[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2017 Edition]
[From the U.S. Government Publishing Office]



[[Page i]]

          
          
          Title 21

Food and Drugs


________________________

Parts 1 to 99

                         Revised as of April 1, 2017

          Containing a codification of documents of general 
          applicability and future effect

          As of April 1, 2017
                    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, 2017), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

    Each volume of the Code contains amendments published in the Federal 
Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
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instances where the effective date is beyond the cut-off date for the 
Code a note has been inserted to reflect the future effective date. In 
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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 
requirements.

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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Affected'' is published at the end of each CFR volume. For changes to 
the Code prior to the LSA listings at the end of the volume, consult 
previous annual editions of the LSA. For changes to the Code prior to 
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 
not accidentally dropped due to a printing or computer error.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
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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 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
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    (b) The matter incorporated is in fact available to the extent 
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alphabetical list of agencies publishing in the CFR are also included in 
this volume.

[[Page vii]]

    An index to the text of ``Title 3--The President'' is carried within 
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INQUIRIES

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    Oliver A. Potts,
    Director,
    Office of the Federal Register.
    April 1, 2017.

                                
                                      
                            

  

[[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, 2017.

    For this volume, Kenneth R. Payne was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of John 
Hyrum Martinez, assisted by Stephen J. Frattini.

[[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.................................         218
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................................         272
20              Public information..........................         275
21              Protection of privacy.......................         306
25              Environmental impact considerations.........         322
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..................         334
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................         516
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.............................         535

[[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 Secs. 101.1, 201.60, 501.1, 701.10 and 801.60 of this chapter; 
and the requirements pertaining to uniform location, lack of 
qualification, and separation of the net quantity declaration in 
Secs. 101.7(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 
Secs. 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 Secs. 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 Secs. 201.62(m), 
701.13(o) and 801.62(m) of this chapter, to initial statement of square 
inches in declaration of net quantity in Secs. 201.62(n), 701.13(p) and 
801.62(n) of this chapter, to prohibition of certain supplemental net 
quantity statements in Secs. 101.7(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 Secs. 137.105, 137.155, 
137.160, 137.165, 137.170, 137.175, 137.180, 137.185, 137.200, and 
137.205 of this chapter, packaged:
    (i) In conventional 2-, 5-, 10-, 25-, 50-, and 100-pound packages 
are exempt from the placement requirement of Sec. 101.7(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 Secs. 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 
Secs. 137.211, 137.215, and Secs. 137.230 through 137.290 of this 
chapter, packaged in conventional 5-, 10-, 25-, 50-, and 100-pound bags 
are exempt from the placement requirement of Sec. 101.7(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 Secs. 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 Secs. 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 Secs. 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 Secs. 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 Secs. 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 Secs. 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 Secs. 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 Secs. 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 Secs. 1.361 and 1.363.
    (l) Nonprofit food establishments are excluded from all of the 
requirements in this subpart, except Secs. 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 Secs. 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 Secs. 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 Secs. 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 
Secs. 1.503 and 1.509, but you are not required to comply with the 
requirements in Sec. 1.502, Secs. 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 Secs. 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 Secs. 1.503, 1.509, and 1.510, but you are not required 
to comply with the requirements in Sec. 1.502 or Secs. 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 Secs. 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 Secs. 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 Secs. 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 Secs. 1.502, 1.503, 
and 1.509, but you are not required to comply with the requirements in 
Secs. 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 Secs. 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

[[Page 81]]

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 Secs. 1.504 through 
1.508. You would still be required to comply with the requirements in 
Secs. 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 Secs. 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 Secs. 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 Secs. 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 
Secs. 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 Secs. 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 Secs. 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 
Secs. 1.621 and 1.662 or, where appropriate, the recognized 
accreditation body's performance under Secs. 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 Secs. 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.

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    (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

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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

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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.

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    (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 Secs. 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 Secs. 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 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.
    Division of Clinical Trial Quality.

[[Page 143]]

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.
Office of Biotechnology Products.

[[Page 144]]

    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.
    Human Resources and Administrative Management Branch.

[[Page 145]]

    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.
    Product Evaluation Branch I.
    Product Evaluation Branch II.

[[Page 146]]

    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.
    Division of Import Operations.

[[Page 147]]

    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]



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 
Secs. 7.41 through 7.59 recognize the voluntary nature of recall by 
providing guidance so that responsible firms may effectively discharge 
their recall responsibilities. These sections also recognize that recall 
is an alternative to a Food and Drug Administration-initiated court 
action for removing or correcting violative, distributed products by 
setting forth specific recall procedures for the Food and Drug 
Administration to monitor recalls and assess the adequacy of a firm's 
efforts in recall.
    (b) Recall may be undertaken voluntarily and at any time by 
manufacturers and distributors, or at the request of the Food and Drug 
Administration. A request by the Food and Drug Administration that a 
firm recall a product is reserved for urgent situations and is to be 
directed to the firm that has primary responsibility for the manufacture 
and marketing of the product that is to be recalled.
    (c) Recall is generally more appropriate and affords better 
protection for consumers than seizure, when many lots of product have 
been widely distributed. Seizure, multiple seizure, or other court 
action is indicated when a firm refuses to undertake a recall requested 
by the Food and Drug Administration, or where the agency has reason to 
believe that a recall would not be effective, determines that a recall 
is 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 Secs. 7.40 
through 7.49, 7.53, and 7.55.
    (b) Use sufficient coding of regulated products to make possible 
positive lot identification and to facilitate effective recall of all 
violative lots.
    (c) Maintain such product distribution records as are necessary to 
facilitate location of products that are being recalled. Such records 
should be maintained for a period of time that exceeds the shelf life 
and expected use of the product and is at least the length of

