------

Office of the Associate Commissioner for Regulatory Affairs.
    Executive Secretariat Staff.
    Information Technology Staff.
Office of Resource Management.\16\
---------------------------------------------------------------------------

    \16\ Mailing address: 12420 Parklawn Dr., Element Building, 
Rockville, MD 20857.
---------------------------------------------------------------------------

    Division of Planning Evaluation and Management.
    Program Planning and Workforce Management Branch.
    Program Evaluation Branch.
    Division of Budget Formulation and Execution.
    Division of Human Resources Development.
    Division of Management Operations.
Office of Criminal Investigations.\17\
---------------------------------------------------------------------------

    \17\ Mailing address: 7500 Standish Pl., MPN2 Building, Rockville, 
MD 20855.
---------------------------------------------------------------------------

    Mid-Atlantic Area Office.
    Philadelphia Resident Unit.
    Midwest Area Office.
    Northeast Area Office.
    Boston, MA Resident Unit.
    Pacific Area Office.
    San Francisco, CA Resident Unit.
    Southeast Area Office.
    San Juan, PR Resident Unit.
    Atlanta, GA Resident Unit.
    New Orleans, LA Resident Unit.
    Southwest Area Office.
    Dallas, TX Resident Unit.
Office of Communications and Quality Program Management.
    Quality Management Systems Staff.
    Project Coordination Staff.
    Division of Communications.
    Public Affairs and Editorial Services Branch.
    Web and Digital Media Strategies Branch.
Office of Partnerships.\18\
---------------------------------------------------------------------------

    \18\ Mailing address: 12420 Parklawn Dr., Element Building, 
Rockville, MD 20857.
---------------------------------------------------------------------------

    Standards Implementation Staff.
    Contracts and Grants Staff.
Office of Policy and Risk Management.\19\
---------------------------------------------------------------------------

    \19\ Mailing address: 12420 Parklawn Dr., Element Building, 
Rockville, MD 20857.
---------------------------------------------------------------------------

    Food and Feed Policy Staff.
    Medical Products and Tobacco Policy Staff.
    Risk Management Staff.
    Division of Planning Evaluation and Management.
    Program Evaluation Branch.
    Work Planning Branch.
Office of Operations.\20\
---------------------------------------------------------------------------

    \20\ Mailing address: 10903 New Hampshire Ave., Bldg. 31, Silver 
Spring, MD 20993.
---------------------------------------------------------------------------

    Audit Staff.
Office of Enforcement and Import Operations.\21\
---------------------------------------------------------------------------

    \21\ Mailing address: 12420 Parklawn Dr., Element Building, 
Rockville, MD 20857.
---------------------------------------------------------------------------

    Division of Enforcement.
    Division of Compliance Systems.
    Enforcement Systems Branch.
    Import Compliance Systems Branch.

[[Page 147]]

    Division of Import Operations.
    Import Operations and Maintenance Branch.
    Import Program Development and Implementation Branch.
Office of Regulatory Science.\22\
---------------------------------------------------------------------------

    \22\ Mailing address: 12420 Parklawn Dr., Element Building, 
Rockville, MD 20857.
---------------------------------------------------------------------------

    Food and Feed Scientific Staff.
    Medical Products and Tobacco Scientific Staff.
    Laboratory Operations and Support Staff.
Office of Food and Feed Operations.\23\
---------------------------------------------------------------------------

    \23\ Mailing address: 12420 Parklawn Dr., Element Building, 
Rockville, MD 20857.
---------------------------------------------------------------------------

    Division of Food Defense Targeting.
    Division of Food and Feed Program Operations and Inspections.
    Food and Feed Program Operations Branch.
    Food and Feed Inspection Branch.
    Food and Feed Trip Planning Branch.
Office of Medical Products and Tobacco Operations.\24\
---------------------------------------------------------------------------

    \24\ Mailing address: 12420 Parklawn Dr., Element Building, 
Rockville, MD 20857.
---------------------------------------------------------------------------

    Division of Products and Tobacco Program Operations.
    Medical Device and Tobacco Program Operations Branch.
    Team Biological Branch.
    Division of Medical Products and Tobacco Inspections.
    Medical Products and Tobacco Inspection Branch.
    Drug Inspection Branch.
    Medical Products and Tobacco Trip Planning Branch.
Regional Field Office, Northeast Region, Jamaica, NY.\25\
---------------------------------------------------------------------------

    \25\ Mailing address: 158-15 Liberty Ave., Jamaica, NY 11433.
---------------------------------------------------------------------------

    Operations Staff.
    Intergovernmental Affairs Staff.
    District Office New York.\26\
---------------------------------------------------------------------------

    \26\ Mailing address: 158-15 Liberty Ave., Jamaica, NY 11433.
---------------------------------------------------------------------------

    Domestic Compliance Branch.
    Domestic Investigations Branch.
    Resident Post Long Island, NY.
    Resident Post White Plains, NY.
    Resident Post Albany, NY.
    Resident Post Binghamton, NY.
    Resident Post Rochester, NY.
    Resident Post Newburgh, NY.
    Resident Post Syracuse, NY.
    Import Operations Branch (Downstate).
    Resident Post Port Elizabeth, NJ.
    Import Operations Branch (Upstate).
    Resident Post Champlain, NY.
    Resident Post Alexandra Bay, NY.
    Resident Post Massena, NY.
    Resident Post Ogdensburg, NY.
    Northeast Regional Laboratory.\27\
---------------------------------------------------------------------------

    \27\ Mailing address: 158-15 Liberty Ave., Jamaica, NY 11433.
---------------------------------------------------------------------------

    Microbiological Science Branch.
    Chemistry Branch 1.
    Chemistry Branch 2.
    New England District Office.\28\
---------------------------------------------------------------------------

    \28\ Mailing address: 1 Montvale Ave., 4th Floor, Stoneham, MA 
02180-3500.
---------------------------------------------------------------------------

    Compliance Branch.
    Investigations Branch.
    Resident Post Augusta, ME.
    Resident Post Bridgeport, CT.
    Resident Post Concord, NH.
    Resident Post Hartford, CT.
    Resident Post Providence, RI.
    Resident Post Worcester, MA.
    Resident Post Calais, ME.
    Resident Post Houlton, ME.
    Resident Post Highgate, VT.
    Winchester Engineering and Analytical Center.\29\
---------------------------------------------------------------------------

    \29\ Mailing address: 109 Holton St., Winchester, MA 01890.
---------------------------------------------------------------------------

    Analytical Branch.
    Engineering Branch.
Regional Field Office, Southwest Region, Dallas, TX.\30\
---------------------------------------------------------------------------

    \30\ Mailing address: 4040 North Central Expressway, Dallas, TX 
75204-3128.
---------------------------------------------------------------------------

    State Cooperative Programs Staff.
    Resident Post Pharr.
    Dallas District Office.\31\
---------------------------------------------------------------------------

    \31\ Mailing address: 4040 North Central Expressway, Suite 300, 
Dallas, TX 75204-3128.
---------------------------------------------------------------------------

    Compliance Branch.
    Investigations Branch.
    Resident Post Austin, TX.
    Resident Post Fort Worth, TX.
    Resident Post Houston, TX.
    Resident Post San Antonio, TX.
    Resident Post Oklahoma City, OK.
    Resident Post Little Rock, AR.
    Kansas City District Office.\32\
---------------------------------------------------------------------------

    \32\ Mailing address: 8050 Marshal Dr., Suite 250, Lenexa, KS 66214.
---------------------------------------------------------------------------

    Investigations Branch.
    Resident Post Wichita, KS.
    Resident Post Omaha, NE.
    Resident Post Des Moines, IA.
    Resident Post Springfield, MO.
    Resident Post St Louis, MO.
    Resident Post Davenport, IA.
    Compliance Branch.
    Denver District Office.\33\
---------------------------------------------------------------------------

    \33\ Mailing address: Sixth Avenue and Kipling Street, Building 20, 
P.O. Box 25087, Denver, CO 80255-0087--Denver Federal Center.
---------------------------------------------------------------------------

    Compliance Branch.
    Investigations Branch.
    Resident Post Salt Lake City, UT.
    Resident Post Albuquerque, NM.
    Arkansas Regional Laboratory.\34\
---------------------------------------------------------------------------

    \34\ Mailing address: 3900 NCTR Rd., Bldg. 26, Jefferson, AR 72079.
---------------------------------------------------------------------------

    General Chemistry Branch.
    Pesticide Chemistry Branch.
    Microbiology Branch.

[[Page 148]]

    Southwest Import District Office Dallas, TX.\35\
---------------------------------------------------------------------------

    \35\ Mailing address: 4040 North Central Expressway, Suite 300, 
Dallas, TX 75204-3128.
---------------------------------------------------------------------------

    Compliance Branch.
    Investigations Branch.
    Resident Post Calexico.
    Resident Post Eagle Pass.
    Resident Post El Paso Bota.
    Resident Post El Paso Bota Westmoreland.
    Resident Post El Paso Ysleta Bridge.
    Resident Post Houston (SWID).
    Resident Post Laredo 2 Bridge.
    Resident Post Laredo Columbia Bridge.
    Resident Post Laredo World Trade Bridge.
    Resident Post Los Tomates.
    Resident Post Nogales 1.
    Resident Post Nogales 2.
    Resident Post Otay Mesa 1.
    Resident Post Otay Mesa 2.
    Resident Post Pharr.
    Resident Post Rio Grande City.
    Resident Post San Luis.
    Kansas City Laboratory.\36\
---------------------------------------------------------------------------

    \36\ Mailing address: 11510 West 80th St., Lenexa, KS 66214.
---------------------------------------------------------------------------

    Denver Laboratory.\37\
---------------------------------------------------------------------------

    \37\ Mailing address: Sixth Avenue and Kipling Street, Building 20, 
Denver, CO 80255-0087--Denver Federal Center.
---------------------------------------------------------------------------

Central Regional Field Office Chicago IL.\38\
---------------------------------------------------------------------------

    \38\ Mailing address: 20 N. Michigan Ave., Suite 510, Chicago, IL 
60602.
---------------------------------------------------------------------------

    State Cooperative Programs Staff I.
    State Cooperative Programs Staff II.
    Regional Operations Staff.
    Baltimore District Office Baltimore, MD.\39\
---------------------------------------------------------------------------

    \39\ Mailing address: 6000 Metro Dr., Suite 101, Baltimore, MD 
21215.
---------------------------------------------------------------------------

    Compliance Branch.
    Investigations Branch.
    Resident Post Charleston, WV.
    Resident Post Falls Church, VA.
    Resident Post Seva.
    Resident Post Richmond, VA.
    Resident Post Roanoke, VA.
    Resident Post Dundalk Marine Terminal, MD.
    Resident Post Morgantown, WV.
    District Office Cincinnati, OH.\40\
---------------------------------------------------------------------------

    \40\ Mailing address: 6751 Steger Dr., Cincinnati, OH 45237.
---------------------------------------------------------------------------

    Compliance Branch.
    Investigations Branch.
    Resident Post Brunswick, OH.
    Resident Post Columbus, OH.
    Resident Post Toledo, OH.
    Resident Post Louisville, KY.
    Forensic Chemistry Center.\41\
---------------------------------------------------------------------------

    \41\ Mailing address: 6751 Steger Dr., Cincinnati, OH 45237.
---------------------------------------------------------------------------

    Inorganic Chemistry Branch.
    Organic Chemistry Branch.
    District Office Parsippany, NJ.\42\
---------------------------------------------------------------------------

    \42\ Mailing address: 10 Waterview Blvd., 3rd Floor, Parsippany, NJ 
07054--Waterview Corporate Center.
---------------------------------------------------------------------------

    Compliance Branch.
    Investigations Branch.
    Resident Post Voorhees, NJ.
    Resident Post North Brunswick, NJ.
    District Office Philadelphia, PA.\43\
---------------------------------------------------------------------------

    \43\ Mailing address: 200 Chestnut St., Room 900, Philadelphia, PA 
19106--U.S. Customs House.
---------------------------------------------------------------------------

    Compliance Branch.
    Investigations Branch.
    Resident Post Harrisburg, PA.
    Resident Post Pittsburgh, PA.
    Resident Post Wilkes-Barre, PA.
    Resident Post Wilmington, PA.
    District Office Chicago, IL.\44\
---------------------------------------------------------------------------

    \44\ Mailing address: 550 West Jackson Blvd., Suite 1500, Chicago, 
IL 60661.
---------------------------------------------------------------------------

    Compliance Branch.
    Investigations Branch.
    Resident Post Peoria, IL.
    Resident Post Hinsdale, IL.
    Resident Post Gurnee, IL.
    Resident Post Springfield, IL.
    Resident Post O'Hare Airport.
    District Office Minneapolis, MN.\45\
---------------------------------------------------------------------------

    \45\ Mailing address: 250 Marquette Ave., Suite 600, Minneapolis, MN 
55401.
---------------------------------------------------------------------------

    Compliance Branch.
    Investigations Branch.
    Resident Post La Crosse, WI.
    Resident Post Green Bay, WI.
    Resident Post Milwaukee, WI.
    Resident Post Madison, WI.
    Resident Post Fargo, ND.
    Resident Post Stevens Point, WI.
    Resident Post Sioux, SD.
    District Office Detroit, MI.\46\
---------------------------------------------------------------------------

    \46\ Mailing address: 300 River Pl., Suite 5900, Detroit, MI 48207.
---------------------------------------------------------------------------

    Compliance Branch.
    Investigations Branch.
    Resident Post Kalamazoo, MI.
    Resident Post South Bend, IN.
    Resident Post Indianapolis, IN.
    Resident Post Evansville, IN.
    Resident Post
    Philadelphia Laboratory.\47\
---------------------------------------------------------------------------

    \47\ Mailing address: 200 Chestnut St., Room 900, Philadelphia, PA 
19106--U.S. Customs House.
---------------------------------------------------------------------------

    Detroit Laboratory.\48\
---------------------------------------------------------------------------

    \48\ Mailing address: 300 River Pl., Suite 5900, Detroit, MI 48207.
---------------------------------------------------------------------------

Southeast Regional Field Office Atlanta, GA.\49\
---------------------------------------------------------------------------

    \49\ Mailing address: 60 Eighth St. NE., Atlanta, GA 30309.
---------------------------------------------------------------------------

    State Cooperative Programs Staff
    Atlanta District Office.\50\
---------------------------------------------------------------------------

    \50\ Mailing address: 60 Eighth St. NE., Atlanta, GA 30309.
---------------------------------------------------------------------------

    Compliance Branch.

[[Page 149]]

    Investigations Branch.
    Resident Post Savannah, GA.
    Resident Post Tifton, GA.
    Resident Post Charlotte, NC.
    Resident Post Greensboro, NC.
    Resident Post Greenville, NC.
    Resident Post Raleigh, NC.
    Resident Post Charleston, SC.
    Resident Post Columbia, SC.
    Resident Post Greenville, SC.
    Resident Post Asheville, NC.
    Florida District Office.\51\
---------------------------------------------------------------------------

    \51\ Mailing address: 555 Winderley Pl., Suite 200, Maitland, FL 
32751.
---------------------------------------------------------------------------

    Compliance Branch.
    Investigations Branch.
    Resident Post Jacksonville, FL.
    Resident Post Miami, FL.
    Resident Post Tallahassee, FL.
    Resident Post Tampa, FL.
    Resident Post Boca Raton, FL.
    Resident Post Ft. Meyers, FL.
    Resident Post Port Everglades, FL.
    New Orleans, LA, District Office.\52\
---------------------------------------------------------------------------

    \52\ Mailing address: 404 BNA Dr., Building 200, Suite 500, 
Nashville, TN 37217.
---------------------------------------------------------------------------

    Compliance Branch.
    Investigations Branch.
    Resident Post Baton Rouge, LA.
    Resident Post Lafayette, LA.
    Resident Post Covington, LA.
    Resident Post Jackson, MS.
    Resident Post Mobile, AL.
    Nashville Branch.
    Resident Post Knoxville, TN.
    Resident Post Memphis, TN.
    Resident Post Birmingham, AL.
    Resident Post Montgomery, AL.
    San Juan District Office.\53\
---------------------------------------------------------------------------

    \53\ Mailing address: 466 Fernandez Juncos Ave., San Juan, PR 00901.
---------------------------------------------------------------------------

    Compliance Branch.
    Investigations Branch.
    Resident Post Aquada, PR.
    Resident Post Ponce, PR.
    Southeast Regional Laboratory Atlanta, GA.\54\
---------------------------------------------------------------------------

    \54\ Mailing address: 60 Eighth St., Atlanta, GA 30309.
---------------------------------------------------------------------------

    Chemistry Branch I.
    Microbiology Branch.
    Atlanta Center for Nutrient Analysis.
    Chemistry Branch II.
    San Juan Laboratory.\55\
---------------------------------------------------------------------------

    \55\ Mailing address: 466 Fernandez Juncos Ave., San Juan, PR 00901.
---------------------------------------------------------------------------

Regional Field Office, Pacific Region, Oakland, CA.\56\
---------------------------------------------------------------------------

    \56\ Mailing address: 1301 Clay St., Room 1180N, Oakland, CA 94612.
---------------------------------------------------------------------------

    State Cooperative Programs Staff.
    District Office San Francisco, CA.\57\
---------------------------------------------------------------------------

    \57\ Mailing address: 1431 Harbor Bay Pkwy., Alameda, CA 94502.
---------------------------------------------------------------------------

    Compliance Branch.
    Investigations Branch.
    Resident Post Las Vegas, NV.
    Resident Post Fresno, CA.
    Resident Post Sacramento, CA.
    Resident Post Honolulu, HI.
    Resident Post San Jose, CA.
    Resident Post Stockton, CA.
    Resident Post South San Francisco.
    District Office Los Angeles, CA.\58\
---------------------------------------------------------------------------

    \58\ Mailing address: 19701 Fairchild Rd., Irvine, CA 92612.
---------------------------------------------------------------------------

    Compliance Branch.
    Import Operations Branch.
    Resident Post Los Angeles Airport.
    Resident Post Ontario, CA--Import.
    Domestic Investigations Branch.
    Resident Post Woodland Hills, CA.
    Resident Post San Diego, CA.
    Resident Post Tempe, AZ.
    Resident Post Ontario, CA--Domestic.
    District Office Seattle, WA.\59\
---------------------------------------------------------------------------

    \59\ Mailing address: 22215 26th Ave. SE., Suite 210, Bothell, WA 
98021.
---------------------------------------------------------------------------

    Compliance Branch.
    Investigations Branch.
    Resident Post Anchorage, AK.
    Resident Post Boise, ID.
    Resident Post Portland, ID.
    Resident Post Spokane, WA.
    Resident Post Oroville, WA.
    Resident Post Portland, OR--Airport.
    Resident Post Blaine, WA.
    Resident Post Helena, MT.
    Resident Post Sweetgrass, MT.
    Resident Post Tacoma, WA.
    Resident Post Puget Sound, WA.
    Pacific Regional Laboratory Southwest.\60\
---------------------------------------------------------------------------

    \60\ Mailing address: 19701 Fairchild Rd., Irvine, CA 92612.
---------------------------------------------------------------------------

    Food Chemistry Branch.
    Drug Chemistry Branch.
    Microbiology Branch.
    Pacific Regional Laboratory Northwest.\61\
---------------------------------------------------------------------------

    \61\ Mailing address: 22201 23rd Dr. SE., Bothell, WA 98021-4421.
---------------------------------------------------------------------------

    Chemistry Branch.
    Microbiology Branch.
    Seafood Products Research Center.
Office of Operations.
Office of Business Services.
    Business Operations Staff.
    Employee Resource and Information Center.
    Division of Ethics and Integrity.
Office of Equal Employment Opportunity.
    Compliance Staff.
Office of Finance, Budget, and Acquisitions.
Office of Budget.
    Division of Budget Formulation.
    Division of Budget Execution and Control.
Office of Acquisition and Grant Services.
    Division of Acquisition Operations.
    Division of Acquisition Programs.
    Division of Acquisition Support and Grants.

[[Page 150]]

    Division of Information Technology.
Office of Financial Operations.
Office of Financial Management.
Office of Financial Services.
Office of Human Resources.
    Commission Corps Affairs Staff.
    Management Analysis Services Staff.
    Business Operations Staff.
    Division of Workforce Relations.
    Division of Policy, Programs, and Executive Resources.
    Division of Human Resource Services for Office of the Commissioner/
Office of Operations.
    Division of Human Resource Services for Office of Foods and 
Veterinary Medicine/Office of Global Operations and Policy.
    Division of Human Resource Services for Office of Medical Products 
and Tobacco.
    FDA University.
Office of Facilities, Engineering and Mission Support Services.
    Jefferson Laboratories Complex Staff.
    Division of Operations Management and Community Relations.
    Division of Planning, Engineering and Safety Management.
Office of Information Management and Technology.
Office of Information Management.
Office of Technology and Delivery.
    Division of Infrastructure Operations.
    Division of Application Services.
    Division of Delivery Management and Support.
Office of Business and Customer Assurance.
    Division of Business Partnership and Support.
    Division of Management Services.
Office of Enterprise and Portfolio Management.
Office of Safety, Security, and Crisis Management.
Office of Security Operations.
Office of Crisis Management.
Office of Emergency Operations.
Office of Policy, Planning, Legislation, and Analysis.\62\
---------------------------------------------------------------------------

    \62\ Mailing address: 10903 New Hampshire Ave., Silver Spring, MD 
20993.
---------------------------------------------------------------------------

    Management and Operations Staff.
    Intergovernment Affairs Staff.
Office of Policy.
    Regulations Policy and Management Staff.
    Policy Development and Coordination Staff.
Office of Planning.
    Planning Staff.
    Program Evaluation and Process Improvement Staff.
    Economics Staff.
    Risk Communication Staff.
Office of Legislation.
Office of Public Health Strategy and Analysis.

[81 FR 78033, Nov. 7, 2016, as amended at 83 FR 13106, Mar. 27, 2018]



Sec.  5.1105  Chief Counsel, Food and Drug Administration.

    The Office of the Chief Counsel's mailing address is White Oak Bldg. 
1, 10903 New Hampshire Ave., Silver Spring, MD 20993.



Sec.  5.1110  FDA public information offices.

    (a) Division of Dockets Management. The Division of Dockets 
Management public room is located in rm. 1061, 5630 Fishers Lane, 
Rockville, MD 20852, Telephone: 301-827-6860.
    (b) Freedom of Information Staff. The Freedom of Information Staff's 
Public Reading Room is located at the address available on the agency's 
web site at http://www.fda.gov.
    (c) Press Relations Staff. Press offices are located in White Oak 
Bldg. 1, 10903 New Hampshire Ave., Silver Spring, MD 20993, Telephone: 
301-827-6242; and at5001 Campus Dr., College Park, MD 20740, Telephone: 
301-436-2335.

[77 FR 15962, Mar. 19, 2012, as amended at 79 FR 68114, Nov. 14, 2014; 
81 FR 49895, July 29, 2016]



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]

[[Page 151]]

                      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, any tobacco product intended for human use, and any item subject to 
a quarantine regulation under part 1240 of this chapter. Product does 
not include an electronic product that emits radiation and is subject to 
parts 1003 and 1004 of this chapter.
    (g) Recall means a firm's removal or correction of a marketed 
product that the Food and Drug Administration considers to be in 
violation of the laws it administers and against which the agency would 
initiate legal action, e.g., seizure. Recall does not include a market 
withdrawal or a stock recovery.
    (h) Correction means repair, modification, adjustment, relabeling, 
destruction, or inspection (including patient monitoring) of a product 
without its physical removal to some other location.
    (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.

[[Page 152]]

    (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; 77 FR 5176, Feb. 2, 2012]



Sec.  7.12  Guaranty.

    In case of the giving of a guaranty or undertaking referred to in 
section 303(c)(2) or (3) of the act, each person signing such guaranty 
or undertaking shall be considered to have given it.



Sec.  7.13  Suggested forms of guaranty.

    (a) A guaranty or undertaking referred to in section 303(c)(2) of 
the act may be:
    (1) Limited to a specific shipment or other delivery of an article, 
in which case it may be a part of or attached to the invoice or bill of 
sale covering such shipment or delivery, or
    (2) General and continuing, in which case, in its application to any 
shipment or other delivery of an article, it shall be considered to have 
been given at the date such article was shipped or delivered by the 
person who gives the guaranty or undertaking.
    (b) The following are suggested forms of guaranty or undertaking 
under section 303(c)(2) of the act:
    (1) Limited form for use on invoice or bill of sale.

    (Name of person giving the guaranty or undertaking) hereby 
guarantees that no article listed herein is adulterated or misbranded 
within the meaning of the Federal Food, Drug, and Cosmetic Act, or is an 
article which may not, under the provisions of section 404, 505, or 512 
of the act, be introduced into interstate commerce.
    (Signature and post-office address of person giving the guaranty or 
undertaking.)

    (2) General and continuing form.

    The article comprising each shipment or other delivery hereafter 
made by (name of person giving the guaranty or undertaking) to, or in 
the order of (name and post-office address of person to whom the 
guaranty or undertaking is given) is hereby guaranteed, as of the date 
of such shipment or delivery, to be, on such date, not adulterated or 
misbranded within the meaning of the Federal Food, Drug, and Cosmetic 
Act, and not an article which may not, under the provisions of section 
404, 505, or 512 of the act, be introduced into interstate commerce.
    (Signature and post-office address of person giving the guaranty of 
undertaking.)

    (c) The application of a guaranty or undertaking referred to in 
section 303(c)(2) of the act to any shipment or other delivery of an 
article shall expire when such article, after shipment or delivery by 
the person who gave such 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

[[Page 153]]

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 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,

[[Page 154]]

etc., who are expected to be exposed to the product being considered, 
with particular attention paid to the hazard to those individuals who 
may be at greatest risk.
    (4) Assessment of the degree of seriousness of the health hazard to 
which the populations at risk would be exposed.
    (5) Assessment of the likelihood of occurrence of the hazard.
    (6) Assessment of the consequences (immediate or long-range) of 
occurrence of the hazard.
    (b) On the basis of this determination, the Food and Drug 
Administration will assign the recall a classification, i.e., Class I, 
Class II, or Class III, to indicate the relative degree of health hazard 
of the product being recalled or considered for recall.



Sec.  7.42  Recall strategy.

    (a) General. (1) A recall strategy that takes into account the 
following factors will be developed by the agency for a Food and Drug 
Administration-requested recall and by the recalling firm for a firm-
initiated recall to suit the individual circumstances of the particular 
recall:
    (i) Results of health hazard evaluation.
    (ii) Ease in identifying the product.
    (iii) Degree to which the product's deficiency is obvious to the 
consumer or user.
    (iv) Degree to which the product remains unused in the market-place.
    (v) Continued availability of essential products.
    (2) The Food and Drug Administration will review the adequacy of a 
proposed recall strategy developed by a recalling firm and recommend 
changes as appropriate. A recalling firm should conduct the recall in 
accordance with an approved recall strategy but need not delay 
initiation of a recall pending review of its recall strategy.
    (b) Elements of a recall strategy. A recall strategy will address 
the following elements regarding the conduct of the recall:
    (1) Depth of recall. Depending on the product's degree of hazard and 
extent of distribution, the recall strategy will specify the level in 
the distribution chain to which the recall is to extend, as follows:
    (i) Consumer or user level, which may vary with product, including 
any intermediate wholesale or retail level; or
    (ii) Retail level, including any intermediate wholesale level; or
    (iii) Wholesale level.
    (2) Public warning. The purpose of a public warning is to alert the 
public that a product being recalled presents a serious hazard to 
health. It is reserved for urgent situations where other means for 
preventing use of the recalled product appear inadequate. The Food and 
Drug Administration in consultation with the recalling firm will 
ordinarily issue such publicity. The recalling firm that decides to 
issue its own public warning is requested to submit its proposed public 
warning and plan for distribution of the warning for review and comment 
by the Food and Drug Administration. The recall strategy will specify 
whether a public warning is needed and whether it will issue as:
    (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

[[Page 155]]

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 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.

[[Page 156]]

Pending this review, the firm need not delay initiation of its product 
removal or correction.
    (c) A firm may decide to recall a product when informed by the Food 
and Drug Administration that the agency has determined that the product 
in question violates the law, but the agency has not specifically 
requested a recall. The firm's action also is considered a firm-
initiated recall and is subject to paragraphs (a) and (b) of this 
section.
    (d) A firm that initiates a removal or correction of its product 
which the firm believes is a market withdrawal should consult with the 
appropriate Food and Drug Administration district office when the reason 
for the removal or correction is not obvious or clearly understood but 
where it is apparent, e.g., because of complaints or adverse reactions 
regarding the product, that the product is deficient in some respect. In 
such cases, the Food and Drug Administration will assist the firm in 
determining the exact nature of the problem.



Sec.  7.49  Recall communications.

    (a) General. A recalling firm is responsible for promptly notifying 
each of its affected direct accounts about the recall. The format, 
content, and extent of a recall communication should be commensurate 
with the hazard of the product being recalled and the strategy developed 
for that recall. In general terms, the purpose of a recall communication 
is to convey:
    (1) That the product in question is subject to a recall.
    (2) That further distribution or use of any remaining product should 
cease immediately.
    (3) Where appropriate, that the direct account should in turn notify 
its customers who received the product about the recall.
    (4) Instructions regarding what to do with the product.
    (b) Implementation. A recall communication can be accomplished by 
telegrams, mailgrams, or first class letters conspicuously marked, 
preferably in bold red type, on the letter and the envelope: ``drug [or 
food, biologic, etc.] recall [or correction]''. The letter and the 
envelope should be also marked: ``urgent'' for class I and class II 
recalls and, when appropriate, for class III recalls. Telephone calls or 
other personal contacts should ordinarily be confirmed by one of the 
above methods and/or documented in an appropriate manner.
    (c) Contents. (1) A recall communication should be written in 
accordance with the following guidelines:
    (i) Be brief and to the point;
    (ii) Identify clearly the product, size, lot number(s), code(s) or 
serial number(s) and any other pertinent descriptive information to 
enable accurate and immediate identification of the product;
    (iii) Explain concisely the reason for the recall and the hazard 
involved, if any;
    (iv) Provide specific instructions on what should be done with 
respect to the recalled products; and
    (v) Provide a ready means for the recipient of the communication to 
report to the recalling firm whether it has any of the product, e.g., by 
sending a postage-paid, self-addressed postcard or 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

[[Page 157]]

certain drugs and devices where the agency determines that public 
notification may cause unnecessary and harmful anxiety in patients and 
that initial consultation between patients and their physicians is 
essential. The report will not include a firm's product removals or 
corrections which the agency determines to be market withdrawals or 
stock recoveries. The report, which also includes other Food and Drug 
Administration regulatory actions, e.g., seizures that were effected and 
injunctions and prosecutions that were filed, is available upon request 
from the Office of Public Affairs (HFI-1), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857.



Sec.  7.53  Recall status reports.

    (a) The recalling firm is requested to submit periodic recall status 
reports to the appropriate Food and Drug Administration district office 
so that the agency may assess the progress of the recall. The frequency 
of such reports will be determined by the relative urgency of the recall 
and will be specified by the Food and Drug Administration in each recall 
case; generally the reporting interval will be between 2 and 4 weeks.
    (b) Unless otherwise specified or inappropriate in a given recall 
case, the recall status report should contain the following information:
    (1) Number of consignees notified of the recall, and date and method 
of notification.
    (2) Number of consignees responding to the recall communication and 
quatity of products on hand at the time it was received.
    (3) Number of consignees that did not respond (if needed, the 
identity of nonresponding consignees may be requested by the Food and 
Drug Administration).
    (4) Number of products returned or corrected by each consignee 
contacted and the quantity of products accounted for.
    (5) Number and results of effectiveness checks that were made.
    (6) Estimated time frames for completion of the recall.
    (c) Recall status reports are to be discontinued when the recall is 
terminated by the Food and Drug Administration.



Sec.  7.55  Termination of a recall.

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

[[Page 158]]

time specified in other applicable regulations concerning records 
retention.

Subpart D [Reserved]



                      Subpart E_Criminal Violations



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

    (a)(1) Except as provided in paragraph (a) (2) and (3) of this 
section, a person against whom criminal prosecution under the Federal 
Food, Drug, and Cosmetic Act is contemplated by the Commissioner of Food 
and Drugs shall be given appropriate notice and an opportunity to 
present information and views to show cause why criminal prosecution 
should not be recommended to a United States attorney.
    (2) Notice and opportunity need not be provided if the Commissioner 
has reason to believe that they may result in the alteration or 
destruction of evidence or in the prospective defendant's fleeing to 
avoid prosecution.
    (3) Notice and opportunity need not be provided if the Commissioner 
contemplates recommending further investigation by the Department of 
Justice.
    (b) If a statute enforced by the Commissioner does not contain a 
provision for an opportunity to present views, the Commissioner need 
not, but may in the Commissioner's discretion, provide notice and an 
opportunity to present views.
    (c) If an apparent violation of the Federal Food, Drug, and Cosmetic 
Act also constitutes a violation of any other Federal statute(s), and 
the Commissioner contemplates recommending prosecution under such other 
statute(s) as well, the notice of opportunity to present views will 
include all violations.
    (d) Notice of an opportunity to present views may be by letter, 
standard form, or other document(s) identifying the products and/or 
conduct alleged to violate the law. The notice shall--
    (1) Be sent by registered or certified mail, telegram, telex, 
personal delivery, or any other appropriate mode of written 
communication;
    (2) Specify the time and place where those named may present their 
views;
    (3) Summarize the violations that constitute the basis of the 
contemplated prosecution;
    (4) Describe the purpose and procedure of the presentation; and
    (5) Furnish a form on which the legal status of any person named in 
the notice may be designated.
    (e) If more than one person is named in a notice, a separate 
opportunity for presentation of views shall be scheduled on request. 
Otherwise, the time and place specified in a notice may be changed only 
upon a showing of reasonable grounds. A request for any change shall be 
addressed to the Food and Drug Administration office that issued the 
notice and shall be received in that office at least 3 working days 
before the date set in the notice.
    (f) A person who has received a notice is under no legal obligation 
to appear or answer in any manner. A person choosing to respond may 
appear personally, with or without a representative, or may designate a 
representative to appear for him or her. Alternatively, a person may 
respond in writing. If a 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

[[Page 159]]

and Drug Administration employees may be present.
    (b) A presentation of views shall not be open to the public. The 
agency employee designated to receive views will permit participation of 
other persons only if they appear with the respondent or the 
respondent's designated representative, and at the request of, and on 
behalf of, the respondent.
    (c) A respondent may present any information of any kind bearing on 
the Commissioner's determination to recommend prosecution. Information 
may include statements of persons appearing on the respondent's behalf, 
letters, documents, laboratory analyses, if applicable, or other 
relevant information or arguments. The opportunity to present views 
shall be informal. The rules of evidence shall not apply. Any 
information given by a respondent, including statements by the 
respondent, shall become part of the agency's records concerning the 
matter and may be used for any official purpose. The Food and Drug 
Administration is under no obligation to present evidence or witnesses.
    (d) If the respondent holds a ``guaranty or undertaking'' as 
described in section 303(c) of the act (21 U.S.C. 333(c)) that is 
applicable to the notice, that document, or a verified copy of it, may 
be presented by the respondent.
    (e) A respondent may have an oral presentation recorded and 
transcribed at his or her expense, in which case a copy of the 
transcription shall be furnished to the Food and Drug Administration 
office from which the notice issued. The employee designated to receive 
views may order a presentation of views recorded and transcribed at 
agency expense, in which case a copy of such transcription shall be 
provided to each respondent.
    (f) If an oral presentation is not recorded and transcribed, the 
agency employee designated to receive views shall dictate a written 
summary of the presentation. A copy of the summary shall be provided to 
each respondent.
    (g) A respondent may comment on the summary or may supplement any 
response by additional written or documentary evidence. Any comment or 
addition shall be furnished to the Food and Drug Administration office 
where the respondent's views were presented. If materials are submitted 
within 10 calendar days after receipt of the copy of the summary or 
transcription of the presentation, as applicable, they will be 
considered before a final decision as to whether or not to recommend 
prosecution. Any materials received after the supplemental response 
period generally will be considered only if the final agency decision 
has not yet been made.
    (h)(1) When consideration of a criminal prosecution recommendation 
involving the same violations is closed by the Commissioner with respect 
to all persons named in the notice, the Commissioner will so notify each 
person in writing.
    (2) When it is determined that a person named in a notice will not 
be included in the Commissioner's recommendation for criminal 
prosecution, the Commissioner will so notify that person, if and when 
the Commissioner concludes that notification will not prejudice the 
prosecution of any other person.
    (3) When a United States attorney informs the agency that no persons 
recommended will be prosecuted, the Commissioner will so notify each 
person in writing, unless the United States attorney has already done 
so.
    (4) When a United States attorney informs the agency of intent to 
prosecute some, but not all, persons who had been provided an 
opportunity to present views and were subsequently named in the 
Commissioner's recommendation for criminal prosecution, the 
Commissioner, after being advised by the United States attorney that the 
notification will not prejudice the prosecution of any other person, 
will so notify those persons eliminated from further consideration, 
unless the 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

[[Page 160]]

law enforcement purposes and may include inter- and intra-agency 
memorandums.
    (1) Notwithstanding the rule established in Sec.  20.21 of this 
chapter, no record related to a section 305 presentation is available 
for public disclosure until consideration of criminal prosecution has 
been closed in accordance with paragraph (b) of this section, except as 
provided in Sec.  20.82 of this chapter. Only very rarely and only under 
circumstances that demonstrate a compelling public interest will the 
Commissioner exercise, in accordance with Sec.  20.82 of this chapter, 
the authorized discretion to disclose records related to a section 305 
presentation before the consideration of criminal prosecution is closed.
    (2) After consideration of criminal prosecution is closed, the 
records are available for public disclosure in response to a request 
under the Freedom of Information Act, except to the extent that the 
exemptions from disclosure in subpart D of part 20 of this chapter are 
applicable. No statements obtained through promises of confidentiality 
shall be available for public disclosure.
    (b) Consideration of criminal prosecution based on a particular 
section 305 notice of opportunity for presentation of views shall be 
deemed to be closed within the meaning of this section and Sec.  7.85 
when a final decision has been made not to recommend criminal 
prosecution to a United States attorney based on charges set forth in 
the notice and considered at the presentation, or when such a 
recommendation has been finally refused by the United States attorney, 
or when criminal prosecution has been instituted and the matter and all 
related appeals have been concluded, or when the statute of limitations 
has run.
    (c) Before disclosure of any record specifically reflecting 
consideration of a possible recommendation for criminal prosecution of 
any individual, all names and other information that would identify an 
individual whose prosecution was considered but not recommended, or who 
was not prosecuted, shall be deleted, unless the Commissioner concludes 
that there is a compelling public interest in the disclosure of the 
names.
    (d) Names and other information that would identify a Food and Drug 
Administration employee shall be deleted from records related to a 
section 305 presentation of views before public disclosure only under 
Sec.  20.32 of this chapter.

[44 FR 12168, Mar. 6, 1979]



PART 10_ADMINISTRATIVE PRACTICES AND PROCEDURES--Table of Contents



                      Subpart A_General Provisions

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

               Subpart B_General Administrative Procedures

10.20 Submission of documents to Division of Dockets Management; 
          computation of time; availability for public disclosure.
10.25 Initiation of administrative proceedings.
10.30 Citizen petition.
10.31 Citizen petitions and petitions for stay of action related to 
          abbreviated new drug applications, certain new drug 
          applications, or certain biologics license applications.
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.

[[Page 161]]

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 
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.

[[Page 162]]

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

[[Page 163]]

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 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

[[Page 164]]

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) Except as provided in Sec.  10.31(b), 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 on which 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 
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:
    (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.

[[Page 165]]

    (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; 81 FR 78505, Nov. 8, 2016]



Sec.  10.25  Initiation of administrative proceedings.

    An administrative proceeding may be initiated in the following three 
ways:
    (a) An interested person may petition the Commissioner to issue, 
amend, or revoke a regulation or order, or to take or refrain from 
taking any other form of administrative action. A petition must be 
either:
    (1) In the form specified in other applicable FDA regulations, e.g., 
the form for a color additive petition in Sec.  71.1, for a food 
additive petition in Sec.  171.1, for a new drug application in Sec.  
314.50, for a new animal drug application in Sec.  514.1, or
    (2) in the form for a citizen petition in Sec.  10.30.
    (b) The Commissioner may initiate a proceeding to issue, amend, or 
revoke a regulation or order or take or refrain from taking any other 
form of administrative action. FDA has primary jurisdiction to make the 
initial determination on issues within its statutory mandate, and will 
request a court to dismiss, or to hold in abeyance its determination of 
or refer to the agency for administrative determination, any issue which 
has not previously been determined by the agency or which, if it has 
previously been determined, the 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

[[Page 166]]

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, if applicable, Sec.  10.31. The 
certification requirement in this section does not apply to petitions 
subject to the certification requirement of Sec.  10.31. The petition 
must also be submitted in accordance with the following paragraphs, as 
applicable:
    (1) Electronic submission. Petitions (including any attachments) may 
be electronically submitted in accordance with paragraph (b)(3) of this 
section and Sec.  10.20 through http://www.regulations.gov at Docket No. 
FDA 2013-S-0610. It is only necessary to submit one copy.
    (2) Mail, delivery services, or other non-electronic submissions. A 
petition (including any attachments), that is not electronically 
submitted under paragraph (b)(1) of this section, must be submitted in 
accordance with paragraph (b)(3) and Sec.  10.20 and delivered to this 
address: Division of Dockets Management, Department of Health and Human 
Services, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. It is only necessary to submit two copies.
    (3) Petition format. A petition submitted under paragraphs (b)(1) or 
(b)(2) of this section must be in accordance with Sec.  10.20 and in the 
following format:

                            Citizen Petition

 Date:__________________________________________________________________

    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) 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)_____________________________________________________

    (c) A petition that appears to meet the requirements of paragraph 
(b)(3) of this section, Sec.  10.20, and, if applicable, Sec.  10.31, 
will be filed by the Division of Dockets Management, stamped with the 
date of filing, and assigned a unique docket number. The unique docket 
number identifies the docket 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

[[Page 167]]

to the assigned docket number assigned in this paragraph and will be 
filed in the established docket file. Related petitions may be filed 
together and given the same docket number. The Division of Dockets 
Management will promptly notify the petitioner of the filing and unique 
docket number of the petition.
    (d) An interested person may submit 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 include, if applicable, the verification under Sec.  10.31, 
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 paragraphs (e)(4) and (5) 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;
    (iii) Dismiss the petition if at any time the Commissioner 
determines that changes in law, facts, or circumstances since the date 
on which the petition was submitted have rendered the petition moot; or
    (iv) 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. If, at any time, the Commissioner determines that 
changes in law, facts, or circumstances since the date on which the 
petition was submitted have rendered the petition moot, the Commissioner 
may dismiss the petition. The petitioner is to be notified of the 
Commissioner's decision. The decision will be placed in the public 
docket file 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.
    (5) The Commissioner intends to furnish a response to each 
petitioner within 150 days of receipt of a petition subject to section 
505(q) of the Federal Food, Drug, and Cosmetic Act.
    (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 
without Agency approval and without prejudice to resubmission at any 
time until the Commissioner rules on the petition, unless the petition 
has been referred for a hearing under parts 12, 13, 14, or 15 of this 
chapter. 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.

[[Page 168]]

    (4) A proposal to issue, amend, or revoke a regulation, in 
accordance with Sec.  10.40 or Sec.  12.20.
    (5) Any other specific public procedure established in this chapter 
and expressly applicable to the matter.
    (i) The record of the administrative proceeding consists of the 
following:
    (1) The petition, including all information on which it relies, 
filed by the 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 
FR 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; 78 FR 76749, Dec. 19, 
2013; 81 FR 78505, Nov. 8, 2016]



Sec.  10.31  Citizen petitions and petitions for stay of action related
to abbreviated new drug applications, certain new drug applications, or
certain biologics license applications.

    (a) Applicability. This section applies to a citizen petition or 
petition for stay of action that meets all of the following criteria:
    (1) The petition requests that the Commissioner take any form of 
action that could, if taken, delay approval of an abbreviated new drug 
application submitted under section 505(j) of the Federal Food, Drug, 
and Cosmetic Act, a new drug application submitted through the pathway 
described by section 505(b)(2) of the Federal, Food, Drug and Cosmetic 
Act, or a biologics license application submitted under section 351(k) 
of the Public Health Service Act.
    (2) The petition is submitted on or after September 27, 2007.
    (3) The petition is submitted in writing and under Sec.  10.30 (for 
citizen petitions) or Sec.  10.35 (for petitions for stay of action).

[[Page 169]]

    (b) Date of submission. A petition subject to this section and 
submitted in accordance with Sec.  10.20, Sec.  10.30, Sec.  10.31, or 
Sec.  10.35 is regarded as submitted on the date on which the petition 
is received by the Division of Dockets Management.
    (c) Certification. (1) FDA will not consider for review a petition 
that is subject to this section unless the petition is in writing and 
contains the following certification:
[GRAPHIC] [TIFF OMITTED] TR08NO16.000

    (2) The certification in paragraph (c)(1) of this section must 
contain one or more specific dates (month, day, and year) in the first 
blank space provided. If different categories of information become 
known at different times, the certification must contain each estimated 
relevant date. The information associated with a particular date must be 
identified.
    (d) Verification. (1) FDA will not accept for review any 
supplemental information or comments on a petition that is subject to 
this section unless the supplemental information or comments are in 
writing and contain the following verification:
[GRAPHIC] [TIFF OMITTED] TR08NO16.001

    (2) The verification in paragraph (d)(1) of this section must 
contain one or more specific dates (month, day, and year) in the first 
blank space provided. If different categories of information become 
known at different times, the verification must contain each estimated 
relevant date. The information associated with a particular date must be 
identified.

[81 FR 78506, Nov. 8, 2016]

[[Page 170]]



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. __.

                          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.

[[Page 171]]

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 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 (except that a request for stay subject to Sec.  10.31 
must also include the certification provided in Sec.  10.31(c)) 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)_____________________________________________________________

[[Page 172]]

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

    (c) A petition for stay of action relating to a petition submitted 
under Sec.  10.25(a)(2) is subject to the requirements of Sec.  10.30 
(c) and (d), except that it will be filed in the same docket file as the 
petition to which it relates.
    (d) Neither the filing of a petition for a stay of action nor action 
taken by an interested person in accordance with any other 
administrative procedure in this part or in any other section of this 
chapter, e.g., the filing of a citizen petition under Sec.  10.30 or a 
petition for reconsideration under Sec.  10.33 or a request for an 
advisory opinion under Sec.  10.85, will stay or otherwise delay any 
administrative action by the Commissioner, including enforcement action 
of any kind, unless one of the following applies:
    (1) The Commissioner determines that a stay or delay is in the 
public interest and stays the action.
    (2) A statute requires that the matter be stayed.
    (3) A court orders that the matter be stayed.
    (e) The Commissioner shall promptly review a petition for stay of 
action. The Commissioner may grant or deny a petition, in whole or in 
part; and may grant such other relief or take such other action as is 
warranted by the petition. If, at any time, the Commissioner determines 
that changes in law, facts, or circumstances since the date on which the 
petition was submitted have rendered the petition moot, the Commissioner 
may dismiss 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).
    (i) A petitioner may supplement, amend, or withdraw a petition for 
stay of action in writing without Agency approval and without prejudice 
to resubmission at any time until the Commissioner rules on the 
petition, provided the resubmission is made in accordance with paragraph 
(b) of this section, unless the petition for stay of action has been 
referred for a hearing

[[Page 173]]

under parts 12, 13, 14, or 15 of this chapter. After a ruling or 
referral, a petition for stay of action 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 for stay of action.

[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; 81 FR 78506, Nov. 8, 2016]



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 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

[[Page 174]]

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, 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

[[Page 175]]

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 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

[[Page 176]]

(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 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

[[Page 177]]

    (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:
    (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

[[Page 178]]

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 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

[[Page 179]]

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 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

[[Page 180]]

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 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.

[[Page 181]]

    (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 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

[[Page 182]]

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);
    (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

[[Page 183]]

such review shall be briefly set forth in writing to the requester. 
Persons who receive a Center denial of their request under this section 
may submit a request for review of the denial. The request should be 
sent to the Chief Mediator and Ombudsman.
    (c) An interested person outside the agency may request internal 
agency review of a decision through the established agency channels of 
supervision or review. Personal review of these matters by center 
directors or the office of the Commissioner will occur for any of the 
following purposes:
    (1) To resolve an issue that cannot be resolved at lower levels 
within the agency (e.g., between two parts of a center or other 
component of the agency, between two centers or other components of the 
agency, or between the agency and an interested person outside the 
agency).
    (2) To review policy matters requiring the attention of center or 
agency management.
    (3) In unusual situations requiring an immediate review in the 
public interest.
    (4) As required by delegations of authority.
    (d) Internal agency review of a decision must be based on the 
information in the administrative file. If an interested person presents 
new information not in the file, the matter will be returned to the 
appropriate lower level in the agency for reevaluation based on the new 
information.

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



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

    (a) A representative of FDA may discuss orally or in writing with an 
interested person ideas and recommendations for notices or regulations. 
FDA welcomes assistance in developing ideas for, and in gathering the 
information to support, notices and regulations.
    (b) Notices and proposed regulations. (1) Once it is determined that 
a notice or proposed regulation will be prepared, the general concepts 
may be discussed by a representative of FDA with an interested person. 
Details of a draft of a notice or proposed regulation may be discussed 
with a person outside the executive branch only with the specific 
permission of the Commissioner. The permission must be in writing and 
filed with the 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

[[Page 184]]

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, 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.)

[[Page 185]]

    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 Division of Freedom 
of Information (ELEM-1029)'' and adding in its place ``(the Freedom of 
Information Staff's address is available on the agency's web site at 
http://www.fda.gov.)
    (e) An advisory opinion represents the formal position of FDA on a 
matter and except as provided in paragraph (f) of this section, 
obligates the agency to follow it until it is amended or revoked. The 
Commissioner may not recommend legal action against a person or product 
with respect to an action taken in conformity with an advisory opinion 
which has not been amended or revoked.
    (f) In unusual situations involving an immediate and significant 
danger to health, the Commissioner may take appropriate civil 
enforcement action contrary to an advisory opinion before amending or 
revoking the opinion. This action may be taken only with the approval of 
the Commissioner, who may not delegate this function. Appropriate 
amendment or revocation of the advisory opinion involved will be 
expedited.
    (g) An advisory opinion may be amended or revoked at any time after 
it has been issued. Notice of amendment or revocation will be given in 
the same manner as notice of the advisory opinion was originally given 
or in the Federal Register, and will be placed on public display as part 
of the file on the matter in the office of the 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

[[Page 186]]

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; 76 FR 31469, June 
1, 2011; 79 FR 68114, Nov. 14, 2014]



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

    (a) Regulations. FDA regulations are issued 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 guidance documents 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 guidance documents subject 
to Sec.  10.115, 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 21 U.S.C. 
360ii. These recommendations may, in the discretion of the Commissioner, 
be handled under the procedures established in Sec.  10.115, 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 guidance documents 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 Division 
of Freedom of Information (ELEM-1029)'' and adding in its place ``(the 
Freedom of Information Staff's address is available on the agency's web 
site at http://www.fda.gov) under Sec.  20.108. A document not included 
in the public file is deemed to be rescinded and has no force or effect 
whatever.

[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 65 
FR 56477, Sept. 19, 2000; 75 FR 16346, Apr. 1, 2010; 79 FR 68114, Nov. 
14, 2014]



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 Division of Freedom of Information 
(ELEM-1029)'' and adding in its place ``(the Freedom of Information 
Staff's address is available on the agency's web site at http://
www.fda.gov).
    (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.

[[Page 187]]

    (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 Division of Freedom of Information 
(ELEM-1029)'' and adding in its place ``(the Freedom of Information 
Staff's address is available on the agency's web site at http://
www.fda.gov).
    (3) The availability for public disclosure of records relating to 
the activity will be governed by part 20.
    (4) If a member of the public is invited by FDA to present views to, 
or to accompany, the FDA employee at a meeting, the invitation will be 
extended to a representative sampling of the public, including consumer 
groups, industry associations, professional societies, and academic 
institutions.
    (5) An FDA employee appointed as the liaison representative to an 
activity shall refer all requests for information about or participation 
in the activity to the group or organization responsible for the 
activity.
    (d) Standard-setting activities by private groups and organizations. 
(1) An FDA employee may engage in these activities after approval of the 
activity under procedures specified in the current agency Staff Manual 
Guide. A request for official participation must be made by the group or 
organization in writing, must describe the scope of the activity, and 
must demonstrate that the minimum standards set out in paragraph (d)(5) 
of this section are met. Except as provided in paragraph (d)(7) of this 
section, a request that is granted will be the subject of a letter from 
the Commissioner or the center director to the organization stating--
    (i) Whether participation by the individual will be as a voting or 
nonvoting liaison representative;
    (ii) That participation by the individual does not connote FDA 
agreement with, or endorsement of, any decisions reached; and
    (iii) That participation by the individual precludes service as the 
deciding official on the standard involved if it should later come 
before FDA. The deciding official is the person who signs a document 
ruling upon the standard.
    (2) The letter requesting official FDA participation, the approval 
form, and the Commissioner's or center director's letter, together with 
all pertinent background information describing the activities involved, 
will be included in the public file on standard-setting activities 
established by the Division of Freedom of Information (ELEM-1029)'' and 
adding in its place ``(the Freedom of Information Staff's address is 
available on the agency's web site at http://www.fda.gov).
    (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.

[[Page 188]]

    (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 Division of Freedom of Information (ELEM-1029)'' and adding in 
its place ``(the Freedom of Information Staff's address is available on 
the agency's web site at http://www.fda.gov) 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 Division of Freedom of Information (ELEM-
1029)'' and adding in its place ``(the Freedom of Information Staff's 
address is available on the agency's web site at http://www.fda.gov).
    (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).
    (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; 76 FR 31469, June 1, 2011; 79 FR 
68114, Nov. 14, 2014]



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.

[[Page 189]]

    (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 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

[[Page 190]]

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 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. If you wish 
to submit the draft of a proposed guidance document electronically, 
submit it through https://www.regulations.gov at Docket No. FDA-2013-S-
0610. It is only necessary to submit one copy.

[[Page 191]]

    (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:
    (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:

[[Page 192]]

    (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.
    (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

[[Page 193]]

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, as amended at 83 FR 13416, Mar. 29, 2018]



      Subpart C_Electronic Media Coverage of Public Administrative 
             Proceedings; Guideline on Policy and Procedures

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



Sec.  10.200  Scope.

    This guideline describes FDA's policy and procedures applicable to 
electronic media coverage of agency public administrative proceedings. 
It is a guideline intended to clarify and explain FDA's policy on the 
presence and operation of electronic recording equipment at such 
proceedings and to assure uniform and consistent application of 
practices and procedures throughout the agency.



Sec.  10.203  Definitions.

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

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



Sec.  10.204  General.

    (a) FDA has for many years willingly committed itself to a policy of 
openness. In many instances FDA has sought to make the open portions of 
agency public administrative proceedings more accessible to public 
participation. Similarly, FDA has sought, wherever possible, to allow 
full written media access to its proceedings, so that members of the 
press would have the opportunity to provide first-hand reports. However, 
because electronic media coverage presents certain difficulties that are 
easier to resolve with advance notice to the agency and all 
participants, FDA believes that codification of its policy will 
facilitate and further increase media access to its public 
administrative proceedings. The agency intends to refer to this 
guideline when notices of hearing, or individual advisory committee 
meetings, are published in the Federal Register. Thus, all parties to a 
proceeding

[[Page 194]]

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 
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.

[[Page 195]]

    (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 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

[[Page 196]]

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 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

[[Page 197]]

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.
    (g) This part does not apply to electronic signatures obtained under 
Sec.  101.11(d) of this chapter.
    (h) This part does not apply to electronic signatures obtained under 
Sec.  101.8(d) of this chapter.
    (i) This part does not apply to records required to be established 
or maintained by part 117 of this chapter. Records that satisfy the 
requirements of part 117 of this chapter, but that also are required 
under other applicable statutory provisions or regulations, remain 
subject to this part.
    (j) This part does not apply to records required to be established 
or

[[Page 198]]

maintained by part 507 of this chapter. Records that satisfy the 
requirements of part 507 of this chapter, but that also are required 
under other applicable statutory provisions or regulations, remain 
subject to this part.
    (k) This part does not apply to records required to be established 
or maintained by part 112 of this chapter. Records that satisfy the 
requirements of part 112 of this chapter, but that also are required 
under other applicable statutory provisions or regulations, remain 
subject to this part.
    (l) This part does not apply to records required to be established 
or maintained by subpart L of part 1 of this chapter. Records that 
satisfy the requirements of subpart L of part 1 of this chapter, but 
that also are required under other applicable statutory provisions or 
regulations, remain subject to this part.
    (m) This part does not apply to records required to be established 
or maintained by subpart M of part 1 of this chapter. Records that 
satisfy the requirements of subpart M of part 1 of this chapter, but 
that also are required under other applicable statutory provisions or 
regulations, remain subject to this part.
    (n) This part does not apply to records required to be established 
or maintained by subpart O of part 1 of this chapter. Records that 
satisfy the requirements of subpart O of part 1 of this chapter, but 
that also are required under other applicable statutory provisions or 
regulations, remain subject to this part.
    (o) This part does not apply to records required to be established 
or maintained by part 121 of this chapter. Records that satisfy the 
requirements of part 121 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; 79 
FR 71253, 71291, Dec. 1, 2014; 80 FR 71253, June 19, 2015; 80 FR 56144, 
56336, Sept. 17, 2015; 80 FR 74352, 74547, 74667, Nov. 27, 2015; 81 FR 
20170, Apr. 6, 2016; 81 FR 34218, May 27, 2016]



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.

[[Page 199]]

    (4) Closed system means an environment in which system access is 
controlled by persons who are responsible for the content of electronic 
records that are on the system.
    (5) Digital signature means an electronic signature based upon 
cryptographic methods of originator authentication, computed by using a 
set of rules and a set of parameters such that the identity of the 
signer and the integrity of the data can be verified.
    (6) Electronic record means any combination of text, graphics, data, 
audio, pictorial, or other information representation in digital form 
that is created, modified, maintained, archived, retrieved, or 
distributed by a computer system.
    (7) Electronic signature means a computer data compilation of any 
symbol or series of symbols executed, adopted, or authorized by an 
individual to be the legally binding equivalent of the individual's 
handwritten signature.
    (8) Handwritten signature means the scripted name or legal mark of 
an individual handwritten by that individual and executed or adopted 
with the present intention to authenticate a writing in a permanent 
form. The act of signing with a writing or marking instrument such as a 
pen or stylus is preserved. The scripted name or legal mark, while 
conventionally applied to paper, may also be applied to other devices 
that capture the name or mark.
    (9) Open system means an environment in which system access is not 
controlled by persons who are responsible for the content of electronic 
records that are on the system.



                      Subpart B_Electronic Records



Sec.  11.10  Controls for closed systems.

    Persons who use closed systems to create, modify, maintain, or 
transmit electronic records shall employ procedures and controls 
designed to ensure the authenticity, integrity, and, when appropriate, 
the confidentiality of electronic records, and to ensure that the signer 
cannot readily repudiate the signed record as not genuine. Such 
procedures and controls shall include the following:
    (a) Validation of systems to ensure accuracy, reliability, 
consistent intended performance, and the ability to discern invalid or 
altered records.
    (b) The ability to generate accurate and complete copies of records 
in both human readable and electronic form suitable for inspection, 
review, and copying by the agency. Persons should contact the agency if 
there are any questions regarding the ability of the agency to perform 
such review and copying of the electronic records.
    (c) Protection of records to enable their accurate and ready 
retrieval throughout the records retention period.
    (d) Limiting system access to authorized individuals.
    (e) Use of secure, computer-generated, time-stamped audit trails to 
independently record the date and time of operator entries and actions 
that create, modify, or delete electronic records. Record changes shall 
not obscure previously recorded information. Such audit trail 
documentation shall be retained for a period at least as long as that 
required for the subject electronic records and shall be available for 
agency review and copying.
    (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:

[[Page 200]]

    (1) Adequate controls over the distribution of, access to, and use 
of documentation for system operation and maintenance.
    (2) Revision and change control procedures to maintain an audit 
trail that documents time-sequenced development and modification of 
systems documentation.



Sec.  11.30  Controls for open systems.

    Persons who use open systems to create, modify, maintain, or 
transmit electronic records shall employ procedures and controls 
designed to ensure the authenticity, integrity, and, as appropriate, the 
confidentiality of electronic records from the point of their creation 
to the point of their receipt. Such procedures and controls shall 
include those identified in Sec.  11.10, as appropriate, and additional 
measures such as document encryption and use of appropriate digital 
signature standards to ensure, as necessary under the circumstances, 
record authenticity, integrity, and confidentiality.



Sec.  11.50  Signature manifestations.

    (a) Signed electronic records shall contain information associated 
with the signing that clearly indicates all of the following:
    (1) The printed name of the signer;
    (2) The date and time when the signature was executed; and
    (3) The meaning (such as review, approval, responsibility, or 
authorship) associated with the signature.
    (b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of 
this section shall be subject to the same controls as for electronic 
records and shall be included as part of any human readable form of the 
electronic record (such as electronic display or printout).



Sec.  11.70  Signature/record linking.

    Electronic signatures and handwritten signatures executed to 
electronic records shall be linked to their respective electronic 
records to ensure that the signatures cannot be excised, copied, or 
otherwise transferred to falsify an electronic record by ordinary means.



                     Subpart C_Electronic Signatures



Sec.  11.100  General requirements.

    (a) Each electronic signature shall be unique to one individual and 
shall not be reused by, or reassigned to, anyone else.
    (b) Before an organization establishes, assigns, certifies, or 
otherwise sanctions an individual's electronic signature, or any element 
of such electronic signature, the organization shall verify the identity 
of the individual.
    (c) Persons using electronic signatures shall, prior to or at the 
time of such use, certify to the agency that the electronic signatures 
in their system, used on or after August 20, 1997, are intended to be 
the legally binding equivalent of traditional handwritten signatures.
    (1) The certification shall be submitted in paper form and signed 
with a traditional handwritten signature, to the Office of Regional 
Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.
    (2) Persons using electronic signatures shall, upon agency request, 
provide additional certification or testimony that a specific electronic 
signature is the legally binding equivalent of the signer's handwritten 
signature.



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

[[Page 201]]

    (3) Be administered and executed to ensure that attempted use of an 
individual's electronic signature by anyone other than its genuine owner 
requires collaboration of two or more individuals.
    (b) Electronic signatures based upon biometrics shall be designed to 
ensure that they cannot be used by anyone other than their genuine 
owners.



Sec.  11.300  Controls for identification codes/passwords.

    Persons who use electronic signatures based upon use of 
identification codes in combination with passwords shall employ controls 
to ensure their security and integrity. Such controls shall include:
    (a) Maintaining the uniqueness of each combined identification code 
and password, such that no two individuals have the same combination of 
identification code and password.
    (b) Ensuring that identification code and password issuances are 
periodically checked, recalled, or revised (e.g., to cover such events 
as password aging).
    (c) Following loss management procedures to electronically 
deauthorize lost, stolen, missing, or otherwise potentially compromised 
tokens, cards, and other devices that bear or generate identification 
code or password information, and to issue temporary or permanent 
replacements using suitable, rigorous controls.
    (d) Use of transaction safeguards to prevent unauthorized use of 
passwords and/or identification codes, and to detect and report in an 
immediate and urgent manner any attempts at their unauthorized use to 
the system security unit, and, as appropriate, to organizational 
management.
    (e) Initial and periodic testing of devices, such as tokens or 
cards, that bear or generate identification code or password information 
to ensure that they function properly and have not been altered in an 
unauthorized manner.



PART 12_FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents



                      Subpart A_General Provisions

Sec.
12.1 Scope.

                   Subpart B_Initiation of Proceedings

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

                 Subpart C_Appearance and Participation

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

                       Subpart D_Presiding Officer

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

                      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.

[[Page 202]]

12.97 Interlocutory appeal from ruling of presiding officer.
12.98 Official transcript.
12.99 Motions.

                     Subpart F_Administrative Record

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

                  Subpart G_Initial and Final Decisions

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

                        Subpart H_Judicial Review

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

    Authority: 21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 42 
U.S.C. 201, 262, 263b-263n, 264; 15 U.S.C. 1451-1461; 5 U.S.C. 551-558, 
701-721; 28 U.S.C. 2112.

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



                      Subpart A_General Provisions



Sec.  12.1  Scope.

    The procedures in this part apply when--
    (a) A person has a right to an opportunity for a hearing under the 
laws specified in Sec.  10.50; or
    (b) The Commissioner concludes that it is in the public interest to 
hold a formal evidentiary public hearing on any matter before FDA.



                   Subpart B_Initiation of Proceedings



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

    (a) A proceeding under section 409(f), 502(n), 512(n)(5), 701(e), or 
721(d) of the act or section 4 or 5 of the Fair Packaging and Labeling 
Act may be initiated--
    (1) By the Commissioner on the Commissioner's own initiative, e.g., 
as provided in Sec.  170.15 for food additives; or
    (2) By a petition--
    (i) In the form specified elsewhere in this chapter, e.g., the form 
for a color additive petition in Sec.  71.1; or
    (ii) If no form is specified, by a petition under Sec.  10.30.
    (b) If the Commissioner receives a petition under paragraph (a)(2) 
of this section, the Commissioner will--
    (1) If it involves any matter subject to section 701(e) of the act 
or section 4 or 5 of the Fair Packaging and Labeling Act, and meets the 
requirements for filing, follow the provisions of Sec.  10.40 (b) 
through (f);
    (2) If it involves a color additive or food additive, and meets the 
requirements for filing in 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--

[[Page 203]]

    (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.
    (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]

[[Page 204]]



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 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

[[Page 205]]

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 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

[[Page 206]]

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--
    (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

[[Page 207]]

    (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.
    (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

[[Page 208]]

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 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]

[[Page 209]]



Sec.  12.50  Advice on public participation in hearings.

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

[[Page 210]]

    (a) Specify and change the date, time, and place of oral hearings 
and conferences;
    (b) Establish the procedures for use in developing evidentiary 
facts, including the procedures in Sec.  12.92(b) and to rule on the 
need for oral testimony and cross-examination under Sec.  12.87(b);
    (c) Prepare statements of the areas of factual disagreement among 
the participants;
    (d) Hold conferences to settle, simplify, or determine the issues in 
a hearing or to consider other matters that may expedite the hearing;
    (e) Administer oaths and affirmations;
    (f) Control the course of the hearing and the conduct of the 
participants;
    (g) Examine witnesses and strike their testimony if they fail to 
respond fully to proper questions;
    (h) Rule on, admit, exclude, or limit evidence;
    (i) Set the time for filing pleadings;
    (j) Rule on motions and other procedural matters;
    (k) Rule on motions for summary decision under Sec.  12.93;
    (l) Conduct the hearing in stages if the number of parties is large 
or the issues are numerous and complex;
    (m) Waive, suspend, or modify any rule in this subpart under Sec.  
10.19 if the presiding officer determines that no party will be 
prejudiced, the ends of justice will be served, and the action is in 
accordance with law;
    (n) Strike the participation of any person under Sec.  12.45(e) or 
exclude any person from the hearing under Sec.  12.90, or take other 
reasonable disciplinary action; and
    (o) Take any action for the fair, expeditious, and orderly conduct 
of the hearing.



Sec.  12.75  Disqualification of presiding officer.

    (a) A participant may request the presiding officer to disqualify 
himself/herself and withdraw from the proceeding. The ruling on any such 
request may be appealed in accordance with Sec.  12.97(b).
    (b) A presiding officer who is aware of grounds for disqualification 
shall withdraw from the proceeding.



Sec.  12.78  Unavailability of presiding officer.

    (a) If the presiding officer is unable to act for any reason, the 
Commissioner will assign the powers and duties to another presiding 
officer. The substitution will not affect the hearing, except as the new 
presiding officer may order.
    (b) Any motion based on the substitution must be made within 10 
days.



                      Subpart E_Hearing Procedures



Sec.  12.80  Filing and service of submissions.

    (a) Submissions, including pleadings in a hearing, are to be filed 
with the 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

[[Page 211]]

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.
    (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.

[[Page 212]]

    (e) Participants may reference each other's submissions. To reduce 
duplicative submissions, participants are encouraged to exchange and 
consolidate lists of documentary evidence. If a particular document is 
bulky or in limited supply and cannot reasonably be reproduced, and it 
constitutes relevant evidence, the presiding officer may authorize 
submission of a reduced number of copies.
    (f) The presiding officer will rule on questions relating to this 
section.

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



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

    (a) The objective of a formal evidentiary hearing is the fair 
determination of relevant facts consistent with the right of all 
interested persons to participate and the public interest in promptly 
settling controversial matters affecting the public health and welfare.
    (b) Accordingly, the evidence at a hearing is to be developed to the 
maximum extent through written submissions, including written direct 
testimony, which may be in narrative or in question-and-answer form.
    (1) In a hearing, the issues may have general applicability and 
depend on general facts that do not concern particular action of a 
specific party, e.g., the safety or effectiveness of a class of drug 
products, the safety of a food or color additive, or a definition and 
standard of identity for a food; or the issues may have specific 
applicability to past action and depend upon particular facts concerning 
only that party, e.g., the applicability of a grandfather clause to a 
particular brand of a drug or the failure of a particular manufacturer 
to meet required manufacturing and processing specifications or other 
general standards.
    (i) If the proceeding involves general issues, direct testimony will 
be submitted in writing, except on a showing that written direct 
testimony is insufficient for a full and true disclosure of relevant 
facts and that the participant will be prejudiced if unable to present 
oral direct testimony. If the proceeding involves particular issues, 
each party may determine whether, and the extent to which, each wishes 
to present direct testimony orally or in writing.
    (ii) Oral cross-examination of witnesses will be permitted if it 
appears that alternative means of developing the evidence are 
insufficient for a full and true disclosure of the facts and that the 
party requesting oral cross-examination will be prejudiced by denial of 
the request or that oral cross-examination is the most effective and 
efficient means to clarify the matters at issue.
    (2) Witnesses shall give testimony under oath.
    (c) Except as provided in paragraph (d) of this section, in a 
hearing involving issuing, amending, or revoking a regulation or order, 
the originator of the proposal or petition or of any significant 
modification will be, within the meaning of 5 U.S.C. 556(d), the 
proponent of the regulation or order, and will have the burden of proof. 
A participant who proposes to substitute a new provision for a provision 
objected to has the burden of proof in relation to the new provision.
    (d) At a hearing involving issuing, amending, or revoking a 
regulation or order relating to the safety or effectiveness of a drug, 
device, food additive, or color additive, the participant who is 
contending that the product is safe or effective or both and who is 
requesting approval or contesting withdrawal of approval has the burden 
of proof in establishing safety or effectiveness or both and thus the 
right to approval. The burden of proof remains on that participant in an 
amendment or revocation proceeding.

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



Sec.  12.89  Participation of nonparties.

    (a) A nonparty participant may--
    (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

[[Page 213]]

    (2) Conduct cross-examination.
    (c) A person whose petition is the subject of the hearing has the 
same right as a party.
    (d) A nonparty participant will be permitted additional rights if 
the presiding officer concludes that the participant's interests would 
not be adequately protected otherwise or that broader participation is 
required for a full and true disclosure of the facts, but the rights of 
a nonparty participant may not exceed the rights of a party.

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



Sec.  12.90  Conduct at oral hearings or conferences.

    All participants in a hearing will conduct themselves with dignity 
and observe judicial standards of practice and ethics. They may not 
indulge in personal attacks, unseemly wrangling, or intemperate 
accusations or characterizations. Representatives of parties shall, to 
the extent possible, restrain clients from improprieties in connection 
with any proceeding. Disrespectful, disorderly, or contumacious language 
or conduct, refusal to comply with directions, use of dilatory tactics, 
or refusal to adhere to reasonable standards of orderly and ethical 
conduct during any hearing, constitute grounds for immediate exclusion 
from the proceeding by the presiding officer.



Sec.  12.91  Time and place of prehearing conference.

    A prehearing conference will commence at the date, time, and place 
announced in the notice of hearing, or in a later notice, or as 
specified by the presiding officer in a notice modifying a prior notice. 
At that conference the presiding officer will establish the methods and 
procedures to be used in developing the evidence, determine reasonable 
time periods for the conduct of the hearing, and designate the times and 
places for the production of witnesses for direct and cross-examination 
if leave to conduct oral examination is granted on any issue, as far as 
practicable at that time.



Sec.  12.92  Prehearing conference procedure.

    (a) Participants in a hearing are to appear at the prehearing 
conference prepared to discuss and resolve all matters specified in 
paragraph (b) of this section.
    (1) To expedite the hearing, participants are encouraged to prepare 
in advance for the prehearing conference. Participants should cooperate 
with each other, and request information and begin preparation of 
testimony at the earliest possible time. Failure of a participant to 
appear at the prehearing conference or to raise matters that could 
reasonably be anticipated and resolved at that time will not delay the 
progress of the hearing, and constitutes a waiver of the rights of the 
participant regarding such matters as objections to the agreements 
reached, actions taken, or rulings issued by the presiding officer and 
may be grounds for striking the participation under Sec.  12.45.
    (2) Participants shall bring to the prehearing conference the 
following specific information, which will be filed with the 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

[[Page 214]]

    (c) The statement either was made before the time the person agreed 
to become a witness or has been made publicly available by the person.
    (b) The presiding officer will conduct a prehearing conference for 
the following purposes:
    (1) To determine the areas of factual disagreement to be considered 
at the hearing. The presiding officer may hold conferences off the 
record in an effort to reach agreement on disputed factual questions.
    (2) To identify the most appropriate techniques for developing 
evidence on issues in controversy and the manner and sequence in which 
they will be used, including, where oral examination is to be conducted, 
the sequence in which witnesses will be produced for, and the time and 
place of, oral examination. The presiding officer may consider--
    (i) Submission of narrative statements of position on factual issues 
in controversy;
    (ii) Submission of evidence or identification of previously 
submitted evidence to support such statements, such as affidavits, 
verified statements of fact, data, studies, and reports;
    (iii) Exchange of written interrogatories directed to particular 
witnesses;
    (iv) Written requests for the production of additional 
documentation, data, or other relevant information;
    (v) Submission of written questions to be asked by the presiding 
officer of a specific witness; and
    (vi) Identification of facts for which oral examination and/or 
cross-examination is appropriate.
    (3) To group participants with substantially like interests for 
presenting evidence, making motions and objections, including motions 
for summary decision, filing briefs, and presenting oral argument.
    (4) To hear and rule on objections to admitting into evidence 
information submitted under Sec.  12.85.
    (5) To obtain stipulations and admissions of facts.
    (6) To take other action that may expedite the hearing.
    (c) The presiding officer shall issue, orally or in writing, a 
prehearing order reciting the actions taken at the prehearing conference 
and setting forth the schedule for the hearing. The order will control 
the subsequent course of the hearing unless modified by the presiding 
officer for good cause.



Sec.  12.93  Summary decisions.

    (a) After the hearing commences, a participant may move, with or 
without supporting affidavits, for a summary decision on any issue in 
the hearing. Any other participant may, within 10 days after service of 
the motion, which time may be extended for an additional 10 days for 
good cause, serve opposing affidavits or countermove for summary 
decision. The presiding officer may set the matter for argument and call 
for the submission of briefs.
    (b) The presiding officer will grant the motion if the objections, 
requests for hearing, other pleadings, affidavits, and other material 
filed in connection with the hearing, or matters officially noticed, 
show that there is no genuine issue as to any material fact and that a 
participant is entitled to summary decision.
    (c) Affidavits should set forth facts that would be admissible in 
evidence and show affirmatively that the affiant is competent to testify 
to the matters stated. When a properly supported motion for summary 
decision is made, a participant opposing the motion may not rest upon 
mere allegations or denials or general descriptions of positions and 
contentions; affidavits or other responses must set forth specific facts 
showing that there is a genuine issue of fact for the hearing.
    (d) Should it appear from the affidavits of a participant opposing 
the motion that for sound reasons stated, facts essential to justify the 
opposition cannot be presented by affidavit, the presiding officer may 
deny the motion for summary decision, order a continuance to permit 
affidavits or additional 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

[[Page 215]]

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--
    (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.

[[Page 216]]

    (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, 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;

[[Page 217]]

    (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.



                  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.

[[Page 218]]



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]



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

    (a) On appeal from or review of the initial decision, the 
Commissioner has all the powers given to make the initial decision. On 
the Commissioner's own initiative or on motion, the Commissioner may 
remand the matter to the presiding officer for any further action 
necessary for a proper decision.
    (b) The scope of the issues on appeal is the same as the scope of 
the issues at the public hearing unless the Commissioner specifies 
otherwise.
    (c) As soon as possible after the filing of briefs and any oral 
argument, the Commissioner will issue a final decision in the 
proceeding, which meets the requirements established in Sec.  12.120 (b) 
and (c).
    (d) The Commissioner may adopt the initial decision as the final 
decision.
    (e) Notice of the Commissioner's decision will be published in the 
Federal Register, or the Commissioner may publish the decision when it 
is of widespread interest.



Sec.  12.139  Reconsideration and stay of action.

    Following notice or publication of the final decisions, a 
participant may petition the Commissioner for reconsideration of any 
part or all of the decision under Sec.  10.33 or may petition for a stay 
of the decision under Sec.  10.35.



                        Subpart H_Judicial Review



Sec.  12.140  Review by the courts.

    (a) The Commissioner's final decision constitutes final agency 
action from which a participant may petition for judicial review under 
the statutes governing the matter involved. Before requesting an order 
from a court for a stay of action pending review, a participant shall 
first submit a petition for a stay of action under Sec.  10.35.
    (b) Under 28 U.S.C. 2112(a), FDA will request consolidation of all 
petitions related to a particular matter.

[[Page 219]]



Sec.  12.159  Copies of petitions for judicial review.

    The Chief Counsel for FDA has been designated by the Secretary as 
the officer on whom copies of petitions of judicial review are to be 
served. This officer is responsible for filing the record on which the 
final decision is based. The record of the proceeding is certified by 
the Commissioner.



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



                      Subpart A_General Provisions

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

                      Subpart B_Hearing Procedures

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

              Subpart C_Records of a Hearing Before a Board

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

    Authority: 5 U.S.C. 551-558, 701-721; 15 U.S.C. 1451-1461; 21 U.S.C. 
141-149, 321-393, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 
262, 263b-263n, 264.

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



                      Subpart A_General Provisions



Sec.  13.1  Scope.

    The procedures in this part apply when--
    (a) The Commissioner concludes, as a matter of discretion, that it 
is in the public interest to hold a public hearing before a Public Board 
of Inquiry (Board) with respect to any matter before FDA;
    (b) Under specific sections of this chapter a matter before FDA is 
subject to a hearing before a Board; or
    (c) Under Sec.  12.32, a person who has a right to an opportunity 
for a formal evidentiary public hearing waives that opportunity and 
requests that a Board act as an administrative law tribunal concerning 
the matters involved, and the Commissioner decides to accept this 
request.



Sec.  13.5  Notice of a hearing before a Board.

    If the Commissioner determines that a Board should be established to 
conduct a hearing on any matter, a notice of hearing will be published 
in the Federal Register setting forth the following information:
    (a) If the hearing is under Sec.  13.1 (a) or (b), all applicable 
information described in Sec.  12.32(e).
    (1) Any written document that is to be the subject matter of the 
hearing will be published as a part of the notice, or the notice will 
refer to it if the document has already been published in the Federal 
Register or state that the document is available from the 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

[[Page 220]]

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.
    (2) If a person fails to submit a list of nominees as required by 
paragraph (b) of this section, the Commissioner may choose a qualified 
member without further consultation with that person.
    (3) The Commissioner will announce the members of a Board by filing 
a memorandum in the record of the proceeding and sending a copy to all 
participants.
    (d) Instead of using the selection method in paragraphs (b) and (c) 
of this section, the director of the center, the other parties to the 
proceeding, and any person whose petition was granted and is the subject 
of the hearing, may, with the approval of the Commissioner, agree that a 
standing advisory committee listed in Sec.  14.80 constitutes the Board 
for a particular proceeding, or that another procedure is to be used for 
selection of the members of the Board, or that the Board consists of a 
larger number of members.
    (e) The members of a Board serve as consultants to the Commissioner 
and are special Government employees or Government employees. A Board 
functions as an administrative law tribunal in the proceeding and is not 
an advisory committee subject to the requirements of the Federal 
Advisory Committee Act or part 14.
    (f) The Chairman of the Board has the authority of a presiding 
officer set out in Sec.  12.70.

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



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

    (a) The proceeding of a Board are subject to the provisions of Sec.  
10.55 relating to separation of functions and ex parte communications. 
Representatives of the participants in any proceeding before a Board, 
including any members of the office of the Chief Counsel of FDA assigned 
to advise the center responsible for the matter, may have no contact 
with the members of the Board, except as participants in the proceeding, 
and may not participate in the deliberations of the Board.

[[Page 221]]

    (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 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

[[Page 222]]

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

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



Sec.  13.30  Proceedings of a Board.

    (a) The purpose of a Board is to review medical, scientific, and 
technical issues fairly and expeditiously. The proceedings of a Board 
are conducted as a scientific inquiry rather than a legal trial.
    (b) A Board may not hold its first hearing until after all 
participants have submitted the information required by Sec.  13.25.
    (c) The Chairman calls the first hearing of the Board. Notice of the 
time and location of the first hearing is to be published at least 15 
days in advance and the hearing will be open to the public. All 
participants will have an opportunity at the first hearing to make an 
oral presentation of the information and views which in their opinion 
are pertinent to the resolution of the issues being considered by a 
Board. A participant's presentation may be made by more than one person. 
The Chairman determines the order of the presentation. Participants may 
not interrupt a presentation, but members of the Board may ask 
questions. At the conclusion of a presentation, each of the other 
participants may briefly comment on the presentation and may request 
that the Board conduct further questioning on specified matters. Members 
of the Board may then ask further questions. Any other participant may 
be permitted to ask questions if the Chairman determines that it will 
help resolve the issues.
    (d) The hearing is informal and the rules of evidence do not apply. 
No motions or objections relating to the admissibility of information 
and views may be made or considered, but other participants may comment 
upon or rebut all such information and views. No participant may 
interrupt the presentation of another participant for any reason.
    (e) Within the time specified by the Board after its first hearing, 
participants may submit written rebuttal information and views in 
accordance with Sec.  13.20. The Chariman will then schedule a second 
hearing, if requested and justified by a participant. A second hearing, 
and any subsequent hearing, will be called only if the Chairman 
concludes that it is needed to fully and fairly present information that 
cannot otherwise adequately be considered and to properly resolve the 
issues. Notice of the time and location of any hearing is to be 
published at least 15 days in advance. The hearing is open to the 
public.
    (f) A Board may consult with any person who it concludes may have 
information or views relevant to the issues.
    (1) The consultation may occur only at an announced hearing of a 
Board. Participants have the right to suggest or, with the permission of 
the Chairman, ask questions of the consultant and present rebuttal 
information and views, as provided in paragraphs (c) and (d) of this 
section except that written statements may be submitted to the Board 
with the consent of all participants.
    (2) A participant may submit a request that the Board consult with a 
specific person who may have information or views relevant to the 
issues. The request will state why the person should be consulted and 
why the person's views cannot be furnished to the Board by means other 
than having FDA arrange for the person's appearance. The Board may, in 
its discretion, grant or deny the request.
    (g) All hearings are to be transcribed. All hearings are open to the 
public, except that a hearing under Sec.  10.20(j)(3) is closed to all 
persons except those persons making and participating in the 
presentation and Federal Government executive branch employees and 
special Government employees. At least a majority of Board members are 
to be present at every hearing. The executive sessions of a Board, 
during which a Board deliberates on the issues, are to be closed and are 
not transcribed. All members of the Board shall vote on the report of 
the Board.

[[Page 223]]

    (h) All legal questions are to be referred to the Chief counsel for 
FDA for resolution. The Chief Counsel's advice on any matter of 
procedure or legal authority is to be transmitted in writing and made a 
part of the record or presented in open session and transcribed.
    (i) At the conclusion of all public hearings the Board will announce 
that the record is closed to receiving information. The Board will 
provide an opportunity for participants to submit written statements of 
their positions, with proposed findings and conclusions, and may in its 
discretion, provide an opportunity for participants to summarize their 
positions orally.
    (j) The Board will prepare a decision on all issues. The decision is 
to include specific findings and references supporting and explaining 
the Board's conclusions, and a detailed statement of the reasoning on 
which the conclusions are based. Any member of the Board may file a 
separate report stating additional or dissenting views.



              Subpart C_Records of a Hearing Before a Board



Sec.  13.40  Administrative record of a Board.

    (a) The administrative record of a hearing before a Board consists 
of the following:
    (1) All relevant Federal Register notices.
    (2) All written submissions under Sec.  13.20.
    (3) The transcripts of all hearings of the Board.
    (4) The initial decision of the Board.
    (b) The record of the administrative proceeding is closed--
    (1) Relevant to receiving information and data, at the time 
specified in Sec.  13.30(i); and
    (2) Relevant to pleadings, at the time specified in Sec.  13.30(i) 
for filing a written statement of position with proposed findings and 
conclusions.
    (c) The Board may, in its discretion, reopen the record to receive 
further evidence at any time before filing an initial decision.



Sec.  13.45  Examination of administrative record.

    (a) The availability for public examination and copying of each 
document which is a part of the administrative record of the hearing is 
governed by Sec.  10.20(j). Each document available for public 
examination or copying is placed on public display in the office of the 
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 Chairperson of an advisory committee.
14.31 Consultation by an advisory committee with other persons.
14.33 Compilation of materials for members of an advisory committee.
14.35 Written submissions to an advisory committee.
14.39 Additional rules for a particular advisory committee.

[[Page 224]]

             Subpart C_Establishment of Advisory Committees

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

  Subpart D_Records of Meetings and Hearings Before Advisory Committees

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

                Subpart E_Members of Advisory Committees

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

                 Subpart F_Standing Advisory Committees

14.100 List of standing advisory committees.

   Subpart G_Technical Electronic Products Radiation Safety Standards 
                                Committee

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

              Subpart H_Color Additive Advisory Committees

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

       Subpart I_Advisory Committees for Human Prescription Drugs

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

    Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 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; Pub. L. 113-54.

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



                      Subpart A_General Provisions



Sec.  14.1  Scope.

    (a) This part governs 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 FD&C 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) [Reserved]
    (vi) Part 860, on classification of devices;
    (vii) Section 514(b)(5) of the FD&C Act on establishment, amendment, 
or

[[Page 225]]

revocation of a device performance standard;
    (viii) Section 515 of the FD&C Act on review of device premarket 
approval applications and product development protocols; and
    (ix) Section 520(f) of the FD&C 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 Chairperson and staff, and serves as a source of 
independent expertise and advice rather than as a representative of or 
advocate for any particular interest. The following groups are not 
advisory committees:
    (i) A group of persons convened on an ad hoc basis to discuss a 
matter of current interest to FDA, but which has no continuing function 
or organization and does not involve substantial special preparation.
    (ii) A group of two or more FDA consultants meeting with the agency 
on an ad hoc basis.
    (iii) A group of experts who are employed by a private company or a 
trade association which has been requested by FDA to provide its views 
on a regulatory matter pending before FDA.
    (iv) A consulting firm hired by FDA to provide advice regarding a 
matter.
    (6) An advisory committee that is utilized by FDA is subject to this 
subpart even though it was not established by FDA. In general, a 
committee is utilized when FDA requests advice or recommendations from 
the committee on a specific matter in order to obtain an independent 
review and consideration of the matter, and not when FDA is merely 
seeking the comments of all interested persons or of persons who have a 
specific interest in the matter.
    (i) A committee formed by an independent scientific or technical 
organization is utilized if FDA requests advice of that committee rather 
than of the parent organization, or if the circumstances show that the 
advice given is that of the committee and not of the parent 
organization. A committee formed by an independent scientific or 
technical organization is not utilized if FDA requests advice of the 
organization rather than of a committee and if the recommendations of 
any committee formed in response to the request are subject to 
substantial independent policy and factual review by the governing body 
of the parent organization.
    (ii) A committee is not utilized by FDA if it provides only 
information, as contrasted with advice or opinions or recommendations.
    (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

[[Page 226]]

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 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; 78 
FR 17087, Mar. 20, 2013; 81 FR 45409, July 14, 2016]



Sec.  14.5  Purpose of proceedings before an advisory committee.

    (a) An advisory committee is utilized to conduct public hearings on 
matters of importance that come before FDA, to review the issues 
involved, and to provide advice and recommendations to the Commissioner.
    (b) The Commissioner has sole discretion concerning action to be 
taken and policy to be expressed on any matter considered by an advisory 
committee.



Sec.  14.7  Administrative remedies.

    A person who alleges noncompliance by the Commissioner or an 
advisory committee with any provision of this part or the Federal 
Advisory Committee Act may pursue the following administrative remedies:
    (a) If the person objects to any action, including a failure to act, 
other than denial of access to an advisory committee document, the 
person shall submit a petition in the form and in accordance with the 
requirements of Sec.  10.30. The provisions of Sec.  10.45 relating to 
exhaustion of administrative remedies are applicable.
    (1) If the person objects to past action, the person shall submit 
the petition within 30 days after the action objected to. If the 
Commissioner determines that there was noncompliance with any provision 
of this subpart or of the Federal Advisory Committee Act, the 
Commissioner will grant any appropriate relief and take appropriate 
steps to prevent its future recurrence.
    (2) If the person objects to proposed future action, the 
Commissioner will expedite the review of the petition and make a 
reasonable effort to render a 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

[[Page 227]]

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.
    (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;

[[Page 228]]

    (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 Designated Federal Officer 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 Designated Federal Officer 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 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 Science Advisory 
Board of the National Center for Toxicological Research will generally 
hold meetings in the Little Rock, AR, vicinity.
    (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

[[Page 229]]

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 
Chairperson 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.

[44 FR 22351, Apr. 13, 1979; 48 FR 40887, Sept. 12, 1983, as amended at 
54 FR 9035, Mar. 3, 1989; 78 FR 17087, Mar. 20, 2013]



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 Chairperson.
    (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

[[Page 230]]

a written determination by the Commissioner under this section.
    (b) The Designated Federal Officer or other designated agency 
employee shall prepare the initial request for a determination to close 
a portion of a meeting, specifying the matter(s) to be discussed during 
the closed portion and the reasons why the portion should be closed. The 
Commissioner, based upon this request and with the concurrence of the 
Chief Counsel, will determine whether to close a portion of a meeting. 
The reasons for closing a portion of a meeting will be announced in the 
Federal Register notice of the meeting under Sec.  14.20 in accordance 
with the following rules:
    (1) Any determination to close a portion of a meeting restricts the 
closing to the shortest possible time consistent with the policy in this 
section.
    (2) A portion of a meeting may be closed only if the Commissioner 
determines that the closing is permitted under 5 U.S.C. 552b(c), and 
that the closing is necessary.
    (3) Portions of meetings may ordinarily be closed if they concern 
the review, discussion, and evaluation of drafts or regulations, 
guidance documents or similar preexisting internal agency documents, but 
only if their premature disclosure would significantly impede proposed 
agency action; review of trade secrets and confidential commercial or 
financial information; consideration of matters involving investigatory 
files compiled for law enforcement purposes; and review of matters, the 
disclosure of which would constitute a clearly unwarranted invasion of 
personal privacy.
    (4) Portions of meetings ordinarily may not be closed if they 
concern review, discussion, and evaluation of general preclinical and 
clinical test protocols and procedures for a class of drugs or devices; 
consideration of labeling requirements for a class of marketed drugs and 
devices; review of information on specific investigational or marketed 
drugs and devices that have previously been made public; presentation of 
any other information not exempt from public disclosure under 5 U.S.C. 
552b(c); the formulation of advice and recommendations to FDA on matters 
that do not independently justify closing.
    (5) No portion of a meeting devoted to matters other than those 
designated in paragraph (b) (1) through (3) of this section may be 
closed.
    (6) A matter which is properly considered in an open portion of a 
meeting may instead be considered in a closed portion only if it is so 
inextricably intertwined with matters to be discussed in a closed 
portion that it is not feasible to separate them or discussion of the 
matter in an open portion would compromise the matters to be discussed 
in the closed portion.
    (c) Attendance at a closed portion of a meeting is governed by the 
following rules:
    (1) A portion of a meeting closed for the presentation or discussion 
of information that constitutes a trade secret or confidential 
commercial or financial information as defined in Sec.  20.61 may be 
attended only by voting advisory committee members, nonvoting members 
representing consumer interests who are also special government 
employees as provided in Sec.  14.80(b), the Designated Federal Officer 
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 Chairperson 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 Designated Federal Officer of the 
committee, a

[[Page 231]]

transcriber, and other regular employees of FDA (including members of 
the Office of the Chief Counsel) whom the Chairperson 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 
Designated Federal Officer and the Chairperson, 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 Designated Federal Officer and the Chairperson 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 Chairperson 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 Chairperson.
    (b) An interested person who wishes to be assured of the right to 
make an oral presentation at a meeting shall inform the Designated 
Federal Officer or other designated agency employee, orally or in 
writing, before the meeting.
    (1) The person shall state the general nature of the presentation 
and the approximate time desired. Whenever possible, all written 
information to be discussed by that person at the meeting should be 
furnished in advance to the Designated Federal Officer 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 Designated Federal Officer 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 Chairperson 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 Chairperson.
    (f) The Chairperson and other members may question a person 
concerning

[[Page 232]]

that person's presentation. No other person, however, may question the 
person. The Chairperson 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 interrupt the 
presentation of another participant.



Sec.  14.30  Chairperson of an advisory committee.

    (a) The advisory committee Chairperson has the authority to conduct 
hearings and meetings, including the authority to adjourn a hearing or 
meeting if the Chairperson 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 Chairperson is not a full-time employee of FDA, the 
Designated Federal Officer or other designated agency employee, or 
alternate, is to be the designated Federal employee who is assigned to 
the advisory committee. The designated Federal employee is also 
authorized to adjourn a hearing or meeting if the employee determines 
adjournment to be in the public interest.



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

    (a) A committee may confer with any person who may have information 
or views relevant to any matter pending before the committee.
    (b) An interested person may submit to the committee a written 
request that it confer with specific persons about any matter pending 
before the committee. The request is to contain adequate justification. 
The committee may, in its discretion, grant the request.
    (c) A committee may confer with a person who is not a Federal 
Government executive branch employee only during the open portions of a 
meeting. The person may, however, submit views in writing to the 
committee as part of the administrative record under Sec.  14.70. The 
person may participate at the closed portions of a meeting only if 
appointed as a special Government employee by the Commissioner as 
provided in paragraph (e) of this section. This paragraph (c) is not 
intended to bar the testimony of a person during a closed portion of a 
meeting about matters prohibited from public disclosure under 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

[[Page 233]]

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 Designated Federal Officer 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 
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 Designated Federal Officer 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 
Designated Federal Officer 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

[[Page 234]]

are not inconsistent with this subpart or with other legal requirements.
    (b) Any additional rules will be included in the minutes of the 
meeting when adopted and in the materials compiled under Sec.  14.33 and 
will be available for public disclosure under Sec.  14.65(c).



             Subpart C_Establishment of Advisory Committees



Sec.  14.40  Establishment and renewal of advisory committees.

    (a) An advisory committee may be established or renewed whenever it 
is necessary or appropriate for the committee to hold a public hearing 
and to review and make recommendations on any matter pending before FDA. 
Except for committees established by statute, before a committee is 
established or renewed it must first be approved by the Department 
pursuant to 45 CFR part 11 and by the General Services Administration.
    (b) When an advisory committee is established or renewed, the 
Commissioner will issue a Federal Register notice certifying that the 
establishment or renewal is in the public interest and stating the 
structure, function, and purposes of the committee and, if it is a 
standing advisory committee, shall amend Sec.  14.100 to add it to the 
list of standing advisory committees. A notice of establishment will be 
published at least 15 days before the filing of the advisory committee 
charter under paragraph (c) of this section. A notice of renewal does 
not require the 15-day notice.
    (c) No committee may meet or take action until its charter is 
prepared and filed as required by section 9(c) of the Federal Advisory 
Committee Act. This requirement is to be met by an advisory committee 
utilized by FDA, even though it is not established by the agency, prior 
to utilization.
    (d) The regulations of the Department cited in paragraph (a) of this 
section provide that the charter of a parent committee may incorporate 
information concerning activities of a subgroup. In such instances, a 
subgroup will not be established as a committee distinct from the parent 
committee. However, a subgroup will be established as a separate 
committee when the charter of the parent committee does not incorporate 
the activities of the subgroup, or when the subgroup includes members 
who are not all drawn from the parent committee.
    (e) An advisory committee not required to be established by law will 
be established or utilized only if it is in the public interest and only 
if its functions cannot reasonably be performed by other existing 
advisory committees or by FDA.
    (f) An advisory committee must meet the following standards:
    (1) Its purpose is clearly defined.
    (2) Its membership is balanced fairly in terms of the points of view 
represented in light of the functions to be performed. Although 
proportional representation is not required, advisory committee members 
are selected without regard to race, color, national origin, religion, 
age, or sex.
    (3) It is constituted and utilizes procedures designed to assure 
that its advice and recommendations are the result of the advisory 
committee's independent judgment.
    (4) Its staff is adequate. The Commissioner designates an Designated 
Federal Officer and alternate for every advisory committee, who are 
employees of FDA. The Designated Federal Officer 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

[[Page 235]]

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, as added by 
the Radiation Control for Health and Safety Act of 1968, transferred to 
the FD&C Act (21 U.S.C. 360kk(f)(1)(A)), 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 FD&C 
Act (21 U.S.C. 360c(b)(1)) and part 860, and the statutory medical 
device good manufacturing practice advisory committees established under 
section 520(f)(3) of the FD&C Act (21 U.S.C. 360j(f)(3)), are 
specifically exempted from the normal 2-year duration period.
    (d) Color additive advisory committees are required to be 
established under the circumstances specified in sections 721(b)(5)(C) 
and (D) of the FD&C Act (21 U.S.C. 379e(b)(5)(C) and (D)). A color 
additive advisory committee is subject to the termination and renewal 
requirements of the Federal Advisory Committee Act and of this part.
    (e) The Tobacco Products Scientific Advisory Committee is a 
permanent statutory advisory committee established by section 917 of the 
Family Smoking Prevention and Tobacco Control Act (21 U.S.C. 387q) (Pub. 
L. 111-31) and is not subject to termination and renewal under paragraph 
(a) of this section.

[44 FR 22351, Apr. 13, 1979, as amended at 75 FR 73953, Nov. 30, 2010; 
78 FR 17087, Mar. 20, 2013]



  Subpart D_Records of Meetings and Hearings Before Advisory Committees



Sec.  14.60  Minutes and reports of advisory committee meetings.

    (a) The Designated Federal Officer 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 
Chairperson. The approval and certification may be accomplished by mail 
or by telephone.
    (b) The minutes include the following:
    (1) The time and place of the meeting.
    (2) The members, committee staff, and agency employees present, and 
the names and affiliations or interests of public participants.
    (3) A copy of or reference to all written information made available 
for consideration by the committee at the proceedings.
    (4) A complete and accurate description of matters discussed and 
conclusions reached. A description is to be kept separately for the 
following portions of the meeting to facilitate their public disclosure: 
The open portions specified in Sec.  14.25 (a) and (b), any closed 
portion during which a presentation is made under Sec.  14.25(c), and 
any closed deliberative portion under Sec.  14.25(d). The minutes of a 
closed deliberative portion of a meeting may not refer to members by 
name, except upon their request, or to data or information described in 
Sec.  14.75(b). Any inadvertent references that occur are to be deleted 
before public disclosure.
    (5) A copy of or reference to all reports received, issued, or 
approved by the committee.
    (6) The extent to which the meeting was open to the public.
    (7) The extent of public participation, including a list of members 
of the public who presented oral or written statements.
    (c) For a meeting that has a closed portion, either (1) the minutes 
of the closed portion are available for public disclosure under Sec.  
14.75(a)(6)(i), or (2) if under Sec.  14.75(a)(6)(ii) they are not 
promptly available, the Designated Federal Officer 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

[[Page 236]]

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 the Committee Management Officer in 
the Advisory Committee Oversight and Management Staff, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver 
Spring, MD 20993.
    (b) Public inquiries on matters relating to a specific committee, 
except requests for records, are to be directed to the Designated 
Federal Officer or the designated agency employee listed in the Federal 
Register notices published under Sec.  14.20.
    (c) Requests for public advisory committee records, including 
minutes, are to be made, to FDA's Division of Freedom of Information 
(the Freedom of Information Staff's address is available on the agency's 
web site at http://www.fda.gov) 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; 76 
FR 31469, June 1, 2011; 78 FR 17087, Mar. 20, 2013; 79 FR 68114, Nov. 
14, 2014]



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

[[Page 237]]

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 Chairperson.
    (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 Chairperson; and
    (ii) For a matter directed to be maintained as confidential under 
Sec.  14.22(i)(2): After the advice or report of the committee relevant 
to those minutes or portions thereof is acted upon by the Commissioner, 
or upon a determination by the Commissioner that such minutes or 
portions thereof may be made available for public disclosure without 
undue interference with agency or advisory committee operations.
    (7) Formal advice or a report of the committee: After it has been 
acted upon, i.e., approved, disapproved, or rejected as inadequate, by 
the Commissioner, or upon a determination by the Commissioner that such 
formal advice or report may be made available for public disclosure 
without undue interference with agency or committee operations. Such 
formal advice or report may be retained as confidential while it is 
under active advisement.
    (8) Any other committee records relating to the matter, except 
transcripts and recordings of closed portions of meetings: After the 
advice or report of the committee relevant to those records is acted 
upon by the Commissioner, or upon a determination by the Commissioner 
that the records may be made available for public disclosure without 
undue interference with agency or committee operations.
    (b) The following information contained in the administrative record 
is not available for public examination or copying except as provided in 
Sec.  12.32(g):
    (1) Material provided to the committee by FDA that is exempt from 
public disclosure under part 20 and the regulations referenced there.
    (2) Material provided to the advisory committee by a person making a 
presentation described in Sec.  14.25(c) and which is prohibited from 
public disclosure under part 20 and the regulations referenced there.
    (c) The 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

[[Page 238]]

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 Chairperson, 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).
    (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.

[[Page 239]]



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 Advisory Committee 
Oversight and Management Staff, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, rm. 1503, Silver Spring, MD 20993.
    (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 Advisory Committee Oversight and Management Staff will 
compile a list of organizations whose objectives are to promote, 
encourage, and contribute to the advancement of consumer education and 
to the resolution of consumer problems. All organizations listed are 
entitled to vote upon the nominees. The list will include organizations 
representing the public interest, consumer advocacy groups, and 
consumer/health branches of Federal, State, and local governments. Any 
organization that meets the criteria may be included on such list on 
request.
    (4) The executive secretary, or other designated agency employee, 
will review the list of nominees and select three to five qualified 
nominees to be placed on a ballot. Names not selected will remain on a 
list of eligible nominees and be reviewed periodically by the Advisory 
Committee Oversight and Management Staff 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

[[Page 240]]

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 
Advisory Committee Oversight and Management Staff 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 Advisory Committee 
Oversight and Management Staff 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; 75 
FR 15342, Mar. 29, 2010]



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

    (a) A nonvoting member of an advisory committee selected to 
represent and serve as a liaison with interested individuals, 
associations, and organizations has the same rights as any other 
committee member except that--
    (1) A nonvoting member may vote only on procedural matters such as 
additional rules adopted under Sec.  14.39(a), approval of minutes under 
Sec.  14.60(a), decisions on transcripts under Sec.  14.61(b), and 
future meeting dates;
    (2) A nonvoting member who is a representative of industry interest 
may have access to data and information that constitute a trade secret 
or confidential commercial or financial information as defined in Sec.  
20.61 only if the person has been appointed as a special Government 
employee under Sec.  14.80(b).
    (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

[[Page 241]]

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 
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

[[Page 242]]

required to travel outside of that commuting area to perform the 
assignment. A committee member will not be paid for time spent on normal 
preparation for a committee meeting.
    (1) An agency-directed assignment is an assignment that meets the 
following criteria:
    (i) An activity that requires undertaking a definitive study. The 
activity must produce a tangible end product, usually a written report. 
Examples are:
    (a) An analysis of the risks and benefits of the use of a class of 
drugs or a report on a specific problem generated by an IND or NDA;
    (b) The performance of similar investigations or analysis of complex 
industry submissions to support advisory committee deliberations other 
than normal meeting preparation;
    (c) The preparation of a statistical analysis leading to an estimate 
of toxicologically safe dose levels; and
    (d) The design or analysis of animal studies of toxicity, 
mutagenicity, teratogenicity, or carcinogenicity.
    (ii) The performance of an IND or NDA review or similar review.
    (2) A committee member who undertakes a special assignment, the end 
product of which does not represent the end product of the advisory 
committee, but rather of the committee member's own assignment, can be 
compensated. Should this preparatory work by members collectively result 
in an end product of the committee, this is to be considered normal 
meeting preparation and committee members are not to be compensated for 
this work.
    (d) Salary while in travel status is authorized when a committee 
member's ordinary pursuits are interrupted for the substantial portion 
of an additional day beyond the day or days spent in performing those 
services, and as a consequence the committee member loses some regular 
compensation. This applies on weekends and holidays if the special 
Government employee loses income that would otherwise be earned on that 
day. For travel purposes, a substantial portion of a day is defined as 
50 percent of the working day, and the traveler will be paid at a daily 
rate.

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



                 Subpart F_Standing Advisory Committees



Sec.  14.100  List of standing advisory committees.

    Standing advisory committees and the dates of their establishment 
are as follows:
    (a) Office of the Commissioner--
    (1) Board of Tea Experts.
    (i) Date established: March 2, 1897.
    (ii) Function: Advises on establishment of uniform standards of 
purity, quality, and fitness for consumption of all tea imported into 
the United States under 21 U.S.C. 42.
    (2) Science Board to the Food and Drug Administration.
    (i) Date established: June 26, 1992.
    (ii) Function: The board shall provide advice primarily to the 
agency's Senior Science Advisor and, as needed, to the Commissioner and 
other appropriate officials on specific complex and technical issues as 
well as emerging issues within the scientific community in industry and 
academia. Additionally, the board will provide advice to the agency on 
keeping pace with technical and scientific evolutions in the fields of 
regulatory science; on formulating an appropriate research agenda; and 
on upgrading its scientific and research facilities to keep pace with 
these changes. It will also provide the means for critical review of 
agency sponsored intramural and extramural scientific research programs.
    (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.
    (4) Risk Communication Advisory Committee.
    (i) Date rechartered: July 9, 2009.
    (ii) Function: The committee reviews and evaluates strategies and 
programs designed to communicate with the public about the risks and 
benefits of FDA-regulated products so as to facilitate optimal use of 
these products. The committee also reviews and evaluates research 
relevant to such communication to the public by both FDA and

[[Page 243]]

other entities. It also facilitates interactively sharing risk and 
benefit information with the public to enable people to make informed 
independent judgments about use of FDA-regulated products.
    (5) Tobacco Products Scientific Advisory Committee.
    (i) Date Established: August 12, 2009.
    (ii) Function: The committee reviews and evaluates safety, 
dependence, and health issues relating to tobacco products and provides 
appropriate advice, information, and recommendations to the Commissioner 
of Food and Drugs. Specifically, the committee will submit reports and 
recommendations on tobacco-related topics, including: The impact of the 
use of menthol in cigarettes on the public health, including such use 
among children, African Americans, Hispanics and other racial and ethnic 
minorities; the nature and impact of the use of dissolvable tobacco 
products on the public health, including such use on children; the 
effects of the alteration of nicotine yields from tobacco products and 
whether there is a threshold level below which nicotine yields do not 
produce dependence on the tobacco product involved; and any application 
submitted by a manufacturer for a modified risk tobacco product. The 
committee may provide recommendations to the Secretary of Health and 
Human Services regarding any regulations to be issued under the Federal 
Food, Drug, and Cosmetic Act and may review any applications for new 
tobacco products or petitions for exemption under section 906(e) of the 
Family Smoking Prevention and Tobacco Control Act. The committee may 
consider and provide recommendations on any other matter as provided in 
the Family Smoking Prevention and Tobacco Control Act.
    (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) 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.
    (c) Center for Drug Evaluation and Research--
    (1) Anesthetic and Analgesic Drug Products Advisory Committee.
    (i) Date established: May 1, 1978.
    (ii) Function: Reviews and evaluates data concerning the safety and 
effectiveness of marketed and investigational human drug products 
including analgesics, e.g., abuse-deterrent opioids, novel analgesics, 
and issues related to opioid abuse, and those for use in anesthesiology.
    (2) Antimicrobial 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

[[Page 244]]

use in the treatment of infectious diseases and disorders.
    (3) Arthritis Advisory Committee.
    (i) Date established: April 5, 1974.
    (ii) Function: Reviews and evaluates data on the safety and 
effectiveness of marketed and investigational human drugs for use in 
arthritic conditions.
    (4) 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.
    (5) 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.
    (6) 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.
    (7) 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.
    (8) Bone, Reproductive and Urologic Drugs Advisory Committee.
    (i) Date established: March 23, 1978.
    (ii) Function: Advises the Commissioner or designee in discharging 
responsibilities as they relate to helping to ensure safe and effective 
drugs for human use and, as required, any other product for which the 
Food and Drug Administration has regulatory responsibility.
    (9) 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.
    (10) 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.
    (11) 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.
    (12) 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.
    (13) 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.
    (14) Medical Imaging Drugs Advisory Committee.
    (i) Date established: May 18, 2011.
    (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.
    (15) Pharmaceutical Science and Clinical Pharmacology Advisory 
Committee.
    (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

[[Page 245]]

regulatory responsibility, and make appropriate recommendations to the 
Commissioner of Food and Drugs. The Committee may also review agency 
sponsored intramural and extramural 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.
    (16) 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.
    (17) Pharmacy Compounding Advisory Committee.
    (i) Date re-established: April 25, 2012.
    (ii) Function: Provides advice on scientific, technical, and medical 
issues concerning drug compounding under sections 503A and 503B of the 
Federal Food, Drug, and Cosmetic Act and, as required, any other product 
for which the Food and Drug Administration has regulatory 
responsibility, and makes appropriate recommendations to the 
Commissioner of Food and Drugs.
    (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.
    (5) Patient Engagement Advisory Committee.
    (i) Date Established: October 6, 2015.
    (ii) Function: Provides advice to the Commissioner on complex issues 
relating to medical devices, the regulation of devices, and their use by 
patients. Agency guidance and policies, clinical trial or registry 
design, patient preference study design, benefit-risk determinations, 
device labeling, unmet clinical needs, available alternatives, patient 
reported outcomes, and device-related quality of life or health status 
issues are among the topics that may be considered by the Committee. The 
Committee provides relevant skills and perspectives in order to improve 
communication of benefits, risks, and clinical outcomes, and increase 
integration of patient perspectives into the regulatory process for 
medical devices. It performs its duties by identifying new approaches, 
promoting innovation, recognizing unforeseen risks or barriers, and 
identifying unintended consequences that could result from FDA policy.
    (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 to 
fulfill regulatory responsibilities.

[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 at www.fdsys.gov.

[[Page 246]]



   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 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360kk(f)(1)(A)) to provide consultation before the Commissioner 
prescribes any performance standard for an electronic product.

[44 FR 22351, Apr. 13, 1979, as amended at 78 FR 17087, Mar. 20, 2013]



Sec.  14.122  Functions of TEPRSSC.

    (a) In performing its function of advising the Commissioner, 
TEPRSSC--
    (1) May propose electronic product radiation safety standards to the 
Commissioner for consideration;
    (2) Provides consultation to the Commissioner on all performance 
standards proposed for consideration under 21 U.S.C. 360kk; 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 21 
U.S.C. 360kk rests with the Commissioner, after receiving the advice of 
TEPRSSC.

[44 FR 22351, Apr. 13, 1979, as amended at 78 FR 17087, Mar. 20, 2013]



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 21 U.S.C. 360kk(f)(1)(A) and in 
Sec.  14.127(a), i.e., Government, industry, and the public.
    (d) The Chairperson 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 Chairperson believes that more time is needed, the 
Chairperson 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; 78 
FR 17087, Mar. 20, 2013]



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 Chairperson 
of TEPRSSC.
    (c) Appointments of members are for a term of 3 years or as 
specified by the Commissioner.
    (1) The Chairperson is appointed for a term concurrent with the 
Chairperson's term as a member of TEPRSSC. If the Chairpersonship 
becomes vacant without adequate notice,

[[Page 247]]

the Designated Federal Officer may appoint a committee member as 
temporary Chairperson pending appointment of a new Chairperson by the 
Commissioner.
    (2) Members may not be reappointed for a second consecutive full 
term.
    (d) A person otherwise qualified for membership is not eligible for 
selection as a member of TEPRSSC from Government agencies or the general 
public if the Commissioner determines that the person does not meet the 
requirements of the conflict of interest laws and regulations.
    (e) Retention of membership is conditioned upon the following:
    (1) Continued status as a member of the group from which the member 
was selected as specified in paragraph (a) of this section.
    (2) Absence of any conflict of interest during the term of 
membership as specified in paragraph (d) of this section.
    (3) Active participation in TEPRSSC activities.
    (f) Appointment as a member of TEPRSSC is conditioned on 
certification that the prospective member:
    (1) Agrees to the procedures and criteria specified in this subpart.
    (2) Has no conflict of interest as specified in paragraph (d) of 
this section.
    (3) Will notify the Designated Federal Officer 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 21 U.S.C. 360kk(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.

[44 FR 22351, Apr. 13, 1979, as amended at 78 FR 17087, Mar. 20, 2013]



              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 FD&C 
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

[[Page 248]]

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 
FD&C Act or that there is no genuine and substantial issue of fact 
requiring scientific judgment, or for any other reason a color additive 
advisory committee is not justified, the Commissioner may deny the 
establishment of a color additive advisory committee.
    (3) Establishment of a color additive advisory committee on the 
request of an interested person is conditioned upon receipt of the 
application fee specified in Sec.  14.155.
    (4) Any person adversely affected may request referral of the matter 
to a color additive advisory committee at any time before, or within 30 
days after, publication of an order of the Commissioner acting upon a 
color additive petition or proposal.



Sec.  14.142  Functions of a color additive advisory committee.

    (a) A color additive advisory committee reviews all available 
information relating to the matter referred to it, including all 
information contained in any pertinent color additive petition and in 
FDA files. All information reviewed is placed on public display and is 
available for review at the office of the 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 Chairperson 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 Chairperson concludes that the color additive advisory 
committee needs additional time, the Chairperson 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 
FD&C Act on the request of an interested person, it shall

[[Page 249]]

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 Chairperson.
    (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 FD&C Act may be waived and the matter may be 
referred to any standing advisory committee listed in Sec.  14.100 or to 
any advisory committee established under any other procedure that is 
mutually agreeable. Once the Commissioner has established a color 
additive advisory committee and has referred to it a matter relating to 
a color additive, no interested person may subsequently request that an 
additional or different color additive advisory committee be established 
to review and make recommendations about that color additive.
    (b) Members of a color additive advisory committee are subject to 
the requirements of the Federal Advisory Committee Act and this subpart, 
except that no member of a color additive advisory committee may by 
reason of such membership alone be a special government employee or be 
subject to the conflict of interest laws and regulations.



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

    (a) When a matter is referred to a color additive advisory 
committee, all related costs, including personal compensation of 
committee members, travel, materials, and other costs, are borne by the 
person requesting the referral, such costs to be assessed on the basis 
of actual cost to the government. The compensation of such costs 
includes personal compensation of committee members at a rate not to 
exceed $128.80 per member per day.
    (b) In the case of a request for referral to a color additive 
advisory committee, a special advance deposit is to be made in the 
amount of $2,500. Where required, further advances in increments of 
$2,500 each are to be made upon request of the Commissioner. All 
deposits for referrals to a color additive advisory committee in excess 
of actual expenses will be refunded to the depositor.
    (c) All deposits and fees required by this section are to be paid by 
money order, bank draft, or certified check drawn to the order of the 
Food and Drug Administration, collectible 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

[[Page 250]]

the advisory committee and on the scientific standards appropriate for a 
determination of safety and effectiveness in that class of drugs.
    (b) Specifically on any particular matter involving a human 
prescription drug pending before FDA, including whether the available 
information is adequate to support a determination that--
    (1) A particular IND study may properly be conducted;
    (2) A particular drug meets the statutory standard for proof of 
safety and effectiveness necessary for approval or continued approval 
for marketing; or
    (3) A particular drug is properly classified as a new drug, an old 
drug, or a banned drug.



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

    (a) Any matter involving a human prescription drug under review 
within the agency may, in the discretion of the Commissioner, be the 
subject of a public hearing and continuing or periodic review by the 
appropriate standing technical advisory committee for human prescription 
drugs. The Commissioner's determinations on the agenda of the committee 
are based upon the priorities of the various matters pending before the 
agency which fall within the pharmacologic class covered by that 
committee.
    (b) High priority for such hearing and review by the appropriate 
standing technical advisory committee for human prescription drugs are 
given to the following types of human prescription drugs:
    (1) Investigational drugs which are potential therapeutic advances 
over currently marketed products from the standpoint of safety or 
effectiveness, or which pose significant safety hazards, or which 
present narrow benefit-risk considerations requiring a close judgmental 
decision on approval for marketing, or which have a novel delivery 
system or formulation, or which are the subject of major scientific or 
public controversy, or which may be subject to special regulatory 
requirements such as a limitation on clinical trials, a patient followup 
requirement, postmarketing Phase IV studies, distributional controls, or 
boxed warnings.
    (2) Marketed drugs for which an important new use has been 
discovered or which pose newly discovered safety hazards, or which are 
the subject of major scientific or public controversy, or which may be 
subject to important regulatory actions such as withdrawal of approval 
for marketing, boxed warnings, distributional controls, or newly 
required scientific studies.
    (c) The committee may request the Commissioner for an opportunity to 
hold a public hearing and to review any matter involving a human 
prescription drug which falls within the pharmacologic class covered by 
the committee. The Commissioner may, after consulting with the committee 
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

[[Page 251]]

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

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



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

    Any interested person may request, under Sec.  10.30, that a 
specific matter relating to a particular human prescription drug be 
submitted to an appropriate advisory committee for a hearing and review 
and recommendations. The request must demonstrate the importance of the 
matter and the reasons why it should be submitted for a hearing at that 
time. The Commissioner may grant or deny the request.



Sec.  14.174  Advice and recommendations in writing.

