[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2004 Edition]
[From the U.S. Government Printing Office]
[[Page i]]
21
Parts 1 to 99
Revised as of April 1, 2004
Food and Drugs
________________________
Containing a codification of documents of general
applicability and future effect
As of April 1, 2004
With Ancillaries
Published by
Office of the Federal Register
National Archives and Records
Administration
A Special Edition of the Federal Register
[[Page ii]]
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[[Page iii]]
Table of Contents
Page
Explanation................................................. v
Title 21:
Chapter I--Food and Drug Administration, Department
of Health and Human Services 3
Finding Aids:
Material Approved for Incorporation by Reference........ 487
Table of CFR Titles and Chapters........................ 489
Alphabetical List of Agencies Appearing in the CFR...... 507
List of CFR Sections Affected........................... 517
[[Page iv]]
----------------------------
Cite this Code: CFR
To cite the regulations in
this volume use title,
part and section number.
Thus, 21 CFR 1.1 refers to
title 21, part 1, section
1.
----------------------------
[[Page v]]
EXPLANATION
The Code of Federal Regulations is a codification of the general and
permanent rules published in the Federal Register by the Executive
departments and agencies of the Federal Government. The Code is divided
into 50 titles which represent broad areas subject to Federal
regulation. Each title is divided into chapters which usually bear the
name of the issuing agency. Each chapter is further subdivided into
parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year
and issued on a quarterly basis approximately as follows:
Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1
The appropriate revision date is printed on the cover of each
volume.
LEGAL STATUS
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HOW TO USE THE CODE OF FEDERAL REGULATIONS
The Code of Federal Regulations is kept up to date by the individual
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To determine whether a Code volume has been amended since its
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EFFECTIVE AND EXPIRATION DATES
Each volume of the Code contains amendments published in the Federal
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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
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placed as close as possible to the applicable recordkeeping or reporting
requirements.
OBSOLETE PROVISIONS
Provisions that become obsolete before the revision date stated on
the cover of each volume are not carried. Code users may find the text
of provisions in effect on a given date in the past by using the
appropriate numerical list of sections affected. For the period before
January 1, 2001, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, 1973-1985, or 1986-2000, published in 11 separate
volumes. For the period beginning January 1, 2001, a ``List of CFR
Sections Affected'' is published at the end of each CFR volume.
INCORPORATION BY REFERENCE
What is incorporation by reference? Incorporation by reference was
established by statute and allows Federal agencies to meet the
requirement to publish regulations in the Federal Register by referring
to materials already published elsewhere. For an incorporation to be
valid, the Director of the Federal Register must approve it. The legal
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This material, like any other properly issued regulation, has the force
of law.
What is a proper incorporation by reference? The Director of the
Federal Register will approve an incorporation by reference only when
the requirements of 1 CFR part 51 are met. Some of the elements on which
approval is based are:
(a) The incorporation will substantially reduce the volume of
material published in the Federal Register.
(b) The matter incorporated is in fact available to the extent
necessary to afford fairness and uniformity in the administrative
process.
(c) The incorporating document is drafted and submitted for
publication in accordance with 1 CFR part 51.
Properly approved incorporations by reference in this volume are
listed in the Finding Aids at the end of this volume.
What if the material incorporated by reference cannot be found? If
you have any problem locating or obtaining a copy of material listed in
the Finding Aids of this volume as an approved incorporation by
reference, please contact the agency that issued the regulation
containing that incorporation. If, after contacting the agency, you find
the material is not available, please notify the Director of the Federal
Register, National Archives and Records Administration, Washington DC
20408, or call (202) 741-6010.
CFR INDEXES AND TABULAR GUIDES
A subject index to the Code of Federal Regulations is contained in a
separate volume, revised annually as of January 1, entitled CFR Index
and Finding Aids. This volume contains the Parallel Table of Statutory
Authorities and Agency Rules (Table I). A list of CFR titles, chapters,
and parts and an alphabetical list of agencies publishing in the CFR are
also included in this volume.
An index to the text of ``Title 3--The President'' is carried within
that volume.
The Federal Register Index is issued monthly in cumulative form.
This index is based on a consolidation of the ``Contents'' entries in
the daily Federal Register.
A List of CFR Sections Affected (LSA) is published monthly, keyed to
the revision dates of the 50 CFR titles.
[[Page vii]]
REPUBLICATION OF MATERIAL
There are no restrictions on the republication of material appearing
in the Code of Federal Regulations.
INQUIRIES
For a legal interpretation or explanation of any regulation in this
volume, contact the issuing agency. The issuing agency's name appears at
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Raymond A. Mosley,
Director,
Office of the Federal Register.
April 1, 2004.
[[Page ix]]
THIS TITLE
Title 21--Food and Drugs is composed of nine volumes. The parts in
these volumes are arranged in the following order: Parts 1-99, 100-169,
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-end. The
first eight volumes, containing parts 1-1299, comprise Chapter I--Food
and Drug Administration, Department of Health and Human Services. The
ninth volume, containing part 1300 to end, includes Chapter II--Drug
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes
represent all current regulations codified under this title of the CFR
as of April 1, 2004.
For this volume, Ruth Green was Chief Editor. The Code of Federal
Regulations publication program is under the direction of Frances D.
McDonald, assisted by Alomha S. Morris.
[[Page x]]
[[Page 1]]
TITLE 21--FOOD AND DRUGS
(This book contains parts 1 to 99)
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Part
chapter i --Food and Drug Administration, Department of
Health and Human Services................................. 1
Cross References: Food Safety and Inspection Service, Department of
Agriculture: 9 CFR chapter III.
Federal Trade Commission: See Commercial Practices, 16 CFR chapter I.
U.S. Customs Service, Department of the Treasury: See Customs Duties,
19 CFR chapter I.
Internal Revenue Service, Department of the Treasury: See Internal
Revenue, 26 CFR chapter I.
Bureau of Alcohol, Tobacco, and Firearms, Department of the Treasury:
See Alcohol, Tobacco Products and Firearms, 27 CFR chapter I.
[[Page 3]]
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
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Editorial Note: For nomenclature changes to chapter I see 66 FR 56035,
Nov. 6, 2001 and 69 FR 13717, Mar. 24, 2004.
SUBCHAPTER A--GENERAL
Part Page
1 General enforcement regulations............. 5
2 General administrative rulings and decisions 36
3 Product jurisdiction........................ 41
5 Delegations of authority and organization... 45
7 Enforcement policy.......................... 97
10 Administrative practices and procedures..... 107
11 Electronic records; electronic signatures... 141
12 Formal evidentiary public hearing........... 145
13 Public hearing before a public board of
inquiry................................. 162
14 Public hearing before a public advisory
committee............................... 167
15 Public hearing before the Commissioner...... 194
16 Regulatory hearing before the Food and Drug
Administration.......................... 196
17 Civil money penalties hearings.............. 202
19 Standards of conduct and conflicts of
interest................................ 214
20 Public information.......................... 216
21 Protection of privacy....................... 247
25 Environmental impact considerations......... 263
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.................. 274
50 Protection of human subjects................ 307
54 Financial disclosure by clinical
investigators........................... 318
56 Institutional Review Boards................. 321
58 Good laboratory practice for nonclinical
laboratory studies...................... 330
60 Patent term restoration..................... 344
[[Page 4]]
70 Color additives............................. 351
71 Color additive petitions.................... 358
73 Listing of color additives exempt from
certification........................... 365
74 Listing of color additives subject to
certification........................... 413
80 Color additive certification................ 453
81 General specifications and general
restrictions for provisional color
additives for use in foods, drugs, and
cosmetics............................... 459
82 Listing of certified provisionally listed
colors and specifications............... 466
83-98
[Reserved]
99 Dissemination of information on unapproved/
new uses for marketed drugs, biologics,
and devices............................. 471
[[Page 5]]
SUBCHAPTER A_GENERAL
PART 1_GENERAL ENFORCEMENT REGULATIONS--Table of Contents
Subpart A_General Provisions
Sec.
1.1 General.
1.3 Definitions.
1.4 Authority citations.
Subpart B_General Labeling Requirements
1.20 Presence of mandatory label information.
1.21 Failure to reveal material facts.
1.23 Procedures for requesting variations and exemptions from required
label statements.
1.24 Exemptions from required label statements.
Subparts C-D [Reserved]
Subpart E_Imports and Exports
1.83 Definitions.
1.90 Notice of sampling.
1.91 Payment for samples.
1.94 Hearing on refusal of admission.
1.95 Application for authorization to relabel and recondition.
1.96 Granting of authorization to relabel and recondition.
1.97 Bonds.
1.99 Costs chargeable in connection with relabeling and reconditioning
inadmissible imports.
1.101 Notification and recordkeeping.
Subparts F-G [Reserved]
Subpart H_Registration of Food Facilities
General Provisions
1.225 Who must register under this subpart?
1.226 Who does not have to register under this subpart?
1.227 What definitions apply to this subpart?
Procedures for Registration of Food Facilities
1.230 When must you register?
1.231 How and where do you register?
1.232 What information is required in the registration?
1.233 What optional items are included in the registration form?
1.234 How and when do you update your facility's registration
information?
1.235 How and when do you cancel your facility's registration
information?
Additional Provisions
1.240 What other registration requirements apply?
1.241 What are the consequences of failing to register, update, or
cancel your registration?
1.242 What does assignment of a registration number mean?
1.243 Is food registration information available to the public?
Subpart I_Prior Notice of Imported Food
General Provisions
1.276 What definitions apply to this subpart?
1.277 What is the scope of this subpart?
Requirements to Submit Prior Notice of Imported Food
1.278 Who is authorized to submit prior notice?
1.279 When must prior notice be submitted to FDA?
1.280 How must you submit prior notice?
1.281 What information must be in a prior notice?
1.282 What must you do if information changes after you have received
confirmation of a prior notice from FDA?
Consequences
1.283 What happens to food that is imported or offered for import
without adequate prior notice?
1.284 What are the other consequences of failing to submit adequate
prior notice or otherwise failing to comply with this subpart?
1.285 What happens to food that is imported or offered for import from
unregistered facilities that are required to register under 21
CFR part 1, subpart H?
Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21
U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355, 360b,
362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262, 264.
Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.
Subpart A_General Provisions
Sec. 1.1 General.
(a) The provisions of regulations promulgated under the Federal
Food, Drug, and Cosmetic Act with respect to the doing of any act shall
be applicable
[[Page 6]]
also to the causing of such act to be done.
(b) The definitions and interpretations of terms contained in
section 201 of the Federal Food, Drug, and Cosmetic Act shall be
applicable also to such terms when used in regulations promulgated under
that act.
(c) The definition of package in Sec. 1.20 and of principal display
panel in Sec. Sec. 101.1, 201.60, 501.1, 701.10 and 801.60 of this
chapter; and the requirements pertaining to uniform location, lack of
qualification, and separation of the net quantity declaration in
Sec. Sec. 101.105(f), 201.62(e), 501.105(f), 701.13(f) and 801.62(e) of
this chapter to type size requirements for net quantity declaration in
Sec. Sec. 101.105(i), 201.62(h), 501.105(i), 701.13(i) and 801.62(h) of
this chapter, to initial statement of ounces in the dual declaration of
net quantity in Sec. Sec. 101.105(j) and (m), 201.62(i) and (k),
501.105(j) and (m), 701.13(j) and (m) and 801.62(i) and (k) of this
chapter, to initial statement of inches in declaration of net quantity
in Sec. Sec. 201.62(m), 701.13(o) and 801.62(m) of this chapter, to
initial statement of square inches in declaration of net quantity in
Sec. Sec. 201.62(n), 701.13(p) and 801.62(n) of this chapter, to
prohibition of certain supplemental net quantity statements in
Sec. Sec. 101.105(o), 201.62(o), 501.105(o), 701.13(q) and 801.62(o) of
this chapter, and to servings representations in Sec. 501.8 of this
chapter are provided for solely by the Fair Packaging and Labeling Act.
The other requirements of this part are issued under both the Fair
Packaging and Labeling Act and the Federal Food, Drug, and Cosmetic Act,
or by the latter act solely, and are not limited in their application by
section 10 of the Fair Packaging and Labeling Act.
[42 FR 15553, Mar. 22, 1977, as amended at 58 FR 17085, Apr. 1, 1993]
Sec. 1.3 Definitions.
(a) Labeling includes all written, printed, or graphic matter
accompanying an article at any time while such article is in interstate
commerce or held for sale after shipment or delivery in interstate
commerce.
(b) Label means any display of written, printed, or graphic matter
on the immediate container of any article, or any such matter affixed to
any consumer commodity or affixed to or appearing upon a package
containing any consumer commodity.
Sec. 1.4 Authority citations.
(a) For each part of its regulations, the Food and Drug
Administration includes a centralized citation of all of the statutory
provisions that provide authority for any regulation that is included in
that part.
(b) The agency may rely on any one or more of the authorities that
are listed for a particular part in implementing or enforcing any
section in that part.
(c) All citations of authority in this chapter will list the
applicable sections in the organic statute if the statute is the Federal
Food, Drug, and Cosmetic Act, the Public Health Service Act, or the Fair
Packaging and Labeling Act. References to an act or a section thereof
include references to amendments to that act or section. These citations
will also list the corresponding United States Code (U.S.C.) sections.
For example, a citation to section 701 of the Federal Food, Drug, and
Cosmetic Act would be listed: Sec. 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371).
(d) If the organic statute is one other than those specified in
paragraph (c) of this section, the citations of authority in this
chapter generally will list only the applicable U.S.C. sections. For
example, a citation to section 552 of the Administrative Procedure Act
would be listed: 5 U.S.C. 552. The agency may, where it determines that
such measures are in the interest of clarity and public understanding,
list the applicable sections in the organic statute and the
corresponding U.S.C. section in the same manner set out in paragraph (c)
of this section. References to an act or a section thereof include
references to amendments to that act or section.
(e) Where there is no U.S.C. provision, the agency will include a
citation to the U.S. Statutes at Large. Citations to the U.S. Statutes
at Large will refer to volume and page.
(f) The authority citations will include a citation to executive
delegations (i.e., Executive Orders), if any,
[[Page 7]]
necessary to link the statutory authority to the agency.
[54 FR 39630, Sept. 27, 1989]
Subpart B_General Labeling Requirements
Sec. 1.20 Presence of mandatory label information.
The term package means any container or wrapping in which any food,
drug, device, or cosmetic is enclosed for use in the delivery or display
of such commodities to retail purchasers, but does not include:
(a) Shipping containers or wrappings used solely for the
transportation of any such commodity in bulk or in quantity to
manufacturers, packers, processors, or wholesale or retail distributors;
(b) Shipping containers or outer wrappings used by retailers to ship
or deliver any such commodity to retail customers if such containers and
wrappings bear no printed matter pertaining to any particular commodity;
or
(c) Containers subject to the provisions of the Act of August 3,
1912 (37 Stat. 250, as amended; 15 U.S.C. 231-233), the Act of March 4,
1915 (38 Stat. 1186, as amended; 15 U.S.C. 234-236), the Act of August
31, 1916 (39 Stat. 673, as amended; 15 U.S.C. 251-256), or the Act of
May 21, 1928 (45 Stat. 635, as amended; 15 U.S.C. 257-257i).
(d) Containers used for tray pack displays in retail establishments.
(e) Transparent wrappers or containers which do not bear written,
printed, or graphic matter obscuring the label information required by
this part.
A requirement contained in this part that any word, statement, or other
information appear on the label shall not be considered to be complied
with unless such word, statement, or information also appears on the
outer container or wrapper of the retail package of the article, or, as
stated in paragraph (e) of this section, such information is easily
legible by virtue of the transparency of the outer wrapper or container.
Where a consumer commodity is marketed in a multiunit retail package
bearing the mandatory label information as required by this part and the
unit containers are not intended to be sold separately, the net weight
placement requirement of Sec. 101.105(f) applicable to such unit
containers is waived if the units are in compliance with all the other
requirements of this part.
Sec. 1.21 Failure to reveal material facts.
(a) Labeling of a food, drug, device, or cosmetic shall be deemed to
be misleading if it fails to reveal facts that are:
(1) Material in light of other representations made or suggested by
statement, word, design, device or any combination thereof; or
(2) Material with respect to consequences which may result from use
of the article under: (i) The conditions prescribed in such labeling or
(ii) such conditions of use as are customary or usual.
(b) Affirmative disclosure of material facts pursuant to paragraph
(a) of this section may be required, among other appropriate regulatory
procedures, by
(1) Regulations in this chapter promulgated pursuant to section
701(a) of the act; or
(2) Direct court enforcement action.
(c) Paragraph (a) of this section does not:
(1) Permit a statement of differences of opinion with respect to
warnings (including contraindications, precautions, adverse reactions,
and other information relating to possible product hazards) required in
labeling for food, drugs, devices, or cosmetics under the act.
(2) Permit a statement of differences of opinion with respect to the
effectiveness of a drug unless each of the opinions expressed is
supported by substantial evidence of effectiveness as defined in
sections 505(d) and 512(d) of the act.
Sec. 1.23 Procedures for requesting variations and exemptions from
required label statements.
Section 403(e) of the act (in this part 1, the term act means the
Federal Food, Drug, and Cosmetic Act) provides for the establishment by
regulation of reasonable variations and exemptions for small packages
from the required declaration of net quantity of
[[Page 8]]
contents. Section 403(i) of the act provides for the establishment by
regulation of exemptions from the required declaration of ingredients
where such declaration is impracticable, or results in deception or
unfair competition. Section 502(b) of the act provides for the
establishment by regulation of reasonable variations and exemptions for
small packages from the required declaration of net quantity of
contents. Section 602(b) of the act provides for the establishment by
regulation of reasonable variations and exemptions for small packages
from the required declaration of net quantity of contents. Section 5(b)
of the Fair Packaging and Labeling Act provides for the establishment by
regulation of exemptions from certain required declarations of net
quantity of contents, identity of commodity, identity and location of
manufacturer, packer, or distributor, and from declaration of net
quantity of servings represented, based on a finding that full
compliance with such required declarations is impracticable or not
necessary for the adequate protection of consumers, and a further
finding that the nature, form, or quantity of the packaged consumer
commodity or other good and sufficient reasons justify such exemptions.
The Commissioner, on his own initiative or on petition of an interested
person, may propose a variation or exemption based upon any of the
foregoing statutory provisions, including proposed findings if section
5(b) of the Fair Packaging and Labeling Act applies, pursuant to parts
10, 12, 13, 14, 15, 16, and 19 of this chapter.
Sec. 1.24 Exemptions from required label statements.
The following exemptions are granted from label statements required
by this part:
(a) Foods. (1) While held for sale, a food shall be exempt from the
required declaration of net quantity of contents specified in this part
if said food is received in bulk containers at a retail establishment
and is accurately weighed, measured, or counted either within the view
of the purchaser or in compliance with the purchaser's order.
(2) Random food packages, as defined in Sec. 101.105(j) of this
chapter, bearing labels declaring net weight, price per pound or per
specified number of pounds, and total price shall be exempt from the
type size, dual declaration, and placement requirements of Sec. 101.105
of this chapter if the accurate statement of net weight is presented
conspicuously on the principal display panel of the package. In the case
of food packed in random packages at one place for subsequent shipment
and sale at another, the price sections of the label may be left blank
provided they are filled in by the seller prior to retail sale. This
exemption shall also apply to uniform weight packages of cheese and
cheese products labeled in the same manner and by the same type of
equipment as random food packages exempted by this paragraph (a)(2)
except that the labels shall bear a declaration of price per pound and
not price per specified number of pounds.
(3) Individual serving-size packages of foods containing less than
\1/2\ ounce or less than \1/2\ fluid ounce for use in restaurants,
institutions, and passenger carriers, and not intended for sale at
retail, shall be exempt from the required declaration of net quantity of
contents specified in this part.
(4) Individually wrapped pieces of penny candy and other
confectionery of less than one-half ounce net weight per individual
piece shall be exempt from the labeling requirements of this part when
the container in which such confectionery is shipped is in conformance
with the labeling requirements of this part. Similarly, when such
confectionery items are sold in bags or boxes, such items shall be
exempt from the labeling requirements of this part, including the
required declaration of net quantity of contents specified in this part
when the declaration on the bag or box meets the requirements of this
part.
(5)(i) Soft drinks packaged in bottles shall be exempt from the
placement requirements for the statement of identity prescribed by Sec.
101.3 (a) and (d) of this chapter if such statement appears
conspicuously on the bottle closure. When such soft drinks are marketed
in a multiunit retail package, the multiunit retail package shall be
exempt from the statement of identity declaration requirements
prescribed by Sec. 101.3
[[Page 9]]
of this chapter if the statement of identity on the unit container is
not obscured by the multiunit retail package.
(ii) A multiunit retail package for soft drinks shall be exempt from
the declaration regarding name and place of business required by Sec.
101.5 of this chapter if the package does not obscure the declaration on
unit containers or if it bears a statement that the declaration can be
found on the unit containers and the declaration on the unit containers
complies with Sec. 101.5 of this chapter. The declaration required by
Sec. 101.5 of this chapter may appear on the top or side of the closure
of bottled soft drinks if the statement is conspicuous and easily
legible.
(iii) Soft drinks packaged in bottles which display other required
label information only on the closure shall be exempt from the placement
requirements for the declaration of contents prescribed by Sec.
101.105(f) of this chapter if the required content declaration is blown,
formed, or molded into the surface of the bottle in close proximity to
the closure.
(iv) Where a trademark on a soft drink package also serves as, or
is, a statement of identity, the use of such trademark on the package in
lines not parallel to the base on which the package rests shall be
exempted from the requirement of Sec. 101.3(d) of this chapter that the
statement be in lines parallel to the base so long as there is also at
least one statement of identity in lines generally parallel to the base.
(v) A multiunit retail package for soft drinks in cans shall be
exempt from the declaration regarding name and place of business
required by Sec. 101.5 of this chapter if the package does not obscure
the declaration on unit containers or if it bears a statement that the
declaration can be found on the unit containers and the declaration on
the unit containers complies with Sec. 101.5 of this chapter. The
declaration required by Sec. 101.5 of this chapter may appear on the
top of soft drinks in cans if the statement is conspicuous and easily
legible, provided that when the declaration is embossed, it shall appear
in type size at least one-eighth inch in height, or if it is printed,
the type size shall not be less than one-sixteenth inch in height. The
declaration may follow the curvature of the lid of the can and shall not
be removed or obscured by the tab which opens the can.
(6)(i) Ice cream, french ice cream, ice milk, fruit sherbets, water
ices, quiescently frozen confections (with or without dairy
ingredients), special dietary frozen desserts, and products made in
semblance of the foregoing, when measured by and packaged in \1/2\-
liquid pint and \1/2\-gallon measure-containers, as defined in the
``Measure Container Code of National Bureau of Standards Handbook 44,''
Specifications, Tolerances, and Other Technical Requirements for
Weighing and Measuring Devices, Sec. 4.45 ``Measure-Containers,'' which
is incorporated by reference, are exempt from the requirements of Sec.
101.105(b)(2) of this chapter to the extent that net contents of 8-fluid
ounces and 64-fluid ounces (or 2 quarts) may be expressed as \1/2\ pint
and \1/2\ gallon, respectively. Copies are available from the Center for
Food Safety and Applied Nutrition (HFS-150), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street NW., suite 700, Washington, DC.
(ii) The foods named in paragraph (a)(6)(i) of this section, when
measured by and packaged in 1-liquid pint, 1-liquid quart, and \1/2\-
gallon measure-containers, as defined in the ``Measure Container Code of
National Bureau of Standards Handbook 44,'' Specifications, Tolerances,
and Other Technical Requirements for Weighing and Measuring Devices,
Sec. 4.45 ``Measure-Containers,'' which is incorporated by reference,
are exempt from the dual net-contents declaration requirement of Sec.
101.105(j) of this chapter. Copies are available from the Center for
Food Safety and Applied Nutrition (HFS-150), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street NW., suite 700, Washington, DC.
(iii) The foods named in paragraph (a)(6)(i) of this section, when
measured by and packaged in \1/2\-liquid pint, 1-liquid pint, 1-liquid
quart, \1/2\-gallon, and 1-gallon measured-containers, as defined in the
``Measure Container Code
[[Page 10]]
of National Bureau of Standards Handbook 44,'' Specifications,
Tolerances, and Other Technical Requirements for Weighing and Measuring
Devices, Sec. 4.45 ``Measure-Containers,'' which is incorporated by
reference, are exempt from the requirement of Sec. 101.105(f) of this
chapter that the declaration of net contents be located within the
bottom 30 percent of the principal display panel. Copies are available
from the Center for Food Safety and Applied Nutrition (HFS-150), Food
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street NW., suite 700, Washington, DC.
(7)(i) Milk, cream, light cream, coffee or table cream, whipping
cream, light whipping cream, heavy or heavy whipping cream, sour or
cultured sour cream, half-and-half, sour or cultured half-and-half,
reconstituted or recombined milk and milk products, concentrated milk
and milk products, skim or skimmed milk, vitamin D milk and milk
products, fortified milk and milk products, homogenized milk, flavored
milk and milk products, buttermilk, cultured buttermilk, cultured milk
or cultured whole buttermilk, low-fat milk (0.5 to 2.0 percent
butterfat), and acidified milk and milk products, when packaged in
containers of 8- and 64-fluid-ounce capacity, are exempt from the
requirements of Sec. 101.105(b)(2) of this chapter to the extent that
net contents of 8 fluid ounces and 64 fluid ounces (or 2 quarts) may be
expressed as \1/2\ pint and \1/2\ gallon, respectively.
(ii) The products listed in paragraph (a)(7)(i) of this section,
when packaged in glass or plastic containers of \1/2\-pint, 1-pint, 1-
quart, \1/2\-gallon, and 1-gallon capacities are exempt from the
placement requirement of Sec. 101.105(f) of this chapter that the
declaration of net contents be located within the bottom 30 percent of
the principal display panel, provided that other required label
information is conspicuously displayed on the cap or outside closure and
the required net quantity of contents declaration is conspicuously
blown, formed, or molded into or permanently applied to that part of the
glass or plastic container that is at or above the shoulder of the
container.
(iii) The products listed in paragraph (a)(7)(i) of this section,
when packaged in containers of 1-pint, 1-quart, and \1/2\-gallon
capacities are exempt from the dual net-contents declaration requirement
of Sec. 101.105(j) of this chapter.
(8) Wheat flour products, as defined by Sec. Sec. 137.105, 137.155,
137.160, 137.165, 137.170, 137.175, 137.180, 137.185, 137.200, and
137.205 of this chapter, packaged:
(i) In conventional 2-, 5-, 10-, 25-, 50-, and 100-pound packages
are exempt from the placement requirement of Sec. 101.105(f) of this
chapter that the declaration of net contents be located within the
bottom 30 percent of the area of the principal display panel of the
label; and
(ii) In conventional 2-pound packages are exempt from the dual net-
contents declaration requirement of Sec. 101.105(j) of this chapter
provided the quantity of contents is expressed in pounds.