[[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 Secs. 25.30, 25.31, 25.32, 
25.33, or Sec. 25.34 of this chapter or an environmental assessment 
under Sec. 25.40 of this chapter.)

                           D. Economic Impact

    (The following information is to be submitted only when requested by 
the Commissioner following review of the petition: A statement of the 
effect of requested action on: (1) Cost (and price) increases to 
industry, government, and consumers; (2) productivity of wage earners, 
businesses, or government; (3) competition; (4) supplies of important 
materials, products, or services; (5) employment; and (6) energy supply 
or demand.)

                            E. Certification

    The undersigned certifies, that, to the best knowledge and belief of 
the undersigned, this petition includes all information and views on 
which the petition relies, and that it includes representative data and 
information known to the petitioner which are unfavorable to the 
petition.

 (Signature)____________________________________________________________

 (Name of petitioner)___________________________________________________

 (Mailing address)______________________________________________________

 (Telephone number)_____________________________________________________

    (c) A petition 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(S) NOT AVAILABLE IN TIFF FORMAT]

    (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(S) NOT AVAILABLE IN TIFF FORMAT]

    (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 Secs. 10.33(k) and 
10.35(h).
    (3) The proposed rule published in the Federal Register, including 
all information identified or filed by the Commissioner with the 
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 
Secs. 10.25 through 10.40 and Sec. 16.1(b), except action subject to 
Sec. 10.50 and part 12.
    (b) A request that the Commissioner take or refrain from taking any 
form of administrative action must first be the subject of a final 
administrative decision based on a petition submitted under 
Sec. 10.25(a) or, where applicable, a hearing under Sec. 16.1(b) before 
any legal action is filed in a court complaining of the action or 
failure to act. If a court action is filed complaining of the action or 
failure to act before the submission of the decision on a petition under 
Sec. 10.25(a) or, where applicable, a hearing under Sec. 16.1(b), the 
Commissioner shall request dismissal of the court action or referral to 
the agency for an initial administrative determination on the grounds of 
a failure to exhaust administrative remedies, the lack of final agency 
action as required by 5 U.S.C. 701 et seq., and the lack of an actual 
controversy as required by 28 U.S.C. 2201.
    (c) A request that administrative action be stayed must first be the 
subject of an administrative decision based 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 Secs. 10.30(i), 
10.33(k), 10.35(h), 10.40(g), and 16.80(a) or the administrative record 
applicable to any decision or action under the regulations referenced in 
Sec. 16.1(b), and that additional information or views may not be 
considered. An interested person who wishes to rely upon information or 
views not included in the administrative record shall submit them to the 
Commissioner with a new petition to modify the action under 
Sec. 10.25(a).
    (g) The Commissioner requests that all petitions for judicial review 
of a particular matter be filed in a single U.S. District court. If 
petitions are filed in more than one jurisdiction, the 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 Secs. 12.20 through 12.22 and other applicable provisions in 
this chapter, e.g., Secs. 314.200, 514.200, and 601.7(a).
    (b) The Commissioner may order a formal evidentiary public hearing 
on any matter whenever it would be in the public interest to do so.
    (c) The provisions of the act, and other laws, that afford a person 
who would be adversely affected by administrative action an opportunity 
for a formal evidentiary public hearing as listed below. The list 
imparts no right to a hearing where the statutory section provides no 
opportunity for a hearing.
    (1) Section 401 on any action for the amendment or repeal of any 
definition and standard of identity for any dairy product (including 
products regulated under parts 131, 133, and 135 of this chapter) or 
maple sirup (regulated under Sec. 168.140 of this chapter).
    (2) Section 403(j) on regulations for labeling of foods for special 
dietary uses.
    (3) Section 404(a) on regulations for emergency permit control.
    (4) Section 406 on tolerances for poisonous substances in food.
    (5) Section 409 (c), (d), and (h) on food additive regulations.
    (6) Section 501(b) on tests or methods of assay for drugs described 
in official compendia.
    (7) [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 
Secs. 314.200(f), 514.200, and 601.7(a) are applicable before 
publication of a notice announcing a formal evidentiary public hearing 
or a hearing before a Public Board of Inquiry. Following publication of 
the notice of hearing, the rules in paragraph (b)(2) of this section 
apply.
    (d) Except as provided in paragraph (e) of this section, between the 
date that separation of functions applies under paragraph (b) or (c) of 
this section and the date of the Commissioner's decision on the matter, 
communication concerning the matter involved in the hearing will be 
restricted as follows:
    (1) No person outside the agency may have an ex parte communication 
with the presiding officer or any person representing the office of the 
Commissioner concerning the matter in the hearing. Neither the presiding 
officer nor any person representing the office of the Commissioner may 
have any ex parte communication with a person outside the agency 
concerning the matter in the hearing. All communications are to be 
public communications, as witness or counsel, under the applicable 
provisions of this part.
    (2) A participant in the hearing may submit a written communication 
to the office of the Commissioner with respect to a proposal for 
settlement. These communications are to be in the form of pleadings, 
served on all other 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 Secs. 20.83 through 20.89.