    Advice and recommendations given by a committee on a specific drug 
or a class of drugs are ordinarily in the form of a written report. The 
report may consist of the approved minutes of the meeting or a separate 
written report. The report responds to the specific issues or questions 
which the Commissioner has addressed to the advisory committee, and 
states the basis of the advice and recommendations of the committee.



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



                      Subpart A_General Provisions

Sec.
15.1 Scope.

     Subpart B_Procedures for Public Hearing Before the Commissioner

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

      Subpart C_Records of a Public Hearing Before the Commissioner

15.40 Administrative record.
15.45 Examination of administrative record.

    Authority: 5 U.S.C. 553; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 
321-393, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b-
263n, 264.

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



                      Subpart A_General Provisions



Sec.  15.1  Scope.

    The procedures in this part apply when:
    (a) The Commissioner concludes, as a matter of discretion, that it 
is in the public interest to permit persons to present information and 
views at a public hearing on any matter pending before the Food and Drug 
Administation.
    (b) The act or regulation specifically provides for a public hearing 
before the Commissioner on a matter, e.g., Sec.  330.10(a)(8) relating 
to over-the-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

[[Page 252]]

the notice will state that the document is available from an agency 
office identified in the notice.
    (ii) The time, date, and place of the hearing, or a statement that 
the information will be contained in a subsequent notice.
    (2) If the hearing is in lieu of a formal evidentiary public hearing 
under Sec.  15.1(c), all of the information described in Sec.  12.32(e).
    (b) The scope of the hearing is determined by the notice of hearing 
and any regulation under which the hearing is held. If a regulation, 
e.g., Sec.  330.10(a)(10), limits a hearing to review of an existing 
administrative record, information not already in the record may not be 
considered at the hearing.
    (c) The notice of hearing may require participants to submit the 
text of their presentations in advance of the hearing if the 
Commissioner determines that advance submissions are necessary for the 
panel to formulate useful questions to be posed at the hearing under 
Sec.  15.30(e). The notice may provide for the submission of a 
comprehensive outline as an alternative to the submission of the text if 
the Commissioner determines that submission of an outline will be 
sufficient.

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



Sec.  15.21  Notice of participation; schedule for hearing.

    (a) The notice of hearing will provide persons an opportunity to 
file a written notice of participation with the 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.

[[Page 253]]

    (c) Persons may use their alloted time in whatever way they wish, 
consistent with a reasonable and orderly hearing. A person may be 
accompanied by any number of additional persons, and may present any 
written information or views for inclusion in the record of the hearing, 
subject to the requirements of Sec.  15.25. The presiding officer may 
allot additional time to any person when the officer concludes that it 
is in the public interest, but may not reduce the time allotted for any 
person without the consent of the person.
    (d) If a person is not present at the time specified for the 
presentation, the persons following will appear in order, with 
adjustments for those appearing at their scheduled time. An attempt will 
be made to hear any person who is late at the conclusion of the hearing. 
Other interested persons attending the hearing who did not request an 
opportunity to make an oral presentation will be given an opportunity to 
make an oral presentation at the conclusion of the hearing, in the 
discretion of the presiding officer, to the extent that time permits.
    (e) The presiding officer and any other persons serving on a panel 
may question any person during or at the conclusion of the presentation. 
No other person attending the hearing may question a person making a 
presentation. The presiding officer may, as a matter of discretion, 
permit questions to be submitted to the presiding officer or panel for 
response by them or by persons attending the hearing.
    (f) The hearing is informal in nature, and the rules of evidence do 
not apply. No motions or objections relating to the admissibility of 
information and views may be made or considered, but other participants 
may comment upon or rebut all such information and views. No participant 
may interrupt the presentation of another participant at any hearing for 
any reason.
    (g) The hearing may end early only if all persons scheduled for a 
later presentation have already appeared or it is past the time 
specified in the hearing schedule, under Sec.  15.21(e), by which 
participants must be present.
    (h) The Commissioner or the presiding officer may, under Sec.  
10.19, suspend, modify, or waive any provision of this part.



      Subpart C_Records of a Public Hearing Before the Commissioner



Sec.  15.40  Administrative record.

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



Sec.  15.45  Examination of administrative record.

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

[[Page 254]]

              Subpart E_Administrative Record and Decision

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

                   Subpart F_Reconsideration and Stay

16.119 Reconsideration and stay of action.

                        Subpart G_Judicial Review

16.120 Judicial review.

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 467f, 
679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

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



                      Subpart A_General Provisions



Sec.  16.1  Scope.

    The procedures in this part apply when:
    (a) The Commissioner is considering any regulatory action, including 
a refusal to act, and concludes, as a matter of discretion, on the 
Commissioner's initiative or at the suggestion of any person, to offer 
an opportunity for a regulatory hearing to obtain additional information 
before making a decision or taking action.
    (b) The act or a regulation provides a person with an opportunity 
for a hearing on a regulatory action, including proposed action, and the 
act or a regulation either specifically provides an opportunity for a 
regulatory hearing under this part or provides an opportunity for a 
hearing for which no procedures are specified by regulation. Listed 
below are the statutory and regulatory provisions under which regulatory 
hearings are available:
    (1) Statutory provisions:

Section 304(g) of the act relating to the administrative detention of 
devices and drugs (see Sec. Sec.  800.55(g) and 1.980(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 419(c)(2)(D) of the Federal Food, Drug, and Cosmetic Act 
relating to the modification or revocation of a variance from the 
requirements of section 419 (see part 112, subpart P 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(b) of the act regarding a proposed regulation to ban a 
medical device with a special effective date.
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).
Section 903(a)(8)(B)(ii) of the Federal Food, Drug, and Cosmetic Act 
relating to the misbranding of tobacco products.
Section 906(e)(1)(B) of the Federal Food, Drug, and Cosmetic Act 
relating to the establishment of good manufacturing practice 
requirements for tobacco products.
Section 910(d)(1) of the Federal Food, Drug, and Cosmetic Act relating 
to the withdrawal of an order allowing a new tobacco product to be 
introduced or delivered for introduction into interstate commerce.
Section 911(j) of the Federal Food, Drug, and Cosmetic Act relating to 
the withdrawal of an order allowing a modified risk tobacco product to 
be introduced or delivered for introduction into interstate commerce.

    (2) Regulatory provisions:

Sec. Sec.  1.634 and 1.664, relating to revocation of recognition of an 
accreditation body and withdrawal of accreditation of third-party 
certification bodies that conduct food safety audits of eligible 
entities in the food import supply chain and issue food and facility 
certifications.
Sec.  56.121(a), relating to disqualifying an institutional review board 
or an institution.
Sec.  58.204(b), relating to disqualifying a testing facility.
Sec.  71.37(a), relating to use of food containing a color additive.

[[Page 255]]

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. Sec.  112.201 through 112.213, (see part 112, subpart R of this 
chapter), relating to withdrawal of a qualified exemption.
Sec. Sec.  117.251 through 117.287 (part 117, subpart E of this 
chapter), relating to withdrawal of a qualified facility exemption.
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 eligible to receive 
test articles under part 312 of this chapter and eligible to conduct any 
clinical investigation that supports an application for a research or 
marketing permit for products regulated by FDA, including drugs, 
biologics, devices, new animal drugs, foods, including dietary 
supplements, that bear a nutrient content claim or a health claim, 
infant formulas, food and color additives, and tobacco products.
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. Sec.  507.60 through 507.85 (part 507, subpart D of this chapter) 
relating to withdrawal of a qualified facility exemption.
Sec.  511.1(b)(5), relating to use of food containing an investigational 
new animal drug.
Sec.  511.1 (c)(1), relating to whether an investigator is eligible to 
receive test articles under part 511 of this chapter and eligible to 
conduct any clinical investigation that supports an application for a 
research or marketing permit for products regulated by FDA including 
drugs, biologics, devices, new animal drugs, foods, including dietary 
supplements, that bear a nutrient content claim or a health claim, 
infant formulas, food and color additives, and tobacco products; and any 
nonclinical laboratory study intended to support an application for a 
research or marketing permit for a new animal drug.
Sec.  511.1(c) (4) and (d), relating to termination of an INAD for a 
sponsor.
Sec.  812.119, relating to whether an investigator is eligible to 
receive test articles under part 812 of this chapter and eligible to 
conduct any clinical investigation that supports an application for a 
research or marketing permit for products regulated by FDA including 
drugs, biologics, devices, new animal drugs, foods, including dietary 
supplements, that bear a nutrient content claim or a health claim, 
infant formulas, food and color additives, and tobacco products.
Sec.  814.46(c) relating to withdrawal of approval of a device premarket 
approval application.
Sec.  822.7(a)(3), relating to an order to conduct postmarket 
surveillance of a medical device under section 522 of the act.
Sec.  830.130, relating to suspension or revocation of the accreditation 
of an issuing agency.
Sec.  895.30(c), regarding a proposed regulation to ban a medical device 
with a special effective date.
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.  1107.1(d), relating to rescission of an exemption from the 
requirement of demonstrating substantial equivalence for a tobacco 
product.
Sec.  1210.30, relating to denial, suspension, or revocation of a permit 
under the Federal Import Milk Act.
Sec.  1270.43(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]

    Editorial Note: For Federal Register citations affecting Sec.  16.1, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and at www.fdsys.gov.



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.

[[Page 256]]

    (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.
    (5) A hearing on an order for diversion or destruction of shell eggs 
under section 361 of the Public Health Service Act (42 U.S.C. 264), and 
Sec.  118.12 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; 74 FR 33095, July 9, 2009]



                   Subpart B_Initiation of Proceedings



Sec.  16.22  Initiation of regulatory hearing.

    (a) A regulatory hearing is initiated by a notice of opportunity for 
hearing from FDA. The notice will--
    (1) Be sent by mail, telegram, telex, personal delivery, or any 
other mode of written communication;
    (2) Specify the facts and the action that are the subject of the 
opportunity for a hearing;
    (3) State that the notice of opportunity for hearing and the hearing 
are governed by this part; and
    (4) State the time within which a hearing may be requested, and 
state the name, address, and telephone number of the FDA employee to 
whom any request for hearing is to be addressed.
    (5) Refer to FDA's guideline on electronic media coverage of its 
administrative proceedings (21 CFR part 10, subpart C).
    (b) A person offered an opportunity for a hearing has the amount of 
time specified in the notice, which may not be less than 3 working days 
after receipt of the notice, within which to request a hearing. The 
request may be filed by mail, telegram, telex, personal delivery, or any 
other mode of written communication, addressed to the designated FDA 
employee. If no response is filed within that time, the offer is deemed 
to have been refused and no hearing will be held.
    (c) If a hearing is requested, the Commissioner will designate a 
presiding officer, and the hearing will take place at a time and 
location agreed upon by the party requesting the hearing, the FDA, and 
the presiding officer or, if agreement cannot be reached, at a 
reasonable time and location designated by the presiding officer.
    (d) A notice of opportunity for hearing under this section will not 
operate to delay or stay any administrative action, including 
enforcement action by the agency unless the Commissioner, as a matter of 
discretion, determines that delay or a stay is in the public interest.

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



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

    (a) A regulatory hearing required by the act or a regulation under 
Sec.  16.1(b) will be initiated in the same manner as other regulatory 
hearings subject to the additional procedures in this section.
    (b) [Reserved]
    (c) The notice will state whether any action concerning the matter 
that is the subject of the opportunity for hearing is or is not being 
taken pending the hearing under paragraph (d) of this section.
    (d) The Commissioner may take such action pending a hearing under 
this

[[Page 257]]

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.
    (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.

[[Page 258]]

    (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 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-

[[Page 259]]

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 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)--

[[Page 260]]

    (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.
    (c) Section 303(f)(3) of the act authorizing civil money penalties 
for certain violations relating to the submission of certifications and/
or clinical trial information to the clinical trial data bank and 
section 303(f)(4) of the act authorizing civil money penalties for 
certain violations of the act relating to

[[Page 261]]

postmarket studies, clinical trial requirements, and risk evaluation and 
mitigation strategies for drugs.
    (d) Section 303(g)(1) of the act authorizing civil money penalties 
for certain violations of the act that relate to dissemination of 
direct-to-consumer advertisements for approved drugs or biological 
products.
    (e) 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.
    (f) Section 539(b)(1) of the act authorizing civil money penalties 
for certain violations of the act that relate to electronic products.
    (g) Section 351(d)(2) of the Public Health Service Act (the PHS Act) 
authorizing civil money penalties for violations of biologic recall 
orders.
    (h) 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.
    (i) 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.
    (j) Section 303(f) of the act authorizing civil money penalties for 
any person who violates a requirement of the Family Smoking Prevention 
and Tobacco Control Act which relates to tobacco products.

[60 FR 38626, July 27, 1995, as amended at 69 FR 43301, July 20, 2004; 
73 FR 66752, Nov. 12, 2008; 75 FR 73953, Nov. 30, 2010]



Sec.  17.2  Maximum penalty amounts.

    The maximum civil money penalties associated with the statutory 
provisions authorizing civil money penalties under the Federal Food, 
Drug, and Cosmetic Act or the Public Health Service Act can be found at 
45 CFR part 102. The table of these maximum civil money penalties can be 
found at 45 CFR 102.3.

[81 FR 62358, Sept. 9, 2016]



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(f)(1):
    (1) Significant departure, for the purpose of interpreting 21 U.S.C. 
333(f)(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(f)(1)(B)(i), means a departure from a requirement taken:
    (i) With actual knowledge that the action is such a departure; or
    (ii) In deliberate ignorance of a requirement; or
    (ii) In reckless disregard of a requirement.
    (3) Minor violations, for the purposes of interpreting 21 U.S.C. 
333(f)(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(f)(1)(B)(iii), includes any defect in performance, manufacture, 
construction, components, materials, specifications, design, 
installation, maintenance, or service of a device, or any defect in 
mechanical, physical, or chemical properties of a device.
    (b) Person or respondent includes an individual, partnership, 
corporation, association, scientific or academic establishment, 
government agency or organizational unit thereof, or other legal entity, 
or as may be defined in the act or regulation pertinent to the civil 
penalty action being brought.
    (c) Presiding officer means an administrative law judge qualified 
under 5 U.S.C. 3105.
    (d) Any term that is defined in the act has the same definition for 
civil money penalty actions that may be brought under that act.
    (e) Any term that is defined in Title 21 of the Code of Federal 
Regulations has the same definition for civil money

[[Page 262]]

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.

[60 FR 38626, July 27, 1995, as amended at 82 FR 34402, July 25, 2017]



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. For a civil money 
penalty action against retailers of tobacco products, the complaint may 
be signed by any Agency employee designated by the Chief Counsel.
    (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.

[60 FR 38626, July 27, 1995, as amended at 79 FR 6091, Feb. 3, 2014]



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;
    (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.

[[Page 263]]

    (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 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.

[[Page 264]]



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 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;

[[Page 265]]

    (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 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

[[Page 266]]

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 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.

[[Page 267]]

    (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 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.

[[Page 268]]

    (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 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;

[[Page 269]]

    (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 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

[[Page 270]]

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 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

[[Page 271]]

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.
    (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

[[Page 272]]

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 
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.

[[Page 273]]



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.
    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

[[Page 274]]

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 Division of Freedom 
of Information, 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; 76 FR 31469, June 1, 2011]



                    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]



                  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,

[[Page 275]]

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.
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.

[[Page 276]]

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 registration and listing information.
20.117 New drug information.
20.118 Advisory committee records.
20.119 Lists of names and addresses.
20.120 Records available in Food 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 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

[[Page 277]]

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 Division of Freedom of 
Information at the address located on the agency's web site at http://
www.fda.gov.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 76 
FR 31469, June 1, 2011; 79 FR 68114, Nov. 14, 2014]



                        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 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

[[Page 278]]

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.



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.

[[Page 279]]

    (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 by accessing the agency's 
web site at http://www.fda.gov. A printed copy of each index is 
available by writing or visiting the Freedom of Information Staff's 
address on the agency's web site at http://www.fda.gov.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 68 
FR 25285, May 12, 2003; 76 FR 31469, June 1, 2011; 79 FR 68114, Nov. 14, 
2014]



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 Division of Freedom of 
Information.

    (a) The office responsible for Agency compliance with the Freedom of 
Information Act and this part is the Division of Freedom of 
Informationat the address located on the agency's web site at http://
www.fda.gov.
    (b) All requests for Agency records shall be sent in writing to this 
office.

[76 FR 31469, June 1, 2011, as amended at 79 FR 68114, Nov. 14, 2014]



Sec.  20.31  Retention schedule of requests for Food and Drug
Administration records.

    (a) Unless unusual circumstances dictate otherwise, the Food and 
Drug Administration shall maintain and dispose of files of requests and 
reponses furnished thereto within the time limits authorized by GSA 
General Records Schedule 14, FPMR 101-11-4, January 10, 1977, as 
follows:
    (1) Files created by the receipt of and response to freedom of 
information requests, except denials and/or appeals, may be destroyed 2 
years from date of final response.
    (2) Files created by a freedom of information request which was 
wholly or partially denied may be destroyed 5 years after the denial 
letter was issued.
    (3) Files created by a freedom of information request which was 
wholly or partially denied and which denial was subsequently appealed to 
the Department of Health and Human Services may be destroyed 4 years 
after final determination by FDA or 3 years after final adjudication by 
courts, whichever is later.
    (b) This destruction schedule will automatically be revised whenever 
the time limits pertaining to these records are revised by the GSA 
General Records Schedule.

[47 FR 24277, June 4, 1982]



Sec.  20.32  Disclosure of Food and Drug Administration employee names.

    The names of Food and Drug Administration employees will not be 
deleted

[[Page 280]]

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 at the address on the agency's web site at http://
www.fda.gov or by faxing it to the fax number listed on the agency's web 
site at http://www.fda.gov. 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 Division of Freedom 
of Information shall enter it in a public log. The log shall state the 
date received, the name of the person making the request, the nature of 
the record requested, the action taken on the request, the date of 
determination letter sent pursuant to Sec.  20.41(b), and the date(s) 
any records are subsequently furnished.
    (d) A request by an individual, as defined in Sec.  21.3(a) of this 
chapter, for a record about himself shall be subject to:
    (1) The special requirements of part 21 of this chapter (the privacy 
regulations), and not to the provisions of this subpart, if the record 
requested is retrieved by the individual's name or other personal 
identifier and is contained in a Privacy Act Record System, as defined 
in Sec.  21.3(c) of this chapter.
    (2) The provisions of this subpart if the record requested is not 
retrieved by the individual's name or other personal identifier, whether 
or not the record is contained in a Privacy Act Record System.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 68 
FR 25285, May 12, 2003; 76 FR 31469, June 1, 2011; 79 FR 68114, Nov. 14, 
2014]



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 
Division of Freedom of Information pursuant to Sec.  20.40(c). An oral 
request for records

[[Page 281]]

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 Division of Freedom of Information 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 
Division of Freedom of Information, 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 Division of Freedom of Information 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; 76 FR 31469, June 1, 2011]



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

[[Page 282]]

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 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 Division of Freedom of Information 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

[[Page 283]]

may appeal the agency's decision by writing to the official identified 
in the denial letter.

[68 FR 25286, May 12, 2003, as amended at 76 FR 31469, June 1, 2011]



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, 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

[[Page 284]]

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 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)

[[Page 285]]

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 section, the Food and Drug Administration will normally 
waive fees. However, in some cases the Food and Drug Administration may 
decide only to reduce the fees. For example, the Food and Drug 
Administration may do this when disclosure of some but not all of the 
requested records passes the tests.
    (e) Procedure for requesting a waiver or reduction. A requester must 
request a waiver or reduction of fees at the same time as the request 
for records. The requester should explain why a waiver or reduction is 
proper under the factors set forth in paragraphs (a) through (d) of this 
section. Only the Associate Commissioner for Public Affairs may make the 
decision whether to waive or reduce the fees. If the Food and Drug 
Administration does not completely grant the request for a waiver or 
reduction, the denial letter will designate a review official. The 
requester may appeal the denial to that official. The appeal letter 
should address reasons for

[[Page 286]]

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 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

[[Page 287]]

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 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

[[Page 288]]

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.
    (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

[[Page 289]]

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.



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

[[Page 290]]

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 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

[[Page 291]]

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]



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

[[Page 292]]

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.
    (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.

[[Page 293]]

    (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]



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]

[[Page 294]]



Sec.  20.84  Disclosure to consultants, advisory committees, State and
local government officials commissioned pursuant to 21 U.S.C. 372(a), and
other special government employees.

    Data and information otherwise exempt from public disclosure may be 
disclosed to Food and Drug Administration consultants, advisory 
committees, State and local government officials commissioned pursuant 
to 21 U.S.C. 372(a), and other special government employees for use only 
in their work with the Food and Drug Administration. Such persons are 
thereafter subject to the same restrictions with respect to the 
disclosure of such data and information as any other Food and Drug 
Administration employee.



Sec.  20.85  Disclosure to other Federal government departments and
agencies.

    Any Food and Drug Administration record otherwise exempt from public 
disclosure may be disclosed to other Federal government departments and 
agencies, except that trade secrets and confidential commercial or 
financial information prohibited from disclosure by 21 U.S.C. 331(j), 21 
U.S.C. 360(j)(c), 42 U.S.C. 263g(d) and 42 U.S.C. 263i(e) may be 
released only as provided by those sections. Any disclosure under this 
section shall be pursuant to a written agreement that the record shall 
not be further disclosed by the other department or agency except with 
the written permission of the Food and Drug Administration.

[47 FR 10804, Mar. 12, 1982, as amended at 59 FR 536, Jan. 5, 1994]



Sec.  20.86  Disclosure in administrative or court proceedings.

    Data and information otherwise exempt from public disclosure may be 
revealed in Food and Drug Administration administrative proceedings 
pursuant to parts 10, 12, 13, 14, 15, 17, and 19 of this chapter or 
court proceedings, where data or information are relevant. The Food and 
Drug Administration will take appropriate measures, or request that 
appropriate measures be taken, to reduce disclosure to the minimum 
necessary under the circumstances.

[42 FR 15616, Mar. 22, 1977, as amended at 60 FR 38633, July 27, 1995]



Sec.  20.87  Disclosure to Congress.

    (a) All records of the Food and Drug Administration shall be 
disclosed to Congress upon an authorized request.
    (b) An authorized request for Food and Drug Administration records 
by Congress shall be made by the chairman of a committee or subcommittee 
of Congress acting pursuant to committee business.
    (c) An individual member of Congress who requests a record for his 
own use or on behalf of any constituent shall be subject to the same 
rules in this part that apply to any other member of the public.

[42 FR 15616, Mar. 22, 1977, as amended at 59 FR 536, Jan. 5, 1994]



Sec.  20.88  Communications with State and local government officials.

    (a) A State or local government official commissioned by the Food 
and Drug Administration pursuant to 21 U.S.C. 372(a) shall have the same 
status with respect to disclosure of Food and Drug Administration 
records as any special government employee.
    (b) Communications with State and local government officials with 
respect to law enforcement activities undertaken pursuant to a contract 
between the Food and Drug Administration and such officials shall be 
subject to the 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

[[Page 295]]

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 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

[[Page 296]]

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 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

[[Page 297]]

submitted to the Food and Drug Administration, or incorporated into 
agency-prepared records, to foreign government officials who perform 
counterpart functions to the Food and Drug Administration as part of 
cooperative law enforcement or regulatory efforts, provided that:
    (i) The foreign government agency has provided both a written 
statement establishing its authority to protect confidential commercial 
information from public disclosure and a written commitment not to 
disclose any such information provided without the written permission of 
the sponsor or written confirmation by the Food and Drug Administration 
that the information no longer has confidential status; and
    (ii) The Commissioner of Food and Drugs or the Commissioner's 
designee makes one or more of the following determinations:
    (A) The sponsor of the product application has provided written 
authorization for the disclosure;
    (B) Disclosure would be in the interest of public health by reason 
of the foreign government's possessing information concerning the 
safety, efficacy, or quality of a product or information concerning an 
investigation; or
    (C) The disclosure is to a foreign scientist visiting the Food and 
Drug Administration on the agency's premises as part of a joint review 
or long-term cooperative training effort authorized under section 708 of 
the act, the review is in the interest of public health, the Food and 
Drug Administration retains physical control over the information, the 
Food and Drug Administration requires the visiting foreign scientist to 
sign a written commitment to protect the confidentiality of the 
information, and the scientist provides a written assurance that he or 
she has no financial interest in the regulated industry of the type that 
would preclude participation in the review of the matter if the 
individual were subject to the conflict of interest rules applicable to 
the Food and Drug Administration advisory committee members under Sec.  
14.80(b)(1) of this chapter. Subject to all of the foregoing conditions, 
visiting foreign scientists may have access to trade secret information, 
entitled to protection under section 301(j) of the Federal Food, Drug, 
and Cosmetic Act (the act), in those cases where such disclosures would 
be a necessary part of the joint review or training.
    (2) Except as provided under paragraph (c)(1)(ii)(C) of this 
section, this provision does not authorize the disclosure to foreign 
government officials of other countries of trade secret information 
concerning manufacturing methods and processes prohibited from 
disclosure by section 301(j) of the act, unless pursuant to an express 
written authorization provided by the submitter of the information.
    (3) Any disclosure under this section of information submitted to 
the Food and Drug Administration or incorporated into agency-prepared 
records does not invoke the rule established in Sec.  20.21 that such 
records shall be made available to all members of the public.
    (d)(1) The Senior Associate Commissioner for Policy, Planning, and 
Legislation, or the Deputy Commissioner for International and 
Constituent Relations, or any other officer or employee of the Food and 
Drug Administration whom the Senior Associate Commissioner for Policy, 
Planning, and Legislation or the Deputy Commissioner for International 
and Constituent Relations may designate to act on their behalf for the 
purpose, may authorize the disclosure to, or receipt from, an official 
of a foreign government agency of nonpublic, predecisional documents 
concerning the Food and Drug Administration's or the other government 
agency's regulations or other regulatory requirements, or other 
nonpublic information relevant to either 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

[[Page 298]]

International and Constituent Relations or their designee makes the 
determination that the exchange is reasonably necessary to facilitate 
global harmonization of regulatory requirements, cooperative regulatory 
activities, or implementation of international agreements.
    (2) Any exchange under this section of nonpublic documents does not 
invoke the rule established in Sec.  20.21 that such records shall be 
made available to all members of the public.
    (e) For purposes of this section, the term ``official of a foreign 
government agency'' includes, but is not limited to, employees (whether 
temporary or permanent) of and agents contracted by the foreign 
government, or by an international organization established by law, 
treaty, or other governmental action and having responsibility to 
facilitate global or regional harmonization of standards and 
requirements in FDA's areas of responsibility or to promote and 
coordinate public health efforts. For such officials, the statement and 
commitment required by paragraph (c)(1)(i) of this section shall be 
provided on behalf of both the organization and the individual.

[42 FR 15616, Mar. 22, 1977, as amended at 58 FR 61603, Nov. 19, 1993; 
60 FR 63382, Dec. 8, 1995; 65 FR 11888, Mar. 7, 2000]



Sec.  20.90  Disclosure to contractors.

    (a) Data and information otherwise exempt from public disclosure may 
be disclosed to contractors with the Food and Drug Administration and 
their employees for use only in their work for the Food and Drug 
Administration. Contractors and their employees are thereafter subject 
to the same legal restrictions and penalties with respect to the 
disclosure of such data and information as Food and Drug Administration 
employees.
    (b) A written agreement between the Food and Drug Administration and 
any contractor shall be entered into before data and information 
otherwise exempt from public disclosure may be disclosed to the 
contractor. The contractor shall agree to establish and follow security 
precautions considered by the Food and Drug Administration to be 
necessary to ensure proper and confidential handling of the data and 
information. The written agreement shall include, where appropriate, 
provisions establishing:
    (1) Restrictions on access to the data and information by the 
contractor, its employees, or other persons;
    (2) Physical storage requirements;
    (3) Requirements for the handling and accountability of the data and 
information by the contractor and its employees;
    (4) Limitations on reproduction, transmission, and disclosure of the 
data and information;
    (5) A requirement of advance approval by the Food and Drug 
Administration of the use by the contractor of subcontractors, vendors, 
or suppliers;
    (6) Procedures to be followed when the contractor employs time-
shared computer operations;
    (7) Methods of destroying source documents or related waste 
material; and
    (8) The period during which the contractor may retain such data and 
information.



Sec.  20.91  Use of data or information for administrative or court
enforcement action.

    Nothing in this part or this chapter shall prevent the Food and Drug 
Administration from using any data or information, whether obtained 
voluntarily or involuntarily and whether or not it is available for 
public disclosure, as the basis for taking any administrative or court 
enforcement action within its jurisdiction. Data and information 
otherwise exempt from public disclosure are nevertheless available for 
public disclosure to the extent necessary to effectuate such action, 
e.g., 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

[[Page 299]]

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.  
207.81 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) [Reserved]
    (23) Investigational new drug notice for a biological product, in 
Sec.  601.50 of this chapter.
    (24) Applications for biologics licenses for biological products, in 
Sec.  601.51 of this chapter.
    (25) Cosmetic establishment registrations, in Sec.  710.7 of this 
chapter.
    (26) Cosmetic product ingredient and cosmetic raw material 
composition statements, Sec.  720.8 of this chapter.
    (27) Cosmetic product experience reports, in Sec.  730.7 of this 
chapter.
    (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.

[[Page 300]]

    (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.
    (43) Minor-use or minor-species (MUMS) drug designations, in Sec.  
516.52 of this chapter.
    (44) Minor-species drug index listings, in Sec.  516.171 of this 
chapter.
    (45) Postmarket notifications of a permanent discontinuance or an 
interruption in manufacturing of certain drugs or biological products, 
in Sec. Sec.  310.306, 314.81(b)(3)(iii), and 600.82 of this chapter.
    (46) Generally recognized as safe (GRAS) notices, in part 170, 
subpart E and part 570, subpart E 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; 72 FR 41017, July 26, 2007; 72 FR 69118, Dec. 6, 2007; 80 FR 
38938, July 8, 2015; 81 FR 45409, July 14, 2016; 81 FR 55046, Aug. 17, 
2016; 81 FR 60212, Aug. 31, 2016]



Sec.  20.101  Administrative enforcement records.

    (a) All Food and Drug Administration records relating to 
administrative enforcement action disclosed to any member of the public, 
including the person who is the subject of such action, are available 
for public disclosure at the time such disclosure is first made. Such 
records include correspondence with companies following factory 
inspection, recall or detention requests, notice of refusal of admission 
of an imported product, regulatory letters, information letters, Forms 
FD-483 and FD-2275 furnished to companies after factory inspection, and 
similar records.
    (b) To the extent that any of such records fall within the exemption 
for investigatory records established in Sec.  20.64, the Commissioner 
determines that they are subject to discretionary release pursuant to 
Sec.  20.82.
    (c) Records relating to administrative enforcement action that are 
not disclosed to any member of the public constitute investigatory 
records that are subject to the rules for disclosure established in 
Sec.  20.64. For example, an establishment inspection report is an 
investigatory record and thus subject to Sec.  20.64 except insofar as 
the Commissioner exercises his discretion to release it pursuant to 
Sec.  20.82.



Sec.  20.102  Court enforcement records.

    (a) All records and documents filed in the courts are available for 
public disclosure unless the court orders otherwise. The Food and Drug 
Administration will make available for public disclosure such records or 
documents if the agency can determine that it has an accurate copy of 
the actual record or document filed in the court. If the Food and Drug 
Administration cannot determine whether it has an accurate copy of such 
a record or document, the person requesting a copy shall be referred to 
the court involved.
    (b) After a recommendation for court action has been finally refused 
by a United States attorney, the correspondence with the United States 
attorney and the Department of Justice with respect to that 
recommendation, including the pleadings recommended for filing with the 
court, is available for public disclosure. Prior to disclosure of any 
record specifically reflecting consideration of possible criminal 
prosecution of any individual, all names and other information that 
would identify an individual who was considered for criminal prosecution 
but

[[Page 301]]

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 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

[[Page 302]]

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 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 
Division of Freedom of Informationat the address located on the agency's 
web site at http://www.fda.gov.; or by visiting the Division of Freedom 
of Information Public Reading Room, located in rm. 1050, 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; 76 FR 31469, June 1, 
2011; 79 FR 68115, Nov. 14, 2014]



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) All written agreements and memoranda of understanding between 
FDA and any entity, including, but not limited to other departments, 
Agencies, and organizations will be made available through the Food and 
Drug Administration Web site at http://www.fda.gov once finalized.
    (c) 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 paragraph (b) of this section. 
Although such agreements and understandings will not be made available 
through the FDA Web site, these agreements will be available for 
disclosure in response to a request from the public after deletion of 
information that would disclose confidential investigative techniques or 
procedures, or information that would disclose guidelines for law 
enforcement investigations if such disclosure could reasonably be 
expected to risk circumvention of the law.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 58 
FR 48794, 48796, Sept. 20, 1993; 76 FR 31470, June 1, 2011; 77 FR 50591, 
Aug. 22, 2012]



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

[[Page 303]]

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:
    (a) Names and any information that would identify the person using 
the product.
    (b) Names and any information that would identify any third party 
involved with the report, such as a physician or hospital or other 
institution.
    (iv) If obtained through a Food and Drug Administration 
investigation, the record shall have the same status as the initial 
report which led to the investigation, i.e., it shall be disclosed in 
accordance with paragraph (c)(3)(i) through (iii) of this section.
    (v) Any compilation of data, information, and reports prepared in a 
way that does not reveal data or information which is not available for 
public

[[Page 304]]

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 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.

[[Page 305]]



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 registration and listing information.

    Information submitted to the Food and Drug Administration pursuant 
to section 510(a) through (j) of the Federal Food, Drug, and Cosmetic 
Act shall be subject only to the special disclosure provisions 
established in Sec. Sec.  207.81 and 807.37 of this chapter.

[81 FR 60212, Aug. 31, 2016]



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.



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

    (a) The Freedom of Information Staff and the Division of Dockets 
Management Public Reading Room are located at the same address. Both are 
located

[[Page 306]]

in rm. 1061, 5630 Fishers Lane, Rockville, MD 20852. The telephone 
number for the Division of Docket Management is 301-827-6860; the 
telephone number for the Freedom of Information Staff's Public Reading 
Room is located at the address on the agency's web site at http://
www.fda.gov. 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 Division of Freedom 
of Information 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 Division of Freedom of 
Information 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, as amended at 76 
FR 31470, June 1, 2011; 79 FR 68115, Nov. 14, 2014]



PART 21_PROTECTION OF PRIVACY--Table of Contents



                      Subpart A_General Provisions

Sec.
21.1 Scope.
21.3 Definitions.
21.10 Policy concerning records about individuals.

    Subpart B_Food and Drug Administration Privacy Act Record Systems

21.20 Procedures for notice of Food and Drug Administration Privacy Act 
          Record Systems.
21.21 Changes in systems and new systems.

        Subpart C_Requirements for Specific Categories of Records

21.30 Records of contractors.
21.31 Records stored by the National Archives and Records 
          Administration.
21.32 Personnel records.
21.33 Medical records.

   Subpart D_Procedures for Notification of and Access to Records in 
                       Privacy Act Record Systems

21.40 Procedures for submitting requests for notification and access.
21.41 Processing of requests.
21.42 Responses to requests.
21.43 Access to requested records.
21.44 Verification of identity.
21.45 Fees.

       Subpart E_Procedures for Requests for Amendment of Records

21.50 Procedures for submitting requests for amendment of records.
21.51 Responses to requests for amendment of records.
21.52 Administrative appeals of refusals to amend records.
21.53 Notation and disclosure of disputed records.
21.54 Amended or disputed records received from other agencies.

[[Page 307]]

                          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 in business as 
proprietors of establishments regulated by the Food and Drug 
Administration are not considered individuals; however, physicians and

[[Page 308]]

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), 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.

[[Page 309]]

    (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.
    (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

[[Page 310]]

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]



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

[[Page 311]]

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 HR-BETHPL RM7114, HFA-705, 7700 Wisconsin 
Ave., 7th & 8th floors, Bethesda, MD 20814, 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 
(the Privacy Act Coordinator is part of the Freedom of Information 
Staff, the address for which is located on the Agency Web site at http:/
/www.fda.gov). 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 responsible 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 grounds that the record is subject to an exemption 
under Sec.  21.61 or 5 CFR 297.111.

[[Page 312]]

    (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; 76 FR 31470, June 1, 2011; 79 FR 68115, Nov. 
14, 2014]



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 (address is located on the agency web site at http://
www.gov.fda).
    (c) Requests shall be in writing and shall name the Privacy Act 
Record System or Systems concerning which the individual requests 
notification of whether there are records about him that are retrieved 
by reference to his name or other personal identifier. To help assure a 
prompt response, an individual should indicate that he is making a 
``Privacy Act Request'' on the envelope and in a prominent manner in the 
letter.
    (d) An individual who merely wishes to be notified whether a Privacy 
Act Record System contains a record about him ordinarily need not 
provide any verification of his identity other than his name. The mere 
fact that the Food and Drug Administration has a record about an 
individual in any of its Privacy Act Records Systems would not be likely 
to constitute a clearly unwarranted invasion of personal privacy. Where 
mere disclosure of the fact that a record about the individual exists 
would be a clearly unwarranted invasion of personal privacy, further

[[Page 313]]

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; 76 FR 31470, June 1, 2011; 79 FR 68115, Nov. 
14, 2014]



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 in the Division of Freedom of 
Information (address is located on the agency web site at http://
www.gov.fda) shall be responsible 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 Division of Freedom of Information (address is 
located on the agency web site at http://www.gov.fda) 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.

[[Page 314]]

    (g) The FDA Privacy Act Coordinator shall ensure that records are 
maintained of the number, status, and disposition of requests under this 
subpart, including the number of requests for records exempt from access 
under this subpart and other information required for purposes of the 
annual report to Congress under the Privacy Act. These temporary 
administrative management records shall not be considered to be Privacy 
Act Record Systems. All records required to be kept under this paragraph 
shall only include requesting individuals' names or personal identifiers 
for so long as any request for notification, access, or amendment is 
pending. The identity of individuals making request under this subpart 
shall be regarded as confidential and shall not be disclosed under part 
20 of this chapter (the public information regulations) to any other 
person or agency except as is necessary for the processing of requests 
under this subpart.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8458, Jan. 27, 1981; 76 
FR 31470, June 1, 2011; 79 FR 68115, Nov. 14, 2014]



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.

[[Page 315]]

    (b) Except as provided in Sec.  21.32, access to a record may only 
be denied by the Associate Commissioner for Public Affairs or his or her 
designate. If access to any record is denied wholly or in substantial 
part, the letter shall state the right of the individual to appeal to 
the Commissioner of Food and Drugs.
    (c) If a request for a copy of the records will result in a fee of 
more than $25, the letter shall specify or estimate the fee involved. 
Where the individual has requested a copy of any records about him and 
copying the records would result in a fee of over $50, the Food and Drug 
Administration shall require advance deposit as well as payment of any 
amount not yet received as a result of any previous request by the 
individual for a record about himself, under this subpart or part 20 of 
this chapter (the public information regulations) before the records are 
made available. If the fee is less than $50, prepayment shall not be 
required unless payment has not yet been received for records disclosed 
as a result of a previous request by the individual for a record about 
himself under this subpart or part 20 of this chapter.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8458, Jan. 27, 1981]



Sec.  21.43  Access to requested records.

    (a) Access may be granted to requested records by:
    (1) Mailing a copy of the records to the requesting individual, or
    (2) Permitting the requesting individual to review the records in 
person between 9 a.m. and 4 p.m. at the office of the FDA Privacy Act 
Coordinator, at the Division of Freedom of Information Public Reading 
Room (address is located on the agency's web site at http://
www.fda.gov), 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; 76 FR 31470, June 1, 2011; 79 FR 68115, Nov. 14, 
2014]



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

[[Page 316]]

record pertaining to an individual under false pretenses is a criminal 
offense subject to a $5,000 fine.
    (c) In making requests under Sec.  21.75, a parent of a minor child 
or legal guardian of an incompetent individual may be required to verify 
his relationship to the minor child or the incompetent individual, in 
addition to verifying his own identity, by providing a copy of the 
minor's birth certificate, a court order, or other evidence of 
guardianship.
    (d) Where an individual seeks access to particularly sensitive 
records, such as medical records, the individual may be required to 
provide additional information beyond that specified in paragraph (b) or 
(c) of this section, such as the individual's years of attendance at a 
particular educational institution, rank attained in the uniformed 
services, date or place of birth, names of parents, an occupation, or 
the specific times the individual received medical treatment.



Sec.  21.45  Fees.

    (a) Where applicable, fees for copying records shall be charged in 
accordance with the schedule set forth in this section. Fees may only be 
charged where an individual has requested that a copy be made of a 
record to which he is granted access. No fee may be charged for making a 
search of a Privacy Act Record System whether the search is manual, 
mechanical, or electronic. Where a copy of the record must be made to 
provide access to the record, e.g., computer printout where no screen 
reading is available, the copy shall be made available to the individual 
without cost. Where a medical record is made available to a 
representative designated by the individual under Sec.  21.33, no fee 
will be charged.
    (b) The fee schedule is as follows:
    (1) Copying of records susceptible to photocopying--$.10 per page.
    (2) Copying of records not susceptible to photocopying, e.g., punch 
cards or magnetic tapes--at actual cost to the determined on a case-by-
case basis.
    (3) No charge will be made if the total amount of copying for an 
individual does not exceed $25.
    (c) When a fee is to be assessed, the individual shall be notified 
prior to the processing of the copies, and be given an opportunity to 
amend his request. Payment shall be made by check or money order made 
payable to the ``Food and Drug Administration,'' and shall be sent to 
the Accounting Branch (HFA-120), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857. Advance deposit shall be required 
where the total amount exceeds $50.

[42 FR 15626, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989]



       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

[[Page 317]]

the Food and Drug Administration to locate the record, a brief 
description of the items of information requested to be amended, and the 
reasons why the record should be amended together with any appropriate 
documentation or arguments in support of the requested amendment. An 
edited copy of the record showing the described amendment may be 
included. Verification of identity should be provided in accordance with 
Sec.  21.44.
    (d) Written acknowledgement of the receipt of a request to amend a 
record shall be provided within 10 working days to the individual who 
requested the amendment. Such acknowledgement may request any additional 
information needed to verify identity or make a determination. No 
acknowledgement need be made if the request can be reviewed, processed, 
and the individual notified of the agency's agreement with the request 
or refusal within the 10-day period.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8459, Jan. 27, 1981]



Sec.  21.51  Responses to requests for amendment of records.

    (a) The Food and Drug Administration shall take one of the following 
actions on a request for amendment of records as promptly as possible:
    (1) Amend any portion of the record which the agency has determined, 
based upon a preponderance of the evidence, is not accurate, relevant to 
a Food and Drug Administration purpose, timely, or complete, and, in 
accordance with paragraph (d)(3) of this section, inform the individual 
and previous recipients of the record that has been amended of the 
amendment.
    (2) Inform the individual of its refusal to amend any portion of the 
record in the manner requested, the reason for the refusal, and the 
opportunity for administrative appeal to the Commissioner of Food and 
Drugs. Except as provided in Sec.  21.32, such refusal may only be 
issued by the Associate Commissioner for Public Affairs or his or her 
designate.
    (3) Where another agency was the source of and has control of the 
record, refer the request to that agency.
    (b) The agency may, for good cause, extend the period for taking 
action an additional 30 working days if notice is provided to the 
individual explaining the circumstances of the delay.
    (c) The officials charged with reviewing a record to determine how 
to respond to a request to amend it, shall assess its accuracy, 
relevance to a Food and Drug Administration purpose, timeliness, or 
completeness. The determination shall be made in the light of the 
purpose for which the records or system is used, the agency's need for 
the record, and the possible adverse consequences to the individual 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,(see the address on the agency's web site 
at http://www.fda.gov).
    (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.

[[Page 318]]

    (2) Of the individual's right to file with the Food and Drug 
Administration a concise statement of the individual's reasons for 
disagreeing with the agency's decision not to amend the record as 
requested.
    (3) That the statement of disagreement will be made available to all 
persons listed in an accounting as having previously received the record 
and any person to whom the record is subsequently disclosed together 
with, in the discretion of the Food and Drug Administration, a brief 
statement summarizing its reasons for refusing to amend the record. Any 
individual who includes false information in the statement of 
disagreement filed with the Food and Drug Administration may be subject 
to penalties under 18 U.S.C. 1001, the False Reports to the Government 
Act.
    (4) That the individual has a right to seek judicial review of the 
refusal to amend the record.
    (c) If the Commissioner on administrative appeal or a court on 
judicial review determines that the record should be amended in 
accordance with the individual's request, the Food and Drug 
Administration shall proceed in accordance with Sec.  21.51(d).
    (d) A final determination on the individual's administrative appeal 
of the initial refusal to amend the record shall be concluded within 30 
working days of the request for such review under paragraph (a) of this 
section, unless the Commissioner extends such period for good cause and 
informs the individual in writing of the reasons for the delay and of 
the approximate date on which a decision of the appeal can be expected.

[42 FR 15626, Mar. 22, 1977, as amended at 50 FR 52278, Dec. 23, 1985; 
79 FR 68115, Nov. 14, 2014]



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

[[Page 319]]

paragraph (b) of this section are exempt from the following provisions 
of the Privacy Act (5 U.S.C. 552a) and of this part:
    (1) Such records are exempt from 5 U.S.C. 552a(c)(3) and Sec.  
21.71(e)(4), requiring that an individual be provided with the 
accounting of disclosures of records about himself from a Privacy Act 
Record System.
    (2) Except where access is required under 5 U.S.C. 552a(k)(2) and 
Sec.  21.65(a)(2), (such records are exempt from 5 U.S.C. 552a(d)(1) 
through (4) and (f)) and 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.
    (d) Records in the following Food and Drug Administration Privacy 
Act Records Systems are exempt under 5 U.S.C. 552a(k)(2) and (k)(5) from 
the provisions enumerated in paragraph (a)(1) through paragraph (a)(3) 
of this section: FDA Records Related to Research Misconduct Proceedings, 
HHS/FDA/OC, 09-10-0020.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8459, Jan. 27, 1981; 50 
FR 52278, Dec. 23, 1985; 78 FR 39186, July 1, 2013]



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

[[Page 320]]

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 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

[[Page 321]]

who have a need for the record in the perfomance of their duties;
    (2) Required under section 552 of the Freedom of Information Act;
    (3) For a routine use as described in the routine use section of 
each specific system notice;
    (4) To the Bureau of Census for purposes of planning or carrying out 
a census or survey or related activity pursuant to the provisions of 
title 13 of the U.S. Code;
    (5) To a recipient who has provided the agency with advance adequate 
written assurance that the record will be used solely as a statistical 
research or reporting record, and that the record is to be transferred 
in a form that is not individually identifiable;
    (6) To the National Archives and Records Administration of the 
United States as a record which has sufficient historical or other value 
to warrant its continued preservation by the U.S. Government, or to the 
Archivist of the United States or his or her designee for evaluation to 
determine whether the record has such value;
    (7) To another agency or to an instrumentality of any government 
jurisdiction within or under the control of the United States for a 
civil or criminal law enforcement activity if the activity is authorized 
by law, and if the head of the agency or instrumentality has made a 
written request to the agency which maintains the record specifying the 
particular portion desired and the law enforcement activity for which 
the record is sought;
    (8) To a person pursuant to a showing of compelling circumstances 
affecting the health or safety of an individual if, upon such 
disclosure, notification is transmitted to the last known address of 
such individual;
    (9) To either House of Congress or, to the extent of matter within 
its jurisdiction, any committee or subcommittee thereof, any joint 
committee of Congress or subcommittee of any such joint committee;
    (10) To the Comptroller General, or any of his or her authorized 
representatives in the course of the performance of the duties of the 
General Accounting Office;
    (11) Pursuant to the order of a court of competent jurisdiction; or
    (12) To a consumer reporting agency in accordance with section 3(d) 
of the Federal Claims Collection Act of 1966 (31 U.S.C. 952(d)). (This 
``Special Disclosure'' statement does not apply to any FDA system of 
records.)
    (b) The Food and Drug Administration may in its discretion refuse to 
make a disclosure permitted under paragraph (a) of this section, if the 
disclosure would in the judgment of the agency, invade the privacy of 
the individual or be inconsistent with the purpose for which the 
information was collected.
    (c) The Food and Drug Administration may require any person 
requesting a disclosure of a record under paragraph (a) of this section 
to provide:
    (1) Information about the purposes to which the disclosed record is 
to be put, and
    (2) A written statement certifying that the record will be used only 
for the stated purposes and will not be further disclosed without the 
written permission of the Food and Drug Administration.


Under 5 U.S.C. 552a(i)(3), any person who knowingly or willfully 
requests or 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).

[[Page 322]]

    (4) Except when the record is exempt from individual access and 
contest under Sec.  21.61 or to the extent that the accounting describes 
a transfer for a law enforcement purpose pursuant to paragraph (a)(7) of 
this section, make the accounting available to the individual to whom 
the record pertains, in accordance with procedures of subpart D of this 
part.
    (f) A single accounting may be used to cover disclosure(s) that 
consist of a continuing dialogue between two agencies over a prolonged 
period, such as discussion of an enforcement action between the Food and 
Drug Administration and the Department of Justice. In such cases, a 
general notation may be made that, as of a certain date, contract was 
initiated, to continue until resolution of the matter.

[42 FR 15626, Mar. 22, 1977, as amended at 50 FR 52278, Dec. 23, 1985; 
54 FR 9038, Mar. 3, 1989]



Sec.  21.72  Individual consent to disclosure of records to other
persons.

    (a) Individuals may consent to disclosure of records about 
themselves to other persons in several ways, for example:
    (1) An individual may give consent at the time that the information 
is collected for disclosure for specific purposes or to specific 
persons.
    (2) An individual may give consent for disclosure of his records to 
a specific person.
    (3) An individual may request the Food and Drug Administration to 
transcribe a specific record for submission to another person.
    (b) In each case the consent shall be in writing and shall specify 
the individual, organizational unit, or class of individuals or 
organizational units to whom the record may be disclosed, which record 
may be disclosed, and, if applicable, for what time period. A blanket 
consent to release all of an individual's records to unspecified 
individuals or organizational units will not be honored. Verification of 
the identity of the individual and, where applicable, of the person to 
whom the record is to be disclosed shall be made in accordance with 
Sec.  21.44. Consent documents shall be retained for a period of at 
least 2 years. If such documents are used as a means of accounting for 
the disclosure, they shall be retained as provided in Sec.  21.71(e)(2).



Sec.  21.73  Accuracy, completeness, timeliness, and relevance of
records disclosed from Privacy Act Record Systems.

    (a) The Food and Drug Administration shall make reasonable efforts 
to assure that a record about an individual in a Privacy Act Record 
System is accurate, relevant to a Food and Drug Administration purpose, 
timely, and complete before such record is disclosed under Sec.  21.71.
    (b) Paragraph (a) of this section shall not apply to disclosures 
that are required under part 20 of this chapter (the public information 
regulations) or made to other Federal Government departments and 
agencies. Where appropriate, the letter disclosing the information shall 
indicate that the Food and Drug Administration has not reviewed the 
record to assure that it is accurate, relevant, timely, and complete.



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.

[[Page 323]]



PART 25_ENVIRONMENTAL IMPACT CONSIDERATIONS--Table of Contents



                      Subpart A_General Provisions

Sec.
25.1 Purpose.
25.5 Terminology.
25.10 Policies and NEPA planning.

     Subpart B_Agency Actions Requiring Environmental Consideration

25.15 General procedures.
25.16 Public health and safety emergencies.
25.20 Actions requiring preparation of an environmental assessment.
25.21 Extraordinary circumstances.
25.22 Actions requiring the preparation of an environmental impact 
          statement.

                    Subpart C_Categorical Exclusions

25.30 General.
25.31 Human drugs and biologics.
25.32 Foods, food additives, and color additives.
25.33 Animal drugs.
25.34 Devices and electronic products.
25.35 Tobacco product applications.

            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).

[[Page 324]]

    (13) Major Federal action (40 CFR 1508.18).
    (14) Mitigation (40 CFR 1508.20).
    (15) NEPA process (40 CFR 1508.21).
    (16) Notice of intent (40 CFR 1508.22).
    (17) Proposal (40 CFR 1508.23).
    (18) Scope (40 CFR 1508.25).
    (19) Significantly (40 CFR 1508.27).
    (b) The following terms are defined solely for the purpose of 
implementing the supplemental procedures provided by this part and are 
not necessarily applicable to any other statutory or regulatory 
requirements:
    (1) Abbreviated application applies to an abbreviated new drug 
application and an abbreviated new animal drug application.
    (2) Active moiety means the molecule or ion, excluding those 
appended portions of the molecule that cause the drug to be an ester, 
salt (including a salt with hydrogen or coordination bonds), or other 
noncovalent derivative (such as a complex chelate or clathrate) of the 
molecule responsible for the physiological or pharmacological action of 
the drug substance.
    (3) Agency means the Food and Drug Administration (FDA).
    (4) Increased use of a drug or biologic product may occur if the 
drug will be administered at higher dosage levels, for longer duration 
or for different indications than were previously in effect, or if the 
drug is a new molecular entity. The term ``use'' also encompasses 
disposal of FDA-regulated articles by consumers.
    (5) Responsible agency official means the agency decisionmaker 
designated in 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.

[[Page 325]]

    (d) Environmental documents shall concentrate on timely and 
significant issues, not amass needless detail.
    (e) If a proposed action for which an EIS will be prepared involves 
possible environmental effects that are required to be considered under 
statutes or Executive Orders other than those referred to under 
``Authority'' in this part, these effects shall be considered in the 
NEPA review, consistent with 40 CFR 1502.25 and the HHS General 
Administration Manual, part 30: Environmental Protection.



     Subpart B_Agency Actions Requiring Environmental Consideration



Sec.  25.15  General procedures.

    (a) All applications or petitions requesting agency action require 
the submission of an EA or a claim of categorical exclusion. A claim of 
categorical exclusion shall include a statement of compliance with the 
categorical exclusion criteria and shall state that to the applicant's 
knowledge, no extraordinary circumstances exist. Failure to submit an 
adequate EA for an application or petition requesting action by the 
agency of a type specified in Sec.  25.20, unless the agency can 
determine that the action qualifies for exclusion under Sec. Sec.  
25.30, 25.31, 25.32, 25.33, 25.34, or 25.35 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, 25.34, or 25.35.
    (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, 
25.34, or 25.35, 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.

[62 FR 40592, July 29, 1997, as amended at 80 FR 57535, Sept. 24, 2015]



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 normally 
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, 25.34, or 25.35:
    (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

[[Page 326]]

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).
    (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) Establishment or amendment of a regulation for a food substance 
as GRAS under the conditions of its intended use for humans or animals 
under parts 182, 184, 186, 582, or 584 of this chapter, or 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), (i), (j), (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, 
actions on INAD's, and granting of requests for determination of 
eligibility for indexing, 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.
    (o) Issuance of an order finding a tobacco product substantially 
equivalent under the Federal Food, Drug, and Cosmetic Act, or granting 
of a request for an exemption under 21 CFR part 1107 from the 
requirement of demonstrating substantial equivalence, unless 
categorically excluded under Sec.  25.35.
    (p) Issuance of an order authorizing marketing of a new tobacco 
product under section 910 of the Federal Food, Drug, and Cosmetic Act or 
an order authorizing marketing of a modified risk tobacco product under 
section 911 of the Federal Food, Drug, and Cosmetic Act, unless 
categorically excluded under Sec.  25.35.

[62 FR 40592, July 29, 1997, as amended at 65 FR 30355, May 11, 2000; 72 
FR 69118, Dec. 6, 2007; 80 FR 57535, Sept. 24, 2015; 81 FR 55047, Aug. 
17, 2016]



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

[[Page 327]]

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 25.35 are categorically excluded and, therefore, ordinarily do 
not require the preparation of an EA or an EIS:
    (a) Routine administrative and management activities, including 
inspections, and issuance of field compliance programs, program 
circulars, or field investigative assignments.
    (b) Recommendation for an enforcement action to be initiated in a 
Federal court.
    (c) Agency requests for initiation of recalls.
    (d) Destruction or disposition of any FDA-regulated article 
condemned after seizure or the distribution or use of which has been 
enjoined or following detention or recall at agency request if the 
method of destruction or disposition of the article, including packaging 
material, is in compliance with all Federal, State, and local 
requirements.
    (e) Extramural contracts, other agreements, or grants for 
statistical and epidemiological studies, surveys and inventories, 
literature searches, and report and manual preparation, or any other 
studies that will not result in the production or distribution of any 
substance and, therefore, will not result in the introduction of any 
substance into the environment.
    (f) Extramural contracts, other agreements, and grants for research 
for such purposes as to develop analytical methods or other test 
methodologies.
    (g) Activities of voluntary Federal-State cooperative programs, 
including issuance of model regulations proposed for State adoption.
    (h) Issuance, amendment, or revocation of procedural or 
administrative regulations and guidance documents, including procedures 
for submission of applications for product development, testing and 
investigational use, and approval.
    (i) Corrections and technical changes in regulations.
    (j) Issuance of CGMP regulations, HACCP regulations, establishment 
standards, emergency permit control regulations, GLP regulations, and 
issuance or denial of permits, exemptions, variances, or stays under 
these regulations.
    (k) Establishment or repeal by regulation of labeling requirements 
for marketed articles if there will be no increase in the existing 
levels of use or change in the intended uses of the product or its 
substitutes.
    (l) Routine maintenance and minor construction activities such as:
    (1) Repair to or replacement of equipment or structural components 
(e.g., door, roof, or window) of facilities controlled by FDA;
    (2) Lease extensions, renewals, or succeeding leases;
    (3) Construction or lease construction of 10,000 square feet or less 
of occupiable space;
    (4) Relocation of employees into existing owned or currently leased 
space;
    (5) Acquisition of 20,000 square feet or less of occupiable space in 
a structure that was substantially completed before the issuance of 
solicitation for offers; and
    (6) Acquisition of between 20,000 square feet and 40,000 square feet 
of occupiable space if it constitutes less than 40 percent of the 
occupiable space in a structure that was substantially completed before 
the solicitation for offers.

[[Page 328]]

    (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; 
80 FR 57535, Sept. 24, 2015]



Sec.  25.31  Human drugs and biologics.

    The classes of actions listed in this section are categorically 
excluded and, therefore, ordinarily do not require the preparation of an 
EA or an EIS:
    (a) Action on an NDA, abbreviated application, application for 
marketing approval of a biologic product, or a supplement to such 
applications, or action on an OTC monograph, if the action does not 
increase the use of the active moiety.
    (b) Action on an NDA, abbreviated application, or a supplement to 
such applications, or action on an OTC monograph, if the action 
increases the use of the active moiety, but the estimated concentration 
of the substance at the point of entry into the aquatic environment will 
be below 1 part per billion.
    (c) Action on an NDA, abbreviated application, application for 
marketing approval of a biologic product, or a supplement to such 
applications, or action on an OTC monograph, for substances that occur 
naturally in the environment when the action does not alter 
significantly the concentration or distribution of the substance, its 
metabolites, or degradation products in the environment.
    (d) Withdrawal of approval of an NDA or an abbreviated application.
    (e) Action on an IND.
    (f) Testing and release by the 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) Establishment or amendment of a regulation for a food substance 
as GRAS under the conditions of its intended use for humans or animals 
under parts 182, 184, 186, 582, or 584 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, establishment or amendment 
of a regulation for a food substance as GRAS under the conditions of its 
intended use for humans or animals under parts 182, 184, 186, 582, or 
584 of

[[Page 329]]

this chapter, 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, establishment or amendment 
of a regulation for a food substance as GRAS under the conditions of its 
intended use for humans or animals under parts 182, 184, 186, 582, or 
584 of this chapter, 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 or color additive petition, 
establishment or amendment of a regulation for a food substance as GRAS 
under the conditions of its intended use for humans or animals under 
parts 182, 184, 186, 582, or 584 of this chapter, or allowing a 
notification submitted under 21 U.S.C. 348(h) to become effective, for 
substances added directly to food that are intended to remain in food 
through ingestion by consumers and that are not intended to replace 
macronutrients in food.
    (l) Approval of a petition for color additives used in contact 
lenses, sutures, filaments used as supporting haptics in intraocular 
lenses, bone cement, and in other FDA-regulated products having 
similarly low levels of use.
    (m) Action to prohibit or otherwise restrict or reduce the use of a 
substance in food, food packaging, or cosmetics.
    (n) Issuance, amendment, or revocation of a regulation pertaining to 
infant formulas.
    (o) Approval of a food additive petition for the intended expression 
product(s) present in food derived from new plant varieties.
    (p) Issuance, amendment, or revocation of a regulation in response 
to a reference amount petition as described in Sec.  101.12(h) of this 
chapter, a nutrient content claim petition as described in Sec.  101.69 
of this chapter, a health claim petition as described in Sec.  101.70 of 
this chapter, or a petition pertaining to the label declaration of 
ingredients as described in Sec.  10.30 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 or color additive petition, 
establishment or amendment of a regulation for a food substance as GRAS 
under the conditions of its intended use for humans or animals under 
parts 182, 184, 186, 582, or 584 of this chapter, 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; 76 
FR 59248, Sept. 26, 2011; 81 FR 55047, Aug. 17, 2016]



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, request for 
determination of eligibility for indexing, a supplement to such 
applications, or a modification of an index listing, 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;

[[Page 330]]

    (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, request for 
determination of eligibility for indexing, a supplement to such 
applications, or a modification of an index listing, 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, request for 
determination of eligibility for indexing, a supplement to such 
applications, or a modification of an index listing, 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 or 
removal of a new animal drug from the index.
    (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; 
72 FR 69119, Dec. 6, 2007]



Sec.  25.34  Devices and electronic products.

    The classes of actions listed in this section are categorically 
excluded and, therefore, ordinarily do not require the preparation of an 
EA or an EIS:
    (a) Action on a device premarket notification submission under 
subpart E of part 807 of this chapter.
    (b) Classification or reclassification of a device under part 860 of 
this chapter, 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]

[[Page 331]]



Sec.  25.35  Tobacco product applications.

    The classes of actions listed in this section are categorically 
excluded and, therefore, normally do not require the preparation of an 
EA or an EIS:
    (a) Issuance of an order finding a tobacco product substantially 
equivalent under section 910(a)(2)(B) of the Federal Food, Drug, and 
Cosmetic Act;
    (b) Issuance of an order finding a tobacco product not substantially 
equivalent under section 910(a) of the Federal Food, Drug, and Cosmetic 
Act, denial of a request for an exemption under 21 CFR part 1107 from 
the requirement of demonstrating substantial equivalence, issuance of an 
order under section 910(c) of the Federal Food, Drug, and Cosmetic Act 
that a new tobacco product may not be introduced or delivered for 
introduction into interstate commerce, or issuance of an order under 
section 911 of the Federal Food, Drug, and Cosmetic Act that a modified 
risk tobacco product may not be introduced or delivered for introduction 
into interstate commerce;
    (c) Rescission or temporary suspension of an order authorizing the 
marketing of a new tobacco product under section 910 of the Federal 
Food, Drug, and Cosmetic Act;
    (d) Rescission of an order authorizing the marketing of a modified 
risk tobacco product under section 911 of the Federal Food, Drug, and 
Cosmetic Act; and
    (e) Rescission of an order granting an exemption request under Sec.  
1107.1 of this chapter.

[80 FR 57535, Sept. 24, 2015]



            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.  25.30, Sec.  25.31, Sec.  25.32, Sec.  
25.33, or Sec.  25.34, or Sec.  25.35. The EA shall focus on relevant 
environmental issues relating to the use and disposal from use of FDA-
regulated articles and shall be a concise, objective, and well-balanced 
document that allows the public to understand the agency's decision. If 
potentially adverse environmental impacts are identified for an action 
or a group of related actions, the EA shall discuss any reasonable 
alternative course of action that offers less environmental risk or that 
is environmentally preferable to the proposed action. The use of a 
scientifically justified tiered testing approach, in which testing may 
be stopped when the results suggest that no significant impact will 
occur, is an acceptable approach.
    (b) Generally, FDA requires an applicant to prepare an EA and make 
necessary corrections to it. Ultimately, FDA is responsible for the 
scope and content of EA's and may include additional information in 
environmental documents when warranted.
    (c) Information concerning the nature and scope of information that 
an applicant or petitioner shall submit in an EA may be obtained from 
the center or other office of the agency having responsibility for the 
action that is the subject of the environmental evaluation. Applicants 
and petitioners are encouraged to submit proposed protocols for 
environmental studies for technical review by agency staff. Applicants 
and petitioners also are encouraged to consult applicable FDA EA 
guidance documents, which provide additional advice on how to comply 
with FDA regulations.
    (d) Consistent with 40 CFR 1500.4(j) and 1502.21, EA's may 
incorporate by reference information presented in other documents that 
are available to FDA and to the public.
    (e) The agency evaluates the information contained in an EA and any 
public input to determine whether it is accurate and objective, whether 
the proposed action may significantly affect the quality of the human 
environment, and whether an EIS or a FONSI will be prepared. The 
responsible agency official examines the environmental

[[Page 332]]

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; 80 
FR 57535, Sept. 24, 2015]



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 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]

[[Page 333]]



    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 
or market authorization of applications, and premarket notifications for 
human drugs, animal drugs, biologic products, devices, and tobacco 
products are protected from disclosure under the Trade Secret Act, 18 
U.S.C. 1905, and section 301(j) of the Federal Food, Drug, and Cosmetic 
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, devices, and tobacco products is 
protected from disclosure under these regulations. Therefore, unless the 
existence of applications for human drugs, animal drugs, biologic 
products, tobacco products, or premarket notification for devices has 
been made publicly available, the release of the environmental document 
before approval or authorization of human drugs, animal drugs, biologic 
products, devices and tobacco products 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.

[62 FR 40592, July 29, 1997, as amended at 80 FR 57535, Sept. 24, 2015]



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 334]]



Sec.  25.52  Environmental impact statements.

    (a) If FDA determines that an EIS is necessary for an action 
involving investigations, approvals, or market authorizations for drugs, 
animal drugs, biologic products, devices, or tobacco products, an EIS 
will be prepared but will become available only at the time of the 
approval or market authorization of the product. 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 or 
market authorization of the drug, animal drug, biologic product, device, 
or tobacco product. Those comments can form the basis for the Agency to 
consider beginning an action to withdraw the approval or market 
authorization of applications for a drug, animal drug, biologic product, 
or tobacco 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, devices, or 
tobacco products has already been disclosed before the Agency approves 
the action, the Agency will ensure appropriate public involvement 
consistent with 40 CFR 1506.6 and part 1503 in preparing and 
implementing the NEPA procedures related to preparing EISs while 
following its own disclosure requirements including those listed in part 
20 and 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; 80 
FR 57535, Sept. 24, 2015]



                      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.

[[Page 335]]

    (2) Coordinate all communications with foreign governments 
concerning environmental agreements and other arrangements in 
implementing the Executive Order.



   PART 26_MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING
   PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND
   CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND
   THE EUROPEAN COMMUNITY--Table of Contents



Sec.
26.0 General.

      Subpart A_Specific Sector Provisions for Pharmaceutical Good 
                         Manufacturing Practices

26.1 Definitions.
26.2 Purpose.
26.3 Scope.
26.4 Product coverage.
26.5 Length of transition period.
26.6 Equivalence assessment.
26.7 Participation in the equivalence assessment and determination.
26.8 Other transition activities.
26.9 Equivalence determination.
26.10 Regulatory authorities not listed as currently equivalent.
26.11 Start of operational period.
26.12 Nature of recognition of inspection reports.
26.13 Transmission of postapproval inspection reports.
26.14 Transmission of preapproval inspection reports.
26.15 Monitoring continued equivalence.
26.16 Suspension.
26.17 Role and composition of the Joint Sectoral Committee.
26.18 Regulatory collaboration.
26.19 Information relating to quality aspects.
26.20 Alert system.
26.21 Safeguard clause.

Appendix A to Subpart A of Part 26--List of Applicable Laws, 
          Regulations, and Administrative Provisions.
Appendix B to Subpart A of Part 26--List of Authorities.
Appendix C to Subpart A of Part 26--Indicative List of Products Covered 
          by Subpart A.
Appendix D to Subpart A of Part 26--Criteria for Assessing Equivalence 
          for Post- and Preapproval.
Appendix E to Subpart A of Part 26--Elements To Be Considered in 
          Developing a Two-Way Alert System.

        Subpart B_Specific Sector Provisions for Medical Devices

26.31 Purpose.
26.32 Scope.
26.33 Product coverage.
26.34 Regulatory authorities.
26.35 Length and purpose of transition period.
26.36 Listing of CAB's.
26.37 Confidence building activities.
26.38 Other transition period activities.
26.39 Equivalence assessment.
26.40 Start of the operational period.
26.41 Exchange and endorsement of quality system evaluation reports.
26.42 Exchange and endorsement of product evaluation reports.
26.43 Transmission of quality system evaluation reports.
26.44 Transmission of product evaluation reports.
26.45 Monitoring continued equivalence.
26.46 Listing of additional CAB's.
26.47 Role and composition of the Joint Sectoral Committee.
26.48 Harmonization.
26.49 Regulatory cooperation.
26.50 Alert system and exchange of postmarket vigilance reports.

Appendix A to Subpart B of Part 26--Relevant Legislation, Regulations, 
          and Procedures.
Appendix B to Subpart B of Part 26--Scope of Product Coverage.
Appendixes C-F to Subpart B of Part 26 [Reserved]

                   Subpart C_``Framework'' Provisions

26.60 Definitions.
26.61 Purpose of this part.
26.62 General obligations.
26.63 General coverage of this part.
26.64 Transitional arrangements.
26.65 Designating authorities.
26.66 Designation and listing procedures.
26.67 Suspension of listed conformity assessment bodies.
26.68 Withdrawal of listed conformity assessment bodies.
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.

[[Page 336]]

26.80 Entry into force, amendment, and termination.
26.81 Final provisions.

    Authority: 5 U.S.C. 552; 15 U.S.C. 1453, 1454, 1455; 18 U.S.C. 1905; 
21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 360c, 360d, 360e, 360f, 
360g, 360h, 360i, 360j, 360l, 360m, 371, 374, 381, 382, 383, 393; 42 
U.S.C. 216, 241, 242l, 262, 264, 265.

    Source: 63 FR 60141, Nov. 6, 1998, unless otherwise noted.



Sec.  26.0  General.

    This part substantially reflects relevant provisions of the 
framework agreement and its sectoral annexes on pharmaceutical good 
manufacturing practices (GMP's) and medical devices of the ``Agreement 
on Mutual Recognition Between the United States of America and the 
European Community'' (the MRA), signed at London May 18, 1998. For 
codification purposes, certain provisions of the MRA have been modified 
for use in this part. This modification is done for purposes of clarity 
only and shall not affect the text of the MRA concluded between the 
United States and the European Community (EC), or the rights and 
obligations of the United States or the EC under that agreement. Whereas 
the parties to the MRA are the United States and EC, this part is 
relevant only to the Food and Drug Administration's (FDA's) 
implementation of the MRA, including the sectoral annexes reflected in 
subparts A and B of this part. This part does not govern implementation 
of the MRA by the EC, which will implement the MRA in accordance with 
its internal procedures, nor does this part address implementation of 
the MRA by other concerned U.S. Federal agencies. For purposes of this 
part, the terms ``party'' or ``parties,'' where relevant to FDA's 
implementation of the MRA, should be considered as referring to FDA 
only. If the parties to the MRA subsequently amend or terminate the MRA, 
FDA will modify this part accordingly, using appropriate administrative 
procedures.



      Subpart A_Specific Sector Provisions for Pharmaceutical Good 
                         Manufacturing Practices



Sec.  26.1  Definitions.

    (a) Enforcement means action taken by an authority to protect the 
public from products of suspect quality, safety, and effectiveness or to 
assure that products are manufactured in compliance with appropriate 
laws, regulations, standards, and commitments made as part of the 
approval to market a product.
    (b) Equivalence of the regulatory systems means that the systems are 
sufficiently comparable to assure that the process of inspection and the 
ensuing inspection reports will provide adequate information to 
determine whether respective statutory and regulatory requirements of 
the authorities have been fulfilled. Equivalence does not require that 
the respective regulatory systems have identical procedures.
    (c) Good Manufacturing Practices (GMP's). [The United States has 
clarified its interpretation that under the MRA, paragraph (c)(1) of 
this section has to be understood as the U.S. definition and paragraph 
(c)(2) as the EC definition.]
    (1) GMP's mean the requirements found in the legislations, 
regulations, and administrative provisions for methods to be used in, 
and the facilities or controls to be used for, the manufacturing, 
processing, packing, and/or holding of a drug to assure that such drug 
meets the requirements as to safety, and has the identity and strength, 
and meets the quality and purity characteristics that it purports or is 
represented to possess.
    (2) GMP's are that part of quality assurance which ensures that 
products are consistently produced and controlled to quality standards. 
For the purpose of this subpart, GMP's include, therefore, the system 
whereby the manufacturer receives the specifications of the product and/
or process from the marketing authorization/product authorization or 
license holder or applicant and ensures the product is made in 
compliance with its specifications (qualified person certification in 
the EC).

[[Page 337]]

    (d) Inspection means an onsite evaluation of a manufacturing 
facility to determine whether such manufacturing facility is operating 
in compliance with GMP's and/or commitments made as part of the approval 
to market a product.
    (e) Inspection report means the written observations and GMP's 
compliance assessment completed by an authority listed in appendix B of 
this subpart.
    (f) Regulatory system means the body of legal requirements for 
GMP's, inspections, and enforcements that ensure public health 
protection and legal authority to assure adherence to these 
requirements.

[63 FR 60141, Nov. 6, 1998; 64 FR 16348, Apr. 5, 1999]



Sec.  26.2  Purpose.

    The provisions of this subpart govern the exchange between the 
parties and normal endorsement by the receiving regulatory authority of 
official good manufacturing practices (GMP's) inspection reports after a 
transitional period aimed at determination of the equivalence of the 
regulatory systems of the parties, which is the cornerstone of this 
subpart.



Sec.  26.3  Scope.

    (a) The provisions of this subpart shall apply to pharmaceutical 
inspections carried out in the United States and Member States of the 
European Community (EC) before products are marketed (hereafter referred 
to as ``preapproval inspections'') as well as during their marketing 
(hereafter referred to as ``postapproval inspections'').
    (b) Appendix A of this subpart names the laws, regulations, and 
administrative provisions governing these inspections and the good 
manufacturing practices (GMP's) requirements.
    (c) Appendix B of this subpart lists the authorities participating 
in activities under this subpart.
    (d) Sections 26.65, 26.66, 26.67, 26.68, 26.69, and 26.70 of subpart 
C of this part do not apply to this subpart.



Sec.  26.4  Product coverage.

    (a) The provisions of this subpart will apply to medicinal products 
for human or animal use, intermediates and starting materials (as 
referred to in the European Community (EC)) and to drugs for human or 
animal use, biological products for human use, and active pharmaceutical 
ingredients (as referred to in the United States), only to the extent 
they are regulated by the authorities of both parties as listed in 
appendix B of this subpart.
    (b) Human blood, human plasma, human tissues and organs, and 
veterinary immunologicals (under 9 CFR 101.2, ``veterinary 
immunologicals'' are referred to as ``veterinary biologicals'') are 
excluded from the scope of this subpart. Human plasma derivatives (such 
as immunoglobulins and albumin), investigational medicinal products/new 
drugs, human radiopharmaceuticals, and medicinal gases are also excluded 
during the transition phase; their situation will be reconsidered at the 
end of the transition period. Products regulated by the Food and Drug 
Administration's Center for Biologics Evaluation and Research 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.

[[Page 338]]

    (c) The equivalence assessment shall include information exchanges 
(including inspection reports), joint training, and joint inspections 
for the purpose of assessing regulatory systems and the authorities' 
capabilities. In conducting the equivalence assessment, the parties will 
ensure that efforts are made to save resources.
    (d) Equivalence assessment for authorities added to appendix B of 
this subpart after the effective date described in Sec.  26.80(a) will 
be conducted as described in this subpart, as soon as practicable.



Sec.  26.7  Participation in the equivalence assessment and determination.

    The authorities listed in appendix B of this subpart will actively 
participate in these programs to build a sufficient body of evidence for 
their equivalence determination. Both parties will exercise good faith 
efforts to complete equivalence assessment as expeditiously as possible 
to the extent the resources of the authorities allow.



Sec.  26.8  Other transition activities.

    As soon as possible, the authorities will jointly determine the 
essential information which must be present in inspection reports and 
will cooperate to develop mutually agreed inspection report format(s).



Sec.  26.9  Equivalence determination.

    (a) Equivalence is established by having in place regulatory systems 
covering the criteria referred to in appendix D of this subpart, and a 
demonstrated pattern of consistent performance in 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.

[[Page 339]]



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 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

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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.
    (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.



   Sec. 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.

[[Page 341]]

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.
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.



      Sec. 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: [Epsi][theta][nu][iota][kappa][omega][sigmav] 
[Omega][rho][gamma][alpha][nu][iota][sigma][mu][omega][sigmav] 
[Phi][alpha][rho][mu][alpha][kappa][omega][upsi], 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).



  Sec. 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

[[Page 342]]

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).



    Sec. 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 and regulations.

                       IV. Conduct of inspections:

A. Adequate preinspection preparation, including appropriate expertise 
of investigator/team, review of firm/product and databases, and 
availability of appropriate inspection equipment.
B. Adequate conduct of inspection, including statutory access to 
facilities, effective response to refusals, depth and competence of 
evaluation of operations, systems and documentation; collection of 
evidence; appropriate duration of inspection and completeness of written 
report of observations to firm management.
C. Adequate postinspection activities, including completeness of 
inspectors' report, inspection report review where appropriate, and 
conduct of followup inspections and other activities where appropriate, 
assurance of preservation and retrieval of records.

 V. Execution of regulatory enforcement actions to achieve corrections, 
 designed to prevent future violations, and to remove products found in 
               violation of requirements from the market.

               VI. Effective use of surveillance systems:

A. Sampling and analysis.
B. Recall monitoring.
C. Product defect reporting system.
D. Routine surveillance inspections.
E. Verification of approved manufacturing process changes to marketing 
authorizations/approved applications.

     VII. Additional specific criteria for preapproval inspections:

A. Satisfactory demonstration through a jointly developed and 
administered training program and joint inspections to assess the 
regulatory authorities' capabilities.
B. Preinspection preparation includes the review of appropriate records, 
including site plans and drug master file or similar documentation to 
enable adequate inspections.
C. Ability to verify chemistry, manufacturing, and control data 
supporting an application is authentic and complete.
D. Ability to assess and evaluate research and development data as 
scientifically sound, especially transfer technology of pilot, scale up 
and full scale production batches.
E. Ability to verify conformity of the onsite processes and procedures 
with those described in the application.
F. Review and evaluate equipment installation, operational and 
performance qualification data, and evaluate test method validation.

[[Page 343]]



 Sec. Appendix E to Subpart A of Part 26--Elements To Be Considered in 
                    Developing a Two-Way Alert System

                            1. Documentation

--Definition of a crisis/emergency and under what circumstances an alert 
is required
--Standard Operating Procedures (SOP's)
--Mechanism of health hazards evaluation and classification
--Language of communication and transmission of information

                       2. Crisis Management System

--Crisis analysis and communication mechanisms
--Establishment of contact points
--Reporting mechanisms

                        3. Enforcement Procedures

--Followup mechanisms
--Corrective action procedures

                       4. Quality Assurance System

--Pharmacovigilance programme
--Surveillance/monitoring of implementation of corrective action

                            5. Contact Points

For the purpose of subpart A of this part, the contact points for the 
alert system will be:

                     A. For the European Community:

the Executive Director of the European Agency for the Evaluation of 
Medicinal Products, 7, Westferry Circus, Canary Wharf, UK - London E14 
4HB, England. Telephone 44-171-418 8400, Fax 418-8416.

                       B. For the United States :

Biologics:Food and Drug Administration, Center for Biologics Evaluation 
and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 
71, Rm. G112, Silver Spring, MD 20993-0002, telephone: 240-402-9153, 
FAX: 301-595-1302.
Human Drugs: Director, Office of Compliance, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, phone: 301-796-3100, fax: 301-847-8747.
Veterinary Drugs: Director, Office of Surveillance and Compliance (HFV-
200), MPN II, 7500 Standish Pl., Rockville, MD 20855-2773, phone: 301-
827-6644, fax: 301-594-1807.

[63 FR 60141, Nov. 6, 1998, as amended at 69 FR 48775, Aug. 11, 2004; 74 
FR 13112, Mar. 26, 2009; 80 FR 18090, Apr. 3, 2015]



        Subpart B_Specific Sector Provisions for Medical Devices



Sec.  26.31  Purpose.

    (a) The purpose of this subpart is to specify the conditions under 
which a party will accept the results of quality system-related 
evaluations and inspections and premarket evaluations of the other party 
with regard to medical devices as conducted by listed conformity 
assessment bodies (CAB's) and to provide for other related cooperative 
activities.
    (b) This subpart is intended to evolve as programs and policies of 
the parties evolve. The parties will review this subpart periodically, 
in order to assess progress and identify potential enhancements to this 
subpart as Food and Drug Administration (FDA) and European Community 
(EC) policies evolve over time.



Sec.  26.32  Scope.

    (a) The provisions of this subpart shall apply to the exchange and, 
where appropriate, endorsement of the following types of reports from 
conformity assessment bodies (CAB's) assessed to be equivalent:
    (1) Under the U.S. system, surveillance/postmarket and initial/
preapproval inspection reports;
    (2) Under the U.S. system, premarket (510(k)) product evaluation 
reports;
    (3) Under the European Community (EC) system, quality system 
evaluation reports; and
    (4) Under the EC system, EC type examination and verification 
reports.
    (b) Appendix A of this subpart names the legislation, regulations, 
and related procedures under which:
    (1) Products are regulated as medical devices by each party;
    (2) CAB's are designated and confirmed; and
    (3) These reports are prepared.
    (c) For purposes of this subpart, equivalence means that: CAB's in 
the EC are capable of conducting product and quality systems evaluations 
against U.S. regulatory requirements in a manner equivalent to those 
conducted by FDA; and CAB's in the United States are capable of 
conducting product and quality systems

[[Page 344]]

evaluations against EC regulatory requirements in a manner equivalent to 
those conducted by EC CAB's.



Sec.  26.33  Product coverage.

    (a) There are three components to this subpart each covering a 
discrete range of products:
    (1) Quality System Evaluations. U.S.-type surveillance/postmarket 
and initial/preapproval inspection reports and European Community (EC)-
type quality system evaluation reports will be exchanged with regard to 
all products regulated under both U.S. and EC law as medical devices.
    (2) Product Evaluation. U.S.-type premarket (510(k)) product 
evaluation reports and EC-type-testing reports will be exchanged only 
with regard to those products classified under the U.S. system as Class 
I/Class II-Tier 2 medical devices which are listed in appendix B of this 
subpart.
    (3) Postmarket Vigilance Reports. Postmarket vigilance reports will 
be exchanged with regard to all products regulated under both U.S. and 
EC law as medical devices.
    (b) Additional products and procedures may be made subject to this 
subpart by agreement of the parties.



Sec.  26.34  Regulatory authorities.

    The regulatory authorities shall have the responsibility of 
implementing the provisions of this subpart, including the designation 
and monitoring of conformity assessment bodies (CAB's). Regulatory 
authorities will be specified in appendix C of this subpart. Each party 
will promptly notify the other party in writing of any change in the 
regulatory authority for a country.



Sec.  26.35  Length and purpose of transition period.

    There will be a 3-year transition period immediately following the 
date described in Sec.  26.80(a). During the transition period, the 
parties will engage in confidence-building activities for the purpose of 
obtaining sufficient evidence to make determinations concerning the 
equivalence of conformity assessment bodies (CAB's) of the other party 
with respect to the ability to perform quality system and product 
evaluations or other reviews resulting in reports to be exchanged under 
this subpart.



Sec.  26.36  Listing of CAB's.

    Each party shall designate conformity assessment bodies (CAB's) to 
participate in confidence building activities by transmitting to the 
other party a list of CAB's which meet the criteria for technical 
competence and independence, as identified in appendix A of this 
subpart. The list shall be accompanied by supporting evidence. 
Designated CAB's will be listed in appendix D of this subpart for 
participation in the confidence building activities once confirmed by 
the importing party. Nonconfirmation would have to be justified based on 
documented evidence.



Sec.  26.37  Confidence building activities.

    (a) At the beginning of the transitional period, the Joint Sectoral 
Group will establish a joint confidence building program calculated to 
provide sufficient evidence of the capabilities of the designated 
conformity assessment bodies (CAB's) to perform quality system or 
product evaluations to the specifications of the parties.
    (b) The joint confidence building program should include the 
following actions and activities:
    (1) Seminars designed to inform the parties and CAB's about each 
party's regulatory system, procedures, and requirements;
    (2) Workshops designed to provide the parties with information 
regarding requirements and procedures for the designation and 
surveillance of CAB's;
    (3) Exchange of information about reports prepared during the 
transition period;
    (4) Joint training exercises; and
    (5) Observed inspections.
    (c) During the transition period, any significant problem that is 
identified with a CAB may be the subject of cooperative activities, as 
resources allow and as agreed to by the regulatory authorities, aimed at 
resolving the problem.
    (d) Both parties will exercise good faith efforts to complete the 
confidence building activities as expeditiously as possible to the 
extent that the resources of the parties allow.

[[Page 345]]

    (e) Both the parties will each prepare annual progress reports which 
will describe the confidence building activities undertaken during each 
year of the transition period. The form and content of the reports will 
be determined by the parties through the Joint Sectoral Committee.



Sec.  26.38  Other transition period activities.

    (a) During the transition period, the parties will jointly determine 
the necessary information which must be present in quality system and 
product evaluation reports.
    (b) The parties will jointly develop a notification and alert system 
to be used in case of defects, recalls, and other problems concerning 
product quality that could necessitate additional actions (e.g., 
inspections by the parties of the importing country) or suspension of 
the distribution of the product.



Sec.  26.39  Equivalence assessment.

    (a) In the final 6 months of the transition period, the parties 
shall proceed to a joint assessment of the equivalence of the conformity 
assessment bodies (CAB's) that participated in the confidence building 
activities. CAB's will be determined to be equivalent provided they have 
demonstrated proficiency through the submission of a sufficient number 
of adequate reports. CAB's may be determined to be equivalent with 
regard to the ability to perform any type of quality system or product 
evaluation covered by this subpart and with regard to any type of 
product covered by this subpart. The parties shall develop a list 
contained in appendix E of this subpart of CAB's determined to be 
equivalent, which shall contain a full explanation of the scope of the 
equivalency determination, including any appropriate limitations, with 
regard to performing any type of quality system or product evaluation.
    (b) The parties shall allow CAB's not listed for participation in 
this subpart, or listed for participation only as to certain types of 
evaluations, to apply for participation in this subpart once the 
necessary measures have been taken or sufficient experience has been 
gained, in accordance with Sec.  26.46.
    (c) Decisions concerning the equivalence of CAB's must be agreed to 
by both parties.



Sec.  26.40  Start of the operational period.

    (a) The operational period will start at the end of the transition 
period after the parties have developed the list of conformity 
assessment bodies (CAB's) found to be equivalent. The provisions of 
Sec. Sec.  26.40, 26.41, 26.42, 26.43, 26.44, 26.45, and 26.46 will 
apply only with regard to listed CAB's and only to the extent of any 
specifications and limitations contained on the list with regard to a 
CAB.
    (b) The operational period will apply to quality system evaluation 
reports and product evaluation reports generated by CAB's listed in 
accordance with this subpart for the evaluations performed in the 
respective territories of the parties, except if the parties agree 
otherwise.



Sec.  26.41  Exchange and endorsement of quality system evaluation reports.

    (a) Listed European Community (EC) conformity assessment bodies 
(CAB's) will provide FDA with reports of quality system evaluations, as 
follows:
    (1) For preapproval quality system evaluations, EC CAB's will 
provide full reports; and
    (2) For surveillance quality system evaluations, EC CAB's will 
provide abbreviated reports.
    (b) Listed U.S. CAB's will provide to the EC Notified Body of the 
manufacturer's choice:
    (1) Full reports of initial quality system evaluations;
    (2) Abbreviated reports of quality systems surveillance audits.
    (c) If the abbreviated reports do not provide sufficient 
information, the importing party may request additional clarification 
from the CAB.
    (d) Based on the determination of equivalence in light of the 
experience gained, the quality system evaluation reports prepared by the 
CAB's listed as equivalent will normally be endorsed by the importing 
party, except under specific and delineated circumstances. Examples of 
such circumstances include indications of material inconsistencies or 
inadequacies in a report, quality defects identified in

[[Page 346]]

postmarket surveillance or other specific evidence of serious concern in 
relation to product quality or consumer safety. In such cases, the 
importing party may request clarification from the exporting party which 
may lead to a request for reinspection. The parties will endeavor to 
respond to requests for clarification in a timely manner. Where 
divergence is not clarified in this process, the importing party may 
carry out the quality system evaluation.



Sec.  26.42  Exchange and endorsement of product evaluation reports.

    (a) European Community (EC) conformity assessment bodies (CAB's) 
listed for this purpose will, subject to the specifications and 
limitations on the list, provide to FDA 510(k) premarket notification 
assessment reports prepared to U.S. medical device requirements.
    (b) U.S. CAB's will, subject to the specifications and limitations 
on the list, provide to the EC Notified Body of the manufacturer's 
choice, type examination, and verification reports prepared to EC 
medical device requirements.
    (c) Based on the determination of equivalence in light of the 
experience gained, the product evaluation reports prepared by the CAB's 
listed as equivalent will normally be endorsed by the importing party, 
except under specific and delineated circumstances. Examples of such 
circumstances include indications of material inconsistencies, 
inadequacies, or incompleteness in a product evaluation report, or other 
specific evidence of serious concern in relation to product safety, 
performance, or quality. In such cases, the importing party may request 
clarification from the exporting party which may lead to a request for a 
reevaluation. The parties will endeavor to respond to requests for 
clarification in a timely manner. Endorsement remains the responsibility 
of the importing party.



Sec.  26.43  Transmission of quality system evaluation reports.

    Quality system evaluation reports covered by Sec.  26.41 concerning 
products covered by this subpart shall be transmitted to the importing 
party within 60-calendar days of a request by the importing party. 
Should a new inspection be requested, the time period shall be extended 
by an additional 30-calendar days. A party may request a new inspection, 
for cause, identified to the other party. If the exporting party cannot 
perform an inspection within a specified period of time, the importing 
party may perform an inspection on its own.



Sec.  26.44  Transmission of product evaluation reports.

    Transmission of product evaluation reports will take place according 
to the importing party's specified procedures.



Sec.  26.45  Monitoring continued equivalence.

    Monitoring activities will be carried out in accordance with Sec.  
26.69.



Sec.  26.46  Listing of additional CAB's.

    (a) During the operational period, additional conformity assessment 
bodies (CAB's) will be considered for equivalence using the procedures 
and criteria described in Sec. Sec.  26.36, 26.37, and 26.39, taking 
into account the level of confidence gained in the overall regulatory 
system of the other party.
    (b) Once a designating authority considers that such CAB's, having 
undergone the procedures of Sec. Sec.  26.36, 26.37, and 26.39, may be 
determined to be equivalent, it will then designate those bodies on an 
annual basis. Such procedures satisfy the procedures of Sec.  26.66(a) 
and (b).
    (c) Following such annual designations, the procedures for 
confirmation of CAB's under Sec.  26.66(c) and (d) shall apply.



Sec.  26.47  Role and composition of the Joint Sectoral Committee.

    (a) The Joint Sectoral Committee for this subpart is set up to 
monitor the activities under both the transitional and operational 
phases of this subpart.
    (b) The Joint Sectoral Committee will be cochaired by a 
representative of the Food and Drug Administration (FDA) for the United 
States and a representative of the European Community (EC) who will each 
have one vote. Decisions will be taken by unanimous consent.

[[Page 347]]

    (c) The Joint Sectoral Committee's functions will include:
    (1) Making a joint assessment of the equivalence of conformity 
assessment bodies (CAB's);
    (2) Developing and maintaining the list of equivalent CAB's, 
including any limitation in terms of their scope of activities and 
communicating the list to all authorities and the Joint Committee 
described in subpart C of this part;
    (3) Providing a forum to discuss issues relating to this subpart, 
including concerns that a CAB may no longer be equivalent and 
opportunity to review product coverage; and
    (4) Consideration of the issue of suspension.



Sec.  26.48  Harmonization.

    During both the transitional and operational phases of this subpart, 
both parties intend to continue to participate in the activities of the 
Global Harmonization Task Force (GHTF) and utilize the results of those 
activities to the extent possible. Such participation involves 
developing and reviewing documents developed by the GHTF and jointly 
determining whether they are applicable to the implementation of this 
subpart.



Sec.  26.49  Regulatory cooperation.

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



Sec.  26.50  Alert system and exchange of postmarket vigilance reports.

    (a) An alert system will be set up during the transition period and 
maintained thereafter by which the parties will notify each other when 
there is an immediate danger to public health. Elements of such a system 
will be described in an appendix F of this subpart. As part of that 
system, each party shall notify the other party of any confirmed problem 
reports, corrective actions, or recalls. These reports are regarded as 
part of ongoing investigations.
    (b) Contact points will be agreed between both parties to permit 
authorities to be made aware with the appropriate speed in case of 
quality defect, batch recalls, counterfeiting and other problems 
concerning quality, which could necessitate additional controls or 
suspension of the distribution of the product.



     Sec. Appendix A to Subpart B of Part 26--Relevant Legislation, 
                      Regulations, and Procedures.

1. For the European Community (EC) the following legislation applies to 
                     Sec.  26.42(a) of this subpart:

    [Copies of EC documents may be obtained from the European Document 
Research, 1100 17th St. NW., suite 301, Washington, DC 20036.]
    a. Council Directive 90/385/EEC of 20 June 1990 on active 
implantable medical devices
    OJ No. L 189, 20.7. 1990, p. 17. Conformity assessment procedures.
    Annex 2 (with the exception of section 4)
    Annex 4
    Annex 5
b. Council Directive 93/42/EEC of 14 June 1993 on Medical Devices OJ No. 
L 169,12.7.1993, p.1. Conformity assessment procedures.
    Annex 2 (with the exception of section 4)
    Annex 3
    Annex 4
    Annex 5
    Annex 6

  2. For the United States, the following legislation applies to Sec.  
                                26.32(a):

    [Copies of FDA documents may be obtained from the Government 
Printing Office, 1510 H St. NW., Washington, DC 20005. FDA documents may 
be viewed on FDA's Internet web site at http://www.fda.gov.]
    a. The Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321 et seq.
    b. The Public Health Service Act, 42 U.S.C. 201 et seq.
    c. Regulations of the United States Food and Drug Administration 
found at 21 CFR, in particular, Parts 800 to 1299.
    d. Medical Devices; Third Party Review of Selected Premarket 
Notifications; Pilot Program, 61 FR 14789-14796 (April 3, 1996).
    e. Draft Guidance Document on Accredited Persons Program, 63 FR 
28392 (May 22, 1998).
    f. Draft Guidance for Staff, Industry and Third Parties, Third Party 
Programs under the Sectoral Annex on Medical Devices to the Agreement on 
Mutual Recognition Between the United States of America and the

[[Page 348]]

European Community (MRA), 63 FR 36240 (July 2, 1998).
    g. Guidance Document on Use of Standards, 63 FR 9561 (February 25, 
1998).



   Sec. Appendix B to Subpart B of Part 26--Scope of Product Coverage

              1. Initial Coverage of the Transition Period

Upon entry into force of this subpart as described in Sec.  26.80 (it is 
understood that the date of entry into force will not occur prior to 
June 1, 1998, unless the parties decide otherwise), products qualifying 
for the transitional arrangements under this subpart include:
    a. All Class I products requiring premarket evaluations in the 
United States--see Table 1.
    b. Those Class II products listed in Table 2.

                     2. During the Transition Period

The parties will jointly identify additional product groups, including 
their related accessories, in line with their respective priorities as 
follows:
    a. Those for which review may be based primarily on written guidance 
which the parties will use their best efforts to prepare expeditiously; 
and
    b. Those for which review may be based primarily on international 
standards, in order for the parties to gain the requisite experience.
The corresponding additional product lists will be phased in on an 
annual basis. The parties may consult with industry and other interested 
parties in determining which products will be added.

                3. Commencement of the Operational Period

    a. At the commencement of the operational period, product coverage 
shall extend to all Class I/II products covered during the transition 
period.
    b. FDA will expand the program to categories of Class II devices as 
is consistent with the results of the pilot, and with FDA's ability to 
write guidance documents if the device pilot for the third party review 
of medical devices is successful. The MRA will cover to the maximum 
extent feasible all Class II devices listed in Table 3 for which FDA-
accredited third party review is available in the United States.

  4. Unless explicitly included by joint decision of the parties, this 
 part does not cover any U.S. Class II-tier 3 or any Class III product 
                          under either system.

    [The lists of medical devices included in these tables are subject 
to change as a result of the Food and Drug Administration Modernization 
Act of 1997.]

 Table 1--Class I Products Requiring Premarket Evaluations in the United
States, Included in Scope of Product Coverage at Beginning of Transition
                               Period \1\
------------------------------------------------------------------------
      21 CFR Section No.                    Regulation Name
------------------------------------------------------------------------
                                       Product Code--Device Name
------------------------------------------------------------------------
Anesthesiology Panel (21 CFR
 part 868)
    868.1910.................  Esophageal Stethoscope
                               BZW--Stethoscope, Esophageal
    868.5620.................  Breathing Mouthpiece
                               BYP--Mouthpiece, Breathing
    868.5640.................  Medicinal Nonventilatory Nebulizer
                                (Atomizer)
                               CCQ--Nebulizer, Medicinal, Nonventilatory
                                (Atomizer)
    868.5675.................  Rebreathing Device
                               BYW--Device, Rebreathing
    868.5700.................  Nonpowered Oxygen Tent
                               FOG--Hood, Oxygen, Infant
                               BYL--Tent, Oxygen
    868.6810.................  Tracheobronchial Suction Catheter
                               BSY--Catheters, Suction, Tracheobronchial
Cardiovascular Panel
    (None)...................
Dental Panel (21 CFR part
 872)
    872.3400.................  Karaya and Sodium Borate With or Without
                                Acacia Denture Adhesive
                               KOM--Adhesive, Denture, Acacia and Karaya
                                With Sodium Borate
    872.3700.................  Dental Mercury (U.S.P.)
                               ELY--Mercury
    872.4200.................  Dental Handpiece and Accessories
                               EBW--Controller, Food, Handpiece and Cord
                               EFB--Handpiece, Air-Powered, Dental
                               EFA--Handpiece, Belt and/or Gear Driven,
                                Dental
                               EGS--Handpiece, Contra- and Right-Angle
                                Attachment, Dental
                               EKX--Handpiece, Direct Drive, AC-Powered
                               EKY--Handpiece, Water-Powered
    872.6640.................  Dental Operative Unit and Accessories

[[Page 349]]

 
                               EIA--Unit, Operative Dental
Ear, Nose, and Throat Panel
 (21 CFR Part 874)
    874.1070.................  Short Increment Sensitivity Index (SISI)
                                Adapter
                               ETR--Adapter, Short Increment Sensitivity
                                Index (SISI)
    874.1500.................  Gustometer
                               ETM--Gustometer
    874.1800.................  Air or Water Caloric Stimulator
                               KHH--Stimulator, Caloric-Air
                               ETP--Stimulator, Caloric-Water
    874.1925.................  Toynbee Diagnostic Tube
                               ETK--Tube, Toynbee Diagnostic
    874.3300.................  Hearing Aid
                               LRB--Face Plate Hearing-Aid
                               ESD--Hearing-aid, Air-Conduction
    874.4100.................  Epistaxis Balloon
                               EMX--Balloon, Epistaxis
    874.5300.................  ENT Examination and Treatment Unit
                               ETF--Unit, Examining/Treatment, ENT
    874.5550.................  Powered Nasal Irrigator
                               KMA--Irrigator, Powered Nasal
    874.5840.................  Antistammering Device
                               KTH--Device, Anti-Stammering
Gastroenterology--Urology
 Panel (21 CFR Part 876)
    876.5160.................  Urological Clamp for Males
                               FHA--Clamp, Penile
    876.5210.................  Enema Kit
                               FCE--Kit, Enema, (for Cleaning Purpose)
    876.5250.................  Urine Collector and Accessories
                               FAQ--Bag, Urine Collection, Leg, for
                                External Use
General Hospital Panel (21
 CFR Part 880)
    880.5270.................  Neonatal Eye Pad
                               FOK--Pad, Neonatal Eye
    880.5420.................  Pressure Infusor for an I.V. Bag
                               KZD--Infusor, Pressure, for I.V. Bags
    880.5680.................  Pediatric Position Holder
                               FRP--Holder, Infant Position
    880.6250.................  Patient Examination Glove
                               LZB--Finger Cot
                               FMC--Glove, Patient Examination
                               LYY--Glove, Patient Examination, Latex
                               LZA--Glove, Patient Examination, Poly
                               LZC--Glove, Patient Examination,
                                Speciality
                               LYZ--Glove, Patient Examination, Vinyl
    880.6375.................  Patient Lubricant
                               KMJ--Lubricant, Patient
    880.6760.................  Protective Restraint
                               BRT--Restraint, Patient, Conductive
                               FMQ--Restraint, Protective
Neurology Panel (21 CFR Part
 882)
    882.1030.................  Ataxiagraph
                               GWW--Ataxiagraph
    882.1420.................  Electroencephalogram (EEG) Signal
                                Spectrum Analyzer
                               GWS--Analyzer, Spectrum,
                                Electroencephalogram Signal
    882.4060.................  Ventricular Cannula
                               HCD--Cannula, Ventricular
    882.4545.................  Shunt System Implantation Instrument
                               GYK--Instrument, Shunt System
                                Implantation
    882.4650.................  Neurosurgical Suture Needle
                               HAS--Needle, Neurosurgical Suture
    882.4750.................  Skull Punch
                               GXJ--Punch, Skull
Obstetrics and Gynecology
 Panel
    (None)...................
Ophthalmology Panel (21 CFR
 Part 886)
    886.1780.................  Retinoscope
                               HKM--Retinoscope, Battery-Powered
    886.1940.................  Tonometer Sterilizer

[[Page 350]]

 
                               HKZ--Sterilizer, Tonometer
    886.4070.................  Powered Corneal Burr
                               HQS--Burr, Corneal, AC-Powered
                               HOG--Burr, Corneal, Battery-Powered
                               HRG--Engine, Trephine, Accessories, AC-
                                Powered
                               HFR--Engine, Trephine, Accessories,
                                Battery-Powered
                               HLD--Engine, Trephine, Accessories, Gas-
                                Powered
    886.4370.................  Keratome
                               HNO--Keratome, AC-Powered
                               HMY--Keratome, Battery-Powered
    886.5850.................  Sunglasses (Nonprescription)
                               HQY--Sunglasses (Nonprescription
                                Including Photosensitive)
Orthopedic Panel (21 CFR Part
 888)
    888.1500.................  Goniometer
                               KQX--Goniometer, AC-Powered
    888.4150.................  Calipers for Clinical Use
                               KTZ--Caliper
Physical Medicine Panel (21
 CFR Part 890)
    890.3850.................  Mechanical Wheelchair
                               LBE--Stroller, Adaptive
                               IOR--Wheelchair, Mechanical
    890.5180.................  Manual Patient Rotation Bed
                               INY--Bed, Patient Rotation, Manual
    890.5710.................  Hot or Cold Disposable Pack
                               IMD--Pack, Hot or Cold, Disposable
Radiology Panel (21 CFR Part
 892)
    892.1100.................  Scintillation (Gamma) Camera
                               IYX--Camera, Scintillation (Gamma)
    892.1110.................  Positron Camera
                               IZC--Camera, Positron
    892.1300.................  Nuclear Rectilinear Scanner
                               IYW--Scanner, Rectilinear, Nuclear
    892.1320.................  Nuclear Uptake Probe
                               IZD--Probe, Uptake, Nuclear
    892.1330.................  Nuclear Whole Body Scanner
                               JAM--Scanner, Whole Body, Nuclear
    892.1410.................  Nuclear Electrocardiograph Synchronizer
                               IVY--Synchronizer, Electrocardiograph,
                                Nuclear
    892.1890.................  Radiographic Film Illuminator
                               IXC--Illuminator, Radiographic-Film
                               JAG--Illuminator, Radiographic-Film,
                                Explosion-Proof
    892.1910.................  Radiographic Grid
                               IXJ--Grid, Radiographic
    892.1960.................  Radiographic Intensifying Screen
                               EAM--Screen, Intensifying, Radiographic
    892.1970.................  Radiographic ECG/Respirator Synchronizer
                               IXO--Synchronizer, ECG/Respirator,
                                Radiographic
    892.5650.................  Manual Radionuclide Applicator System
                               IWG--System, Applicator, Radionuclide,
                                Manual
General and Plastic Surgery
 Panel (21 CFR Part 878)
    878.4200.................  Introduction/Drainage Catheter and
                                Accessories
                               KGZ--Accessories, Catheter
                               GCE--Adaptor, Catheter
                               FGY--Cannula, Injection
                               GBA--Catheter, Balloon Type
                               GBZ--Catheter, Cholangiography
                               GBQ--Catheter, Continuous Irrigation
                               GBY--Catheter, Eustachian, General &
                                Plastic Surgery
                               JCY--Catheter, Infusion
                               GBX--Catheter, Irrigation
                               GBP--Catheter, Multiple Lumen
                               GBO--Catheter, Nephrostomy, General &
                                Plastic Surgery
                               GBN--Catheter, Pediatric, General &
                                Plastic Surgery
                               GBW--Catheter, Peritoneal
                               GBS--Catheter, Ventricular, General &
                                Plastic Surgery
                               GCD--Connector, Catheter
                               GCC--Dilator, Catheter
                               GCB--Needle, Catheter
    878.4320.................  Removable Skin Clip

[[Page 351]]

 
                               FZQ--Clip, Removable (Skin)
    878.4460.................  Surgeon's Gloves
                               KGO--Surgeon's Gloves
    878.4680.................  Nonpowered, Single Patient, Portable
                                Suction Apparatus
                               GCY--Apparatus, Suction, Single Patient
                                Use, Portable, Nonpowered
    878.4760.................  Removable Skin Staple
                               GDT--Staple, Removable (Skin)
    878.4820.................  AC-Powered, Battery-Powered, and
                                Pneumatically Powered Surgical
                                Instrument Motors and Accessories/
                                Attachments
                               GFG--Bit, Surgical
                               GFA--Blade, Saw, General & Plastic
                                Surgery
                               DWH--Blade, Saw, Surgical, Cardiovascular
                               BRZ--Board, Arm (With Cover)
                               GFE--Brush, Dermabrasion
                               GFF--Bur, Surgical, General & Plastic
                                Surgery
                               KDG--Chisel (Osteotome)
                               GFD--Dermatome
                               GFC--Driver, Surgical, Pin
                               GFB--Head, Surgical, Hammer
                               GEY--Motor, Surgical Instrument, AC-
                                Powered
                               GET--Motor, Surgical Instrument,
                                Pneumatic Powered
                               DWI--Saw, Electrically Powered
                               KFK--Saw, Pneumatically Powered
                               HAB--Saw, Powered, and Accessories
    878.4960.................  Air or AC-Powered Operating Table and Air
                                or AC-Powered Operating Chair &
                                Accessories
                               GBB--Chair, Surgical, AC-Powered
                               FQO--Table, Operating-Room, AC-Powered
                               GDC--Table, Operating-Room, Electrical
                               FWW--Table, Operating-Room, Pneumatic
                               JEA--Table, Surgical with Orthopedic
                                Accessories, AC-Powered
    880.5090.................  Liquid Bandage
                               KMF--Bandage, Liquid
------------------------------------------------------------------------
\1\Descriptive information on product codes, panel codes, and other
  medical device identifiers may be viewed on FDA's Internet Web Site at
  http://www.fda.gov/cdrh/prodcode.html.


 Table 2--Class II Medical Devices Included in Scope of Product Coverage
  at Beginning of Transition Period (United States to develop guidance
 documents identifying U.S. requirements and European Community (EC) to
         identify standards needed to meet EC requirements) \1\
------------------------------------------------------------------------
             Panel                21 CFR Section      Regulation Name
-------------------------------        No.        ----------------------
                               -------------------  Product Code--Device
                                                            Name
------------------------------------------------------------------------
    RA........................  892.1000.........  Magnetic Resonance
                                                    Diagnostic Device
                                                   MOS--COIL, Magnetic
                                                    Resonance, Specialty
                                                   LNH--System, Nuclear
                                                    Magnetic Resonance
                                                    Imaging
                                                   LNI--System, Nuclear
                                                    Magnetic Resonance
                                                    Spectroscopic
Diagnostic Ultrasound:
    RA........................  892.1540.........  Nonfetal Ultrasonic
                                                    Monitor
                                                   JAF--Monitor,
                                                    Ultrasonic, Nonfetal
    RA........................  892.1550.........  Ultrasonic Pulsed
                                                    Doppler Imaging
                                                    System
                                                   IYN--System, Imaging,
                                                    Pulsed Doppler,
                                                    Ultrasonic
    RA........................  892.1560.........  Ultrasonic Pulsed
                                                    Echo Imaging System
                                                   IYO--System, Imaging,
                                                    Pulsed Echo,
                                                    Ultrasonic
    RA........................  892.1570.........  Diagnostic Ultrasonic
                                                    Transducer
                                                   ITX--Transducer,
                                                    Ultrasonic,
                                                    Diagnostic
Diagnostic X-Ray Imaging
 Devices (except mammographic
 x-ray systems):
    RA........................  892.1600.........  Angiographic X-Ray
                                                    System
                                                   IZI--System, X-Ray,
                                                    Angiographic
    RA........................  892.1650.........  Image-Intensified
                                                    Fluoroscopic X-Ray
                                                    System
                                                   MQB--Solid State X-
                                                    Ray Imager (Flat
                                                    Panel/Digital
                                                    Imager)
                                                   JAA--System, X-Ray,
                                                    Fluoroscopic, Image-
                                                    Intensified
    RA........................  892.1680.........  Stationary X-Ray
                                                    System

[[Page 352]]

 
                                                   KPR--System, X-Ray,
                                                    Stationary
    RA........................  892.1720.........  Mobile X-Ray System
                                                   IZL--System, X-Ray,
                                                    Mobile
    RA........................  892.1740.........  Tomographic X-Ray
                                                    System
                                                   IZF--System, X-Ray,
                                                    Tomographic
    RA........................  892.1750.........  Computed Tomography X-
                                                    Ray System
                                                   JAK--System, X-Ray,
                                                    Tomography, Computed
ECG-Related Devices:
    CV........................  870.2340.........  Electrocardiograph
                                                   DPS--Electrocardiogra
                                                    ph
                                                   MLC--Monitor, ST
                                                    Segment
    CV........................  870.2350.........  Electrocardiograph
                                                    Lead Switching
                                                    Adaptor
                                                   DRW--Adaptor, Lead
                                                    Switching,
                                                    Electrocardiograph
    CV........................  870.2360.........  Electrocardiograph
                                                    Electrode
                                                   DRX--Electrode,
                                                    Electrocardiograph
    CV........................  870.2370.........  Electrocardiograph
                                                    Surface Electrode
                                                    Tester
                                                   KRC--Tester,
                                                    Electrode, Surface,
                                                    Electrocardiographic
    NE........................  882.1400.........  Electroencephalograph
                                                   GWQ--Electroencephalo
                                                    graph
    HO........................  880.5725.........  Infusion Pump
                                                    (external only)
                                                   MRZ--Accessories,
                                                    Pump, Infusion
                                                   FRN--Pump, Infusion
                                                   LZF--Pump, Infusion,
                                                    Analytical Sampling
                                                   MEB--Pump, Infusion,
                                                    Elastomeric
                                                   LZH--Pump, Infusion,
                                                    Enteral
                                                   MHD--Pump, Infusion,
                                                    Gallstone
                                                    Dissolution
                                                   LZG--Pump, Infusion,
                                                    Insulin
                                                   MEA--Pump, Infusion,
                                                    PCA
Ophthalmic Instruments:
    OP........................  886.1570.........  Ophthalmoscope
                                                   HLI--Ophthalmoscope,
                                                    AC-Powered
                                                   HLJ--Ophthalmoscope,
                                                    Battery-Powered
    OP........................  886.1780.........  Retinoscope
                                                   HKL--Retinoscope, AC-
                                                    Powered
    OP........................  886.1850.........  AC-Powered Slit-Lamp
                                                    Biomicroscope
                                                   HJO--Biomicroscope,
                                                    Slit-Lamp, AC-
                                                    Powered
    OP........................  886.4150.........  Vitreous Aspiration
                                                    and Cutting
                                                    Instrument
                                                   MMC--Dilator,
                                                    Expansive Iris
                                                    (Accessory)
                                                   HQE--Instrument,
                                                    Vitreous Aspiration
                                                    and Cutting, AC-
                                                    Powered
                                                   HKP--Instrument,
                                                    Vitreous Aspiration
                                                    and Cutting, Battery-
                                                    Powered
                                                   MLZ--Vitrectomy,
                                                    Instrument Cutter
    OP........................  886.4670.........  Phacofragmentation
                                                    System
                                                   HQC--Unit,
                                                    Phacofragmentation
    SU........................  878.4580.........  Surgical Lamp
                                                   HBI--Illuminator,
                                                    Fiberoptic, Surgical
                                                    Field
                                                   FTF--Illuminator,
                                                    Nonremote
                                                   FTG--Illuminator,
                                                    Remote
                                                   HJE--Lamp,
                                                    Fluorescein, AC-
                                                    Powered
                                                   FQP--Lamp, Operating-
                                                    Room
                                                   FTD--Lamp, Surgical
                                                   GBC--Lamp, Surgical,
                                                    Incandescent
                                                   FTA--Light, Surgical,
                                                    Accessories
                                                   FSZ--Light, Surgical,
                                                    Carrier
                                                   FSY--Light, Surgical,
                                                    Ceiling Mounted
                                                   FSX--Light, Surgical,
                                                    Connector
                                                   FSW--Light, Surgical,
                                                    Endoscopic
                                                   FST--Light, Surgical,
                                                    Fiberoptic
                                                   FSS--Light, Surgical,
                                                    Floor Standing
                                                   FSQ--Light, Surgical,
                                                    Instrument
    NE........................  882.5890.........  Transcutaneous
                                                    Electrical Nerve
                                                    Stimulator for Pain
                                                    Relief
                                                   GZJ--Stimulator,
                                                    Nerve,
                                                    Transcutaneous, For
                                                    Pain Relief
                                                   Noninvasive Blood
                                                    Pressure Measurement
                                                    Devices:
    CV........................  870.1120.........  Blood Pressure Cuff
                                                   DXQ--Cuff, Blood-
                                                    Pressure
    CV........................  870.1130.........  Noninvasive Blood
                                                    Pressure Measurement
                                                    System (except
                                                    nonoscillometric)

[[Page 353]]

 
                                                   DXN--System,
                                                    Measurement, Blood-
                                                    Pressure,
                                                    Noninvasive
    HO........................  880.6880.........  Steam Sterilizer
                                                    (greater than 2
                                                    cubic feet)
                                                   FLE--Sterilizer,
                                                    Steam
Clinical Thermometers:
    HO........................  880.2910.........  Clinical Electronic
                                                    Thermometer (except
                                                    tympanic or
                                                    pacifier)
                                                   FLL--Thermometer,
                                                    Electronic, Clinical
    AN........................  868.5630.........  Nebulizer
                                                   CAF--Nebulizer
                                                    (Direct Patient
                                                    Interface)
Hypodermic Needles and
 Syringes (except antistick
 and self-destruct):
    HO........................  880.5570.........  Hypodermic Single
                                                    Lumen Needle
                                                   MMK--Container,
                                                    Sharpes
                                                   FMI--Needle,
                                                    Hypodermic, Single
                                                    Lumen
                                                   MHC--Port,
                                                    Intraosseous,
                                                    Implanted
    HO........................  880.5860.........  Piston Syringe
                                                   FMF--Syringe, Piston
Selected Dental Materials:
    DE........................  872.3060.........  Gold-Based Alloys and
                                                    Precious Metal
                                                    Alloys for Clinical
                                                    Use
                                                   EJT--Alloy, Gold
                                                    Based, For Clinical
                                                    Use
                                                   EJS--Alloy, Precious
                                                    Metal, For Clinical
                                                    Use
    DE........................  872.3200.........  Resin Tooth Bonding
                                                    Agent
                                                   KLE--Agent, Tooth
                                                    Bonding, Resin
    DE........................  872.3275.........  Dental Cement
                                                   EMA--Cement, Dental
                                                   EMB--Zinc Oxide
                                                    Eugenol
    DE........................  872.3660.........  Impression Material
                                                   ELW--Material,
                                                    Impression
    DE........................  872.3690.........  Tooth Shade Resin
                                                    Material
                                                   EBF--Material, Tooth
                                                    Shade, Resin
    DE........................  872.3710.........  Base Metal Alloy
                                                   EJH--Metal, Base
Latex Condoms:
    OB........................  884.5300.........  Condom
                                                   HIS--Condom
------------------------------------------------------------------------
\1\Descriptive information on product codes, panel codes, and other
  medical device identifiers may be viewed on FDA's Internet Web Site at
  http://www.fda.gov/cdrh/prodcode.html.


   Table 3--Medical Devices for Possible Inclusion in Scope of Product Coverage During Operational Period \1\
----------------------------------------------------------------------------------------------------------------
           Product Family                21 CFR Section No            Device Name                  Tier
----------------------------------------------------------------------------------------------------------------
Anesthesiology Panel
  Anesthesia Devices................  868.5160...............  Gas machine for            2
                                                                anesthesia or analgesia.
                                      868.5270...............  Breathing system heater..  2
                                      868.5440...............  Portable oxygen generator  2
                                      868.5450...............  Respiratory gas            2
                                                                humidifier.
                                      868.5630...............  Nebulizer................  2
                                      868.5710...............  Electrically powered       2
                                                                oxygen tent.
                                      868.5880...............  Anesthetic vaporizer.....  2
  Gas Analyser......................  868.1040...............  Powered Algesimeter......  2
                                      868.1075...............  Argon gas analyzer.......  2
                                      868.1400...............  Carbon dioxide gas         2
                                                                analyzer.
                                      868.1430...............  Carbon monoxide gas        2
                                                                analyzer.
                                      868.1500...............  Enflurane gas analyzer...  2
                                      868.1620...............  Halothane gas analyzer...  2
                                      868.1640...............  Helium gas analyzer......  2
                                      868.1670...............  Neon gas analyzer........  2
                                      868.1690...............  Nitrogen gas analyzer....  2
                                      868.1700...............  Nitrous oxide gas          2
                                                                analyzer.
                                      868.1720...............  Oxygen gas analyzer......  2
                                      868.1730...............  Oxygen uptake computer...  2
  Peripheral Nerve Stimulators......  868.2775...............  Electrical peripheral      2
                                                                nerve stimulator.