(9)(i) Twelve shell eggs packaged in a carton designed to hold 1
dozen eggs and designed to permit the division of such carton by the
retail customer at the place of purchase into two portions of one-half
dozen eggs each are exempt from the labeling requirements of this part
with respect to each portion of such divided carton if the carton, when
undivided, is in conformance with the labeling requirements of this
part.
(ii) Twelve shell eggs packaged in a carton designed to hold 1 dozen
eggs are exempt from the placement requirements for the declaration of
contents prescribed by Sec. 101.105(f) of this chapter if the required
content declaration is otherwise placed on the principal display panel
of such carton and if, in the case of such cartons designed to permit
division by retail customers into two portions of one-half dozen eggs
each, the required content declaration is placed on the principal
display panel in such a manner that the context of the content
declaration is destroyed upon division of the carton.
(10) Butter as defined in 42 Stat. 1500 (excluding whipped butter):
(i) In 8-ounce and in 1-pound packages is exempt from the
requirements of Sec. 101.105(f) of this chapter that the net contents
declaration be placed
[[Page 11]]
within the bottom 30 percent of the area of the principal display panel;
(ii) In 1-pound packages is exempt from the requirements of Sec.
101.105(j)(1) of this chapter that such declaration be in terms of
ounces and pounds, to permit declaration of ``1-pound'' or ``one
pound''; and
(iii) In 4-ounce, 8-ounce, and 1-pound packages with continuous
label copy wrapping is exempt from the requirements of Sec. Sec. 101.3
and 101.105(f) of this chapter that the statement of identity and net
contents declaration appear in lines generally parallel to the base on
which the package rests as it is designed to be displayed, provided that
such statement and declaration are not so positioned on the label as to
be misleading or difficult to read as the package is customarily
displayed at retail.
(11) Margarine as defined in Sec. 166.110 of this chapter and
imitations thereof in 1-pound rectangular packages, except for packages
containing whipped or soft margarine or packages that contain more than
four sticks, are exempt from the requirement of Sec. 101.105(f) of this
chapter that the declaration of the net quantity of contents appear
within the bottom 30 percent of the principal display panel and from the
requirement of Sec. 101.105(j)(1) of this chapter that such declaration
be expressed both in ounces and in pounds to permit declaration of ``1-
pound'' or ``one pound,'' provided an accurate statement of net weight
appears conspicuously on the principal display panel of the package.
(12) Corn flour and related products, as they are defined by
Sec. Sec. 137.211, 137.215, and Sec. Sec. 137.230 through 137.290 of
this chapter, packaged in conventional 5-, 10-, 25-, 50-, and 100-pound
bags are exempt from the placement requirement of Sec. 101.105(f) of
this chapter that the declaration of net contents be located within the
bottom 30 percent of the area of the principal display panel of the
label.
(13)(i) Single strength and less than single strength fruit juice
beverages, imitations thereof, and drinking water when packaged in glass
or plastic containers of \1/2\-pint, 1-pint, 1-quart, \1/2\-gallon, and
1-gallon capacities are exempt from the placement requirement of Sec.
101.105(f) of this chapter that the declaration of net contents be
located within the bottom 30 percent of the principal display panel:
Provided, That other required label information is conspicuously
displayed on the cap or outside closure and the required net quantity of
contents declaration is conspicuously blown, formed, or molded into or
permanently applied to that part of the glass or plastic container that
is at or above the shoulder of the container.
(ii) Single strength and less than single strength fruit juice
beverages, imitations thereof, and drinking water when packaged in
glass, plastic, or paper (fluid milk type) containers of 1-pint, 1-
quart, and \1/2\-gallon capacities are exempt from the dual net-contents
declaration requirement of Sec. 101.105(j) of this chapter.
(iii) Single strength and less than single strength fruit juice
beverages, imitations thereof, and drinking water when packaged in
glass, plastic, or paper (fluid milk type) containers of 8- and 64-
fluid-ounce capacity, are exempt from the requirements of Sec.
101.105(b)(2) of this chapter to the extent that net contents of 8 fluid
ounces and 64 fluid ounces (or 2 quarts) may be expressed as \1/2\ pint
(or half pint) and \1/2\ gallon (or half gallon), respectively.
(14) The unit containers in a multiunit or multicomponent retail
food package shall be exempt from regulations of section 403 (e)(1),
(g)(2), (i)(2), (k), and (q) of the act with respect to the requirements
for label declaration of the name and place of business of the
manufacturer, packer, or distributor; label declaration of ingredients;
and nutrition information when:
(i) The multiunit or multicomponent retail food package labeling
meets all the requirements of this part;
(ii) The unit containers are securely enclosed within and not
intended to be separated from the retail package under conditions of
retail sale; and
(iii) Each unit container is labeled with the statement ``This Unit
Not Labeled For Retail Sale'' in type size not less than one-sixteenth
of an inch in height. The word ``Individual'' may be used in lieu of or
immediately preceding the word ``Retail'' in the statement.
[[Page 12]]
(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]
Subparts C-D [Reserved]
Subpart E_Imports and Exports
Sec. 1.83 Definitions.
For the purposes of regulations prescribed under section 801(a),
(b), and (c) of the Federal Food, Drug, and Cosmetic Act:
(a) The term owner or consignee means the person who has the rights
of a consignee under the provisions of sections 483, 484, and 485 of the
Tariff Act of 1930, as amended (19 U.S.C. 1483, 1484, 1485).
(b) The term district director means the director of the district of
the Food and Drug Administration having jurisdiction over the port of
entry through which an article is imported or offered for import, or
such officer of the district as he may designate to act in his behalf in
administering and enforcing the provisions of section 801 (a), (b), and
(c).
Sec. 1.90 Notice of sampling.
When a sample of an article offered for import has been requested by
the district director, the collector of customs having jurisdiction over
the article shall give to the owner or consignee prompt notice of
delivery of, or intention to deliver, such sample. Upon receipt of the
notice, the owner or consignee shall hold such article and not
distribute it until further notice from the district director or the
collector of customs of the results of examination of the sample.
Sec. 1.91 Payment for samples.
The Food and Drug Administration will pay for all import samples
which are found to be in compliance with the requirements of the Federal
Food, Drug, and Cosmetic Act. Billing for reimbursement should be made
by the owner or consignee to the Food and Drug Administration district
headquarters in whose territory the shipment was offered for import.
Payment for samples will not be made if the article is found to be in
violation of the act, even though subsequently brought into compliance
under the terms of an authorization to bring the article into compliance
or rendered not a food, drug, device, or cosmetic as set forth in Sec.
1.95.
Sec. 1.94 Hearing on refusal of admission.
(a) If it appears that the article may be subject to refusal of
admission, the district director shall give the owner or consignee a
written notice to that effect, stating the reasons therefor. The notice
shall specify a place and a period of time during which the owner or
consignee shall have an opportunity to introduce testimony. Upon timely
request giving reasonable grounds therefor, such time and place may be
changed. Such testimony shall be confined to matters relevant to the
admissibility of the article, and may be introduced orally or in
writing.
[[Page 13]]
(b) If such owner or consignee submits or indicates his intention to
submit an application for authorization to relabel or perform other
action to bring the article into compliance with the act or to render it
other than a food, drug, device, or cosmetic, such testimony shall
include evidence in support of such application. If such application is
not submitted at or prior to the hearing, the district director shall
specify a time limit, reasonable in the light of the circumstances, for
filing such application.
Sec. 1.95 Application for authorization to relabel and recondition.
Application for authorization to relabel or perform other action to
bring the article into compliance with the act or to render it other
than a food, drug, device or cosmetic may be filed only by the owner or
consignee, and shall:
(a) Contain detailed proposals for bringing the article into
compliance with the act or rendering it other than a food, drug, device,
or cosmetic.
(b) Specify the time and place where such operations will be carried
out and the approximate time for their completion.
Sec. 1.96 Granting of authorization to relabel and recondition.
(a) When authorization contemplated by Sec. 1.95 is granted, the
district director shall notify the applicant in writing, specifying:
(1) The procedure to be followed;
(2) The disposition of the rejected articles or portions thereof;
(3) That the operations are to be carried out under the supervision
of an officer of the Food and Drug Administration or the U.S. Customs
Service, as the case may be;
(4) A time limit, reasonable in the light of the circumstances, for
completion of the operations; and
(5) Such other conditions as are necessary to maintain adequate
supervision and control over the article.
(b) Upon receipt of a written request for extension of time to
complete such operations, containing reasonable grounds therefor, the
district director may grant such additional time as he deems necessary.
(c) An authorization may be amended upon a showing of reasonable
grounds therefor and the filing of an amended application for
authorization with the district director.
(d) If ownership of an article covered by an authorization changes
before the 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
[[Page 14]]
import of food, drugs, devices, or cosmetics which fails to comply with
the Federal Food, Drug, and Cosmetic Act shall be paid by the owner or
consignee who files an application requesting such action and executes a
bond, pursuant to section 801(b) of the act, as amended. The cost of
such supervision shall include, but not be restricted to, the following:
(a) Travel expenses of the supervising officer.
(b) Per diem in lieu of subsistence of the supervising officer when
away from his home station, as provided by law.
(c) The charge for the services of the supervising officer, which
shall include administrative support, shall be computed at a rate per
hour equal to 266 percent of the hourly rate of regular pay of a grade
GS-11/4 employee, except that such services performed by a customs
officer and subject to the provisions of the act of February 13, 1911,
as amended (sec. 5, 36 Stat. 901, as amended (19 U.S.C. 267)), shall be
calculated as provided in that act.
(d) The charge for the service of the analyst, which shall include
administrative and laboratory support, shall be computed at a rate per
hour equal to 266 percent of the hourly rate of regular pay of a grade
GS-12/4 employee. The rate per hour equal to 266 percent of the
equivalent hourly rate of regular pay of the supervising officer (GS-11/
4) and the analyst (GS-12/4) is computed as follows:
Hours
Gross number of working hours in 52 40-hr weeks................ 2,080
Less:
9 legal public holidays--New Years Day, Washington's 72
Birthday, Memorial Day, Independence Day, Labor Day,
Columbus Day, Veterans Day, Thanksgiving Day, and Christmas
Day.........................................................
Annual leave--26 d........................................... 208
Sick leave--13 d............................................. 104
--------
Total.................................................... 384
Net number of working hours.............................. 1,696
Gross number of working hours in 52 40-hr weeks................ 2,080
Working hour equivalent of Government contributions for 176
employee retirement, life insurance, and health benefits
computed at 8\1/2\ pct. of annual rate of pay of employee.....
--------
Equivalent annual working hours.......................... 2,256
--------
Support required to equal to 1 man-year........................ 2,256
Equivalent gross annual working hours charged to Food and 4,512
Drug appropriation......................................
Note: Ratio of equivalent gross annual number of working hours
charged to Food and Drug appropriation to net number of annual working
hours 4,512/1,696=266 pct.
(e) The minimum charge for services of supervising officers and of
analysts shall be not less than the charge for 1 hour, and time after
the first hour shall be computed in multiples of 1 hour, disregarding
fractional parts less than \1/2\ hour.
Sec. 1.101 Notification and recordkeeping.
(a) Scope. This section pertains to notifications and records
required for human drug, biological product, device, animal drug, food,
and cosmetic exports under sections 801 or 802 of the Federal Food,
Drug, and Cosmetic Act (the act) or (21 U.S.C. 381 and 382) or section
351 of the Public Health Service Act (42 U.S.C. 262).
(b) Recordkeeping requirements for human drugs, biological products,
devices, animal drugs, foods, and cosmetics exported under or subject to
section 801(e)(1) of the act. Persons exporting an article under section
801(e)(1) of the act or an article otherwise subject to section
801(e)(1) of the act shall maintain records as enumerated in paragraphs
(b)(1) through (b)(4) of this section demonstrating that the product
meets the requirements of section 801(e)(1) of the act. Such records
shall be maintained for the same period of time as required for records
subject to good manufacturing practice or quality systems regulations
applicable to the product, except that records pertaining to the export
of foods and cosmetics under section 801(e)(1) of the act shall be kept
for 3 years after the date of exportation. The records shall be made
available to the Food and Drug Administration (FDA), upon request,
during an inspection for review and copying by FDA.
(1) Records demonstrating that the product meets the foreign
purchaser's specifications: The records must contain sufficient
information to match the foreign purchaser's specifications to a
particular export;
(2) Records demonstrating that the product does not conflict with
the laws of the importing country: This may consist of either a letter
from an appropriate foreign government agency,
[[Page 15]]
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:
(1) Records demonstrating that the product for export is a partially
processed biological product and not in a form applicable to the
prevention, treatment, or cure of diseases or injuries of man;
(2) Records demonstrating that the partially processed biological
product was manufactured in conformity with current good manufacturing
practice requirements;
(3) Records demonstrating the distribution of the exported partially
processed biological products; and
(4) Copies of all labeling that accompanies the exported partially
processed biological product and other records demonstrating that the
exported partially processed biological product is intended for further
manufacture into a final dosage form outside the United States; this may
include a container label with the statement, ``Caution: For Further
Manufacturing Use Only'' and any package insert.
(d) Notification requirements for drugs, biological products, and
devices exported under section 802 of the act. (1) Persons exporting a
human drug, biological product, or device under section 802 of the act,
other than a drug, biological product, or device for investigational use
exported under section 802(c) of the act, or a drug, biological product,
or device exported in anticipation of marketing authorization under
section 802(d) of the act, shall provide written notification to FDA.
The notification shall identify:
(i) The product's trade name;
(ii) If the product is a drug or biological product, the product's
abbreviated or proper name or, if the product is a device, the type of
device;
(iii) If the product is a drug or biological product, a description
of the product's strength and dosage form or, if the product is a
device, the product's model number; and
(iv) If the export is to a country not listed in section 802(b)(1)
of the act, the country that is to receive the exported article. The
notification may, but is not required to, identify countries listed in
section 802(b)(1) of the act or state that the export is intended for a
listed country without identifying the listed country.
(2) The notification shall be sent to the following addresses:
(i) For biological products and devices regulated by the Center for
Biologics Evaluation and Research--Division of Case Management (HFM-
610), Office of Compliance and Biologics Quality, Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, rm. 200N, Rockville, MD 20852-1448;
(ii) For human drug products--Division of Labeling and
Nonprescription Drug Compliance (HFD-310), Center for Drug Evaluation
and Research, Food
[[Page 16]]
and Drug Administration, 7520 Standish Pl., Rockville, MD 20855-2737;
(iii) For devices--Division of Program Operations (HFZ-305), Center
for Devices and Radiological Health, Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850.
(e) Recordkeeping requirements for products subject to section
802(g) of the act. (1) Any person exporting a product under any
provision of section 802 of the act shall maintain records of all drugs,
biological products, and devices exported and the countries to which the
products were exported. In addition to the requirements in paragraph (b)
of this section, such records include, but are not limited to, the
following:
(i) The product's trade name;
(ii) If the product is a drug or biological product, the product's
abbreviated or proper name or, if the product is a device, the type of
device;
(iii) If the product is a drug or biological product, a description
of its strength and dosage form and the product's lot or control number
or, if the product is a device, the product's model number;
(iv) The consignee's name and address; and
(v) The date on which the product was exported and the quantity of
product exported.
(2) These records shall be kept at the site from which the products
were exported or manufactured, and be maintained for the same period of
time as required for records subject to good manufacturing practice or
quality systems regulations applicable to the product. The records shall
be made available to FDA, upon request, during an inspection for review
and copying by FDA.
[66 FR 65447, Dec. 19, 2001]
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
[[Page 17]]
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?
(a) The act means the Federal Food, Drug, and Cosmetic Act.
(b) In addition, for the purposes of this subpart:
(1) Calendar day means every day shown on the calendar.
(2) Facility means any establishment, structure, or structures under
one ownership at one general physical location, or, in the case of a
mobile facility, traveling to multiple locations, that manufactures/
processes, packs, or holds food for consumption in the United States.
Transport vehicles are not facilities if they hold food only in the
usual course of business as carriers. A facility may consist of one or
more contiguous structures, and a single building may house more than
one distinct facility if the facilities are under separate ownership.
The private residence of an individual is not a facility. Nonbottled
water drinking water collection and distribution establishments and
their structures are not facilities.
(i) Domestic facility means any facility located in any State or
Territory of the United States, the District of Columbia, or the
Commonwealth of Puerto Rico that manufactures/processes, packs, or holds
food for consumption in the United States.
(ii) Foreign facility means a facility other than a domestic
facility that manufactures/processes, packs, or holds food for
consumption in the United States.
(3) Farm means a facility in one general physical location devoted
to the growing and harvesting of crops, the raising of animals
(including seafood), or both. Washing, trimming of outer leaves of, and
cooling produce are considered part of harvesting. The term ``farm''
includes:
(i) Facilities that pack or hold food, provided that all food used
in such activities is grown, raised, or consumed on that farm or another
farm under the same ownership; and
(ii) Facilities that manufacture/process food, provided that all
food used in such activities is consumed on that farm or another farm
under the same ownership.
(4) Food has the meaning given in section 201(f) of the act (21
U.S.C. 321(f)),
(i) Except for purposes of this subpart, it does not include:
(A) Food contact substances as defined in section 409(h)(6) of the
act (21 U.S.C. 348(h)(6)), or
(B) Pesticides as defined in 7 U.S.C. 136(u).
(ii) Examples of food include fruits, vegetables, fish, dairy
products, eggs, raw agricultural commodities for use as food or as
components of food, animal feed (including pet food), food and feed
ingredients, food and feed additives, dietary supplements and dietary
ingredients, infant formula, beverages (including alcoholic beverages
and bottled water), live food animals, bakery goods, snack foods, candy,
and canned foods.
(5) Holding means storage of food. Holding facilities include
warehouses, cold storage facilities, storage silos, grain elevators, and
liquid storage tanks.
(6) Manufacturing/processing means making food from one or more
ingredients, or synthesizing, preparing, treating, modifying or
manipulating food, including food crops or ingredients. Examples of
manufacturing/processing activities are cutting, peeling, trimming,
washing, waxing, eviscerating, rendering, cooking, baking, freezing,
cooling, pasteurizing, homogenizing, mixing, formulating, bottling,
milling, grinding, extracting juice, distilling, labeling, or packaging.
(7) Nonprofit food establishment means a charitable entity that
prepares or serves food directly to the consumer or otherwise provides
food or meals for consumption by humans or animals in the United States.
The term includes central food banks, soup kitchens, and nonprofit food
delivery services. To be
[[Page 18]]
considered a nonprofit food establishment, the establishment must meet
the terms of section 501(c)(3) of the U.S. Internal Revenue Code (26
U.S.C. 501(c)(3)).
(8) Packaging (when used as a verb) means placing food into a
container that directly contacts the food and that the consumer
receives.
(9) Packing means placing food into a container other than packaging
the food.
(10) Restaurant means a facility that prepares and sells food
directly to consumers for immediate consumption. ``Restaurant'' does not
include facilities that provide food to interstate conveyances, central
kitchens, and other similar facilities that do not prepare and serve
food directly to consumers.
(i) Entities in which food is provided to humans, such as
cafeterias, lunchrooms, cafes, bistros, fast food establishments, food
stands, saloons, taverns, bars, lounges, catering facilities, hospital
kitchens, day care kitchens, and nursing home kitchens are restaurants;
and
(ii) Pet shelters, kennels, and veterinary facilities in which food
is provided to animals are restaurants.
(11) Retail food establishment means an establishment that sells
food products directly to consumers as its primary function. A retail
food establishment may manufacture/process, pack, or hold food if the
establishment's primary function is to sell from that establishment
food, including food that it manufactures/processes, packs, or holds,
directly to consumers. A retail food establishment's primary function is
to sell food directly to consumers if the annual monetary value of sales
of food products directly to consumers exceeds the annual monetary value
of sales of food products to all other buyers. The term ``consumers''
does not include businesses. A ``retail food establishment'' includes
grocery stores, convenience stores, and vending machine locations.
(12) Trade name means the name or names under which the facility
conducts business, or additional names by which the facility is known. A
trade name is associated with a facility, and a brand name is associated
with a product.
(13) U.S. agent means a person (as defined in section 201(e) of the
act (21 U.S.C. 321(e))) residing or maintaining a place of business in
the United States whom a foreign facility designates as its agent for
purposes of this subpart. A U.S. agent cannot be in the form of a
mailbox, answering machine or service, or other place where an
individual acting as the foreign facility's agent is not physically
present.
(i) The U.S. agent acts as a communications link between FDA and the
foreign facility for both emergency and routine communications. The U.S.
agent will be the person FDA contacts when an emergency occurs, unless
the registration specifies under Sec. 1.233(e) another emergency
contact.
(ii) FDA will treat representations by the U.S. agent as those of
the foreign facility, and will consider information or documents
provided to the U.S. agent the equivalent of providing the information
or documents to the foreign facility.
(iii) Having a single U.S. agent for the purposes of this subpart
does not preclude facilities from having multiple agents (such as
foreign suppliers) for other business purposes. A firm's commercial
business in the United States need not be conducted through the U.S.
agent designated for purposes of this subpart.
(14) You or registrant means the owner, operator, or agent in charge
of a facility that manufactures/processes, packs, or holds food for
consumption in the United States.
Procedures for Registration of Food Facilities
Sec. 1.230 When must you register?
The owner, operator, or agent in charge of a facility that
manufactures/processes, packs or holds food for consumption in the
United States must register the facility no later than December 12,
2003. The owner, operator, or agent in charge of a facility that begins
to manufacture/process, pack, or hold food for consumption in the United
States on or after December 12, 2003, must register before the facility
[[Page 19]]
begins such activities. An owner, operator, or agent in charge of a
facility may authorize an individual to register the facility on its
behalf.
Sec. 1.231 How and where do you register?
(a) Electronic registration. (1) To register electronically, you
must register at http://www.fda.gov/furls, which is available for
registration 24 hours a day, 7 days a week. This website is available
from wherever the Internet is accessible, including libraries, copy
centers, schools, and Internet cafes. An individual authorized by the
owner, operator, or agent in charge of a facility may also register a
facility electronically.
(2) FDA strongly encourages electronic registration for the benefit
of both FDA and the registrant.
(3) Once you complete your electronic registration, FDA will
automatically provide you with an electronic confirmation of
registration and a permanent registration number.
(4) You will be considered registered once FDA electronically
transmits your confirmation and registration number.
(b) Registration by mail or fax. If, for example, you do not have
reasonable access to the Internet through any of the methods described
in paragraph (a) of this section, you may register by mail or fax.
(1) You must register using Form 3537. You may obtain a copy of this
form by writing to the U.S. Food and Drug Administration (HFS-681), 5600
Fishers Lane, Rockville, MD 20857 or by requesting the form by phone at
1-877-FDA-3882 (1-877-332-3882).
(2) When you receive the form, you must fill it out completely and
legibly and either mail it to the address in paragraph (b)(1) of this
section or fax it to 301-210-0247.
(3) If any required information on the form is incomplete or
illegible when FDA receives it, FDA will return the form to you for
revision, provided that your mailing address or fax number is legible
and valid. When returning a registration form for revision, FDA will use
the means by which the form was received by the agency (i.e., by mail or
fax).
(4) FDA will enter complete and legible mailed and faxed
registration submissions into its registration system, along with CD-ROM
submissions, as soon as practicable, in the order FDA receives them.
(5) FDA will then mail to the address or fax to the fax number on
the registration form a copy of the registration as entered,
confirmation of registration, and your registration number. When
responding to a registration submission, FDA will use the means by which
the registration was received by the agency (i.e., by mail or fax).
(6) If any information you previously submitted was incorrect at the
time of submission, you must immediately update your facility's
registration as specified in Sec. 1.234.
(7) Your facility is considered registered once FDA enters your
facility's registration data into the registration system and the system
generates a registration number.
(c) Registration by CD-ROM for multiple submissions. If, for
example, you do not have reasonable access to the Internet through any
of the methods provided under paragraph (a) of this section, you may
register by CD-ROM.
(1) Registrants submitting their registrations in CD-ROM format must
use ISO 9660 (CD-R or CD-RW) data format.
(2) These files must be submitted on a portable document format
(PDF) rendition of the registration form (Form 3537) and be accompanied
by one signed copy of the certification statement that appears on the
registration form (Form 3537).
(3) Each submission on the CD-ROM must contain the same preferred
mailing address in the appropriate block on Form 3537.
(4) A CD-ROM may contain registrations for as many facilities as
needed up to the CD-ROM's capacity.
(5) The registration on the CD-ROM for each separate facility must
have a unique file name up to 32 characters long, the first part of
which may be used to identify the parent company.
(6) You must mail the CD-ROM to the U.S. Food and Drug
Administration (HFS-681), 5600 Fishers Lane, Rockville, MD 20857.
[[Page 20]]
(7) If FDA receives a CD-ROM that does not comply with these
specifications, it will return the CD-ROM to the submitter unprocessed.
(8) FDA will enter CD-ROM submissions that comply with these
specifications into its registration system, along with the complete and
legible mailed and faxed submissions, as soon as practicable, in the
order FDA receives them.
(9) For each facility on the CD-ROM, FDA will mail to the preferred
mailing address a copy of the registration(s) as entered, confirmation
of registration, and each facility's assigned registration number.
(10) If any information you previously submitted was incorrect at
the time of submission, you must immediately update your facility's
registration as specified in Sec. 1.234.
(11) Your facility is considered registered once FDA enters your
facility's registration data into the registration system and the system
generates a registration number.
(d) Fees. No registration fee is required.
(e) Language. You must submit all registration information in the
English language except an individual's name, the name of a company, the
name of a street, and a trade name may be submitted in a foreign
language. All information, including these items, must be submitted
using the Latin (Roman) alphabet.
Sec. 1.232 What information is required in the registration?
Each registrant must submit the following information through one of
the methods described in Sec. 1.231:
(a) The name, full address, and phone number of the facility;
(b) The name, address, and phone number of the parent company, if
the facility is a subsidiary of the parent company;
(c) For domestic and foreign facilities, the names, addresses, and
phone numbers of the owner, operator, and agent in charge.
(d) For a foreign facility, the name, address, phone number, and
emergency contact phone number of its U.S. agent (if there is no other
emergency contact designated under Sec. 1.233(c));
(e) For a domestic facility, an emergency contact phone number;
(f) All trade names the facility uses;
(g) Applicable food product categories as identified in Sec. 170.3
of this chapter, unless you check either ``most/all human food product
categories,'' according to Sec. 1.233(e), or ``none of the above
mandatory categories'' because your facility manufactures/processes,
packs, or holds a food that is not identified in Sec. 170.3 of this
chapter;
(h) The name, address, and phone number for the owner, operator, or
agent in charge;
(i) A statement in which the owner, operator, or agent in charge
certifies that the information submitted is true and accurate. If the
individual submitting the form is not the owner, operator, or agent in
charge of the facility, the registration must also include a statement
in which the individual certifies that the information submitted is true
and accurate, certifies that he/she is authorized to submit the
registration, and identifies by name, address, and telephone number, the
individual who authorized submission of the registration. Each
registration must include the name of the individual registering the
facility submitting the registration, and the individual's signature
(for the paper and CD-ROM options).