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



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 Secs. 12.20 through 12.22 does not provide a member a 
legal right with respect to the objection or request for hearing that 
the member may individually exercise. A member of an organization 
wishing to file an objection or request for hearing must do so 
individually.
    (e) In a court proceeding in which an organization participates, the 
Commissioner will take appropriate legal measures to have the case 
brought or considered as a class action or otherwise as binding upon all 
members of the organization except those specifically excluded by name. 
Regardless of whether the case is brought or considered as a class 
action or as otherwise binding upon all members of the organization 
except those specifically excluded by name, the Commissioner will take 
the position in any subsequent suit involving the same issues and a 
member of the organization that the issues are precluded from further 
litigation by the member under the doctrines of collateral estoppel or 
res judicata.



Sec. 10.110  Settlement proposals.

    At any time in the course of a proceeding subject to this part, a 
person may propose settlement of the issues involved. A participant in a 
proceeding will have an opportunity to consider a proposed settlement. 
Unaccepted proposals of settlement and related matters, e.g., proposed 
stipulations not agreed to, will not be admissible in evidence in an FDA 
administrative proceeding. FDA will oppose the admission in evidence of 
settlement information

[[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.
    (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

[[Page 191]]

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:
    (i) After it prepares a guidance document, FDA will:
    (A) Post the guidance document on the Internet and make it available 
in hard copy;

[[Page 192]]

    (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 Internet a current list of 
all guidance documents. New documents will be added to this list within 
30 days of issuance.

[[Page 193]]

    (2) Once a year, FDA will publish in the Federal Register its 
comprehensive list of guidance documents. The comprehensive list will 
identify documents that have been added to the list or withdrawn from 
the list since the previous comprehensive list.
    (3) FDA's guidance document lists will include the name of the 
guidance document, issuance and revision dates, and information on how 
to obtain copies of the document.
    (o) What can you do if you believe that someone at FDA is not 
following these GGP's? If you believe that someone at FDA did not follow 
the procedures in this section or that someone at FDA treated a guidance 
document as a binding requirement, you should contact that person's 
supervisor in the center or office that issued the guidance document. If 
the issue cannot be resolved, you should contact the next highest 
supervisor. You can also contact the center or office ombudsman for 
assistance in resolving the issue. If you are unable to resolve the 
issue at the center or office level or if you feel that you are not 
making progress by going through the chain of command, you may ask the 
Office of the Chief Mediator and Ombudsman to become involved.

[65 FR 56477, Sept. 19, 2000]



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

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



Sec. 10.200  Scope.

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



Sec. 10.203  Definitions.

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

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



Sec. 10.204  General.

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

[[Page 194]]

    (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.
    (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

[[Page 195]]

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 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

[[Page 196]]

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 
to record the proceeding electronically. Appeals may be made in writing 
or by phone to the Deputy Commissioner or, in his or her absence, to the 
Associate Commissioner for Regulatory Affairs. The filing of an appeal, 
whether before or during a proceeding, does not require the presiding 
officer to interrupt the proceeding. However, the Deputy Commissioner 
or, in his or her absence, the Associate Commissioner for Regulatory 
Affairs will resolve an appeal as

[[Page 197]]

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 Secs. 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 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

[[Page 198]]

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.
    (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

[[Page 199]]

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:
    (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.

[[Page 200]]



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
    (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.

[[Page 201]]



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.
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.

[[Page 202]]

                        Subpart H_Judicial Review

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

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

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



                      Subpart A_General Provisions



Sec. 12.1  Scope.