[[Page 354]]

 
  Respiratory Monitoring............  868.1750...............  Pressure plethysmograph..  2
                                      868.1760...............  Volume plethysmograph....  2
                                      868.1780...............  Inspiratory airway         2
                                                                pressure meter.
                                      868.1800...............  Rhinoanemometer..........  2
                                      868.1840...............  Diagnostic spirometer....  2
                                      868.1850...............  Monitoring spirometer....  2
                                      868.1860...............  Peak-flow meter for        2
                                                                spirometry.
                                      868.1880...............  Pulmonary-function data    2
                                                                calculator.
                                      868.1890...............  Predictive pulmonary-      2
                                                                function value
                                                                calculator.
                                      868.1900...............  Diagnostic pulmonary-      2
                                                                function interpretation
                                                                calculator.
                                      868.2025...............  Ultrasonic air embolism    2
                                                                monitor.
                                      868.2375...............  Breathing frequency        2
                                                                monitor (except apnea
                                                                detectors).
                                      868.2480...............  Cutaneous carbon dioxide   2
                                                                (PcCO2) monitor.
                                      868.2500...............  Cutaneous oxygen monitor   2
                                                                (for an infant not under
                                                                gas anesthesia).
                                      868.2550...............  Pneumotachomometer.......  2
                                      868.2600...............  Airway pressure monitor..  2
                                      868.5665...............  Powered percussor........  2
                                      868.5690...............  Incentive spirometer.....  2
  Ventilator........................  868.5905...............  Noncontinuous ventilator   2
                                                                (IPPB).
                                      868.5925...............  Powered emergency          2
                                                                ventilator.
                                      868.5935...............  External negative          2
                                                                pressure ventilator.
                                      868.5895...............  Continuous ventilator....  2
                                      868.5955...............  Intermittent mandatory     2
                                                                ventilation attachment.
                                      868.6250...............  Portable air compressor..  2
Cardiovascular Panel
  Cardiovascular Diagnostic.........  870.1425...............  Programmable diagnostic    2
                                                                computer.
                                      870.1450...............  Densitometer.............  2
                                      870.2310...............  Apex cardiograph           2
                                                                (vibrocardiograph).
                                      870.2320...............  Ballistocardiograph......  2
                                      870.2340...............  Electrocardiograph.......  2
                                      870.2350...............  Electrocardiograph lead    1
                                                                switching adaptor.
                                      870.2360...............  Electrocardiograph         2
                                                                electrode.
                                      870.2370...............  Electrocardiograph         2
                                                                surface electrode tester.
                                      870.2400...............  Vectorcardiograph........  1
                                      870.2450...............  Medical cathode-ray tube   1
                                                                display.
                                      870.2675...............  Oscillometer.............  2
                                      870.2840...............  Apex cardiographic         2
                                                                transducer.
                                      870.2860...............  Heart sound transducer...  2
  Cardiovascular Monitoring.........  .......................  Valve, pressure relief,
                                                                cardiopulmonary bypass.

[[Page 355]]

 
                                      870.1100...............  Blood pressure alarm.....  2
                                      870.1110...............  Blood pressure computer..  2
                                      870.1120...............  Blood pressure cuff......  2
                                      870.1130...............  Noninvasive blood          2
                                                                pressure measurement
                                                                system.
                                      870.1140...............  Venous blood pressure      2
                                                                manometer.
                                      870.1220...............  Electrode recording        2
                                                                catheter or electrode
                                                                recording probe.
                                      870.1270...............  Intracavitary              2
                                                                phonocatheter system.
                                      870.1875...............  Stethoscope (electronic).  2
                                      870.2050...............  Biopotential amplifier     2
                                                                and signal conditioner.
                                      870.2060...............  Transducer signal          2
                                                                amplifier and
                                                                conditioner.
                                      870.2100...............  Cardiovascular blood flow- 2
                                                                meter.
                                      870.2120...............  Extravascular blood flow   2
                                                                probe.
                                      870.2300...............  Cardiac monitor            2
                                                                (including
                                                                cardiotachometer and
                                                                rate alarm).
                                      870.2700...............  Oximeter.................  2
                                      870.2710...............  Ear oximeter.............  2
                                      870.2750...............  Impedance phlebograph....  2
                                      870.2770...............  Impedance plethysmograph.  2
                                      870.2780...............  Hydraulic, pneumatic, or   2
                                                                photoelectric
                                                                plethysmographs.
                                      870.2850...............  Extravascular blood        2
                                                                pressure transducer.
                                      870.2870...............  Catheter tip pressure      2
                                                                transducer.
                                      870.2880...............  Ultrasonic transducer....  2
                                      870.2890...............  Vessel occlusion           2
                                                                transducer.
                                      870.2900...............  Patient transducer and     2
                                                                electrode cable
                                                                (including connector).
                                      870.2910...............  Radiofrequency             2
                                                                physiological signal
                                                                transmitter and receiver.
                                      870.2920...............  Telephone                  2
                                                                electrocardiograph
                                                                transmitter and receiver.
                                      870.4205...............  Cardiopulmonary bypass     2
                                                                bubble detector.
                                      870.4220...............  Cardiopulmonary bypass     2
                                                                heart-lung machine
                                                                console.
                                      870.4240...............  Cardiovascular bypass      2
                                                                heat exchanger.
                                      870.4250...............  Cardiopulmonary bypass     2
                                                                temperature controller.
                                      870.4300...............  Cardiopulmonary bypass     2
                                                                gas control unit.
                                      870.4310...............  Cardiopulmonary bypass     2
                                                                coronary pressure gauge.
                                      870.4330...............  Cardiopulmonary bypass on- 2
                                                                line blood gas monitor.
                                      870.4340...............  Cardiopulmonary bypass     2
                                                                level sensing monitor
                                                                and/or control.
                                      870.4370...............  Roller-type                2
                                                                cardiopulmonary bypass
                                                                blood pump.
                                      870.4380...............  Cardiopulmonary bypass     2
                                                                pump speed control.
                                      870.4410...............  Cardiopulmonary bypass in- 2
                                                                line blood gas sensor.
  Cardiovascular Therapeutic........  870.5050...............  Patient care suction       2
                                                                apparatus.
                                      870.5900...............  Thermal regulation system  2
  Defibrillator.....................  870.5300...............  DC-defibrillator           2
                                                                (including paddles).
                                      870.5325...............  Defibrillator tester.....  2
  Echocardiograph...................  870.2330...............  Echocardiograph..........  2
  Pacemaker & Accessories...........  870.1750...............  External programmable      2
                                                                pacemaker pulse
                                                                generator.
                                      870.3630...............  Pacemaker generator        2
                                                                function analyzer.
                                      870.3640...............  Indirect pacemaker         2
                                                                generator function
                                                                analyzer.
                                      870.3720...............  Pacemaker electrode        2
                                                                function tester.
  Miscellaneous.....................  870.1800...............  Withdrawal-infusion pump.  2
                                      870.2800...............  Medical magnetic tape      2
                                                                recorder.
                                      None...................  Batteries, rechargeable,
                                                                class II devices.
Dental Panel
  Dental Equipment..................  872.1720...............  Pulp tester..............  2
                                      872.1740...............  Caries detection device..  2
                                      872.4120...............  Bone cutting instrument    2
                                                                and accessories.
                                      872.4465...............  Gas-powered jet injector.  2
                                      872.4475...............  Spring-powered jet         2
                                                                injector.
                                      872.4600...............  Intraoral ligature and     2
                                                                wire lock.
                                      872.4840...............  Rotary scaler............  2
                                      872.4850...............  Ultrasonic scaler........  2
                                      872.4920...............  Dental electrosurgical     2
                                                                unit and accessories.
                                      872.6070...............  Ultraviolet activator for  2
                                                                polymerization.
                                      872.6350...............  Ultraviolet detector.....  2
  Dental Material...................  872.3050...............  Amalgam alloy............  2

[[Page 356]]

 
                                      872.3060...............  Gold-based alloys and      2
                                                                precious metal alloys
                                                                for clinical use.
                                      872.3200...............  Resin tooth bonding agent  2
                                      872.3250...............  Calcium hydroxide cavity   2
                                                                liner.
                                      872.3260...............  Cavity varnish...........  2
                                      872.3275...............  Dental cement (other than  2
                                                                zinc oxide-eugenol).
                                      872.3300...............  Hydrophilic resin coating  2
                                                                for dentures.
                                      872.3310...............  Coating material for       2
                                                                resin fillings.
                                      872.3590...............  Preformed plastic denture  2
                                                                tooth.
                                      872.3660...............  Impression material......  2
                                      872.3690...............  Tooth shade resin          2
                                                                material.
                                      872.3710...............  Base metal alloy.........  2
                                      872.3750...............  Bracket adhesive resin     2
                                                                and tooth conditioner.
                                      872.3760...............  Denture relining,          2
                                                                repairing, or rebasing
                                                                resin.
                                      872.3765...............  Pit and fissure sealant    2
                                                                and conditioner.
                                      872.3770...............  Temporary crown and        2
                                                                bridge resin.
                                      872.3820...............  Root canal filling resin   2
                                                                (other than chloroform
                                                                use).
                                      872.3920...............  Porcelain tooth..........  2
  Dental X-ray......................  872.1800...............  Extraoral source x-ray     2
                                                                system.
                                      872.1810...............  Intraoral source x-ray     2
                                                                system.
  Dental Implants...................  872.4880...............  Intraosseous fixation      2
                                                                screw or wire.
                                      872.3890...............  Endodontic stabilizing     2
                                                                splint.
  Orthodontic.......................  872.5470...............  Orthodontic plastic        2
                                                                bracket.
Ear/Nose/Throat Panel
  Diagnostic Equipment..............  874.1050...............  Audiometer...............  2
                                      874.1090...............  Auditory impedance tester  2
                                      874.1120...............  Electronic noise           2
                                                                generator for
                                                                audiometric testing.
                                      874.1325...............  Electroglottograph.......  2
                                      874.1820...............  Surgical nerve stimulator/ 2
                                                                locator.
  Hearing Aids......................  874.3300...............  Hearing aid (for bone-     2
                                                                conduction).
                                      874.3310...............  Hearing aid calibrator     2
                                                                and analysis system.
                                      874.3320...............  Group hearing aid or       2
                                                                group auditory trainer.
                                      874.3330...............  Master hearing aid.......  2
  Surgical Equipment................  874.4250...............  Ear, nose, and throat      1
                                                                electric or pneumatic
                                                                surgical drill.
                                      874.4490...............  Argon laser for otology,   2
                                                                rhinology, and
                                                                laryngology.
                                      874.4500...............  Ear, nose, and throat      2
                                                                microsurgical carbon
                                                                dioxide laser.
Gastroenterology/Urology Panel
  Endoscope (including angioscopes,   876.1500...............  Endoscope and accessories  2
   laparscopes, ophthalmic
   endoscopes).
                                      876.4300...............  Endoscopic                 2
                                                                electrosurgical unit and
                                                                accessories.
  Gastroenterology..................  876.1725...............  Gastrointestinal motility  1
                                                                monitoring system.
  Hemodialysis......................  876.5600...............  Sorbent regenerated        2
                                                                dialysate delivery
                                                                system for hemodialysis.
                                      876.5630...............  Peritoneal dialysis        2
                                                                system and accessories.
                                      876.5665...............  Water purification system  2
                                                                for hemodialysis.
                                      876.5820...............  Hemodialysis system and    2
                                                                accessories.
                                      876.5830...............  Hemodialyzer with          2
                                                                disposable insert (kiil-
                                                                type).
  Lithotriptor......................  876.4500...............  Mechanical lithotriptor..  2
  Urology Equipment.................  876.1620...............  Urodynamics measurement    2
                                                                system.
                                      876.5320...............  Nonimplanted electrical    2
                                                                continence device.
                                      876.5880...............  Isolated kidney perfusion  2
                                                                and transport system and
                                                                accessories.
General Hospital Panel
  Infusion Pumps and Systems........  880.2420...............  Electronic monitor for     2
                                                                gravity flow infusion
                                                                systems.
                                      880.2460...............  Electrically powered       2
                                                                spinal fluid pressure
                                                                monitor.
                                      880.5430...............  Nonelectrically powered    2
                                                                fluid injector.
                                      880.5725...............  Infusion pump............  2
  Neonatal Incubators...............  880.5400...............  Neonatal incubator.......  2
                                      880.5410...............  Neonatal transport         2
                                                                incubator.
                                      880.5700...............  Neonatal phototherapy      2
                                                                unit.
  Piston Syringes...................  880.5570...............  Hypodermic single lumen    1
                                                                needle.
                                      880.5860...............  Piston syringe (except     1
                                                                antistick).
                                      880.6920...............  Syringe needle introducer  2
  Miscellaneous.....................  880.2910...............  Clinical electronic        2
                                                                thermometer.
                                      880.2920...............  Clinical mercury           2
                                                                thermometer.
                                      880.5100...............  AC-powered adjustable      1
                                                                hospital bed.
                                      880.5500...............  AC-powered patient lift..  2
                                      880.6880...............  Steam sterilizer (greater  2
                                                                than 2 cubic feet).
Neurology Panel
                                      882.1020...............  Rigidity analyzer........  2
                                      882.1610...............  Alpha monitor............  2
  Neuro-Diagnostic..................  882.1320...............  Cutaneous electrode......  2

[[Page 357]]

 
                                      882.1340...............  Nasopharyngeal electrode.  2
                                      882.1350...............  Needle electrode.........  2
                                      882.1400...............  Electroencephalograph....  2
                                      882.1460...............  Nystagmograph............  2
                                      882.1480...............  Neurological endoscope...  2
                                      882.1540...............  Galvanic skin response     2
                                                                measurement device.
                                      882.1550...............  Nerve conduction velocity  2
                                                                measurement device.
                                      882.1560...............  Skin potential             2
                                                                measurement device.
                                      882.1570...............  Powered direct-contact     2
                                                                temperature measurement
                                                                device.
                                      882.1620...............  Intracranial pressure      2
                                                                monitoring device.
                                      882.1835...............  Physiological signal       2
                                                                amplifier.
                                      882.1845...............  Physiological signal       2
                                                                conditioner.
                                      882.1855...............  Electroencephalogram       2
                                                                (EEG) telemetry system.
                                      882.5050...............  Biofeedback device.......  2
  Echoencephalography...............  882.1240...............  Echoencephalograph.......  2
  RPG...............................  882.4400...............  Radiofrequency lesion      2
                                                                generator.
  Neuro Surgery.....................  none...................  Electrode, spinal          2
                                                                epidural.
                                      882.4305...............  Powered compound cranial   2
                                                                drills, burrs,
                                                                trephines, and their
                                                                accessories.
                                      882.4310...............  Powered simple cranial     2
                                                                drills burrs, trephines,
                                                                and their accessories.
                                      882.4360...............  Electric cranial drill     2
                                                                motor.
                                      882.4370...............  Pneumatic cranial drill    2
                                                                motor.
                                      882.4560...............  Stereotaxic instrument...  2
                                      882.4725...............  Radiofrequency lesion      2
                                                                probe.
                                      882.4845...............  Powered rongeur..........  2
                                      882.5500...............  Lesion temperature         2
                                                                monitor.
  Stimulators.......................  882.1870...............  Evoked response            2
                                                                electrical stimulator.
                                      882.1880...............  Evoked response            2
                                                                mechanical stimulator.
                                      882.1890...............  Evoked response photic     2
                                                                stimulator.
                                      882.1900...............  Evoked response auditory   2
                                                                stimulator.
                                      882.1950...............  Tremor transducer........  2
                                      882.5890...............  Transcutaneous electrical  2
                                                                nerve stimulator for
                                                                pain relief.
Obstetrics/Gynecology Panel
  Fetal Monitoring..................  884.1660...............  Transcervical endoscope    2
                                                                (amnioscope) and
                                                                accessories.
                                      884.1690...............  Hysteroscope and           2
                                                                accessories (for
                                                                performance standards).
                                      884.2225...............  Obstetric-gynecologic      2
                                                                ultrasonic imager.
                                      884.2600...............  Fetal cardiac monitor....  2
                                      884.2640...............  Fetal phonocardiographic   2
                                                                monitor and accessories.
                                      884.2660...............  Fetal ultrasonic monitor   2
                                                                and accessories.
                                      884.2675...............  Fetal scalp circular       1
                                                                (spiral) electrode and
                                                                applicator.
                                      884.2700...............  Intrauterine pressure      2
                                                                monitor and accessories.
                                      884.2720...............  External uterine           2
                                                                contraction monitor and
                                                                accessories.
                                      884.2740...............  Perinatal monitoring       2
                                                                system and accessories.
                                      884.2960...............  Obstetric ultrasonic       2
                                                                transducer and
                                                                accessories.
  Gynecological Surgery Equipment...  884.1720...............  Gynecologic laparoscope    2
                                                                and accessories.
                                      884.4160...............  Unipolar endoscopic        2
                                                                coagulator-cutter and
                                                                accessories.
                                      884.4550...............  Gynecologic surgical       2
                                                                laser.
                                      884.4120...............  Gynecologic                2
                                                                electrocautery and
                                                                accessories.
                                      884.5300...............  Condom...................  2
  Ophthalmic Implants...............  886.3320...............  Eye sphere implant.......  2
  Contact Lens......................  886.1385...............  Polymethylmethacrylate     2
                                                                (PMMA) diagnostic
                                                                contact lens.
                                      886.5916...............  Rigid gas permeable        2
                                                                contact lens (daily wear
                                                                only).
  Diagnostic Equipment..............  886.1120...............  Opthalmic camera.........  1
                                      886.1220...............  Corneal electrode........  1
                                      886.1250...............  Euthyscope (AC-powered)..  1
                                      886.1360...............  Visual field laser         1
                                                                instrument.
                                      886.1510...............  Eye movement monitor.....  1
                                      886.1570...............  Ophthalmoscope...........  1
                                      886.1630...............  AC-powered                 1
                                                                photostimulator.
                                      886.1640...............  Ophthalmic preamplifier..  1
                                      886.1670...............  Ophthalmic isotope uptake  2
                                                                probe.
                                      886.1780...............  Retinoscope (AC-powered    1
                                                                device).
                                      886.1850...............  AC-powered slit lamp       1
                                                                biomicroscope.
                                      886.1930...............  Tonometer and accessories  2
                                      886.1945...............  Transilluminator (AC-      1
                                                                powered device).
                                      886.3130...............  Ophthalmic conformer.....  2
  (Diagnostic/Surgery Equipment)....  886.4670...............  Phacofragmentation system  2
  Ophthalmic Implants...............  886.3340...............  Extraocular orbital        2
                                                                implant.
                                      886.3800...............  Scleral shell............  2
  Surgical Equipment................  880.5725...............  Infusion pump              2
                                                                (performance standards).

[[Page 358]]

 
                                      886.3100...............  Ophthalmic tantalum clip.  2
                                      886.3300...............  Absorbable implant         2
                                                                (scleral buckling
                                                                method).
                                      886.4100...............  Radiofrequency             2
                                                                electrosurgical cautery
                                                                apparatus.
                                      886.4115...............  Thermal cautery unit.....  2
                                      886.4150...............  Vitreous aspiration and    2
                                                                cutting instrument.
                                      886.4170...............  Cryophthalmic unit.......  2
                                      886.4250...............  Ophthalmic electrolysis    1
                                                                unit (AC-powered device).
                                      886.4335...............  Operating headlamp (AC-    1
                                                                powered device).
                                      886.4390...............  Ophthalmic laser.........  2
                                      886.4392...............  Nd:YAG laser for           2
                                                                posterior capsulotomy.
                                      886.4400...............  Electronic metal locator.  1
                                      886.4440...............  AC-powered magnet........  1
                                      886.4610...............  Ocular pressure            2
                                                                applicator.
                                      886.4690...............  Ophthalmic                 2
                                                                photocoagulator.
                                      886.4790...............  Ophthalmic sponge........  2
                                      886.5100...............  Ophthalmic beta radiation  2
                                                                source.
                                      none...................  Ophthalmoscopes,           1
                                                                replacement batteries,
                                                                hand-held.
Orthopedic Panel
  Implants..........................  888.3010...............  Bone fixation cerclage...  2
                                      888.3020...............  Intramedullary fixation    2
                                                                rod.
                                      888.3030...............  Single/multiple component  2
                                                                metallic bone fixation
                                                                appliances and
                                                                accessories.
                                      888.3040...............  Smooth or threaded         2
                                                                metallic bone fixation
                                                                fastener.
                                      888.3050...............  Spinal interlaminal        2
                                                                fixation orthosis.
                                      888.3060...............  Spinal intervertebral      2
                                                                body fixation orthosis.
  Surgical Equipment................  888.1240...............  AC-powered dynamometer...  2
                                      888.4580...............  Sonic surgical instrument  2
                                                                and accessories/
                                                                attachments.
                                      none...................  Accessories, fixation,     2
                                                                spinal interlaminal.
                                      none...................  Accessories, fixation,     2
                                                                spinal intervertebral
                                                                body.
                                      none...................  Monitor, pressure,         1
                                                                intracompartmental.
                                      none...................  Orthosis, fixation,        2
                                                                spinal intervertebral
                                                                fusion.
                                      none...................  Orthosis, spinal pedicle
                                                                fixation.
                                      none...................  System, cement removal     1
                                                                extraction.
Physical Medicine Panel
  Diagnostic Equipment or (Therapy)   890.1225...............  Chronaximeter............  2
   Therapeutic Equipment.
                                      890.1375...............  Diagnostic                 2
                                                                electromyograph.
                                      890.1385...............  Diagnostic                 2
                                                                electromyograph needle
                                                                electrode.
                                      890.1450...............  Powered reflex hammer....  2
                                      890.1850...............  Diagnostic muscle          2
                                                                stimulator.
  or (Therapy)......................  890.5850...............  Powered muscle stimulator  2
  Therapeutic Equipment.............  890.5100...............  Immersion hydrobath......  2
                                      890.5110...............  Paraffin bath............  2
                                      890.5500...............  Infrared lamp............  2
                                      890.5720...............  Water circulating hot or   2
                                                                cold pack.
                                      890.5740...............  Powered heating pad......  2
Radiology Panel
  MRI...............................  892.1000...............  Magnetic resonance         2
                                                                diagnostic device.
  Ultrasound Diagnostic.............  884.2660...............  Fetal ultrasonic monitor   2
                                                                and accessories.
                                      892.1540...............  Nonfetal ultrasonic
                                                                monitor.
                                      892.1560...............  Ultrasonic pulsed echo     2
                                                                imaging system.
                                      892.1570...............  Diagnostic ultrasonic      2
                                                                transducer.
                                      892.1550...............  Ultrasonic pulsed doppler
                                                                imaging system.
  Angiographic......................  892.1600...............  Angiographic x-ray system  2
  Diagnostic X-Ray..................  892.1610...............  Diagnostic x-ray beam-     2
                                                                limiting device.
                                      892.1620...............  Cine or spot               2
                                                                fluorographic x-ray
                                                                camera.
                                      892.1630...............  Electrostatic x-ray        2
                                                                imaging system.
                                      892.1650...............  Image-intensified          2
                                                                fluoroscopic x-ray
                                                                system.
                                      892.1670...............  Spot film device.........  2
                                      892.1680...............  Stationary x-ray system..  2
                                      892.1710...............  Mammographic x-ray system  2
                                      892.1720...............  Mobile x-ray system......  2
                                      892.1740...............  Tomographic x-ray system.  1
                                      892.1820...............  Pneumoencephalographic     2
                                                                chair.
                                      892.1850...............  Radiographic film          1
                                                                cassette.
                                      892.1860...............  Radiographic film/         1
                                                                cassette changer.
                                      892.1870...............  Radiographic film/         2
                                                                cassette changer
                                                                programmer.
                                      892.1900...............  Automatic radiographic     2
                                                                film processor.
                                      892.1980...............  Radiologic table.........  1
  CT Scanner........................  892.1750...............  Computed tomography x-ray  2
                                                                system.
  Radiation Therapy.................  892.5050...............  Medical charged-particle   2
                                                                radiation therapy system.

[[Page 359]]

 
                                      892.5300...............  Medical neutron radiation  2
                                                                therapy system.
                                      892.5700...............  Remote controlled          2
                                                                radionuclide applicator
                                                                system.
                                      892.5710...............  Radiation therapy beam-    2
                                                                shaping block.
                                      892.5730...............  Radionuclide               2
                                                                brachytherapy source.
                                      892.5750...............  Radionuclide radiation     2
                                                                therapy system.
                                      892.5770...............  Powered radiation therapy  2
                                                                patient support assembly.
                                      892.5840...............  Radiation therapy          2
                                                                simulation system.
                                      892.5930...............  Therapeutic x-ray tube     1
                                                                housing assembly.
  Nuclear Medicine..................  892.1170...............  Bone densitometer........  2
                                      892.1200...............  Emission computed          2
                                                                tomography system.
                                      892.1310...............  Nuclear tomography system  1
                                      892.1390...............  Radionuclide rebreathing   2
                                                                system.
General/Plastic Surgery Panel
  Surgical Lamps....................  878.4630...............  Ultraviolet lamp for       2
                                                                dermatologic disorders.
                                      890.5500...............  Infrared lamp............  2
                                      878.4580...............  Surgical lamp............  2
  Electrosurgical Cutting Equipment.  878.4810...............  Laser surgical instrument  2
                                                                for use in general and
                                                                plastic surgery and in
                                                                dermatology.
                                      878.4400...............  Electrosurgical cutting    2
                                                                and coagulation device
                                                                and accessories.
  Miscellaneous.....................  878.4780...............  Powered suction pump.....  2
----------------------------------------------------------------------------------------------------------------
\1\Descriptive information on product codes, panel codes, and other medical device identifiers may be viewed on
  FDA's Internet Web Site at http://www.fda.gov/cdrh/prodcode.html.


[63 FR 60141, Nov. 6, 1998; 64 FR 16348, Apr. 5, 1999]



         Sec. Appendixes C-F to Subpart B of Part 26 [Reserved]



                   Subpart C_``Framework'' Provisions



Sec.  26.60  Definitions.

    (a) The following terms and definitions shall apply to this subpart 
only:
    (1) Designating Authority means a body with power to designate, 
monitor, suspend, remove suspension of, or withdraw conformity 
assessment bodies as specified under this part.
    (2) Designation means the identification by a designating authority 
of a conformity assessment body to perform conformity assessment 
procedures under this part.
    (3) Regulatory Authority means a government agency or entity that 
exercises a legal right to control the use or sale of products within a 
party's jurisdiction and may take enforcement action to ensure that 
products marketed within its jurisdiction comply with legal 
requirements.
    (b) Other terms concerning conformity assessment used in this part 
shall have the meaning given elsewhere in this part or in the 
definitions contained in ``Guide 2: Standardization and Related 
Activities--General Vocabulary of the International Organization for 
Standardization (ISO) and the International Electrotechnical Commission 
(IEC)'' (ISO/IEC Guide 2) (1996 edition), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
are available from the International Organization for Standardization, 
1, rue de Varemb[eacute], Case postale 56, CH-1211 Gen[egrave]ve 20, 
Switzerland, or on the Internet at http://www.iso.ch or may be examined 
at the Food and Drug Administration's Medical Library, 5600 Fishers 
Lane, rm. 11B-40, Rockville, MD 20857, or 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 event of an inconsistency between the ISO/IEC 
Guide 2 and definitions in this part, the definitions in this part shall 
prevail.



Sec.  26.61  Purpose of this part.

    This part specifies the conditions by which each party will accept 
or recognize results of conformity assessment

[[Page 360]]

procedures, produced by the other party's conformity assessment bodies 
(CAB's) or authorities, in assessing conformity to the importing party's 
requirements, as specified on a sector-specific basis in subparts A and 
B of this part, and to provide for other related cooperative activities. 
The objective of such mutual recognition is to provide effective market 
access throughout the territories of the parties with regard to 
conformity assessment for all products covered under this part. If any 
obstacles to such access arise, consultations will promptly be held. In 
the absence of a satisfactory outcome of such consultations, the party 
alleging its market access has been denied may, within 90 days of such 
consultation, invoke its right to terminate the ``Agreement on Mutual 
Recognition Between the United States of America and the European 
Community,'' from which this part is derived, in accordance with Sec.  
26.80.



Sec.  26.62  General obligations.

    (a) The United States shall, as specified in subparts A and B of 
this part, accept or recognize results of specified procedures, used in 
assessing conformity to specified legislative, regulatory, and 
administrative provisions of the United States, produced by the other 
party's conformity assessment bodies (CAB's) and/or authorities.
    (b) The European Community (EC) and its Member States shall, as 
specified in subparts A and B of this part, accept or recognize results 
of specified procedures, used in assessing conformity to specified 
legislative, regulatory, and administrative provisions of the EC and its 
Member States, produced by the other party's CAB's and/or authorities.
    (c) Where sectoral transition arrangements have been specified in 
subparts A and B of this part, the obligations in paragraphs (a) and (b) 
of this section will apply following the successful completion of those 
sectoral transition arrangements, with the understanding that the 
conformity assessment procedures utilized assure conformity to the 
satisfaction of the receiving party, with applicable legislative, 
regulatory, and administrative provisions of that party, equivalent to 
the assurance offered by the receiving party's own procedures.



Sec.  26.63  General coverage of this part.

    (a) This part applies to conformity assessment procedures for 
products and/or processes and to other related cooperative activities as 
described in this part.
    (b) Subparts A and B of this part may include:
    (1) A description of the relevant legislative, regulatory, and 
administrative provisions pertaining to the conformity assessment 
procedures and technical regulations;
    (2) A statement on the product scope and coverage;
    (3) A list of designating authorities;
    (4) A list of agreed conformity assessment bodies (CAB's) or 
authorities or a source from which to obtain a list of such bodies or 
authorities and a statement of the scope of the conformity assessment 
procedures for which each has been agreed;
    (5) The procedures and criteria for designating the CAB's;
    (6) A description of the mutual recognition obligations;
    (7) A sectoral transition arrangement;
    (8) The identity of a sectoral contact point in each party's 
territory; and
    (9) A statement regarding the establishment of a Joint Sectoral 
Committee.
    (c) This part shall not be construed to entail mutual acceptance of 
standards or technical regulations of the parties and, unless otherwise 
specified in subpart A or B of this part, shall not entail the mutual 
recognition of the equivalence of standards or technical regulations.



Sec.  26.64  Transitional arrangements.

    The parties agree to implement the transitional commitments on 
confidence building as specified in subparts A and B of this part.
    (a) The parties agree that each sectoral transitional arrangement 
shall specify a time period for completion.
    (b) The parties may amend any transitional arrangement by mutual 
agreement.
    (c) Passage from the transitional phase to the operational phase 
shall

[[Page 361]]

proceed as specified in subparts A and B of this part, unless either 
party documents that the conditions provided in such subpart for a 
successful transition are not met.



Sec.  26.65  Designating authorities.

    The parties shall ensure that the designating authorities specified 
in subpart B of this part have the power and competence in their 
respective territories to carry out decisions under this part to 
designate, monitor, suspend, remove suspension of, or withdraw 
conformity assessment bodies (CAB's).



Sec.  26.66  Designation and listing procedures.

    The following procedures shall apply with regard to the designation 
of conformity assessment bodies (CAB's) and the inclusion of such bodies 
in the list of CAB's in subpart B of this part:
    (a) The designating authority identified in subpart B of this part 
shall designate CAB's in accordance with the procedures and criteria set 
forth in subpart B of this part;
    (b) A party proposing to add a CAB to the list of such bodies in 
subpart B of this part shall forward its proposal of one or more 
designated CAB's in writing to the other party with a view to a decision 
by the Joint Committee;
    (c) Within 60 days following receipt of the proposal, the other 
party shall indicate its position regarding either its confirmation or 
its opposition. Upon confirmation, the inclusion in subpart B of this 
part of the proposed CAB or CAB's shall take effect; and
    (d) In the event that the other party contests on the basis of 
documented evidence the technical competence or compliance of a proposed 
CAB, or indicates in writing that it requires an additional 30 days to 
more fully verify such evidence, such CAB shall not be included on the 
list of CAB's in subpart B of this part. In this instance, the Joint 
Committee may decide that the body concerned be verified. After the 
completion of such verification, the proposal to list the CAB in subpart 
B may be resubmitted to the other party.



Sec.  26.67  Suspension of listed conformity assessment bodies.

    The following procedures shall apply with regard to the suspension 
of a conformity assessment body (CAB) listed in subpart B of this part.
    (a) A party shall notify the other party of its contestation of the 
technical competence or compliance of a CAB listed in subpart B of this 
part and the contesting party's intent to suspend such CAB. Such 
contestation shall be exercised when justified in an objective and 
reasoned manner in writing to the other party;
    (b) The CAB shall be given prompt notice by the other party and an 
opportunity to present information in order to refute the contestation 
or to correct the deficiencies which form the basis of the contestation;
    (c) Any such contestation shall be discussed between the parties in 
the Joint Sectoral Committee described in subpart B of this part. If 
there is no Joint Sectoral Committee, the contesting party shall refer 
the matter directly to the Joint Committee. If agreement to suspend is 
reached by the Joint Sectoral Committee or, if there is no Joint 
Sectoral Committee, by the Joint Committee, the CAB shall be suspended;
    (d) Where the Joint Sectoral Committee or Joint Committee decides 
that verification of technical competence or compliance is required, it 
shall normally be carried out in a timely manner by the party in whose 
territory the body in question is located, but may be carried out 
jointly by the parties in justified cases;
    (e) If the matter has not been resolved by the Joint Sectoral 
Committee within 10 days of the notice of contestation, the matter shall 
be referred to the Joint Committee for a decision. If there is no Joint 
Sectoral Committee, the matter shall be referred directly to the Joint 
Committee. If no decision is reached by the Joint Committee within 10 
days of the referral to it, the CAB shall be suspended upon the request 
of the contesting party;
    (f) Upon the suspension of a CAB listed in subpart B of this part, a 
party is

[[Page 362]]

no longer obligated to accept or recognize the results of conformity 
assessment procedures performed by that CAB subsequent to suspension. A 
party shall continue to accept the results of conformity assessment 
procedures performed by that CAB prior to suspension, unless a 
regulatory authority of the party decides otherwise based on health, 
safety or environmental considerations or failure to satisfy other 
requirements within the scope of subpart B of this part; and
    (g) The suspension shall remain in effect until agreement has been 
reached by the parties upon the future status of that body.



Sec.  26.68  Withdrawal of listed conformity assessment bodies.

    The following procedures shall apply with regard to the withdrawal 
from subpart B of this part of a conformity assessment body (CAB):
    (a) A party proposing to withdraw a CAB listed in subpart B of this 
part shall forward its proposal in writing to the other party;
    (b) Such CAB shall be promptly notified by the other party and shall 
be provided a period of at least 30 days from receipt to provide 
information in order to refute or to correct the deficiencies which form 
the basis of the proposed withdrawal;
    (c) Within 60 days following receipt of the proposal, the other 
party shall indicate its position regarding either its confirmation or 
its opposition. Upon confirmation, the withdrawal from the list in 
subpart B of this part of the CAB shall take effect;
    (d) In the event the other party opposes the proposal to withdraw by 
supporting the technical competence and compliance of the CAB, the CAB 
shall not at that time be withdrawn from the list of CAB's in subpart B 
of this part. In this instance, the Joint Sectoral Committee or the 
Joint Committee may decide to carry out a joint verification of the body 
concerned. After the completion of such verification, the proposal for 
withdrawal of the CAB may be resubmitted to the other party; and
    (e) Subsequent to the withdrawal of a CAB listed in subpart B of 
this part, a party shall continue to accept the results of conformity 
assessment procedures performed by that CAB prior to withdrawal, unless 
a regulatory authority of the party decides otherwise based on health, 
safety, and environmental considerations or failure to satisfy other 
requirements within the scope of subpart B of this part.



Sec.  26.69  Monitoring of conformity assessment bodies.

    The following shall apply with regard to the monitoring of 
conformity assessment bodies (CAB's) listed in subpart B of this part:
    (a) Designating authorities shall assure that their CAB's listed in 
subpart B of this part are capable and remain capable of properly 
assessing conformity of products or processes, as applicable, and as 
covered in subpart B of this part. In this regard, designating 
authorities shall maintain, or cause to maintain, ongoing surveillance 
over their CAB's by means of regular audit or assessment;
    (b) The parties undertake to compare methods used to verify that the 
CAB's listed in subpart B of this part comply with the relevant 
requirements of subpart B of this part. Existing systems for the 
evaluation of CAB's may be used as part of such comparison procedures;
    (c) Designating authorities shall consult as necessary with their 
counterparts, to ensure the maintenance of confidence in conformity 
assessment procedures. With the consent of both parties, this 
consultation may include joint participation in audits/inspections 
related to conformity assessment activities or other assessments of 
CAB's listed in subpart B of this part; and
    (d) Designating authorities shall consult, as necessary, with the 
relevant regulatory authorities of the other party to ensure that all 
technical requirements are identified and are satisfactorily addressed.



Sec.  26.70  Conformity assessment bodies.

    Each party recognizes that the conformity assessment bodies (CAB's) 
listed in subpart B of this part fulfill the conditions of eligibility 
to assess conformity in relation to its requirements as specified in 
subpart B of this part.

[[Page 363]]

The parties shall specify the scope of the conformity assessment 
procedures for which such bodies are listed.



Sec.  26.71  Exchange of information.

    (a) The parties shall exchange information concerning the 
implementation of the legislative, regulatory, and administrative 
provisions identified in subparts A and B of this part.
    (b) Each party shall notify the other party of legislative, 
regulatory, and administrative changes related to the subject matter of 
this part at least 60 days before their entry into force. Where 
considerations of safety, health or environmental protection require 
more urgent action, a party shall notify the other party as soon as 
practicable.
    (c) Each party shall promptly notify the other party of any changes 
to its designating authorities and/or conformity assessment bodies 
(CAB's).
    (d) The parties shall exchange information concerning the procedures 
used to ensure that the listed CAB's under their responsibility comply 
with the legislative, regulatory, and administrative provisions outlined 
in subpart B of this part.
    (e) Regulatory authorities identified in subparts A and B of this 
part shall consult as necessary with their counterparts, to ensure the 
maintenance of confidence in conformity assessment procedures and to 
ensure that all technical requirements are identified and are 
satisfactorily addressed.



Sec.  26.72  Sectoral contact points.

    Each party shall appoint and confirm in writing contact points to be 
responsible for activities under subparts A and B of this part.



Sec.  26.73  Joint Committee.

    (a) A Joint Committee consisting of representatives of the United 
States and the European Community (EC) will be established. The Joint 
Committee shall be responsible for the effective functioning of the 
``Agreement on Mutual Recognition Between the United States of America 
and the European Community,'' from which this part is derived.
    (b) The Joint Committee may establish Joint Sectoral Committees 
comprised of appropriate regulatory authorities and others deemed 
necessary.
    (c) The United States and the EC shall each have one vote in the 
Joint Committee. The Joint Committee shall make its decisions by 
unanimous consent. The Joint Committee shall determine its own rules and 
procedures.
    (d) The Joint Committee may consider any matter relating to the 
effective functioning of that agreement. In particular it shall be 
responsible for:
    (1) Listing, suspension, withdrawal and verification of conformity 
assessment bodies (CAB's) in accordance with that agreement;
    (2) Amending transitional arrangements in the sectoral annexes to 
that agreement;
    (3) Resolving any questions relating to the application of that 
agreement not otherwise resolved in the respective Joint Sectoral 
Committees;
    (4) Providing a forum for discussion of issues that may arise 
concerning the implementation of that agreement;
    (5) Considering ways to enhance the operation of that agreement;
    (6) Coordinating the negotiation of additional sectoral annexes to 
that agreement; and
    (7) Considering whether to amend that agreement in accordance with 
Sec.  26.80.
    (e) When a party introduces new or additional conformity assessment 
procedures affecting a sectoral annex to that agreement, the parties 
shall discuss the matter in the Joint Committee with a view to bringing 
such new or additional procedures within the scope of that agreement and 
the relevant sectoral annex.



Sec.  26.74  Preservation of regulatory authority.

    (a) Nothing in this part shall be construed to limit the authority 
of a party to determine, through its legislative, regulatory, and 
administrative measures, the level of protection it considers 
appropriate for safety; for protection of human, animal, or plant life 
or health; for the environment; for consumers; and otherwise with regard 
to risks within the scope of the applicable subpart A or B of this part.

[[Page 364]]

    (b) Nothing in this part shall be construed to limit the authority 
of a regulatory authority to take all appropriate and immediate measures 
whenever it ascertains that a product may:
    (1) Compromise the health or safety of persons in its territory;
    (2) Not meet the legislative, regulatory, or administrative 
provisions within the scope of the applicable subpart A or B of this 
part; or
    (3) Otherwise fail to satisfy a requirement within the scope of the 
applicable subpart A or B of this part. Such measures may include 
withdrawing the products from the market, prohibiting their placement on 
the market, restricting their free movement, initiating a product 
recall, and preventing the recurrence of such problems, including 
through a prohibition on imports. If the regulatory authority takes such 
action, it shall inform its counterpart authority and the other party 
within 15 days of taking such action, providing its reasons.



Sec.  26.75  Suspension of recognition obligations.

    Either party may suspend its obligations under subpart A or B of 
this part, in whole or in part, if:
    (a) A party suffers a loss of market access for the party's products 
within the scope of subpart A or B of this part as a result of the 
failure of the other party to fulfill its obligations under this part;
    (b) The adoption of new or additional conformity assessment 
requirements as referenced in Sec.  26.73(e) results in a loss of market 
access for the party's products within the scope of subpart B of this 
part because conformity assessment bodies (CAB's) designated by the 
party in order to meet such requirements have not been recognized by the 
party implementing the requirements; or
    (c) The other party fails to maintain legal and regulatory 
authorities capable of implementing the provisions of this part.



Sec.  26.76  Confidentiality.

    (a) Each party agrees to maintain, to the extent required under its 
laws, the confidentiality of information exchanged under this part.
    (b) In particular, neither party shall disclose to the public, nor 
permit a conformity assessment body (CAB) to disclose to the public, 
information exchanged under this part that constitutes trade secrets, 
confidential commercial or financial information, or information that 
relates to an ongoing investigation.
    (c) A party or a CAB may, upon exchanging information with the other 
party or with a CAB of the other party, designate the portions of the 
information that it considers to be exempt from disclosure.
    (d) Each party shall take all precautions reasonably necessary to 
protect information exchanged under this part from unauthorized 
disclosure.



Sec.  26.77  Fees.

    Each party shall endeavor to ensure that fees imposed for services 
under this part shall be commensurate with the services provided. Each 
party shall ensure that, for the sectors and conformity assessment 
procedures covered under this part, it shall charge no fees with respect 
to conformity assessment services provided by the other party.



Sec.  26.78  Agreements with other countries.

    Except where there is written agreement between the parties, 
obligations contained in mutual recognition agreements concluded by 
either party with a party not a party to the agreement from which this 
part is derived (a third party) shall have no force and effect with 
regard to the other party in terms of acceptance of the results of 
conformity assessment procedures in the third party.



Sec.  26.79  Territorial application.

    The agreement from which this part is derived shall apply, on the 
one hand, to the territories in which the Treaty establishing the 
European Community (EC) is applied, and under the conditions laid down 
in that Treaty and, on the other hand, to the territory of the United 
States.



Sec.  26.80  Entry into force, amendment, and termination.

    (a) The ``Agreement on Mutual Recognition Between the United States 
of

[[Page 365]]

America and the European Community,'' from which this part is derived, 
including its sectoral annexes on telecommunication equipment, 
electromagnetic compatibility, electrical safety, recreational craft, 
pharmaceutical Good Manufacturing Practices (GMP) inspections, and 
medical devices shall enter into force on the first day of the second 
month following the date on which the parties have exchanged letters 
confirming the completion of their respective procedures for the entry 
into force of that agreement.
    (b) That agreement including any sectoral annex may, through the 
Joint Committee, be amended in writing by the parties to that agreement. 
Those parties may add a sectoral annex upon the exchange of letters. 
Such annex shall enter into force 30 days following the date on which 
those parties have exchanged letters confirming the completion of their 
respective procedures for the entry into force of the sectoral annex.
    (c) Either party to that agreement may terminate that agreement in 
its entirety or any individual sectoral annex thereof by giving the 
other party to that agreement 6-months notice in writing. In the case of 
termination of one or more sectoral annexes, the parties to that 
agreement will seek to achieve by consensus to amend that agreement, 
with a view to preserving the remaining Sectoral Annexes, in accordance 
with the procedures in this section. Failing such consensus, that 
agreement shall terminate at the end of 6 months from the date of 
notice.
    (d) Following termination of that agreement in its entirety or any 
individual sectoral annex thereof, a party to that agreement shall 
continue to accept the results of conformity assessment procedures 
performed by conformity assessment bodies under that agreement prior to 
termination, unless a regulatory authority in the party decides 
otherwise based on health, safety and environmental considerations or 
failure to satisfy other requirements within the scope of the applicable 
sectoral annex.



Sec.  26.81  Final provisions.

    (a) The sectoral annexes referred to in Sec.  26.80(a), as well as 
any new sectoral annexes added pursuant to Sec.  26.80(b), shall form an 
integral part of the ``Agreement on Mutual Recognition Between the 
United States of America and the European Community,'' from which this 
part is derived.
    (b) For a given product or sector, the provisions contained in 
subparts A and B of this part shall apply in the first place, and the 
provisions of subpart C of this part in addition to those provisions. In 
the case of any inconsistency between the provisions of subpart A or B 
of this part and subpart C of this part, subpart A or B shall prevail, 
to the extent of that inconsistency.
    (c) The agreement from which this part is derived shall not affect 
the rights and obligations of the parties under any other international 
agreement.
    (d) In the case of subpart B of this part, the parties shall review 
the status of such subpart at the end of 3 years from the date described 
in Sec.  26.80(a).



PART 50_PROTECTION OF HUMAN SUBJECTS--Table of Contents



                      Subpart A_General Provisions

Sec.
50.1 Scope.
50.3 Definitions.

              Subpart B_Informed Consent of Human Subjects

50.20 General requirements for informed consent.
50.23 Exception from general requirements.
50.24 Exception from informed consent requirements for emergency 
          research.
50.25 Elements of informed consent.
50.27 Documentation of informed consent.

Subpart C [Reserved]

 Subpart D_Additional Safeguards for Children in Clinical Investigations

50.50 IRB duties.
50.51 Clinical investigations not involving greater than minimal risk.
50.52 Clinical investigations involving greater than minimal risk but 
          presenting the prospect of direct benefit to individual 
          subjects.
50.53 Clinical investigations involving greater than minimal risk and no 
          prospect of direct benefit to individual subjects, but likely 
          to yield generalizable

[[Page 366]]

          knowledge about the subjects' disorder or condition.
50.54 Clinical investigations not otherwise approvable that present an 
          opportunity to understand, prevent, or alleviate a serious 
          problem affecting the health or welfare of children.
50.55 Requirements for permission by parents or guardians and for assent 
          by children.
50.56 Wards.

    Authority: 21 U.S.C 321, 343, 346, 346a, 348, 350a, 350b, 352, 353, 
355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 
263b-263n.

    Source: 45 FR 36390, May 30, 1980, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  50.1  Scope.

    (a) This part applies to all clinical investigations regulated by 
the Food and Drug Administration under sections 505(i) and 520(g) of the 
Federal Food, Drug, and Cosmetic Act, as well as clinical investigations 
that support applications for research or marketing permits for products 
regulated by the Food and Drug Administration, including foods, 
including dietary supplements, that bear a nutrient content claim or a 
health claim, infant formulas, food and color additives, drugs for human 
use, medical devices for human use, biological products for human use, 
and electronic products. Additional specific obligations and commitments 
of, and standards of conduct for, persons who sponsor or monitor 
clinical investigations involving particular test articles may also be 
found in other parts (e.g., parts 312 and 812). Compliance with these 
parts is intended to protect the rights and safety of subjects involved 
in investigations filed with the Food and Drug Administration pursuant 
to sections 403, 406, 409, 412, 413, 502, 503, 505, 510, 513-516, 518-
520, 721, and 801 of the Federal Food, Drug, and Cosmetic Act and 
sections 351 and 354-360F of the Public Health Service Act.
    (b) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.

[45 FR 36390, May 30, 1980; 46 FR 8979, Jan. 27, 1981, as amended at 63 
FR 26697, May 13, 1998; 64 FR 399, Jan. 5, 1999; 66 FR 20597, Apr. 24, 
2001]



Sec.  50.3  Definitions.

    As used in this part:
    (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended 
(secs. 201-902, 52 Stat. 1040 et seq. as amended (21 U.S.C. 321-392)).
    (b) Application for research or marketing permit includes:
    (1) A color additive petition, described in part 71.
    (2) A food additive petition, described in parts 171 and 571.
    (3) Data and information about a substance submitted as part of the 
procedures for establishing that the substance is generally recognized 
as safe for use that results or may reasonably be expected to result, 
directly or indirectly, in its becoming a component or otherwise 
affecting the characteristics of any food, described in Sec. Sec.  
170.30 and 570.30.
    (4) Data and information about a food additive submitted as part of 
the procedures for food additives permitted to be used on an interim 
basis pending additional study, described in Sec.  180.1.
    (5) Data and information about a substance submitted as part of the 
procedures for establishing a tolerance for unavoidable contaminants in 
food and food-packaging materials, described in section 406 of the act.
    (6) An investigational new drug application, described in part 312 
of this chapter.
    (7) A new drug application, described in part 314.
    (8) Data and information about the bioavailability or bioequivalence 
of drugs for human use submitted as part of the procedures for issuing, 
amending, or repealing a bioequivalence requirement, described in part 
320.
    (9) Data and information about an over-the-counter drug for human 
use submitted as part of the procedures for classifying these drugs as 
generally recognized as safe and effective and not misbranded, described 
in part 330.

[[Page 367]]

    (10) Data and information about a prescription drug for human use 
submitted as part of the procedures for classifying these drugs as 
generally recognized as safe and effective and not misbranded, described 
in this chapter.
    (11) [Reserved]
    (12) An application for a biologics license, described in part 601 
of this chapter.
    (13) Data and information about a biological product submitted as 
part of the procedures for determining that licensed biological products 
are safe and effective and not misbranded, described in part 601.
    (14) Data and information about an in vitro diagnostic product 
submitted as part of the procedures for establishing, amending, or 
repealing a standard for these products, described in part 809.
    (15) An Application for an Investigational Device Exemption, 
described in part 812.
    (16) Data and information about a medical device submitted as part 
of the procedures for classifying these devices, described in section 
513.
    (17) Data and information about a medical device submitted as part 
of the procedures for establishing, amending, or repealing a standard 
for these devices, described in section 514.
    (18) An application for premarket approval of a medical device, 
described in section 515.
    (19) A product development protocol for a medical device, described 
in section 515.
    (20) Data and information about an electronic product submitted as 
part of the procedures for establishing, amending, or repealing a 
standard for these products, described in section 358 of the Public 
Health Service Act.
    (21) Data and information about an electronic product submitted as 
part of the procedures for obtaining a variance from any electronic 
product performance standard, as described in Sec.  1010.4.
    (22) Data and information about an electronic product submitted as 
part of the procedures for granting, amending, or extending an exemption 
from a radiation safety performance standard, as described in Sec.  
1010.5.
    (23) Data and information about a clinical study of an infant 
formula when submitted as part of an infant formula notification under 
section 412(c) of the Federal Food, Drug, and Cosmetic Act.
    (24) Data and information submitted in a petition for a nutrient 
content claim, described in Sec.  101.69 of this chapter, or for a 
health claim, described in Sec.  101.70 of this chapter.
    (25) Data and information from investigations involving children 
submitted in a new dietary ingredient notification, described in Sec.  
190.6 of this chapter.
    (c) Clinical investigation means any experiment that involves a test 
article and one or more human subjects and that either is subject to 
requirements for prior submission to the Food and Drug Administration 
under section 505(i) or 520(g) of the act, or is not subject to 
requirements for prior submission to the Food and Drug Administration 
under these sections of the act, but the results of which are intended 
to be submitted later to, or held for inspection by, the Food and Drug 
Administration as part of an application for a research or marketing 
permit. The term does not include experiments that are subject to the 
provisions of part 58 of this chapter, regarding nonclinical laboratory 
studies.
    (d) Investigator means an individual who actually conducts a 
clinical investigation, i.e., under whose immediate direction the test 
article is administered or dispensed to, or used involving, a subject, 
or, in the event of an investigation conducted by a team of individuals, 
is the responsible leader of that team.
    (e) Sponsor means a person who initiates a clinical investigation, 
but who does not actually conduct the investigation, i.e., the test 
article is administered or dispensed to or used involving, a subject 
under the immediate direction of another individual. A person other than 
an individual (e.g., corporation or agency) that uses one or more of its 
own employees to conduct a clinical investigation it has initiated is 
considered to be a sponsor (not a sponsor-investigator), and the 
employees are considered to be investigators.
    (f) Sponsor-investigator means an individual who both initiates and 
actually

[[Page 368]]

conducts, alone or with others, a clinical investigation, i.e., under 
whose immediate direction the test article is administered or dispensed 
to, or used involving, a subject. The term does not include any person 
other than an individual, e.g., corporation or agency.
    (g) Human subject means an individual who is or becomes a 
participant in research, either as a recipient of the test article or as 
a control. A subject may be either a healthy human or a patient.
    (h) Institution means any public or private entity or agency 
(including Federal, State, and other agencies). The word facility as 
used in section 520(g) of the act is deemed to be synonymous with the 
term institution for purposes of this part.
    (i) Institutional review board (IRB) means any board, committee, or 
other group formally designated by an institution to review biomedical 
research involving humans as subjects, to approve the initiation of and 
conduct periodic review of such research. The term has the same meaning 
as the phrase institutional review committee as used in section 520(g) 
of the act.
    (j) Test article means any drug (including a biological product for 
human use), medical device for human use, human food additive, color 
additive, electronic product, or any other article subject to regulation 
under the act or under sections 351 and 354-360F of the Public Health 
Service Act (42 U.S.C. 262 and 263b-263n).
    (k) Minimal risk means that the probability and magnitude of harm or 
discomfort anticipated in the research are not greater in and of 
themselves than those ordinarily encountered in daily life or during the 
performance of routine physical or psychological examinations or tests.
    (l) Legally authorized representative means an individual or 
judicial or other body authorized under applicable law to consent on 
behalf of a prospective subject to the subject's particpation in the 
procedure(s) involved in the research.
    (m) Family member means any one of the following legally competent 
persons: Spouse; parents; children (including adopted children); 
brothers, sisters, and spouses of brothers and sisters; and any 
individual related by blood or affinity whose close association with the 
subject is the equivalent of a family relationship.
    (n) Assent means a child's affirmative agreement to participate in a 
clinical investigation. Mere failure to object should not, absent 
affirmative agreement, be construed as assent.
    (o) Children means persons who have not attained the legal age for 
consent to treatments or procedures involved in clinical investigations, 
under the applicable law of the jurisdiction in which the clinical 
investigation will be conducted.
    (p) Parent means a child's biological or adoptive parent.
    (q) Ward means a child who is placed in the legal custody of the 
State or other agency, institution, or entity, consistent with 
applicable Federal, State, or local law.
    (r) Permission means the agreement of parent(s) or guardian to the 
participation of their child or ward in a clinical investigation.
    (s) Guardian means an individual who is authorized under applicable 
State or local law to consent on behalf of a child to general medical 
care.

[45 FR 36390, May 30, 1980, as amended at 46 FR 8950, Jan. 27, 1981; 54 
FR 9038, Mar. 3, 1989; 56 FR 28028, June 18, 1991; 61 FR 51528, Oct. 2, 
1996; 62 FR 39440, July 23, 1997; 64 FR 399, Jan. 5, 1999; 64 FR 56448, 
Oct. 20, 1999; 66 FR 20597, Apr. 24, 2001; 78 FR 12950, Feb. 26, 2013]



              Subpart B_Informed Consent of Human Subjects

    Source: 46 FR 8951, Jan. 27, 1981, unless otherwise noted.



Sec.  50.20  General requirements for informed consent.

    Except as provided in Sec. Sec.  50.23 and 50.24, no investigator 
may involve a human being as a subject in research covered by these 
regulations unless the investigator has obtained the legally effective 
informed consent of the subject or the subject's legally authorized 
representative. An investigator shall seek such consent only under 
circumstances that provide the prospective subject or the representative 
sufficient opportunity to consider whether or not to participate and 
that minimize

[[Page 369]]

the possibility of coercion or undue influence. The information that is 
given to the subject or the representative shall be in language 
understandable to the subject or the representative. No informed 
consent, whether oral or written, may include any exculpatory language 
through which the subject or the representative is made to waive or 
appear to waive any of the subject's legal rights, or releases or 
appears to release the investigator, the sponsor, the institution, or 
its agents from liability for negligence.

[46 FR 8951, Jan. 27, 1981, as amended at 64 FR 10942, Mar. 8, 1999]



Sec.  50.23  Exception from general requirements.

    (a) The obtaining of informed consent shall be deemed feasible 
unless, before use of the test article (except as provided in paragraph 
(b) of this section), both the investigator and a physician who is not 
otherwise participating in the clinical investigation certify in writing 
all of the following:
    (1) The human subject is confronted by a life-threatening situation 
necessitating the use of the test article.
    (2) Informed consent cannot be obtained from the subject because of 
an inability to communicate with, or obtain legally effective consent 
from, the subject.
    (3) Time is not sufficient to obtain consent from the subject's 
legal representative.
    (4) There is available no alternative method of approved or 
generally recognized therapy that provides an equal or greater 
likelihood of saving the life of the subject.
    (b) If immediate use of the test article is, in the investigator's 
opinion, required to preserve the life of the subject, and time is not 
sufficient to obtain the independent determination required in paragraph 
(a) of this section in advance of using the test article, the 
determinations of the clinical investigator shall be made and, within 5 
working days after the use of the article, be reviewed and evaluated in 
writing by a physician who is not participating in the clinical 
investigation.
    (c) The documentation required in paragraph (a) or (b) of this 
section shall be submitted to the IRB within 5 working days after the 
use of the test article.
    (d)(1) Under 10 U.S.C. 1107(f) the President may waive the prior 
consent requirement for the administration of an investigational new 
drug to a member of the armed forces in connection with the member's 
participation in a particular military operation. The statute specifies 
that only the President may waive informed consent in this connection 
and the President may grant such a waiver only if the President 
determines in writing that obtaining consent: Is not feasible; is 
contrary to the best interests of the military member; or is not in the 
interests of national security. The statute further provides that in 
making a determination to waive prior informed consent on the ground 
that it is not feasible or the ground that it is contrary to the best 
interests of the military members involved, the President shall apply 
the standards and criteria that are set forth in the relevant FDA 
regulations for a waiver of the prior informed consent requirements of 
section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(i)(4)). Before such a determination may be made that obtaining 
informed consent from military personnel prior to the use of an 
investigational drug (including an antibiotic or biological product) in 
a specific protocol under an investigational new drug application (IND) 
sponsored by the Department of Defense (DOD) and limited to specific 
military personnel involved in a particular military operation is not 
feasible or is contrary to the best interests of the military members 
involved the Secretary of Defense must first request such a 
determination from the President, and certify and document to the 
President that the following standards and criteria contained in 
paragraphs (d)(1) through (d)(4) of this section have been met.
    (i) The extent and strength of evidence of the safety and 
effectiveness of the investigational new drug in relation to the medical 
risk that could be encountered during the military operation supports 
the drug's administration under an IND.

[[Page 370]]

    (ii) The military operation presents a substantial risk that 
military personnel may be subject to a chemical, biological, nuclear, or 
other exposure likely to produce death or serious or life-threatening 
injury or illness.
    (iii) There is no available satisfactory alternative therapeutic or 
preventive treatment in relation to the intended use of the 
investigational new drug.
    (iv) Conditioning use of the investigational new drug on the 
voluntary participation of each member could significantly risk the 
safety and health of any individual member who would decline its use, 
the safety of other military personnel, and the accomplishment of the 
military mission.
    (v) A duly constituted institutional review board (IRB) established 
and operated in accordance with the requirements of paragraphs (d)(2) 
and (d)(3) of this section, responsible for review of the study, has 
reviewed and approved the investigational new drug protocol and the 
administration of the investigational new drug without informed consent. 
DOD's request is to include the documentation required by Sec.  
56.115(a)(2) of this chapter.
    (vi) DOD has explained:
    (A) The context in which the investigational drug will be 
administered, e.g., the setting or whether it will be self-administered 
or it will be administered by a health professional;
    (B) The nature of the disease or condition for which the preventive 
or therapeutic treatment is intended; and
    (C) To the extent there are existing data or information available, 
information on conditions that could alter the effects of the 
investigational drug.
    (vii) DOD's recordkeeping system is capable of tracking and will be 
used to track the proposed treatment from supplier to the individual 
recipient.
    (viii) Each member involved in the military operation will be given, 
prior to the administration of the investigational new drug, a specific 
written information sheet (including information required by 10 U.S.C. 
1107(d)) concerning the investigational new drug, the risks and benefits 
of its use, potential side effects, and other pertinent information 
about the appropriate use of the product.
    (ix) Medical records of members involved in the military operation 
will accurately document the receipt by members of the notification 
required by paragraph (d)(1)(viii) of this section.
    (x) Medical records of members involved in the military operation 
will accurately document the receipt by members of any investigational 
new drugs in accordance with FDA regulations including part 312 of this 
chapter.
    (xi) DOD will provide adequate followup to assess whether there are 
beneficial or adverse health consequences that result from the use of 
the investigational product.
    (xii) DOD is pursuing drug development, including a time line, and 
marketing approval with due diligence.
    (xiii) FDA has concluded that the investigational new drug protocol 
may proceed subject to a decision by the President on the informed 
consent waiver request.
    (xiv) DOD will provide training to the appropriate medical personnel 
and potential recipients on the specific investigational new drug to be 
administered prior to its use.
    (xv) DOD has stated and justified the time period for which the 
waiver is needed, not to exceed one year, unless separately renewed 
under these standards and criteria.
    (xvi) DOD shall have a continuing obligation to report to the FDA 
and to the President any changed circumstances relating to these 
standards and criteria (including the time period referred to in 
paragraph (d)(1)(xv) of this section) or that otherwise might affect the 
determination to use an investigational new drug without informed 
consent.
    (xvii) DOD is to provide public notice as soon as practicable and 
consistent with classification requirements through notice in the 
Federal Register describing each waiver of informed consent 
determination, a summary of the most updated scientific information on 
the products used, and other pertinent information.
    (xviii) Use of the investigational drug without informed consent 
otherwise conforms with applicable law.
    (2) The duly constituted institutional review board, described in 
paragraph (d)(1)(v) of this section, must include at

[[Page 371]]

least 3 nonaffiliated members who shall not be employees or officers of 
the Federal Government (other than for purposes of membership on the 
IRB) and shall be required to obtain any necessary security clearances. 
This IRB shall review the proposed IND protocol at a convened meeting at 
which a majority of the members are present including at least one 
member whose primary concerns are in nonscientific areas and, if 
feasible, including a majority of the nonaffiliated members. The 
information required by Sec.  56.115(a)(2) of this chapter is to be 
provided to the Secretary of Defense for further review.
    (3) The duly constituted institutional review board, described in 
paragraph (d)(1)(v) of this section, must review and approve:
    (i) The required information sheet;
    (ii) The adequacy of the plan to disseminate information, including 
distribution of the information sheet to potential recipients, on the 
investigational product (e.g., in forms other than written);
    (iii) The adequacy of the information and plans for its 
dissemination to health care providers, including potential side 
effects, contraindications, potential interactions, and other pertinent 
considerations; and
    (iv) An informed consent form as required by part 50 of this 
chapter, in those circumstances in which DOD determines that informed 
consent may be obtained from some or all personnel involved.
    (4) DOD is to submit to FDA summaries of institutional review board 
meetings at which the proposed protocol has been reviewed.
    (5) Nothing in these criteria or standards is intended to preempt or 
limit FDA's and DOD's authority or obligations under applicable statutes 
and regulations.
    (e)(1) Obtaining informed consent for investigational in vitro 
diagnostic devices used to identify chemical, biological, radiological, 
or nuclear agents will be deemed feasible unless, before use of the test 
article, both the investigator (e.g., clinical laboratory director or 
other responsible individual) and a physician who is not otherwise 
participating in the clinical investigation make the determinations and 
later certify in writing all of the following:
    (i) The human subject is confronted by a life-threatening situation 
necessitating the use of the investigational in vitro diagnostic device 
to identify a chemical, biological, radiological, or nuclear agent that 
would suggest a terrorism event or other public health emergency.
    (ii) Informed consent cannot be obtained from the subject because:
    (A) There was no reasonable way for the person directing that the 
specimen be collected to know, at the time the specimen was collected, 
that there would be a need to use the investigational in vitro 
diagnostic device on that subject's specimen; and
    (B) Time is not sufficient to obtain consent from the subject 
without risking the life of the subject.
    (iii) Time is not sufficient to obtain consent from the subject's 
legally authorized representative.
    (iv) There is no cleared or approved available alternative method of 
diagnosis, to identify the chemical, biological, radiological, or 
nuclear agent that provides an equal or greater likelihood of saving the 
life of the subject.
    (2) If use of the investigational device is, in the opinion of the 
investigator (e.g., clinical laboratory director or other responsible 
person), required to preserve the life of the subject, and time is not 
sufficient to obtain the independent determination required in paragraph 
(e)(1) of this section in advance of using the investigational device, 
the determinations of the investigator shall be made and, within 5 
working days after the use of the device, be reviewed and evaluated in 
writing by a physician who is not participating in the clinical 
investigation.
    (3) The investigator must submit the written certification of the 
determinations made by the investigator and an independent physician 
required in paragraph (e)(1) or (e)(2) of this section to the IRB and 
FDA within 5 working days after the use of the device.
    (4) An investigator must disclose the investigational status of the 
in vitro diagnostic device and what is known about the performance 
characteristics of the device in the report to the subject's health care 
provider and in any

[[Page 372]]

report to public health authorities. The investigator must provide the 
IRB with the information required in Sec.  50.25 (except for the 
information described in Sec.  50.25(a)(8)) and the procedures that will 
be used to provide this information to each subject or the subject's 
legally authorized representative at the time the test results are 
provided to the subject's health care provider and public health 
authorities.
    (5) The IRB is responsible for ensuring the adequacy of the 
information required in section 50.25 (except for the information 
described in Sec.  50.25(a)(8)) and for ensuring that procedures are in 
place to provide this information to each subject or the subject's 
legally authorized representative.
    (6) No State or political subdivision of a State may establish or 
continue in effect any law, rule, regulation or other requirement that 
informed consent be obtained before an investigational in vitro 
diagnostic device may be used to identify chemical, biological, 
radiological, or nuclear agent in suspected terrorism events and other 
potential public health emergencies that is different from, or in 
addition to, the requirements of this regulation.

[46 FR 8951, Jan. 27, 1981, as amended at 55 FR 52817, Dec. 21, 1990; 64 
FR 399, Jan. 5, 1999; 64 FR 54188, Oct. 5, 1999; 71 FR 32833, June 7, 
2006; 76 FR 36993, June 24, 2011]



Sec.  50.24  Exception from informed consent requirements for 
emergency research.

    (a) The IRB responsible for the review, approval, and continuing 
review of the clinical investigation described in this section may 
approve that investigation without requiring that informed consent of 
all research subjects be obtained if the IRB (with the concurrence of a 
licensed physician who is a member of or consultant to the IRB and who 
is not otherwise participating in the clinical investigation) finds and 
documents each of the following:
    (1) The human subjects are in a life-threatening situation, 
available treatments are unproven or unsatisfactory, and the collection 
of valid scientific evidence, which may include evidence obtained 
through randomized placebo-controlled investigations, is necessary to 
determine the safety and effectiveness of particular interventions.
    (2) Obtaining informed consent is not feasible because:
    (i) The subjects will not be able to give their informed consent as 
a result of their medical condition;
    (ii) The intervention under investigation must be administered 
before consent from the subjects' legally authorized representatives is 
feasible; and
    (iii) There is no reasonable way to identify prospectively the 
individuals likely to become eligible for participation in the clinical 
investigation.
    (3) Participation in the research holds out the prospect of direct 
benefit to the subjects because:
    (i) Subjects are facing a life-threatening situation that 
necessitates intervention;
    (ii) Appropriate animal and other preclinical studies have been 
conducted, and the information derived from those studies and related 
evidence support the potential for the intervention to provide a direct 
benefit to the individual subjects; and
    (iii) Risks associated with the investigation are reasonable in 
relation to what is known about the medical condition of the potential 
class of subjects, the risks and benefits of standard therapy, if any, 
and what is known about the risks and benefits of the proposed 
intervention or activity.
    (4) The clinical investigation could not practicably be carried out 
without the waiver.
    (5) The proposed investigational plan defines the length of the 
potential therapeutic window based on scientific evidence, and the 
investigator has committed to attempting to contact a legally authorized 
representative for each subject within that window of time and, if 
feasible, to asking the legally authorized representative contacted for 
consent within that window rather than proceeding without consent. The 
investigator will summarize efforts made to contact legally authorized 
representatives and make this information available to the IRB at the 
time of continuing review.
    (6) The IRB has reviewed and approved informed consent procedures 
and an informed consent document

[[Page 373]]

consistent with Sec.  50.25. These procedures and the informed consent 
document are to be used with subjects or their legally authorized 
representatives in situations where use of such procedures and documents 
is feasible. The IRB has reviewed and approved procedures and 
information to be used when providing an opportunity for a family member 
to object to a subject's participation in the clinical investigation 
consistent with paragraph (a)(7)(v) of this section.
    (7) Additional protections of the rights and welfare of the subjects 
will be provided, including, at least:
    (i) Consultation (including, where appropriate, consultation carried 
out by the IRB) with representatives of the communities in which the 
clinical investigation will be conducted and from which the subjects 
will be drawn;
    (ii) Public disclosure to the communities in which the clinical 
investigation will be conducted and from which the subjects will be 
drawn, prior to initiation of the clinical investigation, of plans for 
the investigation and its risks and expected benefits;
    (iii) Public disclosure of sufficient information following 
completion of the clinical investigation to apprise the community and 
researchers of the study, including the demographic characteristics of 
the research population, and its results;
    (iv) Establishment of an independent data monitoring committee to 
exercise oversight of the clinical investigation; and
    (v) If obtaining informed consent is not feasible and a legally 
authorized representative is not reasonably available, the investigator 
has committed, if feasible, to attempting to contact within the 
therapeutic window the subject's family member who is not a legally 
authorized representative, and asking whether he or she objects to the 
subject's participation in the clinical investigation. The investigator 
will summarize efforts made to contact family members and make this 
information available to the IRB at the time of continuing review.
    (b) The IRB is responsible for ensuring that procedures are in place 
to inform, at the earliest feasible opportunity, each subject, or if the 
subject remains incapacitated, a legally authorized representative of 
the subject, or if such a representative is not reasonably available, a 
family member, of the subject's inclusion in the clinical investigation, 
the details of the investigation and other information contained in the 
informed consent document. The IRB shall also ensure that there is a 
procedure to inform the subject, or if the subject remains 
incapacitated, a legally authorized representative of the subject, or if 
such a representative is not reasonably available, a family member, that 
he or she may discontinue the subject's participation at any time 
without penalty or loss of benefits to which the subject is otherwise 
entitled. If a legally authorized representative or family member is 
told about the clinical investigation and the subject's condition 
improves, the subject is also to be informed as soon as feasible. If a 
subject is entered into a clinical investigation with waived consent and 
the subject dies before a legally authorized representative or family 
member can be contacted, information about the clinical investigation is 
to be provided to the subject's legally authorized representative or 
family member, if feasible.
    (c) The IRB determinations required by paragraph (a) of this section 
and the documentation required by paragraph (e) of this section are to 
be retained by the IRB for at least 3 years after completion of the 
clinical investigation, and the records shall be accessible for 
inspection and copying by FDA in accordance with Sec.  56.115(b) of this 
chapter.
    (d) Protocols involving an exception to the informed consent 
requirement under this section must be performed under a separate 
investigational new drug application (IND) or investigational device 
exemption (IDE) that clearly identifies such protocols as protocols that 
may include subjects who are unable to consent. The submission of those 
protocols in a separate IND/IDE is required even if an IND for the same 
drug product or an IDE for the same device already exists. Applications 
for investigations under this section may not be submitted as amendments 
under Sec. Sec.  312.30 or 812.35 of this chapter.

[[Page 374]]

    (e) If an IRB determines that it cannot approve a clinical 
investigation because the investigation does not meet the criteria in 
the exception provided under paragraph (a) of this section or because of 
other relevant ethical concerns, the IRB must document its findings and 
provide these findings promptly in writing to the clinical investigator 
and to the sponsor of the clinical investigation. The sponsor of the 
clinical investigation must promptly disclose this information to FDA 
and to the sponsor's clinical investigators who are participating or are 
asked to participate in this or a substantially equivalent clinical 
investigation of the sponsor, and to other IRB's that have been, or are, 
asked to review this or a substantially equivalent investigation by that 
sponsor.

[61 FR 51528, Oct. 2, 1996]



Sec.  50.25  Elements of informed consent.

    (a) Basic elements of informed consent. In seeking informed consent, 
the following information shall be provided to each subject:
    (1) A statement that the study involves research, an explanation of 
the purposes of the research and the expected duration of the subject's 
participation, a description of the procedures to be followed, and 
identification of any procedures which are experimental.
    (2) A description of any reasonably foreseeable risks or discomforts 
to the subject.
    (3) A description of any benefits to the subject or to others which 
may reasonably be expected from the research.
    (4) A disclosure of appropriate alternative procedures or courses of 
treatment, if any, that might be advantageous to the subject.
    (5) A statement describing the extent, if any, to which 
confidentiality of records identifying the subject will be maintained 
and that notes the possibility that the Food and Drug Administration may 
inspect the records.
    (6) For research involving more than minimal risk, an explanation as 
to whether any compensation and an explanation as to whether any medical 
treatments are available if injury occurs and, if so, what they consist 
of, or where further information may be obtained.
    (7) An explanation of whom to contact for answers to pertinent 
questions about the research and research subjects' rights, and whom to 
contact in the event of a research-related injury to the subject.
    (8) A statement that participation is voluntary, that refusal to 
participate will involve no penalty or loss of benefits to which the 
subject is otherwise entitled, and that the subject may discontinue 
participation at any time without penalty or loss of benefits to which 
the subject is otherwise entitled.
    (b) Additional elements of informed consent. When appropriate, one 
or more of the following elements of information shall also be provided 
to each subject:
    (1) A statement that the particular treatment or procedure may 
involve risks to the subject (or to the embryo or fetus, if the subject 
is or may become pregnant) which are currently unforeseeable.
    (2) Anticipated circumstances under which the subject's 
participation may be terminated by the investigator without regard to 
the subject's consent.
    (3) Any additional costs to the subject that may result from 
participation in the research.
    (4) The consequences of a subject's decision to withdraw from the 
research and procedures for orderly termination of participation by the 
subject.
    (5) A statement that significant new findings developed during the 
course of the research which may relate to the subject's willingness to 
continue participation will be provided to the subject.
    (6) The approximate number of subjects involved in the study.
    (c) When seeking informed consent for applicable clinical trials, as 
defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be 
provided to each clinical trial subject in informed consent documents 
and processes. This will notify the clinical trial subject that clinical 
trial information has been or will be submitted for inclusion in the 
clinical trial registry databank under paragraph (j) of section 402 of 
the Public Health Service Act. The statement is: ``A description of this 
clinical

[[Page 375]]

trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This Web site will not include information that can identify 
you. At most, the Web site will include a summary of the results. You 
can search this Web site at any time.''
    (d) The informed consent requirements in these regulations are not 
intended to preempt any applicable Federal, State, or local laws which 
require additional information to be disclosed for informed consent to 
be legally effective.
    (e) Nothing in these regulations is intended to limit the authority 
of a physician to provide emergency medical care to the extent the 
physician is permitted to do so under applicable Federal, State, or 
local law.

[46 FR 8951, Jan. 27, 1981, as amended at 76 FR 270, Jan. 4, 2011]



Sec.  50.27  Documentation of informed consent.

    (a) Except as provided in Sec.  56.109(c), informed consent shall be 
documented by the use of a written consent form approved by the IRB and 
signed and dated by the subject or the subject's legally authorized 
representative at the time of consent. A copy shall be given to the 
person signing the form.
    (b) Except as provided in Sec.  56.109(c), the consent form may be 
either of the following:
    (1) A written consent document that embodies the elements of 
informed consent required by Sec.  50.25. This form may be read to the 
subject or the subject's legally authorized representative, but, in any 
event, the investigator shall give either the subject or the 
representative adequate opportunity to read it before it is signed.
    (2) A short form written consent document stating that the elements 
of informed consent required by Sec.  50.25 have been presented orally 
to the subject or the subject's legally authorized representative. When 
this method is used, there shall be a witness to the oral presentation. 
Also, the IRB shall approve a written summary of what is to be said to 
the subject or the representative. Only the short form itself is to be 
signed by the subject or the representative. However, the witness shall 
sign both the short form and a copy of the summary, and the person 
actually obtaining the consent shall sign a copy of the summary. A copy 
of the summary shall be given to the subject or the representative in 
addition to a copy of the short form.

[46 FR 8951, Jan. 27, 1981, as amended at 61 FR 57280, Nov. 5, 1996]

Subpart C [Reserved]



 Subpart D_Additional Safeguards for Children in Clinical Investigations

    Source: 66 FR 20598, Apr. 24, 2001, unless otherwise noted.



Sec.  50.50  IRB duties.

    In addition to other responsibilities assigned to IRBs under this 
part and part 56 of this chapter, each IRB must review clinical 
investigations involving children as subjects covered by this subpart D 
and approve only those clinical investigations that satisfy the criteria 
described in Sec.  50.51, Sec.  50.52, or Sec.  50.53 and the conditions 
of all other applicable sections of this subpart D.



Sec.  50.51  Clinical investigations not involving greater than minimal risk.

    Any clinical investigation within the scope described in Sec. Sec.  
50.1 and 56.101 of this chapter in which no greater than minimal risk to 
children is presented may involve children as subjects only if the IRB 
finds that:
    (a) No greater than minimal risk to children is presented; and
    (b) Adequate provisions are made for soliciting the assent of the 
children and the permission of their parents or guardians as set forth 
in Sec.  50.55.

[78 FR 12951, Feb. 26, 2013]



Sec.  50.52  Clinical investigations involving greater than minimal risk
but presenting the prospect of direct benefit to individual subjects.

    Any clinical investigation within the scope described in Sec. Sec.  
50.1 and 56.101 of this chapter in which more than minimal risk to 
children is presented by an intervention or procedure that holds out the 
prospect of direct benefit for

[[Page 376]]

the individual subject, or by a monitoring procedure that is likely to 
contribute to the subject's well-being, may involve children as subjects 
only if the IRB finds that:
    (a) The risk is justified by the anticipated benefit to the 
subjects;
    (b) The relation of the anticipated benefit to the risk is at least 
as favorable to the subjects as that presented by available alternative 
approaches; and
    (c) Adequate provisions are made for soliciting the assent of the 
children and permission of their parents or guardians as set forth in 
Sec.  50.55.

[66 FR 20598, Apr. 24, 2001, as amended at 78 FR 12951, Feb. 26, 2013]



Sec.  50.53  Clinical investigations involving greater than minimal risk
and no prospect of direct benefit to individual subjects, but likely to
yield generalizable knowledge about the subjects' disorder or condition.

    Any clinical investigation within the scope described in Sec. Sec.  
50.1 and 56.101 of this chapter in which more than minimal risk to 
children is presented by an intervention or procedure that does not hold 
out the prospect of direct benefit for the individual subject, or by a 
monitoring procedure that is not likely to contribute to the well-being 
of the subject, may involve children as subjects only if the IRB finds 
that:
    (a) The risk represents a minor increase over minimal risk;
    (b) The intervention or procedure presents experiences to subjects 
that are reasonably commensurate with those inherent in their actual or 
expected medical, dental, psychological, social, or educational 
situations;
    (c) The intervention or procedure is likely to yield generalizable 
knowledge about the subjects' disorder or condition that is of vital 
importance for the understanding or amelioration of the subjects' 
disorder or condition; and
    (d) Adequate provisions are made for soliciting the assent of the 
children and permission of their parents or guardians as set forth in 
Sec.  50.55.

[66 FR 20598, Apr. 24, 2001, as amended at 78 FR 12951, Feb. 26, 2013]



Sec.  50.54  Clinical investigations not otherwise approvable that 
present an opportunity to understand, prevent, or alleviate a serious 
problem affecting the health or welfare of children.

    If an IRB does not believe that a clinical investigation within the 
scope described in Sec. Sec.  50.1 and 56.101 of this chapter and 
involving children as subjects meets the requirements of Sec.  50.51, 
Sec.  50.52, or Sec.  50.53, the clinical investigation may proceed only 
if:
    (a) The IRB finds that the clinical investigation presents a 
reasonable opportunity to further the understanding, prevention, or 
alleviation of a serious problem affecting the health or welfare of 
children; and
    (b) The Commissioner of Food and Drugs, after consultation with a 
panel of experts in pertinent disciplines (for example: science, 
medicine, education, ethics, law) and following opportunity for public 
review and comment, determines either:
    (1) That the clinical investigation in fact satisfies the conditions 
of Sec.  50.51, Sec.  50.52, or Sec.  50.53, as applicable, or
    (2) That the following conditions are met:
    (i) The clinical investigation presents a reasonable opportunity to 
further the understanding, prevention, or alleviation of a serious 
problem affecting the health or welfare of children;
    (ii) The clinical investigation will be conducted in accordance with 
sound ethical principles; and
    (iii) Adequate provisions are made for soliciting the assent of 
children and the permission of their parents or guardians as set forth 
in Sec.  50.55.

[66 FR 20598, Apr. 24, 2001, as amended at 78 FR 12951, Feb. 26, 2013]



Sec.  50.55  Requirements for permission by parents or guardians and
for assent by children.

    (a) In addition to the determinations required under other 
applicable sections of this subpart D, the IRB must determine that 
adequate provisions are made for soliciting the assent of the children 
when in the judgment of the IRB the children are capable of providing 
assent.
    (b) In determining whether children are capable of providing assent, 
the

[[Page 377]]

IRB must take into account the ages, maturity, and psychological state 
of the children involved. This judgment may be made for all children to 
be involved in clinical investigations under a particular protocol, or 
for each child, as the IRB deems appropriate.
    (c) The assent of the children is not a necessary condition for 
proceeding with the clinical investigation if the IRB determines:
    (1) That the capability of some or all of the children is so limited 
that they cannot reasonably be consulted, or
    (2) That the intervention or procedure involved in the clinical 
investigation holds out a prospect of direct benefit that is important 
to the health or well-being of the children and is available only in the 
context of the clinical investigation.
    (d) Even where the IRB determines that the subjects are capable of 
assenting, the IRB may still waive the assent requirement if it finds 
and documents that:
    (1) The clinical investigation involves no more than minimal risk to 
the subjects;
    (2) The waiver will not adversely affect the rights and welfare of 
the subjects;
    (3) The clinical investigation could not practicably be carried out 
without the waiver; and
    (4) Whenever appropriate, the subjects will be provided with 
additional pertinent information after participation.
    (e) In addition to the determinations required under other 
applicable sections of this subpart D, the IRB must determine, in 
accordance with and to the extent that consent is required under part 
50, that the permission of each child's parents or guardian is granted.
    (1) Where parental permission is to be obtained, the IRB may find 
that the permission of one parent is sufficient for clinical 
investigations to be conducted under Sec.  50.51 or Sec.  50.52.
    (2) Where clinical investigations are covered by Sec.  50.53 or 
Sec.  50.54 and permission is to be obtained from parents, both parents 
must give their permission unless one parent is deceased, unknown, 
incompetent, or not reasonably available, or when only one parent has 
legal responsibility for the care and custody of the child.
    (f) Permission by parents or guardians must be documented in 
accordance with and to the extent required by Sec.  50.27.
    (g) When the IRB determines that assent is required, it must also 
determine whether and how assent must be documented.

[66 FR 20598, Apr. 24, 2001, as amended at 78 FR 12951, Feb. 26, 2013]



Sec.  50.56  Wards.

    (a) Children who are wards of the State or any other agency, 
institution, or entity can be included in clinical investigations 
approved under Sec.  50.53 or Sec.  50.54 only if such clinical 
investigations are:
    (1) Related to their status as wards; or
    (2) Conducted in schools, camps, hospitals, institutions, or similar 
settings in which the majority of children involved as subjects are not 
wards.
    (b) If the clinical investigation is approved under paragraph (a) of 
this section, the IRB must require appointment of an advocate for each 
child who is a ward.
    (1) The advocate will serve in addition to any other individual 
acting on behalf of the child as guardian or in loco parentis.
    (2) One individual may serve as advocate for more than one child.
    (3) The advocate must be an individual who has the background and 
experience to act in, and agrees to act in, the best interest of the 
child for the duration of the child's participation in the clinical 
investigation.
    (4) The advocate must not be associated in any way (except in the 
role as advocate or member of the IRB) with the clinical investigation, 
the investigator(s), or the guardian organization.



PART 54_FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS--Table of Contents



Sec.
54.1 Purpose.
54.2 Definitions.
54.3 Scope.
54.4 Certification and disclosure requirements.

[[Page 378]]

54.5 Agency evaluation of financial interests.
54.6 Recordkeeping and record retention.

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c-360j, 
371, 372, 373, 374, 375, 376, 379; 42 U.S.C. 262.

    Source: 63 FR 5250, Feb. 2, 1998, unless otherwise noted.



Sec.  54.1  Purpose.

    (a) The Food and Drug Administration (FDA) evaluates clinical 
studies submitted in marketing applications, required by law, for new 
human drugs and biological products and marketing applications and 
reclassification petitions for medical devices.
    (b) The agency reviews data generated in these clinical studies to 
determine whether the applications are approvable under the statutory 
requirements. FDA may consider clinical studies inadequate and the data 
inadequate if, among other things, appropriate steps have not been taken 
in the design, conduct, reporting, and analysis of the studies to 
minimize bias. One potential source of bias in clinical studies is a 
financial interest of the clinical investigator in the outcome of the 
study because of the way payment is arranged (e.g., a royalty) or 
because the investigator has a proprietary interest in the product 
(e.g., a patent) or because the investigator has an equity interest in 
the sponsor of the covered study. This section and conforming 
regulations require an applicant whose submission relies in part on 
clinical data to disclose certain financial arrangements between 
sponsor(s) of the covered studies and the clinical investigators and 
certain interests of the clinical investigators in the product under 
study or in the sponsor of the covered studies. FDA will use this 
information, in conjunction with information about the design and 
purpose of the study, as well as information obtained through on-site 
inspections, in the agency's assessment of the reliability of the data.



Sec.  54.2  Definitions.

    For the purposes of this part:
    (a) Compensation affected by the outcome of clinical studies means 
compensation that could be higher for a favorable outcome than for an 
unfavorable outcome, such as compensation that is explicitly greater for 
a favorable result or compensation to the investigator in the form of an 
equity interest in the sponsor of a covered study or in the form of 
compensation tied to sales of the product, such as a royalty interest.
    (b) Significant equity interest in the sponsor of a covered study 
means any ownership interest, stock options, or other financial interest 
whose value cannot be readily determined through reference to public 
prices (generally, interests in a nonpublicly traded corporation), or 
any equity interest in a publicly traded corporation that exceeds 
$50,000 during the time the clinical investigator is carrying out the 
study and for 1 year following completion of the study.
    (c) Proprietary interest in the tested product means property or 
other financial interest in the product including, but not limited to, a 
patent, trademark, copyright or licensing agreement.
    (d) Clinical investigator means only a listed or identified 
investigator or subinvestigator who is directly involved in the 
treatment or evaluation of research subjects. The term also includes the 
spouse and each dependent child of the investigator.
    (e) Covered clinical study means any study of a drug or device in 
humans submitted in a marketing application or reclassification petition 
subject to this part that the applicant or FDA relies on to establish 
that the product is effective (including studies that show equivalence 
to an effective product) or any study in which a single investigator 
makes a significant contribution to the demonstration of safety. This 
would, in general, not include phase l tolerance studies or 
pharmacokinetic studies, most clinical pharmacology studies (unless they 
are critical to an efficacy determination), large open safety studies 
conducted at multiple sites, treatment protocols, and parallel track 
protocols. An applicant may consult with FDA as to which clinical 
studies constitute ``covered clinical studies'' for purposes of 
complying with financial disclosure requirements.
    (f) Significant payments of other sorts means payments made by the 
sponsor of a covered study to the investigator

[[Page 379]]

or the institution to support activities of the investigator that have a 
monetary value of more than $25,000, exclusive of the costs of 
conducting the clinical study or other clinical studies, (e.g., a grant 
to fund ongoing research, compensation in the form of equipment or 
retainers for ongoing consultation or honoraria) during the time the 
clinical investigator is carrying out the study and for 1 year following 
the completion of the study.
    (g) Applicant means the party who submits a marketing application to 
FDA for approval of a drug, device, or biologic product. The applicant 
is responsible for submitting the appropriate certification and 
disclosure statements required in this part.
    (h) Sponsor of the covered clinical study means the party supporting 
a particular study at the time it was carried out.

[63 FR 5250, Feb. 2, 1998, as amended at 63 FR 72181, Dec. 31, 1998]



Sec.  54.3  Scope.

    The requirements in this part apply to any applicant who submits a 
marketing application for a human drug, biological product, or device 
and who submits covered clinical studies. The applicant is responsible 
for making the appropriate certification or disclosure statement where 
the applicant either contracted with one or more clinical investigators 
to conduct the studies or submitted studies conducted by others not 
under contract to the applicant.



Sec.  54.4  Certification and disclosure requirements.

    For purposes of this part, an applicant must submit a list of all 
clinical investigators who conducted covered clinical studies to 
determine whether the applicant's product meets FDA's marketing 
requirements, identifying those clinical investigators who are full-time 
or part-time employees of the sponsor of each covered study. The 
applicant must also completely and accurately disclose or certify 
information concerning the financial interests of a clinical 
investigator who is not a full-time or part-time employee of the sponsor 
for each covered clinical study. Clinical investigators subject to 
investigational new drug or investigational device exemption regulations 
must provide the sponsor of the study with sufficient accurate 
information needed to allow subsequent disclosure or certification. The 
applicant is required to submit for each clinical investigator who 
participates in a covered study, either a certification that none of the 
financial arrangements described in Sec.  54.2 exist, or disclose the 
nature of those arrangements to the agency. Where the applicant acts 
with due diligence to obtain the information required in this section 
but is unable to do so, the applicant shall certify that despite the 
applicant's due diligence in attempting to obtain the information, the 
applicant was unable to obtain the information and shall include the 
reason.
    (a) The applicant (of an application submitted under sections 505, 
506, 510(k), 513, or 515 of the Federal Food, Drug, and Cosmetic Act, or 
section 351 of the Public Health Service Act) that relies in whole or in 
part on clinical studies shall submit, for each clinical investigator 
who participated in a covered clinical study, either a certification 
described in paragraph (a)(1) of this section or a disclosure statement 
described in paragraph (a)(3) of this section.
    (1) Certification: The applicant covered by this section shall 
submit for all clinical investigators (as defined in Sec.  54.2(d)), to 
whom the certification applies, a completed Form FDA 3454 attesting to 
the absence of financial interests and arrangements described in 
paragraph (a)(3) of this section. The form shall be dated and signed by 
the chief financial officer or other responsible corporate official or 
representative.
    (2) If the certification covers less than all covered clinical data 
in the application, the applicant shall include in the certification a 
list of the studies covered by this certification.
    (3) Disclosure Statement: For any clinical investigator defined in 
Sec.  54.2(d) for whom the applicant does not submit the certification 
described in paragraph (a)(1) of this section, the applicant shall 
submit a completed Form FDA 3455 disclosing completely and accurately 
the following:
    (i) Any financial arrangement entered into between the sponsor of 
the

[[Page 380]]

covered study and the clinical investigator involved in the conduct of a 
covered clinical trial, whereby the value of the compensation to the 
clinical investigator for conducting the study could be influenced by 
the outcome of the study;
    (ii) Any significant payments of other sorts from the sponsor of the 
covered study, such as a grant to fund ongoing research, compensation in 
the form of equipment, retainer for ongoing consultation, or honoraria;
    (iii) Any proprietary interest in the tested product held by any 
clinical investigator involved in a study;
    (iv) Any significant equity interest in the sponsor of the covered 
study held by any clinical investigator involved in any clinical study; 
and
    (v) Any steps taken to minimize the potential for bias resulting 
from any of the disclosed arrangements, interests, or payments.
    (b) The clinical investigator shall provide to the sponsor of the 
covered study sufficient accurate financial information to allow the 
sponsor to submit complete and accurate certification or disclosure 
statements as required in paragraph (a) of this section. The 
investigator shall promptly update this information if any relevant 
changes occur in the course of the investigation or for 1 year following 
completion of the study.
    (c) Refusal to file application. FDA may refuse to file any 
marketing application described in paragraph (a) of this section that 
does not contain the information required by this section or a 
certification by the applicant that the applicant has acted with due 
diligence to obtain the information but was unable to do so and stating 
the reason.

[63 FR 5250, Feb. 2, 1998; 63 FR 35134, June 29, 1998, as amended at 64 
FR 399, Jan. 5, 1999]



Sec.  54.5  Agency evaluation of financial interests.

    (a) Evaluation of disclosure statement. FDA will evaluate the 
information disclosed under Sec.  54.4(a)(2) about each covered clinical 
study in an application to determine the impact of any disclosed 
financial interests on the reliability of the study. FDA may consider 
both the size and nature of a disclosed financial interest (including 
the potential increase in the value of the interest if the product is 
approved) and steps that have been taken to minimize the potential for 
bias.
    (b) Effect of study design. In assessing the potential of an 
investigator's financial interests to bias a study, FDA will take into 
account the design and purpose of the study. Study designs that utilize 
such approaches as multiple investigators (most of whom do not have a 
disclosable interest), blinding, objective endpoints, or measurement of 
endpoints by someone other than the investigator may adequately protect 
against any bias created by a disclosable financial interest.
    (c) Agency actions to ensure reliability of data. If FDA determines 
that the financial interests of any clinical investigator raise a 
serious question about the integrity of the data, FDA will take any 
action it deems necessary to ensure the reliability of the data 
including:
    (1) Initiating agency audits of the data derived from the clinical 
investigator in question;
    (2) Requesting that the applicant submit further analyses of data, 
e.g., to evaluate the effect of the clinical investigator's data on 
overall study outcome;
    (3) Requesting that the applicant conduct additional independent 
studies to confirm the results of the questioned study; and
    (4) Refusing to treat the covered clinical study as providing data 
that can be the basis for an agency action.



Sec.  54.6  Recordkeeping and record retention.

    (a) Financial records of clinical investigators to be retained. An 
applicant who has submitted a marketing application containing covered 
clinical studies shall keep on file certain information pertaining to 
the financial interests of clinical investigators who conducted studies 
on which the application relies and who are not full or part-time 
employees of the applicant, as follows:
    (1) Complete records showing any financial interest or arrangement 
as described in Sec.  54.4(a)(3)(i) paid to such clinical investigators 
by the sponsor of the covered study.

[[Page 381]]

    (2) Complete records showing significant payments of other sorts, as 
described in Sec.  54.4(a)(3)(ii), made by the sponsor of the covered 
clinical study to the clinical investigator.
    (3) Complete records showing any financial interests held by 
clinical investigators as set forth in Sec.  54.4(a)(3)(iii) and 
(a)(3)(iv).
    (b) Requirements for maintenance of clinical investigators' 
financial records. (1) For any application submitted for a covered 
product, an applicant shall retain records as described in paragraph (a) 
of this section for 2 years after the date of approval of the 
application.
    (2) The person maintaining these records shall, upon request from 
any properly authorized officer or employee of FDA, at reasonable times, 
permit such officer or employee to have access to and copy and verify 
these records.



PART 56_INSTITUTIONAL REVIEW BOARDS--Table of Contents



                      Subpart A_General Provisions

Sec.
56.101 Scope.
56.102 Definitions.
56.103 Circumstances in which IRB review is required.
56.104 Exemptions from IRB requirement.
56.105 Waiver of IRB requirement.
56.106 Registration.

                  Subpart B_Organization and Personnel

56.107 IRB membership.

                 Subpart C_IRB Functions and Operations

56.108 IRB functions and operations.
56.109 IRB review of research.
56.110 Expedited review procedures for certain kinds of research 
          involving no more than minimal risk, and for minor changes in 
          approved research.
56.111 Criteria for IRB approval of research.
56.112 Review by institution.
56.113 Suspension or termination of IRB approval of research.
56.114 Cooperative research.

                      Subpart D_Records and Reports

56.115 IRB records.

           Subpart E_Administrative Actions for Noncompliance

56.120 Lesser administrative actions.
56.121 Disqualification of an IRB or an institution.
56.122 Public disclosure of information regarding revocation.
56.123 Reinstatement of an IRB or an institution.
56.124 Actions alternative or additional to disqualification.

    Authority: 21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 
353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 379e, 381; 
42 U.S.C. 216, 241, 262.

    Source: 46 FR 8975, Jan. 27, 1981, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  56.101  Scope.

    (a) This part contains the general standards for the composition, 
operation, and responsibility of an Institutional Review Board (IRB) 
that reviews clinical investigations regulated by the Food and Drug 
Administration under sections 505(i) and 520(g) of the act, as well as 
clinical investigations that support applications for research or 
marketing permits for products regulated by the Food and Drug 
Administration, including foods, including dietary supplements, that 
bear a nutrient content claim or a health claim, infant formulas, food 
and color additives, drugs for human use, medical devices for human use, 
biological products for human use, and electronic products. Compliance 
with this part is intended to protect the rights and welfare of human 
subjects involved in such investigations.
    (b) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.

[46 FR 8975, Jan. 27, 1981, as amended at 64 FR 399, Jan. 5, 1999; 66 FR 
20599, Apr. 24, 2001]



Sec.  56.102  Definitions.

    As used in this part:
    (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended 
(secs. 201-902, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-392)).
    (b) Application for research or marketing permit includes:
    (1) A color additive petition, described in part 71.

[[Page 382]]

    (2) Data and information regarding a substance submitted as part of 
the procedures for establishing that a substance is generally recognized 
as safe for a use which results or may reasonably be expected to result, 
directly or indirectly, in its becoming a component or otherwise 
affecting the characteristics of any food, described in Sec.  170.35.
    (3) A food additive petition, described in part 171.
    (4) Data and information regarding a food additive submitted as part 
of the procedures regarding food additives permitted to be used on an 
interim basis pending additional study, described in Sec.  180.1.
    (5) Data and information regarding a substance submitted as part of 
the procedures for establishing a tolerance for unavoidable contaminants 
in food and food-packaging materials, described in section 406 of the 
act.
    (6) An investigational new drug application, described in part 312 
of this chapter.
    (7) A new drug application, described in part 314.
    (8) Data and information regarding the bioavailability or 
bioequivalence of drugs for human use submitted as part of the 
procedures for issuing, amending, or repealing a bioequivalence 
requirement, described in part 320.
    (9) Data and information regarding an over-the-counter drug for 
human use submitted as part of the procedures for classifying such drugs 
as generally recognized as safe and effective and not misbranded, 
described in part 330.
    (10) An application for a biologics license, described in part 601 
of this chapter.
    (11) Data and information regarding a biological product submitted 
as part of the procedures for determining that licensed biological 
products are safe and effective and not misbranded, as described in part 
601 of this chapter.
    (12) An Application for an Investigational Device Exemption, 
described in part 812.
    (13) Data and information regarding a medical device for human use 
submitted as part of the procedures for classifying such devices, 
described in part 860.
    (14) Data and information regarding a medical device for human use 
submitted as part of the procedures for establishing, amending, or 
repealing a standard for such device, described in part 861.
    (15) An application for premarket approval of a medical device for 
human use, described in section 515 of the act.
    (16) A product development protocol for a medical device for human 
use, described in section 515 of the act.
    (17) Data and information regarding an electronic product submitted 
as part of the procedures for establishing, amending, or repealing a 
standard for such products, described in section 358 of the Public 
Health Service Act.
    (18) Data and information regarding an electronic product submitted 
as part of the procedures for obtaining a variance from any electronic 
product performance standard, as described in Sec.  1010.4.
    (19) Data and information regarding an electronic product submitted 
as part of the procedures for granting, amending, or extending an 
exemption from a radiation safety performance standard, as described in 
Sec.  1010.5.
    (20) Data and information regarding an electronic product submitted 
as part of the procedures for obtaining an exemption from notification 
of a radiation safety defect or failure of compliance with a radiation 
safety performance standard, described in subpart D of part 1003.
    (21) Data and information about a clinical study of an infant 
formula when submitted as part of an infant formula notification under 
section 412(c) of the Federal Food, Drug, and Cosmetic Act.
    (22) Data and information submitted in a petition for a nutrient 
content claim, described in Sec.  101.69 of this chapter, and for a 
health claim, described in Sec.  101.70 of this chapter.
    (23) Data and information from investigations involving children 
submitted in a new dietary ingredient notification, described in Sec.  
190.6 of this chapter.
    (c) Clinical investigation means any experiment that involves a test 
article and one or more human subjects, and that either must meet the 
requirements for prior submission to the Food and Drug Administration 
under section

[[Page 383]]

505(i) or 520(g) of the act, or need not meet the requirements for prior 
submission to the Food and Drug Administration under these sections of 
the act, but the results of which are intended to be later submitted to, 
or held for inspection by, the Food and Drug Administration as part of 
an application for a research or marketing permit. The term does not 
include experiments that must meet the provisions of part 58, regarding 
nonclinical laboratory studies. The terms research, clinical research, 
clinical study, study, and clinical investigation are deemed to be 
synonymous for purposes of this part.
    (d) Emergency use means the use of a test article on a human subject 
in a life-threatening situation in which no standard acceptable 
treatment is available, and in which there is not sufficient time to 
obtain IRB approval.
    (e) Human subject means an individual who is or becomes a 
participant in research, either as a recipient of the test article or as 
a control. A subject may be either a healthy individual or a patient.
    (f) Institution means any public or private entity or agency 
(including Federal, State, and other agencies). The term facility as 
used in section 520(g) of the act is deemed to be synonymous with the 
term institution for purposes of this part.
    (g) Institutional Review Board (IRB) means any board, committee, or 
other group formally designated by an institution to review, to approve 
the initiation of, and to conduct periodic review of, biomedical 
research involving human subjects. The primary purpose of such review is 
to assure the protection of the rights and welfare of the human 
subjects. The term has the same meaning as the phrase institutional 
review committee as used in section 520(g) of the act.
    (h) Investigator means an individual who actually conducts a 
clinical investigation (i.e., under whose immediate direction the test 
article is administered or dispensed to, or used involving, a subject) 
or, in the event of an investigation conducted by a team of individuals, 
is the responsible leader of that team.
    (i) Minimal risk means that the probability and magnitude of harm or 
discomfort anticipated in the research are not greater in and of 
themselves than those ordinarily encountered in daily life or during the 
performance of routine physical or psychological examinations or tests.
    (j) Sponsor means a person or other entity that initiates a clinical 
investigation, but that does not actually conduct the investigation, 
i.e., the test article is administered or dispensed to, or used 
involving, a subject under the immediate direction of another 
individual. A person other than an individual (e.g., a corporation or 
agency) that uses one or more of its own employees to conduct an 
investigation that it has initiated is considered to be a sponsor (not a 
sponsor-investigator), and the employees are considered to be 
investigators.
    (k) Sponsor-investigator means an individual who both initiates and 
actually conducts, alone or with others, a clinical investigation, i.e., 
under whose immediate direction the test article is administered or 
dispensed to, or used involving, a subject. The term does not include 
any person other than an individual, e.g., it does not include a 
corporation or agency. The obligations of a sponsor-investigator under 
this part include both those of a sponsor and those of an investigator.
    (l) Test article means any drug for human use, biological product 
for human use, medical device for human use, human food additive, color 
additive, electronic product, or any other article subject to regulation 
under the act or under sections 351 or 354-360F of the Public Health 
Service Act.
    (m) IRB approval means the determination of the IRB that the 
clinical investigation has been reviewed and may be conducted at an 
institution within the constraints set forth by the IRB and by other 
institutional and Federal requirements.

[46 FR 8975, Jan. 27, 1981, as amended at 54 FR 9038, Mar. 3, 1989; 56 
FR 28028, June 18, 1991; 64 FR 399, Jan. 5, 1999; 64 FR 56448, Oct. 20, 
1999; 65 FR 52302, Aug. 29, 2000; 66 FR 20599, Apr. 24, 2001; 74 FR 
2368, Jan. 15, 2009]



Sec.  56.103  Circumstances in which IRB review is required.

    (a) Except as provided in Sec. Sec.  56.104 and 56.105, any clinical 
investigation which

[[Page 384]]

must meet the requirements for prior submission (as required in parts 
312, 812, and 813) to the Food and Drug Administration shall not be 
initiated unless that investigation has been reviewed and approved by, 
and remains subject to continuing review by, an IRB meeting the 
requirements of this part.
    (b) Except as provided in Sec. Sec.  56.104 and 56.105, the Food and 
Drug Administration may decide not to consider in support of an 
application for a research or marketing permit any data or information 
that has been derived from a clinical investigation that has not been 
approved by, and that was not subject to initial and continuing review 
by, an IRB meeting the requirements of this part. The determination that 
a clinical investigation may not be considered in support of an 
application for a research or marketing permit does not, however, 
relieve the applicant for such a permit of any obligation under any 
other applicable regulations to submit the results of the investigation 
to the Food and Drug Administration.
    (c) Compliance with these regulations will in no way render 
inapplicable pertinent Federal, State, or local laws or regulations.

[46 FR 8975, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981]



Sec.  56.104  Exemptions from IRB requirement.

    The following categories of clinical investigations are exempt from 
the requirements of this part for IRB review:
    (a) Any investigation which commenced before July 27, 1981 and was 
subject to requirements for IRB review under FDA regulations before that 
date, provided that the investigation remains subject to review of an 
IRB which meets the FDA requirements in effect before July 27, 1981.
    (b) Any investigation commenced before July 27, 1981 and was not 
otherwise subject to requirements for IRB review under Food and Drug 
Administration regulations before that date.
    (c) Emergency use of a test article, provided that such emergency 
use is reported to the IRB within 5 working days. Any subsequent use of 
the test article at the institution is subject to IRB review.
    (d) Taste and food quality evaluations and consumer acceptance 
studies, if wholesome foods without additives are consumed or if a food 
is consumed that contains a food ingredient at or below the level and 
for a use found to be safe, or agricultural, chemical, or environmental 
contaminant at or below the level found to be safe, by the Food and Drug 
Administration or approved by the Environmental Protection Agency or the 
Food Safety and Inspection Service of the U.S. Department of 
Agriculture.

[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28028, June 18, 1991]



Sec.  56.105  Waiver of IRB requirement.

    On the application of a sponsor or sponsor-investigator, the Food 
and Drug Administration may waive any of the requirements contained in 
these regulations, including the requirements for IRB review, for 
specific research activities or for classes of research activities, 
otherwise covered by these regulations.



                  Subpart B_Organization and Personnel



Sec.  56.106  Registration.

    (a) Who must register? Each IRB in the United States that reviews 
clinical investigations regulated by FDA under sections 505(i) or 520(g) 
of the act and each IRB in the United States that reviews clinical 
investigations that are intended to support applications for research or 
marketing permits for FDA-regulated products must register at a site 
maintained by the Department of Health and Human Services (HHS). (A 
research permit under section 505(i) of the act is usually known as an 
investigational new drug application (IND), while a research permit 
under section 520(g) of the act is usually known as an investigational 
device exemption (IDE).) An individual authorized to act on the IRB's 
behalf must submit the registration information. All other IRBs may 
register voluntarily.
    (b) What information must an IRB register? Each IRB must provide the 
following information:
    (1) The name, mailing address, and street address (if different from 
the

[[Page 385]]

mailing address) of the institution operating the IRB and the name, 
mailing address, phone number, facsimile number, and electronic mail 
address of the senior officer of that institution who is responsible for 
overseeing activities performed by the IRB;
    (2) The IRB's name, mailing address, street address (if different 
from the mailing address), phone number, facsimile number, and 
electronic mail address; each IRB chairperson's name, phone number, and 
electronic mail address; and the name, mailing address, phone number, 
facsimile number, and electronic mail address of the contact person 
providing the registration information.
    (3) The approximate number of active protocols involving FDA-
regulated products reviewed. For purposes of this rule, an ``active 
protocol'' is any protocol for which an IRB conducted an initial review 
or a continuing review at a convened meeting or under an expedited 
review procedure during the preceding 12 months; and
    (4) A description of the types of FDA-regulated products (such as 
biological products, color additives, food additives, human drugs, or 
medical devices) involved in the protocols that the IRB reviews.
    (c) When must an IRB register? Each IRB must submit an initial 
registration. The initial registration must occur before the IRB begins 
to review a clinical investigation described in paragraph (a) of this 
section. Each IRB must renew its registration every 3 years. IRB 
registration becomes effective after review and acceptance by HHS.
    (d) Where can an IRB register? Each IRB may register electronically 
through http://ohrp.cit.nih.gov/efile. If an IRB lacks the ability to 
register electronically, it must send its registration information, in 
writing, to the Office of Good Clinical Practice, Office of Special 
Medical Programs, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993.
    (e) How does an IRB revise its registration information? If an IRB's 
contact or chair person information changes, the IRB must revise its 
registration information by submitting any changes in that information 
within 90 days of the change. An IRB's decision to review new types of 
FDA-regulated products (such as a decision to review studies pertaining 
to food additives whereas the IRB previously reviewed studies pertaining 
to drug products), or to discontinue reviewing clinical investigations 
regulated by FDA is a change that must be reported within 30 days of the 
change. An IRB's decision to disband is a change that must be reported 
within 30 days of permanent cessation of the IRB's review of research. 
All other information changes may be reported when the IRB renews its 
registration. The revised information must be sent to FDA either 
electronically or in writing in accordance with paragraph (d) of this 
section.

[74 FR 2368, Jan. 15, 2009, as amended at 78 FR 16401, Mar. 15, 2013]



Sec.  56.107  IRB membership.

    (a) Each IRB shall have at least five members, with varying 
backgrounds to promote complete and adequate review of research 
activities commonly conducted by the institution. The IRB shall be 
sufficiently qualified through the experience and expertise of its 
members, and the diversity of the members, including consideration of 
race, gender, cultural backgrounds, and sensitivity to such issues as 
community attitudes, to promote respect for its advice and counsel in 
safeguarding the rights and welfare of human subjects. In addition to 
possessing the professional competence necessary to review the specific 
research activities, the IRB shall be able to ascertain the 
acceptability of proposed research in terms of institutional commitments 
and regulations, applicable law, and standards of professional conduct 
and practice. * * * The IRB shall therefore include persons 
knowledgeable in these areas. If an IRB regularly reviews research that 
involves a vulnerable category of subjects, such as children, prisoners, 
pregnant women, or handicapped or mentally disabled persons, 
consideration shall be given to the inclusion of one or more individuals 
who are knowledgeable about and experienced in working with those 
subjects.
    (b) Every nondiscriminatory effort will be made to ensure that no 
IRB

[[Page 386]]

consists entirely of men or entirely of women, including the 
instituton's consideration of qualified persons of both sexes, so long 
as no selection is made to the IRB on the basis of gender. No IRB may 
consist entirely of members of one profession.
    (c) Each IRB shall include at least one member whose primary 
concerns are in the scientific area and at least one member whose 
primary concerns are in nonscientific areas.
    (d) Each IRB shall include at least one member who is not otherwise 
affiliated with the institution and who is not part of the immediate 
family of a person who is affiliated with the institution.
    (e) No IRB may have a member participate in the IRB's initial or 
continuing review of any project in which the member has a conflicting 
interest, except to provide information requested by the IRB.
    (f) An IRB may, in its discretion, invite individuals with 
competence in special areas to assist in the review of complex issues 
which require expertise beyond or in addition to that available on the 
IRB. These individuals may not vote with the IRB.

[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28028, June 18, 1991; 56 
FR 29756, June 28, 1991; 78 FR 16401, Mar. 15, 2013]



                 Subpart C_IRB Functions and Operations



Sec.  56.108  IRB functions and operations.

    In order to fulfill the requirements of these regulations, each IRB 
shall:
    (a) Follow written procedures: (1) For conducting its initial and 
continuing review of research and for reporting its findings and actions 
to the investigator and the institution; (2) for determining which 
projects require review more often than annually and which projects need 
verification from sources other than the investigator that no material 
changes have occurred since previous IRB review; (3) for ensuring prompt 
reporting to the IRB of changes in research activity; and (4) for 
ensuring that changes in approved research, during the period for which 
IRB approval has already been given, may not be initiated without IRB 
review and approval except where necessary to eliminate apparent 
immediate hazards to the human subjects.
    (b) Follow written procedures for ensuring prompt reporting to the 
IRB, appropriate institutional officials, and the Food and Drug 
Administration of: (1) Any unanticipated problems involving risks to 
human subjects or others; (2) any instance of serious or continuing 
noncompliance with these regulations or the requirements or 
determinations of the IRB; or (3) any suspension or termination of IRB 
approval.
    (c) Except when an expedited review procedure is used (see Sec.  
56.110), review proposed research at convened meetings at which a 
majority of the members of the IRB are present, including at least one 
member whose primary concerns are in nonscientific areas. In order for 
the research to be approved, it shall receive the approval of a majority 
of those members present at the meeting.

[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28028, June 18, 1991; 67 
FR 9585, Mar. 4, 2002]



Sec.  56.109  IRB review of research.

    (a) An IRB shall review and have authority to approve, require 
modifications in (to secure approval), or disapprove all research 
activities covered by these regulations.
    (b) An IRB shall require that information given to subjects as part 
of informed consent is in accordance with Sec.  50.25. The IRB may 
require that information, in addition to that specifically mentioned in 
Sec.  50.25, be given to the subjects when in the IRB's judgment the 
information would meaningfully add to the protection of the rights and 
welfare of subjects.
    (c) An IRB shall require documentation of informed consent in 
accordance with Sec.  50.27 of this chapter, except as follows:
    (1) The IRB may, for some or all subjects, waive the requirement 
that the subject, or the subject's legally authorized representative, 
sign a written consent form if it finds that the research presents no 
more than minimal risk of harm to subjects and involves no procedures 
for which written consent is normally required outside the research 
context; or

[[Page 387]]

    (2) The IRB may, for some or all subjects, find that the 
requirements in Sec.  50.24 of this chapter for an exception from 
informed consent for emergency research are met.
    (d) In cases where the documentation requirement is waived under 
paragraph (c)(1) of this section, the IRB may require the investigator 
to provide subjects with a written statement regarding the research.
    (e) An IRB shall notify investigators and the institution in writing 
of its decision to approve or disapprove the proposed research activity, 
or of modifications required to secure IRB approval of the research 
activity. If the IRB decides to disapprove a research activity, it shall 
include in its written notification a statement of the reasons for its 
decision and give the investigator an opportunity to respond in person 
or in writing. For investigations involving an exception to informed 
consent under Sec.  50.24 of this chapter, an IRB shall promptly notify 
in writing the investigator and the sponsor of the research when an IRB 
determines that it cannot approve the research because it does not meet 
the criteria in the exception provided under Sec.  50.24(a) of this 
chapter or because of other relevant ethical concerns. The written 
notification shall include a statement of the reasons for the IRB's 
determination.
    (f) An IRB shall conduct continuing review of research covered by 
these regulations at intervals appropriate to the degree of risk, but 
not less than once per year, and shall have authority to observe or have 
a third party observe the consent process and the research.
    (g) An IRB shall provide in writing to the sponsor of research 
involving an exception to informed consent under Sec.  50.24 of this 
chapter a copy of information that has been publicly disclosed under 
Sec.  50.24(a)(7)(ii) and (a)(7)(iii) of this chapter. The IRB shall 
provide this information to the sponsor promptly so that the sponsor is 
aware that such disclosure has occurred. Upon receipt, the sponsor shall 
provide copies of the information disclosed to FDA.
    (h) When some or all of the subjects in a study are children, an IRB 
must determine that the research study is in compliance with part 50, 
subpart D of this chapter, at the time of its initial review of the 
research. When some or all of the subjects in a study that was ongoing 
on April 30, 2001, are children, an IRB must conduct a review of the 
research to determine compliance with part 50, subpart D of this 
chapter, either at the time of continuing review or, at the discretion 
of the IRB, at an earlier date.

[46 FR 8975, Jan. 27, 1981, as amended at 61 FR 51529, Oct. 2, 1996; 66 
FR 20599, Apr. 24, 2001; 78 FR 12951, Feb. 26, 2013]



Sec.  56.110  Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in approved
research.

    (a) The Food and Drug Administration has established, and published 
in the Federal Register, a list of categories of research that may be 
reviewed by the IRB through an expedited review procedure. The list will 
be amended, as appropriate, through periodic republication in the 
Federal Register.
    (b) An IRB may use the expedited review procedure to review either 
or both of the following: (1) Some or all of the research appearing on 
the list and found by the reviewer(s) to involve no more than minimal 
risk, (2) minor changes in previously approved research during the 
period (of 1 year or less) for which approval is authorized. Under an 
expedited review procedure, the review may be carried out by the IRB 
chairperson or by one or more experienced reviewers designated by the 
IRB chairperson from among the members of the IRB. In reviewing the 
research, the reviewers may exercise all of the authorities of the IRB 
except that the reviewers may not disapprove the research. A research 
activity may be disapproved only after review in accordance with the 
nonexpedited review procedure set forth in Sec.  56.108(c).
    (c) Each IRB which uses an expedited review procedure shall adopt a 
method for keeping all members advised of research proposals which have 
been approved under the procedure.
    (d) The Food and Drug Administration may restrict, suspend, or 
terminate an institution's or IRB's use of

[[Page 388]]

the expedited review procedure when necessary to protect the rights or 
welfare of subjects.

[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991]



Sec.  56.111  Criteria for IRB approval of research.