Sec. 1.233 What optional items are included in the registration form?
FDA encourages, but does not require, you to submit the following
items in your facility's registration. These data will enable FDA to
communicate more quickly with facilities that may be the target of a
terrorist threat or attack, or otherwise affected by an outbreak of
foodborne illness. This information includes:
(a) Fax number and e-mail address of the facility;
(b) Preferred mailing address, if different from that of the
facility;
(c) Fax number and e-mail address of the parent company, if the
facility is a subsidiary of the parent company;
(d) For a domestic facility, emergency contact name, title, and e-
mail address;
[[Page 21]]
(e) For a foreign facility, an emergency contact name, title, phone
number and e-mail address. FDA will consider the facility's U.S. agent
the facility's emergency contact unless the facility chooses to
designate another person to serve as an emergency contact under this
section;
(f) For a foreign facility, title, fax number, and e-mail address of
the U.S. agent;
(g) Type of activity conducted at the facility (e.g., manufacturing/
processing or holding);
(h) Food categories not identified in Sec. 170.3 of this chapter,
which are provided in Form 3537 sections 11a (e.g., infant formula,
animal byproducts and extracts) and 11b (e.g., grain products, amino
acids);
(i) Type of storage, if the facility is primarily a holding
facility;
(j) A food product category of ``most/all human food product
categories,'' if the facility manufactures/processes, packs, or holds
foods in most or all of the categories identified in Sec. 170.3 of this
chapter;
(k) Approximate dates of operation, if the facility's business is
seasonal;
(l) The fax number and e-mail address of the owner, operator, or
agent in charge; and
(m) The fax number and e-mail address of the individual who
authorized submission of the registration.
Sec. 1.234 How and when do you update your facility's registration
information?
(a) Update requirements. The owner, operator, or agent in charge
must submit an update to a facility's registration within 60 calendar
days of any change to any of the information previously submitted under
Sec. 1.232 (e.g., change of operator, agent in charge, or U.S. agent),
except a change of the owner. The owner, operator, or agent in charge
may authorize an individual to update a facility's registration.
(b) Cancellation due to ownership changes. If the reason for the
update is that the facility has a new owner, the former owner must
cancel the facility's registration as specified in Sec. 1.235 within 60
calendar days of the change and the new owner must re-register the
facility as specified in Sec. 1.231. The former owner may authorize an
individual to cancel a facility's registration.
(c) Electronic update. (1) To update your registration
electronically, you must update at http://www.fda.gov/furls.
(2) Once you complete your electronic update, FDA will automatically
provide you with an electronic confirmation of your update.
(3) Your registration will be considered updated once FDA transmits
your update confirmation, unless notified otherwise.
(d) Update by mail or fax. If, for example, you do not have
reasonable access to the Internet through any of the methods described
in Sec. 1.231(a)), you may update your facility's registration by mail
or by fax:
(1) You must update your registration using Form 3537. You may
obtain a copy of this form by writing to the U.S. Food and Drug
Administration (HFS-681), 5600 Fishers Lane, Rockville, MD 20857 or by
requesting the form by phone at 1-877-FDA-3882 (1-877-332-3882).
(2) When you receive the form, you must legibly fill out the
sections of the form reflecting your updated information and either mail
it to the address in paragraph (d)(1) of this section or fax it to 301-
210-0247.
(3) If the information on the form is incomplete or illegible when
FDA receives it, FDA will return the form to you for revision, provided
that your mailing address or fax number is legible and valid. When
returning a registration form for revision, FDA will use the means by
which the registration was received by the agency (i.e., by mail or
fax).
(4) FDA will enter complete and legible updates into its
registration system, along with CD-ROM submissions, as soon as
practicable, in the order FDA receives them.
(5) FDA will then mail to the address or fax to the fax number on
the registration form a copy of the update as entered and confirmation
of the update. When responding to an update submission, FDA will use the
means by which the form was received by the agency (i.e., by mail or
fax).
(6) If any update information you previously submitted was incorrect
at
[[Page 22]]
the time of submission, you must immediately resubmit your update.
(7) Your registration will be considered updated once FDA enters
your facility's update data into the registration system and the system
generates an update confirmation.
(e) Update by CD-ROM for multiple submissions. If, for example, you
do not have reasonable access to the Internet through any of the methods
provided under Sec. 1.231(a), you may update your facilities'
registrations by CD-ROM.
(1) Registrants submitting their updates in CD-ROM format must use
ISO 9660 (CD-R or CD-RW) data format.
(2) Update files must be submitted on a PDF rendition of FDA's
registration form (Form 3537) and be accompanied by one signed copy of
the certification statement on the registration form (Form 3537).
(3) Each submission on the CD-ROM must contain the same preferred
mailing address in the appropriate block on Form 3537.
(4) The CD-ROM may contain updates for as many facilities as needed
up to the CD-ROM's capacity.
(5) The update for each facility on the CD-ROM must have a unique
file name up to 32 characters long, the first part of which may be used
to identify the parent company.
(6) You must mail the CD-ROM to U.S. Food and Drug Administration
(HFS-681), 5600 Fishers Lane, Rockville, MD 20857.
(7) If FDA receives an update CD-ROM that does not comply with these
specifications, it will return the CD-ROM to the registrant unprocessed.
(8) FDA will enter CD-ROM update submissions into its registration
system, along with the complete and legible mailed and faxed update
submissions, as soon as practicable, in the order FDA receives them.
(9) For each facility on the CD-ROM, FDA will mail to the preferred
mailing address a copy of the update(s) as entered and confirmation of
the update.
(10) If any update information you previously submitted was
incorrect at the time of submission, you must immediately resubmit your
update.
(11) Your registration will be considered updated once FDA enters
your facility's update data into the registration system and the system
generates an update confirmation.
Sec. 1.235 How and when do you cancel your facility's registration
information?
(a) Notification of registration cancellation. A facility canceling
its registration must do so within 60 calendar days of the reason for
cancellation (e.g., facility ceases operations, ceases providing food
for consumption in the United States, or the facility is sold to a new
owner).
(b) Cancellation requirements. The cancellation of a facility's
registration must include the following information:
(1) The facility's registration number;
(2) Whether the facility is domestic or foreign;
(3) The facility name and address;
(4) The name, address, and e-mail address (if available) of the
individual submitting the cancellation; and
(5) A statement certifying that the information submitted is true
and accurate, and that the person submitting the cancellation is
authorized by the facility to cancel its registration.
(c) Electronic cancellation. (1) To cancel your registration
electronically, you must cancel at http://www.fda.gov/furls.
(2) Once you complete your electronic cancellation, FDA will
automatically provide you with an electronic confirmation of your
cancellation.
(3) Your registration will be considered cancelled once FDA
transmits your cancellation confirmation.
(d) Cancellation by mail or fax. If, for example, you do not have
reasonable access to the Internet through any of the methods described
in Sec. 1.231(a), you may cancel your facility's registration by mail
or fax.
(1) You must cancel your registration using Form 3537a. You may
obtain a copy of this form by writing to the U.S. Food and Drug
Administration (HFS-681), 5600 Fishers Lane, Rockville, MD 20857, or by
requesting the form by phone at 1-877-FDA-3882 (1-877-332-3882).
(2) When you receive the form, you must completely and legibly fill
out
[[Page 23]]
the form and either mail it to the address in paragraph (d)(1) of this
section or fax it to 301-210-0247.
(3) If the information on the form is incomplete or illegible when
FDA receives it, FDA will return the form to you for revision, provided
that your mailing address or fax number is legible and valid. When
returning a cancellation form for revision, FDA will use the means by
which the cancellation was received by the agency (i.e., by mail or
fax).
(4) FDA will enter complete and legible mailed and faxed
cancellations into its registration system, along with CD-ROM
cancellations, as soon as practicable, in the order FDA receives them.
(5) FDA will then mail to the address or fax to the fax number on
the cancellation form a copy of the cancellation as entered and
confirmation of the cancellation. When responding to a cancellation, FDA
will use the means by which the form was received by the agency (i.e.,
by mail or fax).
(6) If any information you previously submitted was incorrect at the
time of submission, you must immediately resubmit your cancellation.
(7) Your registration will be considered cancelled once FDA enters
your facility's cancellation data into the registration system and the
system generates a confirmation.
(e) Cancellation by CD-ROM for multiple submissions. If, for
example, you do not have reasonable access to the Internet through any
of the methods described in Sec. 1.231(a), you may cancel your
facilities' registrations using a CD-ROM.
(1) Registrants submitting their cancellations in CD-ROM format must
use ISO 9660 (CD-R or CD-RW) data format.
(2) Cancellation files must be submitted on a PDF rendition of the
cancellation form (Form 3537a) and be accompanied by one signed copy of
the certification statement on the cancellation form.
(3) Each submission on the CD-ROM must contain the same preferred
mailing address in the appropriate block on Form 3537.
(4) The CD-ROM may contain cancellations for as many facilities as
needed up to the CD-ROM's capacity.
(5) The cancellation for each facility on the CD-ROM must have a
unique file name up to 32 characters long, the first part of which may
be used to identify the parent company.
(6) You must mail the CD-ROM to U.S. Food and Drug Administration
(HFS-681), 5600 Fishers Lane, Rockville, MD 20857.
(7) If FDA receives a CD-ROM that does not comply with these
specifications, it will return the CD-ROM to the registrant unprocessed.
(8) FDA will enter CD-ROM submissions that meet the specifications
into its registration system, along with complete and legible mailed and
faxed submissions, as soon as practicable, in the order FDA receives
them.
(9) For each facility on the CD-ROM, FDA will mail to the preferred
mailing address a copy of the cancellation(s) as entered and
confirmation of the cancellation.
(10) If any information you previously submitted was incorrect at
the time of submission, you must immediately resubmit your cancellation.
(11) Your registration will be considered cancelled once FDA enters
your facility's cancellation data into the registration system and the
system generates a confirmation.
Additional Provisions
Sec. 1.240 What other registration requirements apply?
In addition to the requirements of this subpart, you must comply
with the registration regulations found in part 108 of this chapter,
related to emergency permit control, and any other Federal, State, or
local registration requirements that apply to your facility.
Sec. 1.241 What are the consequences of failing to register, update,
or cancel your registration?
(a) Section 301 of the act (21 U.S.C. 331) prohibits the doing of
certain acts or causing such acts to be done. Under section 302 of the
act (21 U.S.C. 332), the United States can bring a civil action in
Federal court to enjoin a person who commits a prohibited act. Under
section 303 of the act (21 U.S.C. 333), the United States can bring a
criminal action in Federal court to prosecute a
[[Page 24]]
person who is responsible for the commission of a prohibited act. Under
section 306 of the act (21 U.S.C. 335a), FDA can seek debarment of any
person who has been convicted of a felony relating to importation of
food into the United States. Failure of an owner, operator, or agent in
charge of a domestic or foreign facility to register its facility, to
update required elements of it's facility's registration, or to cancel
its registration in accordance with the requirements of this subpart is
a prohibited act under section 301(dd) of the act.
(b) FDA will cancel a registration if the agency independently
verifies that the facility is no longer in business or has changed
owners, and the owner, operator, or agent in charge of the facility
fails to cancel the registration, or if FDA determines that the
registration is for a facility that does not exist. If FDA cancels a
facility's registration, FDA will mail a confirmation of the
cancellation to the facility at the address provided in the facility's
registration.
(c) If an article of food is imported or offered for import into the
United States and a foreign facility that manufactured/processed,
packed, or held that article of food has not registered in accordance
with this subpart, the disposition of the article of food shall be
governed by the procedures set out in subpart I of this part.
Sec. 1.242 What does assignment of a registration number mean?
Assignment of a registration number to a facility means that the
facility is registered with FDA. Assignment of a registration number
does not in any way convey FDA's approval or endorsement of a facility
or its products.
Sec. 1.243 Is food registration information available to the public?
(a) The list of registered facilities and registration documents
submitted under this subpart are not subject to disclosure under 5
U.S.C. 552 (the Freedom of Information Act). In addition, any
information derived from such list or registration documents that would
disclose the identity or location of a specific registered person, is
not subject to disclosure under 5 U.S.C. 552 (the Freedom of Information
Act).
(b) Paragraph (a) of this section does not apply to any information
obtained by other means or that has previously been disclosed to the
public as defined in Sec. 20.81 of this chapter.
Subpart I_Prior Notice of Imported Food
Source: 68 FR 59070, Oct. 10, 2003, unless otherwise noted.
General Provisions
Sec. 1.276 What definitions apply to this subpart?
(a) The act means the Federal Food, Drug, and Cosmetic Act.
(b) The definitions of terms in section 201 of the act (21 U.S.C.
321) apply when the terms are used in this subpart, unless defined
below.
(1) Calendar day means every day shown on the calendar.
(2) Country from which the article originates means FDA Country of
Production.
(3) Country from which the article is shipped means the country in
which the article of food is loaded onto the conveyance that brings it
to the United States or, in the case of food sent by international mail,
the country from which the article is mail.
(4) FDA Country of Production means:
(i) For an article of food that is in its natural state, the country
where the article of food was grown, including harvested or collected
and readied for shipment to the United States. If an article of food is
wild fish, including seafood that was caught or harvested outside the
waters of the United States by a vessel that is not registered in the
United States, the FDA Country of Production is the country in which the
vessel is registered. If an article of food that is in its natural state
was grown, including harvested or collected and readied for shipment, in
a Territory, the FDA Country of Production is the United States.
(ii) For an article of food that is no longer in its natural state,
the country where the article was made; except that, if an article of
food is made from wild fish, including seafood, aboard a
[[Page 25]]
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,
(i) Except for purposes of this subpart, it does not include:
(A) Food contact substances as defined in section 409(h)(6) of the
act (21 U.S.C. 348(h)(6)); or
(B) Pesticides as defined in 7 U.S.C. 136(u).
(ii) Examples of food include fruits, vegetables, fish, including
seafood, dairy products, eggs, raw agricultural commodities for use as
food or as components of food, animal feed (including pet food), food
and feed ingredients, food and feed additives, dietary supplements and
dietary ingredients, infant formula, beverages (including alcoholic
beverages and bottled water), live food animals, bakery goods, snack
foods, candy, and canned foods.
(6) Grower means a person who engages in growing and harvesting or
collecting crops (including botanicals), raising animals (including
fish, which includes seafood), or both.
(7) International mail means foreign national mail services.
International mail does not include express carriers, express
consignment operators, or other private delivery services.
(8) No longer in its natural state means that an article of food has
been made from one or more ingredients or synthesized, prepared,
treated, modified, or manipulated. Examples of activities that render
food no longer in its natural state are cutting, peeling, trimming,
washing, waxing, eviscerating, rendering, cooking, baking, freezing,
cooling, pasteurizing, homogenizing, mixing, formulating, bottling,
milling, grinding, extracting juice, distilling, labeling, or packaging.
Crops that have been cleaned (e.g., dusted, washed), trimmed, or cooled
attendant to harvest or collection or treated against pests, waxed, or
polished are still in their natural state for purposes of this subpart.
Whole fish headed, eviscerated, or frozen attendant to harvest are still
in their natural state for purposes of this subpart.
(9) Port of arrival means the water, air, or land port at which the
article of food is imported or offered for import into the United
States, i.e., the port where the article of food first arrives in the
United States. This port may be different than the port where
consumption or warehouse entry or foreign trade zone admission
documentation is presented to the United States Bureau of Customs and
Border Protection (CBP).
(10) Port of entry, in sections 801(m) and 801(l) of the act, means
the port of entry as defined in 19 CFR 101.1.
(11) Registration number refers to the registration number assigned
by FDA under section 415 of the act (21 U.S.C. 350d) and 21 CFR part 1,
subpart H.
(12) Shipper means the owner or exporter of the article of food who
consigns and ships the article from a foreign country or the person who
sends an article of food by international mail to the United States.
(13) United States means the Customs territory of the United States
(i.e., the 50 states, the District of Columbia, and the Commonwealth of
Puerto Rico), but not the Territories.
(14) You means the person submitting the prior notice, i.e., the
submitter, or the person transmitting prior notice information on behalf
of the submitter, i.e., the transmitter.
[68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2004]
Sec. 1.277 What is the scope of this subpart?
(a) This subpart applies to all food for humans and other animals
that is imported or offered for import into the United States for use,
storage, or distribution in the United States, including food for gifts
and trade and quality assurance/quality control samples, food for
transshipment through the United States to another country, food for
future export, and food for use in a U.S. Foreign Trade Zone.
(b) Notwithstanding paragraph (a), this subpart does not apply to:
(1) Food for an individual's personal use when it is carried by or
otherwise accompanies the individual when arriving in the United States;
(2) Food that was made by an individual in his/her personal
residence and
[[Page 26]]
sent by that individual as a personal gift (i.e., for non-business
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.); and
(6) Egg products that at the time of importation are subject to the
exclusive jurisdiction of USDA under the Egg Products Inspection Act (21
U.S.C. 1031 et seq.).
Requirements To Submit Prior Notice of Imported Food
Sec. 1.278 Who is authorized to submit prior notice?
A prior notice for an article of food may be submitted by any person
with knowledge of the required information. This person is the
submitter. The submitter also may use another person to transmit the
required information on his/her behalf. The person who transmits the
information is the transmitter. The submitter and transmitter may be the
same person.
Sec. 1.279 When must prior notice be submitted to FDA?
(a) Except as provided in paragraph (c) of this section, you must
submit the prior notice to FDA and the prior notice submission must be
confirmed by FDA for review as follows:
(1) If the article of food is arriving by land by road, no less than
2 hours before arriving at the port of arrival;
(2) If the article of food is arriving by land by rail, no less than
4 hours before arriving at the port of arrival;
(3) If the article of food is arriving by air, no less than 4 hours
before arriving at the port of arrival; or
(4) If the article of food is arriving by water, no less than 8
hours before arriving at the port of arrival.
(b) Except in the case of an article of food imported or offered for
import by international mail, you may not submit prior notice more than
5 calendar days before the anticipated date of arrival of the food at
the anticipated port of arrival.
(c) Notwithstanding paragraphs (a) and (b) of this section, if the
article of food is arriving by international mail, you must submit the
prior notice before the article of food is sent to the United States.
(d) FDA will notify you that your prior notice has been confirmed
for review with a reply message that contains a Prior Notice (PN)
Confirmation Number. Your prior notice will be considered submitted and
the prior notice time will start when FDA has confirmed your prior
notice for review.
(e) The PN Confirmation Number must accompany any article of food
arriving by international mail. The PN Confirmation Number must appear
on the Customs Declaration that accompanies the package.
(f) A copy of the confirmation, including the PN Confirmation
Number, must accompany any article of food that is subject to this
subpart when it is carried by or otherwise accompanies an individual
when arriving in the United States. The copy of the confirmation must be
provided to CBP or FDA upon arrival.
(g) The PN Confirmation Number must accompany any article of food
for which the prior notice was submitted through the FDA Prior Notice
System Interface (FDA PN System Interface) when the article arrives in
the United States and must be provided to CBP or FDA upon arrival.
[68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2004]
Sec. 1.280 How must you submit prior notice?
(a) You must submit the prior notice electronically to FDA. You must
submit all prior notice information in the English language, except that
an individual's name, the name of a company, and the name of a street
may be submitted in a foreign language. All information, including these
items, must be submitted using the Latin (Roman) alphabet. Unless
paragraphs (c) and (d) of this section apply, you must submit prior
notice through:
[[Page 27]]
(1) The CBP Automated Broker Interface of the Automated Commercial
System (ABI/ACS); or
(2) The FDA PN System Interface at http://www.access.fda.gov. You
must submit prior notice through the FDA PN System Interface for
articles of food imported or offered for import by international mail,
other transaction types that cannot be made through ABI/ACS, and
articles of food that have been refused under section 801(m)(1) of the
act and this subpart.
(b) If a custom broker's or self-filer's system is not working or if
the ABI/ACS interface is not working, prior notice must be submitted
through the FDA PN System Interface.
(c) If FDA determines that FDA PN System Interface is not working,
FDA will issue notification at http://www.access.fda.gov or http://
www.cfsan.fda.gov/furls/fisstat.html, whichever FDA determines is
available. Once FDA issues this notification, if you intended to use the
FDA PN System Interface to submit a prior notice, you must submit prior
notice information by e-mail or by fax to FDA. The location for receipt
of submission by e-mail or fax will be listed at http://
www.access.fda.gov or http://www.cfsan.fda.gov/furls/fisstat.html,
whichever FDA determines is available.
(d) If FDA determines that the Operational and Administration System
for Import Support (OASIS) is not working, FDA will issue notification
at http://www.cfsan.fda.gov/fulrs/fisstat.html, on the FDA Web site at
http://www.fda.gov, and through messages in ABI/ACS. Once FDA issues
this notification, all prior notices must be submitted to FDA by e-mail
or by fax. The location for receipt of submission by e-mail or fax will
be listed at http://www.access.fda.gov or http://www.cfsan.fda.gov/
furls;fisstat.html, whichever FDA determines is available.
(e) Prior notice information will only be accepted at the listed e-
mail or fax locations if FDA determines that the FDA PN System Interface
or OASIS is not working.
[68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2003; 69 FR 8330, Feb.
24, 2004]
Sec. 1.281 What information must be in a prior notice?
(a) General. For each article of food that is imported or offered
for import into the United States, except by international mail, you
must submit the information for the article that is required in this
paragraph.
(1) The name of the individual submitting the prior notice and his/
her business address, and phone number, fax number, and e-mail address,
and the name and address of the submitting firm, if applicable. If a
registration number is provided, city and country may be provided
instead of the full address;
(2) If different from the submitter, the name of the individual and
firm, if applicable, transmitting the prior notice on behalf of the
submitter and his/her business address, and phone number, fax number,
and e-mail address. If a registration number is provided, city and
country may be provided instead of the full address;
(3) The entry type;
(4) The CBP entry identifier (e.g., CBP entry number or in-bond
number), if available;
(5) The identity of the article of food being imported or offered
for import, as follows:
(i) The complete FDA product code;
(ii) The common or usual name or market name;
(iii) The estimated quantity of food that will be shipped, described
from largest container to smallest package size; and
(iv) The lot or code numbers or other identifier of the food if
required by the act or FDA regulations, e.g., low acid canned foods, by
21 CFR 113.60(c); acidified foods, by 21 CFR 114.80(b); and infant
formula, by 21 CFR 106.90;
(6) For an article of food that is no longer in its natural state,
the name and address of the manufacturer and the registration number
assigned to the facility that is associated with the article of food. A
registration number is not required for a facility associated with an
article of food if the article is imported or offered for import for
transshipment, storage and export, or further manipulation and export.
If the article of food is sent by an individual as a personal gift
(i.e., for nonbusiness
[[Page 28]]
reasons) to an individual in the United States, you may provide the name
and address of the firm that appears on the label under 21 CFR 101.5
instead of the name, address, and registration number of the
manufacturer. If a registration number is provided, city and country may
be provided instead of the full address;
(7) For an article of food that is in its natural state, the name
and growing location address of the grower, if known. If the submitter
does not know the identity of the grower or, if the article has been
consolidated and the submitter does not know the identity of any of the
growers, you may provide the name and address of the firm that has
consolidated the articles of food from different growers or different
growing locations;
(8) The FDA Country of Production;
(9) The name and address of the shipper and, if the shipper is
required to register under 21 CFR part 1, subpart H, the registration
number assigned to the shipper's facility that is associated with the
article of food. A registration number is not required for a facility
associated with an article of food if the article is imported or offered
for import for transshipment, storage and export, or further
manipulation and export. If a registration number is provided, city and
country may be provided instead of the full address;
(10) The country from which the article is shipped;
(11) Anticipated arrival information about the article of food being
imported or offered for import, as follows:
(i) The anticipated port of arrival and, if the anticipated port of
arrival has more than one border crossing, the specific anticipated
border crossing where the food will be brought into the United States;
(ii) The anticipated date on which the article of food will arrive
at the anticipated port of arrival; and
(iii) The anticipated time of that arrival;
(12) The name and address of the importer. If a registration number
is provided, city and country may be provided instead of the full
address. The identity of the importer is not required for an article of
food that is imported or offered for import for transshipment through
the United States under a Transportation and Exportation entry;
(13) The name and address of the owner if different from the
importer or ultimate consignee. If a registration number is provided,
city and country may be provided instead of the full address. The
identity of the owner is not required for an article of food that is
imported or offered for import for transshipment through the United
States under a Transportation and Exportation entry;
(14) The name and address of the ultimate consignee. If a
registration number is provided, city and country may be provided
instead of the full address. The identity of the ultimate consignee is
not required for an article of food that is imported or offered for
import for transshipment through the United States under a
Transportation and Exportation entry;
(15) The mode of transportation;
(16) The Standard Carrier Abbreviation Code (SCAC) or International
Air Transportation Association (IATA) code of the carrier which is, or
will be, carrying the article of food from the country from which the
article is shipped to the United States, or if codes are not applicable,
then the name and country of the carrier;
(17) Planned shipment information, as applicable:
(i) The Airway Bill number(s) or Bill of Lading number(s). This
information is not required for an article of food when carried by or
otherwise accompanying an individual when entering the United States;
(ii) For food arriving by ocean vessel, the vessel name and voyage
number;
(iii) For food arriving by air carrier, the flight number;
(iv) For food arriving by truck, bus, or rail, the trip number;
(v) For food arriving as containerized cargo by water, air, or land,
the container number(s). This information is not required for an article
of food when carried by or otherwise accompanying an individual when
entering the United States;
(vi) For food arriving by rail, the car number. This information is
not required for an article of food when carried by or otherwise
accompanying an individual;
[[Page 29]]
(vii) For food arriving by privately owned vehicle, the license
plate number and State or province; and
(viii) The 6-digit Harmonized Tariff Schedule (HTS) code.
(b) Articles arriving by international mail. For each article of
food that is imported or offered for import into the United States by
international mail, you must submit the information for the article that
is required in this paragraph.
(1) The name of the individual submitting the prior notice and his/
her business address, and phone number, fax number, and e-mail address,
and the name and address of the submitting firm, if applicable. If a
registration number is provided, city and country may be provided
instead of the full address;
(2) If different from the submitter, the name of the individual and
firm, if applicable, transmitting the prior notice on behalf of the
submitter and his/her business address and phone number, fax number, and
e-mail address. If a registration number is provided, city and country
may be provided instead of the full address;
(3) The entry type (which will be a mail entry);
(4) The identity of the article of food being imported or offered
for import, as follows:
(i) The complete FDA product code;
(ii) The common or usual name or market name;
(iii) The estimated quantity of food that will be shipped, described
from largest container to smallest package size; and
(iv) The lot or code numbers or other identifier of the food if
required by the act or FDA regulations, e.g., low acid canned foods, by
21 CFR 113.60(c); acidified foods, by 21 CFR 114.80(b); and infant
formula, 21 CFR 106.90;
(5) For an article of food that is no longer in its natural state,
the name and address of the manufacturer and the registration number
assigned to the facility that is associated with the article of food. A
registration number is not required for a facility associated with an
article of food if the article is imported or offered for import for
transshipment, storage and export, or further manipulation and export.