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



                   Subpart B_Initiation of Proceedings



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

    (a) A proceeding under section 409(f), 502(n), 512(n)(5), 701(e), or 
721(d) of the act or section 4 or 5 of the Fair Packaging and Labeling 
Act may be initiated--
    (1) By the Commissioner on the Commissioner's own initiative, e.g., 
as provided in Sec. 170.15 for food additives; or
    (2) By a petition--
    (i) In the form specified elsewhere in this chapter, e.g., the form 
for a color additive petition in Sec. 71.1; or
    (ii) If no form is specified, by a petition under Sec. 10.30.
    (b) If the Commissioner receives a petition under paragraph (a)(2) 
of this section, the Commissioner will--
    (1) If it involves any matter subject to section 701(e) of the act 
or section 4 or 5 of the Fair Packaging and Labeling Act, and meets the 
requirements for filing, follow the provisions of Sec. 10.40 (b) through 
(f);
    (2) If it involves a color additive or food additive, and meets the 
requirements for filing in Secs. 71.1 and 71.2, or in Secs. 171.1, 
171.6, 171.7, and 171.100, publish a notice of filing of the petition 
within 30 days after the petition is filed instead of a notice of 
proposed rulemaking.
    (c) [Reserved]
    (d) The notice promulgating the regulation will describe how to 
submit objections and requests for hearing.
    (e) On or before the 30th day after the date of publication of a 
final regulation, or of a notice withdrawing a proposal initiated by a 
petition under Sec. 10.25(a), a person may submit to the Commissioner 
written objections and a request for a hearing. The 30-day period may 
not be extended except that additional information supporting an 
objection may be received after 30 days upon a showing of inadvertent 
omission and hardship, and if review of the objection and request for 
hearing will not thereby be impeded. If, after a final color additive 
regulation is published, a petition or proposal relating to the 
regulation is referred to an advisory committee in accordance with 
section 721(b)(5)(C) of the act, objections and requests for a hearing 
may be submitted on or before the 30th day after the date on which the 
order confirming or modifying the Commissioner's previous order is 
published.

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



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

    (a) A proceeding under section 505 (d) or (e), 512 (d), (e), (m) (3) 
or (4), of section 515(g)(1) of the act, or section 351(a) of the Public 
Health Service Act, may be initiated--
    (1) By the Commissioner on the Commissioner's own initiative;
    (2) By a petition in the form specified elsewhere in this chapter, 
e.g., Sec. 314.50 for new drug applications, Sec. 514.1 for new animal 
drug applications, Sec. 514.2 for applications for animal feeds, or 
Sec. 601.3 for licenses for biologic products; or
    (3) By a petition under Sec. 10.30.
    (b) A notice of opportunity for hearing on a proposal to deny or 
revoke approval of all or part of an order will be published together 
with an explanation of the grounds for the proposed action. The notice 
will describe how to submit requests for hearing. A person subject

[[Page 203]]

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 Secs. 314.200, 514.200, or 601.7(a).
    (c) If an objection or request for a public hearing fails to meet 
the requirements of this section and the deficiency becomes known to the 
Division of Dockets Management, the Division of Dockets Management shall 
return it with a copy of the applicable regulations, indicating those 
provisions not complied with. A deficient objection or request for a 
hearing may be supplemented and subsequently filed if submitted within 
the 30-day time period specified in Sec. 12.20(e) or Sec. 12.21(b).
    (d) If another person objects to a regulation issued in response to 
a petition submitted under Sec. 12.20(a)(2), the petitioner may submit a 
written reply to the Division of Dockets Management.

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



Sec. 12.23  Notice of filing of objections.

    As soon as practicable after the expiration of the time for filing 
objections to and requests for hearing on agency action involving the 
issuance, amendment, or revocation of a regulation under sections 
502(n), 701(e), or 721(d) of the act or sections 4 or 5 of the Fair 
Packaging and Labeling Act, the Commissioner shall publish a notice in 
the Federal Register specifying those parts of the regulation that have 
been stayed by the filing of proper objections and, if no objections 
have been filed, stating that fact. The notice does not constitute a 
determination that a hearing is justified on any objections or requests 
for hearing that have been filed. When to do so will cause no

[[Page 204]]

undue delay, the notice required by this section may be combined with 
the notices described in Secs. 12.28 and 12.35.



Sec. 12.24  Ruling on objections and requests for hearing.

    (a) As soon as possible the Commissioner will review all objections 
and requests for hearing filed under Sec. 12.22 and determine--
    (1) Whether the regulation should be modified or revoked under 
Sec. 12.26;
    (2) Whether a hearing has been justified; and
    (3) Whether, if requested, a hearing before a Public Board of 
Inquiry under part 13 or before a public advisory committee under part 
14 or before the Commissioner under part 15 has been justified.
    (b) A request for a hearing will be granted if the material 
submitted shows the following:
    (1) There is a genuine and substantial issue of fact for resolution 
at a hearing. A hearing will not be granted on issues of policy or law.
    (2) The factual issue can be resolved by available and specifically 
identified reliable evidence. A hearing will not be granted on the basis 
of mere allegations or denials or general descriptions of positions and 
contentions.
    (3) The data and information submitted, if established at a hearing, 
would be adequate to justify resolution of the factual issue in the way 
sought by the person. A hearing will be denied if the Commissioner 
concludes that the data and information submitted are insufficient to 
justify the factual determination urged, even if accurate.
    (4) Resolution of the factual issue in the way sought by the person 
is adequate to justify the action requested. A hearing will not be 
granted on factual issues that are not determinative with respect to the 
action requested, e.g., if the Commissioner concludes that the action 
would be the same even if the factual issue were resolved in the way 
sought, or if a request is made that a final regulation include a 
provision not reasonably encompassed by the proposal. A hearing will be 
granted upon proper objection and request when a food standard or other 
regulation is shown to have the effect of excluding or otherwise 
affecting a product or ingredient.
    (5) The action requested is not inconsistent with any provision in 
the act or any regulation in this chapter particularizing statutory 
standards. The proper procedure in those circumstances is for the person 
requesting the hearing to petition for an amendment or waiver of the 
regulation involved.
    (6) The requirements in other applicable regulations, e.g., 
Secs. 10.20, 12.21, 12.22, 314.200, 514.200, and 601.7(a), and in the 
notice promulgating the final regulation or the notice of opportunity 
for hearing are met.
    (c) In making the determination in paragraph (a) of this section, 
the Commissioner may use any of the optional procedures specified in 
Sec. 10.30(h) or in other applicable regulations, e.g., Secs. 314.200, 
514.200, and 601.7(a).
    (d) If it is uncertain whether a hearing has been justified under 
the principles in paragraph (b) of this section, and the Commissioner 
concludes that summary decision against the person requesting a hearing 
should be considered, the Commissioner may serve upon the person by 
registered mail a proposed order denying a hearing. The person has 30 
days after receipt of the proposed order to demonstrate that the 
submission justifies a hearing.