    (a) In order to approve research covered by these regulations the 
IRB shall determine that all of the following requirements are 
satisfied:
    (1) Risks to subjects are minimized: (i) By using procedures which 
are consistent with sound research design and which do not unnecessarily 
expose subjects to risk, and (ii) whenever appropriate, by using 
procedures already being performed on the subjects for diagnostic or 
treatment purposes.
    (2) Risks to subjects are reasonable in relation to anticipated 
benefits, if any, to subjects, and the importance of the knowledge that 
may be expected to result. In evaluating risks and benefits, the IRB 
should consider only those risks and benefits that may result from the 
research (as distinguished from risks and benefits of therapies that 
subjects would receive even if not participating in the research). The 
IRB should not consider possible long-range effects of applying 
knowledge gained in the research (for example, the possible effects of 
the research on public policy) as among those research risks that fall 
within the purview of its responsibility.
    (3) Selection of subjects is equitable. In making this assessment 
the IRB should take into account the purposes of the research and the 
setting in which the research will be conducted and should be 
particularly cognizant of the special problems of research involving 
vulnerable populations, such as children, prisoners, pregnant women, 
handicapped, or mentally disabled persons, or economically or 
educationally disadvantaged persons.
    (4) Informed consent will be sought from each prospective subject or 
the subject's legally authorized representative, in accordance with and 
to the extent required by part 50.
    (5) Informed consent will be appropriately documented, in accordance 
with and to the extent required by Sec.  50.27.
    (6) Where appropriate, the research plan makes adequate provision 
for monitoring the data collected to ensure the safety of subjects.
    (7) Where appropriate, there are adequate provisions to protect the 
privacy of subjects and to maintain the confidentiality of data.
    (b) When some or all of the subjects, such as children, prisoners, 
pregnant women, handicapped, or mentally disabled persons, or 
economically or educationally disadvantaged persons, are likely to be 
vulnerable to coercion or undue influence additional safeguards have 
been included in the study to protect the rights and welfare of these 
subjects.
    (c) In order to approve research in which some or all of the 
subjects are children, an IRB must determine that all research is in 
compliance with part 50, subpart D of this chapter.

[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991; 66 
FR 20599, Apr. 24, 2001]



Sec.  56.112  Review by institution.

    Research covered by these regulations that has been approved by an 
IRB may be subject to further appropriate review and approval or 
disapproval by officials of the institution. However, those officials 
may not approve the research if it has not been approved by an IRB.



Sec.  56.113  Suspension or termination of IRB approval of research.

    An IRB shall have authority to suspend or terminate approval of 
research that is not being conducted in accordance with the IRB's 
requirements or that has been associated with unexpected serious harm to 
subjects. Any suspension or termination of approval shall include a 
statement of the reasons for the IRB's action and shall be reported 
promptly to the investigator, appropriate institutional officials, and 
the Food and Drug Administration.



Sec.  56.114  Cooperative research.

    In complying with these regulations, institutions involved in multi-
institutional studies may use joint review, reliance upon the review of 
another qualified IRB, or similar arrangements

[[Page 389]]

aimed at avoidance of duplication of effort.



                      Subpart D_Records and Reports



Sec.  56.115  IRB records.

    (a) An institution, or where appropriate an IRB, shall prepare and 
maintain adequate documentation of IRB activities, including the 
following:
    (1) Copies of all research proposals reviewed, scientific 
evaluations, if any, that accompany the proposals, approved sample 
consent documents, progress reports submitted by investigators, and 
reports of injuries to subjects.
    (2) Minutes of IRB meetings which shall be in sufficient detail to 
show attendance at the meetings; actions taken by the IRB; the vote on 
these actions including the number of members voting for, against, and 
abstaining; the basis for requiring changes in or disapproving research; 
and a written summary of the discussion of controverted issues and their 
resolution.
    (3) Records of continuing review activities.
    (4) Copies of all correspondence between the IRB and the 
investigators.
    (5) A list of IRB members identified by name; earned degrees; 
representative capacity; indications of experience such as board 
certifications, licenses, etc., sufficient to describe each member's 
chief anticipated contributions to IRB deliberations; and any employment 
or other relationship between each member and the institution; for 
example: full-time employee, part-time employee, a member of governing 
panel or board, stockholder, paid or unpaid consultant.
    (6) Written procedures for the IRB as required by Sec.  56.108 (a) 
and (b).
    (7) Statements of significant new findings provided to subjects, as 
required by Sec.  50.25.
    (b) The records required by this regulation shall be retained for at 
least 3 years after completion of the research, and the records shall be 
accessible for inspection and copying by authorized representatives of 
the Food and Drug Administration at reasonable times and in a reasonable 
manner.
    (c) The Food and Drug Administration may refuse to consider a 
clinical investigation in support of an application for a research or 
marketing permit if the institution or the IRB that reviewed the 
investigation refuses to allow an inspection under this section.

[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991; 67 
FR 9585, Mar. 4, 2002]



           Subpart E_Administrative Actions for Noncompliance



Sec.  56.120  Lesser administrative actions.

    (a) If apparent noncompliance with these regulations in the 
operation of an IRB is observed by an FDA investigator during an 
inspection, the inspector will present an oral or written summary of 
observations to an appropriate representative of the IRB. The Food and 
Drug Administration may subsequently send a letter describing the 
noncompliance to the IRB and to the parent institution. The agency will 
require that the IRB or the parent institution respond to this letter 
within a time period specified by FDA and describe the corrective 
actions that will be taken by the IRB, the institution, or both to 
achieve compliance with these regulations.
    (b) On the basis of the IRB's or the institution's response, FDA may 
schedule a reinspection to confirm the adequacy of corrective actions. 
In addition, until the IRB or the parent institution takes appropriate 
corrective action, the Agency may require the IRB to:
    (1) Withhold approval of new studies subject to the requirements of 
this part that are conducted at the institution or reviewed by the IRB;
    (2) Direct that no new subjects be added to ongoing studies subject 
to this part; or
    (3) Terminate ongoing studies subject to this part when doing so 
would not endanger the subjects.
    (c) When the apparent noncompliance creates a significant threat to 
the rights and welfare of human subjects, FDA may notify relevant State 
and Federal regulatory agencies and other parties with a direct interest 
in the Agency's action of the deficiencies in the operation of the IRB.

[[Page 390]]

    (d) The parent institution is presumed to be responsible for the 
operation of an IRB, and the Food and Drug Administration will 
ordinarily direct any administrative action under this subpart against 
the institution. However, depending on the evidence of responsibility 
for deficiencies, determined during the investigation, the Food and Drug 
Administration may restrict its administrative actions to the IRB or to 
a component of the parent institution determined to be responsible for 
formal designation of the IRB.

[46 FR 8975, Jan. 27, 1981, as amended at 81 FR 19035, Apr. 4, 2016]



Sec.  56.121  Disqualification of an IRB or an institution.

    (a) Whenever the IRB or the institution has failed to take adequate 
steps to correct the noncompliance stated in the letter sent by the 
agency under Sec.  56.120(a), and the Commissioner of Food and Drugs 
determines that this noncompliance may justify the disqualification of 
the IRB or of the parent institution, the Commissioner will institute 
proceedings in accordance with the requirements for a regulatory hearing 
set forth in part 16.
    (b) The Commissioner may disqualify an IRB or the parent institution 
if the Commissioner determines that:
    (1) The IRB has refused or repeatedly failed to comply with any of 
the regulations set forth in this part, and
    (2) The noncompliance adversely affects the rights or welfare of the 
human subjects in a clinical investigation.
    (c) If the Commissioner determines that disqualification is 
appropriate, the Commissioner will issue an order that explains the 
basis for the determination and that prescribes any actions to be taken 
with regard to ongoing clinical research conducted under the review of 
the IRB. The Food and Drug Administration will send notice of the 
disqualification to the IRB and the parent institution. Other parties 
with a direct interest, such as sponsors and clinical investigators, may 
also be sent a notice of the disqualification. In addition, the agency 
may elect to publish a notice of its action in the Federal Register.
    (d) The Food and Drug Administration will not approve an application 
for a research permit for a clinical investigation that is to be under 
the review of a disqualified IRB or that is to be conducted at a 
disqualified institution, and it may refuse to consider in support of a 
marketing permit the data from a clinical investigation that was 
reviewed by a disqualified IRB as conducted at a disqualified 
institution, unless the IRB or the parent institution is reinstated as 
provided in Sec.  56.123.



Sec.  56.122  Public disclosure of information regarding revocation.

    A determination that the Food and Drug Administration has 
disqualified an institution and the administrative record regarding that 
determination are disclosable to the public under part 20.



Sec.  56.123  Reinstatement of an IRB or an institution.

    An IRB or an institution may be reinstated if the Commissioner 
determines, upon an evaluation of a written submission from the IRB or 
institution that explains the corrective action that the institution or 
IRB plans to take, that the IRB or institution has provided adequate 
assurance that it will operate in compliance with the standards set 
forth in this part. Notification of reinstatement shall be provided to 
all persons notified under Sec.  56.121(c).



Sec.  56.124  Actions alternative or additional to disqualification.

    Disqualification of an IRB or of an institution is independent of, 
and neither in lieu of nor a precondition to, other proceedings or 
actions authorized by the act. The Food and Drug Administration may, at 
any time, through the Department of Justice institute any appropriate 
judicial proceedings (civil or criminal) and any other appropriate 
regulatory action, in addition to or in lieu of, and before, at the time 
of, or after, disqualification. The agency may also refer pertinent 
matters to another Federal, State, or local government agency for any 
action that that agency determines to be appropriate.

[[Page 391]]



PART 58_GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
--Table of Contents



                      Subpart A_General Provisions

Sec.
58.1 Scope.
58.3 Definitions.
58.10 Applicability to studies performed under grants and contracts.
58.15 Inspection of a testing facility.

                  Subpart B_Organization and Personnel

58.29 Personnel.
58.31 Testing facility management.
58.33 Study director.
58.35 Quality assurance unit.

                          Subpart C_Facilities

58.41 General.
58.43 Animal care facilities.
58.45 Animal supply facilities.
58.47 Facilities for handling test and control articles.
58.49 Laboratory operation areas.
58.51 Specimen and data storage facilities.

                           Subpart D_Equipment

58.61 Equipment design.
58.63 Maintenance and calibration of equipment.

                 Subpart E_Testing Facilities Operation

58.81 Standard operating procedures.
58.83 Reagents and solutions.
58.90 Animal care.

                   Subpart F_Test and Control Articles

58.105 Test and control article characterization.
58.107 Test and control article handling.
58.113 Mixture of articles with carriers.

  Subpart G_Protocol for and Conduct of a Nonclinical Laboratory Study

58.120 Protocol.
58.130 Conduct of a nonclinical laboratory study.

Subparts H-I [Reserved]

                      Subpart J_Records and Reports

58.185 Reporting of nonclinical laboratory study results.
58.190 Storage and retrieval of records and data.
58.195 Retention of records.

            Subpart K_Disqualification of Testing Facilities

58.200 Purpose.
58.202 Grounds for disqualification.
58.204 Notice of and opportunity for hearing on proposed 
          disqualification.
58.206 Final order on disqualification.
58.210 Actions upon disqualification.
58.213 Public disclosure of information regarding disqualification.
58.215 Alternative or additional actions to disqualification.
58.217 Suspension or termination of a testing facility by a sponsor.
58.219 Reinstatement of a disqualified testing facility.

    Authority: 21 U.S.C. 342, 346, 346a, 348, 351, 352, 353, 355, 360, 
360b-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 262, 263b-263n.

    Source: 43 FR 60013, Dec. 22, 1978, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  58.1  Scope.

    (a) This part prescribes good laboratory practices for conducting 
nonclinical laboratory studies that support or are intended to support 
applications for research or marketing permits for products regulated by 
the Food and Drug Administration, including food and color additives, 
animal food additives, human and animal drugs, medical devices for human 
use, biological products, and electronic products. Compliance with this 
part is intended to assure the quality and integrity of the safety data 
filed pursuant to sections 406, 408, 409, 502, 503, 505, 506, 510, 512-
516, 518-520, 721, and 801 of the Federal Food, Drug, and Cosmetic Act 
and sections 351 and 354-360F of the Public Health Service Act.
    (b) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 
64 FR 399, Jan. 5, 1999]



Sec.  58.3  Definitions.

    As used in this part, the following terms shall have the meanings 
specified:
    (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended 
(secs. 201-902, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-392)).

[[Page 392]]

    (b) Test article means any food additive, color additive, drug, 
biological product, electronic product, medical device for human use, or 
any other article subject to regulation under the act or under sections 
351 and 354-360F of the Public Health Service Act.
    (c) Control article means any food additive, color additive, drug, 
biological product, electronic product, medical device for human use, or 
any article other than a test article, feed, or water that is 
administered to the test system in the course of a nonclinical 
laboratory study for the purpose of establishing a basis for comparison 
with the test article.
    (d) Nonclinical laboratory study means in vivo or in vitro 
experiments in which test articles are studied prospectively in test 
systems under laboratory conditions to determine their safety. The term 
does not include studies utilizing human subjects or clinical studies or 
field trials in animals. The term does not include basic exploratory 
studies carried out to determine whether a test article has any 
potential utility or to determine physical or chemical characteristics 
of a test article.
    (e) Application for research or marketing permit includes:
    (1) A color additive petition, described in part 71.
    (2) A food additive petition, described in parts 171 and 571.
    (3) Data and information regarding a substance submitted as part of 
the procedures for establishing that a substance is generally recognized 
as safe for use, which use results or may reasonably be expected to 
result, directly or indirectly, in its becoming a component or otherwise 
affecting the characteristics of any food, described in Sec. Sec.  
170.35 and 570.35.
    (4) Data and information regarding a food additive submitted as part 
of the procedures regarding food additives permitted to be used on an 
interim basis pending additional study, described in Sec.  180.1.
    (5) An investigational new drug application, described in part 312 
of this chapter.
    (6) A new drug application, described in part 314.
    (7) Data and information regarding an over-the-counter drug for 
human use, submitted as part of the procedures for classifying such 
drugs as generally recognized as safe and effective and not misbranded, 
described in part 330.
    (8) Data and information about a substance submitted as part of the 
procedures for establishing a tolerance for unavoidable contaminants in 
food and food-packaging materials, described in parts 109 and 509.
    (9) [Reserved]
    (10) A Notice of Claimed Investigational Exemption for a New Animal 
Drug, described in part 511.
    (11) A new animal drug application, described in part 514.
    (12) [Reserved]
    (13) An application for a biologics license, described in part 601 
of this chapter.
    (14) An application for an investigational device exemption, 
described in part 812.
    (15) An Application for Premarket Approval of a Medical Device, 
described in section 515 of the act.
    (16) A Product Development Protocol for a Medical Device, described 
in section 515 of the act.
    (17) Data and information regarding a medical device submitted as 
part of the procedures for classifying such devices, described in part 
860.
    (18) Data and information regarding a medical device submitted as 
part of the procedures for establishing, amending, or repealing a 
performance standard for such devices, described in part 861.
    (19) Data and information regarding an electronic product submitted 
as part of the procedures for obtaining an exemption from notification 
of a radiation safety defect or failure of compliance with a radiation 
safety performance standard, described in subpart D of part 1003.
    (20) Data and information regarding an electronic product submitted 
as part of the procedures for establishing, amending, or repealing a 
standard for such product, described in section 358 of the Public Health 
Service Act.
    (21) Data and information regarding an electronic product submitted 
as part of the procedures for obtaining a variance from any electronic 
product

[[Page 393]]

performance standard as described in Sec.  1010.4.
    (22) Data and information regarding an electronic product submitted 
as part of the procedures for granting, amending, or extending an 
exemption from any electronic product performance standard, as described 
in Sec.  1010.5.
    (23) A premarket notification for a food contact substance, 
described in part 170, subpart D, of this chapter.
    (f) Sponsor means:
    (1) A person who initiates and supports, by provision of financial 
or other resources, a nonclinical laboratory study;
    (2) A person who submits a nonclinical study to the Food and Drug 
Administration in support of an application for a research or marketing 
permit; or
    (3) A testing facility, if it both initiates and actually conducts 
the study.
    (g) Testing facility means a person who actually conducts a 
nonclinical laboratory study, i.e., actually uses the test article in a 
test system. Testing facility includes any establishment required to 
register under section 510 of the act that conducts nonclinical 
laboratory studies and any consulting laboratory described in section 
704 of the act that conducts such studies. Testing facility encompasses 
only those operational units that are being or have been used to conduct 
nonclinical laboratory studies.
    (h) Person includes an individual, partnership, corporation, 
association, scientific or academic establishment, government agency, or 
organizational unit thereof, and any other legal entity.
    (i) Test system means any animal, plant, microorganism, or subparts 
thereof to which the test or control article is administered or added 
for study. Test system also includes appropriate groups or components of 
the system not treated with the test or control articles.
    (j) Specimen means any material derived from a test system for 
examination or analysis.
    (k) Raw data means any laboratory worksheets, records, memoranda, 
notes, or exact copies thereof, that are the result of original 
observations and activities of a nonclinical laboratory study and are 
necessary for the reconstruction and evaluation of the report of that 
study. In the event that exact transcripts of raw data have been 
prepared (e.g., tapes which have been transcribed verbatim, dated, and 
verified accurate by signature), the exact copy or exact transcript may 
be substituted for the original source as raw data. Raw data may include 
photographs, microfilm or microfiche copies, computer printouts, 
magnetic media, including dictated observations, and recorded data from 
automated instruments.
    (l) Quality assurance unit means any person or organizational 
element, except the study director, designated by testing facility 
management to perform the duties relating to quality assurance of 
nonclinical laboratory studies.
    (m) Study director means the individual responsible for the overall 
conduct of a nonclinical laboratory study.
    (n) Batch means a specific quantity or lot of a test or control 
article that has been characterized according to Sec.  58.105(a).
    (o) Study initiation date means the date the protocol is signed by 
the study director.
    (p) Study completion date means the date the final report is signed 
by the study director.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 
54 FR 9039, Mar. 3, 1989; 64 FR 56448, Oct. 20, 1999; 67 FR 35729, May 
21, 2002]



Sec.  58.10  Applicability to studies performed under grants and contracts.

    When a sponsor conducting a nonclinical laboratory study intended to 
be submitted to or reviewed by the Food and Drug Administration utilizes 
the services of a consulting laboratory, contractor, or grantee to 
perform an analysis or other service, it shall notify the consulting 
laboratory, contractor, or grantee that the service is part of a 
nonclinical laboratory study that must be conducted in compliance with 
the provisions of this part.



Sec.  58.15  Inspection of a testing facility.

    (a) A testing facility shall permit an authorized employee of the 
Food and Drug Administration, at reasonable

[[Page 394]]

times and in a reasonable manner, to inspect the facility and to inspect 
(and in the case of records also to copy) all records and specimens 
required to be maintained regarding studies within the scope of this 
part. The records inspection and copying requirements shall not apply to 
quality assurance unit records of findings and problems, or to actions 
recommended and taken.
    (b) The Food and Drug Administration will not consider a nonclinical 
laboratory study in support of an application for a research or 
marketing permit if the testing facility refuses to permit inspection. 
The determination that a nonclinical laboratory study will not be 
considered in support of an application for a research or marketing 
permit does not, however, relieve the applicant for such a permit of any 
obligation under any applicable statute or regulation to submit the 
results of the study to the Food and Drug Administration.



                  Subpart B_Organization and Personnel



Sec.  58.29  Personnel.

    (a) Each individual engaged in the conduct of or responsible for the 
supervision of a nonclinical laboratory study shall have education, 
training, and experience, or combination thereof, to enable that 
individual to perform the assigned functions.
    (b) Each testing facility shall maintain a current summary of 
training and experience and job description for each individual engaged 
in or supervising the conduct of a nonclinical laboratory study.
    (c) There shall be a sufficient number of personnel for the timely 
and proper conduct of the study according to the protocol.
    (d) Personnel shall take necessary personal sanitation and health 
precautions designed to avoid contamination of test and control articles 
and test systems.
    (e) Personnel engaged in a nonclinical laboratory study shall wear 
clothing appropriate for the duties they perform. Such clothing shall be 
changed as often as necessary to prevent microbiological, radiological, 
or chemical contamination of test systems and test and control articles.
    (f) Any individual found at any time to have an illness that may 
adversely affect the quality and integrity of the nonclinical laboratory 
study shall be excluded from direct contact with test systems, test and 
control articles and any other operation or function that may adversely 
affect the study until the condition is corrected. All personnel shall 
be instructed to report to their immediate supervisors any health or 
medical conditions that may reasonably be considered to have an adverse 
effect on a nonclinical laboratory study.



Sec.  58.31  Testing facility management.

    For each nonclinical laboratory study, testing facility management 
shall:
    (a) Designate a study director as described in Sec.  58.33, before 
the study is initiated.
    (b) Replace the study director promptly if it becomes necessary to 
do so during the conduct of a study.
    (c) Assure that there is a quality assurance unit as described in 
Sec.  58.35.
    (d) Assure that test and control articles or mixtures have been 
appropriately tested for identity, strength, purity, stability, and 
uniformity, as applicable.
    (e) Assure that personnel, resources, facilities, equipment, 
materials, and methodologies are available as scheduled.
    (f) Assure that personnel clearly understand the functions they are 
to perform.
    (g) Assure that any deviations from these regulations reported by 
the quality assurance unit are communicated to the study director and 
corrective actions are taken and documented.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]



Sec.  58.33  Study director.

    For each nonclinical laboratory study, a scientist or other 
professional of appropriate education, training, and experience, or 
combination thereof, shall be identified as the study director. The 
study director has overall responsibility for the technical conduct

[[Page 395]]

of the study, as well as for the interpretation, analysis, documentation 
and reporting of results, and represents the single point of study 
control. The study director shall assure that:
    (a) The protocol, including any change, is approved as provided by 
Sec.  58.120 and is followed.
    (b) All experimental data, including observations of unanticipated 
responses of the test system are accurately recorded and verified.
    (c) Unforeseen circumstances that may affect the quality and 
integrity of the nonclinical laboratory study are noted when they occur, 
and corrective action is taken and documented.
    (d) Test systems are as specified in the protocol.
    (e) All applicable good laboratory practice regulations are 
followed.
    (f) All raw data, documentation, protocols, specimens, and final 
reports are transferred to the archives during or at the close of the 
study.

[43 FR 60013, Dec. 22, 1978; 44 FR 17657, Mar. 23, 1979]



Sec.  58.35  Quality assurance unit.

    (a) A testing facility shall have a quality assurance unit which 
shall be responsible for monitoring each study to assure management that 
the facilities, equipment, personnel, methods, practices, records, and 
controls are in conformance with the regulations in this part. For any 
given study, the quality assurance unit shall be entirely separate from 
and independent of the personnel engaged in the direction and conduct of 
that study.
    (b) The quality assurance unit shall:
    (1) Maintain a copy of a master schedule sheet of all nonclinical 
laboratory studies conducted at the testing facility indexed by test 
article and containing the test system, nature of study, date study was 
initiated, current status of each study, identity of the sponsor, and 
name of the study director.
    (2) Maintain copies of all protocols pertaining to all nonclinical 
laboratory studies for which the unit is responsible.
    (3) Inspect each nonclinical laboratory study at intervals adequate 
to assure the integrity of the study and maintain written and properly 
signed records of each periodic inspection showing the date of the 
inspection, the study inspected, the phase or segment of the study 
inspected, the person performing the inspection, findings and problems, 
action recommended and taken to resolve existing problems, and any 
scheduled date for reinspection. Any problems found during the course of 
an inspection which are likely to affect study integrity shall be 
brought to the attention of the study director and management 
immediately.
    (4) Periodically submit to management and the study director written 
status reports on each study, noting any problems and the corrective 
actions taken.
    (5) Determine that no deviations from approved protocols or standard 
operating procedures were made without proper authorization and 
documentation.
    (6) Review the final study report to assure that such report 
accurately describes the methods and standard operating procedures, and 
that the reported results accurately reflect the raw data of the 
nonclinical laboratory study.
    (7) Prepare and sign a statement to be included with the final study 
report which shall specify the dates inspections were made and findings 
reported to management and to the study director.
    (c) The responsibilities and procedures applicable to the quality 
assurance unit, the records maintained by the quality assurance unit, 
and the method of indexing such records shall be in writing and shall be 
maintained. These items including inspection dates, the study inspected, 
the phase or segment of the study inspected, and the name of the 
individual performing the inspection shall be made available for 
inspection to authorized employees of the Food and Drug Administration.
    (d) A designated representative of the Food and Drug Administration 
shall have access to the written procedures established for the 
inspection and may request testing facility management to certify that 
inspections are being implemented, performed, documented,

[[Page 396]]

and followed-up in accordance with this paragraph.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987; 
67 FR 9585, Mar. 4, 2002]



                          Subpart C_Facilities



Sec.  58.41  General.

    Each testing facility shall be of suitable size and construction to 
facilitate the proper conduct of nonclinical laboratory studies. It 
shall be designed so that there is a degree of separation that will 
prevent any function or activity from having an adverse effect on the 
study.

[52 FR 33780, Sept. 4, 1987]



Sec.  58.43  Animal care facilities.

    (a) A testing facility shall have a sufficient number of animal 
rooms or areas, as needed, to assure proper: (1) Separation of species 
or test systems, (2) isolation of individual projects, (3) quarantine of 
animals, and (4) routine or specialized housing of animals.
    (b) A testing facility shall have a number of animal rooms or areas 
separate from those described in paragraph (a) of this section to ensure 
isolation of studies being done with test systems or test and control 
articles known to be biohazardous, including volatile substances, 
aerosols, radioactive materials, and infectious agents.
    (c) Separate areas shall be provided, as appropriate, for the 
diagnosis, treatment, and control of laboratory animal diseases. These 
areas shall provide effective isolation for the housing of animals 
either known or suspected of being diseased, or of being carriers of 
disease, from other animals.
    (d) When animals are housed, facilities shall exist for the 
collection and disposal of all animal waste and refuse or for safe 
sanitary storage of waste before removal from the testing facility. 
Disposal facilities shall be so provided and operated as to minimize 
vermin infestation, odors, disease hazards, and environmental 
contamination.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]



Sec.  58.45  Animal supply facilities.

    There shall be storage areas, as needed, for feed, bedding, 
supplies, and equipment. Storage areas for feed and bedding shall be 
separated from areas housing the test systems and shall be protected 
against infestation or contamination. Perishable supplies shall be 
preserved by appropriate means.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]



Sec.  58.47  Facilities for handling test and control articles.

    (a) As necessary to prevent contamination or mixups, there shall be 
separate areas for:
    (1) Receipt and storage of the test and control articles.
    (2) Mixing of the test and control articles with a carrier, e.g., 
feed.
    (3) Storage of the test and control article mixtures.
    (b) Storage areas for the test and/or control article and test and 
control mixtures shall be separate from areas housing the test systems 
and shall be adequate to preserve the identity, strength, purity, and 
stability of the articles and mixtures.



Sec.  58.49  Laboratory operation areas.

    Separate laboratory space shall be provided, as needed, for the 
performance of the routine and specialized procedures required by 
nonclinical laboratory studies.

[52 FR 33780, Sept. 4, 1987]



Sec.  58.51  Specimen and data storage facilities.

    Space shall be provided for archives, limited to access by 
authorized personnel only, for the storage and retrieval of all raw data 
and specimens from completed studies.



                           Subpart D_Equipment



Sec.  58.61  Equipment design.

    Equipment used in the generation, measurement, or assessment of data 
and equipment used for facility environmental control shall be of 
appropriate design and adequate capacity to function according to the 
protocol and

[[Page 397]]

shall be suitably located for operation, inspection, cleaning, and 
maintenance.

[52 FR 33780, Sept. 4, 1987]



Sec.  58.63  Maintenance and calibration of equipment.

    (a) Equipment shall be adequately inspected, cleaned, and 
maintained. Equipment used for the generation, measurement, or 
assessment of data shall be adequately tested, calibrated and/or 
standardized.
    (b) The written standard operating procedures required under Sec.  
58.81(b)(11) shall set forth in sufficient detail the methods, 
materials, and schedules to be used in the routine inspection, cleaning, 
maintenance, testing, calibration, and/or standardization of equipment, 
and shall specify, when appropriate, remedial action to be taken in the 
event of failure or malfunction of equipment. The written standard 
operating procedures shall designate the person responsible for the 
performance of each operation.
    (c) Written records shall be maintained of all inspection, 
maintenance, testing, calibrating and/or standardizing operations. These 
records, containing the date of the operation, shall describe whether 
the maintenance operations were routine and followed the written 
standard operating procedures. Written records shall be kept of 
nonroutine repairs performed on equipment as a result of failure and 
malfunction. Such records shall document the nature of the defect, how 
and when the defect was discovered, and any remedial action taken in 
response to the defect.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987; 
67 FR 9585, Mar. 4, 2002]



                 Subpart E_Testing Facilities Operation



Sec.  58.81  Standard operating procedures.

    (a) A testing facility shall have standard operating procedures in 
writing setting forth nonclinical laboratory study methods that 
management is satisfied are adequate to insure the quality and integrity 
of the data generated in the course of a study. All deviations in a 
study from standard operating procedures shall be authorized by the 
study director and shall be documented in the raw data. Significant 
changes in established standard operating procedures shall be properly 
authorized in writing by management.
    (b) Standard operating procedures shall be established for, but not 
limited to, the following:
    (1) Animal room preparation.
    (2) Animal care.
    (3) Receipt, identification, storage, handling, mixing, and method 
of sampling of the test and control articles.
    (4) Test system observations.
    (5) Laboratory tests.
    (6) Handling of animals found moribund or dead during study.
    (7) Necropsy of animals or postmortem examination of animals.
    (8) Collection and identification of specimens.
    (9) Histopathology.
    (10) Data handling, storage, and retrieval.
    (11) Maintenance and calibration of equipment.
    (12) Transfer, proper placement, and identification of animals.
    (c) Each laboratory area shall have immediately available laboratory 
manuals and standard operating procedures relative to the laboratory 
procedures being performed. Published literature may be used as a 
supplement to standard operating procedures.
    (d) A historical file of standard operating procedures, and all 
revisions thereof, including the dates of such revisions, shall be 
maintained.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]



Sec.  58.83  Reagents and solutions.

    All reagents and solutions in the laboratory areas shall be labeled 
to indicate identity, titer or concentration, storage requirements, and 
expiration date. Deteriorated or outdated reagents and solutions shall 
not be used.



Sec.  58.90  Animal care.

    (a) There shall be standard operating procedures for the housing, 
feeding, handling, and care of animals.
    (b) All newly received animals from outside sources shall be 
isolated and their health status shall be evaluated

[[Page 398]]

in accordance with acceptable veterinary medical practice.
    (c) At the initiation of a nonclinical laboratory study, animals 
shall be free of any disease or condition that might interfere with the 
purpose or conduct of the study. If, during the course of the study, the 
animals contract such a disease or condition, the diseased animals shall 
be isolated, if necessary. These animals may be treated for disease or 
signs of disease provided that such treatment does not interfere with 
the study. The diagnosis, authorizations of treatment, description of 
treatment, and each date of treatment shall be documented and shall be 
retained.
    (d) Warm-blooded animals, excluding suckling rodents, used in 
laboratory procedures that require manipulations and observations over 
an extended period of time or in studies that require the animals to be 
removed from and returned to their home cages for any reason (e.g., cage 
cleaning, treatment, etc.), shall receive appropriate identification. 
All information needed to specifically identify each animal within an 
animal-housing unit shall appear on the outside of that unit.
    (e) Animals of different species shall be housed in separate rooms 
when necessary. Animals of the same species, but used in different 
studies, should not ordinarily be housed in the same room when 
inadvertent exposure to control or test articles or animal mixup could 
affect the outcome of either study. If such mixed housing is necessary, 
adequate differentiation by space and identification shall be made.
    (f) Animal cages, racks and accessory equipment shall be cleaned and 
sanitized at appropriate intervals.
    (g) Feed and water used for the animals shall be analyzed 
periodically to ensure that contaminants known to be capable of 
interfering with the study and reasonably expected to be present in such 
feed or water are not present at levels above those specified in the 
protocol. Documentation of such analyses shall be maintained as raw 
data.
    (h) Bedding used in animal cages or pens shall not interfere with 
the purpose or conduct of the study and shall be changed as often as 
necessary to keep the animals dry and clean.
    (i) If any pest control materials are used, the use shall be 
documented. Cleaning and pest control materials that interfere with the 
study shall not be used.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987; 
54 FR 15924, Apr. 20, 1989; 56 FR 32088, July 15, 1991; 67 FR 9585, Mar. 
4, 2002]



                   Subpart F_Test and Control Articles



Sec.  58.105  Test and control article characterization.

    (a) The identity, strength, purity, and composition or other 
characteristics which will appropriately define the test or control 
article shall be determined for each batch and shall be documented. 
Methods of synthesis, fabrication, or derivation of the test and control 
articles shall be documented by the sponsor or the testing facility. In 
those cases where marketed products are used as control articles, such 
products will be characterized by their labeling.
    (b) The stability of each test or control article shall be 
determined by the testing facility or by the sponsor either: (1) Before 
study initiation, or (2) concomitantly according to written standard 
operating procedures, which provide for periodic analysis of each batch.
    (c) Each storage container for a test or control article shall be 
labeled by name, chemical abstract number or code number, batch number, 
expiration date, if any, and, where appropriate, storage conditions 
necessary to maintain the identity, strength, purity, and composition of 
the test or control article. Storage containers shall be assigned to a 
particular test article for the duration of the study.
    (d) For studies of more than 4 weeks' duration, reserve samples from 
each batch of test and control articles shall be retained for the period 
of time provided by Sec.  58.195.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 
67 FR 9585, Mar. 4, 2002]

[[Page 399]]



Sec.  58.107  Test and control article handling.

    Procedures shall be established for a system for the handling of the 
test and control articles to ensure that:
    (a) There is proper storage.
    (b) Distribution is made in a manner designed to preclude the 
possibility of contamination, deterioration, or damage.
    (c) Proper identification is maintained throughout the distribution 
process.
    (d) The receipt and distribution of each batch is documented. Such 
documentation shall include the date and quantity of each batch 
distributed or returned.



Sec.  58.113  Mixtures of articles with carriers.

    (a) For each test or control article that is mixed with a carrier, 
tests by appropriate analytical methods shall be conducted:
    (1) To determine the uniformity of the mixture and to determine, 
periodically, the concentration of the test or control article in the 
mixture.
    (2) To determine the stability of the test and control articles in 
the mixture as required by the conditions of the study either:
    (i) Before study initiation, or
    (ii) Concomitantly according to written standard operating 
procedures which provide for periodic analysis of the test and control 
articles in the mixture.
    (b) [Reserved]
    (c) Where any of the components of the test or control article 
carrier mixture has an expiration date, that date shall be clearly shown 
on the container. If more than one component has an expiration date, the 
earliest date shall be shown.

[43 FR 60013, Dec. 22, 1978, as amended at 45 FR 24865, Apr. 11, 1980; 
52 FR 33781, Sept. 4, 1987]



  Subpart G_Protocol for and Conduct of a Nonclinical Laboratory Study



Sec.  58.120  Protocol.

    (a) Each study shall have an approved written protocol that clearly 
indicates the objectives and all methods for the conduct of the study. 
The protocol shall contain, as applicable, the following information:
    (1) A descriptive title and statement of the purpose of the study.
    (2) Identification of the test and control articles by name, 
chemical abstract number, or code number.
    (3) The name of the sponsor and the name and address of the testing 
facility at which the study is being conducted.
    (4) The number, body weight range, sex, source of supply, species, 
strain, substrain, and age of the test system.
    (5) The procedure for identification of the test system.
    (6) A description of the experimental design, including the methods 
for the control of bias.
    (7) A description and/or identification of the diet used in the 
study as well as solvents, emulsifiers, and/or other materials used to 
solubilize or suspend the test or control articles before mixing with 
the carrier. The description shall include specifications for acceptable 
levels of contaminants that are reasonably expected to be present in the 
dietary materials and are known to be capable of interfering with the 
purpose or conduct of the study if present at levels greater than 
established by the specifications.
    (8) Each dosage level, expressed in milligrams per kilogram of body 
weight or other appropriate units, of the test or control article to be 
administered and the method and frequency of administration.
    (9) The type and frequency of tests, analyses, and measurements to 
be made.
    (10) The records to be maintained.
    (11) The date of approval of the protocol by the sponsor and the 
dated signature of the study director.
    (12) A statement of the proposed statistical methods to be used.
    (b) All changes in or revisions of an approved protocol and the 
reasons therefore shall be documented, signed by the study director, 
dated, and maintained with the protocol.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 
67 FR 9585, Mar. 4, 2002]

[[Page 400]]



Sec.  58.130  Conduct of a nonclinical laboratory study.

    (a) The nonclinical laboratory study shall be conducted in 
accordance with the protocol.
    (b) The test systems shall be monitored in conformity with the 
protocol.
    (c) Specimens shall be identified by test system, study, nature, and 
date of collection. This information shall be located on the specimen 
container or shall accompany the specimen in a manner that precludes 
error in the recording and storage of data.
    (d) Records of gross findings for a specimen from postmortem 
observations should be available to a pathologist when examining that 
specimen histopathologically.
    (e) All data generated during the conduct of a nonclinical 
laboratory study, except those that are generated by automated data 
collection systems, shall be recorded directly, promptly, and legibly in 
ink. All data entries shall be dated on the date of entry and signed or 
initialed by the person entering the data. Any change in entries shall 
be made so as not to obscure the original entry, shall indicate the 
reason for such change, and shall be dated and signed or identified at 
the time of the change. In automated data collection systems, the 
individual responsible for direct data input shall be identified at the 
time of data input. Any change in automated data entries shall be made 
so as not to obscure the original entry, shall indicate the reason for 
change, shall be dated, and the responsible individual shall be 
identified.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 
67 FR 9585, Mar. 4, 2002]

Subparts H-I [Reserved]



                      Subpart J_Records and Reports



Sec.  58.185  Reporting of nonclinical laboratory study results.

    (a) A final report shall be prepared for each nonclinical laboratory 
study and shall include, but not necessarily be limited to, the 
following:
    (1) Name and address of the facility performing the study and the 
dates on which the study was initiated and completed.
    (2) Objectives and procedures stated in the approved protocol, 
including any changes in the original protocol.
    (3) Statistical methods employed for analyzing the data.
    (4) The test and control articles identified by name, chemical 
abstracts number or code number, strength, purity, and composition or 
other appropriate characteristics.
    (5) Stability of the test and control articles under the conditions 
of administration.
    (6) A description of the methods used.
    (7) A description of the test system used. Where applicable, the 
final report shall include the number of animals used, sex, body weight 
range, source of supply, species, strain and substrain, age, and 
procedure used for identification.
    (8) A description of the dosage, dosage regimen, route of 
administration, and duration.
    (9) A description of all circumstances that may have affected the 
quality or integrity of the data.
    (10) The name of the study director, the names of other scientists 
or professionals, and the names of all supervisory personnel, involved 
in the study.
    (11) A description of the transformations, calculations, or 
operations performed on the data, a summary and analysis of the data, 
and a statement of the conclusions drawn from the analysis.
    (12) The signed and dated reports of each of the individual 
scientists or other professionals involved in the study.
    (13) The locations where all specimens, raw data, and the final 
report are to be stored.
    (14) The statement prepared and signed by the quality assurance unit 
as described in Sec.  58.35(b)(7).
    (b) The final report shall be signed and dated by the study 
director.
    (c) Corrections or additions to a final report shall be in the form 
of an amendment by the study director. The amendment shall clearly 
identify that part of the final report that is being added to or 
corrected and the reasons for the correction or addition, and

[[Page 401]]

shall be signed and dated by the person responsible.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987]



Sec.  58.190  Storage and retrieval of records and data.

    (a) All raw data, documentation, protocols, final reports, and 
specimens (except those specimens obtained from mutagenicity tests and 
wet specimens of blood, urine, feces, and biological fluids) generated 
as a result of a nonclinical laboratory study shall be retained.
    (b) There shall be archives for orderly storage and expedient 
retrieval of all raw data, documentation, protocols, specimens, and 
interim and final reports. Conditions of storage shall minimize 
deterioration of the documents or specimens in accordance with the 
requirements for the time period of their retention and the nature of 
the documents or specimens. A testing facility may contract with 
commercial archives to provide a repository for all material to be 
retained. Raw data and specimens may be retained elsewhere provided that 
the archives have specific reference to those other locations.
    (c) An individual shall be identified as responsible for the 
archives.
    (d) Only authorized personnel shall enter the archives.
    (e) Material retained or referred to in the archives shall be 
indexed to permit expedient retrieval.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 
67 FR 9585, Mar. 4, 2002]



Sec.  58.195  Retention of records.

    (a) Record retention requirements set forth in this section do not 
supersede the record retention requirements of any other regulations in 
this chapter.
    (b) Except as provided in paragraph (c) of this section, 
documentation records, raw data and specimens pertaining to a 
nonclinical laboratory study and required to be made by this part shall 
be retained in the archive(s) for whichever of the following periods is 
shortest:
    (1) A period of at least 2 years following the date on which an 
application for a research or marketing permit, in support of which the 
results of the nonclinical laboratory study were submitted, is approved 
by the Food and Drug Administration. This requirement does not apply to 
studies supporting investigational new drug applications (IND's) or 
applications for investigational device exemptions (IDE's), records of 
which shall be governed by the provisions of paragraph (b)(2) of this 
section.
    (2) A period of at least 5 years following the date on which the 
results of the nonclinical laboratory study are submitted to the Food 
and Drug Administration in support of an application for a research or 
marketing permit.
    (3) In other situations (e.g., where the nonclinical laboratory 
study does not result in the submission of the study in support of an 
application for a research or marketing permit), a period of at least 2 
years following the date on which the study is completed, terminated, or 
discontinued.
    (c) Wet specimens (except those specimens obtained from mutagenicity 
tests and wet specimens of blood, urine, feces, and biological fluids), 
samples of test or control articles, and specially prepared material, 
which are relatively fragile and differ markedly in stability and 
quality during storage, shall be retained only as long as the quality of 
the preparation affords evaluation. In no case shall retention be 
required for longer periods than those set forth in paragraphs (a) and 
(b) of this section.
    (d) The master schedule sheet, copies of protocols, and records of 
quality assurance inspections, as required by Sec.  58.35(c) shall be 
maintained by the quality assurance unit as an easily accessible system 
of records for the period of time specified in paragraphs (a) and (b) of 
this section.
    (e) Summaries of training and experience and job descriptions 
required to be maintained by Sec.  58.29(b) may be retained along with 
all other testing facility employment records for the length of time 
specified in paragraphs (a) and (b) of this section.
    (f) Records and reports of the maintenance and calibration and 
inspection of equipment, as required by Sec.  58.63(b) and (c), shall be 
retained for the length of

[[Page 402]]

time specified in paragraph (b) of this section.
    (g) Records required by this part may be retained either as original 
records or as true copies such as photocopies, microfilm, microfiche, or 
other accurate reproductions of the original records.
    (h) If a facility conducting nonclinical testing goes out of 
business, all raw data, documentation, and other material specified in 
this section shall be transferred to the archives of the sponsor of the 
study. The Food and Drug Administration shall be notified in writing of 
such a transfer.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 
54 FR 9039, Mar. 3, 1989]



            Subpart K_Disqualification of Testing Facilities



Sec.  58.200  Purpose.

    (a) The purposes of disqualification are:
    (1) To permit the exclusion from consideration of completed studies 
that were conducted by a testing facility which has failed to comply 
with the requirements of the good laboratory practice regulations until 
it can be adequately demonstrated that such noncompliance did not occur 
during, or did not affect the validity or acceptability of data 
generated by, a particular study; and
    (2) To exclude from consideration all studies completed after the 
date of disqualification until the facility can satisfy the Commissioner 
that it will conduct studies in compliance with such regulations.
    (b) The determination that a nonclinical laboratory study may not be 
considered in support of an application for a research or marketing 
permit does not, however, relieve the applicant for such a permit of any 
obligation under any other applicable regulation to submit the results 
of the study to the Food and Drug Administration.



Sec.  58.202  Grounds for disqualification.

    The Commissioner may disqualify a testing facility upon finding all 
of the following:
    (a) The testing facility failed to comply with one or more of the 
regulations set forth in this part (or any other regulations regarding 
such facilities in this chapter);
    (b) The noncompliance adversely affected the validity of the 
nonclinical laboratory studies; and
    (c) Other lesser regulatory actions (e.g., warnings or rejection of 
individual studies) have not been or will probably not be adequate to 
achieve compliance with the good laboratory practice regulations.



Sec.  58.204  Notice of and opportunity for hearing on proposed 
disqualification.

    (a) Whenever the Commissioner has information indicating that 
grounds exist under Sec.  58.202 which in his opinion justify 
disqualification of a testing facility, he may issue to the testing 
facility a written notice proposing that the facility be disqualified.
    (b) A hearing on the disqualification shall be conducted in 
accordance with the requirements for a regulatory hearing set forth in 
part 16 of this chapter.



Sec.  58.206  Final order on disqualification.

    (a) If the Commissioner, after the regulatory hearing, or after the 
time for requesting a hearing expires without a request being made, upon 
an evaluation of the administrative record of the disqualification 
proceeding, makes the findings required in Sec.  58.202, he shall issue 
a final order disqualifying the facility. Such order shall include a 
statement of the basis for that determination. Upon issuing a final 
order, the Commissioner shall notify (with a copy of the order) the 
testing facility of the action.
    (b) If the Commissioner, after a regulatory hearing or after the 
time for requesting a hearing expires without a request being made, upon 
an evaluation of the administrative record of the disqualification 
proceeding, does not make the findings required in Sec.  58.202, he 
shall issue a final order terminating the disqualification proceeding. 
Such order shall include a statement of the basis for that 
determination. Upon issuing a final order the Commissioner

[[Page 403]]

shall notify the testing facility and provide a copy of the order.



Sec.  58.210  Actions upon disqualification.

    (a) Once a testing facility has been disqualified, each application 
for a research or marketing permit, whether approved or not, containing 
or relying upon any nonclinical laboratory study conducted by the 
disqualified testing facility may be examined to determine whether such 
study was or would be essential to a decision. If it is determined that 
a study was or would be essential, the Food and Drug Administration 
shall also determine whether the study is acceptable, notwithstanding 
the disqualification of the facility. Any study done by a testing 
facility before or after disqualification may be presumed to be 
unacceptable, and the person relying on the study may be required to 
establish that the study was not affected by the circumstances that led 
to the disqualification, e.g., by submitting validating information. If 
the study is then determined to be unacceptable, such data will be 
eliminated from consideration in support of the application; and such 
elimination may serve as new information justifying the termination or 
withdrawal of approval of the application.
    (b) No nonclinical laboratory study begun by a testing facility 
after the date of the facility's disqualification shall be considered in 
support of any application for a research or marketing permit, unless 
the facility has been reinstated under Sec.  58.219. The determination 
that a study may not be considered in support of an application for a 
research or marketing permit does not, however, relieve the applicant 
for such a permit of any obligation under any other applicable 
regulation to submit the results of the study to the Food and Drug 
Administration.

[43 FR 60013, Dec. 22, 1978, as amended at 59 FR 13200, Mar. 21, 1994]



Sec.  58.213  Public disclosure of information regarding disqualification.

    (a) Upon issuance of a final order disqualifying a testing facility 
under Sec.  58.206(a), the Commissioner may notify all or any interested 
persons. Such notice may be given at the discretion of the Commissioner 
whenever he believes that such disclosure would further the public 
interest or would promote compliance with the good laboratory practice 
regulations set forth in this part. Such notice, if given, shall include 
a copy of the final order issued under Sec.  58.206(a) and shall state 
that the disqualification constitutes a determination by the Food and 
Drug Administration that nonclinical laboratory studies performed by the 
facility will not be considered by the Food and Drug Administration in 
support of any application for a research or marketing permit. If such 
notice is sent to another Federal Government agency, the Food and Drug 
Administration will recommend that the agency also consider whether or 
not it should accept nonclinical laboratory studies performed by the 
testing facility. If such notice is sent to any other person, it shall 
state that it is given because of the relationship between the testing 
facility and the person being notified and that the Food and Drug 
Administration is not advising or recommending that any action be taken 
by the person notified.
    (b) A determination that a testing facility has been disqualified 
and the administrative record regarding such determination are 
disclosable to the public under part 20 of this chapter.



Sec.  58.215  Alternative or additional actions to disqualification.

    (a) Disqualification of a testing facility under this subpart is 
independent of, and neither in lieu of nor a precondition to, other 
proceedings or actions authorized by the act. The Food and Drug 
Administration may, at any time, institute against a testing facility 
and/or against the sponsor of a nonclinical laboratory study that has 
been submitted to the Food and Drug Administration any appropriate 
judicial proceedings (civil or criminal) and any other appropriate 
regulatory action, in addition to or in lieu of, and prior to, 
simultaneously with, or subsequent to, disqualification. The Food and 
Drug Administration may also refer the matter to another Federal, State, 
or local government law enforcement or regulatory agency for such action 
as that agency deems appropriate.

[[Page 404]]

    (b) The Food and Drug Administration may refuse to consider any 
particular nonclinical laboratory study in support of an application for 
a research or marketing permit, if it finds that the study was not 
conducted in accordance with the good laboratory practice regulations 
set forth in this part, without disqualifying the testing facility that 
conducted the study or undertaking other regulatory action.



Sec.  58.217  Suspension or termination of a testing facility by a sponsor.

    Termination of a testing facility by a sponsor is independent of, 
and neither in lieu of nor a precondition to, proceedings or actions 
authorized by this subpart. If a sponsor terminates or suspends a 
testing facility from further participation in a nonclinical laboratory 
study that is being conducted as part of any application for a research 
or marketing permit that has been submitted to any Center of the Food 
and Drug Administration (whether approved or not), it shall notify that 
Center in writing within 15 working days of the action; the notice shall 
include a statement of the reasons for such action. Suspension or 
termination of a testing facility by a sponsor does not relieve it of 
any obligation under any other applicable regulation to submit the 
results of the study to the Food and Drug Administration.

[43 FR 60013, Dec. 22, 1978, as amended at 50 FR 8995, Mar. 6, 1985]



Sec.  58.219  Reinstatement of a disqualified testing facility.

    A testing facility that has been disqualified may be reinstated as 
an acceptable source of nonclinical laboratory studies to be submitted 
to the Food and Drug Administration if the Commissioner determines, upon 
an evaluation of the submission of the testing facility, that the 
facility can adequately assure that it will conduct future nonclinical 
laboratory studies in compliance with the good laboratory practice 
regulations set forth in this part and, if any studies are currently 
being conducted, that the quality and integrity of such studies have not 
been seriously compromised. A disqualified testing facility that wishes 
to be so reinstated shall present in writing to the Commissioner reasons 
why it believes it should be reinstated and a detailed description of 
the corrective actions it has taken or intends to take to assure that 
the acts or omissions which led to its disqualification will not recur. 
The Commissioner may condition reinstatement upon the testing facility 
being found in compliance with the good laboratory practice regulations 
upon an inspection. If a testing facility is reinstated, the 
Commissioner shall so notify the testing facility and all organizations 
and persons who were notified, under Sec.  58.213 of the 
disqualification of the testing facility. A determination that a testing 
facility has been reinstated is disclosable to the public under part 20 
of this chapter.



PART 60_PATENT TERM RESTORATION--Table of Contents



                      Subpart A_General Provisions

Sec.
60.1 Scope.
60.2 Purpose.
60.3 Definitions.

                    Subpart B_Eligibility Assistance

60.10 FDA assistance on eligibility.

            Subpart C_Regulatory Review Period Determinations

60.20 FDA action on regulatory review period determinations.
60.22 Regulatory review period determinations.
60.24 Revision of regulatory review period determinations.
60.26 Final action on regulatory review period determinations.
60.28 Time frame for determining regulatory review periods.

                    Subpart D_Due Diligence Petitions

60.30 Filing, format, and content of petitions.
60.32 Applicant response to petition.
60.34 FDA action on petitions.
60.36 Standard of due diligence.

                    Subpart E_Due Diligence Hearings

60.40 Request for hearing.
60.42 Notice of hearing.
60.44 Hearing procedures.
60.46 Administrative decision.

    Authority: 21 U.S.C. 348, 355, 360e, 360j, 371, 379e; 35 U.S.C. 156; 
42 U.S.C. 262.

[[Page 405]]


    Source: 53 FR 7305, Mar. 7, 1988, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 60 appear at 68 FR 
24879, May 9, 2003.



                      Subpart A_General Provisions



Sec.  60.1  Scope.

    (a) This part sets forth procedures and requirements for the Food 
and Drug Administration's review of applications for the extension of 
the term of certain patents under 35 U.S.C. 156. Patent term restoration 
is available for certain patents related to drug products (as defined in 
35 U.S.C. 156(f)(2)), and to medical devices, food additives, or color 
additives subject to regulation under the Federal Food, Drug, and 
Cosmetic Act or the Public Health Service Act. Food and Drug 
Administration actions in this area include:
    (1) Assisting the United States Patent and Trademark Office in 
determining eligibility for patent term restoration;
    (2) Determining the length of a product's regulatory review period;
    (3) If petitioned, reviewing and ruling on due diligence challenges 
to the Food and Drug Administration's regulatory review period 
determinations; and
    (4) Conducting hearings to review initial Food and Drug 
Administration findings on due diligence challenges.
    (b) References in this part to the Code of Federal Regulations are 
to chapter I of title 21, unless otherwise noted.

[53 FR 7305, Mar. 7, 1988, as amended at 57 FR 56261, Nov. 27, 1992]



Sec.  60.2  Purpose.

    (a) The purpose of this part is to establish a thorough yet 
efficient process for the Food and Drug Administration review of patent 
term restoration applications. To achieve this purpose, the regulations 
are intended to:
    (1) Facilitate determinations of patent term restoration eligibility 
and regulatory review period length, and
    (2) Ensure that parties interested in due diligence challenges will 
have an opportunity to participate in that process, including informal 
hearings.
    (b) The regulations are intended to complement those promulgated by 
the United States Patent and Trademark Office to implement those parts 
of the law which are under that agency's jurisdiction. These regulations 
shall be construed in light of these objectives.



Sec.  60.3  Definitions.

    (a) The definitions contained in 35 U.S.C. 156 apply to those terms 
when used in this part.
    (b) The following definitions of terms apply to this part:
    (1) The term Act means the Federal Food, Drug, and Cosmetic Act 
(secs. 201-901, 52 Stat. 1040 et seq. as amended (21 U.S.C. 301-392)).
    (2) Active ingredient means any component that is intended to 
furnish pharmacological activity or other direct effect in the 
diagnosis, cure, mitigation, treatment, or prevention of disease, or to 
affect the structure or any function of the body of man or of animals. 
The term includes those components that may undergo chemical change in 
the manufacture of the drug product and be present in the drug product 
in a modified form intended to furnish the specified activity or effect.
    (3) Applicant means any person who submits an application or an 
amendment or supplement to an application under 35 U.S.C. 156 seeking 
patent term restoration.
    (4) Application means an application for patent term restoration 
submitted under 35 U.S.C. 156.
    (5) Clinical investigation or study means any experiment that 
involves a test article and one or more subjects and that is either 
subject to requirements for prior submission to the Food and Drug 
Administration under section 505(i), 512(j), or 520(g) of the Federal 
Food, Drug, and Cosmetic Act, or is not subject to the requirements for 
prior submission to FDA under those sections of the Federal Food, Drug, 
and Cosmetic Act, but the results of which are intended to be submitted 
later to, or held for inspection by, FDA as part of an application for a 
research or marketing permit. The term does not include experiments that 
are subject to the provisions of part 58 regarding nonclinical 
laboratory studies.

[[Page 406]]

    (6) Color additive means any substance that meets the definition in 
section 201(t) of the Act and which is subject to premarketing approval 
under section 721 of the Act.
    (7) Due diligence petition means a petition submitted under Sec.  
60.30(a).
    (8) FDA means the Food and Drug Administration.
    (9) Food additive means any substance that meets the definition in 
section 201(s) of the Act and which is subject to premarketing approval 
under section 409 of the Act.
    (10) Human drug product means the active ingredient of a new drug or 
human biologic product (as those terms are used in the Act and the 
Public Health Service Act), including any salt or ester of the active 
ingredient, as a single entity or in combination with another active 
ingredient.
    (11) Marketing applicant means any person who submits an application 
for premarketing approval by FDA under:
    (i) Section 505(b) of the Act or section 351 of the Public Health 
Service Act (human drug products);
    (ii) Section 515 of the Act (medical devices);
    (iii) Section 409 or 721 of the Act (food and color additives); or
    (iv) Section 512 of the Act (animal drug products).
    (12) Marketing application means an application for:
    (i) Human drug products submitted under section 505(b) of the Act or 
section 351 of the Public Health Service Act;
    (ii) Medical devices submitted under section 515 of the Act;
    (iii) Food and color additives submitted under section 409 or 721 of 
the Act; or
    (iv) Animal drug products submitted under section 512 of the Act.
    (13) Medical device means any article that meets the definition in 
section 201(h) of the Act and which is subject to premarketing approval 
under section 515 of the Act.
    (14) Product means a human drug product, animal drug product, 
medical device, food additive, or color additive, as those terms are 
defined in this section.
    (15) PTO means the United States Patent and Trademark Office.
    (16) Animal drug product means the active ingredient of a new animal 
drug (as that term is used in the Act) that is not primarily 
manufactured using recombinant deoxyribonucleic acid (DNA), recombinant 
ribonucleic acid (RNA), hybridoma technology, or other processes 
involving site-specific genetic manipulation techniques, including any 
salt or ester of the active ingredient, as a single entity or in 
combination with another active ingredient.

[53 FR 7305, Mar. 7, 1988, as amended at 57 FR 56261, Nov. 27, 1992; 64 
FR 399, Jan. 5, 1999]



                    Subpart B_Eligibility Assistance



Sec.  60.10  FDA assistance on eligibility.

    (a) Upon written request from the U.S. Patent and Trademark Office, 
FDA will assist the U.S. Patent and Trademark Office in determining 
whether a patent related to a product is eligible for patent term 
restoration as follows:
    (1) Verifying whether the product was subject to a regulatory review 
period before its commercial marketing or use;
    (2) For human drug products, food additives, color additives, and 
medical devices, determining whether the permission for commercial 
marketing or use of the product after the regulatory review period is 
the first permitted commercial marketing or use of the product either:
    (i) Under the provision of law under which the regulatory review 
period occurred; or
    (ii) Under the process claimed in the patent when the patent claims 
a method of manufacturing the product that primarily uses recombinant 
deoxyribonucleic acid (DNA) technology in the manufacture of the 
product;
    (3) For animal drug products, determining whether the permission for 
commercial marketing or use of the product after the regulatory review 
period:
    (i) Is the first permitted commercial marketing or use of the 
product; or
    (ii) Is the first permitted commercial marketing or use of the 
product for administration to a food-producing animal, whichever is 
applicable, under the

[[Page 407]]

provision of law under which the regulatory review period occurred;
    (4) Informing the U.S. Patent and Trademark Office whether the 
patent term restoration application was submitted within 60 days after 
the product was approved for marketing or use, or, if the product is an 
animal drug approved for use in a food-producing animal, verifying 
whether the application was filed within 60 days of the first approval 
for marketing or use in a food-producing animal; and
    (5) Providing the U.S. Patent and Trademark Office with any other 
information relevant to the U.S. Patent and Trademark Office's 
determination of whether a patent related to a product is eligible for 
patent term restoration.
    (b) FDA will notify the U.S. Patent and Trademark Office of its 
findings in writing, send a copy of this notification to the applicant, 
and file a copy of the notification in the docket established for the 
application in FDA's Division of Dockets Management (HFA-305), 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

[57 FR 56261, Nov. 27, 1992]



            Subpart C_Regulatory Review Period Determinations



Sec.  60.20  FDA action on regulatory review period determinations.

    (a) FDA will consult its records and experts to verify the dates 
contained in the application and to determine the length of the 
product's regulatory review period under Sec.  60.22. The application 
shall contain information relevant to the determination of the 
regulatory review period as stated in the ``Guidelines for Extension of 
Patent Term Under 35 U.S.C. 156'' published on October 9, 1984, in PTO's 
Official Gazette and as required by 37 CFR chapter I.
    (b) After determining the length of the regulatory review period, 
FDA will notify PTO in writing of its determination, send a copy of this 
determination to the applicant, and file a copy of the determination in 
the docket established for the application in FDA's Division of Dockets 
Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    (c) FDA will also publish the regulatory review period determination 
in the Federal Register. The notice will include the following:
    (1) The name of the applicant;
    (2) The trade name and generic name (if applicable) of the product;
    (3) The number of the patent for which an extension of the term is 
sought;
    (4) The approved indications or uses for the product;
    (5) An explanation of any discrepancies between the dates in the 
application and FDA records;
    (6) Where appropriate, an explanation that FDA has no record in 
which to review the date(s) contained in the application; and
    (7) The regulatory review period determination, including a 
statement of the length of the testing and approval phases and the dates 
used in calculating each phase.

[53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994]



Sec.  60.22  Regulatory review period determinations.

    In determining a product's regulatory review period, which consists 
of the sum of the lengths of a testing phase and an approval phase, FDA 
will review the information in each application using the following 
definitions of the testing phase and the approval phase for that class 
of products.
    (a) For human drugs:
    (1) The testing phase begins on the date an exemption under section 
505(i) of the Act becomes effective (or the date an exemption under 
former section 507(d) of the Act became effective) for the approved 
human drug product and ends on the date a marketing application under 
section 351 of the Public Health Service Act or section 505 of the act 
is initially submitted to FDA (or was initially submitted to FDA under 
former section 507 of the Act), and
    (2) The approval phase begins on the date a marketing application 
under section 351 of the Public Health Service Act or section 505(b) of 
the Act is initially submitted to FDA (or was initially submitted under 
former section 507 of the Act) and ends on the date the application is 
approved.

[[Page 408]]

    (b) For food and color additives:
    (1) The testing phase begins on the date a major health or 
environmental effects test is begun and ends on the date a petition 
relying on the test and requesting the issuance of a regulation for use 
of the additive under section 409 or 721 of the Act is initially 
submitted to FDA.
    (2) The approval phase begins on the date a petition requesting the 
issuance of a regulation for use of the additive under section 409 or 
721 of the Act is initially submitted to FDA and ends upon whichever of 
the following occurs last:
    (i) The regulation for the additive becomes effective; or
    (ii) Objections filed against the regulation that result in a stay 
of effectiveness are resolved and commercial marketing is permitted; or
    (iii) Proceedings resulting from objections to the regulation, after 
commercial marketing has been permitted and later stayed pending 
resolution of the proceedings, are finally resolved and commercial 
marketing is permitted.
    (c) For medical devices:
    (1) The testing phase begins on the date a clinical investigation on 
humans is begun and ends on the date an application for premarket 
approval of the device or a notice of completion of a product 
development protocol is initially submitted under section 515 of the 
Act. For purposes of this part, a clinical investigation is considered 
to begin on whichever of the following dates applies:
    (i) If an investigational device exemption (IDE) under section 
520(g) of the Act is required, the effective date of the exemption.
    (ii) If an IDE is not required, but institutional review board (IRB) 
approval under section 520(g)(3) of the Act is required, the IRB 
approval date.
    (iii) If neither an IDE nor IRB approval is required, the date on 
which the device is first used with human subjects as part of a clinical 
investigation to be filed with FDA to secure premarket approval of the 
device.
    (2) The approval phase either:
    (i) Begins on the date an application for premarket approval of the 
device is initially submitted under section 515 of the Act and ends on 
the date the application is approved; or
    (ii) Begins on the date a notice of completion of a product 
development protocol is initially submitted under section 515 of the Act 
and ends on the date the protocol is declared to be completed.
    (d) For animal drugs:
    (1) The testing phase begins on the date a major health or 
environmental effects test is begun or the date on which the agency 
acknowledges the filing of a notice of claimed investigational exemption 
for a new animal drug, whichever is earlier, and ends on the date a 
marketing application under section 512 of the Act is initially 
submitted to FDA.
    (2) The approval phase begins on the date a marketing application 
under section 512 of the Act is initially submitted to FDA and ends on 
the date the application is approved.
    (e) For purposes of this section, a ``major health or environmental 
effects test'' may be any test which:
    (1) Is reasonably related to the evaluation of the product's health 
or environmental effects, or both:
    (2) Produces data necessary for marketing approval; and
    (3) Is conducted over a period of no less than 6 months duration, 
excluding time required to analyze or evaluate test results.
    (f) For purposes of determining the regulatory review period for any 
product, a marketing application, a notice of completion of a product 
development protocol, or a petition is initially submitted on the date 
it contains sufficient information to allow FDA to commence review of 
the application. A marketing application, a notice of completion of a 
product development protocol, or a petition is approved on the date FDA 
sends the applicant a letter informing it of the approval or, by order 
declares a product development protocol to be completed, or, in the case 
of food and color additives, on the effective date of the final rule 
listing the additive for use as published in the Federal Register or, in 
the case of a new animal drug in a Category II Type A medicated article, 
on the date of publication in the Federal Register of the notice of 
approval pursuant to

[[Page 409]]

section 512(i) of the Act. For purposes of this section, the regulatory 
review period for an animal drug shall mean either the regulatory review 
period relating the drug's approval for use in nonfood-producing animals 
or the regulatory review period relating to the drug's approval for use 
in food-producing animals, whichever is applicable.

[53 FR 7305, Mar. 7, 1988, as amended at 57 FR 56262, Nov. 27, 1992; 64 
FR 400, Jan. 5, 1999]



Sec.  60.24  Revision of regulatory review period determinations.

    (a) Any person may request a revision of the regulatory review 
period determination within 60 days after its initial publication in the 
Federal Register. The request shall be sent to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. The request shall specify the following:
    (1) The type of action requested;
    (2) The identity of the product;
    (3) The identity of the applicant;
    (4) The FDA docket number; and
    (5) The basis for the request for revision, including any 
documentary evidence.
    (b) Unless the applicant is the person requesting the revision, the 
applicant shall respond to the request within 15 days. In responding to 
the request, the applicant may submit information which is relevant to 
the events during the regulatory review period but which was not 
included in the original patent term restoration application. A request 
for a revision is not equivalent to a due diligence petition under Sec.  
60.30 or a request for a hearing under Sec.  60.40. If no response is 
submitted, FDA will decide the matter on the basis of the information in 
the patent term restoration application, request for revision, and FDA 
records.
    (c) FDA shall apply the provisions of Sec.  60.22 in considering the 
request for a revision of the regulatory review period determination. lf 
FDA revises its prior determination, FDA will notify PTO of the 
revision, send a copy of this notification to the applicant, and publish 
the revision in the Federal Register, including a statement giving the 
reasons for the revision.

[53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994; 67 
FR 9585, Mar. 4, 2002]



Sec.  60.26  Final action on regulatory review period determinations.

    (a) FDA will consider a regulatory review period determination to be 
final upon expiration of the 180-day period for filing a due diligence 
petition under Sec.  60.30 unless FDA receives:
    (1) New information from PTO records, FDA records, or FDA centers 
that affects the regulatory review period determination;
    (2) A request under Sec.  60.24 for revision of the regulatory 
review period determination;
    (3) A due diligence petition filed under Sec.  60.30; or
    (4) A request for a hearing filed under Sec.  60.40.
    (b) FDA will notify PTO that the regulatory review period 
determination is final upon:
    (1) The expiration of the 180-day period for filing a due diligence 
petition; or
    (2) If FDA has received a request for a revision, a due diligence 
petition, or a request for a hearing, upon resolution of the request for 
a revision, the petition, or the hearing, whichever is later. FDA will 
send a copy of the notification to the applicant and file a copy of the 
notification in the docket established for the application in FDA's 
Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

[53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994]



Sec.  60.28  Time frame for determining regulatory review periods.

    (a) FDA will determine the regulatory review period for a product 
within 30 days of the receipt of a written request from PTO for such a 
determination and a copy of the patent term restoration application.
    (b) FDA may extend the 30-day period if:
    (1) A related FDA action that may affect the regulatory review 
period determination is pending; or

[[Page 410]]

    (2) PTO requests that FDA temporarily suspend the determination 
process; or
    (3) PTO or FDA receives new information about the product that 
warrants an extension of the time required for the determination of the 
regulatory review period.
    (c) This section does not apply to applications withdrawn by the 
applicant or applications that PTO determines are ineligible for patent 
term restoration.



                    Subpart D_Due Diligence Petitions



Sec.  60.30  Filing, format, and content of petitions.

    (a) Any person may file a petition with FDA, no later than 180 days 
after the publication of a regulatory review period determination under 
Sec.  60.20, that challenges FDA's determination by alleging that the 
applicant for patent term restoration did not act with due diligence in 
seeking FDA approval of the product during the regulatory review period.
    (b) The petition shall be filed in accordance with Sec.  10.20, 
under the docket number of the Federal Register notice of the agency's 
regulatory review period determination, and shall be in the format 
specified in Sec.  10.30. The petition shall contain the information 
specified in Sec.  10.30 and any additional information required by this 
subpart. If any provision of Sec.  10.20 or Sec.  10.30 is inconsistent 
with any provision of this part, FDA will consider the petition in 
accordance with this part.
    (c) The petition shall claim that the applicant did not act with due 
diligence during some part of the regulatory review period and shall set 
forth sufficient facts, including dates if possible, to merit an 
investigation by FDA of whether the applicant acted with due diligence.
    (d) The petition shall contain a certification that the petitioner 
has served a true and complete copy of the petition upon the applicant 
by certified or registered mail (return receipt requested) or by 
personal delivery.

[53 FR 7305, Mar. 7, 1988, as amended at 67 FR 9585, Mar. 4, 2002]



Sec.  60.32  Applicant response to petition.

    (a) The applicant shall file with FDA a written response to the 
petition no later than 30 days after the applicant's receipt of a copy 
of the petition.
    (b) The applicant's response may present additional facts and 
circumstances to address the assertions in the petition, but shall be 
limited to the issue of whether the applicant acted with due diligence 
during the regulatory review period. The applicant's response may 
include documents that were not in the original patent extension 
application.
    (c) If the applicant does not respond to the petition, FDA will 
decide the matter on the basis of the information submitted in the 
patent term restoration application, due diligence petition, and FDA 
records.



Sec.  60.34  FDA action on petitions.

    (a) Within 90 days after FDA receives a petition filed under Sec.  
60.30(a), the agency will either deny the petition under paragraph (b) 
or (c) of this section or investigate and determine under Sec.  60.36 
whether the applicant acted with due diligence during the regulatory 
review period. FDA will publish its due diligence determination in the 
Federal Register, notify PTO of the due diligence determination in 
writing, and send copies of the notice to PTO, the applicant, and the 
petitioner.
    (b) FDA may deny a due diligence petition without considering the 
merits of the petition if:
    (1) The petition is not filed in accordance with Sec.  60.30;
    (2) The petition is not filed in accordance with Sec.  10.20;
    (3) The petition does not contain the information required by Sec.  
10.30;
    (4) The petition fails to contain information or allegations upon 
which it may reasonably be determined that the applicant did not act 
with due diligence during the applicable regulatory review period; or
    (5) The petition fails to allege a sufficient total amount of time 
during which the applicant did not exercise due diligence such that, 
even if the petition were granted, the petition would

[[Page 411]]

not affect the maximum patent extension the applicant sought in the 
application.



Sec.  60.36  Standard of due diligence.

    (a) In determining the due diligence of an applicant, FDA will 
examine the facts and circumstances of the applicant's actions during 
the regulatory review period to determine whether the applicant 
exhibited that degree of attention, continuous directed effort, and 
timeliness as may reasonably be expected from, and are ordinarily 
exercised by, a person during a regulatory review period. FDA will take 
into consideration all relevant factors, such as the amount of time 
between the approval of an investigational exemption or research permit 
and the commencement of a clinical investigation and the amount of time 
required to conduct a clinical investigation.
    (b) For purposes of this part, the actions of the marketing 
applicant shall be imputed to the applicant for patent term restoration. 
The actions of an agent, attorney, contractor, employee, licensee, or 
predecessor in interest of the marketing applicant or applicant for 
patent term restoration shall be imputed to the applicant for patent 
term restoration.



                    Subpart E_Due Diligence Hearings



Sec.  60.40  Request for hearing.

    (a) Any person may request, not later than 60 days after the 
publication under Sec.  60.34(a) of FDA's due diligence determination, 
that FDA conduct an informal hearing on the due diligence determination.
    (b) The request for a hearing under this section shall:
    (1) Be sent by mail, personal delivery, or any other mode of written 
communication to the Division of Dockets Management and filed under the 
relevant product file;
    (2) Specify the facts and the action that are the subject of the 
hearing;
    (3) Provide the name and address of the person requesting the 
hearing; and
    (4) Certify that the requesting party has served a true and complete 
copy of the request upon the petitioner and the applicant by certified 
or registered mail (return receipt requested) or by personal delivery.
    (c) The request shall state whether the requesting party seeks a 
hearing within 30 days or 60 days of FDA's receipt of the request.

[53 FR 7305, Mar. 7, 1988, as amended at 67 FR 9585, Mar. 4, 2002]



Sec.  60.42  Notice of hearing.

    Ten days before the hearing, FDA will notify the requesting party, 
the applicant, and the petitioner, orally or in writing, of the date, 
time, and location of the hearing. The agency will provide the 
requesting party, the applicant, and the petitioner with an opportunity 
to participate as a party in the hearing.



Sec.  60.44  Hearing procedures.

    The due diligence hearing shall be conducted in accordance with this 
part, supplemented by the nonconflicting procedures in part 16. During 
the due diligence hearing, the applicant and the petitioner shall enjoy 
all the rights and privileges accorded a person requesting a hearing 
under part 16. The standard of due diligence set forth in Sec.  60.36 
will apply in the due diligence hearing. The party requesting the due 
diligence hearing shall have the burden of proof at the hearing.



Sec.  60.46  Administrative decision.

    Within 30 days after the completion of the due diligence hearing, 
the Commissioner will affirm or revise the determination made under 
Sec.  60.34(a) and will publish the due diligence redetermination in the 
Federal Register, notify PTO of the redetermination, and send copies of 
the notice to PTO and to the requesting party, the applicant, and the 
petitioner.



PART 70_COLOR ADDITIVES--Table of Contents



                      Subpart A_General Provisions

Sec.
70.3 Definitions.
70.5 General restrictions on use of color additives.
70.10 Color additives in standardized foods and new drugs.
70.11 Related substances.
70.19 Fees for listing.

[[Page 412]]

                    Subpart B_Packaging and Labeling

70.20 Packaging requirements for straight colors (other than hair dyes).
70.25 Labeling requirements for color additives (other than hair dyes).

                       Subpart C_Safety Evaluation

70.40 Safety factors to be considered.
70.42 Criteria for evaluating the safety of color additives.
70.45 Allocation of color additives.
70.50 Application of the cancer clause of section 721 of the act.
70.51 Advisory committee on the application of the anticancer clause.
70.55 Request for scientific studies.

    Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 360b, 361, 371, 
379e.

    Source: 42 FR 15636, Mar. 22, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  70.3  Definitions.

    (a) Secretary means the Secretary of Health and Human Services.
    (b) Department means the Department of Health and Human Services.
    (c) Commissioner means the Commissioner of Food and Drugs.
    (d) Act means the Federal Food, Drug, and Cosmetic Act as amended.
    (e) Color Certification Branch means the unit established within the 
Food and Drug Administration located in the Center for Food Safety and 
Applied Nutrition, charged with the responsibility for the mechanics of 
the certification procedure hereinafter described, and including the 
examination of samples of color additives subject to certification.
    (f) A color additive is any material, not exempted under section 
201(t) of the act, that is a dye, pigment, or other substance made by a 
process of synthesis or similar artifice, or extracted, isolated, or 
otherwise derived, with or without intermediate or final change of 
identity, from a vegetable, animal, mineral, or other source and that, 
when added or applied to a food, drug, or cosmetic or to the human body 
or any part thereof, is capable (alone or through reaction with another 
substance) of imparting a color thereto. Substances capable of imparting 
a color to a container for foods, drugs, or cosmetics are not color 
additives unless the customary or reasonably foreseeable handling or use 
of the container may reasonably be expected to result in the transmittal 
of the color to the contents of the package or any part thereof. Food 
ingredients such as cherries, green or red peppers, chocolate, and 
orange juice which contribute their own natural color when mixed with 
other foods are not regarded as color additives; but where a food 
substance such as beet juice is deliberately used as a color, as in pink 
lemonade, it is a color additive. Food ingredients as authorized by a 
definitions and standard of identity prescribed by regulations pursuant 
to section 401 of the act are color additives, where the ingredients are 
specifically designated in the definitions and standards of identity as 
permitted for use for coloring purposes. An ingredient of an animal feed 
whose intended function is to impart, through the biological processes 
of the animal, a color to the meat, milk, or eggs of the animal is a 
color additive and is not exempt from the requirements of the statute. 
This definition shall apply whether or not such ingredient has nutritive 
or other functions in addition to the property of imparting color. An 
ingested drug the intended function of which is to impart color to the 
human body is a color additive. For the purposes of this part, the term 
color includes black, white, and intermediate grays, but substances 
including migrants from packaging materials which do not contribute any 
color apparent to the naked eye are not color additives.
    (g) For a material otherwise meeting the definition of color 
additive to be exempt from section 721 of the act, on the basis that it 
is used (or intended to be used) solely for a purpose or purposes other 
than coloring, the material must be used in a way that any color 
imparted is clearly unimportant insofar as the appearance, value, 
marketability, or consumer acceptability is concerned. (It is not enough 
to warrant exemption if conditions are such that the primary purpose of 
the material is other than to impart color.)
    (h) The exemption that applies to a pesticide chemical, soil or 
plant nutrient, or other agricultural chemical, where its coloring 
effect results solely

[[Page 413]]

from its aiding, retarding, or otherwise affecting directly or 
indirectly, the growth or other natural physiological processes of 
produce of the soil, applies only to color developed in such product 
through natural physiological processes such as enzymatic action. If the 
pesticide chemical, soil or plant nutrient, or other agricultural 
chemical itself acts as a color or carries as an ingredient a color, and 
because of this property colors the produce of the soil, it is a color 
additive and is not exempt.
    (i) Safe means that there is convincing evidence that establishes 
with reasonable certainty that no harm will result from the intended use 
of the color additive.
    (j) The term straight color means a color additive listed in parts 
73, 74, and 81 of this chapter, and includes lakes and such substances 
as are permitted by the specifications for such color.
    (k) The term mixture means a color additive made by mixing two or 
more straight colors, or one or more straight colors and one or more 
diluents.
    (l) The term lake means a straight color extended on a substratum by 
adsorption, coprecipitation, or chemical combination that does not 
include any combination of ingredients made by simple mixing process.
    (m) The term diluent means any component of a color additive mixture 
that is not of itself a color additive and has been intentionally mixed 
therein to facilitate the use of the mixture in coloring foods, drugs, 
or cosmetics or in coloring the human body. The diluent may serve 
another functional purpose in the foods, drugs, or cosmetics, as for 
example sweetening, flavoring, emulsifying, or stabilizing, or may be a 
functional component of an article intended for coloring the human body.
    (n) The term substratum means the substance on which the pure color 
in a lake is extended.
    (o) The term pure color means the color contained in a color 
additive, exclusive of any intermediate or other component, or of any 
diluent or substratum contained therein.
    (p) The term batch means a homogeneous lot of color additive or 
color additive mixture produced by an identified production operation, 
which is set apart and held as a unit for the purpose of obtaining 
certification of such quantity.
    (q) The term batch number means the number assigned to a batch by 
the person who requests certification thereof.
    (r) The term lot number means an identifying number or symbol 
assigned to a batch by the Food and Drug Administration.
    (s) The term area of the eye means the area enclosed with in the 
circumference of the supra-orbital ridge and the infra-orbital ridge, 
including the eyebrow, the skin below the eyebrow, the eyelids and the 
eyelashes, and conjunctival sac of the eye, the eyeball, and the soft 
areolar tissue that lies within the perimeter of the infra-orbital 
ridge.
    (t) The term package means the immediate container in which a color 
additive or color additive mixture has been packed for shipment or 
delivery. If the package is then packed in a shipping carton or other 
protective container, such container shall not be considered to be the 
immediate container. In the case of color additive mixtures for 
household use containing less than 15 percent pure color, when two or 
more containers of 3 ounces each or less, each containing a different 
color, are distributed as a unit, the immediate container for such unit 
shall be considered to be the package as defined in this section.
    (u) The hair dye exemption in section 601(a) of the act applies to 
coal tar hair dyes intended for use in altering the color of the hair 
and which are, or which bear or contain, color additives derived from 
coal tar with the sensitization potential of causing skin irritation in 
certain individuals and possible blindness when used for dyeing the 
eyelashes or eyebrows. The exemption is permitted with the condition 
that the label of any such article bear conspicuously the statutory 
caution and adequate directions for preliminary patch-testing. The 
exemption does not apply to coloring ingredients in hair dyes not 
derived from coal tar, and it does not extend to poisonous or 
deleterious diluents that may be introduced as wetting agents, hair 
conditions, emulsifiers, or other components

[[Page 414]]

in a color shampoo, rinse, tint, or similar dual-purpose cosmetic that 
alter the color of the hair.
    (v) The terms externally applied drugs and externally applied 
cosmetics mean drugs or cosmetics applied only to external parts of the 
body and not to the lips or any body surface covered by mucous membrane.

[42 FR 15636, Mar. 22, 1977, as amended at 61 FR 14478, Apr. 2, 1996]



Sec.  70.5  General restrictions on use of color additives.

    (a) Color additives for use in the area of the eye. No listing or 
certification of a color additive shall be considered to authorize the 
use of any such color additive in any article intended for use in the 
area of the eye unless such listing or certification of such color 
additive specifically provides for such use. Any color additive used in 
or on any article intended for use in the area of the eye, the listing 
or certification of which color additive does not provide for such use, 
shall be considered to be a color additive not listed under parts 73, 
74, and 81 of this chapter, even though such color additive is certified 
and/or listed for other uses.
    (b) Color additives for use in injections. No listing or 
certification of a color additive shall be considered to authorize the 
use of any such color additive in any article intended for use in 
injections unless such listing or certification of such color additive 
specifically provides for such use. Any color additive used in or on any 
article intended for use in injections, the listing or certification of 
which color additive does not provide for such use, shall be considered 
to be a color additive not listed under parts 73, 74, and 81 of this 
chapter, even though such color additive is certified and/or listed for 
other uses.
    (c) Color additives for use in surgical sutures. No listing or 
certification of a color additive shall be considered to authorize the 
use of any such color additive in any article intended for use as a 
surgical suture unless such listing or certification of such color 
additive specifically provides for such use. Any color additive used in 
or on any article intended for use as a surgical suture, the listing or 
certification of which color additive does not provide for such use, 
shall be considered to be a color additive not listed under parts 73, 
74, and 81 of this chapter, even though such color additive is certified 
and/or listed for other uses.



Sec.  70.10  Color additives in standardized foods and new drugs.

    (a) Standardized foods. (1) Where a petition is received for 
issuance or amendment of a regulation establishing a definition and 
standard of identity for a food under section 401 of the act, which 
proposes the inclusion of a color additive in the standardized food, the 
provisions of the regulations in part 71 of this chapter shall apply 
with respect to the information that must be submitted with respect to 
the safety of the color additive (if such information has not previously 
been submitted and safety of the color additive for the intended use has 
not been already established), and the petition must show also that the 
use of the color additive in the standardized food would be in 
conformance with section 401 of the act or with the terms of a temporary 
permit issued under Sec.  130.17 of this chapter.
    (2) If a petition for a definition and standard of identity contains 
a proposal for a color additive regulation, and the petitioner fails to 
designate it as such, the Commissioner, upon determining that the 
petition includes a proposal for a color additive regulation, shall so 
notify the petitioner and shall thereafter proceed in accordance with 
the regulations in part 71 of this chapter.
    (3) A regulation will not be issued allowing the use of a color 
additive in a food for which a definition and standard of identity is 
established, unless its issuance is in conformance with section 401 of 
the act or with the terms of a temporary permit issued under Sec.  
130.17 of this chapter. When the contemplated use of such additive 
complies with the terms of a temporary permit, the color additive 
regulation will be conditioned on such compliance and will expire with 
the expiration of the temporary permit.
    (b) New drugs. (1) Where an application for a new drug is received 
and this

[[Page 415]]

application proposes, for coloring purposes only, the inclusion of a 
color additive, the provisions of the regulations in part 71 of this 
chapter shall apply with respect to the information that must be 
submitted about the safety of the color additive, if such information 
has not previously been submitted and safety of the color additive for 
the intended use has not already been established.
    (2) If an application for a new drug inferentially contains a 
proposal for a color additive regulation, and the applicant fails to 
designate it as such, the Commissioner, upon determining that the 
application includes a proposal for a color additive regulation, shall 
so notify the applicant and shall thereafter proceed in accordance with 
the regulations in part 71 of this chapter.
    (3) Where a petition for a color additive must be filed in 
accordance with paragraph (b)(2) of this section, the date of filing of 
the color additive petition shall be considered as the date of filing of 
the new-drug application.

[42 FR 15636, Mar. 22, 1977, as amended at 64 FR 400, Jan. 5, 1999]



Sec.  70.11  Related substances.

    (a) Different color additives may cause similar or related 
pharmacological or biological effects, and, in the absence of evidence 
to the contrary, those that do so will be considered to have additive 
toxic effects.
    (b) Food additives may also cause pharmacological or biological 
effects similar or related to such effects caused by color additives, 
and, in the absence of evidence to the contrary, those that do so will 
be considered as having additive toxic effects.
    (c) Pesticide chemicals may also cause pharmacological or biological 
effects similar or related to such effects caused by color additives, 
and, in the absence of evidence to the contrary, those that do so will 
be considered to have additive toxic effects.
    (d) In establishing tolerances for color additives, the Commissioner 
will take into consideration, among other things, the amount of any 
common component permitted in other color additives, in food additives, 
and in pesticide chemical residues as well as the similar biological 
activity (such as cholinesterase inhibition) produced by such substance.



Sec.  70.19  Fees for listing.

    (a) Each petition for the listing of a color additive shall be 
accompanied by a deposit of $3,000.00 if the proposal is for listing the 
color additive for use generally in or on foods, in or on drugs, and in 
or on cosmetics.
    (b) If the petition for the listing is for use in or on foods only, 
the deposit shall be $3,000.00.
    (c) If the petition for the listing is for use in or on drugs and/or 
cosmetics only, the deposit shall be $2,600.00.
    (d) The provisions of paragraphs (a), (b), and (c) of this section 
shall be applicable, whether or not the proposal contemplates any 
tolerances, limitations, or other restrictions placed upon the use of 
the color additive.
    (e) If a petition proposing the issuance of a regulation is 
withdrawn before it is finally accepted for filing, the deposit, less a 
$600.00 fee for clerical handling and administrative and technical 
review, shall be returned to the petitioner.
    (f) If a petition proposing the issuance of a regulation is 
withdrawn within 30 days after filing, the deposit, less $1,800.00 if 
the petition is covered by paragraph (a) or (b) of this section, and 
less $1,600.00, if the petition is covered by paragraph (c) of this 
section, shall be returned to the petitioner.
    (g) When a petition is withdrawn after filing and resubmitted within 
6 months, it shall be accompanied by a deposit of $1,800.00 for a 
petition filed under paragraph (a) or (b) of this section, and $1,600.00 
for a petition filed under paragraph (c) of this section. If a petition 
is resubmitted after 6 months, it shall be accompanied by the deposit 
that would be required if it were being submitted for the first time.
    (h) When the resubmission pertains to a petition that had been 
withdrawn before acceptance for filing, a new advance deposit shall be 
made in full as prescribed in paragraph (a), (b), or (c) of this 
section.
    (i) After a color additive has been listed, any request for an 
amendment or additional tolerance shall be accompanied by a deposit of 
$1,800.00 for use in the items specified in paragraphs (a)

[[Page 416]]

and (b) of this section, or $1,600.00 for use in items specified in 
paragraph (c) of this section.
    (j) The fee for services in listing a diluent under Sec.  80.35 for 
use in color additive mixtures shall be $250.00.
    (k) Objections and request for public hearing under section 721(d) 
of the act or section 203(d)(2)(C) of Pub. L. 86-618 (74 Stat. 404; 21 
U.S.C. 379e, note) shall be accompanied by a filing fee of $250.00.
    (l) In the event of a referral of a petition under this section to 
an advisory committee, all costs related thereto (including personal 
compensation of committee members, travel materials, and other costs) 
shall be borne by the person or organization requesting the referral, 
such costs to be assessed on the basis of actual cost to the Government: 
Provided, That the compensation of such costs shall include personal 
compensation of advisory committee members at a rate not to exceed 
$75.00 per member per day.
    (m) In the case of requests of referrals to advisory committees, a 
special advance deposit shall be made in the amount of $2,500.00. Where 
required, further advance in increments of $2,500.00 each shall be made 
upon request of the Commissioner of Food and Drugs. All deposits for 
referrals to advisory committees in excess of actual expenses shall be 
refunded to the depositor.
    (n) All requests for pharmacological or other scientific studies 
shall be accompanied by an advance deposit of $5,000.00. Further advance 
deposits shall be made upon request of the Commissioner of Food and 
Drugs when necessary to prevent arrears in such cost. Any deposits in 
excess of actual expenses will be refunded to the depositor. If a 
request is denied the advance deposit will be refunded less such costs 
as are incurred for review of the request.
    (o) The person who files a petition for judicial review of an order 
under section 721(d) of the act shall pay the costs of preparing a 
transcript of the record on which the order is based.
    (p) All deposits and fees required by the regulations in this 
section shall be paid by money order, bank draft or certified check 
drawn to the order of the Food and Drug Administration, collectible at 
par at Washington, DC All deposits and fees shall be forwarded to the 
Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, whereupon after 
making appropriate record thereof 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.''
    (q) The Commissioner of Food and Drugs may waive or refund such fees 
in whole or in part when in his judgment such action will promote the 
public interest.
    (r) Any person who believes that payment of these fees will work a 
hardship on him may petition the Commissioner of Food and Drugs to waive 
or refund the fees.

[42 FR 15636, Mar. 22, 1977, as amended at 54 FR 24890, June 12, 1989; 
61 FR 14478, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001; 81 FR 49895, July 
29, 2016]



                    Subpart B_Packaging and Labeling



Sec.  70.20  Packaging requirements for straight colors 
(other than hair dyes).

    Straight colors shall be packaged in containers which prevent 
changes in composition. Packages shall be sealed so that they cannot be 
opened without breaking the seal. An unavoidable change in moisture 
content caused by the ordinary and customary exposure that occurs in 
good storage, packing, and distribution practice is not considered a 
change in composition. If the packaging material is a food additive it 
shall be authorized by an appropriate regulation in parts 170 through 
189 of this chapter.



Sec.  70.25  Labeling requirements for color additives (other than hair dyes).

    (a) General labeling requirements. All color additives shall be 
labeled with sufficient information to assure their safe use and to 
allow a determination of compliance with any limitations imposed by this 
part and parts 71, 73, 74,

[[Page 417]]

80, and 81 of this chapter. In addition to all other information 
required by the act, labels for color additives, except those in a form 
suitable for coloring the human body, shall state:
    (1) The name of the straight color or the name of each ingredient 
comprising the color additive, if it is a mixture.
    (2) A statement indicating general limitations for the use of the 
color additive, such as ``for food use only''; ``for food, drug, and 
cosmetic use''; ``for use in drugs for external application only.''
    (3) Where regulations issued impose quantitative limitations for a 
general or specific use of a straight color, the amount of each such 
straight color in terms of weight per unit/volume or percent by weight.
    (4) An expiration date if stability data require it.
    (b) Special labeling for color additives with tolerances. Where 
tolerances are imposed for a general or specific use of a color 
additive, the label shall in addition provide directions for use of the 
color additive which if followed will preclude the food, drug, or 
cosmetic to which it is added from containing an amount of the color 
additive in excess of the tolerance.
    (c) Special labeling for color additives with other limitations. If 
use of the color additive is subject to other limitations prescribed in 
this part, such limitations shall be stated on the label of the color 
additive by a plain and conspicuous statement. Examples of such 
limitation statements are: ``Do not use in products used in the area of 
the eye''; ``Do not use for coloring drugs for injection.''
    (d) Special labeling for color additives not exempt from 
certification. Color additives not exempt from the certification 
procedures shall in addition include in the labeling the lot number 
assigned by the Color Certification Branch, except that in the case of 
any mixture for household use which contains not more than 15 percent of 
pure color and which is in packages containing not more than 3 ounces 
there appears on the label, a code number which the manufacturer has 
identified with the lot number by giving to the Food and Drug 
Administration written notice that such code number will be used in lieu 
of the lot number.



                       Subpart C_Safety Evaluation



Sec.  70.40  Safety factors to be considered.

    In accordance with section 721(b)(5)(A)(iii) of the act, the 
following safety factor will be applied in determining whether the 
proposed use of a color additive will be safe: Except where evidence is 
submitted which justifies use of a different safety factor, a safety 
factor of 100 to 1 will be used in applying animal experimentation data 
to man; that is, a color additive for use by man will not be granted a 
tolerance that will exceed 1/100th of the maximum no-effect level for 
the most susceptible experimental animals tested. The various species of 
experimental animals used in the tests shall conform to good 
pharmacological practice.



Sec.  70.42  Criteria for evaluating the safety of color additives.

    (a) In deciding whether a petition is complete and suitable for 
filing and in reaching a decision on any petition filed, the 
Commissioner will apply the ``safe-for-use'' principle. This will 
require the presentation of all needed scientific data in support of a 
proposed listing to assure that each listed color additive will be safe 
for its intended use or uses in or on food, drugs, or cosmetics. The 
Commissioner may list a color additive for use generally in or on food, 
in or on drugs, or in or on cosmetics when he finds from the data 
presented that such additive is suitable and may safely be employed for 
such general use; he may list an additive only for more limited use or 
uses for which it is proven suitable and may safely be employed; and he 
is authorized to prescribe broadly the conditions under which the 
additive may be safely employed for such use or uses. This may allow the 
use of a particular dye, pigment, or other substance with certain 
diluents, but not with others, or at a higher concentration with some 
than with others.
    (b) The safety for external color additives will normally be 
determined by tests for acute oral toxicity, primary irritation, 
sensitization, subacute dermal toxicity on intact and abraded

[[Page 418]]

skin, and carcinogenicity by skin application. The Commissioner may 
waive any of such tests if data before him otherwise establish that such 
test is not required to determine safety for the use proposed.
    (c) Upon written request describing the proposed use of a color 
additive and the proposed experiments to determine its safety, the 
Commissioner will advise a person who wishes to establish the safety of 
a color additive whether he believes the experiments planned will yield 
data adequate for an evaluation of the safety of the additive.



Sec.  70.45  Allocation of color additives.

    Whenever, in the consideration of a petition or a proposal to list a 
color additive or to alter an existing listing, the data before the 
Commissioner fail to show that it would be safe to list the color 
additive for all the uses proposed or at the levels proposed, the 
Commissioner will notify the petitioner and other interested persons by 
publication in the Federal Register that it is necessary to allocate the 
safe tolerance for the straight color in the color additive among the 
competing needs. This notice shall call for the presentation of data by 
all interested persons on which the allocation can be made in accordance 
with section 721(b)(8) of the act. The time for acting upon the petition 
shall be stayed until such data are presented, whereupon the time limits 
shall begin to run anew. As promptly as possible after presentation of 
the data, the Commissioner will, by order, announce the allocation and 
the tolerance limitations.



Sec.  70.50  Application of the cancer clause of section 721 of the act.

    (a) Color additives that may be ingested. Whenever (1) the 
scientific data before the Commissioner (either the reports from the 
scientific literature or the results of biological testing) suggest the 
possibility that the color additive including its components or 
impurities has induced cancer when ingested by man or animal; or (2) 
tests which are appropriate for the evaluation of the safety of 
additives in food suggest that the color additive, including its 
components or impurities, induces cancer in man or animal, the 
Commissioner shall determine whether, based on the judgment of 
appropriately qualified scientists, cancer has been induced and whether 
the color additive, including its components or impurities, was the 
causative substance. If it is his judgment that the data do not 
establish these facts, the cancer clause is not applicable; and if the 
data considered as a whole establish that the color additive will be 
safe under the conditions that can be specified in the applicable 
regulation, it may be listed for such use. But if in the judgment of the 
Commissioner, based on information from qualified scientists, cancer has 
been induced, no regulation may issue which permits its use.
    (b) Color additives that will not be ingested. Whenever the 
scientific data before the Commissioner suggest the possibility that the 
color additive, including its components or impurities, has induced 
cancer in man or animals by routes other than ingestion, the 
Commissioner shall determine whether, based on the judgment of 
appropriately qualified scientists, the test suggesting the possibility 
of carcinogenesis is appropriate for the evaluation of the color 
additive for a use which does not involve ingestion, cancer has been 
induced, and the color additive, including its components or impurities, 
was the causative substance. If it is his judgment that the data do not 
establish these facts, the cancer clause is not applicable to preclude 
external drug and cosmetic uses, and if the data as a whole establish 
that the color additive will be safe under conditions that can be 
specified in the regulations, it may be listed for such use. But if, in 
the judgment of the Commissioner, based on information from qualified 
scientists, the test is an appropriate one for the consideration of 
safety for the proposed external use, and cancer has been induced by the 
color additive, including its components or impurities, no regulation 
may issue which permits its use in external drugs and cosmetics.
    (c) Color additives for use as an ingredient of feed for animals 
that are raised for food production. Color additives that are an 
ingredient of the feed for animals raised for food production and that 
have the potential to contaminate

[[Page 419]]

human food with residues whose consumption could present a risk of 
cancer to people must satisfy the requirements of subpart E of part 500 
of this chapter.

[42 FR 15636, Mar. 22, 1977, as amended at 43 FR 22675, May 26, 1978; 52 
FR 49586, Dec. 31, 1987]



Sec.  70.51  Advisory committee on the applicability of the anticancer
clause.

    All requests for and procedures governing any advisory committee on 
the anticancer clause shall be subject to the provisions of part 14 of 
this chapter, and particularly subpart H of that part.



Sec.  70.55  Request for scientific studies.

    The Commissioner will consider requests by any interested person who 
desires the Food and Drug Administration to conduct scientific studies 
to support a petition for a regulation for a color additive. If 
favorably acted upon, such studies will be limited to pharmacological 
investigations, studies of the chemical and physical structure of the 
color additive, and methods of analysis of the pure color additive 
(including impurities) and its identification and determination in 
foods, drugs, or cosmetics, as the case may be. All requests for such 
studies shall be accompanied by the fee prescribed in Sec.  70.19.



PART 71_COLOR ADDITIVE PETITIONS--Table of Contents



                      Subpart A_General Provisions

Sec.
71.1 Petitions.
71.2 Notice of filing of petition.
71.4 Samples; additional information.
71.6 Extension of time for studying petitions; substantive amendments; 
          withdrawal of petitions without prejudice.
71.15 Confidentiality of data and information in color additive 
          petitions.
71.18 Petition for exemption from certification.

              Subpart B_Administrative Action on Petitions

71.20 Publication of regulation.
71.22 Deception as a basis for refusing to issue regulations; deceptive 
          use of a color additive for which a regulation has issued.
71.25 Condition for certification.
71.26 Revocation of exemption from certification.
71.27 Listing and exemption from certification on the Commissioner's 
          initiative.
71.30 Procedure for filing objections to regulations.
71.37 Exemption of color additives for investigational use.

    Authority: 21 U.S.C. 321, 342, 348, 351, 355, 360, 360b-360f, 360h-
360j, 361, 371, 379e, 381; 42 U.S.C. 216, 262.

    Source: 42 FR 15639, Mar. 22, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  71.1  Petitions.

    (a) Any interested person may propose the listing of a color 
additive for use in or on any food, drug, or cosmetic or for coloring 
the human body. Such proposal shall be made in a petition in the form 
prescribed in paragraph (c) of this section. The petition shall be 
submitted in triplicate (quadruplicate, if intended uses include uses in 
meat, meat food product, or poultry product). If any part of the 
material submitted is in a foreign language, it shall be accompanied by 
an accurate and complete English translation. The petitioner shall state 
the post-office address in the United States to which published notices 
or orders issued or objections filed pursuant to section 721 of the act 
may be sent.
    (b) Pertinent information may be incorporated in, and will be 
considered as part of, a petition on the basis of specific reference to 
such information submitted to and retained in the files of the Food and 
Drug Administration. However, any reference to unpublished information 
furnished by a person other than the applicant will not be considered 
unless use of such information is authorized in a written statement 
signed by the person who submitted the information. Any reference to 
published information offered in support of a color additive petition 
should be accompanied by reprints or photostatic copies of such 
references.

[[Page 420]]

    (c) Petitions shall include the following data and be submitted in 
the following form:

                                                        _________ (Date)

Name of petitioner______________________________________________________
Post-office address_____________________________________________________
Name of color additive and proposed use_________________________________

Office of Food Additive Safety (HFS-200),
Center for Food Safety and Applied Nutrition,
Food and Drug Administration,
5001 Campus Dr.,
College Park, MD 20740
Dear Sir:
    Petitioner submits this pursuant to section 721(b)(1) of the Federal 
Food, Drug, and Cosmetic Act requesting listing by the Commissioner of 
the color additive _____ as suitable and safe for use in or on _____ 
subject to the conditions that _______. [Petitioner may propose a 
listing for general use in food, drugs, or cosmetics or, if such general 
listing is not believed suitable and safe, the petitioner shall describe 
the conditions under which he believes the additive can be safely used 
and for which it will be suitable. These conditions may include 
tolerance limitations, specifications as to the manner in which the 
additive may be added or used, and directions and other labeling or 
packaging safeguards that should be applied. The level of use proposed 
should not be higher than reasonably required to accomplish the intended 
color effect.]
    Attached hereto, in triplicate (quadruplicate, if intended uses 
include uses in meat, meat food product, or poultry product), and 
constituting a part of this petition are the following:
    A. The name and all pertinent information concerning the color 
additive, including chemical identity and composition of the color 
additive, its physical, chemical, and biological properties, and 
specifications prescribing its component(s) and identifying and limiting 
the reaction byproducts and other impurities.
    The petition shall contain a description of the chemical and 
physical tests relied upon to identify the color additive and shall 
contain a full description of the methods used in, and the facilities 
and controls used for, the production of the color additive. These shall 
establish that it is a substance of reproducible composition. 
Alternative methods and controls and variations in methods and controls, 
within reasonable limits, that do not affect the characteristics of the 
substance or the reliability of the controls may be specified.
    The petition shall supply a list of all substances used in the 
synthesis, extraction, or other method of preparation of any straight 
color, regardless of whether they undergo chemical change in the 
process. Each substance should be identified by its common or usual name 
and its complete chemical name, using structural formulas when necessary 
for specific identification. If any proprietary preparation is used as a 
component, the proprietary name should be followed by a complete 
quantitive statement of composition. Reasonable alternatives for any 
listed substance may be specified.
    If the petitioner does not himself perform all the manufacturing, 
processing, and packing operations for a color additive, the petitioner 
shall identify each person who will perform a part of such operations 
and designate the part.
    The petition shall include stability data, and, if the data indicate 
that it is needed to insure the identity, strength, quality, or purity 
of the color additive, the expiration period that will be employed as 
well as any packaging and labeling precautions needed to preserve 
stability.
    B. The amount of the color additive proposed for use and the color 
effect intended to be achieved, together with all directions, 
recommendations, and suggestions regarding the proposed use, as well as 
specimens of the labeling proposed for the color additive. If the color 
effect results or may reasonably be expected to result from use of the 
color additive in packaging material, the petitioner shall show how this 
may occur and what residues may reasonably be anticipated.
    Typewritten or other draft-labeling copy will be accepted for 
consideration of the petition provided final printed labeling identical 
in content to the draft copy is submitted as soon as available, and 
prior to the marketing of the color additive. The printed labeling shall 
conform in prominence and conspicuousness with the requirements of the 
act.
    If the color additive is one for which a tolerance limitation is 
required to assure its safety, the level of use proposed should be no 
higher than the amount reasonably required to accomplish the intended 
physical or other technical effect, even though the safety data may 
support a higher tolerance. If the safety data will not support the use 
of the amount of the color additive reasonably needed to accomplish the 
desired color effect, the requested tolerance will not be established. 
Petitioners are expected to propose the use of color additives in 
accordance with sound color chemistry.
    C.1. A description of practicable methods to determine the pure 
color and all intermediates, subsidiary colors, and other components of 
the color additive.
    2. A description of practicable methods to determine the amount of 
the color additive in any raw, processed, and/or finished food, drug, or 
cosmetic in which use of the color additive is proposed. (The tests 
proposed shall be those that can be used for food, drug,

[[Page 421]]

or cosmetic control purposes and can be applied with consistent results 
by any properly equipped laboratory and trained personnel.)
    3. A description of methods for identification and determination of 
any substance formed in or on such food, drug, or cosmetic because of 
the use of the color additive. (If it is the petitioner's view that any 
such method would not be needed, under the terms of section 
721(b)(5)(A)(iv), a statement shall be submitted in lieu of methods as 
to the basis for such view.)
    D. Full reports of investigation made with respect to the safety of 
the color additive.
    (A petition will be regarded as incomplete unless it includes full 
reports of adequate tests reasonably applicable to show whether or not 
the color additive will be safe for its intended use. The reports 
ordinarily should include detailed data derived from appropriate animal 
and other biological experiments in which the methods used and the 
results obtained are clearly set forth. The petition shall not omit 
without explanation any data that would influence the evaluation of the 
safety of the color additive).
    E. Complete data which will allow the Commissioner to consider, 
among other things, the probable consumption of, and/or other relevant 
exposure from the additive and of any substance formed in or on food, 
drugs, or cosmetics because of such additive; and the cumulative effect, 
if any, of such additive in the diet of man or animals, taking into 
account the same or any chemically or pharmacologically related 
substance or substances in the diet including, but not limited to food 
additives and pesticide chemicals for which tolerances or exemptions 
from tolerances have been established.
    F. Proposed tolerances and other limitations on the use of the color 
additive, if tolerances and limitations are required in order to insure 
its safety. A petitioner may include a proposed regulation.
    G. If exemption from batch certification is requested, the reasons 
why it is believed such certification is not necessary (including 
supporting data to establish the safety of the intended use).
    H. If submitting a petition to alter an existing regulation issued 
pursuant to section 721(b) of the act, full information on each proposed 
change that is to be made in the original regulation must be submitted. 
The petition may omit statements made in the original petition 
concerning which no change is proposed. A supplemental petition must be 
submitted for any change beyond the variations provided for in the 
original petition and the regulation issued on the basis of the original 
petition.
    I. The prescribed fee of $______ for admitting the color additive to 
listing is enclosed (unless there is an advance deposit adequate to 
cover the fee).

Yours very truly,
(Petitioner)____________________________________________________________
                                         By _______ (Indicate authority)

    J. The petitioner is required to submit either a claim for 
categorical exclusion under Sec.  25.30 or 25.32 of this chapter or an 
environmental assessment under Sec.  25.40 of this chapter.

    (d) The petitioner will be notified of the date on which his 
petition is filed; and an incomplete petition, or one that has not been 
submitted in triplicate, will be retained but not filed. A petition 
shall be retained but shall not be filed if any of the data listed in 
the above form are lacking or are not set forth so as to be readily 
understood or if the prescribed fee has not been submitted. The 
petitioner will be notified in what respects his petition is incomplete.
    (e) The petition must be signed by the petitioner or by his attorney 
or authorized agent, who is a resident of the United States.
    (f) The data specified under the several lettered headings should be 
submitted on separate sheets or sets of sheets, suitably identified. If 
such data have already been submitted with an earlier application, the 
present petition may incorporate it by specific reference to the earlier 
petition.
    (g) If nonclinical laboratory studies are involved, petitions filed 
with the Commissioner under section 721(b) of the act shall include with 
respect to each nonclinical study contained in the petition, either a 
statement that the study was conducted in compliance with the good 
laboratory practice regulations set forth in part 58 of this chapter, 
or, if the study was not conducted in compliance with such regulations, 
a brief statement of the reason for the noncompliance.
    (h) [Reserved]
    (i) If clinical investigations involving human subjects are 
involved, petitions filed with the Commissioner under section 721(b) of 
the act shall include statements regarding each such clinical 
investigation contained in the petition that it either was conducted in 
compliance with the requirements for institutional review set forth in 
part 56 of this chapter, or was not subject to such requirements in 
accordance with

[[Page 422]]

Sec. Sec.  56.104 or 56.105, and that it was conducted in compliance 
with the requirements for informed consent set forth in part 50 of this 
chapter.
    (j)(1) If intended uses of the color additive include uses in meat, 
meat food product, or poultry product subject to regulation by the U.S. 
Department of Agriculture (USDA) under the Poultry Products Inspection 
Act (PPIA) (21 U.S.C. 451 et seq.) or the Federal Meat Inspection Act 
(FMIA) (21 U.S.C. 601 et seq.), FDA shall, upon filing of the petition, 
forward a copy of the petition or relevant portions thereof to the Food 
Safety and Inspection Service, USDA, for simultaneous review under the 
PPIA and FMIA.
    (2) FDA will ask USDA to advise whether the proposed meat and 
poultry uses comply with the FMIA and PPIA or, if not, whether use of 
the substance would be permitted in products under USDA jurisdiction 
under specified conditions or restrictions.

[42 FR 15639, Mar. 22, 1977, as amended at 43 FR 60021, Dec. 22, 1978; 
46 FR 8952, Jan. 27, 1981; 50 FR 7491, Feb. 22, 1985; 50 FR 16668, Apr. 
26, 1985; 54 FR 24890, June 12, 1989; 61 FR 14478, Apr. 2, 1996; 62 FR 
40598, July 29, 1997; 65 FR 51762, Aug. 25, 2000; 66 FR 56035, Nov. 6, 
2001; 81 FR 49895, July 29, 2016]



Sec.  71.2  Notice of filing of petition.

    (a) Except where the petition involves a new drug, the Commissioner, 
within 15 days after receipt, will notify the petitioner of acceptance 
or nonacceptance of a petition, and if not accepted the reasons 
therefor. If accepted, the date of the notification letter sent to 
petitioner becomes the date of filing for the purposes of section 
721(d)(1) of the act. If the petitioner desires, he may supplement a 
deficient petition after being notified regarding deficiencies. If the 
supplementary material or explanation of the petition is deemed 
acceptable, petitioner shall be notified. The date of such notification 
becomes the date of filing. If the petitioner does not wish to 
supplement or explain the petition and requests in writing that it be 
filed as submitted, the petition shall be filed and the petitioner so 
notified. The date of such notification becomes the date of filing. 
Where the petition involves a new drug, notification to the petitioner 
will be made in accordance with Sec.  70.10(b)(3) of this chapter.
    (b) The Commissioner will cause to be published in the Federal 
Register within 30 days from the date of filing of such petition a 
notice of the filing, the name of the petitioner, and a brief 
description of the proposal in general terms. A copy of the notice will 
be mailed to the petitioner when the original document is signed.

[42 FR 15639, Mar. 22, 1977, as amended at 64 FR 400, Jan. 5, 1999]



Sec.  71.4  Samples; additional information.

    The Commissioner may request samples of the color additive, articles 
used as components thereof, or of the food, drug, or cosmetic in which 
the color additive is proposed to be used, or which comprises the color 
additive, and any additional information needed to clarify a submitted 
method or other aspect of a petition at any time while a petition is 
under consideration. The Commissioner shall specify in the request for a 
sample of the color additive, or articles used as components thereof, or 
of the food, drug, or cosmetic in which the color additive is proposed 
to be used, or which comprises the color additive, a quantity deemed 
adequate to permit tests of analytical methods to determine quantities 
of the color additive present in products for which it is intended to be 
used or adequate for any study or investigation reasonably required with 
respect to the safety of the color additive or the physical or technical 
effect it produces. The date used for computing the 90-day limit for the 
purposes of section 721(d)(1) of the act shall be moved forward 1 day 
for each day, after mailing date of the request, taken by the petitioner 
to submit the information and/or sample. If the information or sample is 
requested a reasonable time in advance of the 180 days, but is not 
submitted within such 180 days after filing of the petition, the 
petition will be considered withdrawn without prejudice.

[[Page 423]]



Sec.  71.6  Extension of time for studying petitions; substantive 
amendments; withdrawal of petitions without prejudice.

    (a) Extension of time for studying petitions. If the Commissioner 
determines that additional time is needed to study and investigate the 
petition, he shall by written notice to the petitioner extend the 90-day 
period for not more than 180 days after the filing of the petition.
    (b) Substantive amendments. After a petition has been filed, the 
petitioner may submit additional information or data in support thereof. 
In such cases, if the Commissioner determines that the additional 
information or data amounts to a substantive amendment, the petition as 
amended will be given a new filing date, and the time limitation will 
begin to run anew. If nonclinical laboratory studies are involved, 
additional information and data submitted in support of filed petitions 
shall include, with respect to each nonclinical laboratory study 
contained in the petition, either a statement that the study was 
conducted in compliance with the requirements set forth in part 58 of 
this chapter, or, if the study was not conducted in compliance with such 
regulations, a brief statement of the reason for the noncompliance. If 
clinical investigations involving human subjects are involved, 
additional information or data submitted in support of filed petitions 
shall include statements regarding each such clinical investigation from 
which the information or data are derived, that it either was conducted 
in compliance with the requirements for institutional review set forth 
in part 56 of this chapter, or was not subject to such requirements in 
accordance with Sec.  56.104 or Sec.  56.105, and that it was conducted 
in compliance with the requirements for informed consent set forth in 
part 50 of this chapter.
    (c) Withdrawal of petitions without prejudice. (1) In some cases the 
Commissioner may notify the petitioner that the petition, while 
technically complete, is inadequate to justify the establishment of a 
regulation or the regulation requested by petitioner. This may be due to 
the fact that the data are not sufficiently clear or complete. In such 
cases, the petitioner may withdraw the petition pending its 
clarification or the obtaining of additional data. This withdrawal will 
be without prejudice to a future filing. Upon refiling, the time 
limitation will begin to run anew from the date of refiling.
    (2) At any time before the order provided for in Sec.  71.20 has 
been forwarded to the Federal Register for publication the petitioner 
may withdraw the petition without prejudice to a future filing. Upon 
refiling, the time limitation will begin to run anew.

[42 FR 15636, Mar. 22, 1977, as amended at 43 FR 60021, Dec. 22, 1978; 
46 FR 8952, Jan. 27, 1981; 50 FR 7491, Feb. 22, 1985]



Sec.  71.15  Confidentiality of data and information in color 
additive petitions.

    (a) The following data and information in a color additive petition 
are available for public disclosure, unless extraordinary circumstances 
are shown, after the notice of filing of the petition is published in 
the Federal Register or, if the petition is not promptly filed because 
of deficiencies in it, after the petitioner is informed that it will not 
be filed because of the deficiencies involved:
    (1) All safety and functionality data and information submitted with 
or incorporated by reference in the petition.
    (2) A protocol for a test or study, unless it is shown to fall 
within the exemption established for trade secrets and confidential 
commercial information in Sec.  20.61 of this chapter.
    (3) Adverse reaction reports, product experience reports, consumer 
complaints, and other similar data and information, after deletion of:
    (i) Names and any information that would identify the person using 
the product.
    (ii) Names and any information that would identify any third party 
involved with the report, such as a physician or hospital or other 
institution.
    (4) A list of all ingredients contained in a color additive, whether 
or not it is in descending order of predominance. A particular 
ingredient or group of ingredients shall be deleted from any such list 
prior to public disclosure if it is shown to fall within the exemption 
established in Sec.  20.61 of this chapter, and

[[Page 424]]

a notation shall be made that any such ingredient list is incomplete.
    (5) An assay method or other analytical method, unless it serves no 
regulatory or compliance purpose and is shown to fall within the 
exemption established in Sec.  20.61 of this chapter.
    (6) All records showing the Food and Drug Administration's testing 
of or action on a particular lot of a certifiable color additive.
    (b) The following data and information in a color additive petition 
are not available for public disclosure unless they have been previously 
disclosed to the public as defined in Sec.  20.81 of this chapter or 
they relate to a product or ingredient that has been abandoned and they 
no longer represent a trade secret or confidential commercial or 
financial information as defined in Sec.  20.61 of this chapter:
    (1) Manufacturing methods or processes, including quality control 
procedures.
    (2) Production, sales, distribution, and similar data and 
information, except that any compilation of such data and information 
aggregated and prepared in a way that does not reveal data or 
information which is not available for public disclosure under this 
provision is available for public disclosure.
    (3) Quantitative or semiquantitative formulas.
    (c) All correspondence and written summaries of oral discussions 
relating to a color additive petition are available for public 
disclosure in accordance with the provisions of part 20 of this chapter 
when the color additive regulation is published in the Federal Register.
    (d) For purposes of this regulation, safety and functionality data 
include all studies and tests of a color additive on animals and humans 
and all studies and tests on a color additive for identity, stability, 
purity, potency, performance, and usefulness.



Sec.  71.18  Petition for exemption from certification.

    A manufacturer, packer, or distributor of a color additive or color 
additive mixture may petition for an exemption from certification 
pursuant to part 10 of this chapter. Any such petition shall show why 
such certification is not necessary for the protection of public health.



              Subpart B_Administrative Action on Petitions



Sec.  71.20  Publication of regulation.

    The Commissioner will forward for publication in the Federal 
Register, within 90 days after filing of the petition (or within 180 
days if the time is extended as provided for in section 721(d)(1) of the 
act):
    (a) A regulation listing in part 73 or 74 of this chapter the color 
additive on the appropriate list or lists as provided under section 
721(b)(1).
    (1) Such a regulation may list the color additive for use generally 
in or on foods, drugs, or cosmetics or for use in coloring the human 
body, as the case may be, or may prescribe the conditions under which 
the color additive may be safely used (including, but not limited to, 
specifications as to the particular food, drug, or cosmetic or classes 
of food, drugs, or cosmetics in or on which such color additive may be 
used, or for the material intended for coloring the human body; the 
maximum quantity of any straight color or diluent that may be used or 
permitted to remain in or on such food, drug, or cosmetic or article 
intended for coloring the human body; the manner in which such color 
additive may be added to or used in or on such food, drug, or cosmetic 
or for coloring the human body; and any directions or other labeling or 
packing requirements for such color additives deemed necessary to assure 
the safety of such use).
    (2) Such regulations shall list the color additive only for the use 
or uses for which it has been found suitable and for which it may safely 
be employed. Alternatively, the Commissioner shall by order deny the 
petition, and notify the petitioner of such order and the reasons 
therefor.
    (3) The regulation shall list any use or uses in meat, meat food 
product, or poultry product subject to the Federal Meat Inspection Act 
(FMIA) (21 U.S.C. 601 et seq.) or the Poultry Products Inspection (PPIA) 
(21 U.S.C. 451 et seq.) for which the color additive has been

[[Page 425]]

found suitable and for which it may safely be employed.
    (b) Whenever the Commissioner finds that batch certification is not 
necessary for the protection of the public health he will, by order, 
exempt the color additive from the certification procedure. In 
determining whether certification of a color additive is necessary, the 
Commissioner will consider the composition of the additive, its 
manufacturing process, possible impurities, its toxic potential, control 
and analytical procedures necessary to assure compliance with the 
listing specifications, and the variability of its composition.