If the article of food is sent by an individual as a personal gift
(i.e., for non-business reasons) to an individual in the United States,
you may provide the name and address of the firm that appears on the
label under 21 CFR 101.5 instead of the name, address, and registration
number of the manufacturer. If a registration number is provided, city
and country may be provided instead of the full address;
(6) For an article of food that is in its natural state, the name
and growing location address of the grower, if known. If the submitter
does not know the identity of the grower or, if the article has been
consolidated and the submitter does not know the identity of any of the
growers, you may provide the name and address of the firm that has
consolidated the articles of food from different growers or different
growing locations;
(7) The FDA Country of Production;
(8) The name and address of the shipper and, if the shipper is
required to register under 21 CFR part 1, subpart H, the registration
number assigned to the shipper's facility that is associated with the
article of food. A registration number is not required for a facility
associated with an article of food if the article is imported or offered
for import for transshipment, storage and export, or further
manipulation and export. If a registration number is provided, city and
country may be provided instead of the full address;
(9) The country from which the article is shipped (i.e., mailed);
(10) The anticipated date of mailing; and
(11) The name and address of the U.S. recipient.
(c) Refused articles. If the article of food has been refused under
section 801(m)(1) of the act and this subpart, you must submit the
information for the article that is required in this paragraph. However,
if the refusal is based on Sec. 1.283(a)(1)(iii) (Untimely Prior
Notice), you do not have to re-submit any information previously
submitted unless it has changed or the article has been exported and the
original prior notice was submitted through ABI/ACS. If the refusal is
based on Sec. 1.283(a)(1)(ii), you should cancel the
[[Page 30]]
previous submission per Sec. 1.282(b) and (c).
(1) The name of the individual submitting the prior notice and his/
her business address, and phone number, fax number, and e-mail address,
and the name and address of the submitting firm, if applicable. If a
registration number is provided, city and country may be provided
instead of the full address;
(2) If different from the submitter, the name of the individual and
firm, if applicable, transmitting the prior notice on behalf of the
submitter and his/her business address, and phone number, fax number,
and e-mail address. If the registration number is provided, city and
country may be provided instead of the full address;
(3) The entry type;
(4) The CBP entry identifier (e.g., CBP entry number or in-bond
number), if available;
(5) The identity of the article of food being imported or offered
for import, as follows:
(i) The complete FDA product code;
(ii) The common or usual name or market name;
(iii) The quantity of food that was shipped, described from largest
container to smallest package size; and
(iv) The lot or code numbers or other identifier of the food if
required by the act or FDA regulations, e.g., low acid canned foods, by
21 CFR 113.60(c); acidified foods, by 21 CFR 114.80(b); and infant
formula, by 21 CFR 106.90;
(6) For an article of food that is no longer in its natural state,
the name and address of the manufacturer and the registration number
assigned to the facility that is associated with the article of food. A
registration number is not required for a facility associated with an
article of food if the article is imported or offered for import for
transshipment, storage and export, or further manipulation and export.
If the article of food is sent by an individual as a personal gift
(i.e., for non-business reasons) to an individual in the United States,
you may provide the name and address of the firm that appears on the
label under 21 CFR 101.5 instead of the name, address, and registration
number of the manufacturer. If a registration number is provided, city
and country may be provided instead of the full address;
(7) For an article of food that is in its natural state, the name
and growing location address of the grower, if known. If the submitter
does not know the identity of the grower or, if the article has been
consolidated and the submitter does not know any of the growers, you may
provide the name and address of the firm that has consolidated the
articles of food from different growers or different growing locations;
(8) The FDA Country of Production;
(9) The name and address of the shipper and, if the shipper is
required to register under 21 CFR part 1, subpart H, the registration
number assigned to the shipper's facility that is associated with the
article of food. A registration number is not required for a facility
associated with an article of food if the article is imported or offered
for import for transshipment, storage and export, or further
manipulation and export. If a registration number is provided, city and
country may be provided instead of the full address;
(10) The country from which the article is shipped;
(11) The port of arrival;
(12) The name and address of the importer. If a registration number
is provided, city and country may be provided instead of the full
address. The identity of the importer is not required for an article of
food that is imported or offered for import for transshipment through
the United States under a Transportation and Exportation entry;
(13) The name and address of the owner, if different from the
importer or ultimate consignee. If a registration number is provided,
city and country may be provided instead of the full address. The
identity of the importer is not required for an article of food that is
imported or offered for import for transshipment through the United
States under a Transportation and Exportation entry;
(14) The name and address of the ultimate consignee. If a
registration number is provided, city and country may be provided
instead of the full address. The identity of the ultimate consignee is
not required for an article of food that is imported or offered for
import
[[Page 31]]
for transshipment through the United States under a Transportation and
Exportation entry;
(15) The mode of transportation;
(16) The Standard Carrier Abbreviation Code (SCAC) or International
Air Transportation Association (IATA) code of the carrier which carried
the article of food from the country from which the article is shipped
to the United States, or if codes are not applicable, then the name and
country of the carrier;
(17) Shipment information, as applicable:
(i) The Airway Bill number(s) or Bill of Lading number(s); however,
this information is not required for an article of food when carried by
or otherwise accompanying an individual when entering the United States;
(ii) For food that arrived by ocean vessel, the vessel name and
voyage number;
(iii) For food that arrived by air carrier, the flight number;
(iv) For food that arrived by truck, bus, or rail, the trip number;
(v) For food that arrived as containerized cargo by water, air, or
land, the container number(s); however, this information is not required
for an article of food when carried by or otherwise accompanying an
individual when entering the United States;
(vi) For food that arrived by rail, the car number; however, this
information is not required for an article of food when carried by or
otherwise accompanying an individual;
(vii) For food that arrived by privately owned vehicle, the license
plate number and State or province;
(viii) The 6-digit HTS code; and
(18) The location and address where the article of refused food will
be or is being held, the date the article has arrived or will arrive at
that location, and identification of a contact at that location.
[68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2004]
Sec. 1.282 What must you do if information changes after you have
received confirmation of a prior notice from FDA?
(a)(1) If any of the information required in Sec. 1.281(a) except
the information required in:
(i) Sec. 1.281(a)(5)(iii) (quantity),
(ii) Sec. 1.281(a)(11) (anticipated arrival information), or
(iii) Sec. 1.281(a)(17) (planned shipment information) changes
after you receive notice that FDA has confirmed your prior notice
submission for review, you must resubmit prior notice in accordance with
this subpart unless the article of food will not be offered for import
or imported into the United States.
(2) If any of the information required in Sec. 1.281(b), except the
information required in Sec. 1.281(b)(10) (the anticipated date of
mailing), changes after you receive notice that FDA has confirmed your
prior notice submission for review, you must resubmit prior notice in
accordance with this subpart, unless the article of food will not be
offered for import or imported into the United States.
(b) If you submitted the prior notice via the FDA PN System
Interface, you should cancel the prior notice via the FDA PN System
Interface.
(c) If you submitted the prior notice via ABI/ACS, you should cancel
the prior notice via ACS by requesting that CBP delete the entry.
Consequences
Sec. 1.283 What happens to food that is imported or offered for import
without adequate prior notice?
(a) For each article of food that is imported or offered for import
into the United States, except for food arriving by international mail
or food carried by or otherwise accompanying an individual, the
consequences are:
(1) Inadequate prior notice--(i) No prior notice. If an article of
food arrives at the port of arrival and no prior notice has been
submitted and confirmed by FDA for review, the food is subject to
refusal of admission under section 801(m)(1) of the act (21 U.S.C.
381(m)(1)). If an article of food is refused for lack of prior notice,
unless CBP concurrence
[[Page 32]]
is obtained for export and the article is immediately exported from the
port of arrival under CBP supervision, it must be held within the port
of entry for the article unless directed by CBP or FDA.
(ii) Inaccurate prior notice. If prior notice has been submitted and
confirmed by FDA for review, but upon review of the notice or
examination of the article of food, the notice is determined to be
inaccurate, the food is subject to refusal of admission under section
801(m)(1) of the act (21 U.S.C. 381(m)(1)). If the article of food is
refused due to inaccurate prior notice, unless CBP concurrence is
obtained for export and the article is immediately exported from the
port of arrival under CBP supervision, it must be held within the port
of entry for the article unless directed by CBP or FDA.
(iii) Untimely prior notice. If prior notice has been submitted and
confirmed by FDA for review, but the full time that applies under Sec.
1.279 of this subpart for prior notice has not elapsed when the article
of food arrives, the food is subject to refusal of admission under
section 801(m)(1) of the act (21 U.S.C. 381(m)(1)), unless FDA has
already reviewed the prior notice, determined its response to the prior
notice, and advised CBP of that response. If the article of food is
refused due to untimely prior notice, unless CBP concurrence is obtained
for export and the article is immediately exported from the port of
arrival under CBP supervision, it must be held within the port of entry
for the article unless directed by CBP or FDA.
(2) Status and movement of refused food. (i) An article of food that
has been refused under section 801(m)(1) of the act and paragraph (a) of
this section shall be considered general order merchandise as described
in section 490 of the Tariff Act of 1930, as amended, 19 U.S.C. 1490.
(ii) Refused food must be moved under appropriate custodial bond.
FDA must be notified of the location where the food has been or will be
moved, within 24 hours of refusal. The refused food shall not be entered
and shall not be delivered to any importer, owner, or ultimate
consignee. The food must be taken directly to the designated location.
(3) Segregation of refused foods. If an article of food that is
refused is part of a shipment that contains articles of food that have
not been placed under hold, the refused article of food may be
segregated from the rest of the shipment. This segregation must take
place where the article is held. FDA or CBP may supervise segregation.
If FDA or CBP determines that supervision is necessary, segregation must
not take place without supervision.
(4) Costs. Neither FDA nor CBP are liable for transportation,
storage, or other expenses resulting from refusal.
(5) Export after refusal. An article of food that has been refused
under Sec. 1.283(a) may be exported with CBP concurrence and under CBP
supervision unless it is seized or administratively detained by FDA or
CBP under other authority. If an article of food that has been refused
admission under Sec. 1.283(a) is exported, the prior notice should be
cancelled within 5 business days of exportation.
(6) No post-refusal submission or request for review. If an article
of food is refused under section 801(m)(1) and no prior notice is
submitted or resubmitted, no request for FDA review is submitted in a
timely fashion, or export has not occurred in accordance with paragraph
(a)(5) of this section, the article of food shall be dealt with as set
forth in CBP regulations relating to general order merchandise (19 CFR
part 127), except that the article may only be sold for export or
destroyed as agreed to by CBP and FDA.
(b) Food carried by or otherwise accompanying an individual. If food
carried by or otherwise accompanying an individual arriving in the
United States is not for personal use and does not have adequate prior
notice or the individual cannot provide FDA or CBP with a copy of the PN
confirmation, the food is subject to refusal of admission under section
801(m)(1) of the act. If before leaving the port, the individual does
not arrange to have the food held at the port or exported, the article
of food may be destroyed.
(c) Post-Refusal Prior Notice Submissions. (1) If an article of food
is refused under Sec. 1.283(a)(1)(i) (no prior notice)
[[Page 33]]
and the food is not exported, prior notice must be submitted in
accordance with Sec. Sec. 1.280 and 1.281(c) of this subpart.
(2) If an article of food is refused under Sec. 1.283(a)(1)(ii)
(inaccurate prior notice) and the food is not exported, you should
cancel the prior notice in accordance with Sec. 1.282 and must resubmit
prior notice in accordance with Sec. Sec. 1.280 and 1.281(c).
(3) Once the prior notice has been submitted or resubmitted and
confirmed by FDA for review, FDA will endeavor to review and respond to
the prior notice submission within the timeframes set out in Sec.
1.279.
(d) FDA Review After Refusal. (1) If an article of food has been
refused admission under section 801(m)(1) of the act, a request may be
submitted asking FDA to review whether the article is subject to the
requirements of this subpart under Sec. 1.276(b)(5) or Sec. 1.277, or
whether the information submitted in a prior notice is accurate. A
request for review may not be used to submit prior notice or to resubmit
an inaccurate prior notice.
(2) A request may be submitted only by the submitter, importer,
owner, or ultimate consignee. A request must identify which one the
requester is.
(3) A request must be submitted in writing to FDA and delivered by
mail, express courier, fax, or e-mail. The location for receipt of a
request is listed at http://www.fda.gov--see Prior Notice. A request
must include all factual and legal information necessary for FDA to
conduct its review. Only one request for review may be submitted for
each refused article.
(4) The request must be submitted within 5 calendar days of the
refusal. FDA will review and respond within 5 calendar days of receiving
the request.
(5) If FDA determines that the article is not subject to the
requirements of this subpart under Sec. 1.276(b)(5) or Sec. 1.277 or
that the prior notice submission is accurate, it will notify the
requester, the transmitter, and CBP that the food is no longer subject
to refusal under section 801(m)(1) of the act.
(e) International Mail. If an article of food arrives by
international mail with inadequate prior notice or the PN confirmation
number is not affixed as required, the parcel will be held by CBP for 72
hours for FDA inspection and disposition. If FDA refuses the article
under section 801(m)(1) of the act and there is a return address, the
parcel may be returned to sender stamped ``No Prior Notice--FDA
Refused.'' If the article is refused and there is no return address or
FDA determines that the article of food in the parcel appears to present
a hazard, FDA may dispose of or destroy the parcel at its expense. If
FDA does not respond within 72 hours of the CBP hold, CBP may return the
parcel to the sender or, if there is no return address, destroy the
parcel, at FDA expense.
(f) Prohibitions on delivery and transfer. (1) Notwithstanding
section 801(b) of the act, an article of food refused under section
801(m)(1) of the act may not be delivered to the importer, owner, or
ultimate consignee until prior notice is submitted to FDA in accordance
with this subpart, FDA has examined the prior notice, FDA has determined
that the prior notice is adequate, and FDA has notified CBP and the
transmitter that the article of food is no longer refused admission
under section 801(m)(1).
(2) During the time an article of food that has been refused under
section 801(m)(1) of the act is held, the article may not be transferred
by any person from the port or the secure facility until prior notice is
submitted to FDA in accordance with this subpart, FDA has examined the
prior notice, FDA has determined that the prior notice is adequate, and
FDA has notified CBP and the transmitter that the article of food no
longer is refused admission under section 801(m)(1). After this
notification by FDA to CBP and transmitter, entry may be made in
accordance with law and regulation.
(g) Relationship to other admissibility decisions. A determination
that an article of food is no longer refused under section 801(m)(1) of
the act is different than, and may come before, determinations of
admissibility under other provisions of the act or other U.S. laws. A
determination that an article of food is no longer refused under section
801(m)(1) does not mean that it will be
[[Page 34]]
granted admission under other provisions of the act or other U.S. laws.
[68 FR 59070, Oct. 10, 2003; 69 FR 4851, 4852, Feb. 2, 2004]
Sec. 1.284 What are the other consequences of failing to submit adequate
prior notice or otherwise failing to comply with this subpart?
(a) The importing or offering for import into the United States of
an article of food in violation of the requirements of section 801(m),
including the requirements of this subpart, is a prohibited act under
section 301(ee) of the act (21 U.S.C. 331(ee)).
(b) Section 301 of the act (21 U.S.C. 331) prohibits the doing of
certain acts or causing such acts to be done.
(1) Under section 302 of the act (21 U.S.C. 332), the United States
can bring a civil action in Federal court to enjoin persons who commit a
prohibited act.
(2) Under section 303 of the act (21 U.S.C. 333), the United States
can bring a criminal action in Federal court to prosecute persons who
are responsible for the commission of a prohibited act.
(c) Under section 306 of the act (21 U.S.C. 335a), FDA can seek
debarment of any person who has been convicted of a felony relating to
importation of food into the United States or any person who has engaged
in a pattern of importing or offering adulterated food that presents a
threat of serious adverse health consequences or death to humans or
animals.
[68 FR 59070, Oct. 10, 2003; 69 FR 4852, Feb. 2, 2004]
Sec. 1.285 What happens to food that is imported or offered for import
from unregistered facilities that are required to register under 21 CFR
part 1, subpart H?
(a) If an article of food from a foreign manufacturer that is not
registered as required under section 415 of the act (21 U.S.C. 350d) and
subpart H is imported or offered for import into the United States, the
food is subject to refusal of admission under section 801(m)(1) of the
act and Sec. 1.283 for failure to provide adequate prior notice. The
failure to provide the correct registration number of the foreign
manufacturer, if registration is required under section 415 of the act
and 21 CFR part 1, subpart H, renders the identity of that facility
incomplete for purposes of prior notice.
(b) Unless CBP concurrence is obtained for export and the article is
immediately exported from the port of arrival, if an article of food is
imported or offered for import from a foreign facility that is not
registered as required under section 415 of the act and is placed under
hold under section 801(l) of the act, it must be held within the port of
entry for the article unless directed by CBP or FDA.
(c) Status and movement of held food. (1) An article of food that
has been placed under hold under section 801(l) of the act shall be
considered general order merchandise as described in section 490 of the
Tariff Act of 1930, as amended (19 U.S.C. 1490).
(2) Food under hold under section 801(l) must be moved under
appropriate custodial bond. FDA must be notified of the location where
the food has been or will be moved, within 24 hours of the hold. The
food subject to hold shall not be entered and shall not be delivered to
any importer, owner, or ultimate consignee. The food must be taken
directly to the designated facility.
(d) Segregation of held foods. If an article of food that has been
placed under hold under section 801(l) of the act is part of a shipment
that contains articles that have not been placed under hold, the food
under hold may be segregated from the rest of the shipment. This
segregation must take place where the article is held, if different. FDA
or CBP may supervise segregation. If FDA or CBP determine that
supervision is necessary, segregation must not take place without
supervision.
(e) Costs. Neither FDA nor CBP will be liable for transportation,
storage, or other expenses resulting from any hold.
(f) Export after hold. An article of food that has been placed under
hold under section 801(l) of the act may be exported with CBP
concurrence and under CBP supervision unless it is seized or
administratively detained by FDA or CBP under other authority.
(g) No Registration or Request for Review. If an article of food is
placed under hold under section 801(l) of the act and no registration or
request for
[[Page 35]]
FDA review is submitted in a timely fashion or export has not occurred
in accordance with subsection (f), the food shall be dealt with as set
forth in CBP regulations relating to general order merchandise, except
that the article may only be sold for export or destroyed as agreed to
by CBP and FDA.
(h) Food carried by or otherwise accompanying an individual. If an
article of food carried by or otherwise accompanying an individual
arriving in the United States is placed under hold under section 801(l)
of the act because it is from a foreign facility that is not registered
as required under section 415 of the act, 21 U.S.C. 350d, and subpart H,
the individual may arrange to have the food held at the port or
exported. If such arrangements cannot be made, the article of food may
be destroyed.
(i) Post-refusal and post-hold submissions. (1) Post-refusal. To
resolve the refusal if an article of food is refused under Sec.
1.283(a) because the facility is not registered, the facility must be
registered and after a registration number has been obtained, you should
cancel the prior notice and must resubmit the prior notice in accordance
with Sec. 1.283(c).
(2) Post-hold. To resolve a hold, if an article of food is held
under Sec. 1.285(b) because it is from a foreign facility that is not
registered, the facility must be registered and a registration number
must be obtained.
(i) FDA must be notified of the applicable registration number in
writing. The notification must provide the name and contact information
for the person submitting the information. The notification may be
delivered to FDA by mail, express courier, fax, or e-mail. The location
for receipt of a notification of registration number associated with an
article of food under hold is listed at http://www.fda.gov--see Food
Facility Registration. The notification should include the applicable
CBP identifier.
(ii) If FDA determines that the article is no longer subject to
hold, it will notify the person who provided the registration
information and CBP that the food is no longer subject to hold under
section 801(l) of the act.
(j) FDA review after hold. (1) If an article of food has been placed
under hold under section 801(l) of the act, a request may be submitted
asking FDA to review whether the facility associated with the article is
subject to the requirements of section 415 of the act. A request for
review may not be submitted to obtain a registration number.
(2) A request may be submitted only by the prior notice submitter,
importer, owner, or ultimate consignee of the article. A request must
identify which one the requestor is.
(3) A request must be submitted in writing to FDA and delivered by
mail, express courier, fax or e-mail. The location for receipt of a
request is listed at http://www.fda.gov--see Food Facility Registration.
A request must include all factual and legal information necessary for
FDA to conduct its review. Only one request for review may be submitted
for each article under hold.
(4) The request must be submitted within 5 calendar days of the
hold. FDA will review and respond within 5 calendar days of receiving
the request.
(5) If FDA determines that the article is not from a facility
subject to the requirements of section 415, it will notify the requestor
and CBP that the food is no longer subject to hold under section 801(l)
of the act.
(k) International mail. If an article of food is that arrives by
international mail is from a foreign facility that is not registered as
required under section 415 of the act (21 U.S.C. 350d) and subpart H,
the parcel will be held by CBP for 72 hours for FDA inspection and
disposition. If the article is held under section 801(1) of the act and
there is a return address, the parcel may be returned to sender stamped
``No Registration--No Admission Permitted.'' If the article is under
hold and there is no return address or FDA determines that the article
of food is in the parcel appears to present a hazard, FDA may dispose of
or destroy the parcel at its expense. If FDA does not respond within 72
hours of the CBP hold, CBP may return the parcel to the sender stamped
``No Registration--No Admission Permitted'' or, if there is no return
address, destroy the parcel, at FDA expense.
[[Page 36]]
(l) Prohibitions on delivery and transfer. (1) Notwithstanding
section 801(b) of the act (21 U.S.C. 381(b)), an article of food that
has been placed under hold section 801(l) of the act may not be
delivered to the importer, owner, or ultimate consignee until prior
notice is submitted to FDA in accordance with this subpart, FDA has
examined the prior notice, FDA has determined that the prior notice is
adequate, and FDA has notified CBP and the transmitter that the article
of food is no longer subject to hold under section 801(l) of the act.
(2) During the time an article of food that has been refused under
section 801(m)(1) of the act is held, the article may not be transferred
by any person from the port or the secure facility location until prior
notice is submitted to FDA in accordance with this subpart, FDA has
examined the prior notice, FDA has determined that the prior notice is
adequate, and FDA has notified CBP and the transmitter that the article
of food is no longer refused admission under section 801(m)(1) of the
act. After this notification by FDA to CBP and transmitter, entry may be
made in accordance with law and regulation.
(m) Relationship to other admissibility provisions. A determination
that an article of food is no longer subject to hold under section
801(l) of the act is different than, and may come before, determinations
of admissibility under other provisions of the act or other U.S. laws. A
determination that an article of food is no longer under hold under
section 801(l) does not mean that it will be granted admission under
other provisions of the act or other U.S. laws.
[68 FR 59070, Oct. 10, 2003; 69 FR 4852, Feb. 2, 2004]
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.
[[Page 37]]
Sec. 2.10 Examination and investigation samples.
(a)(1) When any officer or employee of the Department collects a
sample of a food, drug, or cosmetic for analysis under the act, the
sample shall be designated as an official sample if records or other
evidence is obtained by him or any other officer or employee of the
Department indicating that the shipment or other lot of the article from
which such sample was collected was introduced or delivered for
introduction into interstate commerce, or was in or was received in
interstate commerce, or was manufactured within a Territory. Only
samples so designated by an officer or employee of the Department shall
be considered to be official samples.
(2) For the purpose of determining whether or not a sample is
collected for analysis, the term analysis includes examinations and
tests.
(3) The owner of a food, drug, or cosmetic of which an official
sample is collected is the person who owns the shipment or other lot of
the article from which the sample is collected.
(b) When an officer or employee of the Department collects an
official sample of a food, drug, or cosmetic for analysis under the act,
he shall collect at least twice the quantity estimated by him to be
sufficient for analysis, unless:
(1) The amount of the article available and reasonably accessible
for sampling is less than twice the quantity so estimated, in which case
he shall collect as much as is available and reasonably accessible.
(2) The cost of twice the quantity so estimated exceeds $150.
(3) The sample cannot by diligent use of practicable preservation
techniques available to the Food and Drug Administration be kept in a
state in which it could be readily and meaningfully analyzed in the same
manner and for the same purposes as the Food and Drug Administration's
analysis.
(4) The sample is collected from a shipment or other lot which is
being imported or offered for import into the United States.
(5) The sample is collected from a person named on the label of the
article or his agent, and such person is also the owner of the article.
(6) The sample is collected from the owner of the article, or his
agent, and such article bears no label or, if it bears a label, no
person is named thereon.
In addition to the quantity of sample set forth in this paragraph, the
officer or employee shall, if practicable, collect such further amount
as he estimates will be sufficient for use as trial exhibits.
(c) After the Food and Drug Administration has completed such
analysis of an official sample of a food, drug, or cosmetic as it
determines, in the course of analysis and interpretation of analytical
results, to be adequate to establish the respects, if any, in which the
article is adulterated or misbranded within the meaning of the act, or
otherwise subject to the prohibitions of the act, and has reserved an
amount of the article it estimates to be adequate for use as exhibits in
the trial of any case that may arise under the act based on the sample,
a part of the sample, if any remains available, shall be provided for
analysis, upon written request, by any person named on the label of the
article, or the owner thereof, or the attorney or agent of such person
or owner, except when:
(1) After collection, the sample or remaining part thereof has
become decomposed or otherwise unfit for analysis, or
(2) The request is not made within a reasonable time before the
trial of any case under the act, based on the sample to which such
person or owner is a party. The person, owner, attorney, or agent who
requests the part of sample shall specify the amount desired. A request
from an owner shall be accompanied by a showing of ownership, and a
request from an attorney or agent by a showing of authority from such
person or owner to receive the part of 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,
[[Page 38]]
or of a case under the act, and the person to whom the notice was given,
or any person who is a party to the case, has no right under paragraph
(c) of this section to a part of the sample, such person or his attorney
or agent may obtain a part of the sample upon request accompanied by a
written waiver of right under such paragraph (c) from each person named
on the label of the article and owner thereof, who has not exercised his
right under such paragraph (c). The operation of this paragraph shall be
subject to the exceptions, terms, and conditions prescribed in paragraph
(c) of this section.