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



Sec. 12.26  Modification or revocation of regulation or order.

    If the Commissioner determines upon review of an objection or 
request for hearing that the regulation or order should be modified or 
revoked, the Commissioner will promptly take such action by notice in 
the Federal Register. Further objections to or requests for hearing on 
the modification or revocation may be submitted under Secs. 12.20 
through 12.22 but no further issue may be taken with other provisions in 
the regulation or order. Objections and requests for hearing that are 
not affected by the modification or revocation will remain on file and 
be acted upon in due course.

[[Page 205]]



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 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.

[[Page 206]]



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

    (a) A person with a right to submit objections and a request for 
hearing under Sec. 12.20(d) may submit objections and waive the right to 
a hearing. The waiver may be either an explicit statement, or a failure 
to request a hearing, as provided in 12.22(a)(4).
    (b) If a person waives the right to a hearing, the Commissioner will 
rule upon the person's objections under Secs. 12.24 through 12.28. As a 
matter of discretion, the Commissioner may also order a hearing on the 
matter under any of the provisions of this part.
    (c) If the Commissioner rules adversely on a person's objection, the 
person may petition for judicial review in a U.S. Court of Appeals under 
the act.
    (1) The record for judicial review is the record designated in 
Sec. 12.28(b)(1).
    (2) The time for filing a petition for judicial review begins as of 
the date of publication of the Commissioner's ruling on the objections.



Sec. 12.32  Request for alternative form of hearing.

    (a) A person with a right to request a hearing may waive that right 
and request one of the following alternatives:
    (1) A hearing before a Public Board of Inquiry under part 13.
    (2) A hearing before a public advisory committee under part 14.
    (3) A hearing before the Commissioner under part 15.
    (b) The request--
    (1) May be on the person's own initiative or at the suggestion of 
the Commissioner.
    (2) Must be submitted in the form of a citizen petition under 
Sec. 10.30 before publication of a notice of hearing under Sec. 12.35 or 
a denial of hearing under Sec. 12.28; and
    (3) Must be--
    (i) In lieu of a request for a hearing under this part; or
    (ii) If submitted after or with a request for hearing, in the form 
of a waiver of the right to request a hearing conditioned on an 
alternative form of hearing. Upon acceptance by the Commissioner, the 
waiver becomes binding and may be withdrawn only by waiving any right to 
any form of hearing unless the Commissioner determines otherwise.
    (c) When more than one person requests and justifies a hearing under 
this part, an alternative form of hearing may by used only if all the 
persons concur and waive their right to request a hearing under this 
part.
    (d) The Commissioner will determine whether an alternative form of 
hearing should be used, and if so, which alternative is acceptable, 
after considering the requests submitted and the appropriateness of the 
alternatives for the issues raised in the objections. The Commissioner's 
acceptance is binding unless, for good cause, the Commissioner 
determines otherwise.
    (e) The Commissioner will publish a notice of an alternative form of 
hearing setting forth the following information:
    (1) The regulation or order that is the subject of the hearing.
    (2) A statement specifying any part of the regulation or order that 
has been stayed by operation of law or in the Commissioner's discretion.
    (3) The time, date, and place of the hearing, or a statment that 
such information will be contained in a later notice.
    (4) The parties to the hearing.
    (5) The issues at the hearing. The statement of issues determines 
the scope of the hearing.
    (6) If the hearing will be conducted by a Public Board of Inquiry, 
the time within which--
    (i) The parties should submit nominees for the Board under 
Sec. 13.10(b);
    (ii) A notice of participation under Sec. 12.45 should be filed; and
    (iii) Participants should submit written information under 
Sec. 13.25. The notice will list the contents of the portions of the 
administrative record relevant to the issues at the hearing before the 
Board. The portions listed will be placed on public display in the 
office of the Division of Dockets Management before the notice is 
published. Additional copies of material already submitted under 
Sec. 13.25 need not be included with any later submissions.
    (f)(1) The decision of a hearing before a Public Board of Inquiry or 
a public advisory committee under this section

[[Page 207]]

has legal status of and will be handled as an initial decision under 
Sec. 12.120.
    (2) The decision of a public hearing before the Commissioner under 
this section will be issued as a final order. The final order will have 
the same content as an initial decision, as specified in Sec. 12.120 (b) 
and (c).
    (3) Thereafter, the participants in the proceeding may pursue the 
administrative and court remedies specified in Secs. 12.120 through 
12.159.
    (g) If a hearing before a public advisory committee or a hearing 
before the Commissioner is used as an alternative form of hearing, all 
submissions will be made to the 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 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

[[Page 208]]

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]



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.