[42 FR 15639, Mar. 22, 1977, as amended at 65 FR 51762, Aug. 25, 2000]



Sec.  71.22  Deception as a basis for refusing to issue regulations;
deceptive use of a color additive for which a regulation has issued.

    The Commissioner shall refuse to issue a regulation listing a color 
additive, if in his judgment the data before him show that such proposed 
use would promote deception of the consumer or would result in 
misbranding or adulteration within the meaning of the act. Such a 
finding shall be by order published in the Federal Register subject to 
the filing of objections and a request for a hearing by adversely 
affected parties. The issuance of a regulation for a color additive 
authorizing its use generally in or on a food, drug, or cosmetic shall 
not be construed as authorization to use the color additive in a manner 
that may promote deception or conceal damage or inferiority. The use of 
a color additive to promote deception or conceal damage or inferiority 
shall be considered as the use of a color additive for which no 
regulation has issued pursuant to section 721(b) of the act, even though 
the regulation is effective for other uses.



Sec.  71.25  Condition for certification.

    (a) When the Commissioner cannot conclude from the information 
before him that there is a basis for exempting a color additive from the 
requirement of batch certification, he will so order by appropriate 
listing in part 74 of this chapter. The Commissioner's order shall state 
in detail the specifications that shall be met by the color additive.
    (b) Each order shall state a period of time after which use of a 
color additive subject to batch certification but not from a batch 
certified by procedure prescribed in this section would result in 
adulteration of the product in which it is used.



Sec.  71.26  Revocation of exemption from certification.

    If information becomes available to the Commissioner that a color 
additive that has been granted exemption from certification should not, 
for the protection of the public health, be so exempted, such exemption 
will be canceled by a notice published in the Federal Register.



Sec.  71.27  Listing and exemption from certification on the
Commissioner's initiative.

    Where a petition for a regulation to list a color additive has not 
been received and the Commissioner has available facts which demonstrate 
that a color additive should be listed and/or that certification 
procedure is not necessary in order to protect the public health, he may 
list such color additive by appropriate regulation and listing in part 
73 or 74 of this chapter.



Sec.  71.30  Procedure for filing objections to regulations.

    (a) Objections and hearings relating to color additive regulations 
under section 721 (b) and (c) of the act shall be governed by parts 10, 
12, 13, 14, 15, 16, and 19 of this chapter.
    (b) The fees specified in Sec.  70.19 of this chapter shall be 
applicable.



Sec.  71.37  Exemption of color additives for investigational use.

    (a) A shipment or other delivery of a color additive or of a food, 
drug, or cosmetic containing such a color additive for investigational 
use by experts qualified to determine safety shall be exempt from the 
requirements of section 402(c), 501(a), or 601(e) of the act, provided 
that the color additive or the food, drug, or cosmetic containing the 
color additive bears a label which

[[Page 426]]

states prominently, ``Caution--Contains new color additive--For 
investigational use only.'' No animals used in such investigations, or 
their products, such as milk or eggs, shall be used for food purposes, 
unless the sponsor or the investigator has submitted to the Commissioner 
data demonstrating that such use will be consistent with the public 
health, and the Commissioner, proceeding as he would in a matter 
involving section 409(i) of the act, has notified the sponsor or 
investigator that the proposed disposition for food is authorized. Any 
person who contests a refusal to grant such authorization shall have an 
opportunity for a regulatory hearing before the Food and Drug 
Administration pursuant to part 16 of this chapter.
    (b) The person who introduced such shipment or who delivers the 
color additive or a food, drug, or cosmetic containing such an additive 
into interstate commerce shall maintain adequate records showing the 
name and post-office address of the expert to whom the color additive is 
shipped, date, quantity, and batch or code mark of each shipment and 
delivery for a period of 2 years after such shipment and delivery. Upon 
the request of a properly authorized employee of the Department, at 
reasonable times, he shall make such records available for inspection 
and copying.



PART 73_LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
--Table of Contents



                             Subpart A_Foods

Sec.
73.1 Diluents in color additive mixtures for food use exempt from 
          certification.
73.30 Annatto extract.
73.35 Astaxanthin.
73.37 Astaxanthin dimethyldisuccinate.
73.40 Dehydrated beets (beet powder).
73.50 Ultramarine blue.
73.70 Calcium carbonate.
73.75 Canthaxanthin.
73.85 Caramel.
73.90 [beta]-Apo-8'-carotenal.
73.95 [beta]-Carotene.
73.100 Cochineal extract; carmine.
73.125 Sodium copper chlorophyllin.
73.140 Toasted partially defatted cooked cottonseed flour.
73.160 Ferrous gluconate.
73.165 Ferrous lactate.
73.169 Grape color extract.
73.170 Grape skin extract (enocianina).
73.185 Haematococcus algae meal.
73.200 Synthetic iron oxide.
73.250 Fruit juice.
73.260 Vegetable juice.
73.275 Dried algae meal.
73.295 Tagetes (Aztec marigold) meal and extract.
73.300 Carrot oil.
73.315 Corn endosperm oil.
73.340 Paprika.
73.345 Paprika oleoresin.
73.350 Mica-based pearlescent pigments.
73.352 Paracoccus pigment.
73.355 Phaffia yeast.
73.450 Riboflavin.
73.500 Saffron.
73.530 Spirulina extract.
73.575 Titanium dioxide.
73.585 Tomato lycopene extract; tomato lycopene concentrate.
73.600 Turmeric.
73.615 Turmeric oleoresin.

                             Subpart B_Drugs

73.1001 Diluents in color additive mixtures for drug use exempt from 
          certification.
73.1010 Alumina (dried aluminum hydroxide).
73.1015 Chromium-cobalt-aluminum oxide.
73.1025 Ferric ammonium citrate.
73.1030 Annatto extract.
73.1070 Calcium carbonate.
73.1075 Canthaxanthin.
73.1085 Caramel.
73.1095 [beta]-Carotene.
73.1100 Cochineal extract; carmine.
73.1125 Potassium sodium copper chlorophyllin (chlorophyllin-copper 
          complex).
73.1150 Dihydroxyacetone.
73.1162 Bismuth oxychloride.
73.1200 Synthetic iron oxide.
73.1298 Ferric ammonium ferrocyanide.
73.1299 Ferric ferrocyanide.
73.1326 Chromium hydroxide green.
73.1327 Chromium oxide greens.
73.1329 Guanine.
73.1350 Mica-based pearlescent pigments.
73.1375 Pyrogallol.
73.1400 Pyrophyllite.
73.1410 Logwood extract.
73.1496 Mica.
73.1530 Spirulina extract.
73.1550 Talc.
73.1575 Titanium dioxide.
73.1645 Aluminum powder.
73.1646 Bronze powder.
73.1647 Copper powder.
73.1991 Zinc oxide.

                           Subpart C_Cosmetics

73.2030 Annatto.

[[Page 427]]

73.2085 Caramel.
73.2087 Carmine.
73.2095 [beta]-Carotene.
73.2110 Bismuth citrate.
73.2120 Disodium EDTA-copper.
73.2125 Potassium sodium copper chlorophyllin (chlorophyllin-copper 
          complex).
73.2150 Dihydroxyacetone.
73.2162 Bismuth oxychloride.
73.2180 Guaiazulene.
73.2190 Henna.
73.2250 Iron oxides.
73.2298 Ferric ammonium ferrocyanide.
73.2299 Ferric ferrocyanide.
73.2326 Chromium hydroxide green.
73.2327 Chromium oxide greens.
73.2329 Guanine.
73.2396 Lead acetate.
73.2400 Pyrophyllite.
73.2496 Mica.
73.2500 Silver.
73.2575 Titanium dioxide.
73.2645 Aluminum powder.
73.2646 Bronze powder.
73.2647 Copper powder.
73.2725 Ultramarines.
73.2775 Manganese violet.
73.2991 Zinc oxide.
73.2995 Luminescent zinc sulfide.

                        Subpart D_Medical Devices

73.3100 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-
          methyl-2-propenoic)ester copolymers.
73.3105 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione.
73.3106 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone 
          copolymers.
73.3107 Carbazole violet.
73.3110 Chlorophyllin-copper complex, oil soluble.
73.3110a Chromium-cobalt-aluminum oxide.
73.3111 Chromium oxide greens.
73.3112 C.I. Vat Orange 1.
73.3115 2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-
          benzenetriol.
73.3117 16,23-Dihydrodinaphtho[2,3-a:2',3'-i] naphth [2',3':6,7] indolo 
          [2,3-c] carbazole-5,10,15,17,22,24-hexone.
73.3118 N,N'-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide.
73.3119 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.
73.3120 16,17-Dimethoxydinaphtho [1,2,3-cd:3',2',1'-lm] perylene-5,10-
          dione.
73.3121 Poly(hydroxyethyl methacrylate)-dye copolymers.
73.3122 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-
          pyrazol-3-one.
73.3123 6-Ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2(3H)-ylidene) 
          benzo[b]thiophen-3 (2H)-one.
73.3124 Phthalocyanine green.
73.3125 Iron oxides.
73.3126 Titanium dioxide.
73.3127 Vinyl alcohol/methyl methacrylate-dye reaction products.
73.3128 Mica-based pearlescent pigments.
73.3129 Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-
          sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-
          sulfonate.

    Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 
362, 371, 379e.

    Source: 42 FR 15643, Mar. 22, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 73 appear at 66 FR 
66742, Dec. 27, 2001.



                             Subpart A_Foods



Sec.  73.1  Diluents in color additive mixtures for food use exempt from
certification.

    The following substances may be safely used as diluents in color 
additive mixtures for food use exempt from certification, subject to the 
condition that each straight color in the mixture has been exempted from 
certification or, if not so exempted, is from a batch that has 
previously been certified and has not changed in composition since 
certification. If a specification for a particular diluent is not set 
forth in this part 73, the material shall be of a purity consistent with 
its intended use.
    (a) General use. (1) Substances that are generally recognized as 
safe under the conditions set forth in section 201(s) of the act.
    (2) Substances meeting the definitions and specifications set forth 
under subchapter B of this chapter, and which are used only as 
prescribed by such regulations.
    (3) The following:

[[Page 428]]



------------------------------------------------------------------------
                                 Definitions and
          Substances              specifications        Restrictions
------------------------------------------------------------------------
Calcium disodium EDTA          Contains calcium     May be used in
 (calcium disodium ethyl-       disodium ethyl-      aqueous solutions
 enediamine- tetraacetate).     enediamine-          and aqueous
                                tetraacetate         dispersions as a
                                dihydrate (CAS       preservative and
                                Reg. No. 6766-87-    sequestrant in
                                6) as set forth in   color additive
                                the Food Chemicals   mixtures intended
                                Codex, 3d ed., p.    only for ingested
                                50, 1981.            use; the color
                                                     additive mixture
                                                     (solution or
                                                     dispersion) may
                                                     contain not more
                                                     than 1 percent by
                                                     weight of the
                                                     diluent (calculated
                                                     as anhydrous
                                                     calcium disodium
                                                     ethyl-enediamine-
                                                     tetraacetate).
Castor oil...................  As set forth in      Not more than 500
                                U.S.P. XVI.          p.p.m. in the
                                                     finished food.
                                                     Labeling of color
                                                     additive mixtures
                                                     containing castor
                                                     oil shall bear
                                                     adequate directions
                                                     for use that will
                                                     result in a food
                                                     meeting this
                                                     restriction.
Dioctylsodium sulfosuccinate.  As set forth in      Not more than 9
                                sec. 172.810 of      p.p.m. in the
                                this chapter.        finished food.
                                                     Labeling of color
                                                     additive mixtures
                                                     containing
                                                     dioctylsodium
                                                     sulfosuccinate
                                                     shall bear adequate
                                                     directions for use
                                                     that will result in
                                                     a food meeting this
                                                     restriction.
Disodium EDTA (disodium ethyl- Contains disodium    May be used in
  enediamine- tetraacetate).    ethyl- enediamine-   aqueous solutions
                                tetraacetate         and aqueous
                                dihydrate (CAS       dispersions as a
                                Reg. No. 6381-92-    preservative and
                                6) as set forth in   sequestrant in
                                the Food Chemicals   color additive
                                Codex, 3d ed., p.    mixtures intended
                                104, 1981.           only for ingested
                                                     use; the color
                                                     additive mixture
                                                     (solution or
                                                     dispersion) may
                                                     contain not more
                                                     than 1 percent by
                                                     weight of the
                                                     diluent (calculated
                                                     as anhydrous
                                                     disodium ethyl-
                                                     enediamine-
                                                     tetraacetate).
------------------------------------------------------------------------

    (b) Special use--(1) Diluents in color additive mixtures for marking 
food--(i) Inks for marking food supplements in tablet form, gum, and 
confectionery. Items listed in paragraph (a) of this section and the 
following:

------------------------------------------------------------------------
                                 Definitions and
          Substances              specifications        Restrictions
------------------------------------------------------------------------
Alcohol, SDA-3A..............  As set forth in 26   No residue.
                                CFR pt. 212.
n-Butyl alcohol..............  ...................   Do.
Cetyl alcohol................  As set forth in       Do.
                                N.F. XI.
Cyclohexane..................  ...................   Do.
Ethyl cellulose..............  As set forth in
                                sec. 172.868 of
                                this chapter.
Ethylene glycol monoethyl      ...................   Do.
 ether.
Isobutyl alcohol.............  ...................   Do.
Isopropyl alcohol............  ...................   Do.
Polyoxyethylene sorbitan       As set forth in
 monooleate (polysorbate 80).   sec. 172.840 of
                                this chapter.
Polyvinyl acetate............  Molecular weight,
                                minimum 2,000.
Polyvinylpyrrolidone.........  As set forth in
                                sec. 173.55 of
                                this chapter.
Rosin and rosin derivatives..  As set forth in
                                sec. 172.615 of
                                this chapter.
Shellac, purified............  Food grade.........
------------------------------------------------------------------------

    (ii) Inks for marking fruit and vegetables. Items listed in 
paragraph (a) of this section and the following:

------------------------------------------------------------------------
                                 Definitions and
          Substances              specifications        Restrictions
------------------------------------------------------------------------
Acetone......................  As set forth in      No residue.
                                N.F. XI.
Alcohol, SDA-3A..............  As set forth in 26    Do.
                                CFR pt. 212.
Benzoin......................  As set forth in
                                U.S.P. XVI.
Copal, Manila................  ...................
Ethyl acetate................  As set forth in       Do.
                                N.F. XI.
Ethyl cellulose..............  As set forth in
                                sec. 172.868 of
                                this chapter.
Methylene chloride...........  ...................   Do.
Polyvinylpyrrolidone.........  As set forth in
                                sec. 173.55 of
                                this chapter.
Rosin and rosin derivatives..  As set forth in
                                sec. 172.615 of
                                this chapter.

[[Page 429]]

 
Silicon dioxide..............  As set forth in      Not more than 2 pct
                                sec. 172.480 of      of the ink solids.
                                this chapter.
Terpene resins, natural......  As set forth in
                                sec. 172.615 of
                                this chapter.
Terpene resins, synthetic....  Polymers of [alpha]-
                                 and [beta]-pinene.
------------------------------------------------------------------------

    (2) Diluents in color additive mixtures for coloring shell eggs. 
Items listed in paragraph (a) of this section and the following, subject 
to the condition that there is no penetration of the color additive 
mixture or any of its components through the eggshell into the egg:

Alcohol, denatured, formula 23A (26 CFR part 212), Internal Revenue 
Service.
Damar gum (resin).
Diethylene glycol distearate.
Dioctyl sodium sulfosuccinate.
Ethyl cellulose (as identified in Sec.  172.868 of this chapter).
Ethylene glycol distearate.
Japan wax.
Limed rosin.
Naphtha.
Pentaerythritol ester of fumaric acid-rosin adduct.
Polyethylene glycol 6000 (as identified in Sec.  172.820 of this 
chapter).
Polyvinyl alcohol.
Rosin and rosin derivatives (as identified in Sec.  172.615 of this 
chapter).

    (3) Miscellaneous special uses. Items listed in paragraph (a) of 
this section and the following:

------------------------------------------------------------------------
                                 Definitions and
          Substances              specifications        Restrictions
------------------------------------------------------------------------
Polyvinylpyrrolidone.........  As set forth in      In or as food-tablet
                                sec. 173.55 of       coatings; limit,
                                this chapter.        not more than 0.1
                                                     pct in the finished
                                                     food; labeling of
                                                     color additive
                                                     mixtures containing
                                                     polyvinylpyrrolidon
                                                     e shall bear
                                                     adequate directions
                                                     for use that will
                                                     result in a food
                                                     meeting this
                                                     restriction.
------------------------------------------------------------------------


[42 FR 15643, Mar. 22, 1977, as amended at 57 FR 32175, July 21, 1992; 
69 FR 24511, May 4, 2004]



Sec.  73.30  Annatto extract.

    (a) Identity. (1) The color additive annatto extract is an extract 
prepared from annatto seed, Bixa orellana L., using any one or an 
appropriate combination of the food-grade extractants listed in 
paragraph (a)(1) (i) and (ii) of this section:
    (i) Alkaline aqueous solution, alkaline propylene glycol, ethyl 
alcohol or alkaline solutions thereof, edible vegetable oils or fats, 
mono- and diglycerides from the glycerolysis of edible vegetable oils or 
fats. The alkaline alcohol or aqueous extracts may be treated with food-
grade acids to precipitate annatto pigments, which are separated from 
the liquid and dried, with or without intermediate recrystallization, 
using the solvents listed under paragraph (a)(1)(ii) of this section. 
Food-grade alkalis or carbonates may be added to adjust alkalinity.
    (ii) Acetone, ethylene dichloride, hexane, isopropyl alcohol, methyl 
alcohol, methylene chloride, trichloroethylene.
    (2) Color additive mixtures for food use made with annatto extract 
may contain only diluents that are suitable and that are listed in this 
subpart as safe in color additive mixtures for coloring foods.
    (b) Specifications. Annatto extract, including pigments precipitated 
therefrom, shall conform to the following specifications:
    (1) Arsenic (as As), not more than 3 parts per million; lead as Pb, 
not more than 10 parts per million.
    (2) When solvents listed under paragraph (a)(1)(ii) of this section 
are used, annatto extract shall contain no more solvent residue than is 
permitted of the corresponding solvents in spice oleoresins under 
applicable food additive regulations in parts 170 through 189 of this 
chapter.
    (c) Uses and restrictions. Annatto extract may be safely used for 
coloring

[[Page 430]]

foods generally, in amounts consistent with good manufacturing practice, 
except that it may not be used to color foods for which standards of 
identity have been promulgated under section 401 of the act unless added 
color is authorized by such standards.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom and intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter. Labels 
shall bear information showing that the color is derived from annatto 
seed. The requirements of Sec.  70.25(a) of this chapter that all 
ingredients shall be listed by name shall not be construed as requiring 
the declaration of residues of solvents listed in paragraph (a)(1)(ii) 
of this section.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.35  Astaxanthin.

    (a) Identity. (1) The color additive astaxanthin is 3, 3'-dihydroxy-
[beta], [beta]-carotene-4, 4'-dione.
    (2) Astaxanthin may be added to the fish feed only as a component of 
a stabilized color additive mixture. Color additive mixtures for fish 
feed use made with astaxanthin may contain only those diluents that are 
suitable and are listed in this subpart as safe for use in color 
additive mixtures for coloring foods.
    (b) Specifications. Astaxanthin shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice:

Physical state, solid.
0.05 percent solution in chloroform, complete and clear.
Absorption maximum wavelength 484-493 nanometers (in chloroform).
Residue on ignition, not more than 0.1 percent.
Total carotenoids other than astaxanthin, not more than 4 percent.
Lead, not more than 5 parts per million.
Arsenic, not more than 2 parts per million.
Mercury, not more than 1 part per million.
Heavy metals, not more than 10 parts per million.
Assay, minimum 96 percent.

    (c) Uses and restrictions. Astaxanthin may be safely used in the 
feed of salmonid fish in accordance with the following prescribed 
conditions:
    (1) The color additive is used to enhance the pink to orange-red 
color of the flesh of salmonid fish.
    (2) The quantity of color additive in feed is such that the color 
additive shall not exceed 80 milligrams per kilogram (72 grams per ton) 
of finished feed.
    (d) Labeling requirements. (1) The labeling of the color additive 
and any premixes prepared therefrom shall bear expiration dates for the 
sealed and open container (established through generally accepted 
stability testing methods), other information required by Sec.  70.25 of 
this chapter, and adequate directions to prepare a final product 
complying with the limitations prescribed in paragraph (c) of this 
section.
    (2) The presence of the color additive in finished fish feed 
prepared according to paragraph (c) of this section shall be declared in 
accordance with Sec.  501.4 of this chapter.
    (3) The presence of the color additive in salmonid fish that have 
been fed feeds containing astaxanthin shall be declared in accordance 
with Sec. Sec.  101.22(k)(2) and 101.100(a)(2) of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[60 FR 18738, Apr. 13, 1995]



Sec.  73.37  Astaxanthin dimethyl disuccinate.

    (a) Identity. (1) The color additive astaxanthin dimethyldisuccinate 
is 3,3'-bis(4-methoxy-1,4-dioxobutoxy)-[beta],[beta]-carotene-4,4'-
dione.
    (2) Astaxanthin dimethyldisuccinate may be added to the fish feed 
only as a component of a stabilized mixture. Color additive mixtures for 
fish feed use made with astaxanthin dimethyldisuccinate may contain only 
those diluents that are suitable and are listed in this subpart as safe 
for use in

[[Page 431]]

color additive mixtures for coloring foods.
    (b) Specifications. Astaxanthin dimethyldisuccinate shall conform to 
the following specifications and shall be free from impurities other 
than those named to the extent that such impurities may be avoided by 
good manufacturing practice:
    (1) Physical state, solid.
    (2) 0.05 percent solution in chloroform, complete and clear.
    (3) Absorption maximum wavelength 484-493 nanometers (in 
chloroform).
    (4) Residue on ignition, not more than 0.1 percent.
    (5) Total carotenoids other than astaxanthin dimethyldisuccinate, 
not more than 4 percent.
    (6) Lead, not more than 5 milligrams per kilogram (mg/kg) (5 parts 
per million).
    (7) Arsenic, not more than 2 mg/kg (2 parts per million).
    (8) Mercury, not more than 1 mg/kg (1 part per million).
    (9) Heavy metals, not more than 10 mg/kg (10 parts per million).
    (10) Assay including astaxanthin dimethyldisuccinate, astaxanthin 
monomethylsuccinate, and astaxanthin, minimum 96 percent.
    (c) Uses and restrictions. Astaxanthin dimethyldisuccinate may be 
safely used in the feed of salmonid fish in accordance with the 
following prescribed conditions:
    (1) The color additive is used to enhance the pink to orange-red 
color of the flesh of salmonid fish.
    (2) The quantity of astaxanthin dimethyldisuccinate in the finished 
feed, when used alone or in combination with other astaxanthin color 
additive sources listed in this part 73, shall not exceed 110 milligrams 
per kilogram (mg/kg), which is equivalent to 80 mg/kg astaxanthin (72 
grams per ton).
    (d) Labeling requirements. (1) The labeling of the color additive 
and any premixes prepared therefrom shall bear expiration dates for the 
sealed and open container (established through generally accepted 
stability testing methods), other information required by Sec.  70.25 of 
this chapter, and adequate directions to prepare a final product 
complying with the limitations prescribed in paragraph (c) of this 
section.
    (2) The presence of the color additive in finished fish feed 
prepared according to paragraph (c) of this section shall be declared in 
accordance with Sec.  501.4 of this chapter.
    (3) The presence of the color additive in salmonid fish that have 
been fed feeds containing astaxanthin dimethyldisuccinate shall be 
declared in accordance with Sec. Sec.  101.22(b), (c), and (k)(2), and 
101.100(a)(2) of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[74 FR 57251, Nov. 5, 2009]



Sec.  73.40  Dehydrated beets (beet powder).

    (a) Identity. (1) The color additive dehydrated beets is a dark red 
powder prepared by dehydrating sound, mature, good quality, edible 
beets.
    (2) Color additive mixtures made with dehydrated beets may contain 
as diluents only those substances listed in this subpart as safe and 
suitable for use in color additive mixtures for coloring foods.
    (b) Specifications. The color additive shall conform to the 
following specifications:

Volatile matter, not more than 4 percent.
Acid insoluble ash, not more than 0.5 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Mercury (as Hg), not more than 1 part per million.

    (c) Uses and restrictions. Dehydrated beets may be safely used for 
the coloring of foods generally in amounts consistent with good 
manufacturing practice, except that it may not be used to color foods 
for which standards of identity have been promulgated under section 401 
of the act, unless the use of added color is authorized by such 
standards.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.

[[Page 432]]

    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.50  Ultramarine blue.

    (a) Identity. The color additive ultramarine blue is a blue pigment 
obtained by calcining a mixture of kaolin, sulfur, sodium carbonate, and 
carbon at temperatures above 700 [deg]C. Sodium sulfate and silica may 
also be incorporated in the mixture in order to vary the shade. The 
pigment is a complex sodium aluminum sulfo-silicate having the 
approximate formula 
Na7Ai6Si6O24 
S3.
    (b) Specifications. Ultramarine blue shall conform to the following 
specifications:

Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Mercury (as Hg), not more than 1 part per million.

    (c) Uses and restrictions. The color additive ultramarine blue may 
be safely used for coloring salt intended for animal feed subject to the 
restriction that the quantity of ultramarine blue does not exceed 0.5 
percent by weight of the salt.
    (d) Labeling requirements. The color additive shall be labeled in 
accordance with the requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.70  Calcium carbonate.

    (a) Identity. (1) The color additive calcium carbonate is a fine, 
white powder consisting essentially of calcium carbonate 
(CaCO3) prepared either by grinding naturally occurring 
limestone or synthetically, by precipitation.
    (2) Color additive mixtures for food use made with calcium carbonate 
may contain only those diluents that are suitable and that are listed in 
this subpart as safe for use in color additive mixtures for coloring 
foods.
    (b) Specifications. The color additive meets the specifications of 
the Food Chemicals Codex, 10th ed. (2016), pp. 213-214 (calcium 
carbonate) and p. 754 (limestone, ground), which is incorporated by 
reference. The Director of the Office of the Federal Register approves 
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. You may obtain copies from the United States Pharmacopeial 
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (internet address 
http://www.usp.org). Copies may be examined at the Food and Drug 
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third 
Floor, Silver Spring, MD 20993, 301-796-2039, 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/
cfr/ibr_locations.html.
    (c) Uses and restrictions. Calcium carbonate may be safely used in 
amounts consistent with good manufacturing practice to color soft and 
hard candies and mints, and in inks used on the surface of chewing gum, 
except that it may not be used to color chocolate for which standards of 
identity have been promulgated under section 401 of the Federal Food, 
Drug, and Cosmetic Act unless added color is authorized by such 
standards.
    (d) Labeling requirements. The label of the color additive and of 
any mixtures prepared therefrom intended solely or in part for coloring 
purposes must conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and, 
therefore, batches thereof are exempt from the certification 
requirements of section 721(c) of the Federal Food, Drug, and Cosmetic 
Act.

[82 FR 51557, Nov. 7, 2017]



Sec.  73.75  Canthaxanthin.

    (a) Identity. (1) The color additive canthaxanthin is [beta]-
carotene-4,4'-dione.

[[Page 433]]

    (2) Color additive mixtures for food use made with canthaxanthin may 
contain only those diluents that are suitable and that are listed in 
this subpart as safe for use in color additive mixtures for coloring 
foods.
    (b) Specifications. Canthaxanthin shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such other impurities may be avoided by good 
manufacturing practice:

Physical state, solid.
1 percent solution in chloroform, complete and clear.
Melting range (decomposition), 207 [deg]C. to 212 [deg]C. (corrected).
Loss on drying, not more than 0.2 percent.
Residue on ignition, not more than 0.2 percent.
Total carotenoids other than trans-canthaxanthin, not more than 5 
percent.
Lead, not more than 10 parts per million.
Arsenic, not more than 3 parts per million.
Mercury, not more than 1 part per million.
Assay, 96 to 101 percent.

    (c) Use and restrictions. (1) The color additive canthaxanthin may 
be safely used for coloring foods generally subject to the following 
restrictions:
    (i) The quantity of canthaxanthin does not exceed 30 milligrams per 
pound of solid or semisolid food or per pint of liquid food; and
    (ii) It may not be used to color foods for which standards of 
identity have been promulgated under section 401 of the act unless added 
color is authorized by such standards.
    (2) Canthaxanthin may be safely used in broiler chicken feed to 
enhance the yellow color of broiler chicken skin in accordance with the 
following conditions: The quantity of canthaxanthin incorporated in the 
feed shall not exceed 4.41 milligrams per kilogam (4 grams per ton) of 
complete feed to supplement other known sources of xanthophyll and 
associated carotenoids to accomplish the intended effect.
    (3) Canthaxanthin may be safely used in the feed of salmonid fish in 
accordance with the following prescribed conditions:
    (i) Canthaxanthin may be added to the fish feed only in the form of 
a stabilized color additive mixture;
    (ii) The color additive is used to enhance the pink to orange-red 
color of the flesh of salmonid fish; and
    (iii) The quantity of color additive in feed shall not exceed 80 
milligrams per kilogram (72 grams per ton) of finished feed.
    (d) Labeling requirements. (1) The labeling of the color additive 
and any mixture prepared therefrom intended solely or in part for 
coloring purposes shall conform to the requirements of Sec.  70.25 of 
this chapter.
    (2) For purposes of coloring fish, the labeling of the color 
additive and any premixes prepared therefrom shall bear expiration dates 
(established through generally accepted stability testing methods) for 
the sealed and open container, other information required by Sec.  70.25 
of this chapter, and adequate directions to prepare a final product 
complying with the limitations prescribed in paragraph (c)(3) of this 
section.
    (3) The presence of the color additive in finished fish feed 
prepared according to paragraph (c)(3) of this section shall be declared 
in accordance with Sec.  501.4 of this chapter.
    (4) The presence of the color additive in salmonid fish that have 
been fed feeds containing canthaxanthin shall be declared in accordance 
with Sec. Sec.  101.22(b), (c), and (k)(2), and 101.100(a)(2) of this 
chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 15643, Mar. 22, 1977, as amended at 50 FR 47534, Nov. 19, 1985; 
63 FR 14817, Mar. 27, 1998]



Sec.  73.85  Caramel.

    (a) Identity. (1) The color additive caramel is the dark-brown 
liquid or solid material resulting from the carefully controlled heat 
treatment of the following food-grade carbohydrates:

Dextrose.
Invert sugar.
Lactose.
Malt sirup.
Molasses.
Starch hydrolysates and fractions thereof.
Sucrose.


[[Page 434]]


    (2) The food-grade acids, alkalis, and salts listed in this 
subparagraph may be employed to assist caramelization, in amounts 
consistent with good manufacturing practice.
    (i) Acids:

Acetic acid.
Citric acid.
Phosphoric acid.
Sulfuric acid.
Sulfurous acid.

    (ii) Alkalis:

Ammonium hydroxide.
Calcium hydroxide U.S.P.
Potassium hydroxide.
Sodium hydroxide.

    (iii) Salts: Ammonium, sodium, or potassium carbonate, bicarbonate, 
phosphate (including dibasic phosphate and monobasic phosphate), 
sulfate, and sulfite.
    (3) Polyglycerol esters of fatty acids, identified in Sec.  172.854 
of this chapter, may be used as antifoaming agents in amounts not 
greater than that required to produce the intended effect.
    (4) Color additive mixtures for food use made with caramel may 
contain only diluents that are suitable and that are listed in this 
subpart as safe in color additive mixtures for coloring foods.
    (b) Specifications. Caramel shall conform to the following 
specifications:

Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 0.1 part per million.

    (c) Uses and restrictions. Caramel may be safely used for coloring 
foods generally, in amounts consistent with good manufacturing practice, 
except that it may not be used to color foods for which standards of 
identity have been promulgated under section 401 of the act unless added 
color is authorized by such standards.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom and intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.90  [beta]-Apo-8'-carotenal.

    (a) Identity. (1) The color additive is [beta]-apo-8'-carotenal.
    (2) Color additive mixtures for food use made with [beta]-apo-8'-
carotenal may contain only diluents that are suitable and that are 
listed in this subpart as safe in color additive mixtures for coloring 
foods.
    (b) Specifications. [beta]-Apo-8'-carotenal shall conform to the 
following specifications:

Physical state, solid.
1 percent solution in chloroform, clear.
Melting point (decomposition), 136 [deg]C.-140 [deg]C. (corrected).
Loss of weight on drying, not more than 0.2 percent.
Residue on ignition, not more than 0.2 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Assay (spectrophotometric), 96-101 percent.

    (c) Uses and restrictions. The color additive [beta]-apo-8'-
carotenal may be safely used for coloring foods generally, subject to 
the following restrictions:
    (1) The quantity of [beta]-apo-8'-carotenal does not exceed 15 
milligrams per pound of solid or semisolid food or 15 milligrams per 
pint of liquid food.
    (2) It may not be used to color foods for which standards of 
identity have been promulgated under section 401 of the act unless added 
color is authorized by such standards.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom and intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.95  [beta]-Carotene.

    (a) Identity. (1) The color additive is [beta]-carotene prepared 
synthetically or obtained from natural sources.

[[Page 435]]

    (2) Color additive mixtures for food use made with [beta]-carotene 
may contain only diluents that are suitable and that are listed in this 
subpart as safe in color additive mixtures for coloring foods.
    (b) Specifications. [beta]-carotene shall conform to the following 
specifications:

Physical state, solid.
1 percent solution in chloroform, clear.
Loss of weight on drying, not more than 0.2 percent.
Residue on ignition, not more than 0.2 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Assay (spectrophotometric), 96-101 percent.

    (c) Uses and restrictions. The color additive [beta]-carotene may be 
safely used for coloring foods generally, in amounts consistent with 
good manufacturing practice, except that it may not be used to color 
those foods for which standards of identity have been promulgated under 
section 401 of the act unless added color is authorized by such 
standards.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom and intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.100  Cochineal extract; carmine.

    (a) Identity. (1) The color additive cochineal extract is the 
concentrated solution obtained after removing the alcohol from an 
aqueous-alcoholic extract of cochineal (Dactylopius coccus costa (Coccus 
cacti L.)). The coloring principle is chiefly carminic acid.
    (2) The color additive carmine is the aluminum or calcium-aluminum 
lake on an aluminum hydroxide substrate of the coloring principles, 
chiefly carminic acid, obtained by an aqueous extraction of cochineal 
(Dactylopius coccus costa (Coccus cacti L.)).
    (3) Color additive mixtures for food use made with cochineal extract 
or carmine may contain only diluents that are suitable and that are 
listed in this subpart as safe in color additive mixtures for coloring 
foods.
    (b) Specifications. (1) Cochineal extract shall conform to the 
following specifications:

pH, not less than 5.0 and not more than 5.5 at 25 [deg]C.
Protein (N x 6.25), not more than 2.2 percent.
Total solids, not less than 5.7 and not more than 6.3 percent.
Methyl alcohol, not more than 150 parts per million.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Carminic acid, not less than 1.8 percent.

    (2) Carmine shall conform to the following specifications:

Volatile matter (at 135 [deg]C. for 3 hours), not more than 20.0 
percent.
Ash, not more than 12.0 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Carminic acid, not less than 50.0 percent.


Carmine and cochineal extract shall be pasteurized or otherwise treated 
to destroy all viable Salmonella microorganisms. Pasteurization or such 
other treatment is deemed to permit the adding of safe and suitable 
substances (other than chemical preservatives) that are essential to the 
method of pasteurization or other treatment used. For the purposes of 
this paragraph, safe and suitable substances are those substances that 
perform a useful function in the pasteurization or other treatment to 
render the carmine and cochineal extract free of viable Salmonella 
microorganisms, which substances are not food additives as defined in 
section 201(s) of the act or, if they are food additives as so defined, 
are used in conformity with regulations established pursuant to section 
409 of the act.
    (c) Uses and restrictions. Carmine and cochineal extract may be 
safely used for coloring foods generally in amounts consistent with good 
manufacturing practice, except that they may not be used to color foods 
for which standards

[[Page 436]]

of identity have been promulgated under section 401 of the act unless 
added color is authorized by such standards.
    (d) Labeling requirements. (1) The label of the color additives and 
any mixtures intended solely or in part for coloring purposes prepared 
therefrom shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (2) The label of food products intended for human use, including 
butter, cheese, and ice cream, that contain cochineal extract or carmine 
shall specifically declare the presence of the color additive by listing 
its respective common or usual name, ``cochineal extract'' or 
``carmine,'' in the statement of ingredients in accordance with Sec.  
101.4 of this chapter.
    (e) Exemption from certification. Certification of these color 
additives is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 15643, Mar. 22, 1977, as amended at 74 FR 216, Jan. 5, 2009]



Sec.  73.125  Sodium copper chlorophyllin.

    (a) Identity. (1) The color additive sodium copper chlorophyllin is 
a green to black powder prepared from chlorophyll by saponification and 
replacement of magnesium by copper. Chlorophyll is extracted from 
alfalfa (Medicago sativa) using any one or a combination of the solvents 
acetone, ethanol, and hexane.
    (2) Color additive mixtures made with sodium copper chlorophyllin 
may contain only those diluents that are suitable and are listed in this 
subpart as safe for use in color additive mixtures for coloring foods.
    (b) Specifications. Sodium copper chlorophyllin shall conform to the 
following specifications and shall be free from impurities other than 
those named to the extent that such impurities may be avoided by good 
manufacturing practice:
    (1) Moisture, not more than 5.0 percent.
    (2) Solvent residues (acetone, ethanol, and hexane), not more than 
50 parts per million, singly or, in combination.
    (3) Total copper, not less than 4 percent and not more than 6 
percent.
    (4) Free copper, not more than 200 parts per million.
    (5) Lead (as Pb), not more than 10 parts per million.
    (6) Arsenic (as As), not more than 3 parts per million.
    (7) Mercury (as Hg), not more than 0.5 part per million.
    (8) Ratio of absorbance at 405 nanometers (nm) to absorbance at 630 
nm, not less than 3.4 and not more than 3.9.
    (9) Total copper chlorophyllins, not less than 95 percent of the 
sample dried at 100 [deg]C for 1 hour.
    (c) Uses and restrictions. Sodium copper chlorophyllin may be safely 
used to color citrus-based dry beverage mixes in an amount not exceeding 
0.2 percent in the dry mix.
    (d) Labeling requirements. The label of the color additive and any 
mixtures prepared therefrom shall conform to the requirements of Sec.  
70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[67 FR 35431, May 20, 2002]



Sec.  73.140  Toasted partially defatted cooked cottonseed flour.

    (a) Identity. (1) The color additive toasted partially defatted 
cooked cottonseed flour is a product prepared as follows: Food quality 
cottonseed is delinted and decorticated; the meats are screened, 
aspirated, and rolled; moisture is adjusted, the meats heated, and the 
oil expressed; the cooked meats are cooled, ground, and reheated to 
obtain a product varying in shade from light to dark brown.
    (2) Color additive mixtures for food use made with toasted partially 
defatted cooked cottonseed flour may contain only diluents that are 
suitable and that are listed in this subpart as safe in color additive 
mixtures for coloring foods.
    (b) Specifications. Toasted partially defatted cooked cottonseed 
flour shall conform to the following specifications:


[[Page 437]]


Arsenic: It contains no added arsenic compound and therefore may not 
exceed a maximum natural background level of 0.2 part per million total 
arsenic, calculated as As.
Lead (as Pb), not more than 10 parts per million.
Free gossypol content, not more than 450 parts per million.

    (c) Uses and restrictions. The color additive toasted partially 
defatted cooked cottonseed flour may be safely used for coloring foods 
generally, in amounts consistent with good manufacturing practice, 
except that it may not be used to color foods for which standards of 
identity have been promulgated under section 401 of the act, unless 
added color is authorized by such standards.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom and intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.160  Ferrous gluconate.

    (a) Identity. The color additive ferrous gluconate is the ferrous 
gluconate defined in the Food Chemicals Codex, 3d Ed. (1981), pp. 122-
123, which is incorporated by reference. Copies may be obtained from the 
National Academy Press, 2101 Constitution Ave. NW., Washington, DC 
20418, 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.
    (b) Specifications. Ferrous gluconate shall meet the specifications 
given in the Food Chemicals Codex, 3d Ed. (1981), which is incorporated 
by reference. The availability of this incorporation by reference is 
given in paragraph (a) of this section.
    (c) Uses and restrictions. Ferrous gluconate may be safely used in 
amounts consistent with good manufacturing practice for the coloring of 
ripe olives.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 15643, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 49 
FR 10089, Mar. 19, 1984]



Sec.  73.165  Ferrous lactate.

    (a) Identity. The color additive ferrous lactate is the ferrous 
lactate defined in Sec.  184.1311 of this chapter.
    (b) Specifications. Ferrous lactate shall meet the specifications 
given in the Food Chemicals Codex, 4th ed. (1996), pp. 154 to 155, which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. Copies are available from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Food and Drug Administration's Main Library, 10903 New Hampshire Ave., 
Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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.
    (c) Uses and restrictions. Ferrous lactate may be safely used in 
amounts consistent with good manufacturing practice for the coloring of 
ripe olives.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the Federal Food, Drug, and Cosmetic Act (the act).

[61 FR 40319, Aug. 2, 1996, as amended at 66 FR 66742, Dec. 27, 2001; 81 
FR 5590, Feb. 3, 2016]

[[Page 438]]



Sec.  73.169  Grape color extract.

    (a) Identity. (1) The color additive grape color extract is an 
aqueous solution of anthocyanin grape pigments made from Concord grapes 
or a dehydrated water soluble powder prepared from the aqueous solution. 
The aqueous solution is prepared by extracting the pigments from 
precipitated lees produced during the storage of Concord grape juice. It 
contains the common components of grape juice, namely anthocyanins, 
tartrates, malates, sugars, and minerals, etc., but not in the same 
proportion as found in grape juice. The dehydrated water soluble powder 
is prepared by spray drying the aqueous solution containing added malto-
dextrin.
    (2) Color additive mixtures for food use made with grape color 
extract may contain only those diluents listed in this subpart as safe 
and suitable in color additive mixtures for coloring foods.
    (b) Specifications. Grape color extract shall conform to the 
following specifications: Pesticide residues, not more than permitted in 
or on grapes by regulations promulgated under section 408 of the Federal 
Food, Drug, and Cosmetic Act. Lead (as Pb), not more than 10 parts per 
million. Arsenic (as As), not more than 1 part per million.
    (c) Uses and restrictions. Grape color extract may be safely used 
for the coloring of nonbeverage food, except that it may not be used to 
color foods for which standards of identity have been promulgated under 
section 401 of the act, unless the use of added color is authorized by 
such standards.
    (d) Labeling. The color additive and any mixtures prepared therefrom 
intended solely or in part for coloring purposes shall bear, in addition 
to the other information required by the act, labeling in accordance 
with the provisions of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches are exempt from the certification requirements of 
section 721(c) of the Act.

[46 FR 47532, Sept. 29, 1981]



Sec.  73.170  Grape skin extract (enocianina).

    (a) Identity. (1) The color additive grape skin extract (enocianina) 
is a purplish-red liquid prepared by the aqueous extraction (steeping) 
of the fresh deseeded marc remaining after grapes have been pressed to 
produce grape juice or wine. It contains the common components of grape 
juice; namely, anthocyanins, tartaric acid, tannins, sugars, minerals, 
etc., but not in the same proportions as found in grape juice. During 
the steeping process, sulphur dioxide is added and most of the extracted 
sugars are fermented to alcohol. The extract is concentrated by vacuum 
evaporation, during which practically all of the alcohol is removed. A 
small amount of sulphur dioxide may be present.
    (2) Color additive mixtures for food use made with grape skin 
extract (enocianina) may contain only those diluents listed in this 
subpart as safe and suitable in color additive mixtures for coloring 
foods.
    (b) Specifications. Grape skin extract (enocianina) shall conform to 
the following specifications:

Pesticide residues, not more than permitted in or on grapes by 
regulations promulgated under section 408 of the Federal Food, Drug, and 
Cosmetic Act.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.

    (c) Uses and restrictions. Grape skin extract (enocianina) may be 
safely used for the coloring of still and carbonated drinks and ades, 
beverage bases, and alcoholic beverages subject to the following 
restrictions:
    (1) It may not be used to color foods for which standards of 
identity have been promulgated under section 401 of the act unless 
artificial color is authorized by such standards.
    (2) Its use in alcoholic beverages shall be in accordance with the 
provisions of parts 4 and 5, title 27 CFR.
    (d) Labeling requirements. The label of the color additive and any 
mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter. The common or usual name of the color additive is ``grape

[[Page 439]]

skin extract'' followed, if desired, by ``(enocianina)''.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.185  Haematococcus algae meal.

    (a) Identity. (1) The color additive haematococcus algae meal 
consists of the comminuted and dried cells of the alga Haematococcus 
pluvialis.
    (2) Haematococcus algae meal may be added to the fish feed only as a 
component of a stabilized color additive mixture. Color additive 
mixtures for fish feed use made with haematococcus algae meal may 
contain only those diluents that are suitable and are listed in this 
subpart as safe for use in color additive mixtures for coloring foods.
    (b) Specifications. Haematococcus algae meal shall conform to the 
following specifications and shall be free from impurities other than 
those named to the extent that such impurities may be avoided by good 
manufacturing practice:

Physical state, solid.
Lead, not more than 5 parts per million.
Arsenic, not more than 2 parts per million.
Mercury, not more than 1 part per million.
Heavy metals (as Pb), not more than 10 parts per million.
Astaxanthin, not less than 1.5 percent.

    (c) Uses and restrictions. Haematococcus algae meal may be safely 
used in the feed of salmonid fish in accordance with the following 
prescribed conditions:
    (1) The color additive is used to enhance the pink to orange-red 
color of the flesh of salmonid fish.
    (2) The quantity of astaxanthin in finished feed, from haematococcus 
algae meal when used alone or in combination with other astaxanthin 
color additive sources listed in this part 73, shall not exceed 80 
milligrams per kilogram (72 grams per ton) of finished feed.
    (d) Labeling requirements. (1) The labeling of the color additive 
and any premixes prepared therefrom shall bear expiration dates for the 
sealed and open container (established through generally accepted 
stability testing methods), other information required by Sec.  70.25 of 
this chapter, and adequate directions to prepare a final product 
complying with the limitations prescribed in paragraph (c) of this 
section.
    (2) The presence of the color additive in finished fish feed 
prepared according to paragraph (c) of this section shall be declared in 
accordance with Sec.  501.4 of this chapter.
    (3) The presence of the color additive in salmonid fish that have 
been fed feeds containing haematococcus algae meal shall be declared in 
accordance with Sec. Sec.  101.22(b), (c), and (k)(2), and 101.100(a)(2) 
of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[65 FR 41584, July 6, 2000]



Sec.  73.200  Synthetic iron oxide.

    (a) Identity. (1) The color additive synthetic iron oxide consists 
of any one or any combination of synthetically prepared iron oxides, 
including the hydrated forms. It is free from admixture with other 
substances.
    (2) Color additive mixtures for food use made with synthetic iron 
oxide may contain only those diluents that are suitable and that are 
listed in this subpart as safe for use in color additive mixtures for 
coloring foods.
    (b) Specifications. (1) Synthetic iron oxide for human food use 
shall conform to the following specifications:

Arsenic (as As), not more than 3 milligrams per kilogram (mg/kg) (3 
parts per million (ppm)).
Lead (as Pb), not more than 5 mg/kg (5 ppm).
Mercury (as Hg), not more than 1 mg/kg (1 ppm).

    (2) Synthetic iron oxide for dog and cat food use shall conform to 
the following specifications:

Arsenic (as As), not more than 5 parts per million.
Lead (as Pb), not more than 20 parts per million.
Mercury (as Hg), not more than 3 parts per million.

    (c) Uses and restrictions. (1) Synthetic iron oxide may be safely 
used for

[[Page 440]]

human food use subject to the following restrictions:
    (i) In sausage casings intended for human consumption in an amount 
not exceeding 0.10 percent by weight of the finished food.
    (ii) In soft and hard candy, mints, and chewing gum at levels 
consistent with good manufacturing practice, except that it may not be 
used to color foods for which standards of identity have been issued 
under section 401 of the Federal Food, Drug, and Cosmetic Act, unless 
the use of the added color is authorized by such standards.
    (2) Synthetic iron oxide may be safely used for the coloring of dog 
and cat foods in an amount not exceeding 0.25 percent by weight of the 
finished food.
    (d) Labeling requirements. The label of the color additive and any 
mixture prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 15643, Mar. 22, 1977, as amended at 59 FR 10578, Mar. 7, 1994; 80 
FR 14842, Mar. 20, 2015]



Sec.  73.250  Fruit juice.

    (a) Identity. (1) The color additive fruit juice is prepared either 
by expressing the juice from mature varieties of fresh, edible fruits, 
or by the water infusion of the dried fruit. The color additive may be 
concentrated or dried. The definition of fruit juice in this paragraph 
is for the purpose of identity as a color additive only and shall not be 
construed as a standard of identity under section 401 of the act. 
However, where a standard of identity for a particular fruit juice has 
been promulgated under section 401 of the act, it shall conform to such 
standard.
    (2) Color additive mixtures made with fruit juice may contain as 
diluents only those substances listed in this subpart as safe and 
suitable in color additive mixtures for coloring foods.
    (b) Uses and restrictions. Fruit juice may be safely used for the 
coloring of foods generally, in amounts consistent with good 
manufacturing practice, except that it may not be used to color foods 
for which standards of identity have been promulgated under section 401 
of the act, unless the use of added color is authorized by such 
standards.
    (c) Labeling. The color additive and any mixtures intended solely or 
in part for coloring purposes prepared therefrom shall bear, in addition 
to the other information required by the act, labeling in accordance 
with the provisions of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 15643, Mar. 22, 1977, as amended at 60 FR 52629, Oct. 10, 1995]



Sec.  73.260  Vegetable juice.

    (a) Identity. (1) The color additive vegetable juice is prepared 
either by expressing the juice from mature varieties of fresh, edible 
vegetables, or by the water infusion of the dried vegetable. The color 
additive may be concentrated or dried. The definition of vegetable juice 
in this paragraph is for the purpose of identity as a color additive 
only, and shall not be construed as a standard of identity under section 
401 of the act. However, where a standard of identity for a particular 
vegetable juice has been promulgated under section 401 of the act, it 
shall conform to such standard.
    (2) Color additive mixtures made with vegetable juice may contain as 
diluents only those substances listed in this subpart as safe and 
suitable in color additive mixtures for coloring foods.
    (b) Uses and restrictions. Vegetable juice may be safely used for 
the coloring of foods generally, in amounts consistent with good 
manufacturing practice, except that it may not be used to color foods 
for which standards of identity have been promulgated under section 401 
of the act, unless the use of added color is authorized by such 
standards.
    (c) Labeling. The color additive and any mixtures intended solely or 
in part

[[Page 441]]

for coloring purposes prepared therefrom shall bear, in addition to the 
other information required by the act, labeling in accordance with the 
provisions of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 15643, Mar. 22, 1977, as amended at 60 FR 52629, Oct. 10, 1995]



Sec.  73.275  Dried algae meal.

    (a) Identity. The color additive dried algae meal is a dried mixture 
of algae cells (genus Spongiococcum, separated from its culture broth), 
molasses, cornsteep liquor, and a maximum of 0.3 percent ethoxyquin. The 
algae cells are produced by suitable fermentation, under controlled 
conditions, from a pure culture of the genus Spongiococcum.
    (b) Uses and restrictions. The color additive dried algae meal may 
be safely used in chicken feed in accordance with the following 
prescribed conditions:
    (1) The color additive is used to enhance the yellow color of 
chicken skin and eggs.
    (2) The quantity of the color additive incorporated in the feed is 
such that the finished feed:
    (i) Is supplemented sufficiently with xanthophyll and associated 
carotenoids so as to accomplish the intended effect described in 
paragraph (b)(1) of this section; and
    (ii) Meets the tolerance limitation for ethoxyquin in animal feed 
prescribed in Sec.  573.380 of this chapter.
    (c) Labeling. The label of the color additives and any premixes 
prepared therefrom shall bear in addition to the information required by 
Sec.  70.25 of this chapter.
    (1) A statement of the concentrations of xanthophyll and ethoxyquin 
contained therein.
    (2) Adequate directions to provide a final product complying with 
the limitations prescribed in paragraph (b) of this section.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.295  Tagetes (Aztec marigold) meal and extract.

    (a) Identity. (1) The color additive tagetes (Aztec marigold) meal 
is the dried, ground flower petals of the Aztec marigold (Tagetes erecta 
L.) mixed with not more than 0.3 percent ethoxyquin.
    (2) The color additive tagetes (Aztec marigold) extract is a hexane 
extract of the flower petals of the Aztec marigold (Tagetes erecta L.). 
It is mixed with an edible vegetable oil, or with an edible vegetable 
oil and a hydrogenated edible vegetable oil, and not more than 0.3 
percent ethoxyquin. It may also be mixed with soy flour or corn meal as 
a carrier.
    (b) Specifications. (1) Tagetes (Aztec marigold) meal is free from 
admixture with other plant material from Tageteserecta L. or from plant 
material or flowers of any other species of plants.
    (2) Tagetes (Aztec marigold) extract shall be prepared from tagetes 
(Aztec marigold) petals meeting the specifications set forth in 
paragraph (b)(1) of this section and shall conform to the following 
additional specifications:

Melting point.............................  53.5-55.0 [deg]C.
Iodine value..............................  132-145.
Saponification value......................  175-200.
Acid value................................  0.60-1.20.
Titer.....................................  35.5-37.0 [deg]C.
Unsaponifiable matter.....................  23.0 percent-27.0 percent.
Hexane residue............................  Not more than 25 p.p.m.
 


All determinations, except the hexane residue, shall be made on the 
initial extract of the flower petals (after drying in a vacuum oven at 
60 [deg]C. for 24 hours) prior to the addition of the oils and 
ethoxyquin. The hexane determination shall be made on the color additive 
after the addition of the vegetable oils, hydrogenated vegetable oils, 
and ethoxyquin.
    (c) Uses and restrictions. The color additives tagetes (Aztec 
marigold) meal and extract may be safely used in chicken feed in 
accordance with the following prescribed conditions:
    (1) The color additives are used to enhance the yellow color of 
chicken skin and eggs.

[[Page 442]]

    (2) The quantity of the color additives incorporated in the feed is 
such that the finished feed:
    (i) Is supplemented sufficiently with xanthophyll and associated 
carotenoids so as to accomplish the intended effect described in 
paragraph (c)(1) of this section; and
    (ii) Meets the tolerance limitation for ethoxyquin in animal feed 
prescribed in Sec.  573.380 of this chapter.
    (d) Labeling requirements. The label of the color additives and any 
premixes prepared therefrom shall bear, in addition to the information 
required by Sec.  70.25 of this chapter:
    (1) A statement of the concentrations of xanthophyll and ethoxyquin 
contained therein.
    (2) Adequate directions to provide a final product complying with 
the limitations prescribed in paragraph (c) of this section.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.300  Carrot oil.

    (a) Identity. (1) The color additive carrot oil is the liquid or the 
solid portion of the mixture or the mixture itself obtained by the 
hexane extraction of edible carrots (Daucus carota L.) with subsequent 
removal of the hexane by vacuum distillation. The resultant mixture of 
solid and liquid extractives consists chiefly of oils, fats, waxes, and 
carrotenoids naturally occurring in carrots. The definition of carrot 
oil in this paragraph is for the purpose of identity as a color additive 
only and shall not be construed as setting forth an official standard 
for carrot oil or carrot oleoresin under section 401 of the act.
    (2) Color additive mixtures for food use made with carrot oil may 
contain only those diluents listed in this subpart as safe and suitable 
in color additive mixtures for coloring foods.
    (b) Specifications. Carrot oil shall contain no more than 25 parts 
per million of hexane.
    (c) Uses and restrictions. Carrot oil may be safely used for 
coloring foods generally, in amounts consistent with good manufacturing 
practice, except that it may not be used to color foods for which 
standards of identity have been promulgated under section 401 of the act 
unless the use of added color is authorized by such standards.
    (d) Labeling requirements. The label of the color additive and any 
mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.315  Corn endosperm oil.

    (a) Identity. (1) The color additive corn endosperm oil is a 
reddish-brown liquid composed chiefly of glycerides, fatty acids, 
sitosterols, and carotenoid pigments obtained by isopropyl alcohol and 
hexane extraction from the gluten fraction of yellow corn grain. The 
definition of corn endosperm oil in this paragraph is for the purpose of 
definition as a color additive only and shall not be construed as a food 
standard of identity under section 401 of the act.
    (2) Color additive mixtures for food use made with corn endosperm 
oil may contain only those diluents listed in this subpart as safe and 
suitable in color additive mixtures for coloring foods.
    (b) Specifications. Corn endosperm oil conforms to the following 
specifications:

Total fatty acids, not less than 85 percent.
Iodine value, 118 to 134.
Saponification value, 165 to 185.
Unsaponifiable matter, not more than 14 percent.
Hexane, not more than 25 parts per million.
Isopropyl alcohol, not more than 100 parts per million.

    (c) Uses and restrictions. The color additive corn endosperm oil may 
be safely used in chicken feed in accordance with the following 
prescribed conditions:
    (1) The color additive is used to enhance the yellow color of 
chicken skin and eggs.
    (2) The quantity of the color additive incorporated in the feed is 
such that

[[Page 443]]

the finished feed is supplemented sufficiently with xanthophyll and 
associated carotenoids so as to accomplish the intended effect described 
in paragraph (c)(1) of this section.
    (d) Labeling requirements. The label of the color additive and any 
premixes prepared therefrom shall bear, in addition to the information 
required by Sec.  70.25 of this chapter, a statement of the 
concentration of xanthophyll contained therein.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.340  Paprika.

    (a) Identity. (1) The color additive paprika is the ground dried pod 
of mild capsicum (Capsicum annuum L.). The definition of paprika in this 
paragraph is for the purpose of identity as a color additive only and 
shall not be construed as setting forth an official standard for paprika 
under section 401 of the act.
    (2) Color additive mixtures made with paprika may contain as 
diluents only those substances listed in this subpart as safe and 
suitable in color additive mixtures for coloring foods.
    (b) Uses and restrictions. Paprika may be safely used for the 
coloring of foods generally, in amounts consistent with good 
manufacturing practice, except that it may not be used to color foods 
for which standards of identity have been promulgated under section 401 
of the act, unless the use of added color is authorized by such 
standards.
    (c) Labeling. The color additive and any mixtures intended solely or 
in part for coloring purposes prepared therefrom shall bear, in addition 
to the other information required by the act, labeling in accordance 
with the provisions of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.345  Paprika oleoresin.

    (a) Identity. (1) The color additive paprika oleoresin is the 
combination of flavor and color principles obtained from paprika 
(Capsicum annuum L.) by extraction, using any one or a combination of 
the following solvents:

Acetone
Ethyl alcohol
Ethylene dichloride
Hexane
Isopropyl alcohol
Methyl alcohol
Methylene chloride
Trichloroethylene


The definition of paprika oleoresin in this paragraph is for the purpose 
of identity as a color additive only, and shall not be construed as 
setting forth an official standard for paprika oleoresin under section 
401 of the act.
    (2) Color additive mixtures made with paprika oleoresin may contain 
as diluents only those substances listed in this subpart as safe and 
suitable in color additive mixtures for coloring foods.
    (b) Specifications. Paprika oleoresin shall contain no more residue 
of the solvents listed in paragraph (a)(1) of this section than is 
permitted of the corresponding solvents in spice oleoresins under 
applicable food additive regulations in parts 170 through 189 of this 
chapter.
    (c) Uses and restrictions. Paprika oleoresin may be safely used for 
the coloring of foods generally in amounts consistent with good 
manufacturing practice, except that it may not be used to color foods 
for which standards of identity have been promulgated under section 401 
of the act, unless the use of added color is authorized by such 
standards.
    (d) Labeling. The color additive and any mixtures intended solely or 
in part for coloring purposes prepared therefrom shall bear, in addition 
to the other information required by the act, labeling in accordance 
with the provisions of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[[Page 444]]



Sec.  73.350  Mica-based pearlescent pigments.

    (a) Identity. (1) The color additive is formed by depositing 
titanium salts onto mica, followed by heating to produce titanium 
dioxide on mica. Mica used to manufacture the color additive shall 
conform in identity to the requirements of Sec.  73.1496(a)(1).
    (2) Color additive mixtures for food use made with mica-based 
pearlescent pigments may contain only those diluents listed in this 
subpart as safe and suitable for use in color additive mixtures for 
coloring food.
    (b) Specifications. Mica-based pearlescent pigments shall conform to 
the following specifications and shall be free from impurities other 
than those named to the extent that such other impurities may be avoided 
by good manufacturing practice:
    (1) Lead (as Pb), not more than 4 parts per million (ppm).
    (2) Arsenic (as As), not more than 3 ppm.
    (3) Mercury (as Hg), not more than 1 ppm.
    (c) Uses and restrictions. (1) The substance listed in paragraph (a) 
of this section may be safely used as a color additive in food as 
follows:
    (i) In amounts up to 1.25 percent, by weight, in the following 
foods: Cereals, confections and frostings, gelatin desserts, hard and 
soft candies (including lozenges), nutritional supplement tablets and 
gelatin capsules, and chewing gum.
    (ii) In amounts up to 0.07 percent, by weight, in the following:
    (A) Distilled spirits containing not less than 18 percent and not 
more than 25 percent alcohol by volume.
    (B) Cordials, liqueurs, flavored alcoholic malt beverages, wine 
coolers, and cocktails.
    (C) Non-alcoholic cocktail mixes and mixers, such as margarita mix, 
Bloody Mary mix, and daiquiri mix, but excluding eggnog, tonic water, 
and beverages that are typically consumed without added alcohol (e.g., 
fruit juices, fruit juice drinks, and soft drinks).
    (iii) In egg decorating kits used for coloring the shells of eggs in 
amounts consistent with good manufacturing practice.
    (2) The color additive may not be used to color foods for which 
standards of identity have been issued under section 401 of the act, 
unless the use of the added color is authorized by such standards.
    (d) Labeling. The label of the color additive and of any mixture 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[71 FR 31929, June 2, 2006, as amended at 78 FR 35117, June 12, 2013; 80 
FR 32307, June 8, 2015; 80 FR 58602, Sept. 30, 2015]



Sec.  73.352  Paracoccus pigment.

    (a) Identity. (1) The color additive paracoccus pigment consists of 
the heat-killed, dried cells of a nonpathogenic and nontoxicogenic 
strain of the bacterium Paracoccus carotinifaciens and may contain added 
calcium carbonate to adjust the astaxanthin level.
    (2) Color additive mixtures for fish feed use made with paracoccus 
pigment may contain only those diluents that are suitable and are listed 
in this subpart as safe for use in color additive mixtures for coloring 
foods.
    (b) Specifications. Paracoccus pigment shall conform to the 
following specifications and shall be free from impurities, other than 
those named, to the extent that such impurities may be avoided by good 
manufacturing practice:
    (1) Physical state, solid.
    (2) Lead, not more than 5 milligrams per kilogram (mg/kg) (5 parts 
per million (ppm)).
    (3) Arsenic, not more than 2 mg/kg (2 ppm).
    (4) Mercury, not more than 1 mg/kg (1 ppm).
    (5) Heavy metals (as Pb), not more than 10 mg/kg (10 ppm).
    (6) Astaxanthin, not less than 1.75 percent.
    (c) Uses and restrictions. Paracoccus pigment may be safely used in 
the feed of salmonid fish in accordance with the following prescribed 
conditions:

[[Page 445]]

    (1) The color additive is used to enhance the pink to orange-red 
color of the flesh of salmonid fish.
    (2) The quantity of astaxanthin in finished feed, from paracoccus 
pigment when used alone or in combination with other astaxanthin color 
additive sources listed in this part 73, shall not exceed 80 mg/kg (72 
grams per ton) of finished feed.
    (d) Labeling requirements. (1) The labeling of the color additive 
and any premixes prepared therefrom shall bear expiration dates for the 
sealed and open container (established through generally accepted 
stability testing methods), other information required by Sec.  70.25 of 
this chapter, and adequate directions to prepare a final product 
complying with the limitations prescribed in paragraph (c) of this 
section.
    (2) The presence of the color additive in finished fish feed 
prepared according to paragraph (c) of this section shall be declared in 
accordance with Sec.  501.4 of this chapter.
    (3) The presence of the color additive in salmonid fish that have 
been fed feeds containing paracoccus pigment shall be declared in 
accordance with Sec. Sec.  101.22(b), (c), and (k)(2), and 101.100(a)(2) 
of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore, batches thereof are exempt from the certification 
requirements of section 721(c) of the act.

[74 FR 58845, Nov. 16, 2009]



Sec.  73.355  Phaffia yeast.

    (a) Identity. (1) The color additive phaffia yeast consists of the 
killed, dried cells of a nonpathogenic and nontoxicogenic strain of the 
yeast Phaffia rhodozyma.
    (2) Phaffia yeast may be added to the fish feed only as a component 
of a stabilized color additive mixture. Color additive mixtures for fish 
feed use made with phaffia yeast may contain only those diluents that 
are suitable and are listed in this subpart as safe for use in color 
additive mixtures for coloring foods.
    (b) Specifications. Phaffia yeast shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice:

Physical state, solid.
Lead, not more than 5 parts per million.
Arsenic, not more than 2 parts per million.
Mercury, not more than 1 part per million.
Heavy metals (as Pb), not more than 10 parts per million.
Astaxanthin, not less than 0.4 percent.

    (c) Uses and restrictions. Phaffia yeast may be safely used in the 
feed of salmonid fish in accordance with the following prescribed 
conditions:
    (1) The color additive is used to enhance the pink to orange-red 
color of the flesh of salmonid fish.
    (2) The quantity of astaxanthin in finished feed, from phaffia yeast 
when used alone or in combination with other astaxanthin color additive 
sources listed in this part 73, shall not exceed 80 milligrams per 
kilogram (72 grams per ton) of finished feed.
    (d) Labeling requirements. (1) The labeling of the color additive 
and any premixes prepared therefrom shall bear expiration dates for the 
sealed and open container (established through generally accepted 
stability testing methods), other information required by Sec.  70.25 of 
this chapter, and adequate directions to prepare a final product 
complying with the limitations prescribed in paragraph (c) of this 
section.
    (2) The presence of the color additive in finished fish feed 
prepared according to paragraph (c) of this section shall be declared in 
accordance with Sec.  501.4 of this chapter.
    (3) The presence of the color additive in salmonid fish that have 
been fed feeds containing phaffia yeast shall be declared in accordance 
with Sec. Sec.  101.22(b), (c), and (k)(2) and 101.100(a)(2) of this 
chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[65 FR 41587, July 6, 2000]



Sec.  73.450  Riboflavin.

    (a) Identity. (1) The color additive riboflavin is the riboflavin 
defined in the Food Chemicals Codex, 3d Ed. (1981), pp. 262-263, which 
is incorporated by

[[Page 446]]

reference. Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, 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.
    (2) Color additive mixtures made with riboflavin may contain as 
diluents only those substances listed in this subpart as safe and 
suitable for use in color additive mixtures for coloring foods.
    (b) Specifications. Riboflavin shall meet the specifications given 
in the Food Chemicals Codex, 3d Ed. (1981), which is incorporated by 
reference. The availability of this incorporation by reference is given 
in paragraph (a)(1) of this section.
    (c) Uses and restrictions. Riboflavin may be safely used for the 
coloring of foods generally, in amounts consistent with good 
manufacturing practice; except that it may not be used to color foods 
for which standards of identity have been promulgated under section 401 
of the act, unless the use of added color is authorized by such 
standards.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the Act.

[42 FR 15643, Mar. 22, 1977, as amended at 47 FR 947, Jan. 8, 1982; 49 
FR 10089, Mar. 19, 1984]



Sec.  73.500  Saffron.

    (a) Identity. (1) The color additive saffron is the dried stigma of 
Crocus sativus L. The definition of saffron in this paragraph is for the 
purpose of identity as a color additive only, and shall not be construed 
as setting forth an official standard for saffron under section 401 of 
the act.
    (2) Color additive mixtures made with saffron may contain as 
diluents only those substances listed in this subpart as safe and 
suitable in color additive mixtures for coloring foods.
    (b) Uses and restrictions. Saffron may be safely used for the 
coloring of foods generally, in amounts consistent with good 
manufacturing practice, except that it may not be used to color foods 
for which standards of identity have been promulgated under section 401 
of the act, unless the use of added color is authorized by such 
standards.
    (c) Labeling. The color additive and any mixtures intended solely or 
in part for coloring purposes prepared therefrom shall bear, in addition 
to the other information required by the act, labeling in accordance 
with the provisions of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.530   Spirulina extract.

    (a) Identity. (1) The color additive spirulina extract is prepared 
by the filtered aqueous extraction of the dried biomass of Arthrospira 
platensis. The color additive contains phycocyanins as the principal 
coloring components.
    (2) Color additive mixtures for food use made with spirulina extract 
may contain only those diluents that are suitable and are listed in this 
subpart as safe for use in color additive mixtures for coloring foods.
    (b) Specifications. Spirulina extract must conform to the following 
specifications and must be free from impurities, other than those named, 
to the extent that such other impurities may be avoided by good 
manufacturing practice:
    (1) Lead, not more than 2 milligrams per kilogram (mg/kg) (2 part 
per million (ppm));
    (2) Arsenic, not more than 2 mg/kg (2 ppm);
    (3) Mercury, not more than 1 mg/kg (1 ppm); and
    (4) Negative for microcystin toxin.
    (c) Uses and restrictions. Spirulina extract may be safely used for 
coloring confections (including candy and chewing gum), frostings, ice 
cream and frozen desserts, dessert coatings and toppings, beverage mixes 
and powders, yogurts, custards, puddings, cottage cheese, gelatin, 
breadcrumbs, ready-to-

[[Page 447]]

eat cereals (excluding extruded cereals), coating formulations applied 
to dietary supplement tablets and capsules, at levels consistent with 
good manufacturing practice, and to seasonally color the shells of hard-
boiled eggs, except that it may not be used to color foods for which 
standards of identity have been issued under section 401 of the Federal 
Food, Drug, and Cosmetic Act, unless the use of the added color is 
authorized by such standards.
    (d) Labeling requirements. The label of the color additive and of 
any mixture prepared therefrom intended solely or in part for coloring 
purposes must conform to Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the Federal Food, Drug, and Cosmetic Act.

[78 FR 49120, Aug. 13, 2013, as amended at 79 FR 20098, May 13, 2014; 80 
FR 50765, Aug. 21, 2015; 82 FR 30734, July 3, 2017]



Sec.  73.575  Titanium dioxide.

    (a) Identity. (1) The color additive titanium dioxide is 
synthetically prepared TiO2, free from admixture with other 
substances.
    (2) Color additive mixtures for food use made with titanium dioxide 
may contain only those diluents that are suitable and that are listed in 
this subpart as safe in color additive mixtures for coloring foods, and 
the following: Silicon dioxide, SiO2 and/or aluminum oxide, 
Al2 O3, as dispersing aids--not more than 2 
percent total.
    (b) Specifications. Titanium dioxide shall conform to the following 
specifications:

Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Antimony (as Sb), not more than 2 parts per million.
Mercury (as Hg), not more than 1 part per million.
Loss on ignition at 800 [deg]C. (after drying for 3 hours at 105 
[deg]C.), not more than 0.5 percent.
Water soluble substances, not more than 0.3 percent.
Acid soluble substances, not more than 0.5 percent.
TiO2, not less than 99.0 percent after drying for 3 hours at 
105 [deg]C.


Lead, arsenic, and antimony shall be determined in the solution obtained 
by boiling 10 grams of the titanium dioxide for 15 minutes in 50 
milliliters of 0.5N hydrochloric acid.
    (c) Uses and restrictions. The color additive titanium dioxide may 
be safely used for coloring foods generally, subject to the following 
restrictions:
    (1) The quantity of titanium dioxide does not exceed 1 percent by 
weight of the food.
    (2) It may not be used to color foods for which standards of 
identity have been promulgated under section 401 of the act unless added 
color is authorized by such standards.
    (d) Labeling. The label of the color additive and any mixtures 
intended solely or in part for coloring purposes prepared therefrom 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.585  Tomato lycopene extract; tomato lycopene concentrate.

    (a) Identity. (1) The color additive tomato lycopene extract is a 
red to dark brown viscous oleoresin extracted with ethyl acetate from 
tomato pulp followed by removal of the solvent by evaporation. The pulp 
is produced from fresh, edible varieties of the tomato by removing the 
liquid. The main coloring component is lycopene.
    (2) The color additive tomato lycopene concentrate is a powder 
prepared from tomato lycopene extract by removing most of the tomato 
lipids with ethyl acetate and then evaporating off the solvent.
    (3) Color additive mixtures made with tomato lycopene extract or 
tomato lycopene concentrate may contain only those diluents listed in 
this subpart as safe and suitable for use in color additive mixtures for 
coloring food.
    (b) Specifications. (1) Tomato lycopene extract shall conform to the 
following specification: Lycopene, not less than 5.5 percent of 
oleoresin as determined

[[Page 448]]

by the method entitled ``Qualitative Analysis of Lycopene, Its Isomers 
and Other Carotenoids in Different Concentrations of Lyc-O-Mato [supreg] 
(Tomato Oleoresin) and in Tomato Pulp by High Performance Liquid 
Chromatography (HPLC),'' S.O.P. number : Lab/119/01, Revision 01, dated 
May 30, 2001, published by LycoRed Natural Products Industries, which is 
incorporated by reference, or an equivalent method. The Director of the 
Office of the Federal Register approves this incorporation by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a 
copy of the method from the Center for Food Safety and Applied Nutrition 
(HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740. You may inspect a copy at theFood and Drug Administration's 
Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver 
Spring, MD 20993, 301-796-2039, 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
    (2) Tomato lycopene concentrate shall conform to the following 
specification: Lycopene, not less than 60 percent of oleoresin as 
determined by the method identified in paragraph (b)(1) of this section.
    (c) Uses and restrictions. Tomato lycopene extract and tomato 
lycopene concentrate may be safely used for coloring foods generally in 
amounts consistent with good manufacturing practice, except that they 
may not be used to color foods for which standards of identity have been 
issued under section 401 of the act, unless the use of added color is 
authorized by such standards.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[70 FR 43045, July 26, 2005, as amended at 81 FR 5590, Feb. 3, 2016; 81 
FR 49895, July 29, 2016]



Sec.  73.600  Turmeric.

    (a) Identity. (1) The color additive turmeric is the ground rhizome 
of Curcuma longa L. The definition of turmeric in this paragraph is for 
the purpose of identity as a color additive only, and shall not be 
construed as setting forth an official standard for turmeric under 
section 401 of the act.
    (2) Color additive mixtures made with turmeric may contain as 
diluents only those substances listed in this subpart as safe and 
suitable in color additive mixtures for coloring foods.
    (b) Uses and restrictions. Turmeric may be safely used for the 
coloring of foods generally, in amounts consistent with good 
manufacturing practice, except that it may not be used to color foods 
for which standards of identity have been promulgated under section 401 
of the act, unless the use of added color is authorized by such 
standards.
    (c) Labeling. The color additive and any mixtures intended solely or 
in part for coloring purposes prepared therefrom shall bear, in addition 
to the other information required by the act, labeling in accordance 
with the provisions of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.615  Turmeric oleoresin.

    (a) Identity. (1) The color additive turmeric oleoresin is the 
combination of flavor and color principles obtained from turmeric 
(Curcuma longa L.) by extraction using any one or a combination of the 
following solvents:

Acetone
Ethyl alcohol
Ethylene dichloride
Hexane
Isopropyl alcohol
Methyl alcohol
Methylene chloride
Trichloroethylene


The definition of turmeric oleoresin in this paragraph is for the 
purpose of identity as a color additive only, and shall not be construed 
as setting forth an official standard for turmeric oleoresin under 
section 401 of the act.
    (2) Color additive mixtures made with turmeric oleoresin may contain 
as diluents only those substances listed in this subpart as safe and 
suitable in

[[Page 449]]

color additive mixtures for coloring foods.
    (b) Specifications. Turmeric oleoresin shall contain no more residue 
of the solvents listed under paragraph (a)(1) of this section than is 
permitted for the corresponding solvents in spice oleoresins under 
applicable food additive regulation in parts 170 through 189 of this 
chapter.
    (c) Uses and restrictions. Turmeric oleoresin may be safely used for 
the coloring of foods generally, in amounts consistent with good 
manufacturing practice, except that it may not be used to color foods 
for which standards of identity have been promulgated under section 401 
of the act, unless the use of added color is authorized by such 
standards.
    (d) Labeling. The color additive and any mixtures intended solely or 
in part for coloring purposes prepared therefrom shall bear, in addition 
to the other information required by the act, labeling in accordance 
with the provisions of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



                             Subpart B_Drugs



Sec.  73.1001  Diluents in color additive mixtures for drug use exempt
from certification.

    The following diluents may be safely used in color additive mixtures 
that are exempt from certification and which are to be used for coloring 
drugs, subject to the condition that each straight color in the mixture 
has been exempted from certification or, if not so exempted, is from a 
batch that has previously been certified and has not changed in 
composition since certification. Such listing of diluents is not to be 
construed as superseding any of the other requirements of the Federal 
Food, Drug, and Cosmetic Act with respect to drugs, including new drugs. 
If a definition and specification for a particular diluent is not set 
forth in this subpart, the material shall be of a purity consistent with 
its intended use.
    (a) Ingested drugs--(1) General use. Diluents listed in Sec.  
73.1(a) and the following:

------------------------------------------------------------------------
                                  Definitions and
          Substances               specifications        Restrictions
------------------------------------------------------------------------
Alcohol, specially denatured..  As set forth in 26   As set forth in 26
                                 CFR, pt. 212.        CFR, pt. 211.
Cetyl alcohol.................  As set forth in
                                 N.F. XI.
Isopropyl alcohol.............  ...................  In color coatings
                                                      for pharmaceutical
                                                      forms, no residue.
Polyoxyethylene (20) sorbitan   As set forth in
 monostearate (Polysorbate 60).  sec. 172.836 of
                                 this chapter.
Polyoxyethylene (20) sorbitan   As set forth in
 tristearate (Polysorbate 65).   sec. 172.838 of
                                 this chapter.
Polysorbate 80................  As set forth in
                                 sec. 172.840 of
                                 this chapter.
Polyvinyl-pyrrolidone.........  As set forth in
                                 sec. 173.55 of
                                 this chapter.
Sorbitan monooleate...........
Sorbitan monostearate.........  As set forth in
                                 sec. 172.842 of
                                 this chapter.
Sorbitan trioleate............
------------------------------------------------------------------------

    (2) Special use; inks for branding pharmaceutical forms. Items 
listed in paragraph (a)(1) of this section, Sec.  73.1(b)(1)(i), and the 
following:

Ethyl lactate
Polyoxyethylene sorbitan monolaurate (20)

    (b) Externally applied drugs. Diluents listed in paragraph (a)(1) of 
this section and the following:

------------------------------------------------------------------------
                                                  Definitions and
                Substances                         specifications
------------------------------------------------------------------------
Benzyl alcohol...........................  As set forth in N.F. XI.
Ethyl cellulose..........................  As set forth in Sec.
                                            172.868 of this chapter.
Hydroxyethyl cellulose...................
Hydroxypropyl cellulose..................  As set forth in Sec.
                                            172.870 of this chapter.
------------------------------------------------------------------------


[[Page 450]]



Sec.  73.1010  Alumina (dried aluminum hydroxide).

    (a) Identity. (1) The color additive alumina (dried aluminum 
hydroxide) is a white, odorless, tasteless, amorphous powder consisting 
essentially of aluminum hydroxide (Al2 O3[middot] 
XH2 O).
    (2) Color additive mixtures for drug use made with alumina (dried 
aluminum hydroxide) may contain only those diluents listed in this 
subpart as safe and suitable for use in color additive mixtures for 
coloring drugs.
    (b) Specifications. Alumina (dried aluminum hydroxide) shall conform 
to the following specifications:

Acidity or alkalinity: Agitate 1 gram of the color additive with 25 
milliliters of water and filter. The filtrate shall be neutral to litmus 
paper.
Matter insoluble in dilute hydrochloric acid, not more than 0.5 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Mercury (as Hg), not more than 1 part per million.
Aluminum oxide (Al2 O3), not less than 50 percent.

    (c) Uses and restrictions. Alumina (dried aluminum hydroxide) may be 
safely used in amounts consistent with good manufacturing practice to 
color drugs generally.
    (d) Labeling requirements. The label of the color additive and of 
any mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.1015  Chromium-cobalt-aluminum oxide.

    (a) Identity. The color additive chromium-cobalt-aluminum oxide is a 
blue-green pigment obtained by calcining a mixture of chromium oxide, 
cobalt carbonate, and aluminum oxide. It may contain small amounts (less 
than 1 percent each) of oxides of barium, boron, silicon, and nickel.
    (b) Specifications. Chromium-cobalt-aluminum oxide shall conform to 
the following specifications:

Chromium, calculated as Cr2 O3, 34-37 percent.
Cobalt, calculated as CoO, 29-34 percent.
Aluminum, calculated as AL2 O3, 29-35 percent.
Lead (as Pb), not more than 30 parts per million.
Arsenic (as As), not more than 3 parts per million.
Total oxides of aluminum, chromium, and cobalt not less than 97 percent.


Lead and arsenic shall be determined in the solution obtained by boiling 
10 grams of the chromium-cobalt-aluminum oxide for 15 minutes in 50 
milliliters of 0.5 N hydrochloric acid.
    (c) Uses and restrictions. The color additive chromium-cobalt-
aluminum oxide may be safely used for coloring linear polyethylene 
surgical sutures, United States Pharmacopeia (U.S.P.), for use in 
general surgery, subject to the following restrictions:
    (1) For coloring procedure, the color additive is blended with the 
polyethylene resin. The mixture is heated to a temperature of 500-550 
[deg]F. and extruded through a fixed orifice. The filaments are cooled, 
oriented by drawing, and set by annealing.
    (2) The quantity of the color additive does not exceed 2 percent by 
weight of the suture material.
    (3) The dyed suture shall conform in all respects to the 
requirements of the U.S.P. XX (1980).
    (4) When the sutures are used for the purpose specified in their 
labeling, there is no migration of the color additive to the surrounding 
tissue.
    (5) If the suture is a new drug, an approved new drug application, 
pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act, is 
in effect for it.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
batches thereof are exempt from the certification requirements of 
section 721(c) of the act.

[42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984]

[[Page 451]]



Sec.  73.1025  Ferric ammonium citrate.

    (a) Identity. The color additive ferric ammonium citrate consists of 
complex chelates prepared by the interaction of ferric hydroxide with 
citric acid in the presence of ammonia. The complex chelates occur in 
brown and green forms, are deliquescent in air, and are reducible by 
light.
    (b) Specifications. Ferric ammonium citrate shall conform to the 
following specifications and shall be free from impurities other than 
those named to the extent that such impurities may be avoided by good 
manufacturing practice:

Iron (as Fe), not less than 14.5 percent and not more than 18.5 percent.
Lead (as Pb), not more than 20 p/m.
Arsenic (as As), not more than 3 p/m.

    (c) Uses and restrictions. Ferric ammonium citrate may be safely 
used in combination with pyrogallol (as listed in Sec.  73.1375), for 
coloring plain and chromic catgut sutures for use in general and 
ophthalmic surgery subject to the following conditions:
    (1) The dyed suture shall conform in all respects to the 
requirements of the United States Pharmacopeia XX (1980).
    (2) The level of the ferric ammonium citrate-pyrogallol complex 
shall not exceed 3 percent of the total weight of the suture material.
    (3) When the sutures are used for the purposes specified in their 
labeling, there is no migration of the color additive to the surrounding 
tissue.
    (4) If the suture is a new drug, an approved new drug application, 
pursuant to section 505 of the act, is in effect for it.
    (d) Labeling. The labeling of the color-additive shall conform to 
the requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the requirements of section 
721(c) of the act.

[42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984]



Sec.  73.1030  Annatto extract.

    (a) Identity and specifications. (1) The color additive annatto 
extract shall conform in identity and specifications to the requirements 
of Sec.  73.30(a)(1) and (b).
    (2) Color additive mixtures for drug use made with annatto extract 
may contain only those diluents that are suitable and that are listed in 
this subpart as safe in color additive mixtures for coloring ingested 
drugs.
    (b) Uses and restrictions. Annatto extract may be safely used for 
coloring drugs generally, including those intended for use in the area 
of the eye, in amounts consistent with good manufacturing practice.
    (c) Labeling. The label of the color additive and any mixtures 
prepared therefrom and intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter. Labels 
shall bear information showing that the color is derived from annatto 
seed. The requirements of Sec.  70.25(a) of this chapter that all 
ingredients shall be listed by name shall not be construed as requiring 
the declaration of residues of solvents listed in Sec.  73.30(a)(1)(ii) 
of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are evempt from the certification requirements 
of section 721(c) of the act.

[42 FR 15643, Mar. 22, 1977, as amended at 42 FR 36994, July 19, 1977]



Sec.  73.1070  Calcium carbonate.

    (a) Identity. (1) The color additive calcium carbonate is a fine, 
white, synthetically prepared powder consisting essentially of 
precipitated calcium carbonate (CaCO3).
    (2) Color additive mixtures for drug use made with calcium carbonate 
may contain only those diluents listed in this subpart as safe and 
suitable for use in color additive mixtures for coloring drugs.
    (b) Specifications. Calcium carbonate shall meet the specifications 
for precipitated calcium carbonate in the United States Pharmacopeia XX 
(1980).
    (c) Uses and restrictions. Calcium carbonate may be safely used in 
amounts consistent with good manudacturing practice to color drugs 
generally.
    (d) Labeling requirements. The label of the color additive and of 
any mixtures prepared therefrom intended solely or

[[Page 452]]

in part for coloring purposes shall conform to the requirements of Sec.  
70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984]



Sec.  73.1075  Canthaxanthin.

    (a) Identity and specifications. (1) The color additive 
canthaxanthin shall conform in identity and specifications to the 
requirements of Sec.  73.75(a)(1) and (b).
    (2) Color additive mixtures for ingested drug use made with 
canthaxanthin may contain only those diluents that are suitable and that 
are listed in this subpart as safe in color additive mixtures for 
coloring ingested drugs.
    (b) Uses and restrictions. Canthaxanthin may be safely used for 
coloring ingested drugs generally in amounts consistent with good 
manufacturing practice.
    (c) Labeling requirements. The label of the color additive and of 
any mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.1085  Caramel.

    (a) Identity and specifications. (1) The color additive caramel 
shall conform in identity and specifications to the requirements of 
Sec.  73.85(a) (1), (2), and (3) and (b).
    (2) The diluents in color additive mixtures for drug use containing 
caramel shall be limited to those listed in this subpart as safe and 
suitable in color additive mixtures for coloring drugs.
    (b) Uses and restrictions. Caramel may be used for coloring ingested 
and topically applied drugs generally in amounts consistent with good 
manufacturing practice.
    (c) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the certification requirement 
of section 721(c) of the act.



Sec.  73.1095  [beta]-Carotene.

    (a) Identity and specifications. (1) The color additive [beta]-
carotene shall conform in identity and specifications to the 
requirements of Sec.  73.95(a)(1) and (b).
    (2) The diluents in color additive mixtures for drug use containing 
[beta]-carotene are limited to those listed in this subpart as safe and 
suitable in color additive mixtures for coloring ingested drugs.
    (b) Uses and restrictions. The color additive [beta]-carotene may be 
safely used in coloring drugs generally, including those intended for 
use in the area of the eye, in amounts consistent with good 
manufacturing practice.
    (c) Labeling requirements. The labeling of the color additive and 
any mixtures intended solely or in part for coloring purposes prepared 
therefrom shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 15643, Mar. 22, 1977, as amended at 42 FR 33722, July 1, 1977]



Sec.  73.1100  Cochineal extract; carmine.

    (a) Identity and specifications. (1) The color additives cochineal 
extract and carmine shall conform in identity and specifications to the 
requirements of Sec.  73.100(a) (1) and (2) and (b).
    (2) Color additive mixtures for drug use made with carmine and 
cochineal extract may contain only those diluents that are suitable and 
that are listed in this subpart as safe in color additive mixtures for 
coloring drugs.
    (b) Uses and restrictions. Cochineal extract and carmine may be 
safely used for coloring ingested and externally applied drugs in 
amounts consistent with good manufacturing practice.
    (c) Labeling requirements. The label of the color additives and any 
mixtures intended solely or in part for coloring

[[Page 453]]

purposes prepared therefrom shall conform to the requirements of Sec.  
70.25 of this chapter.
    (d) Exemption from certification. Certification of these color 
additives is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.1125  Potassium sodium copper chloropyhllin 
(chlorophyllin-copper complex).

    (a) Identity. (1) The color additive potassium sodium copper 
chlorophyllin is a green to black powder obtained from chlorophyll by 
replacing the methyl and phytyl ester groups with alkali and replacing 
the magnesium with copper. The source of the chlorophyll is dehydrated 
alfalfa.
    (2) Color additive mixtures for drug use made with potassium sodium 
copper chlorophyllin may contain only those diluents that are suitable 
and that are listed in this subpart as safe for use in color additive 
mixtures for coloring drugs.
    (b) Specifications. Potassium sodium copper chlorophyllin shall 
conform to the following specifications and shall be free from 
impurities other than those named to the extent that such other 
impurities may be avoided by good manufacturing practice:

Moisture, not more than 5.0 percent.
Nitrogen, not more than 5.0 percent.
pH of 1 percent solution, 9 to 11.
Total copper, not less than 4 percent and not more than 6 percent.
Free copper, not more than 0.25 percent.
Iron, not more than 0.5 percent.
Lead (as Pb)), not more than 20 parts per million.
Arsenic (as As), not more than 5 parts per million.
Ratio, absorbance at 405 m[mu] to absorbance at 630 m[mu], not less than 
3.4 and not more than 3.9.
Total color, not less than 75 percent.

    (c) Uses and restrictions. Potassium sodium copper chlorophyllin may 
be safely used for coloring dentifrices that are drugs at a level not to 
exceed 0.1 percent. Authorization for this use shall not be construed as 
waiving any of the requirements of section 505 of the act with respect 
to the drug in which it is used.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.1150  Dihydroxyacetone.

    (a) Identity. (1) The color additive dihydroxyacetone is 1,3-
dihydroxy-2-propanone.
    (2) Color additive mixtures for drug use made with dihydroxyacetone 
may contain only those diluents that are listed in this subpart as safe 
and suitable in color additive mixtures for coloring externally applied 
drugs.
    (b) Specifications. Dihydroxyacetone shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice:

Volatile matter (at 34.6 [deg]C. for 3 hours at a pressure of not more 
than 30 mm. mercury), not more than 0.5 percent.
Residue on ignition, not more than 0.4 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Iron (as Fe), not more than 25 parts per million.
1,3-dihydroxy-2-propanone, not less than 98 percent.

    (c) Uses and restrictions. Dihydroxyacetone may be safely used in 
amounts consistent with good manufacturing practice in externally 
applied drugs intended solely or in part to impart a color to the human 
body. Authorization for this use shall not be construed as waiving any 
of the requirements of section 505 of the act with respect to the drug 
in which it is used.
    (d) Labeling requirements. The label of the color additive and any 
mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.

[[Page 454]]

    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.1162  Bismuth oxychloride.

    (a) Identity. (1) The color additive bismuth oxychloride is a 
synthetically prepared white or nearly white amorphous or finely 
crystalline, odorless powder consisting principally of BiOCl.
    (2) Color additive mixtures for drug use made with bismuth 
oxychloride may contain only those diluents that are suitable and that 
are listed in this subpart as safe in color additive mixtures for 
coloring externally applied drugs.
    (b) Specifications. The color additive bismuth oxychloride shall 
conform to the following specifications and shall be free from 
impurities other than those named to the extent that such other 
impurities may be avoided by good manufacturing practice:

Volatile matter, not more than 0.5 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Bismuth oxychloride, not less than 98 percent.

    (c) Uses and restrictions. The color additive bismuth oxychloride 
may be safely used in coloring externally applied drugs, including those 
intended for use in the area of the eye, in amounts consistent with good 
manufacturing practice.
    (d) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring purposes shall bear, in addition 
to any information required by law, labeling in accordance with the 
provisions of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from certification pursuant to 
section 721(c) of the act.

[42 FR 52394, Sept. 30, 1977]



Sec.  73.1200  Synthetic iron oxide.

    (a) Identity. (1) The color additive synthetic iron oxide consists 
of any one or any combination of synthetically prepared iron oxides, 
including the hydrated forms. It is free from admixture with other 
substances.
    (2) Color additive mixtures for drug use made with synthetic iron 
oxide may contain only those diluents listed in this subpart as safe and 
suitable in color additive mixtures for coloring drugs.
    (b) Specifications. Synthetic iron oxide shall conform to the 
following specifications, all on an ``as is'' basis:

Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 10 parts per million.
Mercury (as Hg), not more than 3 parts per million.

    (c) Uses and restrictions. The color additive synthetic iron oxide 
may be safely used to color ingested or topically applied drugs 
generally subject to the restriction that if the color additive is used 
in drugs ingested by man the amount consumed in accordance with labeled 
or prescribed dosages shall not exceed 5 milligrams, calculated as 
elemental iron, per day.
    (d) Labeling requirements. The label of the color additive and any 
mixtures intended solely or in part for coloring purposes prepared 
therefrom shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from certification requirements of 
section 721(c) of the act.



Sec.  73.1298  Ferric ammonium ferrocyanide.

    (a) Identity. (1) The color additive ferric ammonium ferrocyanide is 
the blue pigment obtained by oxidizing under acidic conditions with 
sodium dichromate the acid digested precipitate resulting from mixing 
solutions of ferrous sulfate and sodium ferrocyanide in the presence of 
ammonium sulfate. The oxidized product is filtered, washed,

[[Page 455]]

and dried. The pigment consists principally of ferric ammonium 
ferrocyanide with smaller amounts of ferric ferrocyanide and ferric 
sodium ferrocyanide.
    (2) Color additive mixtures for drug use made with ferric ammonium 
ferrocyanide may contain only those diluents listed in this subpart as 
safe and suitable for use in color additive mixtures for coloring drugs.
    (b) Specifications. Ferric ammonium ferrocyanide shall conform to 
the following specifications and shall be free of impurities other than 
those named to the extent that the other impurities may be avoided by 
good manufacturing practice:

Oxalic acid or its salts, not more than 0.1 percent.
Water soluble matter, not more than 3 percent.
Water soluble cyanide, not more than 10 parts per million.
Volatile matter, not more than 4 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Nickel (as Ni), not more than 200 parts per million.
Cobalt (as Co), not more than 200 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total iron (as Fe corrected for volatile matter), not less than 33 
percent and not more than 39 percent.

    (c) Uses and restrictions. Ferric ammonium ferrocyanide may be 
safely used in amounts consistent with good manufacturing practice to 
color externally applied drugs, including those for use in the area of 
the eye.
    (d) Labeling requirements. The label of the color additive and of 
any mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therfore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 38562, July 29, 1977, as amended at 44 FR 28322, May 15, 1979]



Sec.  73.1299  Ferric ferrocyanide.

    (a) Identity. (1) The color additive ferric ferrocyanide is a ferric 
hexacyanoferrate pigment characterized by the structual formula 
Fe4[Fe(CN)6]3[middot]XH2O, 
which may contain small amounts of ferric sodium ferrocyanide and ferric 
potassium ferrocyanide.
    (2) Color additive mixtures for drug use made with ferric 
ferrocyanide may contain only those diluents listed in this subpart as 
safe and suitable for use in color additive mixtures for coloring drugs.
    (b) Specifications. Ferric ferrocyanide shall conform to the 
following specifications and shall be free from impurities other than 
those named to the extent that such impurities may be avoided by good 
manufacturing practice:

Water soluble cyanide, not more than 10 parts per million.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Nickel (as Ni), not more than 200 parts per million.
Cobalt (as Co), not more than 200 parts per million.
Mercury (as Hg), not more than 1 part per million.
Oxalic acid, not more than 0.1 percent.
Water soluble matter, not more than 3 percent.
Volatile matter, not more than 10 percent.
Total iron (as Fe corrected for volatile matter), not less than 37 
percent and not more than 45 percent.

    (c) Uses and restrictions. Ferric ferrocyanide may be safely used in 
amounts consistent with good manufacturing practice to color externally 
applied drugs including those intended for use in the area of the eye.
    (d) Labeling requirements. The label of the color additive and of 
any mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from certification requirements of 
section 721(c) of the act.

[43 FR 54235, Nov. 21, 1978]

[[Page 456]]



Sec.  73.1326  Chromium hydroxide green.

    (a) Identity. (1) The color additive chromium hydroxide green is 
principally hydrated chromic sesquioxide 
(Cr2O3[middot]XH2O).
    (2) Color additive mixtures for drug use made with chromium 
hydroxide green may contain only those diluents listed in this subpart 
as safe and suitable for use in color additive mixtures for coloring 
drugs.
    (b) Specifications. Chromium hydroxide green shall conform to the 
following specifications and shall be free from impurities other than 
those named to the extent that such impurities may be avoided by good 
manufacturing practice:

Water soluble matter, not more than 2.5%.
Chromium in 2% NaOH extract, not more than 0.1% as 
Cr2O3 (based on sample weight).
Boron (as B2O3), not more than 8 percent.
Total volatile matter at 1000 [deg]C, not more than 20%.
Cr2O3 not less than 75%.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.

    (c) Uses and restrictions. Chromium hydroxide green may be safely 
used in amounts consistent with good manufacturing practice to color 
externally applied drugs, including those for use in the area of the 
eye.
    (d) Labeling requirements. The label of the color additive and of 
any mixtures prepared therefrom lintended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 36451, July 15, 1977, as amended at 42 FR 59852, Nov. 22, 1977]



Sec.  73.1327  Chromium oxide greens.

    (a) Identity. (1) The color additive chromium oxide greens is 
principally chromic sesquioxide (Cr2O3).
    (2) Color additive mixtures for drug use made with chromium oxide 
greens may contain only those diluents listed in this subpart as safe 
and suitable for use in color additive mixtures for coloring drugs.
    (b) Specifications. the color additive chormium oxide greens shall 
conform to the following specifications and shall be free from 
impurities other than those named to the extent that such impurities may 
be avoided by good manufacturing practice:

Chromium in 2% NaOH extract, not more than 0.075% as 
Cr2O3 (based on sample weight).
Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 20 parts per million.
Mercury (as Hg), not more than 1 part per million.
Cr2O3, not less than 95%.

    (c) Uses and restrictions. Chromium oxide greens is safe for use in 
coloring externally applied drugs, including those intended for use in 
the area of eye, in amounts consistent with good manufacturing practice.
    (d) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring purposes shall bear, in addition 
to any information required by law, labeling in accordance with Sec.  
70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches therof are exempt from certification pursuant to 
section 721(c) of the act.

[42 FR 36451, July 15, 1977]



Sec.  73.1329  Guanine.

    (a) Identity. (1) The color additive guanine is the crystalline 
material obtained from fish scales and consists principally of the two 
purines, guanine and hypoxanthine. The guanine content will vary from 75 
to 97 percent, and the hypoxanthine will vary from 3 to 25 percent, 
depending on the particular fish and tissue from which the crystals are 
derived.
    (2) Color additive mixtures for drug use made with guanine may 
contain only those diluents listed in this subpart as safe and suitable 
for use in color additive mixtures for coloring externally applied 
drugs.

[[Page 457]]

    (b) Specifications. The color additive guanine shall conform to the 
following specifications and shall be free from impurities other than 
those named to the extent that such other impurities may be avoided by 
good manufacturing practice:

Guanine, not less than 75 percent.
Hypoxanthine, not more than 25 percent.
Ash (ignition at 800 [deg]C), not more than 2 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Assay, not less than 96 percent total purines.
Mercury (as Hg), not more than 1 part per million.

    (c) Uses and restrictions. Guanine is safe for use in coloring 
externally applied drugs, including those intended for use in the area 
of the eye, in amounts consistent with good manufacturing practice.
    (d) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring purposes shall bear, in addition 
to any information required by law, labeling in accordance with Sec.  
70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches therof are exempt from certification pursuant to 
section 721(c) of the act.

[42 FR 37537, July 22, 1977]



Sec.  73.1350  Mica-based pearlescent pigments.

    (a) Identity. (1) The color additive is formed by depositing 
titanium and/or iron salts onto mica, followed by heating to produce one 
of the following combinations: Titanium dioxide on mica; iron oxide on 
mica; titanium dioxide and iron oxide on mica. Mica used to manufacture 
the color additive shall conform in identity to the requirements of 
Sec.  73.1496(a)(1).
    (2) Color additive mixtures for drug use made with mica-based 
pearlescent pigments may contain only those diluents listed in this 
subpart as safe and suitable for use in color additive mixtures for 
coloring ingested drugs.
    (b) Specifications. Mica-based pearlescent pigments shall conform to 
the following specifications and shall be free from impurities other 
than those named to the extent that such other impurities may be avoided 
by good manufacturing practice:
    (1) Lead (as Pb), not more than 4 parts per million (ppm).
    (2) Arsenic (as As), not more than 3 ppm.
    (3) Mercury (as Hg), not more than 1 ppm.
    (c) Uses and restrictions. Mica-based pearlescent pigments may be 
safely used to color ingested drugs in amounts up to 3 percent, by 
weight, of the final drug product. The maximum amount of iron oxide to 
be used in producing said pigments is not to exceed 55 percent, by 
weight, in the finished pigment.
    (d) Labeling. The label of the color additive and of any mixture 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the Federal Food, Drug, and Cosmetic Act.

[70 FR 42273, July 22, 2005. Redesignated at 72 FR 10357, Mar. 8, 2007]



Sec.  73.1375  Pyrogallol.

    (a) Identity. The color additive pyrogallol is 1,2,3-
trihydroxybenzene.
    (b) Specifications. Pyrogallol shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice:

Melting point, between 130[deg] and 133 [deg]C.
Residue on ignition, not more than 0.1 percent.
Lead (as Pb), not more than 20 p/m (parts per million).
Arsenic (as As), not more than 3 p/m.

    (c) Uses and restrictions. Pyrogallol may be safely used in 
combination with ferric ammonium citrate (as listed in Sec.  73.1025), 
for coloring plain and chromic catgut sutures for use in general and 
ophthalmic surgery, subject to the following restrictions:

[[Page 458]]

    (1) The dyed suture shall conform in all respects to the 
requirements of the United States Pharmacopeia XX (1980).
    (2) The level of the ferric ammonium citrate-pyrogallol complex 
shall not exceed 3 percent of the total weight of the suture material.
    (3) When the sutures are used for the purposes specified in their 
labeling, there is no migration of the color additive to the surrounding 
tissues.
    (4) If the suture is a new drug, an approved new drug application, 
pursuant to section 505 of the act, is in effect for it.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984]



Sec.  73.1400  Pyrophyllite.

    (a) Identity. (1) The color additive pyrophyllite is a naturally 
occurring mineral substance consisting predominantly of a hydrous 
aluminum silicate, 
Al2O3[middot]4SiO2[middot]H2 
O, intimately mixed with lesser amounts of finely divided silica, 
SiO2. Small amounts, usually less than 3 percent, of other 
silicates, such as potassium aluminum silicate, may be present. 
Pyrophyllite may be identified and semiquantitatively determined by its 
characteristic X-ray powder diffraction pattern and by its optical 
properties.
    (2) Color additive mixtures made with pyrophyllite are limited to 
those listed in this subpart as safe and suitable in color additive 
mixtures for coloring externally applied drugs.
    (b) Specifications. Pyrophyllite shall conform to the following 
specifications:

Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.


Lead and arsenic shall be determined in the solution obtained by boiling 
10 grams of the pyrophyllite for 15 minutes in 50 milliliters of 0.5N 
hydrochloric acid.
    (c) Uses and restrictions. Pyrophyllite may be safely used in 
amounts consistent with good manufacturing practice to color drugs that 
are to be externally applied.
    (d) Labeling requirements. The labeling of the color additive and 
any mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.1410  Logwood extract.

    (a) Identity. The color additive logwood extract is a reddish brown-
to-black solid material extracted from the heartwood of the leguminous 
tree Haematoxylon campechianum. The active colorant substance is 
principally hematein. The latent coloring material is the unoxidized or 
leuco form of hematein called hematoxylin. The leuco form is oxidized by 
air.
    (b) Specifications. Logwood extract shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such imnurities may be avoided by good manufacturing 
practice:

Volatile matter (at 110 [deg]C), not more than 15 percent.
Sulfated ash, not more than 20 percent.
Hematein, not less than 5 percent and not more than 20 percent.
Lead (as Pb), not more than 70 parts per million.
Arsenic (as As), not more than 4 parts per million.
Mercury (as Hg), not more than 3 parts per million.

    (c) Use and restrictions. Logwood extract may be safely used to 
color nylon 66 (the copolymer of hexamethylenediamine and adipic acid), 
nylon 6 (the polymer of e-caprolactam), or silk non-absorable sutures 
for use in general and ophthalmic surgery subject to the following 
restrictions:

[[Page 459]]

    (1) The quantity of color additive does not exceed 1.0 percent by 
weight of the suture.
    (2) When the sutures are used for the purposes specified in their 
labeling, there is no migration of the color additive to the surrounding 
tissue.
    (3) If the suture is a new drug, an approved new drug application, 
pursuant to section 505 of the act, is in effect for it.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 52393, Sept. 30, 1977; 43 FR 1490, Jan. 10, 1978]



Sec.  73.1496  Mica.

    (a) Identity. (1) The color additive mica is a white powder obtained 
from the naturally occurring mineral, muscovite mica, consisting 
predominantly of a potassium aluminum silicate, 
K2Al4(Al2Si6O20)(O
H)4 or, alternatively, H2KAl3 
(SiO4)3. Mica may be identified and 
semiquantitatively determined by its characteristic X-ray diffraction 
pattern and by its optical properties.
    (2) Color additive mixtures for drug use made with mica may contain 
only those diluents listed in this subpart as safe and suitable for use 
in color additive mixtures for coloring drugs.
    (b) Specifications. Mica shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such other impurities may be avoided by good 
manufacturing practice:

Fineness, 100 percent shall pass through a 100-mesh sieve.
Loss on ignition at 600-650 [deg]C, not more than 2 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.

    (c) Uses and restrictions. Mica may be safely used in amounts 
consistent with good manufacturing practice to color dentifrices and 
externally applied drugs, including those for use in the area of the 
eye.
    (d) Labeling requirements. The label of the color additive and of 
any mixture prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches therof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 38561, July 29, 1977, as amended at 52 FR 29665, Aug. 11, 1987]



Sec.  73.1530  Spirulina extract.

    (a) Identity. (1) The color additive spirulina extract is prepared 
by the filtered aqueous extraction of the dried biomass of Arthrospira 
platensis. The color additive contains phycocyanins as the principal 
coloring components.
    (2) Color additive mixtures for drug use made with spirulina extract 
may contain only those diluents that are suitable and are listed in this 
subpart as safe for use in color additive mixtures for coloring ingested 
drugs.
    (b) Specifications. Spirulina extract must conform to the following 
specifications and must be free from impurities, other than those named, 
to the extent that such other impurities may be avoided by good 
manufacturing practice:
    (1) Lead, not more than 2 milligrams per kilogram (mg/kg) (2 parts 
per million (ppm));
    (2) Arsenic, not more than 2 mg/kg (2 ppm);
    (3) Mercury, not more than 1 mg/kg (1 ppm); and
    (4) Negative for microcystin toxin.
    (c) Uses and restrictions. Spirulina extract may be safely used for 
coloring coating formulations applied to drug tablets and capsules, at 
levels consistent with good manufacturing practice.
    (d) Labeling requirements. The label of the color additive and any 
mixture prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Exemption from certification. Certification of this color 
additive is not

[[Page 460]]

necessary for the protection of the public health, and therefore batches 
thereof are exempt from the certification requirements of section 721(c) 
of the Federal Food, Drug, and Cosmetic Act.

[80 FR 50765, Aug. 21, 2015]



Sec.  73.1550  Talc.

    (a) Identity. (1) The color additive talc is a finely powdered, 
native, hydrous magnesium silicate sometimes containing a small 
proportion of aluminum silicate.
    (2) Color additive mixtures for drug use made with talc may contain 
only those diluents listed in this subpart as safe and suitable for use 
in color additive mixtures for coloring drugs.
    (b) Specifications. Talc shall meet the specifications for talc in 
the United States Pharmacopeia XX (1980) and the following:

Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.


Lead and arsenic shall be determined in the solution obtained by boiling 
10 grams of the talc for 15 minutes in 50 milliliters of 0.5N 
hydrochloric acid.
    (c) Uses and restrictions. Talc may be safely used in amounts 
consistent with good manufacturing practice to color drugs generally.
    (d) Labeling requirements. The label of the color additive and of 
any mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984]



Sec.  73.1575  Titanium dioxide.

    (a) Identity and specifications. (1) The color additive titanium 
dioxide shall conform in identity and specifications to the requirements 
of Sec.  73.575(a)(1) and (b).
    (2) Color additive mixtures for drug use made with titanium dioxide 
may contain only those diluents that are suitable and that are listed in 
this subpart as safe in color additive mixtures for coloring drugs, and 
the following: Silicon dioxide, SiO2, and/or aluminum oxide, 
Al2O3, as dispersing aids--not more than 2 percent 
total.
    (b) Uses and restrictions. The color additive titanium dioxide may 
be used for coloring ingested and externally applied drugs generally, in 
amounts consistent with good manufacturing practice. External 
application includes use in the area of the eye.
    (c) Labeling. The label of the color additive and any mixtures 
prepared therefrom and intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of the chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.1645  Aluminum powder.

    (a) Identity. (1) The color additive aluminum powder shall be 
composed of finely divided particles of aluminum prepared from virgin 
aluminum. It is free from admixture with other substances.
    (2) Color additive mixtures for external drug use made with aluminum 
powder may contain only those diluents listed in this subpart as safe 
and suitable in color additive mixtures for coloring externally applied 
drugs.
    (b) Specifications. Aluminum powder shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice:

Fineness, 100 percent shall pass through a 200-mesh screen and 95 
percent shall pass through a 325-mesh screen.
Mercury, not more than 1 part per million.
Arsenic, not more than 3 parts per million.
Lead, not more than 20 parts per million.
Aluminum, not less than 99 percent.

    (c) Uses and restrictions. Aluminum powder is safe for use in 
externally applied drugs, including those intended for use in the area 
of the eye, in amounts consistent with good manufacturing practice.

[[Page 461]]

    (d) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring purposes shall bear, in addition 
to any information required by law, labeling in accordance with Sec.  
70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches therof are exempt from certification pursuant to 
section 721(c) of the act.

[42 FR 38563, July 29, 1977]



Sec.  73.1646  Bronze powder.

    (a) Identity. (1) The color additive bronze powder is a very fine 
metallic powder prepared from alloys consisting principally of virgin 
electrolytic copper and zinc with small amounts of the virgin metals 
aluminum and tin. It contains small amounts of stearic or oleic acid as 
lubricants.
    (2) Color additive mixtures for drug use made with bronze powder may 
contain only those diluents listed in this subpart as safe and suitable 
for use in color additive mixtures for coloring externally applied 
drugs.
    (b) Specifications. Bronze powder shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice:

Stearic or oleic acid, not more than 5 percent.
Cadmium (as Cd), not more than 15 parts per million.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million
Aluminum (as Al), not more than 0.5 percent.
Tin (as Sn), not more than 0.5 percent.
Copper (as Cu), not more than 95 percent and not less than 70 percent.
Zinc (as Zn), not more than 30 percent.
Maximum particle size 45[micro] (95 percent minimum).


Aluminum, zinc, tin, and copper content shall be based on the weight of 
the dried powder after being thoroughly washed with ether.
    (c) Uses and restrictions. Bronze powder may be safely used in color 
externally applied drugs, including those intended for use in the area 
of the eye, in amounts consistent with good manufacturing practice.
    (d) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring purposes shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of the color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 33723, July 1, 1977]



Sec.  73.1647  Copper powder.

    (a) Identity. (1) The color additive copper powder is a very fine 
free-flowing metallic powder prepared from virgin electrolytic copper. 
It contains small amounts of stearic or oleic acid as lubricants.
    (2) Color additive mixtures for drug use made with copper powder may 
contain only those diluents listed in this subpart as safe and suitable 
for use in color additive mixtures for coloring externally applied 
drugs.
    (b) Specifications. Copper powder shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice:

Stearic or oleic acid, not more than 5 percent.
Cadmium (as Cd), not more than 15 parts per million.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Copper (as Cu), not less than 95 percent.
Maximum particle size 45[micro] (95 percent minimum).

    (c) Uses and restrictions. Copper powder may be safely used in 
coloring externally applied drugs, including those intended for use in 
the area of the eye, in amounts consistent with good manufacturing 
practice.
    (d) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring

[[Page 462]]

purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Exemption from certification. Certification of the color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 33723, July 1, 1977]



Sec.  73.1991  Zinc oxide.

    (a) Identity. (1) The color additive zinc oxide is a white or 
yellow-white amorphous powder manufactured by the French process 
(described as the indirect process whereby zinc metal isolated from the 
zinc-containing ore is vaporized and then oxidized). It is principally 
composed of Zn.
    (2) Color additive mixtures for drug use made with zinc oxide may 
contain only those diluents listed in this subpart as safe and suitable 
in color additive mixtures for coloring externally applied drugs.
    (b) Specifications. Zinc oxide shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice:

Zinc oxide (as ZnO), not less than 99 percent.
Loss on ignition at 800 [deg]C, not more than 1 percent.
Cadmium (as Cd), not more than 15 parts per million.
Mercury (as Hg), not more than 1 part per million.
Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 20 parts per million.

    (c) Uses and restrictions. The color additive zinc oxide may be 
safely used for coloring externally applied drugs, including those used 
in the area of the eye, in amounts consistent with good manufacturing 
practice.
    (d) Labeling. The color additive and any mixtues prepared therefrom 
intended solely or in part for coloring purposes shall bear, in addition 
to any information required by law, labeling in accordance with the 
provisions of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches therof are exempt from the certifiation pursuant to 
section 721(c) of the act.

[42 FR 37537, July 22, 1977]



                           Subpart C_Cosmetics



Sec.  73.2030  Annatto.

    (a) Identity and specification. The color additive annatto shall 
conform in identify and specification to the requirements for annatto 
extract in Sec.  73.30(a) (1) and (b).
    (b) Use and restriction. The color additive annatto may be safely 
used in coloring cosmetics generally, including cosmetics intended for 
use in the area of the eye, in amounts consistent with good 
manufacturing practice.
    (c) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring purposes shall bear, in addition 
to any information required by law, labeling in accordance with the 
provisions of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 36994, July 19, 1977]



Sec.  73.2085  Caramel.

    (a) Identity and specifications. The color additive caramel shall 
conform in identity and specifications to the requirements of Sec.  
73.85(a)(1), (2), and (3) and (b).
    (b) Uses and restrictions. Caramel is safe for use in coloring 
cosmetics generally, including cosmetics applied to the area of the eye, 
in amounts consistent with good manufacturing practice.
    (c) Labeling requirements. The label of the color additive and any 
mixtures intended solely or in part for coloring purposes prepared 
therefrom shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (d) Exemption from certification. Certification of this color 
additive is not

[[Page 463]]

necessary for the protection of the public health, and therefore batches 
thereof are exempt from the certification requirement of section 721(c) 
of the act.

[46 FR 38501, July 28, 1981]



Sec.  73.2087  Carmine.

    (a) Identity and specifications. The color additive carmine shall 
conform in identity and specifications to the requirements of Sec.  
73.100 (a)(2) and (b)(2).
    (b) Use and restrictions. Carmine may be safely used in cosmetics 
generally, including cosmetics intended for use in the area of the eye, 
in amounts consistent with good manufacturing practices.
    (c) Labeling. (1) The color additive and any mixture prepared 
therefrom intended solely or in part for coloring purposes shall bear, 
in addition to any information required by law, labeling in accordance 
with the provisions of Sec.  70.25 of this chapter.
    (2) Cosmetics containing carmine that are not subject to the 
requirements of Sec.  701.3 of this chapter shall specifically declare 
the presence of carmine prominently and conspicuously at least once in 
the labeling. For example: ``Contains carmine as a color additive.''
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification pursuant to 
section 721(c) of the act.

[42 FR 32228, June 24, 1977, as amended at 74 FR 216, Jan. 5, 2009]



Sec.  73.2095  [beta]-Carotene.

    (a) Identity and specifications. The color additive [beta]-carotene 
shall conform in identity and specifications to the requirements of 
Sec.  73.95(a)(1) and (b).
    (b) Uses and restrictions. The color additive [beta]-carotene may be 
safely used in coloring cosmetics generally, including cosmetics 
intended for use in the area of the eye, in amounts consistent with good 
manufacturing practices.
    (c) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring purposes shall bear, in addition 
to any information required by law, labeling in accordance with the 
provisions of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches therof are exempt from the certification pursuant to 
section 721(c) of the act.

[42 FR 33722, July 1, 1977]



Sec.  73.2110  Bismuth citrate.

    (a) Identity. The color additive bismuth citrate is the 
synthetically prepared crystalline salt of bismuth and citric acid, 
consisting principally of BiC6H5O7.
    (b) Specifications. The color additive bismuth citrate shall conform 
to the following specifications and shall be free from impurities other 
than those named to the extent that those impurities may be avoided by 
good manufacturing practice:

Bismuth citrate, not less than 97 percent.
Mercury (as Hg), not more than 1 part per million.
Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 20 parts per million.
Volatile matter, not more than 1 percent.

    (c) Uses and restrictions. The color additive bismuth citrate may be 
safely used in cosmetics intended for coloring hair on the scalp, 
subject to the following restrictions:
    (1) The amount of bismuth citrate in the cosmetic shall not be in 
excess of 2.0 percent (w/v).
    (2) The cosmetic may not be used for coloring eyelashes, eyebrows, 
or hair on parts of the body other than the scalp.
    (d) Labeling. (1) The label of the color additive bismuth citrate 
shall bear, in addition to any information required by law, labeling in 
accordance with the provisions of Sec.  70.25 of this chapter.
    (2) The label of a cosmetic containing the color additive bismuth 
citrate shall bear, in addition to other information required by law, 
the following statement, conspicuously displayed thereon:

    Keep this product out of children's reach. Do not use on cut or 
abraded scalp. Do not use to color eyelashes, eyebrows, or hair on parts 
of the body other than the scalp. Wash hands thoroughly after each use.