(e) The Food and Drug Administration is authorized to destroy:
(1) Any official sample when it determines that no analysis of such
sample will be made;
(2) Any official sample or part thereof when it determines that no
notice under section 305 of the act, and no case under the act, is or
will be based on such sample;
(3) Any official sample or part thereof when the sample was the
basis of a notice under section 305 of the act, and when, after
opportunity for presentation of views following such notice, it
determines that no other such notice, and no case under the act, is or
will be based on such sample;
(4) Any official sample or part thereof when the sample was the
basis of a case under the act which has gone to final judgment, and when
it determines that no other such case is or will be based on such
sample;
(5) Any official sample or part thereof if the article is
perishable;
(6) Any official sample or part thereof when, after collection, such
sample or part has become decomposed or otherwise unfit for analysis;
(7) That part of any official sample which is in excess of three
times the quantity it estimates to be sufficient for analysis.
[42 FR 15559, Mar. 22, 1977, as amended at 63 FR 51299, Sept. 25, 1998]
Sec. 2.19 Methods of analysis.
Where the method of analysis is not prescribed in a regulation, it
is the policy of the Food and Drug Administration in its enforcement
programs to utilize the methods of analysis of the Association of
Official Analytical Chemists (AOAC) as published in the latest edition
(13th Ed., 1980) of their publication ``Official Methods of Analysis of
the Association of Official Analytical Chemists,'' and the supplements
thereto (``Changes in Methods'' as published in the March issues of the
``Journal of the Association of Official Analytical Chemists''), which
are incorporated by reference, when available and applicable. Copies are
available from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street NW., suite 700, Washington, DC. In the absence of an AOAC method,
the Commissioner will furnish a copy of the particular method, or a
reference to the published method, that the Food and Drug Administration
will use in its enforcement program. Other methods may be used for
quality control, specifications, contracts, surveys, and similar
nonregulatory functions, but it is expected that they will be calibrated
in terms of the method which the Food and Drug Administration uses in
its enforcement program. Use of an AOAC method does not relieve the
practioner of the responsibility to demonstrate that he can perform the
method properly through the use of positive and negative controls and
recovery and reproducibility studies.
[42 FR 15559, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 54
FR 9034, Mar. 3, 1989]
Subpart B_Human and Animal Foods
Sec. 2.25 Grain seed treated with poisonous substances; color
identification to prevent adulteration of human and animal food.
(a) In recent years there has developed increasing use of poisonous
treatments on seed for fungicidal and other purposes. Such treated seed,
if consumed, presents a hazard to humans and livestock. It is not
unusual for stocks of such treated food seeds to remain on hand after
the planting season has passed. Despite the cautions required by the
Federal Seed Act (53 Stat. 1275, as amended 72 Stat. 476, 7 U.S.C. 1551
et seq.) in the labeling of the
[[Page 39]]
treated seed, the Food and Drug Administration has encountered many
cases where such surplus stocks of treated wheat, corn, oats, rye,
barley, and sorghum seed had been mixed with untreated seed and sent to
market for food or feed use. This has resulted in livestock injury and
in legal actions under the Federal Food, Drug, and Cosmetic Act against
large quantities of food adulterated through such admixture of poisonous
treated seeds with good food. Criminal cases were brought against some
firms and individuals. Where the treated seeds are prominently colored,
buyers and users or processors of agricultural food seed for food
purposes are able to detect the admixture of the poisonous seed and thus
reject the lots; but most such buyers, users, and processors do not have
the facilities or scientific equipment to determine the presence of the
poisonous chemical at the time crops are delivered, in cases where the
treated seeds have not been so colored. A suitable color for this use is
one that is in sufficient contrast to the natural color of the food seed
as to make admixture of treated, denatured seeds with good food easily
apparent, and is so applied that it is not readily removed.
(b) On and after December 31, 1964, the Food and Drug Administration
will regard as adulterated any interstate shipment of the food seeds
wheat, corn, oats, rye, barley, and sorghum bearing a poisonous
treatment in excess of a recognized tolerance or treatment for which no
tolerance or exemption from tolerance is recognized in regulations
promulgated pursuant to section 408 of the Federal Food, Drug, and
Cosmetic Act, unless such seeds have been adequately denatured by a
suitable color to prevent their subsequent inadvertent use as food for
man or feed for animals.
(c) Attention is called to the labeling requirements of the Federal
Hazardous Substances Act, where applicable to denatured seeds in
packages suitable for household use.
Sec. 2.35 Use of secondhand containers for the shipment or storage
of food and animal feed.
(a) Investigations by the Food and Drug Administration, the National
Communicable Disease Center of the U.S. Public Health Service, the
Consumer and Marketing Service of the U.S. Department of Agriculture,
and by various State public health agencies have revealed practices
whereby food and animal feed stored or shipped in secondhand containers
have been rendered dangerous to health. Such contamination has been the
result of the original use of these containers for the storage and
shipment of articles containing or bearing disease organisms or
poisonous or deleterious substances.
(b) The Commissioner concludes that such dangerous or potentially
dangerous practices include, but are not limited to, the following:
(1) Some vegetable growers and packers employ used poultry crates
for shipment of fresh vegetables, including cabbage and celery.
Salmonella organisms are commonly present on dressed poultry and in
excreta and fluid exudates from dressed birds. Thus wooden crates in
which dressed poultry has been iced and packed are potential sources of
Salmonella or other enteropathogenic microorganisms that may contaminate
fresh vegetables which are frequently consumed without heat treatment.
(2) Some potato growers and producers of animal feeds use secondhand
bags for shipment of these articles. Such bags may have originally been
used for shipping or storing pesticide-treated seed or other articles
bearing or containing poisonous substances. 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
[[Page 40]]
may render the contents injurious to health.
Subparts C-E [Reserved]
Subpart F_Caustic Poisons
Sec. 2.110 Definition of ammonia under Federal Caustic Poison Act.
For the purpose of determining whether an article containing ammonia
is subject to the Federal Caustic Poison Act, the ammonia content is to
be calculated as NH3.
Subpart G_Provisions Applicable to Specific Products Subject to the
Federal Food, Drug, and Cosmetic Act
Sec. 2.125 Use of ozone-depleting substances in foods, drugs, devices,
or cosmetics.
(a) As used in this section, ozone-depleting substance (ODS) means
any class I substance as defined in 40 CFR part 82, appendix A to
subpart A, or class II substance as defined in 40 CFR part 82, appendix
B to subpart A.
(b) Except as provided in paragraph (c) of this section, any food,
drug, device, or cosmetic that is, consists in part of, or is contained
in an aerosol product or other pressurized dispenser that releases an
ODS is not an essential use of the ODS under the Clean Air Act.
(c) A food, drug, device, or cosmetic that is, consists in part of,
or is contained in an aerosol product or other pressurized dispenser
that releases an ODS is an essential use of the ODS under the Clean Air
Act if paragraph (e) of this section specifies the use of that product
as essential. For drugs, including biologics and animal drugs, and for
devices, an investigational application or an approved marketing
application must be in effect, as applicable.
(d) [Reserved]
(e) The use of ODSs in the following products is essential:
(1) Metered-dose corticosteroid human drugs for oral inhalation.
Oral pressurized metered-dose inhalers containing the following active
moieties:
(i) Beclomethasone.
(ii) Dexamethasone.
(iii) Flunisolide.
(iv) Fluticasone.
(v) Triamcinolone.
(2) Metered-dose short-acting adrenergic bronchodilator human drugs
for oral inhalation. Oral pressurized metered-dose inhalers containing
the following active moieties:
(i) Albuterol.
(ii) Bitolterol.
(iii) Metaproterenol.
(iv) Pirbuterol.
(v) Epinephrine.
(3) [Reserved]
(4) Other essential uses. (i) Metered-dose salmeterol drug products
administered by oral inhalation for use in humans.
(ii) Metered-dose ergotamine tartrate drug products administered by
oral inhalation for use in humans.
(iii) Anesthetic drugs for topical use on accessible mucous
membranes of humans where a cannula is used for application.
(iv) Metered-dose cromolyn sodium human drugs administered by oral
inhalation.
(v) Metered-dose ipratropium bromide for oral inhalation.
(vi) Metered-dose atropine sulfate aerosol human drugs administered
by oral inhalation.
(vii) Metered-dose nedocromil sodium human drugs administered by
oral inhalation.
(viii) Metered-dose ipratropium bromide and albuterol sulfate, in
combination, administered by oral inhalation for human use.
(ix) Sterile aerosol talc administered intrapleurally by
thoracoscopy for human use.
(f) Any person may file a petition under part 10 of this chapter to
request that FDA initiate rulemaking to amend paragraph (e) of this
section to add an essential use. FDA may initiate notice-and-comment
rulemaking to add an essential use on its own initiative or in response
to a petition, if granted.
(1) If the petition is to add use of a noninvestigational product,
the petitioner must submit compelling evidence that:
[[Page 41]]
(i) Substantial technical barriers exist to formulating the product
without ODSs;
(ii) The product will provide an unavailable important public health
benefit; and
(iii) Use of the product does not release cumulatively significant
amounts of ODSs into the atmosphere or the release is warranted in view
of the unavailable important public health benefit.
(2) If the petition is to add use of an investigational product, the
petitioner must submit compelling evidence that:
(i) Substantial technical barriers exist to formulating the
investigational product without ODSs;
(ii) A high probability exists that the investigational product will
provide an unavailable important public health benefit; and
(iii) Use of the investigational product does not release
cumulatively significant amounts of ODSs into the atmosphere or the
release is warranted in view of the high probability of an unavailable
important public health benefit.
(g) Any person may file a petition under part 10 of this chapter to
request that FDA initiate rulemaking to amend paragraph (e) of this
section to remove an essential use. FDA may initiate notice-and-comment
rulemaking to remove an essential use on its own initiative or in
response to a petition, if granted. If the petition is to remove an
essential use from paragraph (e) of this section, the petitioner must
submit compelling evidence of any one of the following criteria:
(1) The product using an ODS is no longer being marketed; or
(2) After January 1, 2005, FDA determines that the product using an
ODS no longer meets the criteria in paragraph (f) of this section after
consultation with a relevant advisory committee(s) and after an open
public meeting; or
(3) For individual active moieties marketed as ODS products and
represented by one new drug application (NDA):
(i) At least one non-ODS product with the same active moiety is
marketed with the same route of administration, for the same indication,
and with approximately the same level of convenience of use as the ODS
product containing that active moiety;
(ii) Supplies and production capacity for the non-ODS product(s)
exist or will exist at levels sufficient to meet patient need;
(iii) Adequate U.S. postmarketing use data is available for the non-
ODS product(s); and
(iv) Patients who medically required the ODS product are adequately
served by the non-ODS product(s) containing that active moiety and other
available products; or
(4) For individual active moieties marketed as ODS products and
represented by two or more NDAs:
(i) At least two non-ODS products that contain the same active
moiety are being marketed with the same route of delivery, for the same
indication, and with approximately the same level of convenience of use
as the ODS products; and
(ii) The requirements of paragraphs (g)(3)(ii), (g)(3)(iii), and
(g)(3)(iv) of this section are met.
[67 FR 48384, July 24, 2002]
PART 3_PRODUCT JURISDICTION--Table of Contents
Subpart A_Assignment of Agency Component for Review of Premarket
Applications
Sec.
3.1 Purpose.
3.2 Definitions.
3.3 Scope.
3.4 Designated agency component.
3.5 Procedures for identifying the designated agency component.
3.6 Product jurisdiction officer.
3.7 Request for designation.
3.8 Letter of designation.
3.9 Effect of letter of designation.
3.10 Stay of review time.
Subpart B [Reserved]
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 360c-360f, 360h-
360j, 360gg-360ss, 371(a), 379e, 381, 394; 42 U.S.C. 216, 262.
Source: 56 FR 58756, Nov. 21, 1991, unless otherwise noted.
[[Page 42]]
Subpart A_Assignment of Agency Component for Review of Premarket
Applications
Sec. 3.1 Purpose.
This regulation relates to agency management and organization and
has two purposes. The first is to implement section 503(g) of the act,
as added by section 16 of the Safe Medical Devices Act of 1990 (Public
Law 101-629) and amended by section 204 of the Medical Device User Fee
and Modernization Act of 2002 (Public Law 107-250), by specifying how
FDA will determine the organizational component within FDA designated to
have primary jurisdiction for the premarket review and regulation of
products that are comprised of any combination of a drug and a device; a
device and a biological; a biological and a drug; or a drug, a device
and a biological. This determination will eliminate, in most cases, the
need to receive approvals from more than one FDA component for such
combination products. The second purpose of this regulation is to
enhance the efficiency of agency management and operations by providing
procedures for determining which agency component will have primary
jurisdiction for any drug, device, or biological product where such
jurisdiction is unclear or in dispute. Nothing in this section prevents
FDA from using any agency resources it deems necessary to ensure
adequate review of the safety and effectiveness of any product, or the
substantial equivalence of any device to a predicate device.
[56 FR 58756, Nov. 21, 1991, as amended by 68 FR 37077, June 23, 2003]
Sec. 3.2 Definitions.
For the purpose of this part:
(a) Act means the Federal Food, Drug, and Cosmetic Act.
(b) Agency component means the Center for Biologics Evaluation and
Research, the Center for Devices and Radiological Health, the Center for
Drug Evaluation and Research, or alternative organizational component of
the agency.
(c) Applicant means any person who submits or plans to submit an
application to the Food and Drug Administration for premarket review.
For purposes of this section, the terms ``sponsor'' and ``applicant''
have the same meaning.
(d) Biological product has the meaning given the term in section
351(a) of the Public Health Service Act (42 U.S.C. 262(a)).
(e) Combination product includes:
(1) A product comprised of two or more regulated components, i.e.,
drug/device, biologic/device, drug/biologic, or drug/device/biologic,
that are physically, chemically, or otherwise combined or mixed and
produced as a single entity;
(2) Two or more separate products packaged together in a single
package or as a unit and comprised of drug and device products, device
and biological products, or biological and drug products;
(3) A drug, device, or biological product packaged separately that
according to its investigational plan or proposed labeling is intended
for use only with an approved individually specified drug, device, or
biological product where both are required to achieve the intended use,
indication, or effect and where upon approval of the proposed product
the labeling of the approved product would need to be changed, e.g., to
reflect a change in intended use, 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.
[[Page 43]]
(j) Letter of request means an applicant's written submission to the
product jurisdiction officer seeking the designation of the agency
component with primary jurisdiction.
(k) Premarket review includes the examination of data and
information in an application for premarket review described in sections
505, 510(k), 513(f), 515, or 520(g) or 520(l) of the act or section 351
of the Public Health Service Act of data and information contained in
any investigational new drug (IND) application, investigational device
exemption (IDE), new drug application (NDA), biologics license
application, device premarket notification, device reclassification
petition, and premarket approval application (PMA).
(l) Product means any article that contains any drug as defined in
section 201(g)(1) of the act; any device as defined in section 201(h) of
the act; or any biologic as defined in section 351(a) of the Public
Health Service Act (42 U.S.C. 262(a)).
(m) Product jurisdiction officer is the person or persons
responsible for designating the component of FDA with primary
jurisdiction for the premarket review and regulation of a combination
product or any product requiring a jurisdictional designation under this
part.
(n) Sponsor means ``applicant'' (see Sec. 3.2(c)).
[56 FR 58756, Nov. 21, 1991 as amended at 64 FR 398, Jan. 5, 1999; 64 FR
56447, Oct. 20, 1999; 68 FR 37077, June 23, 2003]
Sec. 3.3 Scope.
This section applies to:
(a) Any combination product, or
(b) Any product where the agency component with primary jurisdiction
is unclear or in dispute.
Sec. 3.4 Designated agency component.
(a) To designate the agency component with primary jurisdiction for
the premarket review and regulation of a combination product, the agency
shall determine the primary mode of action of the product. Where the
primary mode of action is that of:
(1) A drug (other than a biological product), the agency component
charged with premarket review of drugs shall have primary jurisdiction;
(2) A device, the agency component charged with premarket review of
devices shall have primary jurisdiction;
(3) A biological product, the agency component charged with
premarket review of biological products shall have primary jurisdiction.
(b) The designation of one agency component as having primary
jurisdiction for the premarket review and regulation of a combination
product does not preclude consultations by that component with other
agency components or, in appropriate cases, the requirement by FDA of
separate applications.
Sec. 3.5 Procedures for identifying the designated agency component.
(a)(1) The Center for Biologics Evaluation and Research, the Center
for Devices and Radiological Health, and the Center for Drug Evaluation
and Research have entered into agreements 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
[[Page 44]]
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 (HFG-3), Food and Drug
Administration, 15800 Crabbs Branch Way, suite 200, Rockville, MD 20855,
301-827-9229, e-mail: [email protected], is the designated product
jurisdiction officer.
[68 FR 37077, June 23, 2003]
Sec. 3.7 Request for designation.
(a) Who should file: the sponsor of:
(1) Any combination product the sponsor believes is not covered by
an intercenter agreement; or
(2) Any product where the agency component with primary jurisdiction
is unclear or in dispute.
(b) When to file: a sponsor should file a request for designation
before filing any application for premarket review, whether an
application for marketing approval or a required investigational notice.
Sponsors are encouraged to file a request for designation as soon as
there is sufficient information for the agency to make a determination.
(c) What to file: an original and two copies of the request for
designation must be filed. The request for designation must not exceed
15 pages, including attachments, and must set forth:
(1) The identity of the sponsor, including company name and address,
establishment registration number, company contact person and telephone
number.
(2) A description of the product, including:
(i) Classification, name of the product and all component products,
if applicable;
(ii) Common, generic, or usual name of the product and all component
products;
(iii) Proprietary name of the product;
(iv) Identification of any component of the product that already has
received premarket approval, is marketed as not being subject to
premarket approval, or has received an investigational exemption, the
identity of the sponsors, and the status of any discussions or
agreements between the sponsors regarding the use of this product as a
component of a new combination product.
(v) Chemical, physical, or biological composition;
(vi) Status and brief reports of the results of developmental work,
including animal testing;
(vii) Description of the manufacturing processes, including the
sources of all components;
(viii) Proposed use or indications;
(ix) Description of all known modes of action, the sponsor's
identification of the primary mode of action, and the basis for that
determination;
(x) Schedule and duration of use;
(xi) Dose and route of administration of drug or biologic;
(xii) Description of related products, including the regulatory
status of those related products; and
(xiii) Any other relevant information.
(3) The sponsor's recommendation as to which agency component should
have primary jurisdiction, with accompanying statement of reasons.
(d) Where to file: all communications pursuant to this subpart shall
be addressed to the attention of the product jurisdiction officer. Such
a request, in its mailing cover should be plainly marked ``Request for
Designation.'' 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]
Sec. 3.8 Letter of designation.
(a) Each request for designation will be reviewed for completeness
within 5 working days of receipt. Any request
[[Page 45]]
for designation determined to be incomplete will be returned to the
applicant with a request for the missing information. The sponsor of an
accepted request for designation will be notified of the filing date.
(b) Within 60 days of the filing date of a request for designation,
the product jurisdiction officer will issue a letter of designation to
the sponsor, with copies to the centers, specifying the agency component
designated to have primary jurisdiction for the premarket review and
regulation of the product at issue, and any consulting agency
components. The product jurisdiction officer may request a meeting with
the sponsor during the review period to discuss the request for
designation. If the product jurisdiction officer has not issued a letter
of designation within 60 days of the filing date of a request for
designation, the sponsor's recommendation of the center with primary
jurisdiction, in accordance with Sec. 3.7(c)(3), shall become the
designated agency component.
(c) Request for reconsideration by sponsor: If the sponsor disagrees
with the designation, it may request the product jurisdiction officer to
reconsider the decision by filing, within 15 days of receipt of the
letter of designation, a written request for reconsideration not
exceeding 5 pages. No new information may be included in a request for
reconsideration. The product jurisdiction officer shall review and act
on the request in writing within 15 days of its receipt.
Sec. 3.9 Effect of letter of designation.
(a) The letter of designation constitutes an agency determination
that is subject to change only as provided in paragraph (b) of this
section.
(b) The product jurisdiction officer may change the designated
agency component with the written consent of the sponsor, or without its
consent to protect the public health or for other compelling reasons. A
sponsor shall be given 30 days written notice of any proposed
nonconsensual change in designated agency component. The sponsor may
request an additional 30 days to submit written objections, not to
exceed 15 pages, to the proposed change, and shall be granted, upon
request, a timely meeting with the product jurisdiction officer and
appropriate center officials. Within 30 days of receipt of the sponsor's
written objections, the product jurisdiction officer shall issue to the
sponsor, with copies to appropriate center officials, a written
determination setting forth a statement of reasons for the proposed
change in designated agency component. A nonconsensual change in the
designated agency component requires the concurrence of the Principal
Associate Commissioner.
[56 FR 58756, Nov. 21, 1991, as amended at 68 FR 37077, June 23, 2003]
Sec. 3.10 Stay of review time.
Any filing with or review by the product jurisdiction officer stays
the review clock or other established time periods for agency action for
an application for marketing approval or required investigational notice
during the pendency of the review by the product jurisdiction officer.
Subpart B [Reserved]
PART 5_DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents
Subpart A_Delegations of Authority to the Commissioner of Food and Drugs
Sec.
5.10 Delegations from the Secretary of Health and Human Services to the
Commissioner of Food and Drugs.
5.11 Reservation of authority.
Subpart B_General Redelegations of Authority
5.20 General redelegations of authority from the Commissioner to other
officers of the Food and Drug Administration.
5.21 Emergency functions.
5.22 Certification of true copies and use of Department seal.
5.23 Disclosure of official records and authorization of testimony.
5.24 Authority relating to technology transfer.
5.25 Research, investigation, and testing programs and health
information and promotion programs.
5.26 Service fellowships.
5.27 Patent term extensions for human drug products, medical devices,
and food and color additives; and authority to perform
[[Page 46]]
due diligence determinations and informal hearings.
5.28 Hearings.
5.29 Petitions under part 10.
5.30 Authority to select temporary voting members for advisory
committees and authority to sign conflict of interest waivers.
5.31 Enforcement activities.
5.32 Certification following inspections.
5.33 Issuance of reports of minor violations.
5.34 Issuance of notices relating to proposals and orders for debarment
and denial of an application to terminate debarment.
5.35 Officials authorized to make certification under 5 U.S.C. 605(b)
for any proposed and final rules.
Subpart C_Human Drugs; Redelegations of Authority
5.100 Issuance of notices implementing the provisions of the Drug
Amendments of 1962.
5.101 Termination of exemptions for new drugs for investigational use in
human beings.
5.102 Authority to approve and to withdraw approval of a charge for
investigational new drugs.
5.103 Approval of new drug applications and their supplements.
5.104 Responses to Drug Enforcement Administration temporary scheduling
notices.
5.105 Issuance of notices relating to proposals to refuse approval or to
withdraw approval of new drug applications and their
supplements.
5.106 Submission of and effective approval dates for abbreviated new
drug applications and certain new drug applications.
5.107 Extensions or stays of effective dates for compliance with certain
labeling requirements for human prescription drugs.
5.108 Authority relating to waivers or reductions of prescription drug
user fees.
5.109 Issuance of written notices concerning patent information, current
good manufacturing practices and false or misleading labeling
of new drugs.
Subpart D_Biologics; Redelegations of Authority
5.200 Functions pertaining to safer vaccines.
5.201 Redelegation of the Center for Biologics Evaluation and Research
Director's program authorities.
5.202 Issuance of notices of opportunity for a hearing on proposals for
denial of approval of applications for licenses, suspension of
licenses, or revocation of licenses and certain notices of
revocation of licenses.
5.203 Issuance and revocation of licenses for the propagation or
manufacture and preparation of biological products.
5.204 Notification of release for distribution of biological products.
Subpart E_Foods and Cosmetics; Redelegations of Authority
5.300 Food standards, food additives, generally recognized as safe
(GRAS) substances, color additives, nutrient content claims,
and health claims.
5.301 Issuance of initial emergency permit orders and notices of
confirmation of effective date of final regulations on food
for human and animal consumption.
5.302 Detention of meat, poultry, eggs, and related products.
5.303 Establishing standards and approving accrediting bodies under the
National Laboratory Accreditation Program.
5.304 Approval of schools providing food-processing instruction.
Subpart F_Medical Devices and Radiological Health; Redelegations of
Authority
5.400 Issuance of Federal Register documents to recognize or to withdraw
recognition of a standard to meet premarket submission
requirements.
5.401 Issuance of Federal Register documents pertaining to exemptions
from premarket notification.
5.402 Detention of adulterated or misbranded medical devices.
5.403 Authorization to use alternative evidence for determination of the
effectiveness of medical devices.
5.404 Notification of petitioners of determinations made on petitions
for reclassification of medical devices.
5.405 Determination of classification of devices.
5.406 Notification of sponsors of deficiencies in petitions for
reclassification of medical devices.
5.407 Approval, disapproval, or withdrawal of approval of product
development protocols and applications for premarket approval
for medical devices.
5.408 Determinations concerning the type of valid scientific evidence
submitted in a premarket approval application.
5.409 Determinations that medical devices present unreasonable risk of
substantial harm.
5.410 Orders to repair or replace, or make refunds for, medical devices.
5.411 Medical device recall authority.
5.412 Temporary suspension of a medical device application.
[[Page 47]]
5.413 Approval, disapproval, or withdrawal of approval of applications
and entering into agreements for investigational device
exemptions.
5.414 Postmarket surveillance.
5.415 Authority relating to medical device reporting procedures.
5.416 Medical device tracking.
5.417 Authority pertaining to accreditation functions for medical
devices.
Subpart G_Animal Drugs; Redelegations of Authority
5.500 Issuance of Federal Register documents pertaining to the
determination of safe levels, notice of need for development
of an analytical method, notice of availability of a developed
analytical method, and prohibition of certain extralabel drug
use.
5.501 Approval of new animal drug applications, medicated feed mill
license applications and their supplements.
5.502 Issuance of notices, proposals, and orders relating to new animal
drugs and medicated feed mill license applications.
5.503 Submission of and effective approval dates for abbreviated new
animal drug applications and certain new animal drug
applications.
5.504 Issuance of written notices concerning patent information, current
good manufacturing practices and false or misleading labeling
of new animal drugs and feeds bearing or containing new animal
drugs.
5.505 Termination of exemptions for new drugs for investigational use in
animals.
Subpart H_Radiation Control; Redelegations of Authority
5.600 Variances from performance standards for electronic products.
5.601 Exemption of electronic products from performance standards and
prohibited acts.
5.602 Testing programs and methods of certification and identification
for electronic products.
5.603 Notification of defects in, and repair or replacement of,
electronic products.
5.604 Manufacturers requirement to provide date to ultimate purchasers
of electronic products.
5.605 Dealer and distributor direction to provide data to manufacturers
of electronic products.
5.606 Acceptance of assistance from State and local authorities for
enforcement of radiation control legislation and regulations.
Subpart I_Product Designation; Redelegations of Authority
5.700 Authority relating to determination of product primary
jurisdiction.
5.701 Premarket approval of a product that is or contains a biologic, a
device, or a drug.