[[Page 209]]

    (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--
    (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;

[[Page 210]]

    (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 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

[[Page 211]]

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.
    (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]

[[Page 212]]



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
    (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,

[[Page 213]]

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
    (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.

[[Page 214]]

    (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 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.

[[Page 215]]

    (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.
    (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.

[[Page 216]]

Briefs must contain proposed findings of fact and conclusions of law.
    (b) The presiding officer may, as a matter of discretion, permit 
oral argument after the briefs are filed.
    (c) Briefs and oral argument are to refrain from disclosing specific 
details of written and oral testimony and documents relating to matters 
specified in Sec. 10.20(j)(2)(i)(a) and (b), except as specifically 
authorized in a protective order issued under Sec. 10.20(j)(3).



Sec. 12.97  Interlocutory appeal from ruling of presiding officer.

    (a) Except as provided in paragraph (b) of this section and in 
Secs. 12.35(b), 12.45(e), 12.93(f), and 12.99(d), when an interlocutory 
appeal is specifically authorized by this subpart, rulings of the 
presiding officer may not be appealed to the Commissioner before the 
Commissioner's consideration of the entire record of the hearing.
    (b) A ruling of the presiding officer is subject to interlocutory 
appeal to the Commissioner if the presiding officer certifies on the 
record or in writing that immediate review is necessary to prevent 
exceptional delay, expense, or prejudice to any participant, or 
substantial harm to the public interest.
    (c) When an interlocutory appeal is made to the Commissioner, a 
participant may file a brief with the Commissioner only if specifically 
authorized by the presiding officer or the Commissioner, and if such 
authorization is granted, within the period the Commissioner directs. If 
a participant is authorized to file a brief, any other participant may 
file a brief in opposition, within the period the Commissioner directs. 
If no briefs are authorized, the appeal will be presented as an oral 
argument to the Commissioner. The oral argument will be transcribed. If 
briefs are authorized, oral argument will be heard only at the 
discretion of the Commissioner.



Sec. 12.98  Official transcript.

    (a) The presiding officer will arrange for a verbatim stenographic 
transcript of oral testimony and for necessary copies of the transcript.
    (b) One copy of the transcript will be placed on public display in 
the office of the Division of Dockets Management upon receipt.
    (c) Except as provided in Sec. 12.105, copies of the transcript may 
be obtained by application to the official reporter and payment of costs 
thereof or under part 20.
    (d) Witnesses, participants, and counsel have 30 days from the time 
the transcript becomes available to propose corrections in the 
transcript of oral testimony. Corrections are permitted only for 
transcription errors. The presiding officer shall promptly order 
justified corrections.



Sec. 12.99  Motions.

    (a) A motion on any matter relating to the proceeding is to be filed 
under Sec. 12.80, and must include a draft order, except one made in the 
course of an oral hearing before the presiding officer.
    (b) A response may be filed within 10 days of service of a motion. 
The time may be shortened or extended by the presiding officer for good 
cause shown.
    (c) The moving party has no right to reply, except as permitted by 
the presiding officer.
    (d) The presiding officer shall rule upon the motion and may certify 
that ruling to the Commissioner for interlocutory review.



                     Subpart F_Administrative Record



Sec. 12.100  Administrative record of a hearing.

    (a) The record of a hearing consists  of--
    (1) The order or regulation or notice of opportunity for hearing 
that gave rise to the hearing;
    (2) All objections and requests for hearing filed by the Division of 
Dockets Management under Secs. 12.20 through 12.22;
    (3) The notice of hearing published under Sec. 12.35;
    (4) All notices of participation filed under Sec. 12.45;
    (5) All Federal Register notices pertinent to the proceeding;
    (6) All submissions filed under Sec. 12.82, e.g., the submissions 
required by Sec. 12.85, all other documentary evidence and

[[Page 217]]

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.



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.

[[Page 218]]

    (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.



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.

[[Page 219]]

                      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 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

[[Page 220]]

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.
    (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 Secs. 13.10(b)(2) 
and 13.45. Submissions of documentary data and information need not be 
sent to each participant, but any accompanying transmittal letter, 
summary, statement of position, certification under paragraph

[[Page 221]]

(d) of this section, or similar document must be.
    (c) A submission must be mailed to the address shown in the notice 
of appearance or personally delivered.
    (d) All submissions are to be accompanied by a certificate of 
service, or a statement that service is not required.
    (e) No written submission or other portion of the administrative 
record may be held in confidence, except as provided in 
Secs. 13.10(b)(2) and 13.45.
    (f) A participant who believes that compliance with the requirements 
of this section constitutes an unreasonable financial burden may submit 
to the Commissioner a petition to participate in forma pauperis in the 
form and manner specified in Sec. 12.82.