[[Page 464]]


    (e) Exemption from certification. Certification of this color 
additive for the prescribed use is not necessary for the protection of 
the public health, and, therefore, batches thereof are exempt from 
certification requirements of section 721(c) of the act.

[43 FR 44831, Sept. 29, 1978, as amended at 75 FR 14493, Mar. 26, 2010]



Sec.  73.2120  Disodium EDTA-copper.

    (a) Identity. The color additive disodium EDTA-copper is disodium 
[[N,N'- 1,2- ethanediylbis[N - (carboxymethyl) glycinato]] (4-)-
N,N',O,O',O\N\,O\N\'] cuprate (2-).
    (b) Specifications. Disodium EDTA-copper shall conform to the 
following specifications and shall be free from impurities other than 
those named to the extent that such impurities may be avoided by good 
manufacturing practice:

Total copper, not less than 13.5 percent.
Total (ethylene-dinitrilo) tetracetic acid, not less than 62.5 percent.
Free copper, not more than 100 parts per million.
Free disodium salt of (ethylene-dinitrilo) tetraacetic acid, not more 
than 1.0 percent.
Moisture, not more than 15 percent.
Water insoluble matter, not more than 0.2 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.

    (c) Uses and restrictions. Disodium EDTA-copper may be safely used 
in amounts consistent with good manufacturing practices in the coloring 
of shampoos which are cosmetics.
    (d) Labeling requirements. The labeling of the color additive shall 
conform to the requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the requirements of section 
721(c) of the act.



Sec.  73.2125  Potassium sodium copper chlorophyllin 
(chlorophyllin-copper complex).

    (a) Identity and specifications. The color additive potassium sodium 
copper chlorophyllin shall conform in identity and specifications to the 
requirements of Sec.  73.1125(a)(1) and (b).
    (b) Uses and restrictions. Potassium sodium copper chlorophyllin may 
be safely used for coloring dentifrices that are cosmetics subject to 
the following conditions:
    (1) It shall not be used at a level in excess of 0.1 percent.
    (2) It may be used only in combination with the following 
substances:

Water.
Glycerin.
Sodium carboxymethylcellulose.
Tetrasodium pyrophosphate.
Sorbitol.
Magnesium phosphate, tribasic.
Calcium carbonate.
Calcium phosphate, dibasic.
Sodium N-lauroyl sarcosinate.
Artificial sweeteners that are generally recognized as safe or that are 
authorized under subchapter B of this chapter.
Flavors that are generally recognized as safe or that are authorized 
under subchapter B of this chapter.
Preservatives that are generally recognized as safe or that are 
authorized under subchapter B of this chapter.

    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.2150  Dihydroxyacetone.

    (a) Identity and specifications. The color additive dihydroxyacetone 
shall conform in identity and specifications to the requirements of 
Sec.  73.1150 (a)(1) and (b).
    (b) Uses and restrictions. Dihydroxyacetone may be safely used in 
amounts consistent with good manufacturing practice in externally 
applied cosmetics intended solely or in part to impart a color to the 
human body.
    (c) Labeling requirements. The labeling of the color additive and 
any mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (d) Exemption from certification. Certification of this color 
additive is not

[[Page 465]]

necessary for the protection of the public health and therefore batches 
thereof are exempt from the requirements of section 721(c) of the act.



Sec.  73.2162  Bismuth oxychloride.

    (a) Identity and specifications. (1) The color additive bismuth 
oxychloride shall conform in identity and specifications to the 
requirements of Sec.  73.1162(a)(1) and (b).
    (2) Color additive mixtures of bismuth oxychloride may contain the 
following diluents:
    (i) For coloring cosmetics generally, only those diluents listed 
under Sec.  73.1001(a)(1);
    (ii) For coloring externally applied cosmetics, only those diluents 
listed in Sec.  73.1001(b) and, in addition, nitrocellulose.
    (b) Uses and restrictions. The color additive bismuth oxychloride 
may be safely used in coloring cosmetics generally, including cosmetics 
intended for use in the area of the eye, in amounts consistent with good 
manufacturing practice.
    (c) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring purposes shall bear, in addition 
to any information required by law, labeling in accordance with the 
provisions of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from certification pursuant to 
section 721(c) of the act.

[42 FR 52394, Sept. 30, 1977]



Sec.  73.2180  Guaiazulene.

    (a) Identity. (1) The color additive, guaiazulene, is principally 
1,4-dimethyl-7-isopropyl-azulene.
    (2) Color additive mixtures of guaiazulene for cosmetic use may 
contain the following diluent:

Polyethylene glycol-40 castor oil (PEG-40 castor oil).
Saponification No., 60 to 70.
Hydroxyl No., 63 to 78.
Acid No., 2.
Specific gravity, 1.05 to 1.07.

    (b) Specifications. Guaiazulene shall conform to the following 
specifications and shall be free from impurities, other than those 
named, to the extent that such other impurities may be avoided by good 
manufacturing practice.

Melting point, 30.5 [deg]C to 31.5 [deg]C.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 99 percent.

    (c) Uses and restrictions. Guaiazulene may be safely used in 
externally applied cosmetics in amounts consistent with good 
manufacturing practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive for the prescribed use is not necessary for the protection of 
the public health and therefore batches thereof are exempt from the 
certification requirements of section 721(c) of the act.



Sec.  73.2190  Henna.

    (a) Identity. The color additive henna is the dried leaf and petiole 
of Lawsonia alba Lam. (Lawsonia inermis L.). It may be identified by its 
characteristic odor and by characteristic plant histology.
    (b) Specifications. Henna shall conform to the following 
specifications:

It shall not contain more than 10 percent of plant material from 
Lawsonia alba Lam. (Lawsonia inermis L.) other than the leaf and 
petiole, and shall be free from admixture with material from any other 
species of plant.
Moisture, not more than 10 percent.
Total ash, not more than 15 percent.
Acid-insoluble ash, not more than 5 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.

    (c) Uses and restrictions. The color additive henna may be safely 
used for coloring hair only. It may not be used for coloring the 
eyelashes or eyebrows, or generally in the area of the eye.
    (d) Labeling. The label for henna shall bear the information 
required by Sec.  70.25 of this chapter and the following statements or 
their equivalent:


[[Page 466]]


``Do not use in the area of the eye.''
``Do not use on cut or abraded scalp.''

    (e) Exemption from certification. Certification of this color 
additive for the prescribed use is not necessary for the protection of 
the public health and therefore batches thereof are exempt from the 
certification requirements of section 721(c) of the act.



Sec.  73.2250  Iron oxides.

    (a) Identity. The color additives iron oxides consist of any one or 
any combination of synthetically prepared iron oxides, including the 
hydrated forms. It is free from admixture with other substances.
    (b) Specifications. Iron oxides shall conform to the following 
specifications, all on an ``as is'' basis:

Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 10 parts per million.
Mercury (as Hg), not more than 3 parts per million.

    (c) Uses and restrictions. Iron oxides are safe for use in coloring 
cosmetics generally, including cosmetics applied to the area of the eye, 
in amounts consistent with good manufacturing practice.
    (d) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring purposes shall bear, in addition 
to any information required by law, labeling in accordance with Sec.  
70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from certification pursuant to 
section 721(c) of the act.



Sec.  73.2298  Ferric ammonium ferrocyanide.

    (a) Identity and specifications. The color additive ferric ammonium 
ferrocyanide shall conform in identify and specifications to the 
requirements of Sec.  73.1298 (a)(1) and (b).
    (b) Uses and restrictions. Ferric ammonium ferrocyanide is safe for 
use in coloring externally applied cosmetics, including cosmetics 
applied to the area of the eye, in amounts consistent with good 
manufacturing practice.
    (c) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring purposes shall bear, in addition 
to any information required by law, labeling in accordance with Sec.  
70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification pursuant to 
section 721(c) of the act.

[42 FR 38562, July 29, 1977, as amended at 43 FR 6939, Feb. 17, 1978]



Sec.  73.2299  Ferric ferrocyanide.

    (a) Identity and specifications. The color additive ferric 
ferrocyanide shall conform in identity and specifications to the 
requirements of Sec.  73.1299(a)(1) and (b).
    (b) Uses and restrictions. Ferric ferrocyanide is safe for use in 
coloring externally applied cosmetics, including cosmetics applied to 
the area of the eye, in amounts consistent with good manufacturing 
practice.
    (c) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring purposes shall bear, in addition 
to any information required by law, labeling in accordance with Sec.  
70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from certification under section 
721(c) of the act.

[43 FR 54236, Nov. 21, 1978]



Sec.  73.2326  Chromium hydroxide green.

    (a) Identity and specifications. The color additive chromium 
hydroxide green shall conform in identity and specifications to the 
requirements of Sec.  73.1326 (a)(1) and (b).
    (b) Uses and restrictions. Chromium hydroxide green is safe for use 
in coloring externally applied cosmetics, including those intended for 
use in the area of the eye, in amounts consistent with good 
manufacturing practice.
    (c) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring

[[Page 467]]

purposes shall bear, in addition to any information required by law, 
labeling in accordance with Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from certification pursuant to 
section 721(c) of the act.

[42 FR 36452, July 15, 1977]



Sec.  73.2327  Chromium oxide greens.

    (a) Identity and specifications. The color additive chromium oxide 
greens shall conform in identify and specifications to the requirements 
of Sec.  73.1327 (a)(1) and (b).
    (b) Uses and restrictions. The color additive chromium oxide greens 
may be safely used in externally applied cosmetics, including cosmetics 
intended for use in the area of the eye, in amounts consistent with good 
manufacturing practice.
    (c) Labeling requirements. The color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall bear, in addition to any information required by law, labeling in 
accordance with the provisions of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification pursuant to 
section 721(c) of the act.

[42 FR 36452, July 15, 1977]



Sec.  73.2329  Guanine.

    (a) Identity and specifications. (1) The color additive guanine 
shall conform in identity and specifications to the requirements of 
Sec.  73.1329 (a)(1) and (b).
    (2) Color additive mixtures of guanine may contain the following 
diluents:
    (i) For coloring cosmetics generally, only those diluents listed 
under Sec.  73.1001(a)(1);
    (ii) For coloring externally applied cosmetics, only those diluents 
listed in Sec.  73.1001(b) and, in addition, nitrocellulose.
    (b) Use and restrictions. The color additive guanine may be safely 
used in cosmetics generally, including cosmetics intended for use in the 
area of the eye, in amounts consistent with good manufacturing practice.
    (c) Labeling requirements. The color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall bear, in addition to any information required by law, labeling in 
accordance with the provisions of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification pursuant to 
section 721(c) of the act.

[42 FR 37537, July 22, 1977]



Sec.  73.2396  Lead acetate.

    (a) Identity. The color additive lead acetate is the trihydrate of 
lead (2 + ) salt of acetic acid. The color additive has the chemical 
formula Pb (OOCCH3)2[middot]3H2O).
    (b) Specifications. Lead acetate shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice:

Water-insoluble matter, not more than 0.02 percent.
pH (30 percent solution weight to volume at 25 [deg]C), not less than 
4.7 and not more than 5.8.
Arsenic (as As), not more than 3 parts per million.
Lead acetate, not less than 99 percent.
Mercury (as Hg), not more than 1 part per million.

    (c) Uses and restrictions. The color additive lead acetate may be 
safely used in cosmetics intended for coloring hair on the scalp only, 
subject to the following restrictions:
    (1) The amount of the lead acetate in the cosmetic shall be such 
that the lead content, calculated as Pb, shall not be in excess of 0.6 
percent (weight to volume).
    (2) The cosmetic is not to be used for coloring mustaches, 
eyelashes, eyebrows, or hair on parts of the body other than the scalp.
    (d) Labeling requirements. (1) The label of the color additive lead 
acetate shall conform to the requirements of Sec.  70.25 of this 
chapter, and bear the following statement or equivalent:


[[Page 468]]


Wash thoroughly if the product comes into contact with the skin.

    (2) The label of the cosmetic containing the color additive lead 
acetate, in addition to other information required by the act, shall 
bear the following cautionary statement, conspicuously displayed 
thereon:

CAUTION: Contains lead acetate. For external use only. Keep this product 
out of children's reach. Do not use on cut or abraded scalp. If skin 
irritation develops, discontinue use. Do not use to color mustaches, 
eyelashes, eyebrows, or hair on parts of the body other than the scalp. 
Do not get in eyes. Follow instructions carefully and wash hands 
thoroughly after each use.

    (e) Exemption for certification. Certification of this color 
additive for the prescribed use is not necessary for the protection of 
the public health and therefore batches thereof are exempt from the 
certification requirements of section 721(c) of the act.

[45 FR 72117, Oct. 31, 1980, as amended at 72 FR 10357, Mar. 8, 2007]



Sec.  73.2400  Pyrophyllite.

    (a) Identity and specifications. The color additive pyrophyllite 
shall conform in identity and specifications to the requirements of 
Sec.  73.1400 (a)(1) and (b).
    (b) Uses and restrictions. Pyrophyllite may be safely used for 
coloring externally applied cosmetics, in amounts consistent with good 
manufacturing practice.
    (c) Labeling requirements. The labeling of the color additive and 
any mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to all applicable requirements of law, including 
the requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.



Sec.  73.2496  Mica.

    (a) Identity and specifications. The color additive mica shall 
conform in identity and specifications to the requirements of Sec.  
73.1496(a)(1) and (b).
    (b) Uses and restrictions. Mica is safe for use in coloring 
cosmetics generally, including cosmetics applied to the area of the eye, 
in amounts consistent with good manufacturing practice.
    (c) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring purposes shall bear, in addition 
to any information required by law, labeling in accordance with of Sec.  
70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification pursuant to 
section 721(c) of the act.

[42 FR 38561, July 29, 1977]



Sec.  73.2500  Silver.

    (a) Identity. (1) The color additive, silver, is a crystalline 
powder of high purity silver prepared by the reaction of silver nitrate 
with ferrous sulfate in the presence of nitric, phosphoric and sulfuric 
acids. Polyvinyl alcohol is used to prevent the agglomeration of 
crystals and the formation of amorphous silver.
    (2) Color additive mixtures of silver may contain only those 
diluents listed in Sec.  73.1001(b) and, in addition, nitrocellulose.
    (b) Specifications. Silver shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such other impurities may be avoided by good 
manufacturing practice:

Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 5 parts per million.
Mercury (as Hg), not more than 1 part per million.
Silver (as Ag), not less than 99.9 percent.

    (c) Uses and restrictions. The color additive silver may be safely 
used for coloring fingernail polish at a level not to exceed 1 percent 
of the final product.
    (d) Labeling. The color additive and any mixtures prepared therefrom 
intended solely or in part for coloring purposes shall bear, in addition 
to any other information required by law, labeling in accordance with 
the provisions of Sec.  70.25 of this chapter.

[[Page 469]]

    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[44 FR 65974, Nov. 16, 1979]



Sec.  73.2575  Titanium dioxide.

    (a) Identity and specifications. The color additive titanium dioxide 
shall conform in identity and specifications to the requirements on 
Sec.  73.575 (a)(1) and (b).
    (b) Uses and restrictions. The color additive titanium dioxide may 
be safely used in cosmetics, including cosmetics intended for use in the 
area of the eye, in amounts consistent with good manufacturing practice.
    (c) Labeling requirements. The color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall bear, in addition to any other information required by law, 
labeling in accordance with the provisions of Sec.  70.25 of this 
chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from certification pursuant to 
section 721(c) of the act.



Sec.  73.2645  Aluminum powder.

    (a) Identity and specifications. The color additive aluminum powder 
shall conform in identity and specifications to the requirements of 
Sec.  73.1645 (a)(1) and (b).
    (b) Uses and restrictions. Aluminum powder may be safely used in 
coloring externally applied cosmetics, including cosmetics intended for 
use in the area of the eye, in amounts consistent with good 
manufacturing practice.
    (c) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring purposes shall bear, in addition 
to any information required by law, labeling in accordance with the 
provisions of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification pursuant to 
section 721(c) of the act.

[42 FR 38563, July 29, 1977]



Sec.  73.2646  Bronze powder.

    (a) Identity and specifications. The color additive bronze powder 
shall conform in identity and specifications to the requirements of 
Sec.  73.1646 (a)(1) and (b).
    (b) Uses and restrictions. Bronze powder may be safely used in 
coloring cosmetics generally, including cosmetics intended for use in 
the area of the eye, in amounts consistent with good manufacturing 
practice.
    (c) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring purposes shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of the color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 33724, July 1, 1977]



Sec.  73.2647  Copper powder.

    (a) Identity and specifications. The color additive copper powder 
shall conform in identity and specifications to the requirements of 
Sec.  73.1647 (a)(1) and (b).
    (b) Uses and restrictions. Copper powder may be safely used in 
coloring cosmetics generally, including cosmetics intended for use in 
the area of the eye, in amounts consistent with good manufacturing 
practice.
    (c) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring purposes shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of the color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[42 FR 33724, July 1, 1977]



Sec.  73.2725  Ultramarines.

    (a) Identity. The color additives, ultramarines (blue, green, pink, 
red, and violet) are pigments obtained by

[[Page 470]]

calcining at temperatures above 700 [deg]C. a mixture of kaolin, sulfur, 
sodium carbonate, silicious matter, sodium sulfate, and carbonaceous 
matter, but not necessarily all these substances, to produce a single 
color. The ultramarines are complex sodium aluminum sulfosilicates 
having a typical formula Na(AlSiO)S with proportions of each element 
varying with each color.
    (b) Specifications. The ultramarines shall conform to the following 
specifications and shall be free from impurities other than those named, 
to the extent that such other impurities may be avoided by good 
manufacturing practice.

Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.

    (c) Uses and restrictions. The ultramarine pigments may be safely 
used for coloring externally applied cosmetics, including cosmetics 
intended for use in the area of the eye, in amounts consistent with good 
manufacturing practice.
    (d) Labeling requirements. The color additives and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall bear, in addition to any other information required by law, 
labeling in accordance with Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from certification pursuant to 
section 721(c) of the act.



Sec.  73.2775  Manganese violet.

    (a) Identity. The color additive manganese violet is a violet 
pigment obtained by reacting phosphoric acid, ammonium dihydrogen 
orthophosphate, and manganese dioxide at temperatures above 450 [deg]F. 
The pigment is a manganese ammonium pyrophosphate complex having the 
approximate formula: Mn(III)NH4P2O7.
    (b) Specifications. Manganese violet shall conform to the following 
specifications and shall be free from impurities other than those named, 
to the extent that such other impurities may be avoided by good 
manufacturing practice:

Ash (at 600 [deg]C), not less than 81 percent.
Volatile matter at 135 [deg]C for 3 hours, not more than 1 percent.
Water soluble substances, not more than 6 percent.
pH of filtrate of 10 grams color additive (shaken occasionally for 2 
hours with 100 milliliters of freshly boiled distilled water), not more 
than 4.7 and not less than 2.5.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, based on Mn content in ``as is'' sample, not less than 93 
percent.

    (c) Uses and restrictions. Manganese violet is safe for use in 
coloring cosmetics generally, including cosmetics applied to the area of 
the eye, in amounts consistent with good manufacturing practice.
    (d) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring purposes shall bear, in addition 
to any information required by law, labeling in accordance with Sec.  
70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from certification pursuant to 
section 721(c) of the act.



Sec.  73.2991  Zinc oxide.

    (a) Identity and specifications. The color additive zinc oxide shall 
conform in identity and specifications to the requirements of Sec.  
73.1991 (a)(1) and (b).
    (b) Uses and restrictions. Zinc oxide may be safely used in 
cosmetics, including cosmetics intended for use in the area of the eye, 
in amounts consistent with good manufacturing practice.
    (c) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring purposes shall bear, in addition 
to any information required by law, labeling in accordance with Sec.  
70.25 of this chapter.

[[Page 471]]

    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification pursuant to 
section 721(c) of the act.

[42 FR 37538, July 22, 1977]



Sec.  73.2995  Luminescent zinc sulfide.

    (a) Identity. The color additive luminescent zinc sulfide is zinc 
sulfide containing a copper activator. Following excitation by daylight 
or a suitable artificial light, luminescent zinc sulfide produces a 
yellow-green phosphorescence with a maximum at 530 nanometers.
    (b) Specifications. Luminescent zinc sulfide shall conform to the 
following specifications and shall be free from impurities other than 
those named to the extent that such impurities may be avoided by good 
manufacturing practice:

Zinc sulfide, not less than 99.8 percent.
Copper, 1005 parts per million.
Lead, not more than 20 parts per million.
Arsenic, not more than 3 parts per million.
Mercury, not more than 1 part per million.
Cadmium, not more than 15 parts per million.

    (c) Uses and restrictions. The color additive luminescent zinc 
sulfide may be safely used for coloring externally applied facial makeup 
preparations and nail polish included under Sec.  720.4(c)(7)(ix) and 
(c)(8)(v) of this chapter, respectively, to the following restrictions:
    (1) The amount of luminescent zinc sulfide in facial makeup 
preparations shall not exceed 10 percent by weight of the final product.
    (2) Facial makeup preparations containing luminescent zinc sulfide 
are intended for use only on limited, infrequent occasions, e.g., 
Halloween, and not for regular or daily use.
    (d) Labeling requirements. (1) The label of the color additive and 
any mixtures prepared therefrom shall bear expiration dates for the 
sealed and open container (established through generally accepted 
stability testing methods), other information required by Sec.  70.25 of 
this chapter, and adequate directions to prepare a final product 
complying with the limitations prescribed in paragraph (c) of this 
section.
    (2) The label of a facial makeup preparation containing the color 
additive shall bear, in addition to other information required by the 
law, the following statement conspicuously displayed:
    Do not use in the area of the eye.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[65 FR 48377, Aug. 8, 2000; 65 FR 75158, Dec. 1, 2000]



                        Subpart D_Medical Devices



Sec.  73.3100  1,4-Bis[(2-hydroxyethyl)amino]-9,
10-anthracenedione bis(2-methyl-2-propenoic)ester copolymers.

    (a) Identity. The color additives are the copolymers formed as the 
reaction product of 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione 
bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) (CAS Reg. No. 
109561-07-1) with one or more vinyl and/or acrylic monomers to form the 
contact lens material.
    (b) Uses and restrictions. (1) The substances listed in paragraph 
(a) of this section may be used in amounts not to exceed the minimum 
reasonably required to accomplish the intended coloring effect.
    (2) Authorization and compliance with these uses shall not be 
construed as waiving any of the requirements of sections 510(k), 515, 
and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with 
respect to the contact lens made from the color additives.
    (c) Labeling. The label of the color additives shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of these color 
additives is not necessary for the protection of the public health and 
therefore the color additives are exempt from the certification 
requirements of section 721(c) of the act.

[61 FR 51586, Oct. 3, 1996, as amended at 78 FR 19415, Apr. 1, 2013]]

[[Page 472]]



Sec.  73.3105  1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione.

    (a) Identity. The color additive is 1,4-bis[(2-methylphenyl)amino]-
9,10-anthracenedione (CAS Reg. No. 6737-68-4).
    (b) Uses and restrictions. (1) The substance listed in paragraph (a) 
of this section may be used as a color additive in contact lenses in 
amounts not to exceed the minimum reasonably required to accomplish the 
intended coloring effect.
    (2) Authorization and compliance with this use shall not be 
construed as waiving any of the requirements of sections 510(k), 515, 
and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act). A 
person intending to introduce a device containing 1,4-bis[(2-
methylphenyl)amino]-9,10-anthracenedione listed under this section into 
commerce shall submit to the Food and Drug Administration either a 
premarket notification in accordance with subpart E of part 807 of this 
chapter, if the device is not subject to premarket approval, or submit 
and receive approval of an original or supplemental premarket approval 
application if the device is subject to premarket approval.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore the color additive is exempt from the certification 
requirements of section 721(c) of the act.

[49 FR 30066, July 26, 1984]



Sec.  73.3106  1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone
copolymers.

    (a) Identity. The color additives are the copolymers formed as the 
reaction product of 1,4-bis[4-(2-methacryloxyethyl) phenylamino]-
anthraquinone (C.I. Reactive Blue 246) (CAS Reg. No. 121888-69-5) with 
one or more vinyl and/or acrylic monomers to form the contact lens 
material.
    (b) Uses and restrictions. (1) The substances listed in paragraph 
(a) of this section may be used in amounts not to exceed the minimum 
reasonably required to accomplish the intended coloring effect.
    (2) Authorization and compliance with these uses shall not be 
construed as waiving any of the requirements of sections 510(k), 515, 
and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with 
respect to contact lenses made from the color additives.
    (c) Labeling. The label of the color additives shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of these color 
additives is not necessary for the protection of the public health and, 
therefore, the color additives are exempt from the certification 
requirements of section 721(c) of the act.

[58 FR 17507, Apr. 5, 1993, as amended at 60 FR 10497, Feb. 27, 1995; 78 
FR 19415, Apr. 1, 2013]



Sec.  73.3107  Carbazole violet.

    (a) Identity. The color additive is carbazole violet (Pigment Violet 
23) (CAS Reg. No. 6358-30-1, Colour Index No. 51319).
    (b) Uses and restrictions. (1) The substance listed in paragraph (a) 
of this section may be used as a color additive in contact lenses in 
amounts not to exceed the minimum reasonably required to accomplish the 
intended coloring effect.
    (2) Authorization for this use shall not be construed as waiving any 
of the requirements of sections 510(k), 515, and 520(g) of the Federal 
Food, Drug, and Cosmetic Act (the act) with respect to the contact lens 
in which the color additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore the color additive is exempt from the certification 
requirements of section 721(c) of the act.

[53 FR 41324, Oct. 21, 1988]

[[Page 473]]



Sec.  73.3110  Chlorophyllin-copper complex, oil soluble.

    (a) Identity. The color additve is chlorophyllin-copper complex, oil 
soluble. The chlorophyllin is obtained by extraction from a mixture of 
fescue and rye grasses. The chlorophyll is acid-treated to remove 
chelated magnesium which is replaced with hydrogen, which is turn is 
replaced with copper. This mixture is diluted to a 5 percent 
concentration with a mixture of palm oil, peanut oil, and hydrogenated 
peanut oil.
    (b) Specifications. The color additive chlorophyllin-copper complex, 
oil soluble (5 percent in palm oil, peanut oil, and hydrogenated peanut 
oil), shall conform to the following specifications and shall be free 
from impurities other than those named to the extent that such other 
impurities may be avoided by current good manufacturing practice:

Moisture, not more than 0.5 percent.
Nitrogen, not less than 0.2 percent and not more than 0.3 percent.
Total copper, not less than 0.2 percent and not more than 0.4 percent.
Free copper, not more than 200 parts per million.
Lead, not more than 20 parts per million.
Arsenic, not more than 5 parts per million.
Sulfated ash, not more than 2.5 percent.
Total color, not less than 4.5 percent and not more than 5.5 percent.

    (c) Uses and restrictions. (1) The color additive chlorophyllin-
copper complex, oil soluble (5 percent in palm oil, peanut oil, and 
hydrogenated peanut oil), may be safely used to color 
polymethylmethacrylate bone cement. Chlorophyllin-copper complex may be 
used at levels that do not exceed 0.003 percent by weight of the bone 
cement.
    (2) Authorization for this use shall not be construed as waiving any 
of the requirements of sections 510(k), 515, and 520(g) of the Federal 
Food, Drug, and Cosmetic Act with respect to the polymethylmethacrylate 
bone cement in which chlorophyllin-copper complex, oil soluble, is used.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore the color additive is exempt from the certification 
requirements of section 721(c) of the act.

[48 FR 56370, Dec. 21, 1983]



Sec.  73.3110a  Chromium-cobalt-aluminum oxide.

    (a) Identity. The color additive chromium-cobalt-aluminum oxide 
(Pigment Blue 36) (CAS Reg. No. 68187-11-1, Colour Index No. 77343) 
shall conform in identity and specifications to the requirements of 
Sec.  73.1015 (a) and (b).
    (b) Uses and restrictions. (1) The substance listed in paragraph (a) 
of this section may be used as a color additive in contact lenses in 
amounts not to exceed the minimum reasonably required to accomplish the 
intended coloring effect.
    (2) Authorization for this use shall not be construed as waiving any 
of the requirements of sections 510(k), 515, and 520(g) of the Federal 
Food, Drug, and Cosmetic Act (the act) with respect to the contact lens 
in which the color additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore the color additive is exempt from the certification 
requirements of section 721(c) of the act.

[53 FR 41325, Oct. 21, 1988]



Sec.  73.3111  Chromium oxide greens.

    (a) Identity and specifications. The color additive chromium oxide 
greens (chromic oxide) (CAS Reg. No. 1308-38-9), Color Index No. 77288, 
shall conform in identity and specifications to the requirements of 
Sec.  73.1327 (a)(1) and (b).
    (b) Uses and restrictions. (1) The substance listed in paragraph (a) 
of this section may be used as a color additive in contact lenses in 
amounts not to exceed the minimum reasonably required to accomplish the 
intended coloring effect.
    (2) Authorization and compliance with this use shall not be 
construed as

[[Page 474]]

waiving any of the requirements of sections 510(k), 515, and 520(g) of 
the Federal Food, Drug, and Cosmetic Act with respect to the contact 
lenses in which the additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore the color additive is exempt from the certification 
requirements of section 721(c) of the act.

[51 FR 24816, July 9, 1986]



Sec.  73.3112  C.I. Vat Orange 1.

    (a) Identity. The color additive is C.I. Vat Orange 1, Colour Index 
No. 59105.
    (b) Uses and restrictions. (1) The substance listed in paragraph (a) 
of this section may be used as a color additive in contact lenses in 
amounts not to exceed the minimum reasonably required to accomplish the 
intended coloring effect.
    (2) Authorization for this use shall not be construed as waiving any 
of the requirements of sections 510(k), 515, and 520(g) of the Federal 
Food, Drug, and Cosmetic Act (the act) with respect to the contact lens 
in which the color additive is used. A person intending to introduce a 
device containing C.I. Vat Orange 1 into commerce shall submit to the 
Food and Drug Administration either a premarket notification in 
accordance with subpart E of part 807 of this chapter, if the device is 
not subject to premarket approval, or submit and receive approval of an 
original or supplemental premarket approval application if the device is 
subject to premarket approval.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore the color additive is exempt from the certification 
requirements of section 721(c) of the act.

[50 FR 20407, May 16, 1985]



Sec.  73.3115  2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,
3,5-benzenetriol.

    (a) Identity. The color additive2-[[2,5-diethoxy-4-[(4-
methylphenyl)thio]phenyl]azo]-1,3,5-benzenetriol is formed in situ in 
soft (hydrophilic) contact lenses.
    (b) Uses and restrictions. The color additive 2-[[2,5-diethoxy-4-
[(4-methylphenyl)thio]phenyl]azo]-1,3,5-benzenetriol may be safely used 
to mark soft (hydrophilic) contact lenses with the letter R or the 
letter L for identification purposes subject to the following 
restrictions:
    (1) The quantity of the color additive does not exceed 1.1 x 
10-7 grams in a soft (hydrophilic) contact lens.
    (2) When used as specified in the labeling, there is no measurable 
migration of the color additive from the contact lens to the surrounding 
ocular tissue.
    (3) Authorization for this use shall not be construed as waiving any 
of the requirements of section 510(k) and 515 of the Federal Food, Drug, 
and Cosmetic Act with respect to the contact lens in which the color 
additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore the color additive is exempt from the certification 
requirements of section 721(c) of the act.

[48 FR 22706, May 20, 1983]



Sec.  73.3117  16,23-Dihydrodinaphtho[2,3-a:2',3'-i] naphth [2',3':6,7]
indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone.

    (a) Identity. The color additive is 16,23-dihydrodinaphtho [2,3- 
a:2',3'-i] napth [2',3':6,7] indolo [2, 3-c] carbazole-5,10, 
15,17,22,24-hexone (CAS Reg. No. 2475-33-4), Colour Index No. 70800.
    (b) Uses and restrictions. (1) The substance listed in paragraph (a) 
of this section may be used as a color additive in contact lenses in 
amounts not to exceed the minimum reasonably required to accomplish the 
intended coloring effect.
    (2) Authorization for this use shall not be construed as waiving any 
of the

[[Page 475]]

requirements of sections 510(k), 515, and 520(g) of the Federal Food, 
Drug, and Cosmetic Act with respect to the contact lens in which the 
color additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore the color additive is exempt from the certification 
requirements of section 721(c) of the act.

[48 FR 31375, July 8, 1983]



Sec.  73.3118  N,N'-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl)
bisbenzamide.

    (a) Identity. The color additive is N,N'-(9,10-dihydro-9,10-dioxo-
1,5-anthracenediyl) bisbenzamide (CAS Reg. No. 82-18-8), Colour Index 
No. 61725.
    (b) Uses and restrictions. (1) The substance listed in paragraph (a) 
of this section may be used as a color additive in contact lenses in 
amounts not to exceed the minimum reasonably required to accomplish the 
intended coloring effect.
    (2) Authorization for this use shall not be construed as waiving any 
of the requirements of sections 510(k), 515, and 520(g) of the Federal 
Food, Drug, and Cosmetic Act with respect to the contact lens in which 
the color additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore the color additive is exempt from the certification 
requirements of section 721(c) of the act.

[48 FR 31375, July 8, 1983]



Sec.  73.3119  7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.

    (a) Identity. The color additive is 7,16-dichloro-6,15-dihydro-
5,9,14,18-anthrazinetetrone (CAS Reg. No. 130-20-1), Colour Index No. 
69825.
    (b) Uses and restrictions. (1) The substance listed in paragraph (a) 
of this section may be used as a color additive in contact lenses in 
amounts not to exceed the minimum reasonably required to accomplish the 
intended coloring effect.
    (2) Authorization for this use shall not be construed as waiving any 
of the requirements of sections 510(k), 515, and 520(g) of the Federal 
Food, Drug, and Cosmetic Act with respect to the contact lens in which 
the color additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore the color additive is exempt from the certification 
requirements of section 721(c) of the act.

[48 FR 31376, July 8, 1983]



Sec.  73.3120  16,17-Dimethoxydinaphtho [1,2,3-cd:3',2',1'-lm]
perylene-5,10-dione.

    (a) Identity. The color additive is 16,17-dimethoydinaphtho[1,2,3,-
cd:3',2',1'-lm]perylene-5,10-dione (CAS Reg. No. 128-58-5), Colour Index 
No. 59825.
    (b) Uses and restrictions. (1) The substance listed in paragraph (a) 
of this section may be used as a color additive in contact lenses in 
amounts not to exceed the minimum reasonably required to accomplish the 
intended coloring effect.
    (2) Authorization for this use shall not be construed as waiving any 
of the requirements of sections 510(k), 515, and 520(g) of the Federal 
Food, Drug, and Cosmetic Act with respect to the contact lens in which 
the color additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore the color additive is exempt from the certification 
requirements of section 721(c) of the act.

[48 FR 31376, July 8, 1983]

[[Page 476]]



Sec.  73.3121  Poly(hydroxyethyl methacrylate)-dye copolymers.

    (a) Identity. The color additives are formed by reacting one or more 
of the reactive dyes listed in this paragraph with poly(hydroxyethyl 
methacrylate), so that the sulfate group (or groups) or chlorine 
substituent of the dye is replaced by an ether linkage to 
poly(hydroxyethyl methacrylate). The dyes that may be used alone or in 
combination are
    (1) Reactive Black 5 [2,7-naphthalenedisulfonic acid, 4-amino-5-
hydroxy-3,6-bis((4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-tetrasodium 
salt] (CAS Reg. No. 17095-24-8);
    (2) Reactive Blue 21 [copper, (29H,31H-phthalocyaninato(2-)-
N\29\,N\30\,N\31\,N\32\)-, sulfo((4-((2-
sulfooxy)ethyl)sulfonyl)phenyl)amino) sulfonyl derivs] (CAS Reg. No. 
73049-92-0);
    (3) Reactive Orange 78 [2-naphthalenesulfonic acid, 7-(acetylamino)-
4-hydroxy-3-((4-((2-(sulfooxy)ethyl) sulfonyl)phenyl)azo)-] CAS Reg. No. 
68189-39-9);
    (4) Reactive Yellow 15 [benzensulfonic acid, 4-(4,5-dihydro-4-((2-
methoxy-5-methyl-4-((2-(sulfooxy)ethyl) sulfonyl)phenyl)azo)-3-methyl-5-
oxo-1H-pyrazol-1-yl)-] (CAS Reg. No. 60958-41-0);
    (5) Reactive Blue No. 19 [2-anthracene-sulfonic acid, 1-amino-9,10-
dihydro-9,10-dioxo-4-((3-((2-(sulfooxy)ethyl)sulfonyl)phenyl)amino)-, 
disodium salt] (CAS Reg. No. 2580-78-1);
    (6) Reactive Blue No. 4 [2-anthracenesulfonic acid, 1-amino-4-(3-
((4,6-dichloro-s-triazin-2-yl)amino)-4-sulfoanilino)-9,10-dihydro-9,10-
dioxo, disodium salt] (CAS Reg. No. 4499-01-8);
    (7) C.I. Reactive Red 11 [5-((4,6-dichloro-1,3,5-triazin-2-
yl)amino)-4-hydroxy-3-((1-sulfo-2-naphthalenyl)azo)-2, 7-
naphthalenedisulfonic acid, trisodium salt] (CAS Reg. No. 12226-08-3);
    (8) C.I. Reactive Yellow 86 [1,3-benzenedisulfonic acid, 4-((5-
aminocarbonyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-
pyridinyl)azo)-6-(4,6-dichloro-1,3,5-triazin-2-yl)amino)-, disodium 
salt] (CAS Reg. No. 61951-86-8);
    (9) C.I. Reactive Blue 163 [triphenodioxazinedisulfonic acid, 6,13-
dichloro-3, 10-bis((4-((4.6-dichloro-1,3,5-triazin-2-yl)amino) 
sulfophenyl)amino)-, tetrasodium salt] (CAS Reg. No. 72847-56-4); and
    (10) C.I. Reactive Red 180 [5-(benzoylamino)-4-hydroxy-3-((1-sulfo-
6-((2-(sulfooxy)ethyl)sulfonyl)-2-naphthalenyl)azo)-2,7- 
naphthalenedisulfonic acid, tetrasodium salt] (CAS Reg. No. 98114-32-0).
    (b) Uses and restrictions. (1) The substances listed in paragraph 
(a) of this section may be used to color contact lenses in amounts not 
to exceed the minimum reasonably required to accomplish the intended 
coloring effect.
    (2) As part of the manufacturing process, the lenses containing the 
color additives are thoroughly washed to remove unbound reactive dyes.
    (3) Authorization and compliance with this use shall not be 
construed as waiving any of the requirements of sections 510(k), 515, 
and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act). A 
person intending to introduce a device containing a poly(hydroxyethyl 
methacrylate)-dye copolymer listed under this section into commerce 
shall submit to the Food and Drug Administration either a premarket 
notification in accordance with subpart E of part 807 of this chapter, 
if the device is not subject to premarket approval, or submit and 
receive approval of an original or supplemental premarket approval 
application if the device is subject to premarket approval.
    (c) Labeling. The label of the color additives shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of these color 
additives is not necessary for the protection of the public health, and 
therefore these color additives are exempt from the certification 
requirements of section 721(c) of the act.

[49 FR 373, Jan. 4, 1984; 49 FR 5094, Feb. 10, 1984, as amended at 50 FR 
9425, Mar. 8, 1985; 50 FR 33338, Aug. 19, 1985; 50 FR 37845, Sept. 18, 
1985; 50 FR 45993, Nov. 6, 1985; 58 FR 9541, Feb. 22, 1993]

[[Page 477]]



Sec.  73.3122  4-[(2,4-dimethylphenyl)azo]-2,
4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one.

    (a) Identity. The color additive is 4-[(2,4-dimethylphenyl)azo]-2,4-
dihydro-5-methyl-2-phenyl-3H- pyrazol-3-one (CAS Reg. No. 6407-78-9).
    (b) Uses and restrictions. (1) The substances listed in paragraph 
(a) of this section may be used as a color additive in contact lenses in 
amounts not to exceed the minimum reasonably required to accomplish the 
intended coloring effect.
    (2) Authorization for this use shall not be construed as waiving any 
of the requirements of sections 510(k), 515, and 520(g) of the Federal 
Food, Drug, and Cosmetic Act with respect to the contact lens in which 
the color additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore the color additive is exempt from the certification 
requirements of section 721(c) of the act.

[51 FR 11432, Apr. 3, 1986]



Sec.  73.3123  6-Ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2(3H)-ylidene) 
benzo[b]thiophen-3 (2H)-one.

    (a) Identity. The color additive is 6-ethoxy-2-(6-ethoxy-3-oxobenzo 
[b]thien-2(3H)-ylidene)benzo[b]thiophen-3(2H)-one (CAS Reg. No. 3263-31-
8), Colour Index No. 73335.
    (b) Uses and restrictions. (1) The substance listed in paragraph (a) 
of this section may be used as a color additive in contact lenses in 
amounts not to exceed the minimum reasonably required to accomplish the 
intended coloring effect.
    (2) Authorization for this use shall not be construed as waiving any 
of the requirements of sections 510(k), 515, and 520(g) of the Federal 
Food, Drug, and Cosmetic Act with respect to the contact lens in which 
the color additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore the color additive is exempt from the certification 
requirements of section 721(c) of the act.

[51 FR 11436, Apr. 3, 1986]



Sec.  73.3124  Phthalocyanine green.

    (a) Identity. The color additive is phthalocyanine green (CAS Reg. 
No. 1328-53-6), Colour Index No. 74260.
    (b) Uses and restrictions. (1) The substance listed in paragraph (a) 
of this section may be used as a color additive in contact lenses in 
amounts not to exceed the minimum reasonably required to accomplish the 
intended coloring effect.
    (2) Authorization for this use shall not be construed as waiving any 
of the requirements of sections 510(k), 515, and 520(g) of the Federal 
Food, Drug, and Cosmetic Act with respect to the contact lens in which 
the additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore the color additive is exempt from the certification 
requirements of section 721(c) of the act.

[51 FR 11433, Apr. 3, 1986]



Sec.  73.3125  Iron oxides.

    (a) Identity and specifications. The color additive iron oxides (CAS 
Reg. No. 1332-37-2), Color Index No. 77491, shall conform in identity 
and specifications to the requirements of Sec.  73.2250 (a) and (b).
    (b) Uses and restrictions. (1) The substance listed in paragraph (a) 
of this section may be used as a color additive in contact lenses in 
amounts not to exceed the minimum reasonably required to accomplish the 
intended coloring effect.
    (2) Authorization and compliance with this use shall not be 
construed as waiving any of the requirements of sections 510(k), 515, 
and 520(g) of the Federal Food, Drug, and Cosmetic Act

[[Page 478]]

with respect to the contact lens in which the additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore the color additive is exempt from the certification 
requirements of section 721(c) of the act.

[51 FR 24816, July 9, 1986, as amended at 69 FR 24511, May 4, 2004]



Sec.  73.3126  Titanium dioxide.

    (a) Identity and specifications. The color additive titanium dioxide 
(CAS Reg. No. 13463-67-7), Color Index No. 77891, shall conform in 
identity and specifications to the requirements of Sec.  73.575(a)(1) 
and (b).
    (b) Uses and restrictions. (1) The substance listed in paragraph (a) 
of this section may be used as a color additive in contact lenses and 
intraocular lens orientation marks in amounts not to exceed the minimum 
reasonably required to accomplish the intended coloring effect.
    (2) Authorization and compliance with this use shall not be 
construed as waiving any of the requirements of sections 510(k), 515, 
and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to 
the contact lenses in which the additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore the color additive is exempt from the certification 
requirements of section 721(c) of the act.

[51 FR 24816, July 9, 1986, as amended at 81 FR 75692, Nov. 1, 2016]



Sec.  73.3127  Vinyl alcohol/methyl methacrylate-dye reaction products.

    (a) Identity. The color additives are formed by reacting the dyes, 
either alone or in combination, with a vinyl alcohol/methyl methacrylate 
copolymer, so that the sulfate groups of the dyes are replaced by ether 
linkages to the vinyl alcohol/methyl methacrylate copolymer. The dyes 
are:
    (1) C.I. Reactive Red 180 [5-(benzoylamino)-4-hydroxy-3-((1-sulfo-6-
((2-(sulfooxy)ethyl)sulfonyl)-2-naphthalenyl)azo)-2,7-
naphthalenedisulfonic acid, tetrasodium salt] (CAS Reg. No. 98114-32-0).
    (2) C.I. Reactive Black 5 [2,7-naphthalenedisulfonic acid, 4-amino-
5-hydroxy-3,6-bis((4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-, 
tetrasodium salt] (CAS Reg. No. 17095-24-8).
    (3) C.I. Reactive Orange 78 [2-naphthalenesulfonic acid, 7-
(acetylamino)-4-hydroxy-3-((4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-] 
(CAS Reg. No. 68189-39-9).
    (4) C.I. Reactive Yellow 15 [benzenesulfonic acid, 4-(4,5-dihydro-4-
((2-methoxy-5-methyl-4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-3-
methyl-5-oxo-1H-pyrazol-1-yl)-] (CAS Reg. No. 60958-41-0).
    (5) C.I. Reactive Blue No. 19 [2-anthracenesulfonic acid, 1-amino-
9,10-dihydro-9,10-dioxo-4-((3-((2-
(sulfooxy)ethyl)sulfonyl)phenyl)amino)-, disodium salt] (CAS Reg. No. 
2580-78-1).
    (6) C.I. Reactive Blue 21 [copper, (29H,31H-phthalocyaninato(2-)-
N\29\, N\30\, N\31\, N\32\)-, sulfo((4-((2-(sulfooxy) 
ethyl)sulfonyl)phenyl)amino)sulfonyl derivatives] (CAS Reg. No. 73049-
92-0).
    (b) Uses and restrictions. (1) The substances listed in paragraph 
(a) of this section may be used to color contact lenses in amounts not 
to exceed the minimum reasonably required to accomplish the intended 
coloring effect.
    (2) As part of the manufacturing process, the lenses containing the 
color additives are thoroughly washed to remove unbound reactive dye.
    (3) Authorization and compliance with this use shall not be 
construed as waiving any of the requirements of sections 510(k), 515, 
and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act). A 
person intending to introduce a device containing a vinyl alcohol/methyl 
methacrylate-dye reaction product listed under this section into 
commerce shall submit to the Food and Drug Administration either a 
premarket notification in accordance with

[[Page 479]]

subpart E of part 807 of this chapter, if the device is not subject to 
premarket approval, or submit and receive approval of an original or 
supplemental premarket approval application if the device is subject to 
premarket approval.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore, this color additive is exempt from the certification 
requirements of section 721(c) of the act.

[58 FR 3227, Jan. 8, 1993, as amended at 58 FR 17510, Apr. 5, 1993]



Sec.  73.3128  Mica-based pearlescent pigments.

    (a) Identity and specifications. The color additive is formed by 
depositing titanium or iron salts from a basic solution onto mica, 
followed by calcination to produce titanium dioxide or iron oxides on 
mica. Mica used to manufacture the color additive shall conform in 
identity and specifications to the requirements of Sec.  73.1496(a)(1) 
and (b).
    (b) Uses and restrictions. (1) Mica-based pearlescent pigments 
listed in paragraph (a) of this section may be used as a color additive 
in contact lenses in amounts not to exceed the minimum reasonably 
required to accomplish the intended coloring effect.
    (2) Authorization and compliance with this use shall not be 
construed as waiving any of the requirements of sections 510(k), 515, 
and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with 
respect to the contact lenses in which the additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements in Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.

[67 FR 65312, Oct. 24, 2002]



Sec.  73.3129  Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-
2-sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulfonate.

    (a) Identity. The color additive is disodium 1-amino-4-[[4-[(2-
bromo-1-oxoallyl)amino]-2-sulfonatophenyl]amino]-9,10-dihydro-9,10-
dioxoanthracene-2-sulfonate (Reactive Blue 69) (CAS Reg. No. 70209-99-3, 
Colour Index No. 612037).
    (b) Uses and restrictions. (1) The substance listed in paragraph (a) 
of this section may be used as a color additive in contact lenses in 
amounts not to exceed the minimum reasonably required to accomplish the 
intended coloring effect.
    (2) Authorization and compliance with this use shall not be 
construed as waiving any of the requirements of sections 510(k), 515, 
and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to 
the contact lenses in which the additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements in Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the Federal Food, Drug, and Cosmetic Act.

[76 FR 25235, May 4, 2011, as amended at 78 FR 14664, Mar. 7, 2013]



PART 74_LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
--Table of Contents



                             Subpart A_Foods

Sec.
74.101 FD&C Blue No. 1.
74.102 FD&C Blue No. 2.
74.203 FD&C Green No. 3.
74.250 Orange B.
74.302 Citrus Red No. 2.
74.303 FD&C Red No. 3.
74.340 FD&C Red No. 40.
74.705 FD&C Yellow No. 5.
74.706 FD&C Yellow No. 6.

                             Subpart B_Drugs

74.1101 FD&C Blue No. 1.
74.1102 FD&C Blue No. 2.
74.1104 D&C Blue No. 4.

[[Page 480]]

74.1109 D&C Blue No. 9.
74.1203 FD&C Green No. 3.
74.1205 D&C Green No. 5.
74.1206 D&C Green No. 6.
74.1208 D&C Green No. 8.
74.1254 D&C Orange No. 4.
74.1255 D&C Orange No. 5.
74.1260 D&C Orange No. 10.
74.1261 D&C Orange No. 11.
74.1303 FD&C Red No. 3.
74.1304 FD&C Red No. 4.
74.1306 D&C Red No. 6.
74.1307 D&C Red No. 7.
74.1317 D&C Red No. 17.
74.1321 D&C Red No. 21.
74.1322 D&C Red No. 22.
74.1327 D&C Red No. 27.
74.1328 D&C Red No. 28.
74.1330 D&C Red No. 30.
74.1331 D&C Red No. 31.
74.1333 D&C Red No. 33.
74.1334 D&C Red No. 34.
74.1336 D&C Red No. 36.
74.1339 D&C Red No. 39.
74.1340 FD&C Red No. 40.
74.1602 D&C Violet No. 2.
74.1705 FD&C Yellow No. 5.
74.1706 FD&C Yellow No. 6.
74.1707 D&C Yellow No. 7.
74.1707a Ext. D&C Yellow No. 7.
74.1708 D&C Yellow No. 8.
74.1710 D&C Yellow No. 10.
74.1711 D&C Yellow No. 11.

                           Subpart C_Cosmetics

74.2052 D&C Black No. 2.
74.2053 D&C Black No. 3.
74.2101 FD&C Blue No. 1.
74.2104 D&C Blue No. 4.
74.2151 D&C Brown No. 1.
74.2203 FD&C Green No. 3.
74.2205 D&C Green No. 5.
74.2206 D&C Green No. 6.
74.2208 D&C Green No. 8.
74.2254 D&C Orange No. 4.
74.2255 D&C Orange No. 5.
74.2260 D&C Orange No. 10.
74.2261 D&C Orange No. 11.
74.2304 FD&C Red No. 4.
74.2306 D&C Red No. 6.
74.2307 D&C Red No. 7.
74.2317 D&C Red No. 17.
74.2321 D&C Red No. 21.
74.2322 D&C Red No. 22.
74.2327 D&C Red No. 27.
74.2328 D&C Red No. 28.
74.2330 D&C Red No. 30.
74.2331 D&C Red No. 31.
74.2333 D&C Red No. 33.
74.2334 D&C Red No. 34.
74.2336 D&C Red No. 36.
74.2340 FD&C Red No. 40.
74.2602 D&C Violet No. 2.
74.2602a Ext. D&C Violet No. 2.
74.2705 FD&C Yellow No. 5.
74.2706 FD&C Yellow No. 6.
74.2707 D&C Yellow No. 7.
74.2707a Ext. D&C Yellow No. 7.
74.2708 D&C Yellow No. 8.
74.2710 D&C Yellow No. 10.
74.2711 D&C Yellow No. 11.

                        Subpart D_Medical Devices

74.3045 [Phthalocyaninato(2-)] copper.
74.3102 FD&C Blue No. 2.
74.3106 D&C Blue No. 6.
74.3206 D&C Green No. 6.
74.3230 D&C Red No. 17.
74.3602 D&C Violet No. 2.
74.3710 D&C Yellow No. 10.

    Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 
362, 371, 379e.

    Source: 42 FR 15654, Mar. 22, 1977, unless otherwise noted.



                             Subpart A_Foods



Sec.  74.101  FD&C Blue No. 1.

    (a) Identity. (1) The color additive FD&C Blue No. 1 is principally 
the disodium salt of ethyl [4-[p-[ethyl (m-sulfobenzyl) amino]-[alpha]-
(o-sulfophenyl) benzylidene] - 2,5 -cyclohexadien - 1 - ylidene] (m-
sulfobenzyl) ammonium hydroxide inner salt with smaller amounts of the 
isomeric disodium salts of ethyl [4-[p-[ethyl(p-sulfobenzyl) amino]-
[alpha]-(o-sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] (p-
sulfobenzyl) ammonium hydroxide inner salt and ethyl [4-[p-[ethyl (o-
sulfobenzyl) amino] - [alpha] - (o -sulfophenyl) benzylidene]-2,5-
cyclohexadien-1-ylidene] (o-sulfobenzyl) ammonium hydroxide inner salt.
    (2) Color additive mixtures for food use (including dietary 
supplements) made with FD&C Blue No. 1 may contain only those diluents 
that are suitable and that are listed in part 73 of this chapter as safe 
for use in color additive mixtures for coloring foods.
    (b) Specifications. FD&C Blue No. 1 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such other impurities may be avoided by current good 
manufacturing practice:

Sum of volatile matter (at 135 [deg]C) and chlorides and sulfates 
(calculated as sodium salts), not more than 15.0 percent.
Water-insoluble matter, not more than 0.2 percent.
Leuco base, not more than 5 percent.

[[Page 481]]

Sum of o-, m-, and p-sulfobenzaldehydes, not more than 1.5 percent.
N-Ethyl,N-(m-sulfobenzyl)sulfanilic acid, not more than 0.3 percent.
Subsidiary colors, not more than 6.0 percent.
Chromium (as Cr), not more than 50 parts per million.
Manganese (as Mn), not more than 100 parts per million.
Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 10 parts per million.
Total color, not less than 85.0 percent.

    (c) Uses and restrictions. FD&C Blue No. 1 may be safely used for 
coloring foods (including dietary supplements) generally in amounts 
consistent with good manufacturing practice except that it may not be 
used to color foods for which standards of identity have been 
promulgated under section 401 of the act unless added color is 
authorized by such standards.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of FD&C Blue No. 1 shall be certified 
in accordance with regulations in part 80 of this chapter.

[42 FR 15654, Mar. 22, 1977, as amended at 58 FR 17511, Apr. 5, 1993]



Sec.  74.102  FD&C Blue No. 2.

    (a) Identity. (1) The color additive FD&C Blue No. 2 is principally 
the disodium salt of 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-
2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid (CAS Reg. No. 860-22-0) with 
smaller amounts of the disodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo-2H-
indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid (CAS Reg. 
No. 54947-75-0) and the sodium salt of 2-(1,3-dihydro-3-oxo-2H-indol-2-
ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid (CAS Reg. No. 605-
18-5). Additionally, FD&C Blue No. 2 is obtained by heating indigo (or 
indigo paste) in the presence of sulfuric acid. The color additive is 
isolated and subjected to purification procedures. The indigo (or indigo 
paste) used above is manufactured by the fusion of N-phenylglycine 
(prepared from aniline and formaldehyde) in a molten mixture of sodamide 
and sodium and potassium hydroxides under ammonia pressure. The indigo 
is isolated and subjected to purification procedures prior to 
sulfonation.
    (2) Color additive mixtures for food use (including dietary 
supplements) made with FD&C Blue No. 2 may contain only those diluents 
that are suitable and that are listed in part 73 of this chapter as safe 
for use in color additive mixtures for coloring foods.
    (b) Specifications. The color additive FD&C Blue No. 2 shall conform 
to the following specifications and shall be free from impurities other 
than those named to the extent that such other impurities may be avoided 
by current good manufacturing practice:

Sum of volatile matter at 135 [deg]C (275 [deg]F) and chlorides and 
sulfates (calculated as sodium salts), not more than 15 percent.
Water insoluble matter, not more than 0.4 percent.
Isatin-5-sulfonic acid, not more than 0.4 percent.
5-Sulfoanthranilic acid, not more than 0.2 percent.
Disodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo-2H-indol-2-ylidene)-2,3-
dihydro-3-oxo-1H-indole-5-sulfonic acid, not more than 18 percent.
Sodium salt of 2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-2,3-dihydro-3-
oxo-1H-indole-5-sulfonic acid, not more than 2 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 85 percent.

    (c) Uses and restrictions. The color additive FD&C Blue No. 2 may be 
safely used for coloring foods (including dietary supplements) generally 
in amounts consistent with current good manufacturing practice except 
that it may not be used to color foods for which standards of identity 
have been promulgated under section 401 of the Federal Food, Drug, and 
Cosmetic Act unless added color is authorized by such standards.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.

[[Page 482]]

    (e) Certification. All batches of FD&C Blue No. 2 shall be certified 
in accordance with regulations in part 80 of this chapter.

[48 FR 5260, Feb. 4, 1983]



Sec.  74.203  FD&C Green No. 3.

    (a) Identity. (1) The color additive FD&C Green No. 3 is principally 
the inner salt disodium salt of N-ethyl-N-[4-[[4-[ethyl[(3-
sulfophenyl)methyl]amino]phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-
cyclohexadien-1-ylidene]-3-sulfobenzenemethanaminium hydroxide (CAS Reg. 
No. 2353-45-9); with smaller amounts of the isomeric inner salt disodium 
salt of N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl] amino]phenyl](4-
hydroxy-2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-4-
sulfobenzenemethanaminium hydroxide; of N-ethyl-N-[4-[[4-[ethyl[(4-
sulfophenyl)methyl]amino]phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-
cyclohexadien-1-ylidene]-4-sulfobenzenemethanaminium hydroxide and of N-
ethyl-N-[4-[[4-[ethyl[(2-sulfophenyl)methyl]amino]phenyl](4-hydroxy-2-
sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-
sulfobenzenemethanaminium hydroxide. Additionally, FD&C Green No. 3 is 
manufactured by the acid catalyzed condensation of one molecule of 2-
formyl-5-hydroxybenzenesulfonic acid with two molecules from a mixture 
consisting principally of 3-[(ethylphenylamino)methyl]

benzensulfonic acid, and smaller amounts of 4-[(ethylphenylamino)methyl]

benzenesulfonic acid and 2-[(ethylphenylamino)methyl]

benzenesulfonic acid to form the leuco base. The leuco base is then 
oxidized with lead dioxide and acid or with dichromate and acid to form 
the dye. The intermediate 2-formyl-5-hydroxybenzenesulfonic acid is 
prepared by the potassium permanganate oxidation of 2,2'-(1,2-
ethenediyl)-bis(5-aminobenzenesulfonic acid) to sodium 5-amino-2-
formylbenzenesulfonate. This amine is diazotized and the resulting 
diazonium salt is hydrolyzed to the desired 2-formyl-5-
hydroxybenzenesulfonic acid.
    (2) Color additive mixtures for food use (including dietary 
supplements) made with FD&C Green No. 3 may contain only those diluents 
that are suitable and that are listed in part 73 of this chapter as safe 
for use in color additive mixtures for coloring food.
    (b) Specifications. The color additive FD&C Green No. 3 shall 
conform to the following specifications and shall be free from 
impurities other than those named to the extent that such other 
impurities may be avoided by current good manufacturing practice:

Sum of volatile matter at 135 [deg]C (275 [deg]F) and chlorides and 
sulfates (calculated as sodium salts), not more than 15 percent.
Water-insoluble matter, not more than 0.2 percent.
Leuco base, not more than 5 percent.
Sum of 2-,3-,4-formylbenzenesulfonic acids, sodium salts, not more than 
0.5 percent.
Sum of 3- and 4-[[ethyl(4-sulfophenyl)amino]methyl] benzenesulfonic 
acid, disodium salts, not more than 0.3 percent.
2-Formyl-5-hydroxybenzenesulfonic acid, sodium salt, not more than 0.5 
percent.
Subsidiary colors, not more than 6 percent.
Chromium (as Cr), not more than 50 parts per million.
Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 10 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 85 percent.

    (c) Uses and restrictions. The color additive FD&C Green No. 3 may 
be safely used for coloring foods (including dietary supplements) 
generally in amounts consistent with current good manufacturing practice 
except that it may not be used to color foods for which standards of 
identity have been promulgated under section 401 of the act unless added 
color is authorized by such standards.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.

[[Page 483]]

    (e) Certification. All batches of FD&C Green No. 3 shall be 
certified in accordance with regulations in part 80 of this chapter.

[47 FR 52143, Nov. 19, 1982; 47 FR 56489, Dec. 17, 1982]



Sec.  74.250  Orange B.

    (a) Identity. (1) The color additive Orange B is principally the 
disodium salt of 1-(4-sulfophenyl)-3-ethylcarboxy-4-(4-
sulfonaphthylazo)-5-hydro-xypyrazole.
    (2) The diluents in color additive mixtures for food use containing 
Orange B are limited to those listed in part 73 of this chapter as safe 
and suitable in color additive mixtures for coloring foods.
    (b) Specifications. Orange B shall conform to the following 
specifications:

Volatile matter (at 135 [deg]C.), not more than 6.0 percent.
Chlorides and sulfates (calculated as the sodium salts), not more than 
7.0 percent.
Water insoluble matter, not more than 0.2 percent.
1-(4-Sulfophenyl)-3-ethylcarboxy-5-hydroxypyrazolone and 1-(4-
sulfophenyl)-3-carboxy-5-hydroxypyrazolone, not more than 0.7 percent.
Naphthionic acid, not more than 0.2 percent.
Phenylhydrazine-p-sulfonic acid, not more than 0.2 percent.
The trisodium salt of 1-(4-sulfophenyl)-3-carboxy-4-(4-
sulfonaphthylazo)-5-hydroxypyrazole, not more than 6.0 percent.
Other subsidiary dyes, not more than 1.0 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Total color, not less than 87.0 percent.

    (c) Uses and restrictions. Orange B may be safely used for coloring 
the casings or surfaces of frankfurters and sausages subject to the 
restriction that the quantity of the color additive does not exceed 150 
parts per million by weight of the finished food.
    (d) Labeling requirements. The label of the color additive and any 
mixtures intended solely or in part for coloring purposes prepared 
therefrom shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Certification. All batches of Orange B shall be certified in 
accordance with regulations promulgated under part 80 of this chapter.



Sec.  74.302  Citrus Red No. 2.

    (a) Identity. (1) The color additive Citrus Red No. 2 is principally 
1-(2,5-dimethoxyphenylazo)-2-naphthol.
    (2) The following diluents may be used in aqueous suspension, in the 
percentages specified, to facilitate application to oranges in 
accordance with paragraph (c)(1) of this section:
    (i) Suitable diluents used in accordance with Sec.  73.1(a) of this 
chapter.
    (ii) Volatile solvents that leave no residue after application to 
the orange.
    (iii) Salts of fatty acids meeting the requirements of Sec.  172.863 
of this chapter.
    (iv) Sodium tripolyphosphate, not more than 0.05 percent.
    (b) Specifications. Citrus Red No. 2 shall conform to the following 
specifications and shall be free from impurities, other than those 
named, to the extent that such other impurities may be avoided by good 
manufacturing practice:

Volatile matter (at 100 [deg]C.), not more than 0.5 percent.
Water-soluble matter, not more than 0.3 percent.
Matter insoluble in carbon tetrachloride, not more than 0.5 percent.
Uncombined intermediates, not more than 0.05 percent.
Subsidiary dyes, not more than 2.0 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Total color, not less than 98 percent.

    (c) Uses and restrictions. (1) Citrus Red No. 2 shall be used only 
for coloring the skins of oranges that are not intended or used for 
processing (or if so used are designated in the trade as Packinghouse 
elimination) and that meet minimum maturity standards established by or 
under the laws of the States in which the oranges are grown.
    (2) Oranges colored with Citrus Red No. 2 shall bear not more than 
2.0 parts per million of such color additive, calculated on the basis of 
the weight of the whole fruit.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom and intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter. To 
meet the requirements

[[Page 484]]

of Sec.  70.25 (b) and (c) of this chapter the label shall bear:
    (1) The statement (or its equivalent) ``To be used only for coloring 
skins of oranges.''
    (2) Directions for use to limit the amount of the color additive to 
not more than 2.0 parts per million, calculated on the basis of the 
weight of the whole fruit.
    (e) Certification. All batches of Citrus Red No. 2 shall be 
certified in accordance with regulations in part 80 of this chapter.



Sec.  74.303  FD&C Red No. 3.

    (a) Identity. (1) The color additive FD&C Red No. 3 is principally 
the monohydrate of 9 (o- carboxyphenyl)-6-hydroxy - 2,4,5,7-tetraiodo-
3H-xanthen-3-one, disodium salt, with smaller amounts of lower imdinated 
fluoresceins.
    (2) Color additive mixtures for food use made with FD&C Red No. 3 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring foods.
    (b) Specifications. FD&C Red No. 3 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such other impurities may be avoided by good 
manufacturing practice:

Volatile matter (at 135 [deg]C.) and chlorides and sulfates (calculated 
as the sodium salts), total not more than 13 percent.
Water-insoluble matter, not more than 0.2 percent.
Unhalogenated intermediates, total not more than 0.1 percent.
Sodium iodide, not more than 0.4 percent.
Triiodoresorcinol, not more than 0.2 percent.
2(2',4'-Dihydroxy-3', 5'-diiodobenzoyl) benzoic acid, not more than 0.2 
percent.
Monoiodofluoresceins not more than 1.0 percent.
Other lower iodinated fluoresceins, not more than 9.0 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Total color, not less than 87.0 percent.

    (c) Uses and restrictions. FD&C Red No. 3 may be safely used for 
coloring foods generally (including dietary supplements) in amounts 
consistent with good manufacturing practice except that it may not be 
used to color foods for which standards of identity have been 
promulgated under section 401 of the act unless added color is 
authorized by such standards.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of FD&C Red No. 3 shall be certified 
in accordance with regulations in part 80 of this chapter.



Sec.  74.340  FD&C Red No. 40.

    (a) Identity. (1) The color additive FD&C Red No. 40 is principally 
the disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-
sulfophenyl)azo]-2-naphthalenesulfonic acid.
    (2) Color additive mixtures for food use (including dietary 
supplements) made with FD&C Red No. 40 may contain only those diluents 
that are suitable and that are listed in part 73 of this chapter as safe 
for use in color additive mixtures for coloring foods.
    (3) The listing of this color additive includes lakes prepared as 
described in Sec.  82.51 of this chapter, except that the color additive 
used is FD&C Red No. 40 and the resultant lakes meet the specification 
and labeling requirements prescribed by Sec.  82.51 of this chapter.
    (b) Specifications. FD&C Red No. 40 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such other impurities may be avoided by good 
manufacturing practice:

Sum of volatile matter (at 135 [deg]C.) and chlorides and sulfates 
(calculated as sodium salts), not more than 14.0 percent.
Water-insoluble matter, not more than 0.2 percent.
Higher sulfonated subsidiary colors (as sodium salts), not more than 1.0 
percent.
Lower sulfonated subsidiary colors (as sodium salts), not more than 1.0 
percent.
Disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl) azo] -
8-(2-methoxy-5-methyl-4-sulfophenoxy)-2-naphthalenesulfonic acid, not 
more than 1.0 percent.
Sodium salt of 6-hydroxy-2-naphthalenesulfonic acid (Schaeffer's salt), 
not more than 0.3 percent.

[[Page 485]]

4-Amino-5-methoxy-o- toluenesulfonic acid, not more than 0.2 percent.
Disodium salt of 6,6'-oxybis (2-naphthalene-sulfonic acid), not more 
than 1.0 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Total color, not less than 85.0 percent.

    (c) Uses and restrictions. FD&C Red No. 40 may be safely used for 
coloring foods (including dietary supplements) generally in amounts 
consistent with good manufacturing practice except that it may not be 
used to color foods for which standards of identity have been 
promulgated under section 401 of the act unless added color is 
authorized by such standards.
    (d) Labeling. The label of the color additive and any lakes or 
mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Certification. All batches of FD&C Red No. 40 and lakes thereof 
shall be certified in accordance with regulations in part 80 of this 
chapter.



Sec.  74.705  FD&C Yellow No. 5.

    (a) Identity. (1) The color additive FD&C Yellow No. 5 is 
principally the trisodium salt of 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-
[4-sulfophenyl-azo]-1H-pyrazole-3-carboxylic acid (CAS Reg. No. 1934-21-
0). To manufacture the additive, 4-amino-benzenesulfonic acid is 
diazotized using hydrochloric acid and sodium nitrite. The diazo 
compound is coupled with 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-
pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or 
a salt of this carboxylic acid. The resulting dye is purified and 
isolated as the sodium salt.
    (2) Color additive mixtures for food use made with FD&C Yellow No. 5 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring foods.
    (b) Specifications. FD&C Yellow No. 5 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such other impurities may be avoided by good 
manufacturing practice:

Sum of volatile matter at 135 [deg]C (275 [deg]F) and chlorides and 
sulfates (calculated as sodium salts), not more than 13 percent.
Water-insoluble matter, not more than 0.2 percent.
4,4'-[4,5-Dihydro-5-oxo-4-[(4-sulfophenyl)hydrazono]-1H-pyrazol-1,3-
diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1 percent.
4-[(4',5-Disulfo[1,1'-biphenyl]-2-yl)hydrazono]-4,5-dihydro-5-oxo-1-(4-
sulfophenyl)-1H-pyrazole-3-carboxylic acid, tetrasodium salt, not more 
than 1 percent.
Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-
sulfophenyl)hydrazono]-1H-pyrazole-3-carboxylate, disodium salt, not 
more than 1 percent.
Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-
carboxylic acid, disodium salt, and 4,5-dihydro-5-oxo-4-(phenylazo)-1-
(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid, disodium salt, not more 
than 0.5 percent.
4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent.
4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid, 
disodium salt, not more than 0.2 percent.
Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-
carboxylate, sodium salt, not more than 0.1 percent.
4,4'-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not 
more than 0.05 percent.
4-Aminoazobenzene, not more than 75 parts per billion.
4-Aminobiphenyl, not more than 5 parts per billion.
Aniline, not more than 100 parts per billion.
Azobenzene, not more than 40 parts per billion.
Benzidine, not more than 1 part per billion.
1,3-Diphenyltriazene, not more than 40 parts per billion.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 87 percent.

    (c) Uses and restrictions. FD&C Yellow No. 5 may be safely used for 
coloring foods (including dietary supplements) generally in amounts 
consistent with good manufacturing practice, except that it may not be 
used to color foods for which standards of identity have been 
promulgated under section 401 of the act unless added color is 
authorized by such standards.
    (d) Labeling requirements. (1) The label of the color additive and 
any mixtures intended solely or in part for coloring

[[Page 486]]

purposes prepared therefrom shall conform to the requirements of Sec.  
70.25 of this chapter.
    (2) Foods for human use that contain FD&C Yellow No. 5, including 
butter, cheese, and ice cream, shall specifically declare the presence 
of FD&C Yellow No. 5 by listing the color additive as FD&C Yellow No. 5 
among the list of ingredients.
    (e) Certification. All batches of FD&C Yellow No. 5 shall be 
certified in accordance with regulations in part 80 of this chapter.

[42 FR 15654, Mar. 22, 1977; 44 FR 17658, Mar. 23, 1979, as amended at 
44 FR 37220, June 26, 1979; 51 FR 24519, July 7, 1986]



Sec.  74.706  FD&C Yellow No. 6.

    (a) Identity. (1) The color additive FD&C Yellow No. 6 is 
principally the disodium salt of 6-hydroxy-5-[(4-sulfophenyl)azo]-2-
naphthalenesulfonic acid (CAS Reg. No. 2783-94-0). The trisodium salt of 
3-hydroxy-4-[(4-sulfophenyl)azo]-2,7-naphthalenedisulfonic acid (CAS 
Reg. No. 50880-65-4) may be added in small amounts. The color additive 
is manufactured by diazotizing 4-aminobenzenesulfonic acid using 
hydrochloric acid and sodium nitrite or sulfuric acid and sodium 
nitrite. The diazo compound is coupled with 6-hydroxy-2-naphthalene-
sulfonic acid. The dye is isolated as the sodium salt and dried. The 
trisodium salt of 3-hydroxy-4-[(4-sulfophenyl)azo]-2,7-
naphthalenedisulfonic acid which may be blended with the principal color 
is prepared in the same manner except the diazo benzenesulfonic acid is 
coupled with 3-hydroxy-2,7-naphthalenedisulfonic acid.
    (2) Color additive mixtures for food use made with FD&C Yellow No. 6 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring foods.
    (b) Specifications. The color additive FD&C Yellow No. 6 shall 
conform to the following specifications and shall be free from 
impurities other than those named to the extent that such other 
impurities may be avoided by current good manufacturing practice:

Sum of volatile matter (at 135 [deg]C) and chlorides and sulfates 
(calculated as sodium salts), not more than 13 percent.
Water insoluble matter, not more than 0.2 percent.
Sodium salt of 4-aminobenzenesulfonic acid, not more than 0.2 percent.
Sodium salt of 6-hydroxy-2-naphthalenesulfonic acid, not more than 0.3 
percent.
Disodium salt of 6,6'-oxybis[2-naphthalenesulfonic acid], not more than 
1 percent.
Disodium salt of 4,4'-(1-triazene-1,3-diyl)bis[benzenesulfonic acid], 
not more than 0.1 percent.
Sum of the sodium salt of 6-hydroxy-5-(phenylazo)-2-naphthalenesulfonic 
acid and the sodium salt of 4-[(2-hydroxy-1-
naphthalenyl)azo]benzenesulfonic acid, not more than 1 percent.
Sum of the trisodium salt of 3-hydroxy-4-[(4-sulfophenyl)azo]-2,7-
naphthalenedisulfonic acid and other higher sulfonated subsidiaries, not 
more than 5 percent.
4-Aminoazobenzene, not more than 50 parts per billion.
4-Aminobiphenyl, not more than 15 parts per billion.
Aniline, not more than 250 parts per billion.
Azobenzene, not more than 200 parts per billion.
Benzidine, not more than 1 part per billion.
1,3-Diphenyltriazene, not more than 40 parts per billion.
1-(Phenylazo)-2-naphthalenol, not more than 10 parts per million.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 87 percent.

    (c) Uses and restrictions. The color additive FD&C Yellow No. 6 may 
be safely used for coloring foods (including dietary supplements) 
generally in amounts consistent with current good manufacturing 
practice, except that it may not be used to color foods for which 
standards of identity have been promulgated under section 401 of the act 
unless added color is authorized by such standards.
    (d) Labeling requirements. (1) The label of the color additive and 
any mixtures intended solely or in part for coloring purposes prepared 
therefrom shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (2) [Reserved]

[[Page 487]]

    (e) Certification. All batches of FD&C Yellow No. 6 shall be 
certified in accordance with regulations in part 80 of this chapter.

[51 FR 41782, Nov. 19, 1986, as amended at 52 FR 21508, June 8, 1987; 53 
FR 49138, Dec. 6, 1988]



                             Subpart B_Drugs



Sec.  74.1101  FD&C Blue No. 1

    (a) Identity. (1) For ingested drugs, the color additive FD&C Blue 
No. 1 shall conform in identity to the requirements of Sec.  
74.101(a)(1).
    (2) For externally applied drugs, the color additive FD&C Blue No. 1 
shall conform in identity to the requirements of Sec.  74.2101(a).
    (3) Color additive mixtures for drug use made with FD&C Blue No. 1 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring drugs.
    (b) Specifications. (1) The color additive FD&C Blue No. 1 for use 
in coloring drugs generally shall conform in specifications to the 
requirements of Sec.  74.101(b).
    (2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance 
with the requirements of Sec.  82.51 of this chapter.
    (c) Uses and restrictions. (1) FD&C Blue No. 1 may be safely used 
for coloring drugs, including drugs intended for use in the area of the 
eye, in amounts consistent with current good manufacturing practice.
    (2) FD&C Blue No. 1 Aluminum Lake may be safely used for coloring 
drugs intended for use in the area of the eye, in amounts consistent 
with current good manufacturing practice, subject to the restrictions on 
the use of color additives in Sec.  70.5(b) and (c) of this chapter.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of FD&C Blue No. 1 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 42565, Sept. 28, 1982, as amended at 59 FR 7638, Feb. 16, 1994]



Sec.  74.1102  FD&C Blue No. 2.

    (a) Identity. (1) The color additive FD&C Blue No. 2 shall conform 
in identity to the requirements of Sec.  74.102(a)(1).
    (2) Color additive mixtures for use in ingested drugs made with FD&C 
Blue No. 2 may contain only those diluents that are suitable and that 
are listed in part 73 of this chapter as safe for use in color additive 
mixtures for coloring drugs.
    (b) The color additive FD&C Blue No. 2 for use in coloring ingested 
drugs shall conform to the specifications in Sec.  74.102(b).
    (c) The color additive FD&C Blue No. 2 may be safely used for 
coloring ingested drugs in amounts consistent with current good 
manufacturing practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of FD&C Blue No. 2 shall be certified 
in accordance with regulations in part 80 of this chapter.

[48 FR 5260, Feb. 4, 1983, as amended at 49 FR 10090, Mar. 19, 1984; 64 
FR 48290, Sept. 3, 1999]



Sec.  74.1104  D&C Blue No. 4.

    (a) Identity. (1) The color additive D&C Blue No. 4 is principally 
the diammonium salt of ethyl[4-[p[ethyl(m- sulfobenzyl)ami-no]-[alpha]-
(o- sulfophenyl)benzylidene]-2,5-cyclo-hexadien-1-ylidene] (m- 
sulfobenzyl) ammonium hydroxide inner salt with smaller amounts of the 
isomeric diammonium salts of ethyl [4-[p-[ethyl(p- sulfobenzyl) amino]-
[alpha]-(o- sulfophenyl) benzylidene]-2,5-cyclohexadien - 1-ylidene](p- 
sulfobenzyl) ammonium hydroxide inner salt and ethyl[4-[p-[ethyl (o- 
sulfobenzyl)amino]-[alpha]-(o- sulfophenyl) benzylidene]-2,5-
cyclohexadien-1-ylidene] (o- sulfobenzyl) ammonium hydroxide inner salt.

[[Page 488]]

    (2) Color additive mixtures for use in externally applied drugs made 
with D&C Blue No. 4 may contain only those diluents that are suitable 
and that are listed in part 73 of this chapter for use in color additive 
mixtures for coloring externally applied drugs.
    (b) Specifications. D&C Blue No. 4 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice:

Sum of volatile matter (at 135 [deg]C) and chlorides and sulfates 
(calculated as sodium salts), not more than 15 percent.
Water-insoluble matter, not more than 0.2 percent.
Leuco base, not more than 5 percent.
Sum of o-, m, and p- sulfobenzaldehydes, ammonium salt, not more than 
1.5 percent.
N-ethyl, N-(m- sulfobenzyl) sulfanilic acid ammonium salt, not more than 
0.3 percent.
Subsidiary colors, not more than 6 percent.
Chromium (as Cr), not more than 50 parts per million.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 85 percent.

    (c) Uses and restrictions. D&C Blue No. 4 may be safely used in 
externally applied drugs in amounts consistent with good manufacturing 
practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Blue No. 4 shall be certified 
in accordance with regulations in part 80 of this chapter.



Sec.  74.1109  D&C Blue No. 9.

    (a) Identity. The color additive D&C Blue No. 9 is principally 7,16-
dichloro-6,15 - dihydro - 5,9,14,18 - anthrazine-tetrone.
    (b) Specifications. D&C Blue No. 9 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice:

Volatile matter (at 135 [deg]C.), not more than 3 percent.
Matter extractable by alcoholic HCl (0.1 ml of concentrated hydrochloric 
acid per 50 ml of 95 percent ethyl alcohol), not more than 1 percent.
2-Amino anthraquinone, not more than 0.2 percent.
Organically combined chlorine in pure dye, 13.0-14.8 percent.
Lead (as Pb), not more than 20 p/m.
Arsenic (as As), not more than 3 p/m.
Total color, not less than 97 percent.

    (c) Uses and restrictions. D&C Blue No. 9 may be safely used for 
coloring cotton and silk surgical sutures, including sutures for 
ophthalmic use, subject to the following restrictions:
    (1) The dyed suture shall conform in all respects to the 
requirements of the United States Pharmacopeia XX (1980).
    (2) The quantity of the color additive does not exceed 2.5 percent 
by weight of the suture.
    (3) When the sutures are used for the purposes specified in their 
labeling, the color additive does not migrate to the surrounding tissue.
    (4) If the suture is a new drug, a new-drug application approved 
pursuant to section 505 of the act is in effect for it.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Blue No. 9 shall be certified 
in accordance with regulations in part 80 of this chapter.

[42 FR 15654, Mar. 22, 1977, as amended at 49 FR 10090, Mar. 19, 1984; 
58 FR 17098, Apr. 1, 1993]



Sec.  74.1203  FD&C Green No. 3.

    (a) Identity and specifications. (1) The color additive FD&C Green 
No. 3 shall conform in identity and specifications to the requirements 
of Sec.  74.203(a)(1) and (b).
    (2) Color additive mixtures for drug use made with FD&C Green No. 3 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring drugs.
    (b) Uses and restrictions. The color additive FD&C Green No. 3 may 
be safely used for coloring drugs generally in amounts consistent with 
current good manufacturing practice.

[[Page 489]]

    (c) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of FD&C Green No. 3 shall be 
certified in accordance with regulations in part 80 of this chapter.

[47 FR 52144, Nov. 19, 1982]



Sec.  74.1205  D&C Green No. 5.

    (a) Identity. (1) The color additive D&C Green No. 5 is principally 
the disodium salt of 2,2'-[(9,10-dihydro-9,10-dioxo-1,4-
anthracenediyl)diimino]bis-[5-methylbenzenesulfonic acid] (CAS Reg. No. 
4403-90-1).
    (2) Color additive mixtures for use in drugs made with D&C Green No. 
5 may contain only those diluents that are suitable and those that are 
listed in part 73 of this chapter for use in color additive mixtures for 
coloring drugs.
    (b) Specifications. (1) D&C Green No. 5 for use in coloring surgical 
sutures shall conform to the following specifications and shall be free 
from impurities other than those named to the extent that such 
impurities may be avoided by current good manufacturing practice:

Sum of volatile matter (at 135 [deg]C) and chlorides and sulfates 
(calculated as sodium salts), not more than 20 percent.
Water insoluble matter, not more than 0.2 percent.
1,4-Dihydroxyanthraquinone, not more than 0.2 percent.
2-Amino-m-toluenesulfonic acid, not more than 0.2 percent.
Subsidiary colors, not more than 5 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Total color, not less than 80 percent.

    (2) D&C Green No. 5 for use in coloring drugs shall conform to the 
following specifications and shall be free from impurities other than 
those named to the extent that such other impurities may be avoided by 
current good manufacturing practice:

Sum of volatile matter (at 135 [deg]C) and chlorides and sulfates 
(calculated as sodium salts), not more than 20 percent.
Water-insoluble matter, not more than 0.2 percent.
1,4-Dihydroxyanthraquinone, not more than 0.2 percent.
Sulfonated toluidines, total not more than 0.2 percent.
p-Toluidine, not more than 0.0015 percent.
Sum of monosulfonated D&C Green No. 6 and Ext. D&C Violet No. 2, not 
more than 3 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 80 percent.

    (c) Use and restrictions. (1) D&C Green No. 5 may be safely used to 
color nylon 66 (the copolymer of adipic acid and hexamethylenediamine) 
and/or nylon 6[poly-(e-caprolactam)]nonabsorbable surgical sutures for 
use in general surgery, subject to the following restrictions:
    (i) The quantity of color additive does not exceed 0.6 percent by 
weight of the suture.
    (ii) When the sutures are used for the purposes specified in their 
labeling, there is no migration of the color additive to the surrounding 
tissue.
    (iii) If the suture is a new drug, an approved new drug application, 
under section 505 of the act, is in effect for it.
    (2) D&C Green No. 5 may be safely used for coloring drugs generally, 
including drugs intended for use in the area of the eye, in amounts 
consistent with current good manufacturing practice.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Green No. 5 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 24284, June 4, 1982; 47 FR 27551, June 25, 1982, as amended at 59 
FR 40805, Aug. 10, 1994]



Sec.  74.1206  D&C Green No. 6.

    (a) Identity. The color additive D&C Green No. 6 is 1,4-bis[(4-
methylphenyl)amino]-9,10-anthracenedione (CAS. Reg. No. 128-80-3).
    (b) Specifications. The color additive D&C Green No. 6 for use in 
coloring externally applied drugs shall conform to the following 
specifications and shall

[[Page 490]]

be free from impurities other than those named to the extent that such 
other impurities may be avoided by current good manufacturing practice:

Volatile matter (at 135 [deg]C), not more than 2.0 percent.
Water-soluble matter, not more than 0.3 percent.
Matter insoluble in carbon tetrachloride, not more than 1.5 percent.
p-Toluidine, not more than 0.1 percent.
1,4-Dihydroxyanthraquinone, not more than 0.2 percent.
1-Hydroxy-4-[(4-methylphenyl)amino]-9, 10-anthracenedione, not more than 
5.0 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 96.0 percent.

    (c) Uses and restrictions. The color additive D&C Green No. 6 may be 
safely used for coloring externally applied drugs in amounts consistent 
with current good manufacturing practice.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Green No. 6 shall be certified 
in accordance with regulations promulgated under part 80 of this 
chapter.

[42 FR 15654, Mar. 22, 1977, as amended at 47 FR 14146, Apr. 2, 1982; 47 
FR 24278, June 4, 1982; 51 FR 9784, Mar. 21, 1986]



Sec.  74.1208  D&C Green No. 8.

    (a) Identity. (1) The color additive D&C Green No. 8 is principally 
the trisodium salt of 8-hydroxy-1,3,6-pyrene-trisulfonic acid.
    (2) Color additive mixtures for use in externally applied drugs made 
with D&C Green No. 8 may contain only those diluents that are suitable 
and that are listed in part 73 of this chapter for use in color additive 
mixtures for coloring externally applied drugs.
    (b) Specifications. D&C Green No. 8 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practices:

Volatile matter (at 135 [deg]C), not more than 15 percent.
Water-insoluble matter, not more than 0.2 percent.
Chlorides and sulfates (calculated as sodium salt), not more than 20 
percent.
The trisodium salt of 1,3,6-pyrenetrisulfonic acid, not more than 6 
percent.
The tetrasodium salt of 1,3,6,8-pyrenetetrasulfonic acid, not more than 
1 percent.
Pyrene, not more than 0.2 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 65 percent.

    (c) Uses and restrictions. D&C Green No. 8 may be safely used in 
externally applied drugs in amounts not exceeding 0.01 percent by weight 
of the finished product.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Green No. 8 shall be certified 
in accordance with regulations in part 80 of this chapter.



Sec.  74.1254  D&C Orange No. 4.

    (a) Identity. (1) the color additive D&C Orange No. 4 is principally 
the sodium salt of 4-[(2-hydroxy-1-naphthalenyl)azo]benzenesulfonic 
acid.
    (2) Color additive mixtures for use in externally applied drugs made 
with D&C Orange No. 4 may contain only those diluents that are suitable 
and that are listed in part 73 of this chapter for use in color additive 
mixtures for coloring externally applied drugs.
    (b) Specifications. D&C Orange No. 4 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice.

Sum of volatile matter (at 135 [deg]C) and chlorides and sulfates 
(calculated as sodium salts), not more than 13 percent.
Water-insoluble matter, not more than 0.2 percent.
2-Naphthol, not more than 0.4 percent.
Sulfanilic acid, sodium salt, not more than 0.2 percent.
Subsidiary colors, not more than 3 percent.

[[Page 491]]

4,4'-(Diazoamino)-dibenzenesulfonic acid, not more than 0.1 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 87 percent.

    (c) Uses and restrictions. D&C Orange No. 4 may be safely used for 
coloring externally applied drugs in amounts consistent with good 
manufacturing practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Orange No. 4 shall be 
certified in accordance with regulations in part 80 of this chapter.

[42 FR 52396, Sept. 30, 1977, as amended at 43 FR 14642, Apr. 7, 1978; 
46 FR 8461, Jan. 27, 1981]



Sec.  74.1255  D&C Orange No. 5.

    (a) Identity. (1) the color additive D&C Orange No. 5 is a mixture 
consisting principally the sodium salt of 4',5'-dibromofluorescein (CAS 
Reg. No. 596-03-2) and 2',4',5'-tribromofluorescein (CAS Reg. No. 25709-
83-5) and 2',4',5',7'-tetrabromofluorescein (CAS Reg. No. 15086-94-9). 
D&C Orange No. 5 is manufactured by brominating fluorescein with 
elemental bromine. The fluorescein is manufactured by the acid 
condensation of resorcinol and phthalic acid or its anhydride. The 
fluorescein is isolated and partially purified prior to bromination.
    (2) Color additive mixtures for drug use made with D&C Orange No. 5 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter for use in color additive mixtures for coloring 
drugs.
    (b) Specifications. D&C Orange No. 5 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice.

4',5'-dibromofluorescein, not less than 50 percent and not more than 65 
percent.
2',4',5'-tribromofluorescein, not less than 30 percent and not more than 
40 percent.
2',4',5',7'-tetrabromofluorescein, not more than 10 percent.
Sum of 2',4'-dibromofluorescein and 2',5'-dibromofluorescein, not more 
than 2 percent.
4'-Bromofluorescein, not more than 2 percent.
Fluorescein, not more than 1 percent.
Phthalic acid, not more than 1 percent.
2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.5 
percent.
Brominated resorcinol, not more than 0.4 percent.
Sum of volatile matter (at 135 [deg]C) and halides and sulfates 
(calculated as sodium salts), not more than 10 percent.
Insoluble matter (alkaline solution), not more than 0.3 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 90 percent.

    (c) Uses and restrictions. D&C Orange No. 5 may be safely used for 
coloring mouthwashes and dentifrices that are ingested drugs in amounts 
consistent with current good manufacturing practice. D&C Orange No. 5 
may be safely used in externally applied drugs in amounts not exceeding 
5 milligrams per daily dose of the drug.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Orange No. 5 shall be 
certified in accordance with regulations in part 80 of this chapter.

[47 FR 44635, Nov. 2, 1982, as amended at 49 FR 13342, Apr. 4, 1984]



Sec.  74.1260  D&C Orange No. 10.

    (a) Identity. (1) The color additive D&C Orange No. 10 is a mixture 
consisting principally of 4',5'-diiodofluorescein, 2',4',5'-
triiodofluorescein, and 2',4',5',7'-tetraiodofluorescein.
    (2) Color additive mixtures for drug use made with D&C Orange No. 10 
may contain only those diluents listed in this subpart as safe and 
suitable for use in color additive mixtures for coloring externally 
applied drugs.

[[Page 492]]

    (b) Specifications. D&C Orange No. 10 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such other impurities may be avoided by good 
manufacturing practice:

Sum of volatile matter (at 135 [deg]C) and halides and sulfates 
(calculated as sodium salts), not more than 8 percent.
Insoluble matter (alkaline solution), not more than 0.5 percent.
Phthalic acid, not more than 0.5 percent.
2-[3',5'-Diiodo-2',4'-dihydroxybenzoyl] benzoic acid, not more than 0.5 
percent.
Fluorescein, not more than 1 percent.
4'-Iodofluorescein, not more than 3 percent.
2',4'-Diiodofluorescein and 2',5'-diiodofluorescein, not more than 2 
percent.
2',4',5'-Triiodofluorescein, not more than 35 percent.
2',4',5',7'-Tetraiodofluorescein, not more than 10 percent.
4',5'-Diiodofluorescein, not less than 60 percent and not more than 95 
percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 92 percent.

    (c) Uses and restrictions. D&C Orange No. 10 may be safely used for 
coloring externally applied drugs in amounts consistent with good 
manufacturing practice.
    (d) Labeling requirements. The label of the color additive and any 
mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Certification. All batches of D&C Orange No. 10 shall be 
certified in accordance with regulations in part 80 of this chapter.

[46 FR 18953, Mar. 27, 1981]



Sec.  74.1261  D&C Orange No. 11.

    (a) Identity. (1) The color additive D&C Orange No. 11 is a mixture 
consisting principally of the disodium salts of 4',5'-diiodofluorescein, 
2',4',5'-triiodofluorescein and 2',4',5',7'-tetraiodofluorescein.
    (2) Color additive mixtures for drug use made with D&C Orange No. 11 
may contain only those diluents listed in this subpart as safe and 
suitable for use in color additive mixtures for coloring externally 
applied drugs.
    (b) Specifications. The color additive D&C Orange No. 11 shall 
conform to the following specifications and shall be free from 
impurities other than those named to the extent that such impurities may 
be avoided by good manufacturing practice:

Sum of volatile matter (at 135 [deg]C) and halides and sulfates 
(calculated as sodium salts), not more than 8 percent.
Water-insoluble matter, not more than 0.5 percent.
Phthalic acid, not more than 0.5 percent.
2-[3',5'-Diiodo-2',4'-dihydroxybenzoyl] benzoic acid, sodium salt, not 
more than 0.5 percent.
Fluorescein, disodium salt, not more than 1 percent.
4'-Iodofluorescein, disodium salt, not more than 3 percent.
2',4'-Diiodofluorescein and 2',5'-diiodofluorescein, not more than 2 
percent.
2',4',5'-Triiodofluorescein, not more than 35 percent.
2',4',5',7'-Tetraiodofluorescein, disodium salt, not more than 10 
percent.
4',5'-Diiodofluorescein, disodium salt, not less than 60 percent and not 
more than 95 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 92 percent.

    (c) Uses and restrictions. D&C Orange No. 11 may be safely used for 
coloring externally applied drugs in amounts consistent with good 
manufacturing practice.
    (d) Labeling requirements. The label of the color additive and any 
mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Certification. All batches of D&C Orange No. 11 shall be 
certified in accordance with regulations in part 80 of this chapter.

[46 FR 18953, Mar. 27, 1981]



Sec.  74.1303  FD&C Red No. 3.

    (a) Identity and specifications. (1) The color additive FD&C Red No. 
3 shall conform in identity and specifications to the requirements of 
Sec.  74.303(a)(1) and (b).

[[Page 493]]

    (2) Color additive mixtures for ingested drug used made with FD&C 
Red No. 3 may contain only those diluents that are suitable and that are 
listed in part 73 of this chapter as safe for use in color additive 
mixtures for coloring ingested drugs.
    (b) Uses and restrictions. FD&C Red No. 3 may be safely used for 
coloring ingested drugs in amounts consistent with good manufacturing 
practice.
    (c) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of FD&C Red No. 3 shall be certified 
in accordance with regulations in part 80 of this chapter.



Sec.  74.1304  FD&C Red No. 4.

    (a) Identity. (1) The color additive FD&C Red No. 4 is principally 
the disodium salt of 3-[(2,4-dimethyl-5-sulfophenyl)azo] -4-hydroxy-1-
naphthalenesulfonic acid.
    (2) Color additive mixtures for use in externally applied drugs made 
with FD&C Red No. 4 may contain only those diluents that are suitable 
and that are listed in part 73 of this chapter for use in color additive 
mixtures for coloring externally applied drugs.
    (b) Specifications. FD&C Red No. 4 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice:

Sum of volatile matter (at 135 [deg]C.) and chlorides and sulfates 
(calculated as sodium salts), not more than 13 percent.
Water-insoluble matter, not more than 0.2 percent.
5-Amino-2,4-dimethyl-1-benzenesulfonic acid, sodium salt, not more than 
0.2 percent.
4-Hydroxy-1-naphthalenesulfonic acid, sodium salt, not more than 0.2 
percent.
Subsidiary colors, not more than 2 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 87 percent.

    (c) Uses and restrictions. FD&C Red No. 4 may be safely used in 
externally applied drugs in amounts consistent with good manufacturing 
practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of FD&C Red No. 4 shall be certified 
in accordance with regulations in part 80 of this chapter.



Sec.  74.1306  D&C Red No. 6.

    (a) Identity. (1) The color additive D&C Red No. 6 is principally 
the disodium salt of 3-hydroxy-4-[(4-methyl-2-sulfophenyl)azo]-2-
naphthalenecarboxylic acid (CAS Reg. No. 5858-81-1). To manufacture the 
additive, 2-amino-5-methylbenzenesulfonic acid is diazotized with 
hydrochloric acid and sodium nitrite. The diazo compound is coupled in 
alkaline medium with 3-hydroxy-2-naphthalenecarboxylic acid. The 
resulting dye precipitates as the disodium salt.
    (2) Color additive mixtures for drug use made with D&C Red No. 6 may 
contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring drugs.
    (b) Specifications. The color additive D&C Red No. 6 shall conform 
to the following specifications and shall be free from impurities other 
than those named to the extent that such impurities may be avoided by 
current good manufacturing practice:

Sum of volatile matter (at 135 [deg]C) and chlorides and sulfates 
(calculated as sodium salts), not more than 10 percent.
1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.
2-Amino-5-methylbenzenesulfonic acid, sodium salt, not more than 0.2 
percent.
3-Hydroxy-2-naphthalenecarboxylic acid, sodium salt, not more than 0.4 
percent.
3-Hydroxy-4-[(4-methylphenyl)azo]-2-naphthalenecarboxylic acid, sodium 
salt, not more than 0.5 percent.
p- Toluidine, not more than 15 parts per million.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 90 percent.


[[Page 494]]


    (c) Uses and restrictions. The color additive D&C Red No. 6 may be 
safely used for coloring drugs such that the combined total of D&C Red 
No. 6 and D&C Red No. 7 does not exceed 5 milligrams per daily dose of 
the drug.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Red No. 6 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 57687, Dec. 28, 1982, as amended at 77 FR 39923, July 6, 2012]



Sec.  74.1307  D&C Red No. 7.

    (a) Identity. (1) The color additive D&C Red No. 7 is principally 
the calcium salt of 3-hydroxy-4-[(4-methyl-2-sulfophenyl)azo]-2-
naphthalenecarboxylic acid (CAS Reg. No. 5281-04-9). To manufacture the 
additive, 2-amino-5-methylbenzenesulfonic acid is diazotized with 
hydrochloric acid and sodium nitrite. The diazo compound is coupled in 
alkaline medium with 3-hydroxy-2-naphthalenecarboxylic acid and the 
resulting dye converted to the calcium salt with calcium chloride.
    (2) Color additive mixtures for drug use made with D&C Red No. 7 may 
contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring drugs.
    (b) Specifications. The color additive D&C Red No. 7 shall conform 
to the following specifications and shall be free from impurities other 
than those named to the extent that such impurities may be avoided by 
current good manufacturing practice:

Sum of volatile matter (at 135 [deg]C) and chlorides and sulfates 
(calculated as sodium salts), not more than 10 percent.
1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.
2-Amino-5-methylbenzenesulfonic acid, calcium salt, not more than 0.2 
percent.
3-Hydroxy-2-naphthalenecarboxylic acid, calcium salt, not more than 0.4 
percent.
3-Hydroxy-4-[(4-methylphenyl)azo]-2-naphthalenecarboxylic acid, calcium 
salt, not more than 0.5 percent.
p-Toluidine, not more than 15 parts per million.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 90 percent.

    (c) Uses and restrictions. The color additive D&C Red No. 7 may be 
safely used for coloring drugs such that the combined total of D&C Red 
No. 6 and D&C Red No. 7 does not exceed 5 milligrams per daily dose of 
the drug.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Red No. 7 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 57687, Dec. 28, 1982, as amended at 77 FR 39923, July 6, 2012]



Sec.  74.1317  D&C Red No. 17.

    (a) Identity. (1) The color additive D&C Red No. 17 is principally 
1-[[4-(phenylazo)phenyl]azo]-2-naphthalenol.
    (2) Color additive mixtures for drug use made with D&C Red No. 17 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring externally applied drugs.
    (b) Specifications. D&C Red No. 17 shall conform to the following 
specifications and shall be free from impurities, other than those 
named, to the extent that such other impurities may be avoided by good 
manufacturing practice:

Volatile matter (at 135 [deg]C), not more than 5 percent.
Matter insoluble in both toluene and water (color additive mixed in 
toluene and the resultant residue isolated and mixed with water to 
obtain the matter insoluble in both toluene and water), not more than 
0.5 percent.
Chlorides and sulfates (calculated as sodium salts), not more than 3 
percent.
Aniline, not more than 0.2 percent.
4-Aminoazobenzene, not more than 0.1 percent.
2-Naphthol, not more than 0.2 percent.
1-(Phenylazo)-2-naphthol, not more than 3 percent.
1-[[2-(phenylazo) phenyl]azo]-2-naphthalenol, not more than 2 percent.

[[Page 495]]

Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 90 percent.

    (c) Uses and restrictions. D&C Red No. 17 may be safely used in 
externally applied drugs in amounts consistent with good manufacturing 
practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Red No. 17 shall be certified 
in accordance with regulations in part 80 of this chapter.

[42 FR 15654, Mar. 22, 1977, as amended at 42 FR 27225, May 27, 1977]



Sec.  74.1321  D&C Red No. 21.

    (a) Identity. (1) The color additive D&C Red No. 21 is principally 
2',4',5',7'-tetrabromofluorescein (CAS Reg. No. 15086-94-9), and may 
contain smaller amounts of 2',4',5'-tribromofluorescein (CAS Reg. No. 
25709-83-5) and 2',4',7'-tribromofluorescein (CAS Reg. No. 25709-84-6). 
The color additive is manufactured by brominating fluorescein with 
elemental bromine. The fluorescein is manufactured by the acid 
condensation of resorcinol and phthalic acid or its anhydride. The 
fluorescein is isolated and partially purified prior to bromination.
    (2) Color additive mixtures for drug use made with D&C Red No. 21 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring drugs.
    (b) Specifications. The color additive D&C Red No. 21 shall conform 
to the following specifications and shall be free from impurities other 
than those named to the extent that such impurities may be avoided by 
current good manufacturing practice:

Sum of volatile matter (at 135 [deg]C) and halides and sulfates 
(calculated as sodium salts), not more than 10 percent.
Insoluble matter (alkaline solution), not more than 0.5 percent.
Phthalic acid, not more than 1 percent.
2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.5 
percent.
2',4',5',7'-Tetrabromofluorescein, ethyl ester, not more than 1 percent.
Brominated resorcinol, not more than 0.4 percent.
Fluorescein, not more than 0.2 percent.
Sum of mono- and dibromofluoresceins, not more than 2 percent.
Tribromofluoresceins, not more than 11 percent.
2',4',5',7'-Tetrabromofluorescein, not less than 87 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 90 percent.

    (c) Uses and restrictions. The color additive D&C Red No. 21 may be 
safely used for coloring drugs generally in amounts consistent with 
current good manufacturing practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Red No. 21 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 53846, Nov. 30, 1982]



Sec.  74.1322  D&C Red No. 22.

    (a) Identity. (1) The color additive D&C Red No. 22 is principally 
the disodium salt of 2',4',5'7'-tetrabromofluorescein (CAS Reg. No. 
17372-87-1) and may contain smaller amounts of the disodium salts of 
2',4',5'-tribromofluorescein and 2',4',7'-tribromofluorescein. The color 
additive is manufactured by alkaline hydrolysis of 2',4',5',7'-
tetrabromofluorescein. 2',4',5',7'-Tetrabromofluorescein is manufactured 
by brominating fluorescein with elemental bromine. The fluorescein is 
manufactured by the acid condensation of resorcinol and phthalic acid or 
its anhydride. Fluorescein is isolated and partially purified prior to 
bromination.
    (2) Color additive mixtures for drug use made with Red No. 22 may 
contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring drugs.

[[Page 496]]

    (b) Specifications. The color additive D&C Red No. 22 shall conform 
to the following specifications and shall be free from impurities other 
than those named to the extent that such impurities may be avoided by 
current good manufacturing practice:

Sum of volatile matter (at 135 [deg]C) and halides and sulfates 
(calculated as soduim salts), not more than 10 percent.
Water-insoluble matter not more than 0.5 percent.
Disodium salt of phthalic acid, not more than 1 percent.
Sodium salt of 2-(3,5-Dibromo-2,4-dihydroxybenzoyl)benzoic acid, not 
more than 0.5 percent.
2',4',5',7'-Tetrabromofluorescein, ethyl ester, not more than 1 percent.
Brominated resorcinol, not more than 0.4 percent.
Sum of disodium salts of mono- and dibromofluoresceins, not more than 2 
percent.
Sum of disodium salts of tribromofluoresceins, not more than 25 percent.
Disodium salt of 2',4',5',7'-Tetrabromofluorescein, not less than 72 
percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 90 percent.

    (c) Uses and restrictions. The color additive D&C Red No. 22 may be 
safely used for coloring drugs generally in amounts consistent with 
current good manufacturing practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Red No. 22 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 53846, Nov. 30, 1982]



Sec.  74.1327  D&C Red No. 27.

    (a) Identity. (1) The color additive D&C Red No. 27 is principally 
2',4',5',7'-tetrabromo-4,5,6,7-tetrachlorofluorescein (CAS Reg. No. 
13473-26-2). The color additive is manufactured by brominating 4,5,6,7-
tetrachlorofluorescein with elemental bromine. The 4,5,6,7-
tetrachlorofluorescein is manufactured by the acid condensation of 
resorcinol and tetrachlorophthalic acid or its anhydride. The 4,5,6,7-
tetrachlorofluorescein is isolated and partially purified prior to 
bromination.
    (2) Color additive mixtures for drug use made with D&C Red No. 27 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring drugs.
    (b) Specifications. D&C Red No. 27 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by current good 
manufacturing practice:

Sum of volatile matter (at 135 [deg]C) and halides and sulfates 
(calculated as sodium salts), not more than 10 percent.
Insoluble matter (alkaline solution), not more than 0.5 percent.
Tetrachlorophthalic acid, not more than 1.2 percent.
Brominated resorcinol, not more than 0.4 percent.
2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-dihydroxybenzoyl) benzoic acid, 
not more than 0.7 percent.
2',4',5',7'-Tetrabromo-4,5,6,7-tetrachlorofluorescein, ethyl ester, not 
more than 2 percent.
Lower halogenated subsidiary colors, not more than 4 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 90 percent.

    (c) Uses and restrictions. D&C Red No. 27 may be safely used for 
coloring drugs generally in amounts consistent with current good 
manufacturing practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Red No. 27 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 42567, Sept. 28, 1982; 47 FR 51106, Nov. 12, 1982]

[[Page 497]]



Sec.  74.1328  D&C Red No. 28.

    (a) Identity. (1) The color additive D&C Red No. 28 is principally 
the disodium salt of 2',4',5',7'-tetrabromo-4,5,6,7-
tetrachlorofluorescein (CAS Reg. No. 18472-87-2) formed by alkaline 
hydrolysis of the parent tetrabromotetrachlorofluorescein.
    (2) Color additive mixtures for drug use made with D&C Red No. 28 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring drugs.
    (b) Specifications. D&C Red No. 28 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by current good 
manufacturing practice:

Sum of volatile matter (at 135 [deg]C) and halides and sulfates 
(calculated as sodium salts), not more than 15 percent.
Insoluble matter (alkaline solution), not more than 0.5 percent.
Tetrachlorophthalic acid, not more than 1.2 percent.
Brominated resorcinol, not more than 0.4 percent.
2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-dihydroxybenzoyl)benzoic acid, 
not more than 0.7 percent.
2',4',5',7'-Tetrabromo-4,5,6,7-tetrachlorofluorescein, ethyl ester, not 
more than 2 percent.
Lower halogenated subsidiary colors, not more than 4 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 85 percent.

    (c) Uses and restrictions. D&C Red No. 28 may be safely used for 
coloring drugs generally in amounts consistent with current good 
manufacturing practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Red No. 28 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 42568, Sept. 28, 1982]



Sec.  74.1330  D&C Red No. 30.

    (a) Identity. (1) The color additive D&C Red No. 30 is principally 
6-chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-
methyl-benzo[b]thiophen-3(2H)-one (CAS Reg. No. 2379-74-0).
    (2) Color additive mixtures for drug use made with D&C Red No. 30 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring drugs.
    (b) Specifications. D&C Red No. 30 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by current good 
manufacturing practice:

Volatile matter (at 135 [deg]C), not more than 5 percent.
Chlorides and sulfates (calculated as sodium salts), not more than 3 
percent.
Matter soluble in acetone, not more than 5 percent.
Total color, not less than 90 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.

    (c) Uses and restrictions. D&C Red No. 30 may be safely used for 
coloring drugs generally in amounts consistent with current good 
manufacturing practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Red No. 30 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 22510, May 25, 1982]



Sec.  74.1331  D&C Red No. 31.

    (a) Identity. (1) The color additive D&C Red No. 31 is principally 
the calcium salt of 3-hydroxy-4-(phenylazo)-2-naphthalenecarboxylic 
acid.
    (2) Color additive mixtures for drug use made with D&C Red No. 31 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color

[[Page 498]]

additive mixtures for coloring externally applied drugs.
    (b) Specifications. D&C Red No. 31 shall conform to the following 
specifications and shall be free from impurities, other than those 
named, to the extent that such other impurities may be avoided by good 
manufacturing practice:

Sum of volatile matter (at 135 [deg]C) and chlorides and sulfates 
(calculated as sodium salts), not more than 10 percent.
Aniline, not more than 0.2 percent.
3-Hydroxy-2-naphthoic acid, calcium salt, not more than 0.4 percent.
Subsidiary colors, not more than 1 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 90 percent.

    (c) Uses and restrictions. D&C Red No. 31 may be safely used in 
externally applied drugs in amounts consistent with good manufacturing 
practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Red No. 31 shall be certified 
in accordance with regulations in part 80 of this chapter.



Sec.  74.1333  D&C Red No. 33.

    (a) Identity. (1) The color additive D&C Red No. 33 is principally 
the disodium salt of 5-amino-4-hydroxy-3-(phenylazo)-2,7-
naphthalenedisulfonic acid (CAS Reg. No. 3567-66-6). To manufacture the 
additive, the product obtained from the nitrous acid diazotization of 
aniline is coupled with 4-hydroxy-5-amino-2,7-naphthalenedisulfonic acid 
in an alkaline aqueous medium. The color additive is isolated as the 
sodium salt.
    (2) Color additive mixtures for drug use made with D&C Red No. 33 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring drugs.
    (b) Specifications. D&C Red No. 33 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by current good 
manufacturing practices:

Sum of volatile matter at 135 [deg]C (275 [deg]F) and chlorides and 
sulfates (calculated as sodium salts), not more than 18 percent.
Water-insoluble matter, not more than 0.3 percent.
4-Amino-5-hydroxy-2,7-naphthalenedisulfonic acid, disodium salt, not 
more than 0.3 percent.
4,5-Dihydroxy-3-(phenylazo)-2,7-naphthalenedisulfonic acid, disodium 
salt, not more than 3.0 percent.
Aniline, not more than 25 parts per million.
4-Aminoazobenzene, not more than 100 parts per billion.
1,3-Diphenyltriazene, not more than 125 parts per billion.
4-Aminobiphenyl, not more than 275 parts per billion.
Azobenzene, not more than 1 part per million.
Benzidine, not more than 20 parts per billion.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 82 percent.

    (c) Uses and restrictions. The color additive D&C Red. No 33 may be 
safely used for coloring ingested drugs, other than mouthwashes and 
dentifrices, in amounts not to exceed 0.75 milligram per daily dose of 
the drug. D&C Red No. 33 may be safely used for coloring externally 
applied drugs, mouthwashes, and dentifrices in amounts consistent with 
current good manufacturing practice.
    (d) Labeling requirements. The label of the color additive and any 
mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Certification. All batches of D&C Red No. 33 shall be certified 
in accordance with regulations in part 80 of this chapter.

[53 FR 33120, Aug. 30, 1988]



Sec.  74.1334  D&C Red No. 34.

    (a) Identity. (1) The color additive D&C Red No. 34 is principally 
the calcium salt of 3-hydroxy-4-[(1-sulfo-2-naphthalenyl)azo]-2-
naphthalene-carboxylic acid.

[[Page 499]]

    (2) Color additive mixtures for drug use made with D&C Red No. 34 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring externally applied drugs.
    (b) Specifications. D&C Red No. 34 shall conform to the following 
specifications and shall be free from impurities, other than those 
named, to the extent that such other impurities may be avoided by good 
manufacturing practice:

Sum of volatile matter (at 135 [deg]C) and chlorides and sulfates 
(calculated at sodium salts), not more than 15 percent.
2-Amino-1-naphthalenesulfonic acid, calcium salt, not more than 0.2 
percent.
3-Hydroxy-2-naphthoic acid, not more than 0.4 percent.
Subsidiary colors, not more than 4 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color not less than 85 percent.

    (c) Uses and restrictions. The color additive D&C Red No. 34 may be 
safely used for coloring externally applied drugs in amounts consistent 
with good manufacturing practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Red No. 34 shall be certified 
in accordance with regulations in part 80 of this chapter.



Sec.  74.1336  D&C Red No. 36.

    (a) Identity. (1) The color additive D&C Red No. 36 is 1-[(2-chloro-
4-nitrophenyl)azo]-2-naphthalenol (CAS Reg. No. 2814-77-9). The color 
additive is manufactured by diazotization of 2-chloro-4-nitrobenzenamine 
in acid medium and coupling with 2-naphthalenol in acid medium.
    (2) Color additive mixtures for drug use made with D&C Red No. 36 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring drugs.
    (b) Specifications. D&C Red No. 36 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by current good 
manufacturing practice:

Volatile matter at 135 [deg]C (275 [deg]F), not more than 1.5 percent.
Matter insoluble in toluene, not more than 1.5 percent.
2-Chloro-4-nitrobenzenamine, not more than 0.3 percent.
2-Naphthalenol, not more than 1 percent.
2,4-Dinitrobenzenamine, not more than 0.02 percent.
1-[(2,4-Dinitrophenyl)azo]-2-naphthalenol, not more than 0.5 percent.
4-[(2-Chloro-4-nitrophenyl)azo]-1-naphthalenol, not more than 0.5 
percent.
1-[(4-Nitrophenyl)azo]-2-naphthalenol, not more than 0.3 percent.
1-[(4-Chloro-2-nitrophenyl)azo]-2-naphthalenol, not more than 0.3 
percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 95 percent.

    (c) Uses and restrictions. The color additive D&C Red No. 36 may be 
safely used for coloring ingested drugs, other than mouthwashes and 
dentifrices, in amounts not to exceed 1.7 milligrams per daily dose of 
the drug for drugs that are taken continuously only for less than 1 
year. For drugs taken continuously for longer than 1 year, the color 
additive shall not be used in amounts to exceed 1.0 milligram per daily 
dose of the drug. D&C Red No. 36 may be safely used for coloring 
externally applied drugs in amounts consistent with current good 
manufacturing practice.
    (d) Labeling requirements. The label of the color additive and any 
mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (e) Certification. All batches of D&C Red No. 36 shall be certified 
in accordance with regulations in part 80 of this chapter.

[53 FR 29031, Aug. 2, 1988; 53 FR 35255, Sept. 12, 1988, as amended at 
53 FR 52130, Dec. 27, 1988]

[[Page 500]]



Sec.  74.1339  D&C Red No. 39.

    (a) Identity. (1) The color additive D&C Red No. 39 is o-
[p([beta],[beta]'-dihydroxy-diethylamino)-phenylazo]-benzoic acid.
    (2) Color additive mixtures made with D&C Red No. 39 may contain the 
following diluents: Water, acetone, isopropyl alcohol, and specially 
denatured alcohols used in accordance with 26 CFR part 212.
    (b) Specifications. D&C Red No. 39 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such other impurities may be avoided by good 
manufacturing practice:

Volatile matter (at 100 [deg]C.), not more than 2.0 percent.
Matter insoluble in acetone, not more than 1.0 percent.
Anthranilic acid, not more than 0.2 percent.
N,N-([beta],[beta]'-Dihydroxy-diethyl) aniline, not more than 0.2 
percent.
Subsidiary colors, not more than 3.0 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Total color, not less than 95.0 percent.

    (c) Uses and restrictions. The color additive D&C Red No. 39 may be 
safely used for the coloring of quaternary ammonium type germicidal 
solutions intended for external application only, and subject to the 
further restriction that the quantity of the color additive does not 
exceed 0.1 percent by weight of the finished drug product.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom and intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Red No. 39 shall be certified 
in accordance with regulations promulgated under part 80 of this 
chapter.



Sec.  74.1340  FD&C Red No. 40.

    (a) Identity and specifications. (1) The color additive FD&C Red No. 
40 shall conform in identity and specifications to the requirements of 
Sec.  74.340(a)(1) and (b).
    (2) Color additive mixtures for drug use made with FD&C Red No. 40 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring drugs.
    (3) The listing of this color additive includes lakes prepared as 
described in Sec. Sec.  82.51 and 82.1051 of this chapter, except that 
the color additive used is FD&C Red No. 40 and the resultant lakes meet 
the specification and labeling requirements prescribed by Sec. Sec.  
82.51 or 82.1051 of this chapter.)
    (b) Uses and restrictions. (1) FD&C Red No. 40 and FD&C Red No. 40 
Aluminum Lake may be safely used in coloring drugs, including those 
intended for use in the area of the eye, subject to the restrictions on 
the use of color additives in Sec.  70.5(b) and (c) of this chapter, in 
amounts consistent with current good manufacturing practice.
    (2) Other lakes of FD&C Red No. 40 may be safely used in coloring 
drugs, subject to the restrictions on the use of color additives in 
Sec.  70.5 of this chapter, in amounts consistent with current good 
manufacturing practice.
    (c) Labeling. The label of the color additive and any lakes or 
mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (d) Certification. All batches of FD&C Red No. 40 and lakes thereof 
shall be certified in accordance with regulations, in part 80 of this 
chapter.

[42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994]



Sec.  74.1602  D&C Violet No. 2.