Subpart J_Imports and Exports; Redelegations of Authority
5.800 Imports and exports.
5.801 Export of unapproved drugs.
5.802 Manufacturer's resident import agents.
Subpart K_Orphan Products; Redelegations of Authority
5.900 Orphan products.
Subpart L_Mammography Facilities; Redelegations of Authority
5.1000 Authority to ensure that mammography facilities meet quality
standards.
Subpart M_Organization
5.1100 Headquarters.
5.1105 Chief Counsel, Food and Drug Administration.
5.1110 Food and Drug Administration Public Information Offices.
5.1115 Field Structure.
Authority: 5 U.S.C. 504, 552, App. 2 605; 7 U.S.C. 138a, 2217; 15
U.S.C. 638, 1261-1282, 1451-1461, 3701-3711a; 21 U.S.C., 61-63, 141-149,
301-394, 467f, 679(b), 801-886, 1031-1309, 1401-1403; 35 U.S.C. 156; 42
U.S.C. 238, 241, 242, 242a, 242l, 242n, 242o, 243, 262, 263, 264, 265,
300u-300u-5, 300aa-1, 300ar-25-28, 300cc, 300ff, 1395y, 4332, 4831(a),
10007-10008; E.O. 11921, 41 FR 24294, 3 CFR, 1977 Comp., p. 124-131;
E.O. 12591, 52 FR 13414, 3 CFR, 1988 Comp., p. 220-223.
Source: 66 FR 30993, June 8, 2001, unless otherwise noted.
Subpart A_Delegations of Authority to the Commissioner of Food and Drugs
Sec. 5.10 Delegations from the Secretary of Health and Human Services
to the Commissioner of Food and Drugs.
(a) The Secretary of Health and Human Services (the Secretary) has
redelegated to the Commissioner of Food and Drugs (Commissioner), with
authority to redelegate (except when specifically prohibited), all
authority as follows:
[[Page 48]]
(1) Functions vested in the Secretary under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.), as amended, the Filled Milk
Act (21 U.S.C. 61-63), the Federal Import Milk Act (21 U.S.C. 141 et
seq.), the Federal Caustic Poison Act (44 Stat. 1406; see also Public
Law 86-613, section 19, formerly section 18) and The Fair Packaging and
Labeling Act (15 U.S.C. 1451 et seq.), under section 12 of
Reorganization Plan No. IV and Reorganization Plan No. 1 of 1953,
including authority to administer oaths vested in the Secretary of
Agriculture by 7 U.S.C. 2217.
(2) Functions vested in the Secretary under section 301 (Research
and Investigations); section 307 (International Cooperation); and
section 311 (Federal-State Cooperation) of the Public Health Service Act
(the PHS Act) (42 U.S.C. 241, 242l, 243), as amended, which relate to
the functions of the Food and Drug Administration.
(3) Functions vested in the Secretary under section 361 of the PHS
Act (42 U.S.C. 264), as amended, which relate to the law enforcement
functions of the Food and Drug Administration concerning the following
products and activities: Biologicals (including blood and blood
products); interstate travel sanitation (except interstate
transportation of etiologic agents under 42 CFR part 72); food
(including milk and food service sanitation and shellfish sanitation);
and drugs, devices, cosmetics, electronic products, and other items or
products regulated by the Food and Drug Administration.
(4) Functions vested in the Secretary under sections 351 and 352 of
part F, subpart 1 of the PHS Act (42 U.S.C. 262 and 263), as amended
(Biological Products), insofar as they relate to the functions assigned
to the Food and Drug Administration.
(5) Functions vested in the Secretary under section 302(a) of the
PHS Act (42 U.S.C. 242(a)), as amended, which relate to the
determination and reporting requirements with respect to the medicinal
and scientific requirements of the United States for controlled
substances.
(6) Functions vested in the Secretary under section 303 of the PHS
Act (42 U.S.C. 242a), as amended, which relate to the authorization of
persons engaged in research on the use and effect of drugs to protect
the identity of their research subjects with respect to drugs scheduled
under Public Law 91-513 for which an investigational new drug
application is filed with the Food and Drug Administration and with
respect to all drugs not scheduled under Public Law 91-513.
(7) Functions vested in the Secretary pertaining to section 4 of the
Comprehensive Drug Abuse Prevention and Control Act of 1970 (Public Law
91-513, 84 Stat. 1241) which relate to the determination of the safety
and effectiveness of drugs or to approve new drugs to be used in the
treatment of narcotic addicts.
(8) Functions vested in the Secretary pertaining to section 303(f)
of the Controlled Substances Act (21 U.S.C. 823(f)), which relate to the
merits of the research protocol and to the determination of the
qualifications and competency of practitioners wishing to conduct
research with controlled substances listed in Schedule I of the Act.
(9) Functions vested in the Secretary pertaining to provisions of
the Controlled Substances Act (21 U.S.C. 801 et seq.), which relate to
administration of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.).
(10) Functions vested in the Secretary under section 409(b) of the
Federal Meat Inspection Act (21 U.S.C. 679(b)), which relate to the
detention of any carcass, part thereof, meat, or meat product of cattle,
sheep, swine, goats, or equines.
(11) Functions vested in the Secretary under section 24(b) of the
Poultry Products Inspection Act (21 U.S.C. 467f(b)), which relate to the
detention of any poultry carcass, part thereof, or poultry product.
(12) Functions vested in the Secretary under the Egg Products
Inspection Act (21 U.S.C. 1031 et seq.).
(13) Functions vested in the Secretary by amendments to the
foregoing statutes subsequent to Reorganization Plan No. 1 of 1953.
(14) Function of issuing all regulations of the Food and Drug
Administration, except as provided in Sec. 5.11. The reservation of
authority contained in Chapter 2-000 of the Department Organization
Manual shall not apply.
[[Page 49]]
(15) Functions vested in the Secretary under section 1103 of
Executive Order 11490, as amended by Executive Order 11921, which relate
to emergency health functions as they pertain to the operations and
functional responsibilities assigned to the agency. This authority shall
be exercised in accordance with section 102 and pertinent sections of
part 30 of Executive Order 11490 and guidelines issued by the Federal
Preparedness Agency of the General Services Administration and the
Office of the Secretary.
(16) Function vested in the Secretary of authorizing and approving
miscellaneous and emergency expenses of enforcement activities.
(17) Functions vested in the Secretary under the Federal Advisory
Committee Act, Public Law 92-463, to:
(i) Renew, recharter, amend and terminate established Federal
Advisory Committees;
(ii) Authority to approve waivers to appoint committee members to
established Federal Advisory Committees;
(iii) Authority to close review meetings following approval by the
Office of the General Counsel based on a determination that the Advisory
Committee meeting or a portion thereof may be closed to the public under
the provisions of 5 U.S.C. 552b(c) and section 10(d) of the Federal
Advisory Committee Act. These authorities are to be exercised in
accordance with the requirements of 5 U.S.C. 552b; the Federal Advisory
Committee Act (Public Law 92-463); Departmental regulations (45 CFR part
11, superseded by 41 CFR part 101-6); and any other applicable statutes
and regulations. These authorities may be redelegated.
(18) Functions vested in the Secretary under the second sentence of
section 310(a) and under section 310(b) (Health Conferences and Health
Education Information) of the PHS Act (42 U.S.C. 242o), as amended, to
call for a conference and invite as many health authorities and
officials of State or local public or private agencies or organizations
as deemed necessary or proper on subjects related to the functions of
the Food and Drug Administration, and to issue information related to
health for the use of the public and other pertinent health information
for the use of persons and institutions concerned with health services
when such information is related to the functions of the Food and Drug
Administration.
(19) Functions vested in the Secretary under section 2701 of the PHS
Act (42 U.S.C. 238), as amended, to accept offers of gifts, excluding
the acceptance of gifts of real property. Only the authority to accept
unconditional gifts of personal property valued at $5,000 or less may be
redelegated.
(20) Functions vested in the Secretary under section 362 of the PHS
Act (42 U.S.C. 265), as amended, which relate to the prohibition of the
introduction of foods, drugs, devices, cosmetics, electronic products,
and other items or products regulated by the Food and Drug
Administration into the United States when it is determined that it is
required in the interest of public health when such functions relate to
the law enforcement functions of the Food and Drug Administration.
(21) Functions vested in the Secretary under section 401(a) of the
Lead-Based Paint Poisoning Prevention Act, as amended by Public Law 94-
317 (42 U.S.C. 4831(a)), relating to the prohibition of the application
of lead-based paint to cooking, drinking, or eating utensils.
(22) Functions vested in the Secretary for the health information
and health promotion program under title XVII of the PHS Act (42 U.S.C.
300u et seq.), as amended, insofar as the authorities pertain to
functions assigned to the Food and Drug Administration. The delegation
includes, but is not limited to, the authorities under: Section
1702(a)(1) and (3) and section 1704(1) and (2) (42 U.S.C. 300u-1(a) and
(3) and 300u-3(1) and (2)). The delegation excludes the authority to
select all Senior Executive Service, supergrade and equivalent, and
Schedule C (GS-12 and above) positions; issue regulations; and submit
reports to the President.
(23) To administer a Small Business Innovation Research Program
under section 9 of the Small Business Act (15 U.S.C. 638), as amended.
The delegation excludes the authority to issue regulations, establish
advisory councils and committees, appoint members to advisory councils
and committees, and submit reports to Congress.
[[Page 50]]
(24) Functions vested in the Secretary under sections 982 and 983 of
the Consumer-Patient Radiation Health and Safety Act of 1981 (the Act)
(42 U.S.C. 10007 and 10008), as amended. The delegation excludes the
authority to issue regulations and submit reports to Congress. The
authority delegated under section 983 of the Act may only be exercised
as it relates to functions assigned to the Food and Drug Administration.
(25) Functions vested in the Secretary under section 156 of title 35
of the U.S. Code (35 U.S.C. 156), as amended, which allows for the
extension of patent terms for human drug products, medical devices, food
additives, and color additives subject to the Federal Food, Drug, and
Cosmetic Act (the act). These authorities may be redelegated, except the
authority to make due diligence determinations under section
156(d)(2)(B), which may not be redelegated to an Office below the Office
of the Commissioner of Food and Drugs.
(26) Functions vested in the Secretary under the Stevenson-Wydler
Technology Innovation Act of 1980 (15 U.S.C. 3701 et seq.) (the Act), as
amended, and under Executive Order 12591 of April 10, 1987, as they
pertain to the functions of the Food and Drug Administration. The
delegation excludes the authority to issue regulations and submit
reports to Congress; under section 11(a)(2) of the Act (15 U.S.C.
3710a(a)(2)) to approve agreements and contracts with invention
management organizations; and under section 11(c)(3)(B) of the Act (15
U.S.C. 3710a(c)(3)(B)) to propose necessary statutory changes regarding
conflict of interest.
(i) The authorities under section 11(c)(5)(A) and (B) of the act (15
U.S.C. 3710a(c)(5)(A) and (B)) to disapprove or require the modification
of cooperative research and development agreements and licensing
agreements after the agreement is presented to the Commissioner by the
head of the laboratory concerned, and to transmit written explanation of
such disapproval or modification to the head of the laboratory
concerned, may be redelegated only to a senior official in the immediate
Office of the Commissioner.
(ii) The following authorities may not be redelegated: The authority
under section 11(b)(3)(D) of the Act (15 U.S.C. 3710a(b)(3)(D)) to waive
a right of ownership which the Federal Government may have to an
invention made under a cooperative research and development agreement;
the authority under section 11(b)(3)(C) of the Act (15 U.S.C.
3710a(b)(3)(C)) to permit employees or former employees to participate
in efforts to commercialize inventions they made while in the service of
the United States; the authority under section 11(c)(3)(A) of the Act
(15 U.S.C. 3710a(c)(3)(A)) to review employee standards of conduct for
resolving potential conflicts of interest; the authority under section
13(a)(1) of the Act (15 U.S.C. 3710c(a)(1)) to retain any royalties or
other income, except as provided in section 13(a)(2) of the Act (15
U.S.C. 3710c(a)(2)); and the authority under section 13(a)(1)(A)(i) of
the Act (15 U.S.C. 3710c(a)(1)(A)(i)) to pay royalties or other income
the agency receives on account of an invention to the inventor if the
inventor was an employee of the agency at the time the invention was
made.
(iii) Any authorities under paragraph (a)(26) of this section
delegated by the Commissioner may not be further redelegated.
(27) Functions vested in the Secretary under sections 4702, 4703,
and 4704 of the Pesticide Monitoring Improvements Act of 1988 (21 U.S.C.
1401-1403) that relate to pesticide monitoring and enforcement
information, foreign pesticide information, and pesticide analytical
methods. The delegation excludes the authority to submit reports to
Congress.
(28) Functions vested in the Secretary under sections 2312(a)(1) and
(2)(B), (b), and (c) (Use of Investigational New Drugs with Respect to
Acquired Immunodeficiency Syndrome); 2314(c) (Scientific and Ethical
Guidelines for Certain Treatments); and 2317(d) and (e) (Information
Services) of title XXIII of the PHS Act (42 U.S.C. 300cc-12(a)(1) and
(2)(B), (b) and (c), 300cc-14(c) and 300cc-17(d) and (e)), as amended,
insofar as these authorities pertain to the functions assigned to the
Food and Drug Administration. The delegation excludes the authority to
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issue regulations, submit reports to the Congress, establish advisory
committees or national commissions, and appoint members to such
committees or commissions.
(29) Functions vested in the Secretary under section 2672(a)(1) (A)
and (B) (Provisions Relating to Blood Banks) and section 2672(a)(2)
(Information and Training Programs) of the PHS Act (42 U.S.C. 300ff-
72(a)(1)(A) and (B) and (a)(2) et seq.), as amended, insofar as these
authorities pertain to the functions assigned to the Food and Drug
Administration. The delegations exclude the authority to issue
regulations, submit reports to the Congress, establish advisory
committees or national commissioners, and appoint members to such
committees or commissions.
(30) Functions vested in the Secretary under sections 1322(b) and
(c) of the Food, Agriculture, Conservation, and Trade Act of 1990 (the
National Laboratory Accreditation Program) (7 U.S.C. 138a), as amended
hereafter, which relate to setting standards for the National Laboratory
Accreditation Program and approving State agencies or private, nonprofit
entities as accrediting bodies to implement certification and quality
assurance programs in accordance with the requirements of this section.
The delegation excludes the authority to submit reports to Congress.
(31) Functions vested in the Secretary under part C, subtitle 2 of
title XXI of the PHS Act (42 U.S.C. 300aa-25 et seq.), as amended, and
the National Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1
note), as amended hereafter, as follows:
(i) Section 2125 of the PHS Act (42 U.S.C. 300aa-25)--Recording and
reporting of information.
(ii) Section 2127 of the PHS Act (42 U.S.C. 300aa-27)---Mandate for
safer childhood vaccines.
(iii) Section 2128 of the PHS Act (42 U.S.C. 300aa-28)--Manufacturer
recordkeeping and reporting.
(iv) Section 312 of the National Childhood Vaccine Injury Act of
1986--Related studies (42 U.S.C. 300aa-1 note).
(v) Section 313 of the National Childhood Vaccine Injury Act of
1986--Study of other vaccine risks (42 U.S.C. 300aa-1 note).
(vi) Section 314 of the National Childhood Vaccine Injury Act of
1986--Review of warnings, use instructions, and precautionary
information (42 U.S.C. 300aa-1 note).
(vii) The delegation excludes the authority to issue regulations and
submit reports to Congress.
(32) Functions vested in the Secretary under section 201(h)(4) of
the Controlled Substances Act (Title II of the Comprehensive Drug Abuse
Prevention and Control Act of 1970, as amended) (21 U.S.C. 811(h)(4)) to
provide responses to the Drug Enforcement Administration's temporary
scheduling notices. The delegation excludes the authority to submit
reports to Congress.
(33) Functions vested in the Secretary under the Safe Medical
Devices Act of 1990 (Pub. L. 101-629), as amended hereafter (e.g., 21
U.S.C. 360c note, 360i note, and 360j note). The delegation excludes the
authority to submit reports to Congress.
(34) Functions vested in the Secretary under section 601 of
Effective Medication Guides of the Agriculture, Rural Development, Food
and Drug Administration, and Related Agencies Appropriations Act of 1997
(Public Law 104-180), as amended hereafter. The delegation excludes the
authority to issue reports to Congress.
(35) The Secretary has redelegated to the Commissioner of Food and
Drugs, or his designee, the authority to take final action on matters
pertaining to section 203 of the Equal Access to Justice Act (5 U.S.C.
504), and to develop procedures and regulations where necessary to
supplement the Department's regulations, 45 CFR part 13.
(36) The Secretary has delegated to the Commissioner, the authority
to administer and make decisions regarding the invention and patent
program as they pertain to the functions of the Food and Drug
Administration and to make determinations of rights in inventions and
patents in which the Department has an interest. This delegation
excludes the authority to submit reports to Congress and further, it
excludes those authorities under the Stevenson-Wydler Technology
Innovation
[[Page 52]]
Act of 1980, as amended by the Federal Technology Transfer Act of 1986
and the National Technology Transfer and Advancement Act of 1995, which
are governed by a separate delegation (under Sec. 5.10(a)(26)). All
authorities other than the authority under 35 U.S.C. section 203 (March-
In Rights) may be redelegated.
(37) Functions vested in the Secretary under title III, Section 354,
of the PHS Act (42 U.S.C. 262 et seq.), as amended. The authority
pertains to the Food and Drug Administration's oversight of mammography
facilities.
(38) The Deputy Assistant Secretary for Health Management
Operations, Public Health Service, has redelegated to the Commissioner
of Food and Drugs, with authority to redelegate, the authority to
certify true copies of any books, records, or other documents on file
within the Food and Drug Administration, or extracts from such; to
certify that true copies are true copies of the entire file of the
Administration; to certify the complete original record or to certify
the nonexistence of records on file within the Administration; and to
cause the Seal of the Department to be affixed to such certifications
and to agreements, awards, citations, diplomas, and similar documents.
(39) The Secretary of Health and Human Services has redelegated to
the Commissioner, of Food and Drugs, under 45 CFR 5b.8 regulations,
appeal authority to take final action upon an individual's appeal of a
refusal to correct or amend the individual's record when the appeal has
been made by the individual under Privacy Act regulations (part 21 of
this chapter and 45 CFR part 5b). The authority may not be redelegated.
(b) The Chief Counsel of the Food and Drug Administration has been
authorized to report apparent violations to the Department of Justice
for the institution of criminal proceedings, under section 305 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335), section 4 of the
Federal Import Milk Act (21 U.S.C. 144), and section 9(b) of the Federal
Caustic Poison Act.
Sec. 5.11 Reservation of authority.
(a) Notwithstanding provisions of Sec. 5.10 or any previous
delegations of authority to the contrary, the Secretary of Health and
Human Services (Secretary) reserves the authority to approve regulations
of the Food and Drug Administration, except regulations to which
sections 556 and 557 of title 5 U.S.C. apply, which:
(1) Establish procedural rules applicable to a general class of
foods, drugs, cosmetics, medical devices, or other subjects of
regulation; or
(2) Present highly significant public issues involving the quality,
availability, marketability, or cost of one or more foods, drugs,
cosmetics, medical devices, or other subjects of regulation.
(b) Nothing in this section precludes the Secretary from approving a
regulation, or being notified in advance of an action, to which sections
556 and 557 of title 5 U.S.C. apply, which meets one of the criteria in
paragraph (a) of this section.
(c) This reservation of authority is intended only to improve the
internal management of the Department of Health and Human Services, and
it is not intended to create any right or benefit, substantive or
procedural, enforceable at law by a party against the United States, the
Department of Health and Human Services, the Food and Drug
Administration, any agency, officer, or employee of the United States,
or any person. Regulations issued by the Food and Drug Administration
without the approval of the Secretary are to be conclusively viewed as
falling outside the scope of this reservation of authority.
Subpart B_General Redelegations of Authority
Sec. 5.20 General redelegations of authority from the Commissioner to
other officers of the Food and Drug Administration.
(a) Final authority of the Commissioner of Food and Drugs
(Commissioner) is redelegated as set forth in these subparts. The
Commissioner may continue to exercise all authority delegated in
subparts B through L.
(b) The following officials are authorized to perform all of the
functions of
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the Commissioner. These officials may not further redelegate this
authority, or any part of this authority, except as elsewhere specified:
(1) Deputy Commissioner;
(2) Associate Commissioner for Regulatory Affairs;
(3) Senior Associate Commissioner;
(4) Senior Associate Commissioner for Management and Systems;
(5) Senior Associate Commissioner for Policy, Planning, and
Legislation; and
(6) Deputy Commissioner for International and Constituent Relations.
(c)(1) During the absence or disability of the Commissioner or in
the event of a vacancy in that position, the first official who is
available in the following positions, or who has been designated by the
Commissioner to act in such position, shall act as Commissioner:
(i) Deputy Commissioner;
(ii) Associate Commissioner for Regulatory Affairs; or
(iii) Senior Associate Commissioner.
(2) These officials may not further redelegate this authority.
However, for a planned period of absence, the Commissioner (or someone
``acting'' on his/her behalf) may specify a different order of
succession.
(d) Authority delegated to a position by title may be exercised by a
person officially designated to serve in that position in an acting
capacity or on a temporary basis, unless prohibited by a restriction in
the document designating him/her as ``acting'' or unless not legally
permissible.
(e)(1) The Senior Associate Commissioner is authorized to make
determinations that advisory committee meetings are concerned with
matters listed in 5 U.S.C. 552(b) and therefore may be closed to the
public in accordance with Sec. 5.10(a)(17).
(2) The Senior Associate Commissioner is authorized to perform other
associated advisory committee functions (e.g., establishing technical
and scientific review groups (advisory committees)); appointing and
paying members; approving waivers to appoint members to established
advisory committees; renewing and rechartering of established advisory
committees; amending charters of established advisory committees; and
terminating established advisory committees.
(3) The Senior Associate Commissioner is authorized to approve
conflict of interest waivers for special Government employees serving on
advisory committees in accordance with 18 U.S.C. 208(b)(3), as amended.
(4) The Senior Associate Commissioner is authorized to select
temporary members to advisory committees if such voting members are
serving on an advisory committee managed by another center.
(5) The Senior Associate Commissioner may not further redelegate
these authorities.
(f)(1) The Senior Associate Commissioner for Policy, Planning, and
Legislation (SACPPL) and the Associate Commissioner for Policy (ACP) are
authorized to perform any of the functions of the Commissioner with
respect to the issuance of Federal Register notices and proposed and
final regulations of the Food and Drug Administration. These officials
may not further redelegate this authority.
(2) The SACPPL and the ACP are authorized to issue responses to the
following matters under part 10 of this chapter as follows and these
officials may not further redelegate this authority:
(i) Requests for waiver, suspension, or modification of procedural
requirements under Sec. 10.19 of this chapter;
(ii) Citizen petitions under Sec. 10.30 of this chapter;
(iii) Petitions for reconsideration under Sec. 10.33 of this
chapter;
(iv) Petitions for stay under Sec. 10.35 of this chapter; or
(v) Requests for advisory opinions under Sec. 10.85 of this
chapter.
(3) With respect to any matter delegated to the SACPPL and the ACP
under this paragraph, the SACPPL and the ACP are authorized to perform
the function of the Commissioner under Sec. Sec. 10.40, 10.45, 10.50,
10.55, 10.60, 10.65, 10.80, 10.90, and 10.95 of this chapter and of the
Deputy Commissioner under Sec. 10.206(g) and (h) of this chapter. These
officials may not further redelegate this authority.
(4) The SACPPL and the ACP are authorized under the Regulatory
Flexibility Act (5 U.S.C. 605(b)) to certify
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that a proposed or final rule, if issued, will not have a significant
economic impact on a substantial number of small entities. The SACPPL
and the ACP may further redelegate this authority.
(g) The following officials are authorized to perform all the
functions of the officials under them in their respective offices and
they may not further redelegate this authority:
(1) Senior Associate Commissioner;
(2) Deputy Commissioner for International and Constituent Relations;
(3) Senior Associate Commissioner for Management and Systems; or
(4) Senior Associate Commissioner for Policy, Planning, and
Legislation.
(h)(1) The Chief Mediator and Ombudsman and the Deputy Chief
Mediator and Ombudsman are authorized to act upon requests for
reconsideration of any user fee decisions under section 735 of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379h) made by
such officers and the former Deputy User Fee Waiver Officer prior to
July 1, 1999. These officials may not further redelegate this authority.
(See subpart C, Sec. 5.108 for the user fee-related redelegation to
officials within the Center for Drug Evaluation and Research.)
(2) The Senior Associate Commissioner for Management and Systems and
the Director, Office of Financial Management, are authorized to perform
the functions of the Commissioner under section 736(d)(1)(c) of the act
(21 U.S.C. 379h(d)(1)(C)), as amended, to waive or reduce prescription
drug user fees in situation where he or she finds that ``the fees will
exceed the anticipated present and future costs.'' These officials may
not further redelegate this authority.
(3) The Deputy Commissioner, or in the event of a vacancy in that
position, the Senior Associate Commissioner, Office of the Commissioner,
is designated as the User Fee Appeals Officer. The User Fee Appeals
Officer is authorized to hear and decide user fee waiver appeals. The
decision of the User Fee Appeals Officer will constitute final agency
action on such matters. The User Fee Appeals Officer may not further
redelegate this authority.
(i) The Senior Associate Commissioner for Management and Systems is
authorized to perform all of the administrative authorities (i.e.,
financial, personnel, facilities management, property management, etc.)
of the Commissioner. These authorities may be further redelegated,
except when specifically prohibited.
(j) Unless specifically noted, the persons to whom the Commissioner
has delegated authority in subparts B through L of this part may not
further redelegate that authority.
Sec. 5.21 Emergency functions.
(a) Each Regional Food and Drug Director is authorized, during any
period when normal channels of direction are disrupted between the Food
and Drug Administration headquarters and his or her region to:
(1) Fully represent the Food and Drug Administration within his or
her region in cooperation with the Department of Health and Human
Services regional emergency plans, and
(2) Exercise the authority of the Commissioner of Food and Drugs for
supervision of and direction to all Food and Drug Administration
activities and use of resources within his or her region for continuity
and for Federal Emergency Health Service operations.
(b) These same officials are authorized to provide in Regional
Emergency Plans for the delegation of Food and Drug Administration
regional authorities to heads of field activities when such activities
are cut off from national and regional headquarters. These officials may
not further redelegate this authority.
Sec. 5.22 Certification of true copies and use of Department seal.
(a) The following officials are authorized to certify true copies
of, or extracts from, any books, records, papers, or other documents on
file within the Food and Drug Administration, to certify that copies are
true copies of the entire file, to certify the complete original record,
or to certify the nonexistence of records on file within the Food and
Drug Administration, and to cause the seal of the Department to be
affixed to such certifications:
[[Page 55]]
(1) The Deputy Commissioner, the Senior Associate Commissioner, the
Deputy Commissioner for International and Constituent Relations, the
Senior Associate Commissioner for Management and Systems, and the Senior
Associate Commissioner for Policy, Planning, and Legislation.