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

    (a) Before the notice of hearing is published under Sec. 13.5, the 
director of the center responsible for the matters involved in the 
hearing must submit to the 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 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

[[Page 222]]

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.
    (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.

[[Page 223]]



              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.

             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.

[[Page 224]]

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 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.

[[Page 225]]

    (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 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

[[Page 226]]

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 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

[[Page 227]]

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;
    (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

[[Page 228]]

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 any advisory committee meeting which is not closed.
    (f) Whenever feasible, meetings are to be held in government 
facilities or other facilities involving the least expense to the 
public. The size of the meeting room is to be reasonable, considering 
such factors as the size of the committee, the number of persons 
expected to attend a meeting, and the resources and facilities 
available.
    (g) The Commissioner may authorize a meeting to be held by 
conference telephone call. For these meetings, a speaker phone will be 
provided in a conference room located in Washington, DC, or Rockville, 
MD, or the immediate vicinity, to permit public participation in open 
portions of the meetings, as provided in Secs. 14.25 and 14.29. These 
meetings generally will be brief, and authorized--
    (1) For the purpose of taking final votes or otherwise confirming 
actions taken by the committee at other meetings; or
    (2) Where time does not permit a meeting to be held at a central 
location.
    (h) Any portion of a meeting will be closed by the committee 
Chairperson

[[Page 229]]

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 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

[[Page 230]]

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 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

[[Page 231]]

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 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

[[Page 232]]

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 
Secs. 14.25(c) and 14.27(c).
    (d) To prevent inadvertent violation of Federal conflict of interest 
laws and laws prohibiting disclosure of trade secrets (18 U.S.C. 208, 21 
U.S.C. 331(j), 18 U.S.C. 1905), Federal executive branch employees who 
are not employees of the Department may not confer, testify, or 
otherwise participate (other than as observers) at any portion of an 
advisory committee meeting unless they are appointed as special 
Government employees by the Commissioner under paragraph (e) of this 
section. this paragraph does not apply to Federal executive branch 
employees who are appointed as members of TEPRSSC, as provided in 
Sec. 14.127.
    (e) The Commissioner may appoint persons as special Government 
employees to be consultants to an advisory committee. Consultants may be 
appointed to provide expertise, generally concerning a highly technical 
matter, not readily available from the members of the committee. 
Consultants may be either from outside the Government or from agencies 
other than the Food and Drug Administration. Reports, data, information, 
and other written submissions made to a public advisory committee by a 
consultant are part of the administrative record itemized in Sec. 14.70.

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



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

    The Commissioner shall prepare and provide to all committee members 
a compilation of materials bearing upon members' duties and 
responsibilities, including--
    (a) All applicable conflict of interest laws and regulations and a 
summary of their principal provisions;
    (b) All applicable laws and regulations relating to trade secrets 
and confidential commercial or financial information that may not be 
disclosed publicly and a summary of their principal provisions;
    (c) All applicable laws, regulations, and guidance documents 
relating to the subject matter covered by the advisory committee and a 
summary of their principal provisions;
    (d) All applicable laws, regulations, including the regulations in 
part 20 of this chapter, advisory committee charters, Federal Register 
notices, curricula vitae, rules adopted by the advisory committee, and 
other material relating to the formation, composition, and operation of 
the advisory committee, and a summary of their principal provisions;
    (e) Instructions on whom to contact when questions arise; and
    (f) Other material relating to FDA and the subject matter covered by 
the

[[Page 233]]

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 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

[[Page 234]]

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 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

[[Page 235]]

(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 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

[[Page 236]]

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 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):

[[Page 237]]

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 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.

[[Page 238]]

    (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 Secs. 14.82 and 14.84 and 
from any other sources by the Secretary, or, by delegation of authority, 
by the Assistant Secretary for Health, or the Commissioner.
    (e) Members appointed to an advisory committee serve for the 
duration of the committee, or until their terms of appointment expire, 
they resign, or they are removed from membership by the Commissioner.
    (f) A committee member may be removed from membership for good 
cause. Good cause includes excessive absenteeism from committee 
meetings, a demonstrated bias that interferes with the ability to render 
objective advice, failure to abide by the procedures established in this 
subpart, or violation of other applicable rules and regulations, e.g., 
for nonvoting members, the provisions of Sec. 14.86(c).
    (g) Consultants appointed under Sec. 14.31(e) are not members of 
advisory committees.

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



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

    (a) The Commissioner will publish one or more notices in the Federal 
Register each year requesting nominations for voting members of all 
existing standing advisory committees. The notice will invite the 
submission of nominations for voting members from both individuals and 
organizations.
    (b) The notice announcing the establishment of a new committee under 
Sec. 14.40(b) will invite the submission of nominations for voting 
members.
    (c) A person may nominate one or more qualified persons to an 
advisory committee. Nominations will specify the advisory committee for 
which the nominee is recommended and will include a complete curriculum 
vitae of the nominee. Nominations are to state that the nominee is aware 
of the nomination, is willing to serve as a member of the advisory 
committee, and appears to have no conflict of interest that would 
preclude membership.
    (d) Voting members serve as individuals and not as representatives 
of any group or organization which nominated them or with which they may 
be affiliated.