    (a) Identity. (1) The color additive D&C Violet No. 2 is principally 
1-hydroxy -4-[(4-methylphenyl)amino]-9,10-anthracenedione.
    (2) Color additive mixtures for use in externally applied drugs made 
with D&C Violet No. 2 may contain only those diluents that are suitable 
and that are listed in part 73 of this chapter as safe for use in color 
additive mixtures for coloring externally applied drugs.
    (b) Specifications. D&C Violet No. 2 shall conform to the following 
specifications and shall be free from impurities, other than those 
named, to the extent that such other impurities can be avoided by good 
manufacturing practice:


[[Page 501]]


Volatile matter (at 135 [deg]C.), not more than 2.0 percent.
Matter insoluble in both carbon tetrachloride and water, not more than 
0.5 percent.
p- Toluidine, not more than 0.2 percent.
1-Hydroxy-9,10-anthracenedione, not more than 0.5 percent.
1,4-Dihydroxy-9,10-anthracenedione, not more than 0.5 percent.
Subsidiary colors, not more than 1.0 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Total color, not less than 96.0 percent.

    (c) Uses and restrictions. The color additive D&C Violet No. 2 may 
be safely used for coloring externally applied drugs in amounts 
consistent with good manufacturing practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Violet No. 2 shall be 
certified in accordance with regulations in part 80 of this chapter.

[42 FR 15654, Mar. 22, 1977, as amended at 45 FR 62978, Sept. 23, 1980; 
55 FR 18868, May 7, 1990]



Sec.  74.1705  FD&C Yellow No. 5.

    (a) Identity and specifications. (1) The color additive FD&C Yellow 
No. 5 shall conform in identity and specifications to the requirements 
of Sec.  74.705 (a)(1) and (b).
    (2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance 
with the requirements of Sec.  82.51 of this chapter.
    (3) Color additive mixtures for drug use made with FD&C Yellow No. 5 
may contain only those diluents that are suitable and are listed in part 
73 of this chapter as safe for use in color additive mixtures for 
coloring drugs.
    (b) Uses and restrictions. (1) FD&C Yellow No. 5 may be safely used 
for coloring drugs generally, including drugs intended for use in the 
area of the eye, in amounts consistent with current good manufacturing 
practice.
    (2) FD&C Yellow No. 5 Aluminum Lake may be safely used for coloring 
drugs intended for use in the area of the eye, when prepared in 
accordance with Sec.  82.51 of this chapter.
    (c) Labeling requirements. (1) The label of the color additive and 
any mixtures intended solely or in part for coloring purposes prepared 
therefrom shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (2) The label of OTC and prescription drug products intended for 
human use administered orally, nasally, rectally, or vaginally, or for 
use in the area of the eye, containing FD&C Yellow No. 5 shall 
specifically declare the presence of FD&C Yellow No. 5 by listing the 
color additive using the names FD&C Yellow No. 5 and tartrazine. The 
label shall bear a statement such as ``Contains FD&C Yellow No. 5 
(tartrazine) as a color additive'' or ``Contains color additives 
including FD&C Yellow No. 5 (tartrazine).'' The labels of certain drug 
products subject to this labeling requirement that are also cosmetics, 
such as: antibacterial mouthwashes and fluoride toothpastes, need not 
comply with this requirement provided they comply with the requirements 
of Sec.  701.3 of this chapter.
    (3) For prescription drugs for human use containing FD&C Yellow No. 
5 that are administered orally, nasally, vaginally, or rectally, or for 
use in the area of the eye, the labeling required by Sec.  201.100(d) of 
this chapter shall, in addition to the label statement required under 
paragraph (c)(2) of this section, bear the warning statement ``This 
product contains FD&C Yellow No. 5 (tartrazine) which may cause 
allergic-type reactions (including bronchial asthma) in certain 
susceptible persons. Although the overall incidence of FD&C Yellow No. 5 
(tartrazine) sensitivity in the general population is low, it is 
frequently seen in patients who also have aspirin hypersensitivity.'' 
This warning statement shall appear in the ``Precautions'' section of 
the labeling.
    (d) Certification. All batches of FD&C Yellow No. 5 shall be 
certified in accordance with regulations in part 80 of this chapter.

[42 FR 15654, Mar. 22, 1977, as amended at 44 FR 37220, June 26, 1979; 
50 FR 35782, Sept. 4, 1985; 51 FR 24519, July 7, 1986; 59 FR 60897, Nov. 
29, 1994]

[[Page 502]]



Sec.  74.1706  FD&C Yellow No. 6.

    (a) Identity and specifications. (1) The color additive FD&C Yellow 
No. 6 shall conform in identity and specifications to the requirements 
of Sec.  74.706(a)(1) and (b).
    (2) Color additive mixtures for drug use made with FD&C Yellow No. 6 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring drugs.
    (b) Uses and restrictions. FD&C Yellow No. 6 may be safely used for 
coloring drugs generally in amounts consistent with current good 
manufacturing practice.
    (c) Labeling requirements. (1) The label of the color additive and 
any mixtures intended solely or in part for coloring purposes prepared 
therefrom shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (2) [Reserved]
    (d) Certification. All batches of FD&C Yellow No. 6 shall be 
certified in accordance with regulations in part 80 of this chapter.

[51 FR 41782, Nov. 19, 1986, as amended at 52 FR 21508, June 8, 1987; 53 
FR 49138, Dec. 6, 1988]



Sec.  74.1707  D&C Yellow No. 7.

    (a) Identity. (1) The color additive D&C Yellow No. 7 is principally 
fluorescein.
    (2) Color additive mixtures for use in externally applied drugs made 
with D&C Yellow No. 7 may contain only those diluents that are suitable 
and that are listed in part 73 of this chapter for use in color additive 
mixtures for coloring externally applied drugs.
    (b) Specifications. D&C Yellow No. 7 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice:

Sum of water and chlorides and sulfates (calculated as sodium salts), 
not more than 6 percent.
Matter insoluble in alkaline water, not more than 0.5 percent.
Resorcinol, not more than 0.5 percent.
Phthalic acid, not more than 0.5 percent.
2-2,4-(Dihydroxybenzoyl) benzoic acid, not more than 0.5 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 94 percent.

    (c) Uses and restrictions. D&C Yellow No. 7 may be safely used in 
externally applied drugs in amounts consistent with good manufacturing 
practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Yellow No. 7 shall be 
certified in accordance with regulations in part 80 of this chapter.



Sec.  74.1707a  Ext. D&C Yellow No. 7.

    (a) Identity. (1) The color additive Ext. D&C Yellow No. 7 is 
principally the disodium salt of 8-hydroxy-5,7-di-nitro-2-
naphthalenesulfonic acid.
    (2) Color additive mixtures for drug use made with Ext. D&C Yellow 
No. 7 may contain only those diluents that are suitable and that are 
listed in part 73 of this chapter as safe for use in color additive 
mixtures for coloring externally applied drugs.
    (b) Specifications. Ext. D&C Yellow No. 7 shall conform to the 
following specifications and shall be free from impurities, other than 
those named, to the extent that such other impurities may be avoided by 
good manufacturing practice:

Sum of volatile matter (at 135 [deg]C) and chlorides and sulfates 
(calculated as sodium salts), not more than 15 percent.
Water-insoluble matter, not more than 0.2 percent.
1-Naphthol, not more than 0.2 percent.
2,4-Dinitro-1-naphthol, not more than 0.03 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 85 percent.

    (c) Uses and restrictions. Ext. D&C Yellow No. 7 may be safely used 
in externally applied drugs in amounts consistent with good 
manufacturing practice.

[[Page 503]]

    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of Ext. D&C Yellow No. 7 shall be 
certified in accordance with regulations in part 80 of this chapter.



Sec.  74.1708  D&C Yellow No. 8.

    (a) Identity. (1) The color additive D&C Yellow No. 8 is principally 
the disodium salt of fluorescein.
    (2) Color additive mixtures for use in externally applied drugs made 
with D&C Yellow No. 8 may contain only those diluents that are suitable 
and that are listed in part 73 of this chapter for use in color additive 
mixtures for coloring externally applied drugs.
    (b) Specifications. D&C Yellow No. 8 shall be free from impurities 
other than those named to the extent that such impurities may be avoided 
by good manufacturing practice:

Sum of water and chlorides and sulfates (calculated as sodium salts), 
not more than 15 percent.
Matter insoluble in alkaline water, not more than 0.3 percent.
Resorcinol, not more than 0.5 percent.
Phthalic acid, not more than 1 percent.
2-(2,4-Dihydroxybenzoyl) benzoic acid, not more than 0.5 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 85 percent.

    (c) Uses and restrictions. D&C Yellow No. 8 may be safely used in 
externally applied drugs in amounts consistent with good manufacturing 
practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Yellow No. 8 shall be 
certified in accordance with regulations in part 80 of this chapter.



Sec.  74.1710  D&C Yellow No. 10.

    (a) Identity. (1) The color additive D&C Yellow No. 10 is a mixture 
of the sodium salts of the mono- and disulfonic acids of 2-(2-
quinolinyl)-1H-indene-1,3 (2H)-dione consisting principally of the 
sodium salts of 2-(2,3-dihydro-1,3-dioxo-1H-indene-2-yl)-6-
quinolinesulfonic acid and 2-(2,3-dihydro-1,3-dioxo-1H-indene-2-yl)-8-
quinolinesulfonic acid with lesser amounts of the disodium salts of the 
disulfonic acids of 2-(2-quinolinyl)-1H-indene-1,3(2H)-dione (CAS Reg. 
No. 8004-92-0). D&C Yellow No. 10 is manufactured by condensing 
quinaldine with phthalic anhydride to give the unsulfonated dye, which 
is then sulfonated with oleum.
    (2) Color additive mixtures made with D&C Yellow No. 10 for drug use 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring drugs.
    (b) Specifications. The color additive D&C Yellow No. 10 shall 
conform to the following specifications and shall be free from 
impurities other than those named to the extent that such other 
impurities may be avoided by current good manufacturing practice:

Sum of volatile matter at 135 [deg]C (275 [deg]F) and chlorides and 
sulfates (calculated as sodium salts), not more than 15 percent.
Matter insoluble in both water and chloroform, not more than 0.2 
percent.
Total sulfonated quinaldines, sodium salts, not more than 0.2 percent.
Total sulfonated phthalic acids, sodium salts, not more than 0.2 
percent.
2-(2-Quinolinyl)-1H-indene-1,3 (2H)-dione, not more than 4 parts per 
million.
Sum of sodium salts of the monosulfonates of 2-(2-quinolinyl)-1H-indene-
1,3 (2H)-dione, not less than 75 percent.
Sum of sodium salts of the disulfonates of 2-(2-quinolinyl)-1H-indene-
1,3 (2H)-dione, not more than 15 percent.
2-(2,3-Dihydro-1,3-dioxo-1H-indene-2-yl)-6, 8-quinolinedisulfonic acid, 
disodium salt, not more than 3 percent.
Diethyl ether soluble matter other than that specified, not more than 2 
parts per million, using added 2-(2-quinolinyl)-1H-indene-1,3 (2H)-dione 
for calibration.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 85 percent.

    (c) Uses and restrictions. The color additive D&C Yellow No. 10 may 
be safely

[[Page 504]]

used for coloring drugs generally in amounts consistent with current 
good manufacturing practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom and intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Yellow No. 10 shall be 
certified in accordance with regulations in part 80 of this chapter.

[48 FR 39219, Aug. 30, 1983, as amended at 49 FR 8432, Mar. 7, 1984]



Sec.  74.1711  D&C Yellow No. 11.

    (a) Identity. (1) The color additive D&C Yellow No. 11 is 
principally 2-(2-quinolyl)-1,3-indandione.
    (2) Color additive mixtures, for drug use made with D&C Yellow No. 
11 may contain only those diluents that are suitable and that are listed 
in part 73 of this chapter as safe for use in color additive mixtures 
for coloring externally applied drugs.
    (b) Specifications. D&C Yellow No. 11 shall conform to the following 
specifications and shall be free from impurities, other than those 
named, to the extent that such other impurities may be avoided by good 
manufacturing practice:

Volatile matter (at 135 [deg]C), not more than 1 percent.
Ethyl alcohol-insoluble matter, not more than 0.4 percent.
Phthalic acid, not more than 0.3 percent.
Quinaldine, not more than 0.2 percent.
Subsidiary colors, not more than 5 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 96 percent.

    (c) Uses and restrictions. D&C Yellow No. 11 may be safely used in 
externally applied drugs in amounts consistent with good manufacturing 
practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Yellow No. 11 shall be 
certified in accordance with regulations in part 80 of this chapter.



                           Subpart C_Cosmetics



Sec.  74.2052  D&C Black No. 2.

    (a) Identity. The color additive D&C Black No. 2 is a high-purity 
carbon black prepared by the oil furnace process. It is manufactured by 
the combustion of aromatic petroleum oil feedstock and consists 
essentially of pure carbon, formed as aggregated fine particles with a 
surface area range of 200 to 260 meters (m)\2\/gram.
    (b) Specifications. D&C Black No. 2 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such other impurities may be avoided by good 
manufacturing practice:
    (1) Surface area by nitrogen BET (Brunauer, Emmett, Teller) method, 
200 to 260 m\2\/gram.
    (2) Weight loss on heating at 950 [deg]C for 7 minutes (predried for 
1 hour at 125 [deg]C), not more than 2 percent.
    (3) Ash content, not more than 0.15 percent.
    (4) Arsenic (total), not more than 3 milligrams per kilogram (mg/kg) 
(3 parts per million).
    (5) Lead (total), not more than 10 mg/kg (10 parts per million).
    (6) Mercury (total), not more than 1 mg/kg (1 part per million).
    (7) Total sulfur, not more than 0.65 percent.
    (8) Total PAHs, not more than 0.5 mg/kg (500 parts per billion).
    (9) Benzo[a]pyrene, not more than 0.005 mg/kg (5 parts per billion).
    (10) Dibenz[a,h]anthracene, not more than 0.005 mg/kg (5 parts per 
billion).
    (11) Total color (as carbon), not less than 95 percent.
    (c) Uses and restrictions. D&C Black No. 2 may be safely used for 
coloring the following cosmetics in amounts consistent with current good 
manufacturing practice: Eyeliner, brush-on-brow, eye shadow, mascara, 
lipstick, blushers and rouge, makeup and foundation, and nail enamel.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.

[[Page 505]]

    (e) Certification. All batches of D&C Black No. 2 shall be certified 
in accordance with regulations in part 80 of this chapter.

[69 FR 44930, July 28, 2004, as amended at 72 FR 10357]



Sec.  74.2053  D&C Black No. 3.

    (a) Identity. The color additive D&C Black No. 3 is a washed bone 
char prepared from calcined cattle bones. The bones are twice heated in 
excess of 700 [deg]C for at least 6 hours.
    (b) Specifications. D&C Black No. 3 shall conform to the following 
specifications and shall be free from impurities other than those named, 
to the extent that such other impurities may be avoided by current good 
manufacturing practices:
    (1) Calcium hydroxyapatite (CaO and P2O5), not 
less than 75 percent and not more than 84 percent;
    (2) Elemental carbon, not less than 7 percent;
    (3) Moisture, not more than 7 percent;
    (4) Silica (SiO2), not more than 5 percent;
    (5) Arsenic, not more than 3 milligrams (mg)/kilogram (kg) (3 parts 
per million (ppm));
    (6) Lead, not more than 10 mg/kg (10 ppm); and
    (7) Total polycyclic aromatic hydrocarbons (PAHs), not more than 5 
mg/kg (5 ppm).
    (c) Uses and restrictions. Cosmetics containing D&C Black No. 3 must 
comply with Sec.  700.27 of this chapter with respect to prohibited 
cattle materials in cosmetic products. D&C Black No. 3 may be safely 
used for coloring the following cosmetics in amounts consistent with 
current good manufacturing practice: Eyeliner, eye shadow, mascara, and 
face powder.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Black No. 3 shall be certified 
in accordance with regulations in part 80 of this chapter.

[72 FR 33666, June 19, 2007]



Sec.  74.2101  FD&C Blue No. 1.

    (a) Identity. The color additive FD&C Blue No. 1 is principally the 
disodium salt of ethyl[4-[p-[ethyl(m-sulfobenzyl)amino]-[alpha]-(o-
sulfophenyl)benzylidene]-2,5-cyclohexadien-1-ylidene](m-
sulfobenzyl)ammonium hydroxide inner salt with smaller amounts of the 
isomeric disodium salts of ethyl[4-[p-[ethyl(p-sulfobenzyl)amino]-
[alpha]-(o-sulfophenyl)benzylidene]-2,5-cyclohexadien-1-ylidene](p-
sulfobenzyl)ammonium hydroxide inner salt and ethyl[4-[p-[ethyl(o-
sulfobenzyl)amino]-[alpha]-(o-sulfophenyl)benzylidene]-2,5-
cyclohexadien-1-ylidene](o-sulfobenzyl)ammonium hydroxide inner salt. 
Additionally, FD&C Blue No. 1 is manufactured by the acid catalyzed 
condensation of one mole of sodium 2-formylbenzenesulfonate with two 
moles from a mixture consisting principally of 3-
[(ethylphenylamino)methyl] benzenesulfonic acid, and smaller amounts of 
4-[(ethylphenylamino)methyl] benzenesulfonic acid and 2-
[(ethylphenylamino)methyl] benzenesulfonic acid to form the leuco base. 
The leuco base is then oxidized with lead dioxide and acid, or with 
dichromate and acid, or with manganese dioxide and acid to form the dye. 
The intermediate sodium 2-formylbenzenesulfonate is prepared from 2-
chlorobenzaldehyde and sodium sulfite.
    (b) Specifications. (1) The color additive FD&C Blue No. 1 shall 
conform in specifications to the requirements of Sec.  74.101(b).
    (2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance 
with the requirements of Sec.  82.51 of this chapter.
    (c) Uses and restrictions. (1) FD&C Blue No. 1 may be safely used 
for coloring cosmetics generally, including cosmetics intended for use 
in the area of the eye, in amounts consistent with current good 
manufacturing practice.
    (2) FD&C Blue No. 1 Aluminum Lake may be safely used for coloring 
cosmetics intended for use in the area of the eye, in amounts consistent 
with current good manufacturing practice.

[[Page 506]]

    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of FD&C Blue No. 1 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 42565, Sept. 28, 1982, as amended at 58 FR 17511, Apr. 5, 1993; 
59 FR 7638, Feb. 16, 1994]



Sec.  74.2104  D&C Blue No. 4.

    (a) Identity and specifications. The color additive D&C Blue No. 4 
shall conform in identity and specifications to the requirements of 
Sec.  74.1104(a)(1) and (b).
    (b) Uses and restrictions. D&C Blue No. 4 may be safely used for 
coloring externally applied cosmetics in amounts consistent with good 
manufacturing practice.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Blue No. 4 shall be certified 
in accordance with regulations in part 80 of this chapter.



Sec.  74.2151  D&C Brown No. 1.

    (a) Identity. The color additive D&C Brown No. 1 is a mixture of the 
sodium salts of 4[[5-[(dialkylphenyl)- azo]-2,4-dihydroxyphenyl]azo]-
benzene sulfonic acid. The alkyl group is principally the methyl group.
    (b) Specifications. D&C Brown No. 1 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such other impurities may be avoided by good 
manufacturing practice:

Sum of volatile matter (at 135 [deg]C) and chlorides and sulfates 
(calculated as sodium salts), not more than 16 percent.
Water-insoluble matter, not more than 0.2 percent.
Sulfanilic acid, sodium salt, not more than 0.2 percent.
Resorcinol, not more than 0.2 percent.
Xylidines, not more than 0.2 percent.
Disodium salt of 4[[5-[(4-sulfophenyl)-azo]-2,4-dihydroxyphenyl]azo] 
benzenesulfonic acid, not more than 3 percent.
Monosodium salt of 4[[5-[(2,4-dimethyl-phenyl)azo] -2,4-
dihydroxyphenyl]azo] benzenesulfonic acid, not less than 29 percent and 
not more than 39 percent.
Monosodium salt of 4[[5-[(2,5-dimethyl-phenyl)azo] -2,4-
dihydroxyphenyl]azo] benzenesulfonic acid, not less than 12 percent and 
not more than 17 percent.
Monosodium salt of 4[[5-[(2,3-dimethyl-phenyl)azo] - 2,4-
dihydroxyphenyl]azo] benzenesulfonic acid, not less than 6 percent and 
not more than 13 percent.
Monosodium salt of 4[[5-[(2-ethylphenyl)-azo]-2,4-dihydroxyphenyl]-azo] 
benzenesulfonic acid, not less than 5 percent and not more than 12 
percent.
Monosodium salt of 4[[5-[(3,4-dimethyl-phenyl)azo] -2,4-
dihydroxyphenyl]azo] benzenesulfonic acid, not less than 3 percent and 
not more than 9 percent.
Monosodium salt of 4[[5-[(2,6-dimethyl-phenyl)azo] -2,4-
dihydroxyphenyl]azo] benzenesulfonic acid, not less than 3 percent and 
not more than 8 percent.
Monosodium salt of 4[[5-[(4-ethylphenyl) azo]-2,4-dihydroxyphenyl]-azo] 
benzenesulfonic acid, not less than 2 percent and not more than 8 
percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 84 percent.

    (c) Uses and restrictions. D&C Brown No. 1 may be safely used for 
coloring externally applied cosmetics in amounts consistent with good 
manufacturing practice.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Brown No. 1 shall be certified 
in accordance with regulations in part 80 of this chapter.



Sec.  74.2203  FD&C Green No. 3.

    (a) Identity and specifications. The color additive FD&C Green No. 3 
shall conform in identity and specifications to the requirements of 
Sec.  74.203(a)(1) and (b).
    (b) Uses and restrictions. The color additive FD&C Green No. 3 may 
be safely used for coloring cosmetics generally in amounts consistent 
with current good manufacturing practice.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.

[[Page 507]]

    (d) Certification. All batches of FD&C Green No. 3 shall be 
certified in accordance with regulations in part 80 of this chapter.

[47 FR 52144, Nov. 19, 1982]



Sec.  74.2205  D&C Green No. 5.

    (a) Identity and specifications. The color additive D&C Green No. 5 
shall conform in identity and specifications to the requirements of 
Sec.  74.1205 (a)(1) and (b)(2).
    (b) Uses and restrictions. D&C Green No. 5 may be safely used for 
coloring cosmetics generally, including cosmetics intended for use in 
the area of the eye, in amounts consistent with current good 
manufacturing practice.
    (c) Labeling requirements. The label of the color additive shall 
conform to the requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Green No. 5 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 24285, June 4, 1982, as amended at 59 FR 40805, Aug. 10, 1994]



Sec.  74.2206  D&C Green No. 6.

    (a) Identity and specifications. The color additive D&C Green No. 6 
shall conform in identity and specifications to the requirements of 
Sec.  74.1206 (a) and (b).
    (b) Uses and restrictions. D&C Green No. 6 may be safely used for 
coloring externally applied cosmetics in amounts consistent with good 
manufacturing practice.
    (c) Labeling requirements. The label of the color additive shall 
conform to the requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Green No. 6 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 14146, Apr. 4, 1982, as amended at 51 FR 9784, Mar. 21, 1986]



Sec.  74.2208  D&C Green No. 8.

    (a) Identity and specifications. The color additive D&C Green No. 8 
shall conform in identity and specifications to the requirements of 
Sec.  74.1208(a)(1) and (b).
    (b) Uses and restrictions. D&C Green No. 8 may be safely used for 
coloring externally applied cosmetics in amounts not exceeding 0.01 
percent by weight of the finished cosmetic product.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Green No. 8 shall be certified 
in accordance with regulations in part 80 of this chapter.



Sec.  74.2254  D&C Orange No. 4.

    (a) Identity and specifications. The color additive D&C Orange No. 4 
shall conform in identity and specifications to the requirements of 
Sec.  74.1254 (a)(1) and (b).
    (b) Uses and restrictions. D&C Orange No. 4 may be safely used for 
coloring externally applied cosmetics in amounts consistent with good 
manufacturing practice.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Orange No. 4 shall be 
certified in accordance with regulations in part 80 of this chapter.

[42 FR 52396, Sept. 30, 1977]



Sec.  74.2255  D&C Orange No. 5.

    (a) Identity and specifications. The color additive D&C Orange No. 5 
shall conform in identity and specifications to the requirements of 
Sec.  74.1255 (a)(1) and (b).
    (b) Uses and restrictions. D&C Orange No. 5 may be safely used for 
coloring mouthwashes and dentifrices that are ingested cosmetics in 
amounts consistent with current good manufacturing practice. D&C Orange 
No. 5 may be safely used for coloring lipsticks and other cosmetics 
intended to be applied to the lips in amounts not exceeding 5.0 percent 
by weight of the finished cosmetic products. D&C Orange No. 5 may be 
safely used for coloring externally applied cosmetics in amounts 
consistent with current good manufacturing practice.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.

[[Page 508]]

    (d) Certification. All batches of D&C Orange No. 5 shall be 
certified in accordance with regulations in part 80 of this chapter.

[47 FR 49635, Nov. 2, 1982, as amended at 49 FR 13342, Apr. 4, 1984]



Sec.  74.2260  D&C Orange No. 10.

    (a) Identity and specifications. The color additive D&C Orange No. 
10 shall conform in identity and specifications to the requirements of 
Sec.  74.1260(a)(1) and (b).
    (b) Uses and restrictions. D&C Orange No. 10 may be safely used for 
coloring externally applied cosmetics in amounts consistent with good 
manufacturing practice.
    (c) Labeling requirements. The label of the color additive shall 
conform to the requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Orange No. 11 shall be 
certified in accordance with regulations in part 80 of this chapter.

[46 FR 18954, Mar. 27, 1981]



Sec.  74.2261  D&C Orange No. 11.

    (a) Identity and specifications. The color additive D&C Orange No. 
11 shall conform in identity and specifications to the requirements of 
Sec.  74.1261(a)(1) and (b).
    (b) Uses and restrictions. D&C Orange No. 11 may be safely used for 
coloring externally applied cosmetics in amounts consistent with good 
manufacturing practice.
    (c) Labeling requirements. The label of the color additive shall 
conform to the requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Orange No. 11 shall be 
certified in accordance with regulations in part 80 of this chapter.

[46 FR 18954, Mar. 27, 1981]



Sec.  74.2304  FD&C Red No. 4.

    (a) Identity and specifications. The color additive FD&C Red No. 4 
shall conform in identity and specifications to the requirements of 
Sec.  74.1304(a)(1) and (b).
    (b) Uses and restrictions. FD&C Red No. 4 may be safely used for 
coloring externally applied cosmetics in amounts consistent with good 
manufacturing practice.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of FD&C Red No. 4 shall be certified 
in accordance with regulations in part 80 of this chapter.



Sec.  74.2306  D&C Red No. 6.

    (a) Identity and specifications. The color additive D&C Red No. 6 
shall conform in identity and specifications to the requirements of 
Sec.  74.1306 (a)(1) and (b).
    (b) Uses and restrictions. The color additive D&C Red No. 6 may be 
safely used for coloring cosmetics generally in amounts consistent with 
current good manufacturing practice.
    (c) Labeling requirements. The label of the color additive shall 
conform to the requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Red No. 6 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 57688, Dec. 28, 1982]



Sec.  74.2307  D&C Red No. 7

    (a) Identity and specifications. The color additive D&C Red No. 7 
shall conform in identity and specifications to the requirements of 
Sec.  74.1307 (a)(1) and (b).
    (b) Uses and restrictions. The color additive D&C Red No. 7 may be 
safely used for coloring cosmetics generally in amounts consistent with 
current good manufacturing practice.
    (c) Labeling requirements. The label of the color additive shall 
conform to the requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Red No. 7 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 57688, Dec. 28, 1982]



Sec.  74.2317  D&C Red No. 17.

    (a) Identity and specifications. The color additive D&C Red No. 17 
shall conform in identity and specifications to the requirements of 
Sec.  74.1317(a)(1) and (b).
    (b) Uses and restrictions. D&C Red No. 17 may be safely used for 
coloring externally applied cosmetics in amounts

[[Page 509]]

consistent with good manufacturing practice.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Red No. 17 shall be certified 
in accordance with regulations in part 80 of this chapter.



Sec.  74.2321  D&C Red No. 21.

    (a) Identity and specifications. The color additive D&C Red No. 21 
shall conform in identity and specifications to the requirements of 
Sec.  74.1321(a)(1) and (b).
    (b) Uses and restrictions. The color additive D&C Red No. 21 may be 
safely used for coloring cosmetics generally in amounts consistent with 
current good manufacturing practice.
    (c) Labeling requirements. The label of the color additive shall 
conform to the requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Red No. 21 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 53846, Nov. 30, 1982]



Sec.  74.2322  D&C Red No. 22.

    (a) Identity and specifications. The color additive D&C Red No. 22 
shall conform in identity and specifications to the requirements of 
Sec.  74.1322(a)(1) and (b).
    (b) Uses and restrictions. The color additive D&C Red No. 22 may be 
safely used for coloring cosmetics generally in amounts consistent with 
current good manufacturing practice.
    (c) Labeling requirements. The label of the color additive shall 
conform to the requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Red No. 22 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 53846, Nov. 30, 1982]



Sec.  74.2327  D&C Red No. 27.

    (a) Identity and specifications. The color additive D&C Red No. 27 
shall conform in identity and specifications to the requirements of 
Sec.  74.1327 (a)(1) and (b).
    (b) Uses and restrictions. D&C Red No. 27 may be safely used for 
coloring cosmetics generally in amounts consistent with current good 
manufacturing practice.
    (c) Labeling requirements. The label of the color additive shall 
conform to the requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Red No. 27 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 42568, Sept. 28, 1982]



Sec.  74.2328  D&C Red No. 28.

    (a) Identity and specifications. The color additive D&C Red No. 28 
shall conform in identity and specifications to the requirements of 
Sec.  74.1328 (a)(1) and (b).
    (b) Uses and restrictions. D&C Red No. 28 may be safely used for 
coloring cosmetics generally in amounts consistent with current good 
manufacturing practice.
    (c) Labeling requirements. The label of the color additive shall 
conform to the requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Red No. 28 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 42568, Sept. 28, 1982]



Sec.  74.2330  D&C Red No. 30.

    (a) Identity and specifications. The color additive D&C Red No. 30 
shall conform in identity and specifications to the requirements of 
Sec.  74.1330 (a)(1) and (b).
    (b) Uses and restrictions. D&C Red No. 30 may be safely used for 
coloring cosmetics generally in amounts consistent with current good 
manufacturing practice.
    (c) Labeling requirements. The label of the color additive shall 
conform to the requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Red No. 30 shall be certified 
in accordance with regulations in part 80 of this chapter.

[47 FR 22511, May 25, 1982]



Sec.  74.2331  D&C Red No. 31.

    (a) Identity and specifications. The color additive D&C Red No. 31 
shall conform in identity and specifications to the requirements of 
Sec.  74.1331(a)(1) and (b).

[[Page 510]]

    (b) Uses and restrictions. D&C Red No. 31 may be safely used for 
coloring externally applied cosmetics in amounts consistent with good 
manufacturing practice.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Red No. 31 shall be certified 
in accordance with regulations in part 80 of this chapter.



Sec.  74.2333  D&C Red No. 33.

    (a) Identity and specifications. The color additive D&C Red No. 33 
shall conform in identity and specifications to the requirements of 
Sec.  74.1333(a) (1) and (b).
    (b) Uses and restrictions. The color additive D&C Red No. 33 may be 
safely used for coloring cosmetic lip products in amounts not to exceed 
3 percent total color by weight of the finished cosmetic products. D&C 
Red No. 33 may be safely used for coloring mouthwashes (including breath 
fresheners), dentifrices, and externally applied cosmetics in amounts 
consistent with current good manufacturing practice.
    (c) Labeling requirements. The label of the color additive and any 
mixtures prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter.
    (d) Certification. All batches of D&C Red No. 33 shall be certified 
in accordance with regulations in part 80 of this chapter.

[53 FR 33120, Aug. 30, 1988]



Sec.  74.2334  D&C Red No. 34.

    (a) Identity and specifications. The color additive D&C Red No. 34 
shall conform in identity and specifications to the requirements of 
Sec.  74.1334(a)(1) and (b).
    (b) Uses and restrictions. D&C Red No. 34 may be safely used for 
coloring externally applied cosmetics in amounts consistent with good 
manufacturing practice.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Red No. 34 shall be certified 
in accordance with regulations in part 80 of this chapter.



Sec.  74.2336  D&C Red No. 36.

    (a) Identity and specifications. The color additive D&C Red No. 36 
shall conform in identity and specifications to the requirements of 
Sec.  74.1336 (a)(1) and (b).
    (b) Uses and restrictions. The color additive D&C Red No. 36 may be 
safely used for coloring cosmetic lip products in amounts not to exceed 
3 percent total color by weight of the finished cosmetic products. D&C 
Red No. 36 may be safely used for coloring externally applied cosmetics 
in amounts consistent with current good manufacturing practice.
    (c) Labeling requirements. The label of the color additive shall 
conform to the requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Red No. 36 shall be certified 
in accordance with regulations in part 80 of this chapter.

[53 FR 29031, Aug. 2, 1988]



Sec.  74.2340  FD&C Red No. 40.

    (a) Identity and specifications. (1) The color additive FD&C Red No. 
40 shall conform in identity and specifications to the requirements of 
Sec.  74.340(a)(1) and (b) of this chapter.
    (2) The listing of this color additive includes lakes prepared as 
described in Sec. Sec.  82.51 and 82.1051 of this chapter, except that 
the color additive used is FD&C Red No. 40 and the resultant lakes meet 
the specification and labeling requirements prescribed by Sec.  82.51 or 
Sec.  82.1051 of this chapter.
    (b) Uses and restrictions. FD&C Red No. 40 may be safely used in 
coloring cosmetics generally, except that only FD&C Red No. 40 and FD&C 
Red No. 40 Aluminum Lake may be safely used in coloring cosmetics 
intended for use in the area of the eye. These uses are subject to the 
following restrictions:
    (1) The color additive may be used in amounts consistent with 
current good manufacturing practice.
    (2) The color additive shall not be exposed to oxidizing or reducing 
agents that may affect the integrity of the color additives or any other 
condition that may affect their integrity.

[[Page 511]]

    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of FD&C Red No. 40 shall be certified 
in accordance with regulations in part 80 of this chapter.

[42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994]



Sec.  74.2602  D&C Violet No. 2.

    (a) Identity and specifications. The color additive D&C Violet No. 2 
shall conform in identity and specifications to the requirements of 
Sec.  74.1602(a)(1) and (b).
    (b) Uses and restrictions. The color additive D&C Violet No. 2 may 
be safely used for coloring externally applied cosmetics in amounts 
consistent with good manufacturing practice.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Violet No. 2 shall be 
certified in accordance with regulations in part 80 of this chapter.



Sec.  74.2602a  Ext. D&C Violet No. 2.

    (a) Identity. The color additive Ext. D&C Violet No. 2 is 
principally the monosodium salt of 2-[(9,10-dihydro-4-hydroxy -9,10-
dioxo-1-anthracenyl) amino]-5-methyl-benzenesulfonic acid.
    (b) Specifications. Ext. D&C Violet No. 2 shall conform to the 
following specifications and shall be free from impurities, other than 
those named, to the extent that such other impurities may be avoided by 
good manufacturing practice:

Sum of volatile matter (at 135 [deg]C) and chlorides and sulfates 
(calculated as sodium salts), not more than 18 percent.
Water-insoluble matter, not more than 0.4 percent.
1-Hydroxy-9,10-anthracenedione, not more than 0.2 percent.
1,4-Dihydroxy-9,10-anthracenedione, not more than 0.2 percent.
p- Toluidine, not more than 0.1 percent.
p- Toluidine sulfonic acids, sodium salts, not more than 0.2 percent.
Subsidiary colors, not more than 1 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 80 percent.

    (c) Uses and restrictions. The color additive Ext. D&C Violet No. 2 
may be safely used for coloring externally applied cosmetics in amounts 
consistent with good manufacturing practice.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of Ext. D&C Violet No. 2 shall be 
certified in accordance with regulations in part 80 of this chapter.



Sec.  74.2705  FD&C Yellow No. 5.

    (a) Identity. The color additive FD&C Yellow No. 5 is principally 
the trisodium salt of 4,5-dihydro-5-oxo-(1-4-sulfophenyl)-4-[(4-
sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid (CAS Reg. No. 1934-21-0). 
To manufacture the additive, 4-aminobenzenesulfonic acid is diazotized 
using hydrochloric acid and sodium nitrite. The diazo compound is 
coupled with 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-
carboxylic acid or with the methyl ester, the ethyl ester, or a salt of 
this carboxylic acid. The resulting dye is purified and isolated as the 
sodium salt.
    (b) Specifications. (1) FD&C Yellow No. 5 shall conform to the 
following specifications and shall be free from impurities other than 
those named to the extent that such other impurities may be avoided by 
good manufacturing practice:

Sum of volatile matter at 135 [deg]C (275 [deg]F) and chlorides and 
sulfates (calculated as sodium salts), not more than 13 percent.
Water-insoluble matter, not more than 0.2 percent.
4,4'-[4,5-Dihydro-5-oxo-4-[(4-sulfophenyl)hydrazono]-1H-pyrazol-1,3-
diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1 percent.
4-[(4',5-Disulfo[1,1'-biphenyl]-2-yl)hydrazono]-4,5-dihydro-5-oxo-1-(4-
sulfophenyl)-1H-pyrazole-3-carboxylic acid, tetrasodium salt, not more 
than 1 percent.
Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-
sulfophenyl)hydrazono]-1H-pyrazole-3-carboxylate, disodium salt, not 
more than 1 percent.
Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-
carboxylic acid, disodium salt, and 4,5-dihydro-5-oxo-

[[Page 512]]

4-(phenylazo)-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid, disodium 
salt, not more than 0.5 percent.
4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent.
4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid, 
disodium salt, not more than 0.2 percent.
Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-
carboxylate, sodium salt, not more than 0.1 percent.
4,4'-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not 
more than 0.05 percent.
4-Aminoazobenzene, not more than 75 parts per billion.
4-Aminobiphenyl, not more than 5 parts per billion.
Aniline, not more than 100 parts per billion.
Azobenzene, not more than 40 parts per billion.
Benzidine, not more than 1 part per billion.
1,3-Diphenyltriazene, not more than 40 parts per billion.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 87 percent.

    (2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance 
with the requirements of Sec.  82.51 of this chapter.
    (c) Uses and restrictions. (1) FD&C Yellow No. 5 may be safely used 
for coloring cosmetics generally, including cosmetics intended for use 
in the area of the eye, in amounts consistent with current good 
manufacturing practice.
    (2) FD&C Yellow No. 5 Aluminum Lake may be safely used for coloring 
cosmetics intended for use in the area of the eye, subject to the 
restrictions on use of color additives in Sec.  70.5(b) and (c) of this 
chapter, in amounts consistent with current good manufacturing practice.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of FD&C Yellow No. 5 shall be 
certified in accordance with regulations in part 80 of this chapter.

[50 FR 35782, Sept. 4, 1985, as amended at 51 FR 24524, July 7, 1986; 59 
FR 60898, Nov. 29, 1994]



Sec.  74.2706  FD&C Yellow No. 6.

    (a) Identity and specifications. The color additive FD&C Yellow No. 
6 shall conform in identity and specifications to the requirements of 
Sec.  74.706 (a)(1) and (b).
    (b) Uses and restrictions. FD&C Yellow No. 6 may be safely used for 
coloring cosmetics generally in amounts consistent with current good 
manufacturing practice.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of FD&C Yellow No. 6 shall be 
certified in accordance with regulations in part 80 of this chapter.

[51 FR 41782, Nov. 19, 1986]



Sec.  74.2707  D&C Yellow No. 7.

    (a) Identity and specifications. The color additive D&C Yellow No. 7 
shall conform in identity and specifications to the requirements of 
Sec.  74.1707(a)(1) and (b).
    (b) Uses and restrictions. D&C Yellow No. 7 may be safely used for 
coloring externally applied cosmetics in amounts consistent with good 
manufacturing practice.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Yellow No. 7 shall be 
certified in accordance with regulations in part 80 of this chapter.



Sec.  74.2707a  Ext. D&C Yellow No. 7.

    (a) Identity and specifications. The color additive Ext. D&C Yellow 
No. 7 shall conform in identity and specifications to the requirements 
of Sec.  74.1707a (a)(1) and (b).
    (b) Uses and restrictions. Ext. D&C Yellow No. 7 may be safely used 
for coloring externally applied cosmetics in amounts consistent with 
good manufacturing practice.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of Ext. D&C Yellow No. 7 shall be 
certified in accordance with regulations in part 80 of this chapter.

[[Page 513]]



Sec.  74.2708  D&C Yellow No. 8.

    (a) Identity and specifications. The color additive D&C Yellow No. 8 
shall conform in identity and specifications to the requirements of 
Sec.  74.1708(a)(1) and (b).
    (b) Uses and restrictions. D&C Yellow No. 8 may be safely used for 
coloring externally applied cosmetics in amounts consistent with good 
manufacturing practice.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Yellow No. 8 shall be 
certified in accordance with regulations in part 80 of this chapter.



Sec.  74.2710  D&C Yellow No. 10.

    (a) Identity and specifications. The color additive D&C Yellow No. 
10 shall conform in identity and specifications to the requirements of 
Sec.  74.1710(a)(1) and (b).
    (b) Uses and restrictions. The color additive D&C Yellow No. 10 may 
be safely used for coloring cosmetics generally in amounts consistent 
with current good manufacturing practice.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Yellow No. 10 shall be 
certified in accordance with regulations in part 80 of this chapter.

[48 FR 39220, Aug. 30, 1983, as amended at 49 FR 8432, Mar. 7, 1984]



Sec.  74.2711  D&C Yellow No. 11.

    (a) Identity and specifications. The color additive D&C Yellow No. 
11 shall conform in identity and specifications to the requirements of 
Sec.  74.1711(a)(1) and (b).
    (b) Uses and restrictions. D&C Yellow No. 11 may be safely used for 
coloring externally applied cosmetics in amounts consistent with good 
manufacturing practice.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Yellow No. 11 shall be 
certified in accordance with regulations in part 80 of this chapter.



                        Subpart D_Medical Devices



Sec.  74.3045  [Phthalocyaninato(2-)] copper.

    (a) Identity. The color additive is [phthalocyaninato(2-)] copper 
(CAS Reg. No. 147-14-8) having the structure shown in Colour Index No. 
74160.
    (b) Specifications. The color additive [phthalocyaninato(2-)] copper 
shall conform to the following specifications and shall be free from 
impurities other than those named to the extent that such impurities may 
be avoided by current good manufacturing practice:

Volatile matter 135 [deg]C (275 [deg]F), not more than 0.3 percent.
Salt content (as NaC1), not more than 0.3 percent.
Alcohol soluble matter, not more than 0.5 percent.
Organic chlorine, not more than 0.5 percent.
Aromatic amines, not more than 0.05 percent.
Lead (as Pb), not more than 40 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 98.5 percent.

    (c) Uses and restrictions. (1) The color additive 
[phthalocyaninato(2-)] copper may be safely used to color polypropylene 
sutures, polybutester (the generic designation for the suture fabricated 
from 1,4-benzenedicarboxylic acid, polymer with 1,4-butanediol and 
alpha-hydro-omega-hydroxypoly(oxy-1,4-butanediyl), CAS Reg. No. 37282-
12-5) nonabsorbable sutures for use in general and ophthalmic surgery, 
polybutylene terephthalate nonabsorbable monofilament sutures for 
general and ophthalmic surgery, nonabsorbable sutures made from 
poly(vinylidene fluoride) and poly(vinylidene fluoride-co-
hexafluoropropylene) for general and ophthalmic surgery, 
polymethylmethacrylate monofilament used as supporting haptics for 
intraocular lenses, and polymers used in orientation marks for 
intraocular lenses, subject to the following restrictions:
    (i) The quantity of the color additive does not exceed 0.5 percent 
by weight of the suture, haptic material, or orientation mark.

[[Page 514]]

    (ii) The dyed suture shall conform in all respects to the 
requirements of the U.S. Pharmacopeia.
    (2) The color additive [phthalocyaninato(2-)] copper may be safely 
used for coloring contact lenses in amounts not to exceed the minimum 
reasonably required to accomplish the intended coloring effect.
    (3) Authorization for these uses shall not be construed as waiving 
any of the requirements of section 510(k), 515, or 520(g) the Federal 
Food, Drug, and Cosmetic Act with respect to the medical device in which 
[phthalocyaninato(2-)] copper is used.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of [phthalocyaninato (2-)] copper 
shall be certified in accordance with regulations in part 80 of this 
chapter.

[48 FR 34947, Aug. 2, 1983, as amended at 50 FR 16228, Apr. 25, 1985; 51 
FR 22929, June 24, 1986; 51 FR 28930, Aug. 13, 1986; 51 FR 39371, Oct. 
28, 1986; 52 FR 15945, May 1, 1987; 55 FR 19620, May 10, 1990; 64 FR 
23186, Apr. 30, 1999; 81 FR 75692, Nov. 1, 2016]



Sec.  74.3102  FD&C Blue No. 2.

    (a) Identity. The color additive FD&C Blue No. 2 shall conform in 
identity to the requirements of Sec.  74.102(a)(1).
    (b) Specifications. (1) The color additive FD&C Blue No. 2 for use 
in coloring surgical sutures shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by current good 
manufacturing practice:

Sum of volatile matter at 135 [deg]C (275 [deg]F) and chlorides and 
sulfates (calculated as sodium salts), not more than 15 percent.
Water insoluble matter, not more than 0.4 percent.
Isatin-5-sulfonic acid, not more than 0.4 percent.
Isomeric colors, not more than 18 percent.
Lower sulfonated subsidiary colors, not more than 5 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Total color, not less than 85 percent.

    (2) The color additive FD&C Blue No. 2-Aluminum Lake on alumina for 
use in bone cement shall be prepared in accordance with the requirements 
of Sec.  82.51 of this chapter.
    (c) Uses and restrictions. (1) The color additive FD&C Blue No. 2 
may be safely used for coloring nylon (the copolymer of adipic acid and 
hexamethylene diamine) surgical sutures for use in general surgery 
subject to the following restrictions:
    (i) The quantity of color additive does not exceed 1 percent by 
weight of the suture;
    (ii) The dyed suture shall conform in all respects to the 
requirements of the United States Pharmacopeia XX (1980); and
    (iii) When the sutures are used for the purposes specified in their 
labeling, the color additive does not migrate to the surrounding 
tissues.
    (2) The color additive FD&C Blue No. 2-Aluminum Lake on alumina may 
be safely used for coloring bone cement at a level not to exceed 0.1 
percent by weight of the bone cement.
    (3) Authorization and compliance with these uses shall not be 
construed as waiving any of the requirements of sections 510(k), 515, 
and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to 
the medical device in which the color additive FD&C Blue No. 2 and the 
color additive FD&C Blue No. 2-Aluminum Lake on alumina are used.
    (d) Labeling. The labels of the color additive FD&C Blue No. 2 and 
the color additive FD&C Blue No. 2-Aluminum Lake on alumina shall 
conform to the requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of FD&C Blue No. 2 and its lake shall 
be certified in accordance with regulations in part 80 of this chapter.

[64 FR 48290, Sept. 3, 1999]



Sec.  74.3106  D&C Blue No. 6.

    (a) Identity. The color additive D&C Blue No. 6 is principally 
[[Delta]2,2'-biindoline]-3,3' dione (CAS Reg. No. 482-89-3).
    (b) Specifications. D&C Blue No. 6 shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice:


[[Page 515]]


Volatile matter at 135 [deg]C (275 [deg]F), not more than 3 percent.
Matter insoluble in N,N- dimethylformamide, not more than 1 percent.
Isatin, not more than 0.3 percent.
Anthranilic acid, not more than 0.3 percent.
Indirubin, not more than 1 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 95 percent.

    (c) Uses and restrictions. (1) D&C Blue No. 6 may be safely used at 
a level--
    (i) Not to exceed 0.2 percent by weight of the suture material for 
coloring polyethylene terephthalate surgical sutures for general 
surgical use;
    (ii) Not to exceed 0.25 percent by weight of the suture material for 
coloring plain or chromic collagen absorbable sutures for general 
surgical use;
    (iii) Not to exceed 0.5 percent by weight of the suture material for 
coloring plain or chromic collagen absorbable sutures for ophthalmic 
surgical use;
    (iv) Not to exceed 0.5 percent by weight of the suture material for 
coloring polypropylene surgical sutures for general surgical use; and
    (v) Not to exceed 0.5 percent by weight of the suture material for 
coloring polydioxanone synthetic absorbable sutures for ophthalmic and 
general surgical use.
    (2) Authorization for these uses shall not be construed as waiving 
any of the requirements of sections 510(k), 515, and 520(g) of the 
Federal Food, Drug, and Cosmetic Act with respect to the medical device 
in which the color additive is used.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Blue No. 6 shall be certified 
in accordance with regulations in part 80 of this chapter.

[49 FR 29956, July 25, 1984; 49 FR 34447, Aug. 31, 1984, as amended at 
50 FR 30698, July 29, 1985]



Sec.  74.3206  D&C Green No. 6.

    (a) Identity. The color additive D&C Green No. 6 shall conform in 
identity to the requirements of Sec.  74.1206(a).
    (b) Specifications. The color additive D&C Green No. 6 for use in 
medical devices shall conform to the specifications of Sec.  74.1206(b).
    (c) Uses and restrictions. (1) The color additive D&C Green No. 6 
may be safely used at a level
    (i) Not to exceed 0.03 percent by weight of the lens material for 
coloring contact lenses;
    (ii) Not to exceed 0.75 percent by weight of the suture material for 
coloring polyethylene terephthalate surgical sutures, including sutures 
for ophthalmic use;
    (iii) Not to exceed 0.1 percent by weight of the suture material for 
coloring polyglycolic acid surgical sutures with diameter greater than 
U.S.P. size 8-0, including sutures for ophthalmic use;
    (iv) Not to exceed 0.5 percent by weight of the suture material for 
coloring polyglycolic acid surgical sutures with diameter not greater 
than U.S.P. size 8-0, including sutures for ophthalmic use;
    (v) Not to exceed 0.21 percent by weight of the suture material for 
coloring poly(glycolic acid-co-trimethylene carbonate) sutures (also 
referred to as 1,4-dioxan-2,5-dione polymer with 1,3-dioxan-2-one) for 
general surgical use; and
    (vi) Not to exceed 0.10 percent by weight of the haptic material for 
coloring polymethylmethacrylate support haptics of intraocular lenses.
    (2) Authorization for these uses shall not be construed as waiving 
any of the requirements of sections 510(k), 515, and 520(g) of the 
Federal Food, Drug, and Cosmetic Act with respect to the medical device 
in which D&C Green No. 6 is used.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Green No. 6 shall be certified 
in accordance with regulations in part 80 of this chapter.

[48 FR 13022, Mar. 29, 1983, as amended at 51 FR 9784, Mar. 21, 1986; 51 
FR 37909, Oct. 27, 1986; 58 FR 21542, Apr. 22, 1993]

[[Page 516]]



Sec.  74.3230  D&C Red No. 17.

    (a) Identity and specifications. The color additive D&C Red No. 17 
shall conform in identity and specifications to the requirements of 
Sec.  74.1317(a)(1) and (b).
    (b) Uses and restrictions. (1) The substance listed in paragraph (a) 
of this section may be used as a color additive in contact lens in 
amounts not to exceed the minimum reasonably required to accomplish the 
intended coloring effect.
    (2) Authorization for this use shall not be construed as waiving any 
of the requirements of section 510(k), 515, and 520(g) of the Federal 
Food, Drug, and Cosmetic Act with respect to the contact lens in which 
the color additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Red No. 17 shall be certified 
in accordance with regulations in part 80 of this chapter.

[55 FR 22898, June 5, 1990]



Sec.  74.3602  D&C Violet No. 2.

    (a) Identity and specifications. The color additive D&C Violet No. 2 
shall conform in identity and specifications to the requirements of 
Sec.  74.1602(a)(1) and (b).
    (b) Uses and restrictions. (1) The color additive, D&C Violet No. 2, 
may be safely used for coloring contact lenses in amounts not to exceed 
the minimum reasonably required to accomplish the intended coloring 
effect.
    (2) D&C Violet No. 2 may be safely used for coloring sutures for use 
in surgery subject to the following conditions:
    (i) At a level not to exceed 0.2 percent by weight of the suture 
material for coloring copolymers of 90 percent glycolide and 10 percent 
L-lactide synthetic absorbable sutures for use in general and ophthalmic 
surgery; and
    (ii) At a level not to exceed 0.3 percent by weight of the suture 
material for coloring polydioxanone synthetic absorbable sutures for use 
in general and ophthalmic surgery.
    (iii) At a level not to exceed 0.25 percent by weight of the suture 
material for coloring poliglecaprone 25 ([epsi]-caprolactone/glycolide 
copolymer) synthetic absorbable sutures for use in general surgery.
    (iv) At a level not to exceed 0.1 percent by weight of the suture 
material for coloring poly([epsi]-caprolactone) absorbable sutures for 
use in general surgery.
    (v) At a level not to exceed 0.2 percent by weight of the suture 
material for coloring glycolide/dioxanone/trimethylene carbonate 
tripolymer absorbable sutures for use in general surgery.
    (vi) At a level not to exceed 0.2 percent by weight of the suture 
material for coloring absorbable sutures prepared from homopolymers of 
glycolide for use in general surgery.
    (3) The color additive, D&C Violet No. 2, may be safely used for 
coloring polymethylmethacrylate intraocular lens haptics at a level not 
to exceed 0.2 percent by weight of the haptic material.
    (4) The color additive, D&C Violet No. 2, may be safely used for 
coloring absorbable meniscal tacks made from poly (L-lactic acid) at a 
level not to exceed 0.15 percent by weight of the tack material.
    (5) Authorization for these uses shall not be construed as waiving 
any of the requirements of sections 510(k), 515, and 520(g) of the 
Federal Food, Drug, and Cosmetic Act with respect to the medical devices 
in which the color additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Violet No. 2 shall be 
certified in accordance with regulations in part 80 of this chapter.

[52 FR 19722, May 27, 1987, as amended at 55 FR 18868, May 7, 1990; 58 
FR 60109, Nov. 15, 1993; 59 FR 11720, Mar. 14, 1994; 63 FR 20098, Apr. 
23, 1998; 64 FR 32805, June 18, 1999; 65 FR 46344, July 28, 2000]



Sec.  74.3710  D&C Yellow No. 10.

    (a) Identity. The color additive D&C Yellow No. 10 shall conform to 
the identity requirements of Sec.  74.1710(a).
    (b) Specifications. The color additive D&C Yellow No. 10 for use in 
contact

[[Page 517]]

lenses shall conform to the specifications of Sec.  74.1710(b).
    (c) Uses and restrictions. (1) The color additive D&C Yellow No. 10 
may be used for coloring contact lenses in amounts not to exceed the 
minimum reasonably required to accomplish the intended coloring effect.
    (2) Authorization for this use shall not be construed as waiving any 
of the requirements of sections 510(k), 515, and 520(g) of the Federal 
Food, Drug, and Cosmetic Act with respect to the contact lens in which 
the color additive is used.
    (d) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Yellow No. 10 shall be 
certified in accordance with regulations in part 80 of this chapter.

[52 FR 28690, Aug. 3, 1987]



PART 80_COLOR ADDITIVE CERTIFICATION--Table of Contents



                      Subpart A_General Provisions

Sec.
80.10 Fees for certification services.

                   Subpart B_Certification Procedures

80.21 Request for certification.
80.22 Samples to accompany requests for certification.
80.31 Certification.
80.32 Limitations of certificates.
80.34 Authority to refuse certification service.
80.35 Color additive mixtures; certification and exemption from 
          certification.
80.37 Treatment of batch pending certification.
80.38 Treatment of batch after certification.
80.39 Records of distribution.

    Authority: 21 U.S.C. 371, 379e.

    Source: 42 FR 15662, Mar. 22, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  80.10  Fees for certification services.

    (a) Fees for straight colors including lakes. The fee for the 
services provided by the regulations in this part in the case of each 
request for certification submitted in accordance with Sec.  80.21(j)(1) 
and (j)(2) shall be $0.35 per pound of the batch covered by such 
requests, but no such fee shall be less than $224.
    (b) Fees for repacks of certified color additives and color additive 
mixtures. The fees for the services provided under the regulations in 
this part in the case of each request for certification submitted in 
accordance with Sec.  80.21(j)(3) and (j)(4) shall be:
    (1) 100 pounds or less--$35.
    (2) Over 100 pounds but not over 1,000 pounds--$35 plus $0.06 for 
each pound over 100 pounds.
    (3) Over 1,000 pounds--$89 plus $0.02 for each pound over 1,000 
pounds.
    (c) Advance deposits. Any person regularly requesting certification 
services may deposit funds in advance of requests as prepayment of fees 
required by this section.
    (d) Method of payment. All deposits and fees required by this 
section shall be paid by money order, bank draft, or certified check, 
drawn to the order of the Food and Drug Administration, collectible at 
par at Washington, DC. All such deposits and fees shall be forwarded to 
the Center for Food Safety and Applied Nutrition (HFS-100), Food and 
Drug Administration, 5001 Campus Dr., College Park, MD 20740, whereupon 
after making appropriate records thereof, they will be transmitted to 
the Treasurer of the United States for deposit to the special account 
``Salaries and Expenses, Certification, Inspection, and Other Services, 
Food and Drug Administration.''
    (e) Refunds from advance deposits. Whenever in the judgment of the 
Commissioner the ratio between fees collected (which are based upon 
experience and the best estimate of costs and the best estimate of 
earnings) and the costs of providing the service during an elapsed 
period of time, in the light of all circumstances and contingencies, 
warrants a refund from the fund collected during such period, he shall 
make ratable refunds to those persons to whom the services were rendered 
and charged, except that no refund

[[Page 518]]

shall be made where the computed ratable amount for the elapsed period 
is less than $5.00.

[42 FR 15662, Mar. 22, 1977, as amended at 47 FR 24692, June 8, 1982; 54 
FR 24890, June 12, 1989; 59 FR 60899, Nov. 29, 1994; 61 FR 3572, Feb. 1, 
1996; 61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001; 70 FR 15756, 
Mar. 29, 2005; 71 FR 70875, Dec. 7, 2006; 81 FR 49895, July 29, 2016]



                   Subpart B_Certification Procedures



Sec.  80.21  Request for certification.

    A request for certification of a batch of color additive shall:
    (a) Be addressed to the Commissioner of Food and Drugs.
    (b) Be prepared in the manner set forth in paragraph (j) of this 
section.
    (c) Be submitted in duplicate.
    (d) Be signed by a responsible officer of the person requesting 
certification of the batch. In the case of a foreign manufacturer, the 
request for certification must be signed by a responsible officer of 
such firm, and, by his agent who resides in the United States.
    (e) Show the name and post office address of the actual manufacturer 
in case such manufacturer is not the person requesting certification of 
the batch.
    (f) Be accompanied by the fee prescribed in Sec.  80.10 unless the 
person has established with the Food and Drug Administration an advanced 
deposit to be used for prepayment of such fees. In no case shall the 
Commissioner consider a request for certification of a batch of color 
additive if the fee accompanying such request is less than that required 
by Sec.  80.10 or if such fee exceeds the amount held in the advance 
deposit account of the manufacturer submitting such request for 
certification.
    (g) Be accompanied by the sample prescribed in Sec.  80.22 
consisting of:
    (1) Four ounces in the case of straight colors and lakes.
    (2) Two ounces in the case of repacks and mixtures.

A sample accompanying a request for certification must be submitted 
under separate cover and should be addressed to the Color Certification 
Branch.
    (h) The name of a color additive shall be given in the following 
manner:
    (1) The name of a straight color shall be the name of the color as 
listed in parts 74 and 81 of this chapter.
    (2) The name of a lake shall be the name derived in the manner 
described in part 82 of this chapter.
    (3) The name of a mixture shall be the name given to such mixture by 
the person requesting certification.
    (4) The name of a repack shall be the name described in paragraph 
(h)(1), (2), or (3) of this section, whichever is applicable.
    (i) The information and samples enumerated in paragraphs (a) to (h), 
inclusive, of this section are the minimum required. Additional 
information and samples shall be submitted at the request of the Food 
and Drug Administration when such additional information and samples are 
necessary to determine compliance with the requirements of Sec.  80.31 
for the issuance of a certificate.
    (j) The form for submission of the application shall be one of the 
following, depending upon whether the color additive is a straight 
color, a lake, a repack of a previously certified color additive, or a 
color additive mixture.
    (1) Request for certification of a batch of straight color additive.

                                                               Date ____
Office of Cosmetics and Colors (HFS-100),
Center for Food Safety and Applied Nutrition,
Food and Drug Administration,
5001 Campus Dr.,
College Park, MD 20740
    In accordance with the regulations promulgated under the Federal 
Food, Drug, and Cosmetic Act, we hereby make application for the 
certification of a batch of straight color additive.

Name of color___________________________________________________________
                                           (As listed in 21 CFR part 74)

Batch number____________________________________________________________
                                                 (Manufacturer's number)

Batch weighs __ pounds
Batch manufactured by ______ at _________ (Name and address of actual 
manufacturer)

How stored pending certification________________________________________
________________________________________________________________________
(State conditions of storage, with kind and size of containers, 
          location, etc.)
Certification requested of this color for use in________________________

[[Page 519]]

________________________________________________________________________
________________________________________________________________________
 (State proposed uses)

Required fee, $__ (drawn to the order of Food and Drug Administration).
    The accompanying sample was taken after the batch was mixed in 
accordance with 21 CFR 80.22 and is accurately representative thereof.

                                                     (Signed) __________
                                                           By __________
                                                              __________
                                                                 (Title)

    (2) Request for certification of a batch of color additive lake.

                                                               Date ____

Office of Cosmetics and Colors (HFS-100),
Center for Food Safety and Applied Nutrition,
Food and Drug Administration,
5001 Campus Dr.,
College Park, MD 20740
    In accordance with the regulations promulgated under the Federal 
Food, Drug, and Cosmetic Act, we hereby make application for the 
certification of a batch of color additive lake.

Name of color___________________________________________________________
Batch number____________________________________________________________
                                                 (Manufacturer's number)

Batch weighs __ pounds

Name of color used______________________________________________________

Quantity __ pounds

Lot number______________________________________________________________
                                         (When certification of the lake
                                          for use in foods is requested)
Precipitant used________________________________________________________
Substratum used_________________________________________________________

Quantity __ pounds
Batch manufactured by _____ at _______ (Name and address of actual 
manufacturer)

How stored pending certification________________________________________
________________________________________________________________________
(State conditions of storage, with kind and size of containers, 
          location, etc.)
Certification requested of this color for use in________________________
________________________________________________________________________
________________________________________________________________________
 (State proposed uses)

Required fee, $__ (drawn to the order of Food and Drug Administration).
    The accompanying sample was taken after the batch was mixed in 
accordance with 21 CFR 80.22 and is accurately representative thereof.

                                                     (Signed) __________
                                                           By __________
                                                              __________
                                                                 (Title)

    (3) Request for certification of a repack of a batch of certified 
color additive.

                                                              Date _____

Office of Cosmetics and Colors (HFS-100),
Center for Food Safety and Applied Nutrition,
Food and Drug Administration,
5001 Campus Dr.,
College Park, MD 20740
    In accordance with the regulations promulgated under the Federal 
Food, Drug, and Cosmetic Act, we hereby make application for the 
certification of a batch of color additive repack.

Name of color___________________________________________________________
(As listed in regulations and as certified; or repacker's name, if a 
          mixture)
Original lot number_____________________________________________________
Certified color content_________________________________________________
This color obtained from________________________________________________
Batch number____________________________________________________________

Batch weighs __ pounds

How stored pending certification________________________________________
________________________________________________________________________
(State conditions of storage, with kind and size of containers, 
          location, etc.)
Certification requested for use in______________________________________
________________________________________________________________________
________________________________________________________________________
 (State proposed uses)

Required fee, $__ (drawn to the order of Food and Drug Administration).
    The accompanying sample was taken after the batch was mixed in 
accordance with 21 CFR 80.22 and is accurately representative thereof.

                                                      (Signed) _________
                                                           By __________
                                                              __________
                                                                 (Title)

    (4) Request for certification of a batch of color additive mixture.

                                                              Date _____

Office of Cosmetics and Colors (HFS-100),
Center for Food Safety and Applied Nutrition,
Food and Drug Administration,
5001 Campus Dr.,
College Park, MD 20740
    In accordance with the regulations promulgated under the Federal 
Food, Drug, and Cosmetic Act, we hereby make application for the 
certification of a batch of color additive mixture.


[[Page 520]]


Name of mixture_________________________________________________________
                                             (Manufacturer's trade name)
Batch number____________________________________________________________
                                                 (Manufacturer's number)

Weight of batch __ pounds
Volume of batch __ (If liquid) gallons

Batch manufactured by___________________________________________________

Constituents of the mixture:
1. Color(s). (List separately each color and each lot number.)

Name of color
as certified Lot number
________________________________________________________________________
________________________________________________________________________
Quantity used
(in pounds) Obtained from
________________________________________________________________________
________________________________________________________________________
2. List of diluents. (List separately each diluent.)

                             Name of diluent

________________________________________________________________________
________________________________________________________________________

                              Quantity used

                                                               By volume
                                                   By weight (if liquid)
________________________________________________________________________
________________________________________________________________________
Batch mixed as follows__________________________________________________
                                                    (Describe in detail)
How stored pending certification________________________________________
________________________________________________________________________
(State conditions of storage, with kind and size of containers, 
          location, etc.)
Certification requested for use in______________________________________
________________________________________________________________________
________________________________________________________________________
 (State proposed uses)

Required fee, $__ (drawn to the order of Food and Drug Administration).
    The accompanying sample was taken after the batch was mixed in 
accordance with 21 CFR 80.22 and is accurately representative thereof.

                                                     (Signed) __________
                                                            By _________
                                                              __________
                                                                 (Title)

[42 FR 15662, Mar. 22, 1977; 44 FR 17658, Mar. 23, 1979; 44 FR 22053, 
Apr. 13, 1979, as amended at 54 FR 24890, June 12, 1989; 61 FR 14479, 
Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001; 81 FR 49895, July 29, 2016]



Sec.  80.22  Samples to accompany requests for certification.

    A sample of a batch of color additive which is to accompany a 
request for certification shall:
    (a) Be taken only after such batch has been so thoroughly mixed as 
to be of uniform composition throughout.
    (b) Held under the control of the person requesting certification 
until certified.
    (c) Be labeled to show:
    (1) The name of the color additive.
    (2) The manufacturer's batch number.
    (3) The quantity of such batch.
    (4) The name and post-office address of the person requesting 
certification of such batch.
    (5) Be accompanied by any label or labeling intended to be used.



Sec.  80.31  Certification.

    (a) If the Commissioner determines, after such investigations as he 
considers to be necessary, that:
    (1) A request submitted in accordance with Sec.  80.21 appears to 
contain no untrue statement of a material fact;
    (2) Such color additive conforms to the specifications and any other 
conditions set forth therefor in parts 81 and 82 of this chapter.
    (3) The batch covered by such request otherwise appears to comply 
with the regulations in this chapter, the Commissioner shall issue to 
the person who submitted such request a certificate showing the lot 
number assigned to such batch and that such batch, subject to the terms, 
conditions, and restrictions prescribed by part 74, 81, and 82 of this 
chapter, is a certified batch.
    (b) If the Commissioner determines, after such investigation as he 
considers to be necessary, that a request submitted in accordance with 
Sec.  80.21, or the batch of color additive covered by such request, 
does not comply with the requirements prescribed by paragraph (a) of 
this section for the issuance of a certificate, the Commissioner shall 
refuse to certify such batch and shall give notice thereof to the person 
who submitted such request, stating his reasons for refusal. Any person 
who contests such refusal shall have an opportunity for a regulatory 
hearing before the Food and Drug Administration pursuant to part 16 of 
this chapter.



Sec.  80.32  Limitations of certificates.

    (a) If a certificate is obtained through fraud or misrepresentation 
of

[[Page 521]]

a material fact, such certificate shall not be effective, and a color 
additive from the batch on which such certificate was issued shall be 
considered to be from a batch that has not been certified in accordance 
with the regulations in this part. Whenever, the Commissioner learns 
that any certificate has been obtained through fraud or material 
misrepresentation, he shall notify the holder of the certificate that it 
is of no effect.
    (b) If between the time a sample of color additive accompanying a 
request for certification is taken and the time a certificate covering 
the batch of such color additive is received by the person to whom it is 
issued, any such color additive becomes changed in composition, such 
certificates shall not be effective with respect to such changed color 
additive and such changed color additive shall be considered to be from 
a batch that has not been certified in accordance with the regulations 
in this part.
    (c) If at any time after a certificate is received by the person to 
whom it is issued any color additive from the batch covered by such 
certificate becomes changed in composition, such certificate shall 
expire with respect to such changed color additive. After such 
expiration, such color additive shall be considered to be from a batch 
that has not been certified in accordance with this part; except that 
such color additive shall not be so considered when used for coloring a 
food, drug, or cosmetic, or for the purpose of certifying a batch of a 
mixture in which such color additive was used as an ingredient, or for 
use in preparing a batch of a mixture for which exemption from 
certification has been authorized, if such change resulted solely from 
such use.
    (d) A certificate shall expire with respect to any color additive 
covered thereby if the package in which such color additive was closed 
for shipment or delivery is opened. After such expiration such color 
additive shall be considered to be from a batch that has not been 
certified, except that such color additive shall not be so considered 
when the package is opened;
    (1) and such color additive is used, subject to the restrictions 
prescribed by paragraphs (f), (g), and (h) of this section, in coloring 
a food, drug, or cosmetic;
    (2) for the purpose of certifying a batch made by repacking such 
color;
    (3) for the purpose of certifying a batch of a mixture in which such 
color is used as an ingredient; or
    (4) for the purpose of preparing a batch of a mixture for which 
exemption from certification has been authorized; or
    (5) when the package is reopened solely for repackaging by the 
person to whom such certificate was issued.
    (e) A certificate shall not be effective with respect to a package 
of color additive and such color additive shall be considered to be from 
a batch that has not been certified if such package is shipped or 
delivered under a label which does not bear all words, statements, and 
other information required by Sec.  70.25 of this chapter to appear 
thereon.
    (f) A certificate shall not be effective with respect to a package 
of color additive, and such color additive shall be considered to be 
from a batch that has not been certified if:
    (1) Such package has not been sealed in accordance with Sec.  70.20 
of this chapter.
    (2) Such package has been sealed in accordance with Sec.  70.20 of 
this chapter and the seal has been broken, intentionally or 
accidentally, unless such seal has been broken for the purpose of using 
color additive in accordance with Sec.  80.38, or, such package has been 
opened by a duly authorized representative of the Administration or 
Department in the performance of his official duties, and he has 
immediately resealed the package in conformance with Sec.  70.20 of this 
chapter.
    (g) A certificate shall not be effective with respect to a package 
of color additive and such color additive shall be considered to be from 
a batch that has not been certified if such color additive is used in 
any manner other than that for which it was certified.
    (h) When the listing or the specifications for a color additive are 
revoked or amended, the final order effecting the revocation or 
amendment may specify, in addition to its own effective date, a date on 
which all certificates

[[Page 522]]

for existing batches and portions of batches of such a color additive 
theretofore issued under such revoked or amended regulations shall cease 
to be effective; and any such lots of the color additive shall be 
regarded as uncertified after the date specified unless a new 
certificate can be and is obtained in conformance with the new 
regulations. When a certificate thus ceases to be effective for a color 
additive, any certificates previously issued for a color additive 
mixture containing that color additive shall cease to be effective on 
the same date. Use of such color additive or color additive mixture 
after such specified date without the new certificate in preparing 
foods, drugs, or cosmetics will result in such food, drugs, or cosmetics 
being adulterated. When a certified color additive has been used in 
food, drugs, or cosmetics and the status of the color additive is 
thereafter changed by amendment or revocation of its listing or 
specification regulations, such food, drugs, and cosmetics will not be 
regarded as adulterated by reason of the use of such color additive, 
unless the hazard to health is such that existing stocks of the foods, 
drugs, or cosmetics cannot be safely used, in which cases findings to 
that effect will be made and regulations appropriate for such special 
cases will be issued.



Sec.  80.34  Authority to refuse certification service.

    (a) When it appears to the Commissioner that a person has:
    (1) Obtained, or attempted to obtain, a certificate through fraud or 
misrepresentation of a material fact.
    (2) Falsified the records required to be kept by Sec.  80.39; or
    (3) Failed to keep such records, or to make them available, or to 
accord full opportunity to make inventory of stocks on hand or otherwise 
to check the correctness of such records, as required by Sec.  80.39; or
    (4) Refused to permit duly authorized employees of the Food and Drug 
Administration free access to all manufacturing facilities, processes, 
and formulae involved in the manufacture of color additives and 
intermediates from which such color additives are derived; he may 
immediately suspend certification service to such person and may 
continue such suspension until adequate corrective action has been 
taken.
    (b) Any person who contests suspension of service shall have an 
opportunity for a regulatory hearing before the Food and Drug 
Administration pursuant to part 16 of this chapter.



Sec.  80.35  Color additive mixtures; certification and exemption
from certification.

    (a) Color additive mixtures to be certified. Any color additive 
mixture that contains one or more straight colors listed in part 74 of 
this chapter, together with any diluents listed in such subparts for use 
with such straight colors, shall be certified if intended for use in 
foods, drugs, or cosmetics, or in coloring the human body, as the case 
may be, subject to any restriction prescribed in parts 70 and 71 of this 
chapter.
    (b) Color additive mixtures exempted from certification. A color 
additive mixture prepared from a previously certified batch of one or 
more straight colors, with or without any diluent that has been listed 
in part 73 of this chapter for use in mixtures, shall be exempt from 
batch certification if the straight color used has not changed in 
composition in any manner whatsoever since its certification and if it 
is simply mixed with the approved diluents for exempt mixtures. The 
label of such color additive mixtures shall not bear the lot number 
assigned by the Food and Drug Administration to the certified straight 
color components, but shall bear the manufacturer's control number 
through which the history of the straight color can be determined.
    (c) Additions to the list of diluents. A person requesting additions 
to the list of diluents authorized for the purposes described in 
paragraphs (a) and (b) of this section shall submit a petition in 
accordance with the provisions of Sec.  71.1 of this chapter. Each such 
petition shall be accompanied by the fee prescribed in Sec.  70.19 of 
this chapter, unless there is an advance deposit to be used for 
prepayment of such fees.


[[Page 523]]


    Note: The provisions of Sec.  80.35 with respect only to diluents 
for use in cosmetic color additive mixtures were stayed, until a 
regulation is effected listing safe diluents for cosmetic use, including 
cosmetics which color the human body, 29 FR 18495, Dec. 29, 1964.



Sec.  80.37  Treatment of batch pending certification.

    Immediately after the sample that is to accompany a request for 
certification of a batch of color additive is taken, the batch shall be:
    (a) Stored in containers of such kind as to prevent change in 
composition.
    (b) Held under the control of the person requesting certification 
until certified.
    (c) Marked, by labeling or otherwise, in a manner such that there 
can be no question as to the identity of the batch and no question that 
it is not to be used until the requested certificate has been issued.



Sec.  80.38  Treatment of batch after certification.

    (a) Immediately upon notification that a batch of color additive has 
been certified, the person requesting certification thereof shall 
identify such batch, by labeling, with the certified lot number.
    (b) The person requesting certification shall maintain storage in 
such manner as to prevent change in composition until such batch has 
been packaged and labeled as required by Sec. Sec.  70.20 and 70.25 of 
this chapter, except that the person requesting certification may use 
such color additive for the purpose of coloring a food, drug, or 
cosmetic.



Sec.  80.39  Records of distribution.

    (a) The person to whom a certificate is issued shall keep complete 
records showing the disposal of all the color additive from the batch 
covered by such certificate. Upon the request of any officer or employee 
of the Food and Drug Administration or of any other officer or employee 
acting on behalf of the Secretary of Health and Human Services, such 
person, at all reasonable hours until at least 2 years after disposal of 
all such color additive, shall make such records available to any such 
officer or employee, and shall accord to such officer or employee full 
opportunity to make inventory of stocks of such color additive on hand 
and otherwise to check the correctness of such records.
    (b) The records required to be kept by paragraph (a) of this section 
shall show:
    (1) Each quantity used by such person from such batch and the date 
and kind of such use.
    (2) The date and quantity of each shipment or delivery from such 
batch, and the name and post-office address of the person to whom such 
shipment or delivery was made.
    (c) The records required to be kept by paragraph (a) of this section 
shall be kept separately from all other records.



PART 81_GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL
COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS--Table of Contents



Sec.
81.1 Provisional lists of color additives.
81.10 Termination of provisional listings of color additives.
81.30 Cancellation of certificates.
81.32 Limitation of certificates.

    Authority: 21 U.S.C. 371, 379e, 379e note.



Sec.  81.1  Provisional lists of color additives.

    The Commissioner of Food and Drugs finds that the following lists of 
color additives are provisionally listed under section 203(b) of the 
Color Additive Amendments of 1960 (sec. 203(b), 74 Stat. 405 (21 U.S.C. 
379e note)). Except for color additives for which petitions have been 
filed, progress reports are required by January 1, 1968, and at 6-month 
intervals thereafter. Specifications for color additives listed in 
paragraphs (a), (b), and (c) of this section appear in the respective 
designated sections. The listing of color additives in this section is 
not to be construed as a listing for surgical suture use unless color 
additive petitions have been submitted for such use or the Commissioner 
has been notified of studies underway to establish the safety of the 
color additive for such use. The color additives listed in paragraphs 
(a), (b), and (c) of this section may not be used in products which are 
intended to be

[[Page 524]]

used in the area of the eye. The color additives listed in paragraphs 
(a), (b), and (c) of this section are provisionally listed until the 
closing dates set forth therein.
    (a) Color additives previously and presently subject to 
certification and provisionally listed for food, drug, and cosmetic use.

----------------------------------------------------------------------------------------------------------------
                                                         Closing date
            Color additive            --------------------------------------------------       Restrictions
                                               Food use          Drug and cosmetic use
----------------------------------------------------------------------------------------------------------------
Lakes (FD&C) (sec. 82.51 of this
 chapter).
----------------------------------------------------------------------------------------------------------------

    (b) Color additives previously and presently subject to 
certification and provisionally listed for drug and cosmetic use.

------------------------------------------------------------------------
                                     Closing date        Restrictions
------------------------------------------------------------------------
Lakes (D&C) (Sec. 82.2051 of
 this chapter).
------------------------------------------------------------------------

    (c) Color additives previously and presently subject to 
certification and provisionally listed for use in externally applied 
drugs and cosmetics.

------------------------------------------------------------------------
                                     Closing date        Restrictions
------------------------------------------------------------------------
Lakes (Ext. D&C) (sec. 82.105(1)
 of this chapter)
------------------------------------------------------------------------


[42 FR 15665, Mar. 22, 1977]

    Editorial Note: For Federal Register citations affecting Sec.  81.1, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and at www.fdsys.gov.



Sec.  81.10  Termination of provisional listings of color additives.

    (a) Ext. D&C Yellow Nos. 9 and 10. These colors cannot be produced 
with any assurance that they do not contain [beta]-naphthylamine as an 
impurity. While it has been asserted that the two colors can be produced 
without the impurity named, no method of analysis has been suggested to 
establish the fact. [beta]-Naphthylamine is a known carcinogen; 
therefore, there is no scientific evidence that will support a safe 
tolerance for these colors in products to be used in contact with the 
skin. The Commissioner of Food and Drugs, having concluded that such 
action is necessary to protect the public health, hereby terminated the 
provisional listing of Ext. D&C Yellow No. 9 and Ext. D&C Yellow No. 10.
    (b) [Reserved]
    (c) FD&C Red No. 1. Results of recent feeding tests of this color 
additive have demonstrated it to be toxic upon ingestion:
    (1) Groups of 50 rats are being fed diets containing FD&C Red No. 1 
at levels of 5 percent, 2 percent, 1 percent, 0.5 percent, and 0 
percent. At this stage of the tests, which have now been in progress for 
from 15 months to 18 months, 116 animals from the 250 being fed FD&C Red 
No. 1 at various levels and 27 of the 100 controls have died. Of these, 
11 being fed at the 5 percent level, 16 being fed at the 2 percent 
level, 11 being fed at the 1 percent level, and 2 being fed at the 0.5 
percent level, have shown liver damage. None of the controls that have 
died have shown liver damage.
    (2) Groups of 100 mice are being fed diets containing 2 percent, 1 
percent, 0.5 percent, and 0.1 percent FD&C Red No. 1, with 400 mice as 
controls. All mice on dosage levels of 2 percent and 1 percent died 
before the seventieth week. Gross liver damage has been observed in all 
groups fed at the 0.5 percent diet and above.
    (3) Groups of 4 dogs are being fed diets containing 2 percent, 1 
percent, 0.25 percent, and 0 percent FD&C Red No. 1. Three of the dogs 
on the 2 percent dosage level died before 32 weeks; the other is living. 
Three of the dogs on the 1 percent dosage level died or were sacrificed 
within 13 months. All deceased or sacrificed dogs have shown liver 
damage grossly and/or microscopically. Deceased dogs on the 1 percent 
and 2 percent dosage level showed poor physical condition.

The Commissioner of Food and Drugs having concluded that ingestion of 
this color additive over a long period of time would be unsafe, and in 
order to protect the public health, hereby terminates the provisional 
listing of FD&C Red No. 1 for use in foods, drugs, and cosmetics.
    (d) FD&C Red No. 4. Feeding tests of this color additive have been 
conducted with three species:

[[Page 525]]

    (1) Rats of the Osborne-Mendel and Sprague-Dawley strains were fed 
FD&C Red No. 4 for 2 years at levels of 5 percent, 2 percent, 1 percent, 
and 0.5 percent of the diet. No effect was found.
    (2) Mice of the C3Hf and C57BL strains were fed FD&C Red No. 4 for 2 
years at levels of 2 percent and 1 percent of the diet. No effect was 
found.
    (3) Dogs were fed FD&C Red No. 4 at levels of 2 percent and 1 
percent of the diet. Adverse effects were found at both levels in the 
urinary bladder and in the adrenals. Three dogs of five fed on the 2-
percent level died after 6 months, 9 months, and 5\1/2\ years on the 
test. Two of the dogs on the 2-percent level and all five of the dogs on 
the 1-percent level survived to the completion of the 7 year study.

The Commissioner of Food and Drugs has concluded that available data do 
not permit the establishment of a safe level of use of this color 
additive in food, ingested drugs and ingested cosmetics. In order to 
protect the public health, the Commissioner hereby terminates the 
provisional listing of FD&C Red No. 4 for use in food and ingested 
drugs. The Commissioner has previously terminated the provisional 
listing of FD&C Red No. 4 for use in ingested cosmetics. FD&C Red No. 4 
is listed for use in externally applied drugs and cosmetics by 
Sec. Sec.  74.1304 and 74.2304 of this chapter, respectively. Section 
82.304 of this chapter is retained in part 82 of this chapter to permit 
the use of lakes of FD&C Red No. 4 in externally applied drugs and 
cosmetics.
    (e) FD&C Violet No. 1. The Commissioner of Food and Drugs, in order 
to protect the public health, hereby terminates the provisional listing 
of FD&C Violet No. 1 for use in foods, drugs, and cosmetics.
    (f) FD&C Red No. 2. The Commissioner of Food and Drugs, in order to 
protect the public health, hereby terminates the provisional listing of 
FD&C Red No. 2 for use in food, drugs, and cosmetics.
    (g) Carbon black (prepared by the ``impingement'' or ``channel'' 
process). The Commissioner of Food and Drugs, in order to protect the 
public health, hereby terminates the provisional listing of carbon black 
(prepared by the impingement or channel process) for use in food, drugs, 
and cosmetics.
    (h) D&C Red Nos. 10, 11, 12, and 13. The petition for these color 
additives was withdrawn so that there no longer exists a basis for their 
continued provisional listing. In addition, the Commissioner has learned 
of the possible contamination of D&C Red No. 10, D&C Red No. 11, D&C Red 
No. 12, and D&C Red No. 13 with [beta]-naphthyl-amine. The Commissioner 
concludes that these colors cannot be produced with any reasonable 
assurance that they will not contain [beta]-naphthylamine as an impurity 
or not yield [beta]-naphthylamine from the metabolism of subsidiary 
colors present in them. [beta]-Naphthylamine is a known carcinogen; 
therefore, there is no scientific evidence that will support a safe 
tolerance for these colors in drugs or cosmetics. The Commissioner of 
Food and Drugs, upon withdrawal of the petition for their use and in 
order to protect the public health, hereby terminates the provisional 
listing of D&C Red No. 10, D&C Red No. 11, D&C Red No. 12, and D&C Red 
No. 13 for use in drugs and cosmetics, effective December 13, 1977.
    (i) Ext. D&C Yellow No. 1. The Commissioner has learned of the 
contamination of Ext. D&C Yellow No. 1 with 4-aminobiphenyl. The 
Commissioner concludes that this color cannot be produced with any 
reasonable assurance that it will not contain 4-aminobiphenyl as an 
impurity or not yield benzidine from the decomposition of a subsidiary 
reaction product that might be present in the color. 4-Aminobiphenyl and 
benzidine are known carcinogens; therefore, there is no scientific 
evidence that will support a safe tolerance for these colors in drugs or 
cosmetics. In addition, insufficient data have been submitted to permit 
establishment of appropriate specifications for the batch certification 
of the color. The Commissioner of Food and Drugs, in order to protect 
the public health, hereby terminates the provisional listing of Ext. D&C 
Yellow No. 1 for use in externally applied drugs and cosmetics, 
effective December 13, 1977.
    (j) Graphite. Data have been developed that show the contamination 
of

[[Page 526]]

graphite with polynuclear aromatic hydrocarbons (PNA's). There is no 
reasonable assurance this color can be produced so that it will not 
contain PNA's as an impurity. The presence of certain PNA's in graphite 
would indicate that PNA's known to be carcinogenic to animals and humans 
may also be present. Therefore, there is no scientific evidence that 
will support a safe tolerance for this color in drugs or cosmetics. The 
Commissioner of Food and Drugs, in order to protect the public health, 
hereby terminates the provisional listing of graphite for use in 
externally applied cosmetics, effective November 29, 1977.
    (k) Ext. D&C Green No. 1. The Commissioner concludes that there are 
inadequate analytical methods to permit certification of the color 
additive Ext. D&C Green No. 1. In addition, the Commissioner has found 
that there was a failure to comply with the conditions attached to the 
postponement of the closing date in accordance with section 203(a)(2) of 
the transitional provisions of the Color Additive Amendments of 1960. 
The Commissioner of Food and Drugs hereby terminates the provisional 
listing of Ext. D&C Green No. 1 for use in externally applied drugs and 
cosmetics, effective November 29, 1977.
    (l) [Reserved]
    (m) D&C Orange Nos. 10 and 11. In the absense of a petition to list 
D&C Orange No. 10 and D&C Orange No. 11 for use in ingested drugs and 
cosmetics, there no longer exists a basis for provisional listing for 
such uses. Therefore, FDA is terminating the provisional listing of D&C 
Orange No. 10 and D&C Orange No. 11 for use in ingested drugs and 
cosmetics, effective April 28, 1981.
    (n) D&C Blue No. 6. The Commissioner of Food and Drugs, having 
concluded that unresolved questions remain concerning the chemistry of 
unidentified minor components, hereby terminates the provisional listing 
of D&C Blue No. 6 for use in drugs and cosmetics.
    (o) D&C Green No. 6. In the absence of a petition to list D&C Green 
No. 6 for use in ingested drugs and cosmetics, there no longer exists a 
basis for provisional listing for such uses. Accordingly, the 
Commissioner of Food and Drugs hereby terminates the provisional listing 
of D&C Green No. 6 for use in ingested drugs and cosmetics, effective 
March 27, 1981.
    (p) [Reserved]
    (q)(1) D&C Red No. 19 and D&C Red No. 37. Having concluded that, 
when ingested, D&C Red No. 19 causes cancer in rats and mice, the agency 
hereby terminates the provisional listings of D&C Red No. 19 and 
chemically related D&C Red No. 37 for use in ingested drugs and ingested 
cosmetics, effective February 4, 1983.
    (2) D&C Red No. 37. In the absence of a petition to list D&C Red No. 
37 for external uses, there no longer exists a basis for provisional 
listing for such uses. Accordingly, the Commissioner of Food and Drugs 
hereby terminates the provisional listings of D&C Red No. 37 for use in 
externally applied drugs and cosmetics, effective June 6, 1986.
    (r) [Reserved]
    (s) D&C Orange No. 17. Having concluded that, when ingested, D&C 
Orange No. 17 causes cancer in rats and mice, the agency has terminated 
the provisional listing of D&C Orange No. 17 for use in ingested drugs 
and ingested cosmetics, effective March 31, 1983.
    (t) D&C Red No. 8 and D&C Red No. 9. In the absence of a petition to 
list D&C Red No. 8 and D&C Red No. 9 for mouthwash, dentifrices, and 
ingested drugs, except ingested drug lip products, there no longer 
exists a basis for provisional listing for such uses. Accordingly, the 
Commissioner of Food and Drugs hereby terminates the provisional 
listings of D&C Red No. 8 and D&C Red No. 9 for use in mouthwash, 
dentifrices, and ingested drugs, except ingested drug lip products, 
effective January 6, 1987.
    (u) FD&C Red No. 3. Having concluded that FD&C Red No. 3 causes 
cancer in rats, the agency hereby terminates the provisional listing of 
FD&C Red No. 3 for use in cosmetics and externally applied drugs and the 
provisional listing of the lakes of FD&C Red No. 3 for use in food, 
drug, and cosmetic products, effective January 29, 1990.

[42 FR 15665, Mar. 22, 1977]

    Editorial Note: For Federal Register citations affecting Sec.  
81.10, see the List of CFR Sections Affected, which appears in the

[[Page 527]]

Finding Aids section of the printed volume and at www.fdsys.gov.



Sec.  81.30  Cancellation of certificates.

    (a) Certificates issued heretofore for colors being removed from the 
provisional list (Sec.  81.10(a)) are cancelled and of no effect after 
December 1, 1960, and use of such color additives in drugs or cosmetics 
after that date will result in adulteration.
    (b)(1) Certificates issued heretofore for the color additive 
designated FD&C Red No. 1 are cancelled as of the date of the 
publication of this Order, and use of this color additive in the 
manufacture of foods, drugs, or cosmetics after that date will result in 
adulteration.
    (2) The Commissioner finds that no action needs to be taken to 
remove foods, drugs, and cosmetics containing this color additive from 
the market on the basis of the scientific evidence before him, taking 
into account that the additive is not an acute toxic substance and that 
it is only used in small amounts in foods, drugs, and cosmetics.
    (c) Certificates issued for FD&C Red No. 4 and all mixtures 
containing this color additive are cancelled and have no effect after 
September 23, 1976 insofar as food, ingested drugs, and ingested 
cosmetics are concerned, and use of this color additive in the 
manufacture of food, ingested drugs, and ingested cosmetics after this 
date will result in adulteration. The certificates shall continue in 
effect for the use of FD&C Red No. 4 in externally applied drugs and 
cosmetics. The Commissioner finds, on the basis of the scientific 
evidence before him that no action has to be taken to remove from the 
market food, ingested drugs and ingested cosmetics containing the color 
additive.
    (d) Certificates issued for the following color additives and all 
mixtures containing these color additives are canceled and have no 
effect after October 4, 1966, and use of such color additives in the 
manufacture of foods, drugs, or cosmetics after that date will result in 
adulteration:

FD&C Green No. 1.
FD&C Green No. 2.
D&C Green No. 7.
D&C Red No. 5.
D&C Red No. 14.
D&C Red No. 18.
D&C Red No. 24.
D&C Red No. 29.
D&C Red No. 35.
D&C Red No. 38.
D&C Orange No. 3.
D&C Orange No. 8.
D&C Orange No. 14.
D&C Orange No. 15.
D&C Orange No. 16.
D&C Blue No. 7.
D&C Black No. 1.
Ext. D&C Yellow No. 5.
Ext. D&C Yellow No. 6.
Ext. D&C Red No. 1.
Ext. D&C Red No. 2.
Ext. D&C Red No. 3.
Ext. D&C Red No. 10.
Ext. D&C Red No. 11.
Ext. D&C Red No. 13.
Ext. D&C Red No. 14.
Ext. D&C Red No. 15.
Ext. D&C Blue No. 1.
Ext. D&C Blue No. 4.
Ext. D&C Orange No. 1.
Ext. D&C Orange No. 4.

    (e) Certificates issued for the following color additives and all 
mixtures containing these color additives are canceled and have no 
effect after July 1, 1968, and use of such color additives in the 
manufacture of drugs or cosmetics after that date will result in 
adulteration:

Ext. D&C Yellow No. 3.
Ext. D&C Red No. 8
Ext. D&C Orange No. 3.

    (f) Certificates issued for D&C Yellow No. 11 and all mixtures 
containing this color additive are canceled and have no effect after 
April 30, 1968, insofar as ingested use is concerned. Use of this color 
additive in the manufacture of ingested drugs or cosmetics subject to 
ingestion after that date will result in adulteration.
    (g) Certificates issued for D&C Red No. 17, D&C Red No. 31, D&C Red 
No. 34, D&C Orange No. 4, and D&C Violet No. 2, and all mixtures 
containing these color additives, are canceled and have no effect after 
December 31, 1968, insofar as ingested use is concerned. Use of these 
color additives in the manufacture of ingested drugs or cosmetics 
subject to ingestion after that date will result in adulteration.
    (h)(1) Certificates issued for FD&C Violet No. 1 and all mixtures 
containing this color additive are canceled

[[Page 528]]

and have no effect after April 10, 1973, and use of such color additive 
in the manufacture of foods, drugs, or cosmetics after that date will 
result in adulteration.
    (2) The Commissioner finds that no action needs to be taken to 
remove foods, drugs, and cosmetics containing this color additive from 
the market on the basis of the scientific evidence before him.
    (i) Certificates issued prior to July 1, 1968, for D&C Brown No. 1 
and Ext. D&C Violet No. 2 and all mixtures containing these colors are 
canceled and have no effect. This cancellation does not apply to 
certificates issued after March 15, 1973, for D&C Brown No. 1 and Ext. 
D&C Violet No. 2, which are provisionally listed in Sec.  81.1(b) and 
(c) respectively for coloring externally applied cosmetics.
    (j)(1) Certificates issued for FD&C Red No. 2 and all mixtures 
containing this color additive are canceled and have no effect after 
January 28, 1976, and use of this color additive in the manufacture of 
food, drugs, or cosmetics after this date will result in adulteration.
    (2) The Commissioner finds, on the basis of the scientific evidence 
before him, that no action has to be taken to remove from the market 
food, drugs, and cosmetics containing the color additive.
    (k)(1) Certificates issued for D&C Red No. 10, D&C Red No. 11, D&C 
Red No. 12, and D&C Red No. 13, their lakes and all mixtures containing 
these color additives or their lakes are cancelled and have no effect 
after December 13, 1977, and use of these color additivies in the 
manufacture of drugs or cosmetics after this date will result in 
adulteration.
    (2) The Commissioner finds, on the basis of the scientific evidence 
before him, that no action has to be taken to remove from the market, 
drug and cosmetic products containing the color additives.
    (l)(1) Certificates issued for Ext. D&C Yellow No. 1 and all 
mixtures containing this color additive are cancelled and have no effect 
after December 13, 1977, and use of this color additive in the 
manufacture of drugs or cosmetics after this date will result in 
adulteration.
    (2) The Commissioner finds, on the basis of the scientific evidence 
before him, that no action has to be taken to remove from the market 
drugs and cosmetics containing the color additive.
    (m)(1) Certificates issued for Ext. D&C Green No. 1 and all mixtures 
containing this color additive are cancelled and have no effect after 
November 29, 1977, and use of the color additive in the manufacture of 
drugs or cosmetics after this date will result in adulteration.
    (2) The Commissioner finds, on the basis of the scientific evidence 
before him, that no action has to be taken to remove from the market 
drugs and cosmetics containing the color additive.
    (n)(1) Certificates issued for D&C Orange No. 10, D&C Orange No. 11, 
their lakes, and all mixtures containing these color additives are 
cancelled and have no effect as pertains to their use in ingested drugs 
and cosmetics after April 28, 1981 and use of these color additives in 
the manufacture of ingested drugs or cosmetics after this date will 
result in adulteration.
    (2) The agency finds, on the basis of the scientific evidence before 
it, that no action has to be taken to remove from the market drugs and 
cosmetics to which the color additives were added on or before April 28, 
1981.
    (o)(1) Certificates issued for D&C Blue No. 6 and all mixtures 
containing this color additive are cancelled insofar as its use in drugs 
and cosmetics is concerned and have no effect after December 13, 1977, 
and use of the color additive in the manufacture of drugs or cosmetics 
after this date will result in adulteration. The color will continue to 
be certified for use in the coloring of surgical sutures.
    (2) The Commissioner finds, on the basis of the scientific evidence 
before him, that no action has to be taken to remove from the market 
drugs and cosmetics containing the color additive.
    (p)(1) Certificates issued for D&C Green No. 6, its lakes and all 
mixtures containing this color additive are cancelled and have no effect 
as pertains to their use in ingested drugs and cosmetics after May 4, 
1982 and use of the color additive in the manufacture of

[[Page 529]]

ingested drugs or cosmetics after this date will result in adulteration.
    (2) The agency finds, on the basis of the scientific evidence before 
it, that no action has to be taken to remove from the market ingested 
drugs and cosmetics containing the color additive.
    (q) [Reserved]
    (r)(1) Certificates issued for D&C Red No. 19 and D&C Red No. 37, 
their lakes, and all mixtures containing these color additives are 
cancelled and have no effect as pertains to their use in ingested drugs 
and cosmetics after February 4, 1983, and use of these color additives 
in the manufacture of ingested drugs or cosmetics after this date will 
result in adulteration.
    (2) The agency finds, on the scientific evidence before it, that no 
action has to be taken to remove from the market ingested drugs and 
cosmetics to which D&C Red No. 19 and D&C Red No. 37 were added on or 
before February 4, 1983, or externally applied drugs and cosmetics to 
which D&C Red No. 37 was added on or before June 6, 1986.
    (3) Certificates issued for D&C Red No. 37, its lakes, and all 
mixtures containing this color additive are cancelled and have no effect 
as pertains to its use in externally applied drugs and cosmetics after 
June 6, 1986, and use of this color additive in the manufacture of 
externally applied drugs or cosmetics after this date will result in 
adulteration.
    (4) Certificates issued for D&C Red No. 19, its lakes, and all 
mixtures containing this color additive are cancelled and have no effect 
as pertains to its use in externally applied drugs and cosmetics after 
July 15, 1988, and use of this color in the manufacture of externally 
applied drugs or cosmetics after this date will result in adulteration.
    (5) The agency finds, on the scientific evidence before it, that no 
action has to be taken to remove from the market externally applied 
drugs and cosmetics to which D&C Red No. 19 was added on or before July 
15, 1988.
    (s)(1) Certificates issued for D&C Red No. 8 and D&C Red No. 9, 
their lakes, and all mixtures containing these color additives are 
canceled and have no effect as pertains to their use in mouthwash, 
dentifrices, and ingested drugs, except ingested drug lip products, 
after January 6, 1987, and use of these color additives in the 
manufacture of mouthwash, dentifrices, and ingested drugs, except 
ingested drug lip products, after this date will result in adulteration.
    (2) The agency finds, on the basis of the scientific evidence before 
it, that no action has to be taken to remove from the market mouthwash, 
dentifrices, and ingested drugs to which the color additives were added 
on or before January 6, 1987. Ingested drug lip products, however, are 
regulated for use in Sec. Sec.  74.1308 and 74.1309.
    (3) Certificates issued for D&C Red No. 8, and D&C Red No. 9, their 
lakes, and all mixtures containing these color additives are cancelled 
and have no effect as pertains to their use in ingested drug and 
cosmetic lip products and in externally applied drugs and cosmetics 
after July 15, 1988, and use of these color additives in the manufacture 
of ingested drugs and cosmetic lip products and in externally applied 
drugs and cosmetics after this date will result in adulteration.
    (4) The agency finds, on the basis of the scientific evidence before 
it, that no action has to be taken to remove from the market ingested 
drug and cosmetic lip products and externally applied drugs and 
cosmetics to which the color additives were added on or before July 15, 
1988.
    (t)(1) Certificates issued for D&C Orange No. 17, its lakes, and all 
mixtures containing this color additive are cancelled and have no effect 
as pertains to its use in ingested drugs and ingested cosmetics after 
March 31, 1983 and use of this color additive in the manufacture of 
ingested drugs or ingested cosmetics after this date will result in 
adulteration.
    (2) The agency finds, on the scientific evidence before it, that no 
action has to be taken to remove from the market drugs and cosmetics to 
which the color additive was added on or before March 31, 1983.
    (3) Certificates issued for D&C Orange No. 17, its lakes and all 
mixtures containing this color additive are cancelled and have no effect 
as pertains to its use in externally applied drugs and cosmetics after 
July 15, 1988, and use of

[[Page 530]]

this color in the manufacture of externally applied drugs or cosmetics 
after this date will result in adulteration.
    (4) The agency finds, on the scientific evidence before it, that no 
action has to be taken to remove from the market externally applied 
drugs and cosmetics to which D&C Orange No. 17 was added on or before 
July 15, 1988.
    (u)(1) Certificates issued for FD&C Red No. 3 and all mixtures 
containing this color additive are cancelled and have no effect as 
pertains to their use in cosmetics and externally applied drugs after 
January 29, 1990. Certificates issued for FD&C Red No. 3 lakes and all 
mixtures containing these lakes are cancelled and have no effect as 
pertains to their use in food, drugs, and cosmetics after January 29, 
1990. Certificates issued for D&C Red No. 3 lakes and all mixtures 
containing those lakes are cancelled and have no effect as pertains to 
their use in drugs and cosmetics after January 29, 1990. Use of this 
color additve in the manufacture of cosmetics and of externally applied 
drugs and any use of the lakes of FD&C Red No. 3 (including the lakes of 
D&C Red No. 3) after this date will result in adulteration.
    (2) The agency finds, on the scientific evidence before it, that no 
action must be taken to remove from the market food, drugs, and 
cosmetics to which the provisionally listed color additive or its lakes 
were added on or before January 29, 1990.

[42 FR 15665, Mar. 22, 1977]

    Editorial Note: For Federal Register citations affecting Sec.  
81.30, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec.  81.32  Limitation of certificates.

    Certificates issued for the color additives listed in Sec.  81.25 
and for all mixtures containing these color additives are limited to the 
conditions stated in Sec.  81.25. The use of these color additives in 
drugs and cosmetics in any other manner will result in adulteration. 
Each of these color additives shall bear a label statement of the 
tolerance and use limitations applicable to it.

[44 FR 48966, Aug. 21, 1979]



PART 82_LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND
SPECIFICATIONS--Table of Contents



                      Subpart A_General Provisions

Sec.
82.3 Definitions.
82.5 General specifications for straight colors.
82.6 Certifiable mixtures.

                  Subpart B_Foods, Drugs, and Cosmetics

82.50 General.
82.51 Lakes (FD&C).
82.101 FD&C Blue No. 1.
82.102 FD&C Blue No. 2.
82.203 FD&C Green No. 3.
82.304 FD&C Red No. 4.
82.705 FD&C Yellow No. 5.
82.706 FD&C Yellow No. 6.

                      Subpart C_Drugs and Cosmetics

82.1050 General.
82.1051 Lakes (D&C).
82.1104 D&C Blue No. 4.
82.1205 D&C Green No. 5.
82.1206 D&C Green No. 6.
82.1254 D&C Orange No. 4.
82.1255 D&C Orange No. 5.
82.1260 D&C Orange No. 10.
82.1261 D&C Orange No. 11.
82.1306 D&C Red No. 6.
82.1307 D&C Red No. 7.
82.1317 D&C Red No. 17.
82.1321 D&C Red No. 21.
82.1322 D&C Red No. 22.
82.1327 D&C Red No. 27.
82.1328 D&C Red No. 28.
82.1330 D&C Red No. 30.
82.1331 D&C Red No. 31.
82.1333 D&C Red No. 33.
82.1334 D&C Red No. 34.
82.1336 D&C Red No. 36.
82.1602 D&C Violet No. 2.
82.1707 D&C Yellow No. 7.
82.1708 D&C Yellow No. 8.
82.1710 D&C Yellow No. 10.

            Subpart D_Externally Applied Drugs and Cosmetics

82.2050 General.
82.2051 Lakes (Ext. D&C).
82.2707a Ext. D&C Yellow No. 7.

    Authority: 21 U.S.C. 371, 379e, 379e note.

    Source: 42 FR 15669, Mar. 22, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  82.3  Definitions.

    For the purposes of this part:

[[Page 531]]

    (a)-(f) [Reserved]
    (g) The term alumina means a suspension in water of precipitated 
aluminum hydroxide.
    (h) The term blanc fixe means a suspension in water of precipitated 
barium sulfate.
    (i) The term gloss white means a suspension in water of co-
precipitated aluminum hydroxide and barium sulfate.
    (j) The term mixed oxides means the sum of the quantities of 
aluminum, iron, calcium, and magnesium (in whatever combination they may 
exist in a coal-tar color) calculated as aluminum trioxide, ferric 
oxide, calcium oxide, and magnesium oxide.
    (k)-(m) [Reserved]
    (n) The term externally applied drugs and cosmetics means drugs and 
cosmetics which are applied only to external parts of the body and not 
to the lips or any body surface covered by mucous membrane.
    (o)-(p) [Reserved]
    (q) The definitions and interpretations of terms contained in 
section 201 of the Federal Food, Drug, and Cosmetic Act shall be 
applicable also to such terms when used in this part.



Sec.  82.5  General specifications for straight colors.

    No batch of a straight color listed in subpart B, C, or D shall be 
certified under this part unless:
    (a) It is free from all impurities (other than those named in 
paragraph (b) of this section or in the specifications set forth in such 
paragraph for such color) to the extent that such impurities can be 
avoided by good manufacturing practice.
    (b) It conforms to the following specifications:
    (1) In the case of a straight color listed in subpart B:
    (i) Lead (as Pb), not more than 0.001 percent.
    (ii) Arsenic (as As2O3), not more than 0.00014 
percent.
    (iii) Heavy metals (except Pb and As) (by precipitation as 
sulfides), not more than trace.
    (2) In the case of a straight color listed in subpart C or D:
    (i) Lead (as Pb), not more than 0.002 percent.
    (ii) Arsenic (as As2O3), not more than 0.0002 
percent.
    (iii) Heavy metals (except Pb and As) (by precipitation as 
sulfides), not more than 0.003 percent.
    (3) In the case of a straight color which contains a barium salt 
listed in subpart C or D--soluble barium (in dilute HCl) (as 
BaCl2), not more than 0.05 percent.



Sec.  82.6  Certifiable mixtures.

    (a) A batch of a mixture which contains no straight color listed in 
subpart C or D may be certified for use in food, drugs and cosmetics, 
if:
    (1) Each coal-tar color used as an ingredient in mixing such batch 
is from a previously certified batch and such color has not changed in 
composition in any manner whatever since such previous certification, 
except by mixing into such batch of mixture;
    (2) Each diluent in such batch of mixture is harmless and suitable 
for use therein; and
    (3) No diluent (except resins, natural gum, pectin and, in the case 
of mixtures which are aqueous solutions or aqueous pastes, sodium 
benzoate in a quantity of not more than \1/10\ of 1 percent) in such 
mixture is a nonnutritive substance, unless such mixture is for external 
application to shell eggs, or for use in coloring a food specified in 
the requests for certification of such batch submitted in accordance 
with Sec.  80.21 of this chapter, and such diluent, in the usual process 
of manufacturing such food, is removed and does not become a component 
of such food.
    (b) A batch of a mixture which contains no straight color listed in 
subpart D, or which contains a diluent not permitted by paragraph (a)(3) 
of this section, may be certified in accordance with the provisions of 
this part, for use only in drugs and cosmetics, if:
    (1) Each coal-tar color used as an ingredient in mixing such batch 
is from a previously certified batch and such color has not changed in 
composition in any manner whatever since such previous certification, 
except by mixing into such batch of mixture.
    (2) Each diluent in such batch of mixture is harmless and suitable 
for use therein.

[[Page 532]]

    (c) A batch of a mixture which contains a straight color listed in 
subpart D may be certified in accordance with the provisions of this 
part, for use only in externally applied drugs and cosmetics, if:
    (1) Each coal-tar color used as an ingredient in mixing such batch 
is from a previously certified batch and such color has not changed in 
composition in any manner whatever since such previous certification, 
except by mixing into such batch of mixture; and
    (2) Each diluent in such batch of mixture is harmless and suitable 
for use therein.



                  Subpart B_Foods, Drugs, and Cosmetics



Sec.  82.50  General.

    A batch of a straight color listed in this subpart may be certified, 
in accordance with the provisions of the regulations in this part, for 
use in food, drugs, and cosmetics, if such batch conforms to the 
requirements of Sec.  82.5 and to the specifications in this subpart set 
forth for such color.



Sec.  82.51  Lakes (FD&C).

    (a)(1) General. Any lake made by extending on a substratum of 
alumina, a salt prepared from one of the certified water-soluble 
straight colors hereinbefore listed in this subpart by combining such 
color with the basic radical aluminum or calcium.
    (2) Specifications. Prepared from previously certified colors listed 
in this subpart.

Soluble chlorides and sulfates (as sodium salts), not more than 2.0 
percent.
Inorganic matter, insoluble HCl, not more than 0.5 percent.

    (b) Each lake made as prescribed in paragraph (a) of this section 
shall be considered to be a straight color and to be listed therein 
under the name which is formed as follows:
    (1) The listed name of the color from which the lake is prepared;
    (2) The name of the basic radical combined in such color; and
    (3) The word ``Lake''.


(For example, the name of a lake prepared by extending the aluminum salt 
prepared from FD&C Blue No. 1 upon the substratum would be FD&C Blue No. 
1--Aluminum Lake.)



Sec.  82.101  FD&C Blue No. 1.

    The color additive FD&C Blue No. 1 shall conform in identity and 
specifications to the requirements of Sec.  74.101(a)(1) and (b) of this 
chapter.



Sec.  82.102  FD&C Blue No. 2.

    The color additive FD&C Blue No. 2 shall conform in identity and 
specifications to the requirements of Sec.  74.102(a)(1) and (b) of this 
chapter.

[48 FR 5261, Feb. 4, 1983]



Sec.  82.203  FD&C Green No. 3.

    The color additive FD&C Green No. 3 shall conform in identity and 
specifications to the requirements of Sec.  74.203(a)(1) and (b) of this 
chapter.

[47 FR 52144, Nov. 19, 1982]



Sec.  82.304  FD&C Red No. 4.

    The color additive FD&C Red No. 4 shall conform in identity and 
specifications to the requirements of Sec.  74.1304(a)(1) and (b) of 
this chapter. FD&C Red No. 4 is restricted to use in externally applied 
drugs and cosmetics.



Sec.  82.705  FD&C Yellow No. 5.

    The color additive FD&C Yellow No. 5 shall conform in identity and 
specifications to the requirements of Sec.  74.705 (a)(1) and (b) of 
this chapter.

[51 FR 24519, July 7, 1986]



Sec.  82.706  FD&C Yellow No. 6.

    (a) The color additive FD&C Yellow No. 6 shall conform in identity 
and specifications to the requirements of Sec.  74.706 (a)(1) and (b) of 
this chapter.
    (b) All lakes including current D&C external and D&C lakes of FD&C 
Yellow No. 6 shall be manufactured from previously certified batches of 
the straight color additive.

[52 FR 21509, June 8, 1987]



                      Subpart C_Drugs and Cosmetics



Sec.  82.1050  General.

    A batch of a straight color listed in this subpart may be certified, 
in accordance with the provisions of this

[[Page 533]]

part, for use only in drugs and cosmetics, if such batch conforms to the 
requirements of Sec.  82.5 and to the specifications set forth in this 
subpart for such color.



Sec.  82.1051  Lakes (D&C).

    (a)(1) General. Any lake, other than those listed in subpart B, made 
by extending on a substratum of alumina, blanc fixe, gloss white, clay, 
titanium dioxide, zinc oxide, talc, rosin, aluminum benzoate, calcium 
carbonate, or any combination of two or more of these, (i) one of the 
straight colors (except lakes) listed in subpart B or hereinbefore 
listed in this subpart, which color is a salt in which is combined the 
basic radical sodium, potassium, aluminum, barium, calcium, strontium, 
or zirconium; or (ii) a salt prepared from one of the straight colors 
(except lakes) listed in subpart B, or hereinbefore listed in this 
subpart, by combining such color with the basic radical sodium, 
potassium, aluminum, barium, calcium, strontium, or zirconium.
    (2) Specifications.

Ether extracts, not more than 0.5 percent.
Soluble chlorides and sulfates (as sodium salts), not more than 3.0 
percent.
Intermediates, not more than 0.2 percent.

    (b) Each lake made as prescribed in paragraph (a) of this section 
shall be considered to be a straight color and to be listed therein 
under the name which is formed as follows:
    (1) The listed name of the color from which the lake is prepared, 
except that if such name contains the symbol ``FD&C'' such symbol shall 
be changed to ``D&C'';
    (2) The name of the basic radical combined in such color; and
    (3) The word ``Lake.''

(For example, the name of a lake prepared by extending the color D&C Red 
No. 9 upon a substratum is ``D&C Red No. 9--Barium Lake'', and a lake 
prepared by extending the aluminum salt prepared from FD&C Green No. 1 
upon a substratum other than alumina is ``D&C Green No. 1--Aluminum 
Lake''.)



Sec.  82.1104  D&C Blue No. 4.

    The color additive D&C Blue No. 4 shall conform in identity and 
specifications to the requirements of Sec.  74.1104(a)(1) and (b) of 
this chapter. D&C Blue No. 4 is restricted to use in externally applied 
drugs and cosmetics.



Sec.  82.1205  D&C Green No. 5.

    The color additive D&C Green No. 5 shall conform in identity and 
specifications to the requirements of Sec.  74.1205(a)(1) and (b)(2) of 
this chapter.

[47 FR 24285, June 4, 1982]



Sec.  82.1206  D&C Green No. 6.

    The color additive D&C Green No. 6 shall conform in identity and 
specifications to the requirements of Sec.  74.1206 (a) and (b) of this 
chapter. D&C Green No. 6 is restricted to use in externally applied 
drugs and cosmetics.

[47 FR 14147, Apr. 2, 1982, as amended at 51 FR 9785, Mar. 21, 1986]



Sec.  82.1254  D&C Orange No. 4.

    The color additive D&C Orange No. 4 shall conform in identity and 
specifications to the requirements of Sec.  74.1254(a)(1) and (b) of 
this chapter. D&C Orange No. 4 is restricted to use in externally 
applied drugs and cosmetics.

[42 FR 52396, Sept. 30, 1977]



Sec.  82.1255  D&C Orange No. 5.

    (a) The color additive D&C Orange No. 5 shall conform in identity 
and specifications to the requirements of Sec.  74.1255(a)(1) and (b) of 
this chapter. D&C Orange No. 5 is restricted to the uses described in 
this section.
    (b) The color additive D&C Orange No. 5. may be safely used for 
coloring externally applied drugs in amounts not exceeding 5 milligrams 
per daily dose of the drug. The color additive D&C Orange No. 5 may be 
safely used for coloring lipsticks and other cosmetics intended to be 
applied to the lips in amounts not exceeding 5.0 percent by weight of 
the finished cosmetic products, and for coloring mouthwashes, 
dentifrices, and externally applied cosmetics in amounts consistent with 
current good manufacturing practice.

[49 FR 13343, Apr. 4, 1984]

[[Page 534]]



Sec.  82.1260  D&C Orange No. 10.

    The color additive D&C Orange No. 10 shall conform in identity and 
specifications to the requirements to Sec.  74.1260(a)(1) and (b) of 
this chapter. D&C Orange No. 10 is restricted to use in externally 
applied drugs and cosmetics.

[46 FR 18954, Mar. 27, 1981]



Sec.  82.1261  D&C Orange No. 11.

    The color additive D&C Orange No. 11 shall conform in identity and 
specifications to the requirements of Sec.  74.1261(a)(1) and (b) of 
this chapter. D&C Orange No. 11 is restricted to use in externally 
applied drugs and cosmetics.

[46 FR 18954, Mar. 27, 1981]



Sec.  82.1306  D&C Red No. 6.

    (a) The color additive D&C Red No. 6 shall conform in identity and 
specifications to the requirements of Sec.  74.1306 (a)(1) and (b) of 
this chapter.
    (b) The color additive D&C Red No. 6 may be safely used for coloring 
drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7 
does not exceed 5 milligrams per daily dose of the drug.

[47 FR 57691, Dec. 28, 1982]



Sec.  82.1307  D&C Red No. 7.

    (a) The color additive D&C Red No. 7 shall conform in identity and 
specifications to the requirements of Sec.  74.1307 (a)(1) and (b) of 
this chapter.
    (b) The color additive D&C Red No. 7 may be safely used for coloring 
drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7 
does not exceed 5 milligrams per daily dose of the drug.

[47 FR 57691, Dec. 28, 1982]



Sec.  82.1317  D&C Red No. 17.

    The color additive D&C Red No. 17 shall conform in identity and 
specifications to the requirements of Sec.  74.1317 (a)(1) and (b) of 
this chapter. D&C Red No. 17 is restricted to use in externally applied 
drugs and cosmetics.



Sec.  82.1321  D&C Red No. 21.

    The color additive D&C Red No. 21 shall conform in identity and 
specifications to the requirements of Sec.  74.1321 (a)(1) and (b) of 
this chapter.

[47 FR 53847, Nov. 30, 1982]



Sec.  82.1322  D&C Red No. 22.

    The color additive D&C Red No. 22 shall conform in identity and 
specifications to the requirements of Sec.  74.1322 (a)(1) and (b) of 
this chapter.

[47 FR 53847, Nov. 30, 1982]



Sec.  82.1327  D&C Red No. 27.

    The color additive D&C Red No. 27 shall conform in identity and 
specifications to the requirements of Sec.  74.1327 (a)(1) and (b) of 
this chapter.

[47 FR 42568, Sept. 28, 1982]



Sec.  82.1328  D&C Red No. 28.

    The color additive D&C Red No. 28 shall conform in identity and 
specifications to the requirements of Sec.  74.1328 (a)(1) and (b) of 
this chapter.

[47 FR 42568, Sept. 28, 1982]



Sec.  82.1330  D&C Red No. 30.

    The color additive D&C Red No. 30 shall conform in identity and 
specifications to the requirements of Sec.  74.1330 (a)(1) and (b) of 
this chapter.

[47 FR 22511, May 25, 1982]



Sec.  82.1331  D&C Red No. 31.

    The color additive D&C Red No. 31 shall conform in identity and 
specifications to the requirements of Sec.  74.1331(a)(1) and (b) of 
this chapter. D&C Red No. 31 is restricted to use in externally applied 
drugs and cosmetics.