(2) The Associate and Deputy Associate Commissioners and the Chief
Counsel and Deputy Chief Counsels.
(3) The Director, Office of the Executive Secretariat, Office of the
Senior Associate Commissioner, Office of the Commissioner (OC).
(4) The Director, Office of Executive Operations, Office of the
Senior Associate Commissioner, OC.
(5)(i) The Director and Deputy Director, Office of Enforcement,
Office of Regulatory Affairs (ORA).
(ii) The Director and Deputy Director, Office of Regional
Operations, ORA.
(iii) The Director and Deputy Director, Office of Resource
Management (ORM), ORA.
(iv) The Director, Division of Management Operations, ORM, ORA.
(v) Team Leader, FDA History Staff, ORM, ORA.
(6)(i) The Director, Office of Human Resources and Management
Services (OHRMS), Office of Management and Systems (OMS), OC.
(ii) The Director, Division of Management Programs (DMP), OHRMS,
OMS, OC.
(iii) The Chief, Division of Dockets Management, DMP, OHRMS, OMS,
OC.
(7) The Associate Commissioner for Public Affairs, Office of Public
Affairs (OPA), Office of the Senior Associate Commissioner (OSAC), OC.
(8)(i) The Chief Information Officer, Office of Information
Resources Management (OIRM), Office of Management and Systems (OMS), OC.
(ii) The Director, Freedom of Information Staff, OIRM, OMS, OC.
(9)(i) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER).
(ii) The Director, Office of Management, CBER.
(iii) The Director and Deputy Directors of the Office of Compliance
and Biologics Quality, CBER.
(iv) The Director and Deputy Director, Office of Communication,
Training, and Manufacturer's Assistance, CBER.
(v) The Director and Branch Chiefs, Division of Case Management,
Office of Compliance and Biologics Quality (OCBQ), CBER; and the
Consumer Safety Officers, OCBQ, CBER.
(10)(i) The Director and Deputy Director, Center for Food Safety and
Applied Nutrition (CFSAN).
(ii) The Director of Regulations and Policy, CFSAN.
(iii) The Director, Office of Management Systems, CFSAN.
(iv) The Director, Office of Cosmetics and Colors, CFSAN.
(v) The Director, Office of Plant and Dairy Foods and Beverages,
CFSAN.
(vi) The Director, Office of Seafood, CFSAN.
(vii) The Director, Office of Nutritional Products, Labeling, and
Dietary Supplements, CFSAN.
(viii) The Director, Office of Special Research Skills, CFSAN.
(ix) The Director, Office of Constituent Operations, CFSAN.
(x) The Director, Office of Field Programs, CFSAN.
(xi) The Director, Office of Premarket Approval, CFSAN.
(xii) The Director, Office of Scientific Analysis and Support,
CFSAN.
(11)(i) The Director and Deputy Directors, Center for Devices and
Radiological Health (CDRH).
(ii) The Associate Director and Deputy Associate Director for
Management and Systems, CDRH.
(iii) The Director and Deputy Director, Office of Compliance, CDRH.
(iv) For medical devices assigned to their respective divisions, the
Division Directors, Office of Compliance, CDRH.
(v) The Director and Deputy Director, Office of Surveillance and
Biometrics (OSB), CDRH, and the Director and Deputy Director, Division
of Surveillance Systems (DSS), OSB, CDRH.
(vi) The Director, Office of Systems and Management, CDRH.
(vii) Freedom of Information Officers, CDRH.
(12)(i) The Director and Deputy Director, Center for Veterinary
Medicine (CVM).
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(ii) The Director and Deputy Director, Office of Management and
Communications, CVM.
(iii) The Director and Deputy Director, Office of Surveillance and
Compliance, CVM.
(iv) The Director, Division of Compliance, Office of Surveillance
and Compliance, CVM.
(13)(i) The Director and Deputy Director for Washington Operations,
National Center for Toxicological Research (NCTR).
(ii) The Deputy Center Director, Office of Management (OM), NCTR,
and the Associate Director, Office of Management Services, OM, NCTR.
(iii) The Deputy Center Director, Office of Research, NCTR.
(14)(i) The Director and Deputy Director, the Directors, Office of
Review Management and Office of Pharmaceutical Science, the Associate
Director for Regulatory Policy, and the Associate Director for Medical
Policy, Center for Drug Evaluation and Research (CDER).
(ii) The Director and Deputy Director, Office of Management, CDER.
(iii) The Director and Deputy Director, Office of Compliance, CDER.
(iv) The Directors and Deputy Directors of the Offices of Drug
Evaluation I, II, III, IV, and V, and the Director and Deputy Director
of the Office of Biostatistics, Office of Review Management, CDER.
(v) The Directors and Deputy Directors of the Offices of Testing and
Research, Generic Drugs, New Drug Chemistry, and Clinical Pharmacology
and Biopharmaceutics, Office of Pharmaceutical Science, CDER.
(vi) The Director, Office of Training and Communications (OTCOM),
and the Director, Division of Information Disclosure Policy, Office of
Regulatory Policy, CDER.
(vii) The Directors of the Divisions of Labeling and Non-
prescription Drug Compliance, Prescription Drug Compliance and
Surveillance, and Manufacturing and Product Quality, Office of
Compliance, CDER.
(15)(i) Regional Food and Drug Directors.
(ii) District Directors.
(iii) The Director, St. Louis Branch.
(iv) The Director, Northeast Regional Laboratory, Northeast Region.
(v) The Director, Southeast Regional Laboratory, Southeast Region.
(vi) The Director, National Forensic Chemistry Center.
(vii) The Director, Arkansas Regional Laboratory.
(viii) The Director, Winchester Engineering Analytical Center.
(b) The following officials are authorized to cause the seal of the
Department to be affixed to agreements, awards, citations, diplomas, and
similar documents:
(1) Deputy Commissioner; the Senior Associate Commissioner; the
Deputy Commissioner for International and Constituent Relations; the
Senior Associate Commissioner for Management and Systems; and the Senior
Associate Commissioner for Policy, Planning, and Legislation.
(2) The Associate and Deputy Associate Commissioners and the Chief
Counsel and Deputies.
(3) The Director and Deputy Directors, CBER; the Director and Deputy
Director, CFSAN; the Director and Deputy Directors, CDRH; the Director
and Deputy Director, CVM; the Director and Deputy Directors, CDER; and
the Director, NCTR, the Deputy Director for Washington Operations, NCTR,
and the Deputy Center Directors, Offices of Management and Research,
respectively, NCTR.
(4) The Director, Office of Executive Operations, Office of the
Senior Associate Commissioner (OSAC), OC; Director, Office of
Management, CBER; Director, Office of Management, CDER; Director, Office
of Management Systems, CFSAN; Director, Office of Systems and
Management, CDRH; Director, Office of Management and Communications,
CVM; Associate Director, Office of Management Services, NCTR; and the
Director, Office of Resource Management, ORA.
(5) The Director, Office of Human Resources and Management Services
(OHRMS), Office of Management and Systems (OMS), OC.
(c) The following officials may further redelegate the authorities
under paragraphs (a) and (b) of this section the Deputy Commissioner;
the Senior Associate Commissioner; the Deputy
[[Page 57]]
Commissioner for International and Constituent Relations; the Senior
Associate Commissioner for Management and Systems; the Senior Associate
Commissioner for Policy, Planning, and Legislation; the Associate and
Deputy Associate Commissioners; the Chief Counsel and Deputy Chief
Counsels; the Directors and Deputy Directors for CBER, CFSAN, CDRH, CVM,
CDER, and NCTR; the Director, Office of Executive Operations, OSAC, OC;
the Directors of the Offices of Management, CBER and CDER; the Director,
Office of Management Systems, CFSAN; the Director, Office of Systems and
Management, CDRH; the Director, Office of Management and Communications,
CVM; the Associate Director, Office of Management Services, NCTR; the
Director, Office of Resource Management, ORA; and the Director, OHRMS,
OMS, OC. The other officials delegated authority by this section may not
further redelegate it.
(d) The Chief, Regulations Editorial Section (RES), Regulations
Policy and Management Staff (RPMS), Office of Policy, Planning, and
Legislation (OPPL), OC, and his or her alternates are authorized to
certify true copies of Federal Register documents. The Chief, RES, RPMS,
OPPL, OC may designate alternates as required.
Sec. 5.23 Disclosure of official records and authorization of testimony.
(a) The following officials are authorized to make determinations to
disclose official records and information under part 20 of this chapter,
except that only the officials, listed in paragraphs (a)(2) through
(a)(8) of this section, have the authority under specific sections of
part 20 of this chapter.
(1)(i) Deputy Commissioner, the Senior Associate Commissioner, the
Deputy Commissioner for International and Constituent Relations, the
Senior Associate Commissioner for Management and Systems, the Senior
Associate Commissioner for Policy, Planning, and Legislation, and the
Associate and Deputy Associate Commissioners.
(ii) The Director, Office of Executive Operations, Office of the
Senior Associate Commissioner, Office of the Commissioner (OC).
(iii) The Director, Office of the Executive Secretariat, Office of
the Senior Associate Commissioner, OC.
(iv) The Director, Office of Human Resources and Management Services
(OHRMS), Office of Management and Systems (OMS), OC; the Director,
Division of Management Programs (DMP), OHRMS, OMS, OC; and the Chief,
Division of Dockets Management, DMP, OHRMS, OMS, OC.
(v) Program officials at all organizational levels down to and
including branch level for all Headquarters organizations.
(vi) Regional Food and Drug Directors and District Directors.
(vii) Director, Winchester Engineering and Analytical Center.
(viii) Chiefs of branches Field/District Offices and Centers.
(ix) Freedom of Information Officers and other employees engaged in
Freedom of Information activities.
(x) The Director, Office of Enforcement (OE), Office of Regulatory
Affairs (ORA); Deputy Director, OE, ORA; and Director, Division of
Compliance Policy, OE, ORA.
(xi) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER); and the Director and Deputy Director,
Office of Communication, Training, and Manufacturer's Assistance
(OCTMA), CBER.
(xii) The Director and Deputy Director, the Directors, Office of
Review Management and Office of Pharmaceutical Science, the Associate
Director for Medical Policy, and the Associate Director for Regulatory
Policy, Center for Drug Evaluation and Research (CDER).
(xiii) The Director, Center for Devices and Radiological Health
(CDRH), the Deputy Director for Regulations and Policy, and the Deputy
Director for Science, CDRH.
(xiv) The Director and Deputy Director, Center for Food Safety and
Applied Nutrition (CFSAN).
(xv) The Director and Deputy Director, Center for Veterinary
Medicine (CVM).
(xvi) The Director, National Center for Toxicological Research
(NCTR); the Deputy Center Directors, Offices of Research and Management,
respectively,
[[Page 58]]
NCTR; and the Deputy Director for Washington Operations, NCTR.
(xvii) These officials may not further redelegate this authority.
(2) The Deputy Associate Commissioner for Regulatory Affairs (Deputy
ACRA), ORA; the Director and Deputy Director, Office of Enforcement OE,
ORA; and the Director, Division of Compliance Policy, OE, ORA are
delegated the authority to grant requests for testimony or to authorize
the giving of testimony under Sec. 20.1 of this chapter. These
officials may not further redelegate this authority.
(3) The Associate and Deputy Associate Commissioners are delegated
the authority to disclose official records and information under Sec.
20.82 of this chapter. These officials may not further redelegate this
authority.
(4) The Associate and Deputy Associate Commissioners; the Director
and Deputy Director, OE, ORA; and the Director, Division of Compliance
Policy, OE, ORA are delegated the authority to disclose official records
and information under Sec. 20.85 of this chapter. These officials may
not further redelegate this authority.
(5) The following officials are delegated the authority to disclose
confidential commercial information to State government officials under
Sec. 20.88(d) of this chapter and the ACRA and the Center Directors may
further redelegate this authority.
(i) The ACRA, the Deputy ACRA, ORA and the Director, OE, ORA.
(ii) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER); and the Director and Deputy Director,
Office of Communication, Training, and Manufacturer's Assistance
(OCTMA), CBER.
(iii) The Director and Deputy Director, CDER; the Directors, Office
of Review Management and Office of Pharmaceutical Science, CDER; the
Associate Director for Regulatory Policy, CDER.
(iv) The Director, CDRH, the Deputy Director for Regulations and
Policy, the Deputy Director for Science, and the Director, Office of
Health and Industry Programs, CDRH.
(v) The Director and Deputy Director, CFSAN.
(vi) The Director and Deputy Director, CVM.
(vii) The Director, the Deputy Center Directors, Offices of Research
and Management, respectively, NCTR, and the Deputy Director for
Washington Operations, NCTR.
(6) The following officials are delegated the authority to disclose
nonpublic, predecisional documents to State and foreign government
officials under Sec. Sec. 20.88(e) and 20.89(d) of this chapter and
they may not further redelegate this authority.
(i) The Associate Commissioner for Policy, Office of Policy,
Planning and Legislation (OPPL); and the Director, Office of
International Programs, Office of International and Constituent
Relations (OICR).
(ii) For level 2 nonpublic, predecisional guidance documents, any
Center Director or Deputy Director, and any Director for an OC office
having program responsibilities.
(7) The Associate Commissioner for Policy, OPPL; and the Director,
Office of International Programs, OICR are delegated the authority to
receive nonpublic, predecisional documents from State and foreign
government officials under Sec. Sec. 20.88(e) and 20.89(d) of this
chapter. These officials may not further redelegate this authority.
(8) The following officials are authorized to disclose confidential
commercial information to foreign government officials under Sec.
20.89(c) of this chapter; and they may not further redelegate it:
(i) The Deputy ACRA, ORA; and the Director, OE, ORA.
(ii) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER); and the Director and Deputy Director,
Office of Communication, Training, and Manufacturer's Assistance
(OCTMA), CBER.
(iii) The Director and Deputy Director, CDER; the Directors, Office
of Review Management and Office of Pharmaceutical Science, CDER; the
Associate Director for Medical Policy, CDER; the Associate Director for
Regulatory Policy, CDER, and the Director, Division of Information
Disclosure Policy, Office of Regulatory Policy, CDER.
(iv) The Director, CDRH, the Deputy Director for Regulations and
Policy
[[Page 59]]
and the Deputy Director for Science, CDRH.
(v) The Director and Deputy Director, CFSAN.
(vi) The Director and Deputy Director, CVM.
(vii) The Director, the Deputy Center Directors, Offices of Research
and Management, respectively, and the Deputy Director for Washington
Operations, NCTR.
(b) The Chief, Information Management Team, Division of Data
Management and Services, Office of Information Technology, CDER, is
authorized to sign affidavits regarding the presence or absence of
records of Registration of Drug Establishments. This official may not
further redelegate this authority.
(c) The following officials are authorized to sign affidavits
regarding the presence or absence of medical device establishment
registration records and these officials may not further redelegate this
authority:
(1) The Director, the Deputy Director for Regulations and Policy,
and the Deputy Director for Science, CDRH.
(2) The Director and Deputy Director, Office of Compliance, CDRH.
(3) The Director and Deputy Director, Division of Program
Operations, Office of Compliance, CDRH.
(4) The Chief, Information Processing and Office Automation Branch,
Division of Program Operations, Office of Compliance, CDRH.
(d) The Director, Office of Resource Management, Office of
Regulatory Affairs is authorized to sign affidavits regarding the
presence or absence of records in the files of that office and this
official may not further redelegate this authority.
(e) The Director and Deputy Directors, CBER, the Director and Deputy
Director, Office of Blood Research and Review (OBRR), and the Director
and Deputy Director, Division of Blood Applications, OBRR, CBER, are
authorized to sign affidavits regarding the presence or absence of
records of registration of blood product establishments. These officials
may not further redelegate this authority.
Sec. 5.24 Authority relating to technology transfer.
(a) The Associate Commissioner for Regulatory Affairs is authorized
to perform the functions of the Commissioner of Food and Drugs as
requested by the Commissioner regarding the authority to disapprove or
require modification of cooperative research and development agreements
and licensing agreements and transmit written explanation of such
approval or disapproval to the head of the laboratory concerned under
section 11(c)(5)(A) and (B) of the Stevenson-Wydler Technology
Innovation Act of 1980 (the Act) (15 U.S.C. 3710a(c)(5) (A) and (B)), as
amended.
(b) The following officials are authorized to perform the functions
of the Commissioner of Food and Drugs (Commissioner) requested by the
Commissioner under the Act (15 U.S.C. 3701 et seq.), as amended, and
Executive Order 12591 of April 10, 1987 (except to the extent that
redelegation of those functions is specifically limited in Sec.
5.10(a)(26)), as they pertain to the functions of their respective
organizations, including the authority to perform the functions of
laboratory directors under the Act as the heads of their respective
Federal laboratories, subject to the discretion of the Commissioner to
require that agreements entered into under section 11(a) of the Act (15
U.S.C. 3710a(a)) include provisions in accordance with section
11(c)(5)(A) of the Act (15 U.S.C. 3710a(c)(5)(A):
(1) The Director, Center for Biologics Evaluation and Research.
(2) The Director, Center for Devices and Radiological Health.
(3) The Director, Center for Drug Evaluation and Research.
(4) The Director, Center for Food Safety and Applied Nutrition.
(5) The Director, Center for Veterinary Medicine.
(6) The Director, National Center for Toxicological Research.
(7) The Associate Commissioner for Regulatory Affairs.
(c) These officials may not further redelegate these authorities.
[[Page 60]]
Sec. 5.25 Research, investigation, and testing programs and health
information and promotion programs.
(a) The following officials are authorized under sections 301, 307,
311, 1701, 1702, 1703, and 1704 of the Public Health Service Act (the
PHS Act) (42 U.S.C. 241, 242l, 243, 300u, 300u-1, 300u-2, 300u-3) to
establish research, investigation, and testing programs and health
information and health promotion programs, which relate to their
assigned functions, and to approve grants for conducting such programs:
(1) The Director, the Deputy Director for Washington Operations, and
the Deputy Center Directors, Offices of Research and Management,
respectively, National Center for Toxicological Research (NCTR).
(2) The Director and Deputy Directors for Science and for
Regulations and Policy, Centers for Devices and Radiological Health
(CDRH).
(3) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER).
(4) The Director and Deputy Director, Center for Food Safety and
Applied Nutrition (CFSAN).
(5) The Director and Deputy Director, Center for Veterinary Medicine
(CVM).
(6) The Director and Deputy Director, the Directors, Office of
Review Management and Office of Pharmaceutical Science, Center for Drug
Evaluation and Research (CDER).
(7) The Director, Office of Orphan Products Development (OPD),
Office of the Senior Associate Commissioner (OSAC), Office of the
Commissioner (OC).
(b) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH, are authorized to establish an electronic
product radiation control program and to approve grants for conducting
the program under section 532 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360ii).
(c) The Senior Associate Commissioner for Management and Systems,
Office of Management and Systems (OMS), OC; the Director and Deputy
Director, Office of Facilities, Acquisitions, and Central Services
(OFACS), OMS, OC; the Director, Division of Contracts and Procurement
Management (DCPM), OFACS, OMS, OC; and the Chief Grants Management
Officer and the Grants Management Officer, DCPM, OFACS, OMS, OC are
authorized to sign and issue all notices of grant awards and amendments
thereto and sign and issue notices of suspension and termination thereof
for grants approved under the authority delegated in paragraphs (a) and
(b) of this section.
(d) The Director, NCTR, is authorized under section 301 of the PHS
Act (42 U.S.C. 241), as amended by Public Law 95-622, to make available
to educational institutions, for biomedical and behavioral research,
laboratory animals bred for research purposes of the Center that are not
required to support Center research programs.
(e) The Senior Associate Commissioner for Management and Systems may
further redelegate the authorities in paragraph (c) of this section.
With the exception for paragraph (c) of this section, these officials
may not further redelegate these authorities.
Sec. 5.26 Service fellowships.
(a) Under authority of sections 207(g) and 208(f) of the PHS Act (42
U.S.C. 209(g) and 210(f)), and within the limits of an approved service
fellowship plan, the following officials are authorized to designate
persons to receive service fellowships, appoint service fellows, and
determine specific stipend rates for individual actions within the
ranges established under an approved service fellowship plan:
(1) The Deputy Commissioner; the Senior Associate Commissioner; the
Deputy Commissioner for International and Constituent Relations; the
Senior Associate Commissioner for Management and Systems; the Senior
Associate Commissioner for Policy, Planning, and Legislation; the Chief
Counsel and Deputy Chief Counsels; and the Associate Commissioners and
their Deputies.
(2) The Director, the Deputy Director for Washington Operations, the
Deputy Center Directors for Research and Management, respectively, and
the Associate Director, Office of Management Services, National Center
for Toxicological Research (NCTR).
[[Page 61]]
(3) The Director, the Deputy Directors for Science and for
Regulations and Policy, and the Director, Office of Systems and
Management, Center for Devices and Radiological Health (CDRH).
(4) The Director, the Deputy Directors, the Associate Director for
Research, the Office Directors, and the Director, Office of Management,
Center for Biologics Evaluation and Research (CBER).
(5) The Director, the Deputy Director, and Director, Office of
Management Systems, Center for Food Safety and Applied Nutrition
(CFSAN).
(6) The Director, the Deputy Director, and the Director, Office of
Management and Communications, Center for Veterinary Medicine (CVM).
(7) The Director and Deputy Director, the Directors, Office of
Review Management and Office of Pharmaceutical Science, and the Director
and Deputy Director, Office of Management, Center for Drug Evaluation
and Research (CDER).
(8) The Director, Office of Executive Operations, Office of the
Senior Associate Commissioner, Office of the Commissioner and the
Director, Office of Resource Management, ORA.
(9) Director, Office of Human Resources and Management Services,
Office of Management and Systems, Office of the Commissioner.
(b) These officials may further redelegate this authority, with the
limitation that the Director, Office of Human Resources and Management
Services, OMS, OC, is delegated the authority to approve service
fellowship plans and exceptions to the approved plans, and this official
may not further redelegate this authority.
Sec. 5.27 Patent term extensions for human drug products, medical
devices, and food and color additives; and authority to perform due
diligence determinations and informal hearings.
(a) The Deputy Commissioner is authorized to perform the due
diligence determinations and informal hearings functions under section
156(d)(2)(B)(ii) of title 35 U.S.C. (35 U.S.C. 156), as amended,
relative to patent term extensions.
(b) The Director, Center for Drug Evaluation and Research (CDER) and
the Associate Director for Regulatory Policy, CDER, are authorized to
perform the functions delegated to the Commissioner under title 35
U.S.C. 156, as amended, except for making due diligence determinations
and holding of informal hearings under title 35 U.S.C. 156(d)(2)(B).
(c) The Chief Mediator and Ombudsman, Office of the Ombudsman,
Office of the Senior Associate Commissioner, Office of the Commissioner,
is authorized to perform the functions delegated to the Commissioner to
make due diligence determinations under title 35 U.S.C. 156(d)(2)(B), as
amended, except for holding of informal hearings under title 35 U.S.C.
156(d)(2)(B)(ii).
(d) These officials may not further redelegate this authority.
Sec. 5.28 Hearings.
(a) The following officials are authorized to designate officials to
hold informal hearings that relate to their assigned functions under
sections 305, 404(b), and 801(a) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 335, 344(b), and 381(a)); section 6 of the Fair Packaging
and Labeling Act (15 U.S.C. 1455) (21 U.S.C. 145); section 9(b) of the
Federal Caustic Poison Act (44 Stat. 1406; see also Public Law 86-613,
section 19 formerly section 18); and section 5 of the Federal Import
Milk Act. Officials so designated are delegated authority vested in the
Secretary of Agriculture by 7 U.S.C. 2217 (43 Stat. 803) to administer
to take from any person an oath, affirmation, affidavit, or deposition
for use in any prosecution or proceeding under, or in enforcement of,
any law as cited in this part:
(1) The Director and Deputy Director, Center for Food Safety and
Applied Nutrition (CFSAN); and the Director of Regulations and Policy,
CFSAN.
(2) The Director and Deputy Director, the Directors, Office of
Review Management and Office of Pharmaceutical Science, Center for Drug
Evaluation and Research (CDER); the Associate Director for Regulatory
Policy and the Associate Director for Medical Policy, CDER; the
Directors of the Offices of Drug Evaluation I, II, III, IV, and V,
Office of Review Management, CDER;
[[Page 62]]
and the Director and Deputy Director, Office of Compliance, CDER.
(3) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH).
(4) The Director and Deputy Director, Center for Veterinary Medicine
(CVM).
(5) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER), and the Directors and Deputy Directors,
Office of Blood Research and Review, Office of Vaccines Research and
Review, Office of Therapeutics Research and Review, and Office of
Compliance and Biologics Quality, CBER.
(6) Regional Food and Drug Directors.
(7) District Directors.
(8) The Director, St. Louis Branch.
(b) The Director and Deputy Directors for Science and for
Regulations Policy, CDRH, are authorized to hold hearings, and to
designate other officials to hold informal hearings, under section
360(a) of the PHS Act.
(c) The following officials are authorized to serve as the presiding
officer, and to designate other Food and Drug Administration employees
to serve as the presiding officer, at a regulatory hearing and to
conduct such a hearing under the provisions of part 16 of this chapter.
An official can serve as the presiding officer in a particular hearing
only if he or she satisfies the requirements of Sec. 16.42(b) of this
chapter with respect to the action that is the subject of the hearing.
Such officials are delegated authority vested in the Secretary of
Agriculture by 7 U.S.C. 2217 (43 Stat. 803) to administer or to take
from any person an oath, affirmation, or deposition for use in any
prosecution or proceeding under, or in enforcement of, any law as cited
in this part:
(1) The Director, Office of the Ombudsman, Office of External
Relations, Office of the Commissioner.
(2) The Director and Deputy Director, CFSAN.
(3) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER); the Directors, Office of Review Management and Office
of Pharmaceutical Science, CDER; the Associate Director for Regulatory
Policy and the Associate Director for Medical Policy, CDER, the
Directors of the Offices of Drug Evaluation I, II, III, IV, and V,
Office of Review Management, CDER; and the Director and Deputy Director,
Office of Compliance, CDER.
(4) The Director and Deputy Directors for Science and for
Regulations Policy, CDRH.
(5) The Director and Deputy Director, CVM.
(6) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER), and the Directors and Deputy Directors,
Office of Blood Research and Review, Office of Vaccines Research and
Review, Office of Therapeutics Research and Review, and Office of
Compliance and Biologics Quality, CBER.
(7) Regional Food and Drug Directors.
(8) District Directors.
(9) The Director, St. Louis Branch.
(10) An Administrative Law Judge.