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

    (a) This section applies when the Commissioner concludes that a 
technical advisory committee should include nonvoting members to 
represent and serve as a liaison with interested individuals and 
organizations.
    (b) Except when the Commissioner concludes otherwise, nonvoting 
members of a technical advisory committee are selected in accordance 
with paragraphs (c) and (d) of this section and are normally limited to 
one person selected by consumer groups and organizations and one person 
selected by industry groups and organizations.
    (c) To select a nonvoting member to represent consumer interests, 
except as provided in paragraph (c)(5) of this section, the Commissioner 
publishes a notice in the Federal Register requesting nominations for 
each specific committee, or subcommittee, for which nonvoting members 
are to be appointed.
    (1) A period of 30 days will be permitted for submission of 
nominations for that committee or subcommittee. Interested persons may 
nominate one

[[Page 239]]

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 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

[[Page 240]]

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 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

[[Page 241]]

inform the committee but need not be absent during the discussion or 
decline to participate in the discussion. a nonvoting industry member 
may not discuss the company's position as such, but may discuss any 
matter in general terms. All presentations and discussions of scientific 
data and their interpretation on behalf of a company will occur in open 
session, except as provided in Sec. 14.25(c).
    (5) A nonvoting member of an advisory committee may not make any 
presentation to that advisory committee during a hearing conducted by 
that committee.
    (6) Although a nonvoting member serves in a representative capacity, 
the nonvoting member shall exercise restraint in performing such 
functions and may not engage in unseemly advocacy or attempt to exert 
undue influence over the other members of the committee.
    (d) A nonvoting member of an advisory committee may be removed by 
the Commissioner for failure to comply with this section as well as 
Sec. 14.80(f).



Sec. 14.90  Ad hoc advisory committee members.

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



Sec. 14.95  Compensation of advisory committee members.

    (a)(1) Except as provided in paragraphs (a) (2) and (3) of this 
section, all voting advisory committee members shall, and nonvoting 
members may, be appointed as special Government employees and receive a 
consultant fee and be reimbursed for travel expenses, including per diem 
in lieu of subsistence, unless such compensation and reimbursement are 
waived.
    (2) Members of the Technical Electronic Product Radiation Safety 
Standards Committee (TEPRSSC) are not appointed as special Government 
employees. Any member of TEPRSSC who is not a Federal employee or member 
of the uniformed services, including the Commissioned Corps of the 
Public Health Service, shall receive a consultant fee and be reimbursed 
for travel expenses, including per diem in lieu of subsistence, unless 
such compensation and reimbursement are waived.
    (3) Voting and nonvoting advisory committee members who are members 
of the uniformed services, including the Commissioned Corps of the 
Public Health Service, provide service on Food and Drug Administration 
advisory committees as part of their assigned functions, are not 
appointed as special government employees, but are reimbursed by the 
Food and Drug Administration for travel expenses.
    (b) Notwithstanding the member's primary residence, an advisory 
committee member, while attending meetings of the full committee or a 
subcommittee, will be paid whether the meetings are held in the 
Washington, DC, area or elsewhere.
    (c) A committee member who participates in any agency-directed 
assignment will be paid at an hourly rate when doing assigned work at 
home, a place of business, or in an FDA facility located within the 
member's commuting area, and at a daily rate when required to travel 
outside of that commuting area to perform the assignment. A committee 
member will not be paid for time spent on normal preparation for a 
committee meeting.
    (1) An agency-directed assignment is an assignment that meets the 
following criteria:
    (i) An activity that requires undertaking a definitive study. The 
activity must produce a tangible end product, usually a written report. 
Examples are:
    (a) An analysis of the risks and benefits of the use of a class of 
drugs or a report on a specific problem generated by an IND or NDA;
    (b) The performance of similar investigations or analysis of complex 
industry submissions to support advisory committee deliberations other 
than normal meeting preparation;
    (c) The preparation of a statistical analysis leading to an estimate 
of toxicologically safe dose levels; and
    (d) The design or analysis of animal studies of toxicity, 
mutagenicity, teratogenicity, or carcinogenicity.
    (ii) The performance of an IND or NDA review or similar review.

[[Page 242]]

    (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 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

[[Page 243]]

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 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.

[[Page 244]]

    (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 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

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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.
    (f) Center for Food Safety and Applied Nutrition--Food Advisory 
Committee.
    (1) Date established: December 15, 1991.
    (2) Function: The committee provides advice on emerging food safety, 
food science, and nutrition issues that FDA considers of primary 
importance in the next decade.

[54 FR 9036, Mar. 3, 1989]

    Editorial Note: For Federal Register citations affecting 
Sec. 14.100, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



   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]

[[Page 246]]



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 Secs. 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, 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

[[Page 247]]

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 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

[[Page 248]]

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 esta