Sec.  82.1333  D&C Red No. 33.

    (a) The color additive D&C Red. No. 33 shall conform in identity and 
specifications to the requirements of Sec.  74.1333(a) (1) and (b) of 
this chapter.
    (b) All lakes of D&C Red. No. 33 shall be manufactured from 
previously certified batches of the straight color additive.

[53 FR 33121, Aug. 30, 1988]

[[Page 535]]



Sec.  82.1334  D&C Red No. 34.

    Calcium salt of 3-hydroxy-4-[(1-sulfo-2 -naphthalenyl)azol-2-
naphthalenecarboxylic acid.

Sum of volatile matter (at 135 [deg]C) and chlorides and sulfates 
(calculated as sodium salts), not more than 15 percent.
2-Amino-1-naphthalenesulfonic acid, calcium salt, not more than 0.2 
percent.
3-Hydroxy-2-naphthoic acid, not more than 0.4 percent.
Subsidiary colors, not more than 4 percent.
Total color not less than 85 percent.



Sec.  82.1336  D&C Red No. 36.

    (a) The color additive D&C Red No. 36 shall conform in identity and 
specifications to the requirements of Sec.  74.1336 (a)(1) and (b) of 
this chapter.
    (b) All lakes of D&C Red No. 36 shall be manufactured from 
previously certified batches of the straight color additive.

[53 FR 29031, Aug. 2, 1988]



Sec.  82.1602  D&C Violet No. 2.

    The color additive D&C Violet No. 2 shall conform in identity and 
specifications to the requirements of Sec.  74.1602(a)(1) and (b) of 
this chapter.



Sec.  82.1707  D&C Yellow No. 7.

    The color additive D&C Yellow No. 7 shall conform in identity and 
specifications to the requirements of Sec.  74.1707(a)(1) and (b) of 
this chapter. D&C Yellow No. 7 is restricted to use in externally 
applied drugs and cosmetics.



Sec.  82.1708  D&C Yellow No. 8.

    The color additive D&C Yellow No. 8 shall conform in identity and 
specifications to the requirements of Sec.  74.1707(a)(1) and (b) of 
this chapter. D&C Yellow No. 8 is restricted to use in externally 
applied drugs and cosmetics.



Sec.  82.1710  D&C Yellow No. 10.

    The color additive D&C Yellow No. 10 shall conform in identity and 
specifications to the requirements of Sec.  74.1710(a)(1) and (b) of 
this chapter.

[48 FR 39220, Aug. 30, 1983]



            Subpart D_Externally Applied Drugs and Cosmetics



Sec.  82.2050  General.

    A batch of a straight color listed in this subpart may be certified, 
in accordance with the provisions of this part, for use in externally 
applied drugs and cosmetics, if such batch conforms to the requirements 
of Sec.  82.5 and to the specifications set forth in this subpart for 
such color.



Sec.  82.2051  Lakes (Ext. D&C).

    (a)(1) General. Any lake made by extending on a substratum of 
alumina, blanc fixe, gloss white, clay, titanium dioxide, zinc oxide, 
talc, rosin, aluminum benzoate, calcium carbonate, or on any combination 
of two or more of these (i) one of the straight colors hereinbefore 
listed in this subpart, which color is a salt in which is combined the 
basic radical sodium, potassium, barium, or calcium; or (ii) a salt 
prepared from one of the straight colors hereinbefore listed in this 
subpart by combining such color with the basic radical sodium, 
potassium, aluminum, barium, calcium, strontium, or zirconium.
    (2) Specifications.

Ether extracts, not more than 0.5 percent.
Soluble chlorides and sulfates (as sodium salts), not more than 3.0 
percent.
Intermediates, not more than 0.2 percent.

    (b) Each lake made as prescribed in paragraph (a) of this section 
shall be considered to be a straight color and to be listed therein 
under the name which is formed as follows:
    (1) The listed name of the color from which the lake is prepared;
    (2) The name of the basic radical combined in such color; and
    (3) The word ``Lake.'' (For example, the name of a lake prepared by 
extending the color Ext. D&C Yellow No. 2 upon a substratum is ``Ext. 
D&C Yellow No. 2--Calcium Lake,'' and a lake prepared by extending the 
barium salt prepared from Ext. D&C Red No. 2 upon the substratum is 
``Ext. D&C Red No. 2--Barium Lake.'')



Sec.  82.2707a  Ext. D&C Yellow No. 7.

    The color additive Ext. D&C Yellow No. 7 shall conform in identity 
with

[[Page 536]]

specifications to the requirements of Sec.  74.1707a(a)(1) and (b) of 
this chapter. Ext. D&C Yellow No. 7 is restricted to use in externally 
applied drugs and cosmetics.

                         PARTS 83	98 [RESERVED]



PART 99_DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED
DRUGS, BIOLOGICS, AND DEVICES--Table of Contents



                      Subpart A_General Information

Sec.
99.1 Scope.
99.3 Definitions.

                Subpart B_Information To Be Disseminated

99.101 Information that may be disseminated.
99.103 Mandatory statements and information.
99.105 Recipients of information.

    Subpart C_Manufacturer's Submissions, Requests, and Applications

99.201 Manufacturer's submission to the agency.
99.203 Request to extend the time for completing planned studies.
99.205 Application for exemption from the requirement to file a 
          supplemental application.

     Subpart D_FDA Action on Submissions, Requests, and Applications

99.301 Agency action on a submission.
99.303 Extension of time for completing planned studies.
99.305 Exemption from the requirement to file a supplemental 
          application.

       Subpart E_Corrective Actions and Cessation of Dissemination

99.401 Corrective actions and cessation of dissemination of information.
99.403 Termination of approvals of applications for exemption.
99.405 Applicability of labeling, adulteration, and misbranding 
          authority.

                   Subpart F_Recordkeeping and Reports

99.501 Recordkeeping and reports.

    Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360c, 360e, 
360aa-360aaa-6, 371, and 374; 42 U.S.C. 262.

    Source: 63 FR 64581, Nov. 20, 1998, unless otherwise noted.



                      Subpart A_General Information



Sec.  99.1  Scope.

    (a) This part applies to the dissemination of information on human 
drugs, including biologics, and devices where the information to be 
disseminated:
    (1) Concerns the safety, effectiveness, or benefit of a use that is 
not included in the approved labeling for a drug or device approved by 
the Food and Drug Administration for marketing or in the statement of 
intended use for a device cleared by the Food and Drug Administration 
for marketing; and
    (2) Will be disseminated to a health care practitioner, pharmacy 
benefit manager, health insurance issuer, group health plan, or Federal 
or State Government agency.
    (b) This part does not apply to a manufacturer's dissemination of 
information that responds to a health care practitioner's unsolicited 
request.



Sec.  99.3  Definitions.

    (a) Agency or FDA means the Food and Drug Administration.
    (b) For purposes of this part, a clinical investigation is an 
investigation in humans that tests a specific clinical hypothesis.
    (c) Group health plan means an employee welfare benefit plan (as 
defined in section 3(1) of the Employee Retirement Income Security Act 
of 1974 (29 U.S.C. 1002(1))) to the extent that the plan provides 
medical care (as defined in paragraphs (c)(1) through (c)(3) of this 
section and including items and services paid for as medical care) to 
employees or their dependents (as defined under the terms of the plan) 
directly or through insurance, reimbursement, or otherwise. For purposes 
of this part, the term medical care means:
    (1) Amounts paid for the diagnosis, cure, mitigation, treatment, or 
prevention of disease, or amounts paid for the purpose of affecting any 
structure or function of the body;
    (2) Amounts paid for transportation primarily for and essential to 
medical care referred to in paragraph (c)(1) of this section; and

[[Page 537]]

    (3) Amounts paid for insurance covering medical care referred to in 
paragraphs (c)(1) and (c)(2) of this section.
    (d) Health care practitioner means a physician or other individual 
who is a health care provider and licensed under State law to prescribe 
drugs or devices.
    (e) Health insurance issuer means an insurance company, insurance 
service, or insurance organization (including a health maintenance 
organization, as defined in paragraph (e)(2) of this section) which is 
licensed to engage in the business of insurance in a State and which is 
subject to State law which regulates insurance (within the meaning of 
section 514(b)(2) of the Employee Retirement Income Security Act of 1974 
(29 U.S.C. 1144(b)(2))).
    (1) Such term does not include a group health plan.
    (2) For purposes of this part, the term health maintenance 
organization means:
    (i) A Federally qualified health maintenance organization (as 
defined in section 1301(a) of the Public Health Service Act (42 U.S.C. 
300e(a)));
    (ii) An organization recognized under State law as a health 
maintenance organization; or
    (iii) A similar organization regulated under State law for solvency 
in the same manner and to the same extent as such a health maintenance 
organization.
    (f) Manufacturer means a person who manufactures a drug or device or 
who is licensed by such person to distribute or market the drug or 
device. For purposes of this part, the term may also include the sponsor 
of the approved, licensed, or cleared drug or device.
    (g) New use means a use that is not included in the approved 
labeling of an approved drug or device, or a use that is not included in 
the statement of intended use for a cleared device.
    (h) Pharmacy benefit manager means a person or entity that has, as 
its principal focus, the implementation of one or more device and/or 
prescription drug benefit programs.
    (i) A reference publication is a publication that:
    (1) Has not been written, edited, excerpted, or published 
specifically for, or at the request of, a drug or device manufacturer;
    (2) Has not been edited or significantly influenced by such a 
manufacturer;
    (3) Is not solely distributed through such a manufacturer, but is 
generally available in bookstores or other distribution channels where 
medical textbooks are sold;
    (4) Does not focus on any particular drug or device of a 
manufacturer that disseminates information under this part and does not 
have a primary focus on new uses of drugs or devices that are marketed 
or are under investigation by a manufacturer supporting the 
dissemination of information; and
    (5) Does not present materials that are false or misleading.
    (j) Scientific or medical journal means a scientific or medical 
publication:
    (1) That is published by an organization that has an editorial 
board, that uses experts who have demonstrated expertise in the subject 
of an article under review by the organization and who are independent 
of the organization, to review and objectively select, reject, or 
provide comments about proposed articles, and that has a publicly stated 
policy, to which the organization adheres, of full disclosure of any 
conflict of interest or biases for all authors or contributors involved 
with the journal or organization;
    (2) Whose articles are peer-reviewed and published in accordance 
with the regular peer-review procedures of the organization;
    (3) That is generally recognized to be of national scope and 
reputation;
    (4) That is indexed in the Index Medicus of the National Library of 
Medicine of the National Institutes of Health; and
    (5) That is not in the form of a special supplement that has been 
funded in whole or in part by one or more manufacturers.
    (k) Supplemental application means:
    (1) For drugs, a supplement to support a new use to an approved new 
drug application;
    (2) For biologics, a supplement to an approved license application;
    (3) For devices that are the subject of a cleared 510(k) submission 
and devices that are exempt from the 510(k) process, a new 510(k) 
submission to support a new use or, for devices that are the

[[Page 538]]

subject of an approved premarket approval application, a supplement to 
support a new use to an approved premarket approval application.



                Subpart B_Information To Be Disseminated



Sec.  99.101  Information that may be disseminated.

    (a) A manufacturer may disseminate written information concerning 
the safety, effectiveness, or benefit of a use not described in the 
approved labeling for an approved drug or device or in the statement of 
intended use for a cleared device, provided that the manufacturer 
complies with all other relevant requirements under this part. Such 
information shall:
    (1) Be about a drug or device that has been approved, licensed, or 
cleared for marketing by FDA;
    (2) Be in the form of:
    (i) An unabridged reprint or copy of an article, peer-reviewed by 
experts qualified by scientific training or experience to evaluate the 
safety or effectiveness of the drug or device involved, which was 
published in a scientific or medical journal. In addition, the article 
must be about a clinical investigation with respect to the drug or 
device and must be considered to be scientifically sound by the experts 
described in this paragraph; or
    (ii) An unabridged reference publication that includes information 
about a clinical investigation with respect to the drug or device, which 
experts qualified by scientific training or experience to evaluate the 
safety or effectiveness of the drug or device that is the subject of the 
clinical investigation would consider to be scientifically sound;
    (3) Not pose a significant risk to the public health;
    (4) Not be false or misleading. FDA may consider information 
disseminated under this part to be false or misleading if, among other 
things, the information includes only favorable publications when 
unfavorable publications exist or excludes articles, reference 
publications, or other information required under Sec.  99.103(a)(4) or 
the information presents conclusions that clearly cannot be supported by 
the results of the study; and
    (5) Not be derived from clinical research conducted by another 
manufacturer unless the manufacturer disseminating the information has 
the permission of such other manufacturer to make the dissemination.
    (b) For purposes of this part:
    (1) FDA will find that all journal articles and reference 
publications (as those terms are defined in Sec.  99.3) are 
scientifically sound except:
    (i) Letters to the editor;
    (ii) Abstracts of a publication;
    (iii) Those regarding Phase 1 trials in healthy people;
    (iv) Flagged reference publications that contain little or no 
substantive discussion of the relevant clinical investigation; and
    (v) Those regarding observations in four or fewer people that do not 
reflect any systematic attempt to collect data, unless the manufacturer 
demonstrates to FDA that such reports could help guide a physician in 
his/her medical practice.
    (2) A reprint or copy of an article or reference publication is 
``unabridged'' only if it retains the same appearance, form, format, 
content, or configuration as the original article or publication. Such 
reprint, copy of an article, or reference publication shall not be 
disseminated with any information that is promotional in nature. A 
manufacturer may cite a particular discussion about a new use in a 
reference publication in the explanatory or other information attached 
to or otherwise accompanying the reference publication under Sec.  
99.103.



Sec.  99.103  Mandatory statements and information.

    (a) Any information disseminated under this part shall include:
    (1) A prominently displayed statement disclosing:
    (i) For a drug, ``This information concerns a use that has not been 
approved by the Food and Drug Administration.'' For devices, the 
statement shall read, ``This information concerns a use that has not 
been approved or cleared by the Food and Drug Administration.'' If the 
information to be disseminated includes both an approved and unapproved 
use or uses or a cleared and uncleared use or uses, the manufacturer 
shall modify the statement to

[[Page 539]]

identify the unapproved or uncleared new use or uses. The manufacturer 
shall permanently affix the statement to the front of each reprint or 
copy of an article from a scientific or medical journal and to the front 
of each reference publication disseminated under this part;
    (ii) If applicable, the information is being disseminated at the 
expense of the manufacturer;
    (iii) If applicable, the names of any authors of the information who 
were employees of, or consultants to, or received compensation from the 
manufacturer, or who had a significant financial interest in the 
manufacturer during the time that the study that is the subject of the 
dissemination was conducted up through 1 year after the time the 
article/reference publication was written and published;
    (iv) If applicable, a statement that there are products or 
treatments that have been approved or cleared for the use that is the 
subject of the information being disseminated; and
    (v) The identification of any person that has provided funding for 
the conduct of a study relating to the new use of a drug or device for 
which such information is being disseminated; and
    (2) The official labeling for the drug or device;
    (3) A bibliography of other articles (that concern reports of 
clinical investigations both supporting and not supporting the new use) 
from a scientific reference publication or scientific or medical journal 
that have been previously published about the new use of the drug or 
device covered by the information that is being disseminated, unless the 
disseminated information already includes such a bibliography; and
    (4) Any additional information required by FDA under Sec.  
99.301(a)(2). Such information shall be attached to the front of the 
disseminated information or, if attached to the back of the disseminated 
information, its presence shall be made known to the reader by a sticker 
or notation on the front of the disseminated information and may consist 
of:
    (i) Objective and scientifically sound information pertaining to the 
safety or effectiveness of the new use of the drug or device and which 
FDA determines is necessary to provide objectivity and balance. This may 
include information that the manufacturer has submitted to FDA or, where 
appropriate, a summary of such information and any other information 
that can be made publicly available; and
    (ii) An objective statement prepared by FDA, based on data or other 
scientifically sound information, bearing on the safety or effectiveness 
of the new use of the drug or device.
    (b) Except as provided in paragraphs (a)(1)(i) and (a)(4) of this 
section, the statements, bibliography, and other information required by 
this section shall be attached to such disseminated information.
    (c) For purposes of this section, factors to be considered in 
determining whether a statement is ``prominently displayed'' may 
include, but are not limited to, type size, font, layout, contrast, 
graphic design, headlines, spacing, and any other technique to achieve 
emphasis or notice. The required statements shall be outlined, boxed, 
highlighted, or otherwise graphically designed and presented in a manner 
that achieves emphasis or notice and is distinct from the other 
information being disseminated.



Sec.  99.105  Recipients of information.

    A manufacturer disseminating information on a new use under this 
part may only disseminate that information to a health care 
practitioner, a pharmacy benefit manager, a health insurance issuer, a 
group health plan, or a Federal or State Government agency.



    Subpart C_Manufacturer's Submissions, Requests, and Applications



Sec.  99.201  Manufacturer's submission to the agency.

    (a) Sixty days before disseminating any written information 
concerning the safety, effectiveness, or benefit of a new use for a drug 
or device, a manufacturer shall submit to the agency:
    (1) An identical copy of the information to be disseminated, 
including any information (e.g., the bibliography) and statements 
required under Sec.  99.103;

[[Page 540]]

    (2) Any other clinical trial information which the manufacturer has 
relating to the effectiveness of the new use, any other clinical trial 
information that the manufacturer has relating to the safety of the new 
use, any reports of clinical experience pertinent to the safety of the 
new use, and a summary of such information. For purposes of this part, 
clinical trial information includes, but is not limited to, published 
papers and abstracts, even if not intended for dissemination, and 
unpublished manuscripts, abstracts, and data analyses from completed or 
ongoing investigations. The reports of clinical experience required 
under this paragraph shall include case studies, retrospective reviews, 
epidemiological studies, adverse event reports, and any other material 
concerning adverse effects or risks reported for or associated with the 
new use. If the manufacturer has no knowledge of clinical trial 
information relating to the safety or effectiveness of the new use or 
reports of clinical experience pertaining to the safety of the new use, 
the manufacturer shall provide a statement to that effect;
    (3) An explanation of the manufacturer's method of selecting the 
articles for the bibliography (e.g., the databases or sources and 
criteria (i.e., subject headings/keywords) used to generate the 
bibliography and the time period covered by the bibliography); and
    (4) If the manufacturer has not submitted a supplemental application 
for the new use, one of the following:
    (i) If the manufacturer has completed studies needed for the 
submission of a supplemental application for the new use:
    (A) A copy of the protocol for each completed study or, if such 
protocol was submitted to an investigational new drug application or an 
investigational device exemption, the number(s) for the investigational 
new drug application or investigational device exemption covering the 
new use, the date of submission of the protocol(s), the protocol 
number(s), and the date of any amendments to the protocol(s); and
    (B) A certification stating that, ``On behalf of [insert 
manufacturer's name], I certify that [insert manufacturer's name] has 
completed the studies needed for the submission of a supplemental 
application for [insert new use] and will submit a supplemental 
application for such new use to the Food and Drug Administration no 
later than [insert date no later than 6 months from date that 
dissemination of information under this part can begin]''; or
    (ii) If the manufacturer has planned studies that will be needed for 
the submission of a supplemental application for the new use:
    (A) The proposed protocols and schedule for conducting the studies 
needed for the submission of a supplemental application for the new use. 
The protocols shall comply with all applicable requirements in parts 312 
of this chapter (investigational new drug applications) and 812 of this 
chapter (investigational device exemptions). The schedule shall include 
the projected dates on which the manufacturer expects the principal 
study events to occur (e.g., initiation and completion of patient 
enrollment, completion of data collection, completion of data analysis, 
and submission of the supplemental application); and
    (B) A certification stating that, ``On behalf of [insert 
manufacturer's name], I certify that [insert manufacturer's name] will 
exercise due diligence to complete the clinical studies necessary to 
submit a supplemental application for [insert new use] and will submit a 
supplemental application for such new use to the Food and Drug 
Administration no later than [insert date no later than 36 months from 
date that dissemination of information under this part can begin or no 
later than such time period as FDA may specify pursuant to an extension 
granted under Sec.  99.303(a)];'' or
    (iii) An application for exemption from the requirement of a 
supplemental application; or
    (5) If the manufacturer has submitted a supplemental application for 
the new use, a cross-reference to that supplemental application.
    (b) The manufacturer's attorney, agent, or other authorized official 
shall sign the submission and certification statement or application for 
exemption. If the manufacturer does not have a place of business in the 
United

[[Page 541]]

States, the submission and certification statement or application for 
exemption shall contain the signature, name, and address of the 
manufacturer's attorney, agent, or other authorized official who resides 
or maintains a place of business in the United States.
    (c) The manufacturer shall send three copies of the submission and 
certification statement or application for exemption to FDA. The outside 
of the shipping container shall be marked as ``Submission for the 
Dissemination of Information on an Unapproved/New Use.'' The 
manufacturer shall send the submission and certification statement or 
application for exemption to the appropriate FDA component listed in 
paragraphs (c)(1) through (c)(3) of this section.
    (1) For biological products and devices regulated by the Food and 
Drug Administration, Center for Biologics Evaluation and Research, 
Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, 
Silver Spring, MD 20993-0002;
    (2) For human drug products, biological products, and devices 
regulated by the Center for Drug Evaluation and Research, the Division 
of Drug Marketing, Advertising, and Communications (HFD-42), Center for 
Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857; or
    (3) For medical devices, the Promotion and Advertising Policy Staff 
(HFZ-302), Office of Compliance, Center for Devices and Radiological 
Health, Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 
20850.
    (d) The 60-day period shall begin when FDA receives a manufacturer's 
submission, including, where applicable, a certification statement or an 
application for an exemption.

[63 FR 64581, Nov. 20, 1998, as amended at 70 FR 14980, Mar. 24, 2005; 
80 FR 18090, Apr. 3, 2015]



Sec.  99.203  Request to extend the time for completing planned studies.

    (a) A manufacturer may request, prior to or at the time of making a 
submission to FDA under Sec.  99.201, that FDA extend the 36-month time 
period for completing the studies and submitting a supplemental 
application for the new use that is the subject of the information to be 
disseminated. Such request must set forth the reasons that such studies 
cannot be completed and submitted in a supplemental application within 
36 months.
    (b) A manufacturer who has certified that it will complete the 
studies necessary to submit a supplemental application for a new use 
within a specified period of time from the date that dissemination of 
information under this part can begin under Sec.  99.201(a)(4)(ii), but 
later finds that it will be unable to complete such studies and submit a 
supplemental application within that time period may request an 
extension of time from FDA. The manufacturer, in its request for 
extension, shall identify the product, the new use, and shall:
    (1) Describe the study or studies that cannot be completed on time 
and explain why the study or studies cannot be completed on time;
    (2) Describe the current status of the incomplete study or studies 
and summarize the work conducted, including the dates on which principal 
events concerning the study or studies occurred; and
    (3) Estimate the additional time needed to complete the studies and 
submit a supplemental application. The requested extension shall not 
exceed an additional 24 months.
    (c) The manufacturer shall send three copies of the request for 
extension to the same FDA office that received the manufacturer's 
initial submission and certification statement. The outside of the 
envelope shall be marked as ``Request for Time Extension--Dissemination 
of Information on an Unapproved Use.''



Sec.  99.205  Application for exemption from the requirement to file a
supplemental application.

    (a) In certain circumstances, described in paragraph (b) of this 
section, a manufacturer may submit an application for an exemption from 
the requirement to submit a supplemental application for a new use for 
purposes of disseminating information on that use.
    (b) The manufacturer's application for an exemption shall identify 
the basis for the proposed exemption and

[[Page 542]]

shall include materials demonstrating that it would be economically 
prohibitive or that it would be unethical to conduct the studies 
necessary to submit a supplemental application for the new use.
    (1) If the basis for the manufacturer's application for exemption is 
that it would be economically prohibitive to incur the costs necessary 
to submit a supplemental application for a new use, the manufacturer 
shall, at a minimum, provide:
    (i) Evidence explaining why existing data characterizing the safety 
and effectiveness of the drug or device, including data from the study 
described in the information to be disseminated, are not adequate to 
support the submission of a supplemental application for the new use. 
Such evidence shall include an analysis of all data relevant to the 
safety and effectiveness of the use, a summary of those data, and any 
documentation resulting from prior discussions with the agency 
concerning the adequacy of the existing data; and
    (ii) Evidence demonstrating that the cost of the study or studies 
for the new use reasonably exceeds the expected revenue from the new use 
minus the costs of goods sold and marketing and administrative expenses 
attributable to the new use of the product. Such evidence shall include:
    (A) A description of the additional studies that the manufacturer 
believes are necessary to support the submission of a supplemental 
application for the new use, including documentation from prior 
discussions, if any, with the agency concerning the studies that would 
be needed, and an estimate of the projected costs for such studies;
    (B) The expected patient population for the new use;
    (C) The expected revenue for the new use, including an explanation 
of the price at which the drug or device will be sold;
    (D) Any exclusivity for the drug or device for the new use; and
    (E) Any other information that the manufacturer has showing that 
conducting the studies on the new use would be economically prohibitive; 
and
    (iii) An attestation by a responsible individual of the manufacturer 
or an individual acting on the manufacturer's behalf verifying that the 
estimates included with the submission are accurate and were prepared in 
accordance with generally accepted accounting procedures. The data 
underlying and supporting the estimates shall be made available to FDA 
upon request. Alternatively, a manufacturer may submit a report of an 
independent certified public accountant in accordance with the Statement 
of Standards for Attestation established by the American Institute of 
Certified Public Accountants and agreed upon procedures performed with 
respect to the estimates submitted under this section.
    (2) If the basis for the manufacturer's application for exemption is 
that it would be unethical to conduct the studies necessary for the 
supplemental application for a new use, the manufacturer shall provide 
evidence:
    (i) Explaining why existing data characterizing the safety and 
effectiveness of the drug or device, including data from the study 
described in the information to be disseminated, are not adequate to 
support the submission of a supplemental application for the new use. 
Such evidence shall include an analysis of all data relevant to the 
safety and effectiveness of the new use, a summary of those data, and 
any documentation resulting from prior discussions with the agency 
concerning the adequacy of the existing data; and
    (ii) Explaining why it would be unethical to conduct the further 
studies that would be necessary for the approval of the new use. Such 
evidence shall establish that, notwithstanding the insufficiency of 
available data to support the submission of a supplemental application 
for the new use, the data are persuasive to the extent that withholding 
the drug or device in a controlled study (e.g., by providing no therapy, 
a placebo, an alternative therapy, or an alternative dose) would pose an 
unreasonable risk of harm to human subjects. In assessing the 
appropriateness of conducting studies to support the new use, the 
manufacturer may provide evidence showing that the new use is broadly 
accepted as current standard medical treatment or therapy. The 
manufacturer shall also address the possibility of conducting studies in 
different populations or of

[[Page 543]]

modified design (e.g., adding the new therapy to existing treatments or 
using an alternative dose if monotherapy studies could not be 
conducted).



     Subpart D_FDA Action on Submissions, Requests, and Applications



Sec.  99.301  Agency action on a submission.

    (a) Submissions. Within 60 days after receiving a submission under 
this part, FDA may:
    (1) Determine that the manufacturer does not comply with the 
requirements under this part and that, as a result, the manufacturer 
shall not disseminate any information under this part;
    (2) After providing the manufacturer notice and an opportunity for a 
meeting, determine that the information submitted regarding a new use 
fails to provide data, analyses, or other written matter that is 
objective and balanced and:
    (i) Require the manufacturer to disseminate additional information, 
including information that the manufacturer has submitted to FDA or, 
where appropriate, a summary of such information or any other 
information that can be made publicly available, which, in the agency's 
opinion:
    (A) Is objective and scientifically sound;
    (B) Pertains to the safety or effectiveness of the new use; and
    (C) Is necessary to provide objectivity and balance; and
    (ii) Require the manufacturer to disseminate an objective statement 
prepared by FDA that is based on data or other scientifically sound 
information available to the agency and bears on the safety or 
effectiveness of the drug or device for the new use; and
    (3) Require the manufacturer to maintain records that will identify 
individual recipients of the information that is to be disseminated when 
such individual records are warranted due to special safety 
considerations associated with the new use.
    (b) Protocols/Studies. Within 60 days after receiving a submission 
under this part, FDA shall:
    (1) If the manufacturer has planned studies that will be needed for 
the submission of a supplemental application for the new use, review the 
manufacturer's proposed protocols and schedule for completing such 
studies and determine whether the proposed protocols are adequate and 
whether the proposed schedule for completing the studies is reasonable. 
FDA shall notify the manufacturer of its determination; or
    (2) If the manufacturer has completed studies that the manufacturer 
believes would be an adequate basis for the submission of a supplemental 
application for the new use, conduct a review of the protocols submitted 
for such studies to determine whether they are adequate. FDA shall 
notify the manufacturer of its determination.



Sec.  99.303  Extension of time for completing planned studies.

    (a) Upon review of a drug or device manufacturer's proposed 
protocols and schedules for conducting studies needed for the submission 
of a supplemental application for a new use, FDA may, with or without a 
request for an extension from the manufacturer, determine that such 
studies cannot be completed and submitted within 36 months. The agency 
may exercise its discretion in extending the time period for completing 
the studies and submitting a supplemental application. Extensions under 
this paragraph are not subject to any time limit, but shall be made 
before the manufacturer begins the studies needed for the submission of 
a supplemental application for the new use.
    (b) The manufacturer may, after beginning the studies needed for the 
submission of a supplemental application for a new use, request in 
writing that FDA extend the time period for conducting studies needed 
for the submission of a supplemental application for a new use and 
submitting a supplemental application to FDA. FDA may grant or deny the 
request or, after consulting the manufacturer, grant an extension 
different from that requested by the manufacturer. FDA may grant a 
manufacturer's request for an extension if FDA determines that the 
manufacturer has acted with due diligence to conduct the studies needed 
for the

[[Page 544]]

submission of a supplemental application for a new use and to submit 
such a supplemental application to FDA in a timely manner and that, 
despite such actions, the manufacturer needs additional time to complete 
the studies and submit the supplemental application. Extensions under 
this paragraph shall not exceed 24 months.
    (c) If FDA extends the time period for completing the studies and 
submitting a supplemental application under paragraph (a) of this 
section after the manufacturer has submitted a certification under Sec.  
99.201(a)(4)(ii)(B), or if FDA grants a manufacturer's request for an 
extension under paragraph (b) of this section, the manufacturer shall 
submit a new certification under Sec.  99.201(a)(4)(ii)(B) that sets 
forth the timeframe within which clinical studies will be completed and 
a supplemental application will be submitted to FDA.



Sec.  99.305  Exemption from the requirement to file a supplemental application.

    (a) Within 60 days after receipt of an application for an exemption 
from the requirement of a supplemental application, FDA shall approve or 
deny the application.
    (1) If FDA does not act on the application for an exemption within 
the 60-day period, the application for an exemption shall be deemed to 
be approved.
    (2) If an application for an exemption is deemed to be approved, FDA 
may, at any time, terminate such approval if it determines that the 
requirements for granting an exemption have not been met. FDA shall 
notify the manufacturer if the approval is terminated.
    (b) In reviewing an application for an exemption, FDA shall consider 
the materials submitted by the manufacturer and may consider any other 
appropriate information, including, but not limited to, any pending or 
previously approved applications for exemption submitted by the 
manufacturer.
    (c) FDA may grant an application for an exemption if FDA determines 
that:
    (1) It would be economically prohibitive for the manufacturer to 
incur the costs necessary to submit a supplemental application for a new 
use, which at a minimum requires:
    (i) That existing data characterizing the safety and effectiveness 
of the drug or device, including data from the study described in the 
information to be disseminated are not adequate to support the 
submission of a supplemental application for the new use; and
    (ii) That the cost of the study or studies for the new use 
reasonably exceeds the expected revenue from the new use minus the cost 
of goods sold and marketing and administrative expenses attributable to 
the new use of the product, and there are not less expensive ways to 
obtain the needed information; or
    (2) It would be unethical to conduct clinical studies needed to 
support the submission of a supplemental application for the new use 
because:
    (i) Existing data characterizing the safety and effectiveness of the 
drug or device, including data from the study described in the 
information to be disseminated are not adequate to support the 
submission of a supplemental application for the new use; and
    (ii) Although available evidence would not support the submission of 
a supplemental application for the new use, the data are persuasive to 
the extent that withholding the drug or device in a controlled study 
would pose an unreasonable risk of harm to human subjects and no studies 
in different populations or of modified design can be utilized. In 
determining whether it would be unethical to conduct clinical studies, 
the agency shall consider, in addition to the persuasiveness of 
available evidence of effectiveness, whether the new use of the drug or 
device is broadly accepted as current standard medical treatment or 
therapy.



       Subpart E_Corrective Actions and Cessation of Dissemination



Sec.  99.401  Corrective actions and cessation of dissemination of
information.

    (a) FDA actions based on post dissemination data. If FDA receives 
data after a manufacturer has begun disseminating information on a new 
use and, based on that data, determines that

[[Page 545]]

the new use that is the subject of information disseminated under this 
part may not be effective or may present a significant risk to public 
health, FDA shall consult the manufacturer and, after such consultation, 
take appropriate action to protect the public health. Such action may 
include ordering the manufacturer to cease disseminating information on 
the new use and to take appropriate corrective action.
    (b) FDA actions based on information disseminated by a manufacturer. 
If FDA determines that a manufacturer is disseminating information that 
does not comply with the requirements under this part, FDA may:
    (1) Provide to the manufacturer an opportunity to bring itself into 
compliance with the requirements under this part if the manufacturer's 
noncompliance constitutes a minor violation of these requirements; or
    (2) Order the manufacturer to cease dissemination of information and 
to take corrective action. FDA shall issue such an order only after it 
has:
    (i) Provided notice to the manufacturer regarding FDA's intent to 
issue an order to cease dissemination; and
    (ii) Provided to the manufacturer an opportunity for a meeting. FDA 
need not provide an opportunity for a meeting if the manufacturer 
certified that it will submit a supplemental application for the new use 
within 6 months of the date that dissemination can begin and the 
noncompliance involves a failure to submit such supplemental 
application.
    (c) FDA actions based on a manufacturer's supplemental application. 
FDA may order a manufacturer to cease disseminating information under 
this part and to take corrective action if:
    (1) In the case of a manufacturer that has submitted a supplemental 
application for the new use, FDA determines that the supplemental 
application does not contain adequate information for approval of the 
new use;
    (2) In the case of a manufacturer that has certified that it will 
submit a supplemental application for the new use within 6 months, the 
manufacturer has not, within the 6-month period, submitted a 
supplemental application for the new use;
    (3) In the case of a manufacturer that has certified that it will 
submit a supplemental application for the new use within 36 months or 
within such time as FDA has determined to be appropriate under Sec.  
99.303(a) or (b), such manufacturer has not submitted the supplemental 
application within the certified time, or FDA, after an informal 
hearing, has determined that the manufacturer is not acting with due 
diligence to initiate or complete the studies necessary to support a 
supplemental application for the new use; or
    (4) In the case of a manufacturer that has certified that it will 
submit a supplemental application for the new use within 36 months or 
within such time as FDA has determined to be appropriate under Sec.  
99.303(a) or (b), the manufacturer has discontinued or terminated the 
clinical studies that would be necessary to support a supplemental 
application for a new use.
    (d) Effective date of orders to cease dissemination. An order to 
cease dissemination of information shall be effective upon date of 
receipt by the manufacturer, unless otherwise stated in such order.
    (e) Cessation of dissemination by a noncomplying manufacturer. A 
manufacturer that begins to disseminate information in compliance with 
this part, but subsequently fails to comply with this part, shall 
immediately cease disseminating information under this part. A 
manufacturer that discontinues, terminates, or fails to conduct with due 
diligence clinical studies that it certified it would complete under 
Sec.  99.201(a)(4)(ii) shall be deemed not in compliance with this part. 
A manufacturer shall notify FDA immediately if it ceases dissemination 
under this paragraph.



Sec.  99.403  Termination of approvals of applications for exemption.

    (a) FDA may, at any time, terminate the approval of an application 
for an exemption from the requirement to file a supplemental application 
if:
    (1) The application for an exemption had been deemed to be approved 
because the agency had not acted on the application within 60 days after 
its receipt by FDA;

[[Page 546]]

    (2) The manufacturer is disseminating written information on the new 
use; and
    (3) FDA determines that it would be economically and ethically 
possible for the manufacturer to conduct the clinical studies needed to 
submit a supplemental application for the new use.
    (b) If FDA terminates a deemed approval of an application for an 
exemption under paragraph (a) of this section, FDA also may:
    (1) Order the manufacturer to cease disseminating information; and
    (2) Order the manufacturer to take action to correct the information 
that has been disseminated if FDA determines that the new use described 
in the disseminated information would pose a significant risk to public 
health.
    (c) FDA shall notify the manufacturer if it terminates the deemed 
approval of an application for an exemption under paragraph (a) of this 
section. If FDA also issues an order to cease dissemination of 
information, the manufacturer shall comply with the order no later than 
60 days after its receipt.
    (d) FDA may, at any time, terminate the approval of an application 
for an exemption from the requirement to file a supplemental application 
for a new use if, after consulting with the manufacturer that was 
granted such exemption, FDA determines that the manufacturer no longer 
meets the requirements for an exemption on the basis that it is 
economically prohibitive or unethical to conduct the studies needed to 
submit a supplemental application for the new use.
    (e) If FDA terminates an approval of an application for an exemption 
under paragraph (d) of this section, the manufacturer must, within 60 
days of being notified by FDA that its exemption approval has been 
terminated, file a supplemental application for the new use that is the 
subject of the information being disseminated under the exemption, 
certify, under Sec.  99.201(a)(4)(i) or (a)(4)(ii) that it will file a 
supplemental application for the new use, or cease disseminating the 
information on the new use. FDA may require a manufacturer that ceases 
dissemination of information on the new use to undertake corrective 
action.



Sec.  99.405  Applicability of labeling, adulteration, and misbranding
authority.

    The dissemination of information relating to a new use for a drug or 
device may constitute labeling, evidence of a new intended use, 
adulteration, or misbranding of the drug or device if such dissemination 
fails to comply with section 551 of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 360aaa) and the requirements of this part. A 
manufacturer's failure to exercise due diligence in submitting the 
clinical studies that are necessary for the approval of a new use that 
is the subject of information disseminated under this part or in 
beginning or completing such clinical studies shall be deemed a failure 
to comply with section 551 of the act and the requirements of this part.



                   Subpart F_Recordkeeping and Reports



Sec.  99.501  Recordkeeping and reports.

    (a) A manufacturer disseminating information under this part shall:
    (1) Maintain records sufficient to allow the manufacturer to take 
corrective action as required by FDA. The manufacturer shall make such 
records available to FDA, upon request, for inspection and copying. Such 
records shall either:
    (i) Identify, by name, those persons receiving the disseminated 
information; or
    (ii) Identify, by category, the recipients of the disseminated 
information, unless FDA requires the manufacturer to retain records 
identifying individual recipients of the disseminated information. 
Manufacturers whose records identify recipients by category only shall:
    (A) Identify subcategories of recipients where appropriate (e.g., 
oncologists, pediatricians, obstetricians, etc.); and
    (B) Ensure that any corrective action to be taken will be 
sufficiently conspicuous to individuals within that category of 
recipients;
    (2) Maintain an identical copy of the information disseminated under 
this part; and

[[Page 547]]

    (3) Upon the submission of a supplemental application to FDA, notify 
the appropriate office identified in Sec.  99.201(c) of this part.
    (b) A manufacturer disseminating information on a new use for a drug 
or device shall, on a semiannual basis, submit to the FDA office 
identified in Sec.  99.201(c) of this part:
    (1) A list containing the titles of articles and reference 
publications relating to the new use of drugs or devices that the 
manufacturer disseminated to a health care practitioner, pharmacy 
benefit manager, health insurance issuer, group health plan, or Federal 
or State Government agency. The list shall cover articles and reference 
publications disseminated in the 6-month period preceding the date on 
which the manufacturer provides the list to FDA;
    (2) A list identifying the categories of health care practitioners, 
pharmacy benefit managers, health insurance issuers, group health plans, 
or Federal or State Government agencies that received the articles and 
reference publications in the 6-month period described in paragraph 
(b)(1) of this section. The list shall also identify which category of 
recipients received a particular article or reference publication;
    (3) A notice and summary of any additional clinical research or 
other data relating to the safety or effectiveness of the new use, and, 
if the manufacturer possesses such clinical research or other data, a 
copy of the research or data. Such other data may include, but is not 
limited to, new articles published in scientific or medical journals, 
reference publications, and summaries of adverse effects that are or may 
be associated with the new use;
    (4) If the manufacturer is conducting studies necessary for the 
submission of a supplemental application, the manufacturer shall submit 
periodic progress reports on these studies to FDA. Such reports shall 
describe the studies' current status (i.e., progress on patient 
enrollment, any significant problems that could affect the 
manufacturer's ability to complete the studies, and expected completion 
dates). If the manufacturer discontinues or terminates a study before 
completing it, the manufacturer shall, as part of the next periodic 
progress report, state the reasons for such discontinuation or 
termination; and
    (5) If the manufacturer was granted an exemption from the 
requirements to submit a supplemental application for the new use, any 
new or additional information that relates to whether the manufacturer 
continues to meet the requirements for such exemption. This information 
may include, but is not limited to, new or additional information 
regarding revenues from the product that is the subject of the 
dissemination and new or additional information regarding the 
persuasiveness of the data on the new use, including information 
regarding whether the new use is broadly accepted as current standard 
medical treatment or therapy.
    (c) A manufacturer shall maintain a copy of all information, lists, 
records, and reports required or disseminated under this part for 3 
years after it has ceased dissemination of such information and make 
such documents available to FDA for inspection and copying.

[[Page 549]]



                              FINDING AIDS




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

  A list of CFR titles, subtitles, chapters, subchapters and parts and 
an alphabetical list of agencies publishing in the CFR are included in 
the CFR Index and Finding Aids volume to the Code of Federal Regulations 
which is published separately and revised annually.

  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  List of CFR Sections Affected

[[Page 551]]



                    Table of CFR Titles and Chapters




                      (Revised as of April 1, 2018)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
       III  Administrative Conference of the United States (Parts 
                300--399)
        IV  Miscellaneous Agencies (Parts 400--599)
        VI  National Capital Planning Commission (Parts 600--699)

                    Title 2--Grants and Agreements

            Subtitle A--Office of Management and Budget Guidance 
                for Grants and Agreements
         I  Office of Management and Budget Governmentwide 
                Guidance for Grants and Agreements (Parts 2--199)
        II  Office of Management and Budget Guidance (Parts 200--
                299)
            Subtitle B--Federal Agency Regulations for Grants and 
                Agreements
       III  Department of Health and Human Services (Parts 300--
                399)
        IV  Department of Agriculture (Parts 400--499)
        VI  Department of State (Parts 600--699)
       VII  Agency for International Development (Parts 700--799)
      VIII  Department of Veterans Affairs (Parts 800--899)
        IX  Department of Energy (Parts 900--999)
         X  Department of the Treasury (Parts 1000--1099)
        XI  Department of Defense (Parts 1100--1199)
       XII  Department of Transportation (Parts 1200--1299)
      XIII  Department of Commerce (Parts 1300--1399)
       XIV  Department of the Interior (Parts 1400--1499)
        XV  Environmental Protection Agency (Parts 1500--1599)
     XVIII  National Aeronautics and Space Administration (Parts 
                1800--1899)
        XX  United States Nuclear Regulatory Commission (Parts 
                2000--2099)
      XXII  Corporation for National and Community Service (Parts 
                2200--2299)
     XXIII  Social Security Administration (Parts 2300--2399)
      XXIV  Department of Housing and Urban Development (Parts 
                2400--2499)
       XXV  National Science Foundation (Parts 2500--2599)
      XXVI  National Archives and Records Administration (Parts 
                2600--2699)

[[Page 552]]

     XXVII  Small Business Administration (Parts 2700--2799)
    XXVIII  Department of Justice (Parts 2800--2899)
      XXIX  Department of Labor (Parts 2900--2999)
       XXX  Department of Homeland Security (Parts 3000--3099)
      XXXI  Institute of Museum and Library Services (Parts 3100--
                3199)
     XXXII  National Endowment for the Arts (Parts 3200--3299)
    XXXIII  National Endowment for the Humanities (Parts 3300--
                3399)
     XXXIV  Department of Education (Parts 3400--3499)
      XXXV  Export-Import Bank of the United States (Parts 3500--
                3599)
     XXXVI  Office of National Drug Control Policy, Executive 
                Office of the President (Parts 3600--3699)
    XXXVII  Peace Corps (Parts 3700--3799)
     LVIII  Election Assistance Commission (Parts 5800--5899)
       LIX  Gulf Coast Ecosystem Restoration Council (Parts 5900--
                5999)

                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  Government Accountability Office (Parts 1--199)

                   Title 5--Administrative Personnel

         I  Office of Personnel Management (Parts 1--1199)
        II  Merit Systems Protection Board (Parts 1200--1299)
       III  Office of Management and Budget (Parts 1300--1399)
        IV  Office of Personnel Management and Office of the 
                Director of National Intelligence (Parts 1400--
                1499)
         V  The International Organizations Employees Loyalty 
                Board (Parts 1500--1599)
        VI  Federal Retirement Thrift Investment Board (Parts 
                1600--1699)
      VIII  Office of Special Counsel (Parts 1800--1899)
        IX  Appalachian Regional Commission (Parts 1900--1999)
        XI  Armed Forces Retirement Home (Parts 2100--2199)
       XIV  Federal Labor Relations Authority, General Counsel of 
                the Federal Labor Relations Authority and Federal 
                Service Impasses Panel (Parts 2400--2499)
       XVI  Office of Government Ethics (Parts 2600--2699)
       XXI  Department of the Treasury (Parts 3100--3199)
      XXII  Federal Deposit Insurance Corporation (Parts 3200--
                3299)
     XXIII  Department of Energy (Parts 3300--3399)
      XXIV  Federal Energy Regulatory Commission (Parts 3400--
                3499)
       XXV  Department of the Interior (Parts 3500--3599)
      XXVI  Department of Defense (Parts 3600--3699)

[[Page 553]]

    XXVIII  Department of Justice (Parts 3800--3899)
      XXIX  Federal Communications Commission (Parts 3900--3999)
       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)
    XXXIII  Overseas Private Investment Corporation (Parts 4300--
                4399)
     XXXIV  Securities and Exchange Commission (Parts 4400--4499)
      XXXV  Office of Personnel Management (Parts 4500--4599)
     XXXVI  Department of Homeland Security (Parts 4600--4699)
    XXXVII  Federal Election Commission (Parts 4700--4799)
        XL  Interstate Commerce Commission (Parts 5000--5099)
       XLI  Commodity Futures Trading Commission (Parts 5100--
                5199)
      XLII  Department of Labor (Parts 5200--5299)
     XLIII  National Science Foundation (Parts 5300--5399)
       XLV  Department of Health and Human Services (Parts 5500--
                5599)
      XLVI  Postal Rate Commission (Parts 5600--5699)
     XLVII  Federal Trade Commission (Parts 5700--5799)
    XLVIII  Nuclear Regulatory Commission (Parts 5800--5899)
      XLIX  Federal Labor Relations Authority (Parts 5900--5999)
         L  Department of Transportation (Parts 6000--6099)
       LII  Export-Import Bank of the United States (Parts 6200--
                6299)
      LIII  Department of Education (Parts 6300--6399)
       LIV  Environmental Protection Agency (Parts 6400--6499)
        LV  National Endowment for the Arts (Parts 6500--6599)
       LVI  National Endowment for the Humanities (Parts 6600--
                6699)
      LVII  General Services Administration (Parts 6700--6799)
     LVIII  Board of Governors of the Federal Reserve System 
                (Parts 6800--6899)
       LIX  National Aeronautics and Space Administration (Parts 
                6900--6999)
        LX  United States Postal Service (Parts 7000--7099)
       LXI  National Labor Relations Board (Parts 7100--7199)
      LXII  Equal Employment Opportunity Commission (Parts 7200--
                7299)
     LXIII  Inter-American Foundation (Parts 7300--7399)
      LXIV  Merit Systems Protection Board (Parts 7400--7499)
       LXV  Department of Housing and Urban Development (Parts 
                7500--7599)
      LXVI  National Archives and Records Administration (Parts 
                7600--7699)
     LXVII  Institute of Museum and Library Services (Parts 7700--
                7799)
    LXVIII  Commission on Civil Rights (Parts 7800--7899)
      LXIX  Tennessee Valley Authority (Parts 7900--7999)
       LXX  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 8000--8099)
      LXXI  Consumer Product Safety Commission (Parts 8100--8199)
    LXXIII  Department of Agriculture (Parts 8300--8399)

[[Page 554]]

     LXXIV  Federal Mine Safety and Health Review Commission 
                (Parts 8400--8499)
     LXXVI  Federal Retirement Thrift Investment Board (Parts 
                8600--8699)
    LXXVII  Office of Management and Budget (Parts 8700--8799)
      LXXX  Federal Housing Finance Agency (Parts 9000--9099)
   LXXXIII  Special Inspector General for Afghanistan 
                Reconstruction (Parts 9300--9399)
    LXXXIV  Bureau of Consumer Financial Protection (Parts 9400--
                9499)
    LXXXVI  National Credit Union Administration (Parts 9600--
                9699)
     XCVII  Department of Homeland Security Human Resources 
                Management System (Department of Homeland 
                Security--Office of Personnel Management) (Parts 
                9700--9799)
    XCVIII  Council of the Inspectors General on Integrity and 
                Efficiency (Parts 9800--9899)
      XCIX  Military Compensation and Retirement Modernization 
                Commission (Parts 9900--9999)
         C  National Council on Disability (Parts 10000--10049)

                      Title 6--Domestic Security

         I  Department of Homeland Security, Office of the 
                Secretary (Parts 1--199)
         X  Privacy and Civil Liberties Oversight Board (Parts 
                1000--1099)

                         Title 7--Agriculture

            Subtitle A--Office of the Secretary of Agriculture 
                (Parts 0--26)
            Subtitle B--Regulations of the Department of 
                Agriculture
         I  Agricultural Marketing Service (Standards, 
                Inspections, Marketing Practices), Department of 
                Agriculture (Parts 27--209)
        II  Food and Nutrition Service, Department of Agriculture 
                (Parts 210--299)
       III  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 300--399)
        IV  Federal Crop Insurance Corporation, Department of 
                Agriculture (Parts 400--499)
         V  Agricultural Research Service, Department of 
                Agriculture (Parts 500--599)
        VI  Natural Resources Conservation Service, Department of 
                Agriculture (Parts 600--699)
       VII  Farm Service Agency, Department of Agriculture (Parts 
                700--799)
      VIII  Grain Inspection, Packers and Stockyards 
                Administration (Federal Grain Inspection Service), 
                Department of Agriculture (Parts 800--899)
        IX  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Fruits, Vegetables, Nuts), Department 
                of Agriculture (Parts 900--999)

[[Page 555]]

         X  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Milk), Department of Agriculture 
                (Parts 1000--1199)
        XI  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Miscellaneous Commodities), Department 
                of Agriculture (Parts 1200--1299)
       XIV  Commodity Credit Corporation, Department of 
                Agriculture (Parts 1400--1499)
        XV  Foreign Agricultural Service, Department of 
                Agriculture (Parts 1500--1599)
       XVI  Rural Telephone Bank, Department of Agriculture (Parts 
                1600--1699)
      XVII  Rural Utilities Service, Department of Agriculture 
                (Parts 1700--1799)
     XVIII  Rural Housing Service, Rural Business-Cooperative 
                Service, Rural Utilities Service, and Farm Service 
                Agency, Department of Agriculture (Parts 1800--
                2099)
        XX  Local Television Loan Guarantee Board (Parts 2200--
                2299)
       XXV  Office of Advocacy and Outreach, Department of 
                Agriculture (Parts 2500--2599)
      XXVI  Office of Inspector General, Department of Agriculture 
                (Parts 2600--2699)
     XXVII  Office of Information Resources Management, Department 
                of Agriculture (Parts 2700--2799)
    XXVIII  Office of Operations, Department of Agriculture (Parts 
                2800--2899)
      XXIX  Office of Energy Policy and New Uses, Department of 
                Agriculture (Parts 2900--2999)
       XXX  Office of the Chief Financial Officer, Department of 
                Agriculture (Parts 3000--3099)
      XXXI  Office of Environmental Quality, Department of 
                Agriculture (Parts 3100--3199)
     XXXII  Office of Procurement and Property Management, 
                Department of Agriculture (Parts 3200--3299)
    XXXIII  Office of Transportation, Department of Agriculture 
                (Parts 3300--3399)
     XXXIV  National Institute of Food and Agriculture (Parts 
                3400--3499)
      XXXV  Rural Housing Service, Department of Agriculture 
                (Parts 3500--3599)
     XXXVI  National Agricultural Statistics Service, Department 
                of Agriculture (Parts 3600--3699)
    XXXVII  Economic Research Service, Department of Agriculture 
                (Parts 3700--3799)
   XXXVIII  World Agricultural Outlook Board, Department of 
                Agriculture (Parts 3800--3899)
       XLI  [Reserved]
      XLII  Rural Business-Cooperative Service and Rural Utilities 
                Service, Department of Agriculture (Parts 4200--
                4299)

[[Page 556]]

                    Title 8--Aliens and Nationality

         I  Department of Homeland Security (Immigration and 
                Naturalization) (Parts 1--499)
         V  Executive Office for Immigration Review, Department of 
                Justice (Parts 1000--1399)

                 Title 9--Animals and Animal Products

         I  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 1--199)
        II  Grain Inspection, Packers and Stockyards 
                Administration (Packers and Stockyards Programs), 
                Department of Agriculture (Parts 200--299)
       III  Food Safety and Inspection Service, Department of 
                Agriculture (Parts 300--599)

                           Title 10--Energy

         I  Nuclear Regulatory Commission (Parts 0--199)
        II  Department of Energy (Parts 200--699)
       III  Department of Energy (Parts 700--999)
         X  Department of Energy (General Provisions) (Parts 
                1000--1099)
      XIII  Nuclear Waste Technical Review Board (Parts 1300--
                1399)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)
     XVIII  Northeast Interstate Low-Level Radioactive Waste 
                Commission (Parts 1800--1899)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)
        II  Election Assistance Commission (Parts 9400--9499)

                      Title 12--Banks and Banking

         I  Comptroller of the Currency, Department of the 
                Treasury (Parts 1--199)
        II  Federal Reserve System (Parts 200--299)
       III  Federal Deposit Insurance Corporation (Parts 300--399)
        IV  Export-Import Bank of the United States (Parts 400--
                499)
         V  Office of Thrift Supervision, Department of the 
                Treasury (Parts 500--599)
        VI  Farm Credit Administration (Parts 600--699)
       VII  National Credit Union Administration (Parts 700--799)
      VIII  Federal Financing Bank (Parts 800--899)
        IX  Federal Housing Finance Board (Parts 900--999)
         X  Bureau of Consumer Financial Protection (Parts 1000--
                1099)
        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XII  Federal Housing Finance Agency (Parts 1200--1299)

[[Page 557]]

      XIII  Financial Stability Oversight Council (Parts 1300--
                1399)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Department of the Treasury (Parts 1500--1599)
       XVI  Office of Financial Research (Parts 1600--1699)
      XVII  Office of Federal Housing Enterprise Oversight, 
                Department of Housing and Urban Development (Parts 
                1700--1799)
     XVIII  Community Development Financial Institutions Fund, 
                Department of the Treasury (Parts 1800--1899)

               Title 13--Business Credit and Assistance

         I  Small Business Administration (Parts 1--199)
       III  Economic Development Administration, Department of 
                Commerce (Parts 300--399)
        IV  Emergency Steel Guarantee Loan Board (Parts 400--499)
         V  Emergency Oil and Gas Guaranteed Loan Board (Parts 
                500--599)

                    Title 14--Aeronautics and Space

         I  Federal Aviation Administration, Department of 
                Transportation (Parts 1--199)
        II  Office of the Secretary, Department of Transportation 
                (Aviation Proceedings) (Parts 200--399)
       III  Commercial Space Transportation, Federal Aviation 
                Administration, Department of Transportation 
                (Parts 400--1199)
         V  National Aeronautics and Space Administration (Parts 
                1200--1299)
        VI  Air Transportation System Stabilization (Parts 1300--
                1399)

                 Title 15--Commerce and Foreign Trade

            Subtitle A--Office of the Secretary of Commerce (Parts 
                0--29)
            Subtitle B--Regulations Relating to Commerce and 
                Foreign Trade
         I  Bureau of the Census, Department of Commerce (Parts 
                30--199)
        II  National Institute of Standards and Technology, 
                Department of Commerce (Parts 200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  Foreign-Trade Zones Board, Department of Commerce 
                (Parts 400--499)
       VII  Bureau of Industry and Security, Department of 
                Commerce (Parts 700--799)
      VIII  Bureau of Economic Analysis, Department of Commerce 
                (Parts 800--899)
        IX  National Oceanic and Atmospheric Administration, 
                Department of Commerce (Parts 900--999)

[[Page 558]]

        XI  National Technical Information Service, Department of 
                Commerce (Parts 1100--1199)
      XIII  East-West Foreign Trade Board (Parts 1300--1399)
       XIV  Minority Business Development Agency (Parts 1400--
                1499)
            Subtitle C--Regulations Relating to Foreign Trade 
                Agreements
        XX  Office of the United States Trade Representative 
                (Parts 2000--2099)
            Subtitle D--Regulations Relating to Telecommunications 
                and Information
     XXIII  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                2300--2399) [Reserved]

                    Title 16--Commercial Practices

         I  Federal Trade Commission (Parts 0--999)
        II  Consumer Product Safety Commission (Parts 1000--1799)

             Title 17--Commodity and Securities Exchanges

         I  Commodity Futures Trading Commission (Parts 1--199)
        II  Securities and Exchange Commission (Parts 200--399)
        IV  Department of the Treasury (Parts 400--499)

          Title 18--Conservation of Power and Water Resources

         I  Federal Energy Regulatory Commission, Department of 
                Energy (Parts 1--399)
       III  Delaware River Basin Commission (Parts 400--499)
        VI  Water Resources Council (Parts 700--799)
      VIII  Susquehanna River Basin Commission (Parts 800--899)
      XIII  Tennessee Valley Authority (Parts 1300--1399)

                       Title 19--Customs Duties

         I  U.S. Customs and Border Protection, Department of 
                Homeland Security; Department of the Treasury 
                (Parts 0--199)
        II  United States International Trade Commission (Parts 
                200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  U.S. Immigration and Customs Enforcement, Department 
                of Homeland Security (Parts 400--599) [Reserved]

                     Title 20--Employees' Benefits

         I  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 1--199)
        II  Railroad Retirement Board (Parts 200--399)

[[Page 559]]

       III  Social Security Administration (Parts 400--499)
        IV  Employees' Compensation Appeals Board, Department of 
                Labor (Parts 500--599)
         V  Employment and Training Administration, Department of 
                Labor (Parts 600--699)
        VI  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 700--799)
       VII  Benefits Review Board, Department of Labor (Parts 
                800--899)
      VIII  Joint Board for the Enrollment of Actuaries (Parts 
                900--999)
        IX  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 1000--1099)

                       Title 21--Food and Drugs

         I  Food and Drug Administration, Department of Health and 
                Human Services (Parts 1--1299)
        II  Drug Enforcement Administration, Department of Justice 
                (Parts 1300--1399)
       III  Office of National Drug Control Policy (Parts 1400--
                1499)

                      Title 22--Foreign Relations

         I  Department of State (Parts 1--199)
        II  Agency for International Development (Parts 200--299)
       III  Peace Corps (Parts 300--399)
        IV  International Joint Commission, United States and 
                Canada (Parts 400--499)
         V  Broadcasting Board of Governors (Parts 500--599)
       VII  Overseas Private Investment Corporation (Parts 700--
                799)
        IX  Foreign Service Grievance Board (Parts 900--999)
         X  Inter-American Foundation (Parts 1000--1099)
        XI  International Boundary and Water Commission, United 
                States and Mexico, United States Section (Parts 
                1100--1199)
       XII  United States International Development Cooperation 
                Agency (Parts 1200--1299)
      XIII  Millennium Challenge Corporation (Parts 1300--1399)
       XIV  Foreign Service Labor Relations Board; Federal Labor 
                Relations Authority; General Counsel of the 
                Federal Labor Relations Authority; and the Foreign 
                Service Impasse Disputes Panel (Parts 1400--1499)
        XV  African Development Foundation (Parts 1500--1599)
       XVI  Japan-United States Friendship Commission (Parts 
                1600--1699)
      XVII  United States Institute of Peace (Parts 1700--1799)

                          Title 23--Highways

         I  Federal Highway Administration, Department of 
                Transportation (Parts 1--999)

[[Page 560]]

        II  National Highway Traffic Safety Administration and 
                Federal Highway Administration, Department of 
                Transportation (Parts 1200--1299)
       III  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 1300--1399)

                Title 24--Housing and Urban Development

            Subtitle A--Office of the Secretary, Department of 
                Housing and Urban Development (Parts 0--99)
            Subtitle B--Regulations Relating to Housing and Urban 
                Development
         I  Office of Assistant Secretary for Equal Opportunity, 
                Department of Housing and Urban Development (Parts 
                100--199)
        II  Office of Assistant Secretary for Housing-Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 200--299)
       III  Government National Mortgage Association, Department 
                of Housing and Urban Development (Parts 300--399)
        IV  Office of Housing and Office of Multifamily Housing 
                Assistance Restructuring, Department of Housing 
                and Urban Development (Parts 400--499)
         V  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 500--599)
        VI  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 600--699) [Reserved]
       VII  Office of the Secretary, Department of Housing and 
                Urban Development (Housing Assistance Programs and 
                Public and Indian Housing Programs) (Parts 700--
                799)
      VIII  Office of the Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Section 8 Housing Assistance 
                Programs, Section 202 Direct Loan Program, Section 
                202 Supportive Housing for the Elderly Program and 
                Section 811 Supportive Housing for Persons With 
                Disabilities Program) (Parts 800--899)
        IX  Office of Assistant Secretary for Public and Indian 
                Housing, Department of Housing and Urban 
                Development (Parts 900--1699)
         X  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Interstate Land Sales 
                Registration Program) (Parts 1700--1799)
       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XV  Emergency Mortgage Insurance and Loan Programs, 
                Department of Housing and Urban Development (Parts 
                2700--2799) [Reserved]
        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3899)

[[Page 561]]

      XXIV  Board of Directors of the HOPE for Homeowners Program 
                (Parts 4000--4099) [Reserved]
       XXV  Neighborhood Reinvestment Corporation (Parts 4100--
                4199)

                           Title 25--Indians

         I  Bureau of Indian Affairs, Department of the Interior 
                (Parts 1--299)
        II  Indian Arts and Crafts Board, Department of the 
                Interior (Parts 300--399)
       III  National Indian Gaming Commission, Department of the 
                Interior (Parts 500--599)
        IV  Office of Navajo and Hopi Indian Relocation (Parts 
                700--899)
         V  Bureau of Indian Affairs, Department of the Interior, 
                and Indian Health Service, Department of Health 
                and Human Services (Parts 900--999)
        VI  Office of the Assistant Secretary, Indian Affairs, 
                Department of the Interior (Parts 1000--1199)
       VII  Office of the Special Trustee for American Indians, 
                Department of the Interior (Parts 1200--1299)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--End)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Alcohol and Tobacco Tax and Trade Bureau, Department 
                of the Treasury (Parts 1--399)
        II  Bureau of Alcohol, Tobacco, Firearms, and Explosives, 
                Department of Justice (Parts 400--699)

                   Title 28--Judicial Administration

         I  Department of Justice (Parts 0--299)
       III  Federal Prison Industries, Inc., Department of Justice 
                (Parts 300--399)
         V  Bureau of Prisons, Department of Justice (Parts 500--
                599)
        VI  Offices of Independent Counsel, Department of Justice 
                (Parts 600--699)
       VII  Office of Independent Counsel (Parts 700--799)
      VIII  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 800--899)
        IX  National Crime Prevention and Privacy Compact Council 
                (Parts 900--999)
        XI  Department of Justice and Department of State (Parts 
                1100--1199)

[[Page 562]]

                            Title 29--Labor

            Subtitle A--Office of the Secretary of Labor (Parts 
                0--99)
            Subtitle B--Regulations Relating to Labor
         I  National Labor Relations Board (Parts 100--199)
        II  Office of Labor-Management Standards, Department of 
                Labor (Parts 200--299)
       III  National Railroad Adjustment Board (Parts 300--399)
        IV  Office of Labor-Management Standards, Department of 
                Labor (Parts 400--499)
         V  Wage and Hour Division, Department of Labor (Parts 
                500--899)
        IX  Construction Industry Collective Bargaining Commission 
                (Parts 900--999)
         X  National Mediation Board (Parts 1200--1299)
       XII  Federal Mediation and Conciliation Service (Parts 
                1400--1499)
       XIV  Equal Employment Opportunity Commission (Parts 1600--
                1699)
      XVII  Occupational Safety and Health Administration, 
                Department of Labor (Parts 1900--1999)
        XX  Occupational Safety and Health Review Commission 
                (Parts 2200--2499)
       XXV  Employee Benefits Security Administration, Department 
                of Labor (Parts 2500--2599)
     XXVII  Federal Mine Safety and Health Review Commission 
                (Parts 2700--2799)
        XL  Pension Benefit Guaranty Corporation (Parts 4000--
                4999)

                      Title 30--Mineral Resources

         I  Mine Safety and Health Administration, Department of 
                Labor (Parts 1--199)
        II  Bureau of Safety and Environmental Enforcement, 
                Department of the Interior (Parts 200--299)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
         V  Bureau of Ocean Energy Management, Department of the 
                Interior (Parts 500--599)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)
       XII  Office of Natural Resources Revenue, Department of the 
                Interior (Parts 1200--1299)

                 Title 31--Money and Finance: Treasury

            Subtitle A--Office of the Secretary of the Treasury 
                (Parts 0--50)
            Subtitle B--Regulations Relating to Money and Finance
         I  Monetary Offices, Department of the Treasury (Parts 
                51--199)
        II  Fiscal Service, Department of the Treasury (Parts 
                200--399)
        IV  Secret Service, Department of the Treasury (Parts 
                400--499)
         V  Office of Foreign Assets Control, Department of the 
                Treasury (Parts 500--599)

[[Page 563]]

        VI  Bureau of Engraving and Printing, Department of the 
                Treasury (Parts 600--699)
       VII  Federal Law Enforcement Training Center, Department of 
                the Treasury (Parts 700--799)
      VIII  Office of Investment Security, Department of the 
                Treasury (Parts 800--899)
        IX  Federal Claims Collection Standards (Department of the 
                Treasury--Department of Justice) (Parts 900--999)
         X  Financial Crimes Enforcement Network, Department of 
                the Treasury (Parts 1000--1099)

                      Title 32--National Defense

            Subtitle A--Department of Defense
         I  Office of the Secretary of Defense (Parts 1--399)
         V  Department of the Army (Parts 400--699)
        VI  Department of the Navy (Parts 700--799)
       VII  Department of the Air Force (Parts 800--1099)
            Subtitle B--Other Regulations Relating to National 
                Defense
       XII  Defense Logistics Agency (Parts 1200--1299)
       XVI  Selective Service System (Parts 1600--1699)
      XVII  Office of the Director of National Intelligence (Parts 
                1700--1799)
     XVIII  National Counterintelligence Center (Parts 1800--1899)
       XIX  Central Intelligence Agency (Parts 1900--1999)
        XX  Information Security Oversight Office, National 
                Archives and Records Administration (Parts 2000--
                2099)
       XXI  National Security Council (Parts 2100--2199)
      XXIV  Office of Science and Technology Policy (Parts 2400--
                2499)
     XXVII  Office for Micronesian Status Negotiations (Parts 
                2700--2799)
    XXVIII  Office of the Vice President of the United States 
                (Parts 2800--2899)

               Title 33--Navigation and Navigable Waters

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Corps of Engineers, Department of the Army, Department 
                of Defense (Parts 200--399)
        IV  Saint Lawrence Seaway Development Corporation, 
                Department of Transportation (Parts 400--499)

                          Title 34--Education

            Subtitle A--Office of the Secretary, Department of 
                Education (Parts 1--99)
            Subtitle B--Regulations of the Offices of the 
                Department of Education
         I  Office for Civil Rights, Department of Education 
                (Parts 100--199)

[[Page 564]]

        II  Office of Elementary and Secondary Education, 
                Department of Education (Parts 200--299)
       III  Office of Special Education and Rehabilitative 
                Services, Department of Education (Parts 300--399)
        IV  Office of Career, Technical and Adult Education, 
                Department of Education (Parts 400--499)
         V  Office of Bilingual Education and Minority Languages 
                Affairs, Department of Education (Parts 500--599) 
                [Reserved]
        VI  Office of Postsecondary Education, Department of 
                Education (Parts 600--699)
       VII  Office of Educational Research and Improvement, 
                Department of Education (Parts 700--799) 
                [Reserved]
            Subtitle C--Regulations Relating to Education
        XI  (Parts 1100--1199) [Reserved]
       XII  National Council on Disability (Parts 1200--1299)

                          Title 35 [Reserved]

             Title 36--Parks, Forests, and Public Property

         I  National Park Service, Department of the Interior 
                (Parts 1--199)
        II  Forest Service, Department of Agriculture (Parts 200--
                299)
       III  Corps of Engineers, Department of the Army (Parts 
                300--399)
        IV  American Battle Monuments Commission (Parts 400--499)
         V  Smithsonian Institution (Parts 500--599)
        VI  [Reserved]
       VII  Library of Congress (Parts 700--799)
      VIII  Advisory Council on Historic Preservation (Parts 800--
                899)
        IX  Pennsylvania Avenue Development Corporation (Parts 
                900--999)
         X  Presidio Trust (Parts 1000--1099)
        XI  Architectural and Transportation Barriers Compliance 
                Board (Parts 1100--1199)
       XII  National Archives and Records Administration (Parts 
                1200--1299)
        XV  Oklahoma City National Memorial Trust (Parts 1500--
                1599)
       XVI  Morris K. Udall Scholarship and Excellence in National 
                Environmental Policy Foundation (Parts 1600--1699)

             Title 37--Patents, Trademarks, and Copyrights

         I  United States Patent and Trademark Office, Department 
                of Commerce (Parts 1--199)
        II  U.S. Copyright Office, Library of Congress (Parts 
                200--299)
       III  Copyright Royalty Board, Library of Congress (Parts 
                300--399)
        IV  National Institute of Standards and Technology, 
                Department of Commerce (Parts 400--599)

[[Page 565]]

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--199)
        II  Armed Forces Retirement Home (Parts 200--299)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Regulatory Commission (Parts 3000--3099)

                  Title 40--Protection of Environment

         I  Environmental Protection Agency (Parts 1--1099)
        IV  Environmental Protection Agency and Department of 
                Justice (Parts 1400--1499)
         V  Council on Environmental Quality (Parts 1500--1599)
        VI  Chemical Safety and Hazard Investigation Board (Parts 
                1600--1699)
       VII  Environmental Protection Agency and Department of 
                Defense; Uniform National Discharge Standards for 
                Vessels of the Armed Forces (Parts 1700--1799)
      VIII  Gulf Coast Ecosystem Restoration Council (Parts 1800--
                1899)

          Title 41--Public Contracts and Property Management

            Subtitle A--Federal Procurement Regulations System 
                [Note]
            Subtitle B--Other Provisions Relating to Public 
                Contracts
        50  Public Contracts, Department of Labor (Parts 50-1--50-
                999)
        51  Committee for Purchase From People Who Are Blind or 
                Severely Disabled (Parts 51-1--51-99)
        60  Office of Federal Contract Compliance Programs, Equal 
                Employment Opportunity, Department of Labor (Parts 
                60-1--60-999)
        61  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 61-1--61-999)
   62--100  [Reserved]
            Subtitle C--Federal Property Management Regulations 
                System
       101  Federal Property Management Regulations (Parts 101-1--
                101-99)
       102  Federal Management Regulation (Parts 102-1--102-299)
  103--104  [Reserved]
       105  General Services Administration (Parts 105-1--105-999)
       109  Department of Energy Property Management Regulations 
                (Parts 109-1--109-99)
       114  Department of the Interior (Parts 114-1--114-99)
       115  Environmental Protection Agency (Parts 115-1--115-99)
       128  Department of Justice (Parts 128-1--128-99)
  129--200  [Reserved]
            Subtitle D--Other Provisions Relating to Property 
                Management [Reserved]

[[Page 566]]

            Subtitle E--Federal Information Resources Management 
                Regulations System [Reserved]
            Subtitle F--Federal Travel Regulation System
       300  General (Parts 300-1--300-99)
       301  Temporary Duty (TDY) Travel Allowances (Parts 301-1--
                301-99)
       302  Relocation Allowances (Parts 302-1--302-99)
       303  Payment of Expenses Connected with the Death of 
                Certain Employees (Part 303-1--303-99)
       304  Payment of Travel Expenses from a Non-Federal Source 
                (Parts 304-1--304-99)

                        Title 42--Public Health

         I  Public Health Service, Department of Health and Human 
                Services (Parts 1--199)
   ii--III  [Reserved]
        IV  Centers for Medicare & Medicaid Services, Department 
                of Health and Human Services (Parts 400--699)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1099)

                   Title 43--Public Lands: Interior

            Subtitle A--Office of the Secretary of the Interior 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Lands
         I  Bureau of Reclamation, Department of the Interior 
                (Parts 400--999)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10099)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency, Department of 
                Homeland Security (Parts 0--399)
        IV  Department of Commerce and Department of 
                Transportation (Parts 400--499)

                       Title 45--Public Welfare

            Subtitle A--Department of Health and Human Services 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Welfare
        II  Office of Family Assistance (Assistance Programs), 
                Administration for Children and Families, 
                Department of Health and Human Services (Parts 
                200--299)

[[Page 567]]

       III  Office of Child Support Enforcement (Child Support 
                Enforcement Program), Administration for Children 
                and Families, Department of Health and Human 
                Services (Parts 300--399)
        IV  Office of Refugee Resettlement, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 400--499)
         V  Foreign Claims Settlement Commission of the United 
                States, Department of Justice (Parts 500--599)
        VI  National Science Foundation (Parts 600--699)
       VII  Commission on Civil Rights (Parts 700--799)
      VIII  Office of Personnel Management (Parts 800--899)
        IX  Denali Commission (Parts 900--999)
         X  Office of Community Services, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 1000--1099)
        XI  National Foundation on the Arts and the Humanities 
                (Parts 1100--1199)
       XII  Corporation for National and Community Service (Parts 
                1200--1299)
      XIII  Administration for Children and Families, Department 
                of Health and Human Services (Parts 1300--1399)
       XVI  Legal Services Corporation (Parts 1600--1699)
      XVII  National Commission on Libraries and Information 
                Science (Parts 1700--1799)
     XVIII  Harry S. Truman Scholarship Foundation (Parts 1800--
                1899)
       XXI  Commission of Fine Arts (Parts 2100--2199)
     XXIII  Arctic Research Commission (Parts 2300--2399)
      XXIV  James Madison Memorial Fellowship Foundation (Parts 
                2400--2499)
       XXV  Corporation for National and Community Service (Parts 
                2500--2599)

                          Title 46--Shipping

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Maritime Administration, Department of Transportation 
                (Parts 200--399)
       III  Coast Guard (Great Lakes Pilotage), Department of 
                Homeland Security (Parts 400--499)
        IV  Federal Maritime Commission (Parts 500--599)

                      Title 47--Telecommunication

         I  Federal Communications Commission (Parts 0--199)
        II  Office of Science and Technology Policy and National 
                Security Council (Parts 200--299)
       III  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                300--399)

[[Page 568]]

        IV  National Telecommunications and Information 
                Administration, Department of Commerce, and 
                National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 400--499)
         V  The First Responder Network Authority (Parts 500--599)

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  Defense Acquisition Regulations System, Department of 
                Defense (Parts 200--299)
         3  Department of Health and Human Services (Parts 300--
                399)
         4  Department of Agriculture (Parts 400--499)
         5  General Services Administration (Parts 500--599)
         6  Department of State (Parts 600--699)
         7  Agency for International Development (Parts 700--799)
         8  Department of Veterans Affairs (Parts 800--899)
         9  Department of Energy (Parts 900--999)
        10  Department of the Treasury (Parts 1000--1099)
        12  Department of Transportation (Parts 1200--1299)
        13  Department of Commerce (Parts 1300--1399)
        14  Department of the Interior (Parts 1400--1499)
        15  Environmental Protection Agency (Parts 1500--1599)
        16  Office of Personnel Management, Federal Employees 
                Health Benefits Acquisition Regulation (Parts 
                1600--1699)
        17  Office of Personnel Management (Parts 1700--1799)
        18  National Aeronautics and Space Administration (Parts 
                1800--1899)
        19  Broadcasting Board of Governors (Parts 1900--1999)
        20  Nuclear Regulatory Commission (Parts 2000--2099)
        21  Office of Personnel Management, Federal Employees 
                Group Life Insurance Federal Acquisition 
                Regulation (Parts 2100--2199)
        23  Social Security Administration (Parts 2300--2399)
        24  Department of Housing and Urban Development (Parts 
                2400--2499)
        25  National Science Foundation (Parts 2500--2599)
        28  Department of Justice (Parts 2800--2899)
        29  Department of Labor (Parts 2900--2999)
        30  Department of Homeland Security, Homeland Security 
                Acquisition Regulation (HSAR) (Parts 3000--3099)
        34  Department of Education Acquisition Regulation (Parts 
                3400--3499)
        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199)
        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)
        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399) 
                [Reserved]

[[Page 569]]

        54  Defense Logistics Agency, Department of Defense (Parts 
                5400--5499)
        57  African Development Foundation (Parts 5700--5799)
        61  Civilian Board of Contract Appeals, General Services 
                Administration (Parts 6100--6199)
        99  Cost Accounting Standards Board, Office of Federal 
                Procurement Policy, Office of Management and 
                Budget (Parts 9900--9999)

                       Title 49--Transportation

            Subtitle A--Office of the Secretary of Transportation 
                (Parts 1--99)
            Subtitle B--Other Regulations Relating to 
                Transportation
         I  Pipeline and Hazardous Materials Safety 
                Administration, Department of Transportation 
                (Parts 100--199)
        II  Federal Railroad Administration, Department of 
                Transportation (Parts 200--299)
       III  Federal Motor Carrier Safety Administration, 
                Department of Transportation (Parts 300--399)
        IV  Coast Guard, Department of Homeland Security (Parts 
                400--499)
         V  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 500--599)
        VI  Federal Transit Administration, Department of 
                Transportation (Parts 600--699)
       VII  National Railroad Passenger Corporation (AMTRAK) 
                (Parts 700--799)
      VIII  National Transportation Safety Board (Parts 800--999)
         X  Surface Transportation Board (Parts 1000--1399)
        XI  Research and Innovative Technology Administration, 
                Department of Transportation (Parts 1400--1499) 
                [Reserved]
       XII  Transportation Security Administration, Department of 
                Homeland Security (Parts 1500--1699)

                   Title 50--Wildlife and Fisheries

         I  United States Fish and Wildlife Service, Department of 
                the Interior (Parts 1--199)
        II  National Marine Fisheries Service, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 200--299)
       III  International Fishing and Related Activities (Parts 
                300--399)
        IV  Joint Regulations (United States Fish and Wildlife 
                Service, Department of the Interior and National 
                Marine Fisheries Service, National Oceanic and 
                Atmospheric Administration, Department of 
                Commerce); Endangered Species Committee 
                Regulations (Parts 400--499)
         V  Marine Mammal Commission (Parts 500--599)

[[Page 570]]

        VI  Fishery Conservation and Management, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 600--699)

[[Page 571]]





           Alphabetical List of Agencies Appearing in the CFR




                      (Revised as of April 1, 2018)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

Administrative Committee of the Federal Register  1, I
Administrative Conference of the United States    1, III
Advisory Council on Historic Preservation         36, VIII
Advocacy and Outreach, Office of                  7, XXV
Afghanistan Reconstruction, Special Inspector     5, LXXXIII
     General for
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development              2, VII; 22, II
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, IX, X, XI
Agricultural Research Service                     7, V
Agriculture Department                            2, IV; 5, LXXIII
  Advocacy and Outreach, Office of                7, XXV
  Agricultural Marketing Service                  7, I, IX, X, XI
  Agricultural Research Service                   7, V
  Animal and Plant Health Inspection Service      7, III; 9, I
  Chief Financial Officer, Office of              7, XXX
  Commodity Credit Corporation                    7, XIV
  Economic Research Service                       7, XXXVII
  Energy Policy and New Uses, Office of           2, IX; 7, XXIX
  Environmental Quality, Office of                7, XXXI
  Farm Service Agency                             7, VII, XVIII
  Federal Acquisition Regulation                  48, 4
  Federal Crop Insurance Corporation              7, IV
  Food and Nutrition Service                      7, II
  Food Safety and Inspection Service              9, III
  Foreign Agricultural Service                    7, XV
  Forest Service                                  36, II
  Grain Inspection, Packers and Stockyards        7, VIII; 9, II
       Administration
  Information Resources Management, Office of     7, XXVII
  Inspector General, Office of                    7, XXVI
  National Agricultural Library                   7, XLI
  National Agricultural Statistics Service        7, XXXVI
  National Institute of Food and Agriculture      7, XXXIV
  Natural Resources Conservation Service          7, VI
  Operations, Office of                           7, XXVIII
  Procurement and Property Management, Office of  7, XXXII
  Rural Business-Cooperative Service              7, XVIII, XLII
  Rural Development Administration                7, XLII
  Rural Housing Service                           7, XVIII, XXXV
  Rural Telephone Bank                            7, XVI
  Rural Utilities Service                         7, XVII, XVIII, XLII
  Secretary of Agriculture, Office of             7, Subtitle A
  Transportation, Office of                       7, XXXIII
  World Agricultural Outlook Board                7, XXXVIII
Air Force Department                              32, VII
  Federal Acquisition Regulation Supplement       48, 53
Air Transportation Stabilization Board            14, VI
Alcohol and Tobacco Tax and Trade Bureau          27, I
Alcohol, Tobacco, Firearms, and Explosives,       27, II
     Bureau of
AMTRAK                                            49, VII
American Battle Monuments Commission              36, IV
American Indians, Office of the Special Trustee   25, VII

[[Page 572]]

Animal and Plant Health Inspection Service        7, III; 9, I
Appalachian Regional Commission                   5, IX
Architectural and Transportation Barriers         36, XI
     Compliance Board
Arctic Research Commission                        45, XXIII
Armed Forces Retirement Home                      5, XI
Army Department                                   32, V
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 51
Bilingual Education and Minority Languages        34, V
     Affairs, Office of
Blind or Severely Disabled, Committee for         41, 51
     Purchase from People Who Are
Broadcasting Board of Governors                   22, V
  Federal Acquisition Regulation                  48, 19
Career, Technical and Adult Education, Office of  34, IV
Census Bureau                                     15, I
Centers for Medicare & Medicaid Services          42, IV
Central Intelligence Agency                       32, XIX
Chemical Safety and Hazardous Investigation       40, VI
     Board
Chief Financial Officer, Office of                7, XXX
Child Support Enforcement, Office of              45, III
Children and Families, Administration for         45, II, III, IV, X, XIII
Civil Rights, Commission on                       5, LXVIII; 45, VII
Civil Rights, Office for                          34, I
Council of the Inspectors General on Integrity    5, XCVIII
     and Efficiency
Court Services and Offender Supervision Agency    5, LXX
     for the District of Columbia
Coast Guard                                       33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage)                46, III
Commerce Department                               2, XIII; 44, IV; 50, VI
  Census Bureau                                   15, I
  Economic Analysis, Bureau of                    15, VIII
  Economic Development Administration             13, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 13
  Foreign-Trade Zones Board                       15, IV
  Industry and Security, Bureau of                15, VII
  International Trade Administration              15, III; 19, III
  National Institute of Standards and Technology  15, II; 37, IV
  National Marine Fisheries Service               50, II, IV
  National Oceanic and Atmospheric                15, IX; 50, II, III, IV, 
       Administration                             VI
  National Technical Information Service          15, XI
  National Telecommunications and Information     15, XXIII; 47, III, IV
       Administration
  National Weather Service                        15, IX
  Patent and Trademark Office, United States      37, I
  Secretary of Commerce, Office of                15, Subtitle A
Commercial Space Transportation                   14, III
Commodity Credit Corporation                      7, XIV
Commodity Futures Trading Commission              5, XLI; 17, I
Community Planning and Development, Office of     24, V, VI
     Assistant Secretary for
Community Services, Office of                     45, X
Comptroller of the Currency                       12, I
Construction Industry Collective Bargaining       29, IX
     Commission
Consumer Financial Protection Bureau              5, LXXXIV; 12, X
Consumer Product Safety Commission                5, LXXI; 16, II
Copyright Royalty Board                           37, III
Corporation for National and Community Service    2, XXII; 45, XII, XXV
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Court Services and Offender Supervision Agency    5, LXX; 28, VIII
     for the District of Columbia
Customs and Border Protection                     19, I
Defense Contract Audit Agency                     32, I
Defense Department                                2, XI; 5, XXVI; 32, 
                                                  Subtitle A; 40, VII
  Advanced Research Projects Agency               32, I

[[Page 573]]

  Air Force Department                            32, VII
  Army Department                                 32, V; 33, II; 36, III; 
                                                  48, 51
  Defense Acquisition Regulations System          48, 2
  Defense Intelligence Agency                     32, I
  Defense Logistics Agency                        32, I, XII; 48, 54
  Engineers, Corps of                             33, II; 36, III
  National Imagery and Mapping Agency             32, I
  Navy Department                                 32, VI; 48, 52
  Secretary of Defense, Office of                 2, XI; 32, I
Defense Contract Audit Agency                     32, I
Defense Intelligence Agency                       32, I
Defense Logistics Agency                          32, XII; 48, 54
Defense Nuclear Facilities Safety Board           10, XVII
Delaware River Basin Commission                   18, III
Denali Commission                                 45, IX
District of Columbia, Court Services and          5, LXX; 28, VIII
     Offender Supervision Agency for the
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Analysis, Bureau of                      15, VIII
Economic Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          2, XXXIV; 5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office of
  Career, Technical and Adult Education, Office   34, IV
       of
  Civil Rights, Office for                        34, I
  Educational Research and Improvement, Office    34, VII
       of
  Elementary and Secondary Education, Office of   34, II
  Federal Acquisition Regulation                  48, 34
  Postsecondary Education, Office of              34, VI
  Secretary of Education, Office of               34, Subtitle A
  Special Education and Rehabilitative Services,  34, III
       Office of
  Career, Technical, and Adult Education, Office  34, IV
       of
Educational Research and Improvement, Office of   34, VII
Election Assistance Commission                    2, LVIII; 11, II
Elementary and Secondary Education, Office of     34, II
Emergency Oil and Gas Guaranteed Loan Board       13, V
Emergency Steel Guarantee Loan Board              13, IV
Employee Benefits Security Administration         29, XXV
Employees' Compensation Appeals Board             20, IV
Employees Loyalty Board                           5, V
Employment and Training Administration            20, V
Employment Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             2, IX; 5, XXIII; 10, II, 
                                                  III, X
  Federal Acquisition Regulation                  48, 9
  Federal Energy Regulatory Commission            5, XXIV; 18, I
  Property Management Regulations                 41, 109
Energy, Office of                                 7, XXIX
Engineers, Corps of                               33, II; 36, III
Engraving and Printing, Bureau of                 31, VI
Environmental Protection Agency                   2, XV; 5, LIV; 40, I, IV, 
                                                  VII
  Federal Acquisition Regulation                  48, 15
  Property Management Regulations                 41, 115
Environmental Quality, Office of                  7, XXXI
Equal Employment Opportunity Commission           5, LXII; 29, XIV
Equal Opportunity, Office of Assistant Secretary  24, I
     for
Executive Office of the President                 3, I
  Environmental Quality, Council on               40, V
  Management and Budget, Office of                2, Subtitle A; 5, III, 
                                                  LXXVII; 14, VI; 48, 99
  National Drug Control Policy, Office of         2, XXXVI; 21, III
  National Security Council                       32, XXI; 47, 2

[[Page 574]]

  Presidential Documents                          3
  Science and Technology Policy, Office of        32, XXIV; 47, II
  Trade Representative, Office of the United      15, XX
       States
Export-Import Bank of the United States           2, XXXV; 5, LII; 12, IV
Family Assistance, Office of                      45, II
Farm Credit Administration                        5, XXXI; 12, VI
Farm Credit System Insurance Corporation          5, XXX; 12, XIV
Farm Service Agency                               7, VII, XVIII
Federal Acquisition Regulation                    48, 1
Federal Aviation Administration                   14, I
  Commercial Space Transportation                 14, III
Federal Claims Collection Standards               31, IX
Federal Communications Commission                 5, XXIX; 47, I
Federal Contract Compliance Programs, Office of   41, 60
Federal Crop Insurance Corporation                7, IV
Federal Deposit Insurance Corporation             5, XXII; 12, III
Federal Election Commission                       5, XXXVII; 11, I
Federal Emergency Management Agency               44, I
Federal Employees Group Life Insurance Federal    48, 21
     Acquisition Regulation
Federal Employees Health Benefits Acquisition     48, 16
     Regulation
Federal Energy Regulatory Commission              5, XXIV; 18, I
Federal Financial Institutions Examination        12, XI
     Council
Federal Financing Bank                            12, VIII
Federal Highway Administration                    23, I, II
Federal Home Loan Mortgage Corporation            1, IV
Federal Housing Enterprise Oversight Office       12, XVII
Federal Housing Finance Agency                    5, LXXX; 12, XII
Federal Housing Finance Board                     12, IX
Federal Labor Relations Authority                 5, XIV, XLIX; 22, XIV
Federal Law Enforcement Training Center           31, VII
Federal Management Regulation                     41, 102
Federal Maritime Commission                       46, IV
Federal Mediation and Conciliation Service        29, XII
Federal Mine Safety and Health Review Commission  5, LXXIV; 29, XXVII
Federal Motor Carrier Safety Administration       49, III
Federal Prison Industries, Inc.                   28, III
Federal Procurement Policy Office                 48, 99
Federal Property Management Regulations           41, 101
Federal Railroad Administration                   49, II
Federal Register, Administrative Committee of     1, I
Federal Register, Office of                       1, II
Federal Reserve System                            12, II
  Board of Governors                              5, LVIII
Federal Retirement Thrift Investment Board        5, VI, LXXVI
Federal Service Impasses Panel                    5, XIV
Federal Trade Commission                          5, XLVII; 16, I
Federal Transit Administration                    49, VI
Federal Travel Regulation System                  41, Subtitle F
Financial Crimes Enforcement Network              31, X
Financial Research Office                         12, XVI
Financial Stability Oversight Council             12, XIII
Fine Arts, Commission of                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
Food and Drug Administration                      21, I
Food and Nutrition Service                        7, II
Food Safety and Inspection Service                9, III
Foreign Agricultural Service                      7, XV
Foreign Assets Control, Office of                 31, V
Foreign Claims Settlement Commission of the       45, V
     United States
Foreign Service Grievance Board                   22, IX
Foreign Service Impasse Disputes Panel            22, XIV
Foreign Service Labor Relations Board             22, XIV
Foreign-Trade Zones Board                         15, IV
Forest Service                                    36, II
General Services Administration                   5, LVII; 41, 105

[[Page 575]]

  Contract Appeals, Board of                      48, 61
  Federal Acquisition Regulation                  48, 5
  Federal Management Regulation                   41, 102
  Federal Property Management Regulations         41, 101
  Federal Travel Regulation System                41, Subtitle F
  General                                         41, 300
  Payment From a Non-Federal Source for Travel    41, 304
       Expenses
  Payment of Expenses Connected With the Death    41, 303
       of Certain Employees
  Relocation Allowances                           41, 302
  Temporary Duty (TDY) Travel Allowances          41, 301
Geological Survey                                 30, IV
Government Accountability Office                  4, I
Government Ethics, Office of                      5, XVI
Government National Mortgage Association          24, III
Grain Inspection, Packers and Stockyards          7, VIII; 9, II
     Administration
Gulf Coast Ecosystem Restoration Council          2, LIX; 40, VIII
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          2, III; 5, XLV; 45, 
                                                  Subtitle A
  Centers for Medicare & Medicaid Services        42, IV
  Child Support Enforcement, Office of            45, III
  Children and Families, Administration for       45, II, III, IV, X, XIII
  Community Services, Office of                   45, X
  Family Assistance, Office of                    45, II
  Federal Acquisition Regulation                  48, 3
  Food and Drug Administration                    21, I
  Indian Health Service                           25, V
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Homeland Security, Department of                  2, XXX; 5, XXXVI; 6, I; 8, 
                                                  I
  Coast Guard                                     33, I; 46, I; 49, IV
  Coast Guard (Great Lakes Pilotage)              46, III
  Customs and Border Protection                   19, I
  Federal Emergency Management Agency             44, I
  Human Resources Management and Labor Relations  5, XCVII
       Systems
  Immigration and Customs Enforcement Bureau      19, IV
  Transportation Security Administration          49, XII
HOPE for Homeowners Program, Board of Directors   24, XXIV
     of
Housing and Urban Development, Department of      2, XXIV; 5, LXV; 24, 
                                                  Subtitle B
  Community Planning and Development, Office of   24, V, VI
       Assistant Secretary for
  Equal Opportunity, Office of Assistant          24, I
       Secretary for
  Federal Acquisition Regulation                  48, 24
  Federal Housing Enterprise Oversight, Office    12, XVII
       of
  Government National Mortgage Association        24, III
  Housing--Federal Housing Commissioner, Office   24, II, VIII, X, XX
       of Assistant Secretary for
  Housing, Office of, and Multifamily Housing     24, IV
       Assistance Restructuring, Office of
  Inspector General, Office of                    24, XII
  Public and Indian Housing, Office of Assistant  24, IX
       Secretary for
  Secretary, Office of                            24, Subtitle A, VII
Housing--Federal Housing Commissioner, Office of  24, II, VIII, X, XX
     Assistant Secretary for
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Immigration and Customs Enforcement Bureau        19, IV
Immigration Review, Executive Office for          8, V
Independent Counsel, Office of                    28, VII
Independent Counsel, Offices of                   28, VI
Indian Affairs, Bureau of                         25, I, V
Indian Affairs, Office of the Assistant           25, VI
   Secretary
[[Page 576]]

Indian Arts and Crafts Board                      25, II
Indian Health Service                             25, V
Industry and Security, Bureau of                  15, VII
Information Resources Management, Office of       7, XXVII
Information Security Oversight Office, National   32, XX
     Archives and Records Administration
Inspector General
  Agriculture Department                          7, XXVI
  Health and Human Services Department            42, V
  Housing and Urban Development Department        24, XII, XV
Institute of Peace, United States                 22, XVII
Inter-American Foundation                         5, LXIII; 22, X
Interior Department                               2, XIV
  American Indians, Office of the Special         25, VII
       Trustee
  Endangered Species Committee                    50, IV
  Federal Acquisition Regulation                  48, 14
  Federal Property Management Regulations System  41, 114
  Fish and Wildlife Service, United States        50, I, IV
  Geological Survey                               30, IV
  Indian Affairs, Bureau of                       25, I, V
  Indian Affairs, Office of the Assistant         25, VI
       Secretary
  Indian Arts and Crafts Board                    25, II
  Land Management, Bureau of                      43, II
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Natural Resource Revenue, Office of             30, XII
  Ocean Energy Management, Bureau of              30, V
  Reclamation, Bureau of                          43, I
  Safety and Enforcement Bureau, Bureau of        30, II
  Secretary of the Interior, Office of            2, XIV; 43, Subtitle A
  Surface Mining Reclamation and Enforcement,     30, VII
       Office of
Internal Revenue Service                          26, I
International Boundary and Water Commission,      22, XI
     United States and Mexico, United States 
     Section
International Development, United States Agency   22, II
     for
  Federal Acquisition Regulation                  48, 7
International Development Cooperation Agency,     22, XII
     United States
International Joint Commission, United States     22, IV
     and Canada
International Organizations Employees Loyalty     5, V
     Board
International Trade Administration                15, III; 19, III
International Trade Commission, United States     19, II
Interstate Commerce Commission                    5, XL
Investment Security, Office of                    31, VIII
James Madison Memorial Fellowship Foundation      45, XXIV
Japan-United States Friendship Commission         22, XVI
Joint Board for the Enrollment of Actuaries       20, VIII
Justice Department                                2, XXVIII; 5, XXVIII; 28, 
                                                  I, XI; 40, IV
  Alcohol, Tobacco, Firearms, and Explosives,     27, II
       Bureau of
  Drug Enforcement Administration                 21, II
  Federal Acquisition Regulation                  48, 28
  Federal Claims Collection Standards             31, IX
  Federal Prison Industries, Inc.                 28, III
  Foreign Claims Settlement Commission of the     45, V
       United States
  Immigration Review, Executive Office for        8, V
  Independent Counsel, Offices of                 28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor Department                                  2, XXIX; 5, XLII
  Employee Benefits Security Administration       29, XXV
  Employees' Compensation Appeals Board           20, IV
  Employment and Training Administration          20, V
  Employment Standards Administration             20, VI
  Federal Acquisition Regulation                  48, 29
  Federal Contract Compliance Programs, Office    41, 60
     of
[[Page 577]]

  Federal Procurement Regulations System          41, 50
  Labor-Management Standards, Office of           29, II, IV
  Mine Safety and Health Administration           30, I
  Occupational Safety and Health Administration   29, XVII
  Public Contracts                                41, 50
  Secretary of Labor, Office of                   29, Subtitle A
  Veterans' Employment and Training Service,      41, 61; 20, IX
       Office of the Assistant Secretary for
  Wage and Hour Division                          29, V
  Workers' Compensation Programs, Office of       20, I, VII
Labor-Management Standards, Office of             29, II, IV
Land Management, Bureau of                        43, II
Legal Services Corporation                        45, XVI
Library of Congress                               36, VII
  Copyright Royalty Board                         37, III
  U.S. Copyright Office                           37, II
Local Television Loan Guarantee Board             7, XX
Management and Budget, Office of                  5, III, LXXVII; 14, VI; 
                                                  48, 99
Marine Mammal Commission                          50, V
Maritime Administration                           46, II
Merit Systems Protection Board                    5, II, LXIV
Micronesian Status Negotiations, Office for       32, XXVII
Military Compensation and Retirement              5, XCIX
     Modernization Commission
Millennium Challenge Corporation                  22, XIII
Mine Safety and Health Administration             30, I
Minority Business Development Agency              15, XIV
Miscellaneous Agencies                            1, IV
Monetary Offices                                  31, I
Morris K. Udall Scholarship and Excellence in     36, XVI
     National Environmental Policy Foundation
Museum and Library Services, Institute of         2, XXXI
National Aeronautics and Space Administration     2, XVIII; 5, LIX; 14, V
  Federal Acquisition Regulation                  48, 18
National Agricultural Library                     7, XLI
National Agricultural Statistics Service          7, XXXVI
National and Community Service, Corporation for   2, XXII; 45, XII, XXV
National Archives and Records Administration      2, XXVI; 5, LXVI; 36, XII
  Information Security Oversight Office           32, XX
National Capital Planning Commission              1, IV, VI
National Commission for Employment Policy         1, IV
National Commission on Libraries and Information  45, XVII
     Science
National Council on Disability                    5, C; 34, XII
National Counterintelligence Center               32, XVIII
National Credit Union Administration              5, LXXXVI; 12, VII
National Crime Prevention and Privacy Compact     28, IX
     Council
National Drug Control Policy, Office of           2, XXXVI; 21, III
National Endowment for the Arts                   2, XXXII
National Endowment for the Humanities             2, XXXIII
National Foundation on the Arts and the           45, XI
     Humanities
National Geospatial-Intelligence Agency           32, I
National Highway Traffic Safety Administration    23, II, III; 47, VI; 49, V
National Imagery and Mapping Agency               32, I
National Indian Gaming Commission                 25, III
National Institute of Food and Agriculture        7, XXXIV
National Institute of Standards and Technology    15, II; 37, IV
National Intelligence, Office of Director of      5, IV; 32, XVII
National Labor Relations Board                    5, LXI; 29, I
National Marine Fisheries Service                 50, II, IV
National Mediation Board                          29, X
National Oceanic and Atmospheric Administration   15, IX; 50, II, III, IV, 
                                                  VI
National Park Service                             36, I
National Railroad Adjustment Board                29, III
National Railroad Passenger Corporation (AMTRAK)  49, VII
National Science Foundation                       2, XXV; 5, XLIII; 45, VI

[[Page 578]]

  Federal Acquisition Regulation                  48, 25
National Security Council                         32, XXI
National Security Council and Office of Science   47, II
     and Technology Policy
National Telecommunications and Information       15, XXIII; 47, III, IV, V
     Administration
National Transportation Safety Board              49, VIII
Natural Resources Conservation Service            7, VI
Natural Resource Revenue, Office of               30, XII
Navajo and Hopi Indian Relocation, Office of      25, IV
Navy Department                                   32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Northeast Interstate Low-Level Radioactive Waste  10, XVIII
     Commission
Nuclear Regulatory Commission                     2, XX; 5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Ocean Energy Management, Bureau of                30, V
Oklahoma City National Memorial Trust             36, XV
Operations Office                                 7, XXVIII
Overseas Private Investment Corporation           5, XXXIII; 22, VII
Patent and Trademark Office, United States        37, I
Payment From a Non-Federal Source for Travel      41, 304
     Expenses
Payment of Expenses Connected With the Death of   41, 303
     Certain Employees
Peace Corps                                       2, XXXVII; 22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, XXXV; 5, IV; 45, 
                                                  VIII
  Human Resources Management and Labor Relations  5, XCVII
       Systems, Department of Homeland Security
  Federal Acquisition Regulation                  48, 17
  Federal Employees Group Life Insurance Federal  48, 21
       Acquisition Regulation
  Federal Employees Health Benefits Acquisition   48, 16
       Regulation
Pipeline and Hazardous Materials Safety           49, I
     Administration
Postal Regulatory Commission                      5, XLVI; 39, III
Postal Service, United States                     5, LX; 39, I
Postsecondary Education, Office of                34, VI
President's Commission on White House             1, IV
     Fellowships
Presidential Documents                            3
Presidio Trust                                    36, X
Prisons, Bureau of                                28, V
Privacy and Civil Liberties Oversight Board       6, X
Procurement and Property Management, Office of    7, XXXII
Public Contracts, Department of Labor             41, 50
Public and Indian Housing, Office of Assistant    24, IX
     Secretary for
Public Health Service                             42, I
Railroad Retirement Board                         20, II
Reclamation, Bureau of                            43, I
Refugee Resettlement, Office of                   45, IV
Relocation Allowances                             41, 302
Research and Innovative Technology                49, XI
     Administration
Rural Business-Cooperative Service                7, XVIII, XLII
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII, XXXV
Rural Telephone Bank                              7, XVI
Rural Utilities Service                           7, XVII, XVIII, XLII
Safety and Environmental Enforcement, Bureau of   30, II
Saint Lawrence Seaway Development Corporation     33, IV
Science and Technology Policy, Office of          32, XXIV
Science and Technology Policy, Office of, and     47, II
     National Security Council
Secret Service                                    31, IV

[[Page 579]]

Securities and Exchange Commission                5, XXXIV; 17, II
Selective Service System                          32, XVI
Small Business Administration                     2, XXVII; 13, I
Smithsonian Institution                           36, V
Social Security Administration                    2, XXIII; 20, III; 48, 23
Soldiers' and Airmen's Home, United States        5, XI
Special Counsel, Office of                        5, VIII
Special Education and Rehabilitative Services,    34, III
     Office of
State Department                                  2, VI; 22, I; 28, XI
  Federal Acquisition Regulation                  48, 6
Surface Mining Reclamation and Enforcement,       30, VII
     Office of
Surface Transportation Board                      49, X
Susquehanna River Basin Commission                18, VIII
Tennessee Valley Authority                        5, LXIX; 18, XIII
Thrift Supervision Office, Department of the      12, V
     Treasury
Trade Representative, United States, Office of    15, XX
Transportation, Department of                     2, XII; 5, L
  Commercial Space Transportation                 14, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 12
  Federal Aviation Administration                 14, I
  Federal Highway Administration                  23, I, II
  Federal Motor Carrier Safety Administration     49, III
  Federal Railroad Administration                 49, II
  Federal Transit Administration                  49, VI
  Maritime Administration                         46, II
  National Highway Traffic Safety Administration  23, II, III; 47, IV; 49, V
  Pipeline and Hazardous Materials Safety         49, I
       Administration
  Saint Lawrence Seaway Development Corporation   33, IV
  Secretary of Transportation, Office of          14, II; 49, Subtitle A
  Transportation Statistics Bureau                49, XI
Transportation, Office of                         7, XXXIII
Transportation Security Administration            49, XII
Transportation Statistics Bureau                  49, XI
Travel Allowances, Temporary Duty (TDY)           41, 301
Treasury Department                               2, X;5, XXI; 12, XV; 17, 
                                                  IV; 31, IX
  Alcohol and Tobacco Tax and Trade Bureau        27, I
  Community Development Financial Institutions    12, XVIII
       Fund
  Comptroller of the Currency                     12, I
  Customs and Border Protection                   19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Claims Collection Standards             31, IX
  Federal Law Enforcement Training Center         31, VII
  Financial Crimes Enforcement Network            31, X
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  Investment Security, Office of                  31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
  Thrift Supervision, Office of                   12, V
Truman, Harry S. Scholarship Foundation           45, XVIII
United States and Canada, International Joint     22, IV
     Commission
United States and Mexico, International Boundary  22, XI
     and Water Commission, United States Section
U.S. Copyright Office                             37, II
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs Department                       2, VIII; 38, I
  Federal Acquisition Regulation                  48, 8
Veterans' Employment and Training Service,        41, 61; 20, IX
     Office of the Assistant Secretary for
Vice President of the United States, Office of    32, XXVIII
Wage and Hour Division                            29, V
Water Resources Council                           18, VI

[[Page 580]]

Workers' Compensation Programs, Office of         20, I, VII
World Agricultural Outlook Board                  7, XXXVIII

[[Page 581]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations (CFR) that 
were made by documents published in the Federal Register since January 
1, 2013, are enumerated in the following list. Entries indicate the 
nature of the changes effected. Page numbers refer to Federal Register 
pages. The user should consult the entries for chapters, parts and 
subparts as well as sections for revisions.
For changes to this volume of the CFR prior to this listing, consult the 
annual edition of the monthly List of CFR Sections Affected (LSA). The 
LSA is available at www.fdsys.gov. For changes to this volume of the CFR 
prior to 2001, see the ``List of CFR Sections Affected, 1949-1963, 1964-
1972, 1973-1985, and 1986-2000'' published in 11 separate volumes. The 
``List of CFR Sections Affected 1986-2000'' is available at 
www.fdsys.gov.

                                  2013

21 CFR
                                                                   78 FR
                                                                    Page
Chapter I
1 Authority citation revised.......................................69543
1.1 (c) amended....................................................69543
1.20 Introductory text corrected; CFR correction...................54568
    Introductory text revised......................................69543
1.281 Regulation at 76 FR 25545 confirmed..........................32362
1.378 Regulation at 76 FR 25541 confirmed...........................7997
1.393 Regulation at 76 FR 25541 confirmed...........................7997
4 Added; eff. 7-22-13...............................................4321
10.30 (b), (c), (d), (e)(3) and (g) revised........................76749
14 Amended.........................................................17087
14.1 (a) introductory text, (2)(vii) and (f) revised...............17087
14.22 (b)(6) and (i)(4) revised....................................17087
14.55 (d) removed; (e) and (f) redesignated (d) and (e); (c) and 
        new (d) revised............................................17087
14.65 (a) revised..................................................17087
14.100 (f) removed; (g) redesignated as (f)........................69992
14.120 Amended.....................................................17087
14.122 (a)(2) and (b) amended......................................17087
14.125 (c) amended.................................................17087
14.130 (a) amended.................................................17087
16.1 (b)(2) amended................................................58817
21.61 Regulation at 77 FR 51912 withdrawn...........................2892
    (d) added......................................................39186
50.3 (n), (r) and (s) revised......................................12950
50.51 Revised......................................................12951
50.52 Introductory text revised....................................12951
50.53 Introductory text revised....................................12951
50.54 (a) revised..................................................12951
50.55 (e) revised..................................................12951
56.106 (d) correctly revised.......................................16401
56.107 (a) correctly amended.......................................16401
56.109 (h) amended.................................................12951
73 Technical correction............................................42451
73.350 (c)(1) revised..............................................35117
    Regulation at 78 FR 35117 confirmed............................54758
73.530 Added.......................................................49120
    Regulation at 78 FR 49120 confirmed............................68713
73.3100 Heading and (a) revised....................................19415
    Regulation at 78 FR 19415 eff. date confirmed..................37962
73.3106 (a) revised................................................19415
    Regulation at 78 FR 19415 eff. date confirmed..................37962
73.3129 Heading revised; (a) amended...............................14664

                                  2014

21 CFR
                                                                   79 FR
                                                                    Page
Chapter I
1 Authority citation revised.......................................30719
1.361 Regulation at 77 FR 10662 confirmed..........................18799
1.980 (Subpart Q) Added............................................30719

[[Page 582]]

5.1110 (b) revised.................................................68114
10.85 (d)(4) amended...............................................68114
10.90 (d) amended..................................................68114
10.95 (b)(2), (c)(2), (d)(2), (7) and (8) amended..................68114
11.1 (g) added; eff. 12-1-15.......................................71253
    (h) added; eff. 12-1-16........................................71291
14.65 (c) amended..................................................68114
14.100 (c)(18) revised..............................................2094
    (c)(9) heading and (ii) revised................................20095
16 Authority citation revised......................................30721
16.1 (b)(1) amended................................................30721
17.2 Revised; eff. 6-18-14..........................................6090
    Regulation at 79 FR 6090 eff. date confirmed...................32643
17.5 (a) revised; eff. 6-18-14......................................6092
    Regulation at 79 FR 6090 eff. date confirmed...................32643
20.3 (b) amended...................................................68114
20.26 (b) revised..................................................68114
20.30 (a) amended..................................................68115
20.40 (a) revised..................................................68115
20.107 (a) amended.................................................68115
20.120 (a) revised.................................................68115
21.32 (b)(2) amended...............................................68115
21.40 (b) amended..................................................68115
21.41 (c) and (e) amended..........................................68115
21.43 (a)(2) amended...............................................68115
21.52 (a) amended..................................................68115
73.530 (c) revised.................................................20098
    Regulation at 79 FR 20098 eff. date confirmed..................33431

                                  2015

21 CFR
                                                                   80 FR
                                                                    Page
Chapter I
1 Technical correction.............................................22403
    Compliance date clarification..................................71934
    Authority citation revised..............................74340, 74650
1.94 Revised.......................................................55242
1.101 (d)(2)(i) amended............................................18090
1.227 Revised......................................................56141
1.241 (a) revised..................................................56143
1.276 (b)(9) revised...............................................56143
1.328 Amended......................................................56143
1.363 Revised......................................................56144
1.500--1.514 (Subpart L) Added.....................................74340
1.600--1.695 (Subpart M) Added.....................................74650
11 Compliance date clarification...................................71934
11 Policy statement................................................13225
11.1 Regulation at 79 FR 71253 and 71291 compliance date extended 
                                                                   39675
    (i) added......................................................56144
    (j) added......................................................56336
    (l) added......................................................74352
    (k) added......................................................74547
    (m) added......................................................74667
14.100 (c)(3) removed; (c)(4) through (18) redesignated as new 
        (c)(3) through (17)........................................14839
    (c)(2) introductory text revised...............................18307
16 Technical correction............................................22403
    Authority citation revised.....................................42723
    Compliance date clarification..................................71934
16.1 (b)(2) amended.........................................56144, 56336
    (b)(1) and (2) amended.........................................74547
    (b)(2) amended.................................................74667
20.100 (c)(45) added...............................................38938
25 Technical correction............................................70679
25.15 (a), (c) and (d) amended.....................................57535
25.20 Introductory text revised; (o) and (p) added.................57535
25.30 Introductory text amended....................................57535
25.35 Added........................................................57535
25.40 (a) amended..................................................57535
25.50 (b) amended..................................................57535
25.52 (a) amended; (b) and (c) revised.............................57535
26.1--26.21 (Subpart A) Appendix E amended.........................18090
73.200 (b)(1) and (c)(1) revised...................................14842
    Regulation at 80 FR 14842 eff. date confirmed..................31466
73.350 (c)(1)(ii) revised; (c)(1)(iii) added.......................32307
    Regulation at 80 FR 32307 confirmed............................46190
    (c)(1)(ii)(A) revised..........................................58602
    Regulation at 80 FR 58602 eff. date confirmed..................76859
73.530 (c) revised.................................................50765
    Regulation at 80 FR 50765 eff. date confirmed..................66415
73.1530 Added......................................................50765
    Regulation at 80 FR 50765 eff. date confirmed..................66415
99.201 (c)(1) amended..............................................18090

                                  2016

21 CFR
                                                                   81 FR
                                                                    Page
Chapter I
1 Authority citation revised..................20166, 45949, 85870, 90193
    Policy statement.................................39183, 57784, 88099
    Nomenclature change............................................49895

[[Page 583]]

    Meeting.........................................................9761
1.1 (c) amended....................................................59131
1.20 Amended.......................................................59131
1.24 Amended.......................................................59131
1.70--1.81 (Subpart D) Added.......................................85870
1.83 (a) revised...................................................85872
1.90 Revised.......................................................85872
1.94 (a) and (c) amended...........................................85873
1.227 Amended................................................3715, 45949
1.230 Revised......................................................45950
1.231 Revised......................................................45950
1.232 Revised......................................................45951
1.233 Revised......................................................45952
1.234 Revised......................................................45952
1.235 Revised......................................................45952
1.241 Revised......................................................45953
1.245 Added........................................................45953
1.328 Amended.......................................................3715
1.500 Amended......................................................25327
1.501 Heading revised..............................................25327
1.511 Heading, (a) heading and (b) heading revised.................25327
1.512 (b)(3)(ii) introductory text and (c)(1)(i) amended; 
        (b)(3)(iii) and (iv) revised...............................25327
1.634 (a)(4)(iii) added............................................90193
1.664 (a)(4) added.................................................90193
1.700 Undesignated center heading and section added................90193
1.705 Added........................................................90193
1.710 Added........................................................90193
1.715 Added........................................................90193
1.720 Added........................................................90193
1.725 Added........................................................90193
1.900--1.934 (Subpart O) Added.....................................20166
2.125 (e)(4)(vi) and (ix) removed..................................74302
4.100--4.105 (Subpart B) Added.....................................92624
5 Nomenclature change..............................................49895
5.1100 Revised.....................................................78033
10.20 (e) revised..................................................78505
10.30 (b) introductory text revised; (c), (d), (e)(2), (ii) and 
        (3) amended; (e)(2)(iii) redesignated as (e)(2)(iv); new 
        (e)(2)(iii) and (5) added..................................78505
10.31 Added........................................................78506
10.35 (b) and (e) introductory text amended; (i) added.............78506
11 Policy statement.........................................54499, 57784
11 Meeting..........................................................9761
11.1 (n) added.....................................................20170
    (o) added......................................................34218
    Regulation at 79 FR 71253 compliance date extended to 5-5-17 
                                                                   96364
14.1 (a)(2)(v) removed.............................................45409
14.100 (c)(15) heading revised.....................................11663
    (d)(5) added...................................................14976
    (b)(5) redesignated as (b)(4); (b)(6) removed..................37153
16 Policy statement................................................57784
16 Meeting..........................................................9761
16.1 (b)(1) and (2) amended........................................52995
17.2 Revised.......................................................62358
20 Technical correction............................................89848
20.100 (c)(22) removed.............................................45409
    (c)(46) added..................................................55046
    (c)(9) amended.................................................60212
    Regulation at 81 FR 55046 eff. date corrected..................62004
20.116 Revised.....................................................60212
25.20 (k) revised..................................................55047
    Regulation at 81 FR 55047 eff. date corrected..................62004
25.32 (f), (i), (j), (k) and (r) revised...........................55047
    Regulation at 81 FR 55047 eff. date corrected..................62004
56 Authority citation revised......................................19035
    Regulation at 81 FR 19035 eff. date confirmed..................47288
56.120 (b)(4) and (c) redesignated as (c) and (d); (b) and new (c) 
        revised....................................................19035
    Regulation at 81 FR 19035 eff. date confirmed..................47288
70 Nomenclature change.............................................49895
71 Nomenclature change.............................................49895
73 Nomenclature change.............................................49895
73.165 (b) amended..................................................5590
73.585 (b) amended..................................................5590
73.3126 (b)(1) revised.............................................75692
74.3045 (c)(1) introductory text and (i) revised...................75692
80 Nomenclature change.............................................49895

                                  2017

21 CFR
                                                                   82 FR
                                                                    Page
Chapter I
1 Policy statement............................16733, 30730, 51345, 55503
1.279 (b)(1) revised...............................................15629
1.280 (a)(1), (2) and (b) revised..................................15629
1.281 (a) introductory text, (11)(iv), (17)(i), (iii), (b) 
        introductory text, (c) introductory text, (11)(iii), 
        (17)(i) and (iii) revised..................................15629
1.282 (c) revised..................................................15629
1.285 (i)(2) amended...............................................15629
1.403 (f) revised..................................................14144

[[Page 584]]

1.404 Revised......................................................14144
1.980 (g)(3)(iv) and (4) revised...................................14144
2.125 Regulation at 81 FR 74302 eff. date confirmed................12067
11 Compliance notification; interim................................20825
    Technical correction; interim..................................34401
11.1 Regulation at 82 FR 20825 comment period extended to 8-2-17; 
        interim....................................................30730
14.100 (f) removed.................................................58554
16.1 (b)(2) amended................................................61446
17.3 (a) revised...................................................34402
21.112 Notification................................................42031
73.70 Added........................................................51557
73.530 (c) revised.................................................30734
    Regulation at 82 FR 30734 confirmed............................43845
73.3126 Regulation at 81 FR 75692 eff. date confirmed...............7648
74.3045 Regulation at 81 FR 75692 eff. date confirmed...............7648

                                  2018

   (Regulations published from January 1, 2018, through April 1, 2018)

21 CFR
                                                                   83 FR
                                                                    Page
Chapter I
1 Policy statement...................................................598
    Notification...................................................12483
4 Policy statement.................................................12259
5.1100 Amended.....................................................13106
10.115 (f)(3) amended..............................................13416
11 Policy statement..................................................598
16 Policy statement............................................598, 2057
73.70 Regulation at 82 FR 51557 eff. date confirmed.................4423


                                  [all]