(11) Such other FDA official as is designated by the Commissioner by
memorandum in the proceeding.
(d) These officials may not further redelegate this authority.
[66 FR 30993, June 8, 2001, as amended at 67 FR 53306, Aug. 15, 2002]
Sec. 5.29 Petitions under part 10.
(a) For drugs assigned to their organizations, the following
officials are authorized to grant or deny citizen petitions submitted
under Sec. 10.30 of this chapter for a stay of an effective date in
Sec. 201.59 of this chapter for compliance with certain labeling
requirements for human prescription drugs:
(1)(i) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER).
(ii) The Directors and Deputy Directors, Office of Blood Research
and Review (OBRR), Office of Vaccines Research and Review (OVRR), and
Office of Therapeutics Research and Review (OTRR), CBER.
(iii) The Directors and Deputy Directors of the Divisions in OBRR,
OVRR, and OTRR, CBER.
(2)(i) The Director, the Deputy Director, and the Directors, Office
of Review Management and Office of Pharmaceutical Science, Center for
Drug Evaluation and Research (CDER).
[[Page 63]]
(ii) The Directors and Deputy Directors of the Offices of Drug
Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(iii) The Directors and Deputy Directors of the divisions in the
Offices of Drug Evaluation I, II, III, IV, and V, Office of Review
Management, CDER.
(b) The following officials are authorized to grant or deny citizen
petitions submitted under Sec. 10.30 of this chapter requesting in
vitro test modifications under Sec. 331.29 of this chapter:
(1) The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, CDER.
(2) The Director, Office of Drug Evaluation V, Office of Review
Management, CDER.
(3) The Director and Deputy Director, Division of Over-the-Counter
Drug Products, Office of Drug Evaluation V, Office of Review Management,
CDER.
(c) The following officials are authorized to grant or deny citizen
petitions submitted under Sec. 10.30 of this chapter for a stay of an
effective date or for an exemption from the tamper-resistant packaging
and labeling requirements set forth in Sec. Sec. 211.132, 700.25, or
800.12 of this chapter for certain over-the-counter human drug and
cosmetic products and medical devices which relate to the assigned
functions of the respective organizations:
(1) The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, CDER.
(2) The Director and Deputy Director, Center for Food Safety and
Applied Nutrition (CFSAN); and the Director of Regulations and Policy,
CFSAN.
(3) The Director and the Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH).
(d) The following officials are authorized to grant or deny citizen
petitions submitted under Sec. 10.30 of this chapter requesting
exemption from the general pregnancy-nursing warning for over-the-
counter (OTC) drugs required under Sec. 201.63 of this chapter,
requesting exemption from a general overdose warning required under
Sec. 330.1(g) of this chapter, and requesting exemption from OTC drug
administrative procedures under Sec. 330.10 of this chapter:
(1) The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, CDER.
(2) The Director, Office of Drug Evaluation V, Office of Review
Management, CDER.
(3) The Director and Deputy Director, Division of Over-the-Counter
Drug Products, Office of Drug Evaluation V, Office of Review Management,
CDER.
(e)(1) The following officials are authorized to issue 180-day
tentative responses to citizen petitions on food and cosmetic matters
under Sec. 10.30(e)(2)(iii) of this chapter that relate to the assigned
functions of that Center:
(i) The Director and Deputy Director, CFSAN.
(ii) The Director of Regulations and Policy, CFSAN.
(iii) The Director, Office of Cosmetics and Colors, CFSAN.
(iv) The Director, Office of Nutritional Products, Labeling and
Dietary Supplements, CFSAN.
(v) The Director, Office of Premarket Approval, CFSAN.
(vi) The Director, Office of Plant and Dairy Foods and Beverages,
CFSAN.
(vii) The Director, Office of Seafood, CFSAN.
(viii) The Director, Office of Field Programs, CFSAN.
(2) The Director and Deputy Director, Center for Veterinary Medicine
(CVM), are authorized to issue 180-day tentative responses to citizen
petitions on animal food and drug matters under Sec. 10.30(e)(2)(iii)
of this chapter that relate to the assigned functions of that Center.
(3) The Director and Deputy Directors, CBER, are authorized to issue
180-day tentative responses to citizen petitions on biological product
matters under Sec. 10.30(e)(2)(iii) of this chapter that relate to the
assigned functions of that Center.
(4) The Director, the Deputy Director, and the Associate Director
for Regulatory Policy, CDER, are authorized to issue 180-day tentative
responses to citizen petitions on drug product matters under Sec.
10.30(e)(2)(iii) of this chapter that relate to the assigned functions
of that Center.
[[Page 64]]
(5) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH, are authorized to issue 180-day tentative
responses to citizen petitions on medical device matters under Sec.
10.30(e)(2)(iii) of this chapter that relate to the assigned functions
of that Center.
(f)(1) The Director and Deputy Directors, CBER, are authorized to
grant or deny citizen petitions submitted under Sec. 10.30 of this
chapter on drug and biological product matters in program areas where
they have been delegated final approval authority in the following
sections of this chapter:
(i) Section 5.203 Issuance and revocation of licenses for the
propagation or manufacture and preparation of biological products;
(ii) Section 5.204 Notification of release for distribution of
biological products;
(iii) Section 5.101 Termination of exemptions for new drugs for
investigational use in human beings or in animals;
(iv) Section 5.103 Approval of new drug applications and their
supplements.
(v) Section 5.105 Issuance of notices relating to proposals to
refuse approval or to withdraw approval of new drug applications and
their supplements.
(vi) Section 5.34 Issuance of notices relating to proposals and
orders for debarment and denial of an application to terminate
debarment.
(2) The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, CDER, are
authorized to grant or deny citizen petitions submitted under Sec.
10.30 of this chapter on drug product matters in program areas where
they have been delegated final approval authority in the following
sections of this chapter:
(i) Section 5.100 Issuance of notices implementing the provisions of
the Drug Amendments of 1962;
(ii) Section 5.101 Termination of exemptions for new drugs for
investigational use in human beings or in animals;
(iii) Section 5.103 Approval of new drug applications and their
supplements.
(iv) Section 5.105 Issuance of notices relating to proposals to
refuse approval or to withdraw approval of new drug applications and
their supplements.
(v) Section 5.34 Issuance of notices relating to proposals and
orders for debarment and denial of an application to terminate
debarment.
(3) The Director and Deputy Director, Office of Generic Drugs,
Office of Pharmaceutical Science, CDER, except for those drug products
listed in Sec. 314.440(b) of this chapter, are authorized to issue
responses to citizen petitions submitted under Sec. 10.30 of this
chapter seeking a determination of the suitability of an abbreviated new
drug application for a drug product.
(4) The Directors and Deputy Directors of OBRR, OVRR, and OTRR,
CBER, for those drug products listed in Sec. 314.440(b) of this
chapter, are authorized to issue responses to citizen petitions
submitted under Sec. 10.30 of this chapter seeking a determination of
the suitability of an abbreviated new drug application for a drug
product.
(5) For drugs assigned to their organization, the following
officials are authorized to issue responses to citizen petitions
submitted under Sec. 10.30 of this chapter from sponsors of an
investigational new drug application who request approval to ship in
interstate commerce, in accordance with Sec. 2.125(j) of this chapter,
an investigational new drug for human use containing a
chlorofluorocarbon.
(i) The Director and Deputy Directors, CBER.
(ii) The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, CDER.
(6) The Director and Deputy Director, CVM, are authorized to issue
responses to citizen petitions submitted under Sec. 10.30 of this
chapter from sponsors of an investigational new animal drug application
who request approval to ship in interstate commerce, in accordance with
Sec. 21.125(j) of this chapter, an investigational new animal drug for
animal use containing a chlorofluorocarbon.
(7) The Director and Deputy Director, Office of New Animal Drug
Evaluation, CVM, are authorized to issue responses to citizen petitions
submitted under Sec. 10.30 of this chapter, seeking a determination of
the suitability of an abbreviated new animal drug application for an
animal drug product.
(8) The Director and Deputy Director, CVM, are authorized to grant
or deny citizen petitions submitted under Sec. 10.30
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of this chapter concerning actions they are authorized to take under
Sec. 5.34 Issuance of notices relating to proposals and orders for
debarment and denial of an application to terminate debarment.
(g) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH, and the Director, Office of Compliance,
CDRH, are authorized to grant or deny citizen petitions submitted under
Sec. Sec. 10.30 and 821.2(b) of this chapter, requesting an exemption
or variance from medical device tracking requirements in part 821 of
this chapter.
(h) These officials may not further redelegate this authority.
Sec. 5.30 Authority to select temporary voting members for advisory
committees and authority to sign conflict of interest waivers.
(a) Each Center director is authorized to select members of, and
consultants to, scientific and technical FDA advisory committees under
that Center's management to serve temporarily as voting members on
another advisory committee under that Center's management when expertise
is required that is not available among current voting standing members
of a committee or to comprise a quorum when, because of unforeseen
circumstances, a quorum is or will be lacking. When additional voting
members are added to a committee to provide needed expertise not
available among current voting standing members of a committee, a quorum
will be based on the total of regular and added members. Authority to
select temporary voting members to advisory committees, if such voting
members are serving on an advisory committee managed by another Center,
has not been redelegated. This authority will continue to be exercised
by the Commissioner of Food and Drugs (Commissioner) or the Senior
Associate Commissioner, Office of the Commissioner.
(b) Each Center director is authorized, under 18 U.S.C. 208(b)(1),
to sign conflict of interest waivers for special Government employees
without substantial interest to serve as consultants to advisory
committees or in any other capacity within the Centers except as
advisory committee members.
(c) These officials may not further redelegate this authority.
Sec. 5.31 Enforcement activities.
(a) Designated officers and employees of the Food and Drug
Administration who have been issued the Food and Drug Administration
official credentials consisting of Form FDA-200A, Identification Record,
and Form FDA-200B, Specification of General Authority, are authorized:
(1) To conduct examinations, inspections, and investigations; to
collect and obtain samples; to have access to and to copy and verify
records as authorized by law; to make seizures of items under section
702(e)(5) of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 372 (e) (5)); and to supervise compliance operations for the
enforcement of the act, the Fair Packaging and Labeling Act (15 U.S.C.
1451-1461), the Federal Caustic Poison Act (44 Stat. 140b; see also
Public Law 86-613, section 19, formerly section 18), the Import Milk Act
(21 U.S.C. 141-149), the Filled Milk Act (21 U.S.C. 61-64), and sections
351 and 361 of the PHS Act (42 U.S.C. 262 and 264).
(2) To administer oaths and affirmations under section 1 of the act
of January 31, 1925 (Ch. 124, 43 Stat. 803); sections 12 to 15 of
Reorganization Plan No. IV, effective June 30, 1940; and Reorganization
Plan No. 1 of 1953, effective April 11, 1953.
(b) Any officer or employee of the Food and Drug Administration who
has been designated by the Commissioner of Food and Drugs (Commissioner)
to conduct examinations, investigations, or inspections under the act
relating to counterfeit drugs and issued the Food and Drug
Administration Official Credential consisting of Form FDA-200D, Special
Authority for Criminal Investigators, is authorized to do the following:
(1) As set forth under section 702(e)(1) through (e)(5) of the act
(21 U.S.C. 372(e)(1)-(e)(5)):
(i) Carry firearms;
(ii) Serve and execute search warrants and arrest warrants;
(iii) Execute seizure by process issued under libel under section
304 of the act (21 U.S.C. 334);
[[Page 66]]
(iv) Make arrests without warrant for an offense under the act with
respect to counterfeit drugs if the offense is committed in the presence
of the criminal investigator or, in the case of a felony, if the
investigator has probable cause to believe that the person so arrested
has committed, or is committing, such offense; and
(v) Make, prior to the institution of libel proceedings under
section 304(a)(2) of the act (21 U.S.C. 334(a)(2)), seizures of drugs or
containers or of equipment, punches, dies, plates, stones, labeling, or
other things, if they are, or the criminal investigator has reasonable
grounds to believe that they are, subject to seizure and condemnation
under section 304(a)(2) of the act.
(2) Perform such other functions under the act, or any other law, as
the Commissioner may prescribe.
(3) To administer oaths and affirmations under section 1 of the act
of January 31, 1925 (Ch. 124, 43 Stat. 803); sections 12 to 15 of
Reorganization Plan No. IV, effective June 30, 1940; and Reorganization
Plan No. 1 of 1953, effective April 11, 1953.
(c) Any officer or employee of the Food and Drug Administration who
has been designated by the Commissioner to provide specialized law
enforcement support involving criminal investigations under the act, and
other duties as assigned by the Commissioner, and issued the Food and
Drug Administration Official Credential consisting of Form FDA-200E,
Special Authority for Criminal Investigative Specialists, is authorized
to receive information as to all matters relating to such act and
regulations issued under the act.
(d) These officials may not further redelegate these authorities.
Sec. 5.32 Certification following inspections.
Regional Food and Drug Directors and District Directors are
authorized to issue certificates of sanitation under Sec. 1240.20 of
this chapter. These officials may not further redelegate this authority.
Sec. 5.33 Issuance of reports of minor violations.
(a) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs (Commissioner) under
section 309 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 336)
(the act) regarding the issuance of written notices or warnings:
(1)(i) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER).
(ii) The Director and Deputy Directors, Office of Compliance and
Biologics Quality, CBER.
(2)(i) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH).
(ii) The Director and Deputy Director, Office of Compliance, CDRH.
(iii) For medical devices assigned to their respective divisions,
the Division Directors, Office of Compliance, CDRH.
(iv) The Director and Deputy Director, Office of Surveillance and
Biometrics (OSB), CDRH, and the Director and Deputy Director, Division
of Surveillance Systems (DSS), OSB, CDRH.
(3)(i) The Director and Deputy Director, Center for Food Safety and
Applied Nutrition (CFSAN).
(ii) The Director of Regulations and Policy, CFSAN.
(iii) The Director, Office of Field Programs, CFSAN.
(iv) The Director, Division of Enforcement and Programs, Office of
Field Programs, CFSAN.
(4)(i) The Director and Deputy Director, Center for Veterinary
Medicine (CVM).
(ii) The Director and Deputy Director, Office of Surveillance and
Compliance, CVM.
(iii) The Director, Division of Compliance, Office of Surveillance
and Compliance, CVM.
(5)(i) The Director, the Deputy Director, the Associate Director for
Regulatory Policy, and the Directors, Office of Review Management and
Office of Pharmaceutical Science, Center for Drug Evaluation and
Research (CDER).
(ii) The Director and Deputy Director, Office of Compliance, CDER.
(iii) The Associate Director for Medical Policy, CDER.
(iv) The Director, Division of Drug Marketing, Advertising, and
Communications, Office of Medical Policy, CDER.
[[Page 67]]
(6)(i) Regional Food and Drug Directors.
(ii) District Directors.
(iii) Chiefs of District Compliance Branches.
(iv) The Director, St. Louis Branch.
(v) The Director, Northeast Regional Laboratory, Northeast Region.
(vi) The Director, Southeast Regional Laboratory, Southeast Region.
(vii) The Director, Winchester Engineering and Analytical Center.
(viii) The Director, National Forensic Chemistry Center.
(ix) The Director, Arkansas Regional Laboratory.
(b) The following officials are authorized to perform all the
functions of the Commissioner under section 539(d) of the act (21 U.S.C.
360pp(d)) regarding the issuance of written notices or warnings:
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH).
(2) The Director and Deputy Director, Office of Compliance, CDRH.
(3) For medical devices assigned to their respective divisions, the
Division Directors, Office of Compliance, CDRH.
(4) The Director and Deputy Director, Office of Surveillance and
Biometrics (OSB), CDRH, and the Director and Deputy Director, Division
of Surveillance Systems (DSS), OSB, CDRH.
(5) Regional Food and Drug Directors; District Directors; the
Director, St. Louis Branch; the Director, Northeast Regional Laboratory,
Northeast Region; the Director, Southeast Regional Laboratory, Southeast
Region; the Director, Winchester Engineering and Analytical Center; the
Director, National Forensic Chemistry Center, and the Director, Arkansas
Regional Laboratory when such functions relate to:
(i) Assemblers of diagnostic x-ray systems, as defined in Sec.
1020.30(b) of this chapter; and
(ii) Manufacturers of sunlamp products and ultraviolet lamps
intended for use in any sunlamp product as defined in Sec. 1040.20(b)
of this chapter.
(c) These officials may not further redelegate these authorities.
Sec. 5.34 Issuance of notices relating to proposals and orders for
debarment and denial of an application to terminate debarment.
(a) The Director, the Deputy Director, and the Associate Director
for Regulatory Policy, Center for Drug Evaluation and Research, the
Director and Deputy Director, Center for Veterinary Medicine, and the
Director and Deputy Directors, Center for Biologics Evaluation and
Research are authorized to issue the following notices and make all
findings required in relation to these notices under section 306 of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 335a) which
relate to the assigned functions of their organizations:
(1) Notices of opportunity for hearing on proposals for mandatory or
permissive debarment.
(2) Notices ordering debarment when opportunity for a hearing has
been waived.
(3) Notices ordering debarment where the person notifies the agency
that the person consents to debarment under section 306(c)(2)(B) of the
act (21 U.S.C. 335a(c)(2)(B)).
(4) Notices of opportunity for hearing on proposals denying an
application to terminate debarment under section 306(d)(3) of the act
(21 U.S.C. 335u(d)(3)).
(5) Orders denying an application to terminate debarment under
section 306(d)(3) of the act (21 U.S.C. 335u(d)(3)) when opportunity for
a hearing has been waived.
(b) These officials may not further redelegate these authorities.
Sec. 5.35 Officials authorized to make certification under 5 U.S.C. 605(b)
for any proposed and final rules.
(a) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs with regard to decisions
made under the Regulatory Flexibility Act (5 U.S.C. 605(b)), to certify
that a proposed or final rule, if issued, will not have a significant
economic impact on a substantial number of small entities:
(1) The Associate Commissioner for Regulatory Affairs.
(2) The Director, Center for Biologics Evaluation and Research.
[[Page 68]]
(3) The Director, Center for Drug Evaluation and Research.
(4) The Director, Center for Devices and Radiological Health.
(5) The Director, Center for Food Safety and Applied Nutrition.
(6) The Director, Center for Veterinary Medicine.
(7) Other Food and Drug Administration Officials authorized to issue
Federal Register documents.
(b) These officials may not further redelegate this authority.
Subpart C_Human Drugs; Redelegations of Authority
Sec. 5.100 Issuance of notices implementing the provisions of the Drug
Amendments of 1962.
The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, Center for Drug
Evaluation and Research; and the Director, the Deputy Directors for
Regulations and Policy and for Science, and the Director and Deputy
Directors, Office of Device Evaluation, Center for Devices and
Radiological Health, are authorized to issue notices and amendments
thereto implementing section 107(c)(3) of the Drug Amendments of 1962
(Pub. L. 87-781) by announcing new or revised efficacy findings on human
drugs that are or were subject to the provisions of section 506 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355). These officials
may not further redelegate this authority.
Sec. 5.101 Termination of exemptions for new drugs for investigational
use in human beings.
(a) The following officials, for drugs under their jurisdiction, are
authorized to perform all the functions of the Commissioner of Food and
Drugs on the termination of exemptions for new drugs (including those
that are biological products which are subject to the licensing
provisions of the Public Health Service Act) for investigational use in
human beings under Sec. 312.44 of this chapter and in animals under
Sec. 312.160 of this chapter:
(1) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER).
(2) The Director, the Deputy Director, and the Directors, Office of
Review Management and Pharmaceutical Science, Center for Drug Evaluation
and Research (CDER).
(3) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH).
(b) The following officials, for drugs under their jurisdiction, are
authorized to terminate exemptions for new drugs for investigational use
when sponsors fail to submit an annual progress report under Sec.
312.44(b)(1)(viii) of this chapter:
(1) The Directors and Deputy Directors of the Offices of Drug
Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(2) The Directors and Deputy Directors of the divisions in the
Offices of Drug Evaluation I, II, III, IV, and V, Office of Review
Management, CDER.
(3) The Directors and Deputy Directors, Office of Blood Research and
Review (OBRR), OVRR, and Office of Therapeutics Research and Review
(OTRR), CBER.
(4) The Directors and Deputy Directors of the Division of Blood
Applications, OBRR, the Division of Vaccines and Related Products
Applications, OVRR, and the Division of Application Review and Policy,
OTRR, CBER.
(5) The Director and Deputy Directors, Office of Device Evaluation
(ODE), CDRH.
(c) The following officials, for drugs under their jurisdiction, are
authorized to make the findings set forth in Sec. 312.44(b) of this
chapter and to notify sponsors and invite correction before termination
action on such exemptions:
(1) The Directors and Deputy Directors of the Offices of Drug
Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(2) The Directors and Deputy Directors of the divisions in the
Offices of Drug Evaluation I, II, III, IV, and V, Office of Review
Management, CDER.
(3) The Directors and Deputy Directors, Office of Blood Research and
Review (OBRR), Office of Vaccines Research and Review (OVRR), and Office
of Therapeutics Research and Review (OTRR), CBER.
[[Page 69]]
(4) The Directors and Deputy Directors of the Division of Blood
Applications, OBRR, the Division of Vaccines and Related Products
Applications, OVRR, and the Division of Application Review and Policy,
OTRR, CBER.
(5) The Director and Deputy Directors, ODE, CDRH.
(d) These officials may not further redelegate these authorities.
Sec. 5.102 Authority to approve and to withdraw approval of a charge
for investigational new drugs.
(a) The following officials, for drugs under their jurisdiction, are
authorized to perform all the functions of the Commissioner of Food and
Drugs to approve a charge and to withdraw approval to charge for
investigational drugs in a clinical trial under an investigational new
drug application under Sec. 312.7(d)(1) of this chapter:
(1) The Director, the Deputy Director, and the Directors, Office of
Review Management and the Office of Pharmaceutical Science, Center for
Drug Evaluation and Research.
(2) The Director and Deputy Directors, Center for Biologics
Evaluation and Research.
(b) These officials may not further redelegate this authority.
Sec. 5.103 Approval of new drug applications and their supplements.
(a)(1) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs (Commissioner) with
regard to approval of new drug applications and supplements thereto on
drugs for human use, except for those drugs listed in Sec. 314.440(b)
of this chapter, that have been submitted under section 505 of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355):
(i) The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, Center for Drug
Evaluation and Research (CDER).
(ii) The Directors and Deputy Directors of the Offices of Drug
Evaluation I, II, III, IV, and V, Office of Review Management, CDER, for
drugs under their jurisdiction.
(2) The Director and Deputy Directors, Center for Biologics
Evaluation and Research, for drugs listed in Sec. 314.440(b) of this
chapter, are authorized to perform all the functions of the Commissioner
with regard to approval of new drug applications and supplements thereto
on drugs for human use that have been submitted under section 505 of the
act.
(b) The Directors and Deputy Directors of the divisions in the
Offices of Drug Evaluation I, II, III, IV, and V, Office of Review
Management, CDER, for drugs under their jurisdiction, are authorized to
perform all functions of the Commissioner with regard to approval of
supplemental applications to approved new drug applications for drugs
for human use that have been submitted under Sec. 314.70 of this
chapter and of new drug applications for drug products other than those
that contain new molecular entities (new chemical entities). The
applications to which this authorization applies may, in appropriate
circumstances, continue to be acted upon by the officials so authorized
in Sec. 5.10(a) and paragraph (a) of this section.
(c) The following officials are authorized to perform all the
functions of the Commissioner with regard to approval of abbreviated new
drug applications and supplements thereto for drugs for human use and
new drug applications for drugs with a 5S classification whose clinical
safety and efficacy may be supported by appropriate literature citations
in lieu of submission of data from original proprietary studies, or
section 505(b)(2) of the act (21 U.S.C. 355(b)(2)) applications under
their jurisdiction. The applications to which this authorization applies
may, in appropriate circumstances, continue to be acted upon by the
officials so authorized in Sec. 5.10(a) and paragraph (a) of this
section.
(1) For drugs submitted under Sec. Sec. 314.50, 314.70, and 314.94
of this chapter, except for those drug products listed in Sec.
314.440(b):
(i) The Director and Deputy Director, Office of Generic Drugs (OGD),
Office of Pharmaceutical Science, CDER, except that the Director and
Deputy Director, OGD are not authorized to approve new drug applications
with a 5S classification if clinical studies are needed.
(ii) The Directors and Deputy Directors of the divisions in Offices
of Drug
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Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(2) For drug products listed in Sec. 314.440(b) of this chapter and
submitted under Sec. Sec. 314.50, 314.70, and 314.94 of this chapter:
The Directors and Deputy Directors, Office of Blood Research and Review,
Office of Vaccines Research and Review, Office of Therapeutics Research
and Review, and Office of Compliance and Biologics Quality, CBER.
(d) The following officials are authorized to perform all functions
of the Commissioner with respect to approval of supplemental
applications to abbreviated new drug applications, 5S applications, or
section 505(b)(2) applications for drugs for human use that are
described in Sec. Sec. 314.70(b)(1), (b)(2)(ii) through (b)(2)(x),
(c)(1), and (c)(3) of this chapter. (Authority to approve supplements
that require in vivo bioavailability studies or that include in vivo
bioavailability study waiver requests are not included in this
paragraph.)
(1) The Director and Deputy Director, Division of Chemistry I,
Office of Generic Drugs, Office of Pharmaceutical Science, CDER.
(2) The Director and Deputy Director, Division of Chemistry II,
Office of Generic Drugs, Office of Pharmaceutical Science, CDER.
(3) Associate Director for Chemistry, Office of New Drug Chemistry,
Office of Pharmaceutical Science, CDER.
(e) The Director, Division of Labeling and Program Support, Office
of Generic Drugs, Office of Pharmaceutical Science, CDER, are authorized
to perform all the functions of the Commissioner with respect to
approval of supplemental applications to abbreviated new drug
applications, 5S applications, or section 505(b)(2) applications for
drugs for human use that are described in Sec. Sec. 314.70(b)(3) and
(c)(2)(i) through (c)(2)(iv) of this chapter. Authority to approve
supplements that require in vivo bioavailability studies or in vivo
study waiver requests is not included in this paragraph.
(f) The supervisory and team leader chemists in the Divisions of New
Drug Chemistry I, II, and III, Office of New Drug Chemistry, Office of
Pharmaceutical Science, CDER, are authorized to perform all functions of
the Commissioner with respect to approval of supplemental applications
to new drug applications for drugs for human use that are described in
Sec. Sec. 314(b)(1), (b)(2)(ii) through (b)(2)(x), (c)(1), and (c)(3)
of this chapter. Authority to approve supplements that require in vivo
bioavailability information or that require a change in the labeling of
the drug, except changes that reflect only the use of a different
facility or establishment, are not included in this paragraph. The
supplemental applications to which this authorization applies may
continue to be acted upon by the officials so authorized in Sec.
5.10(a) and paragraphs (a) and (b) of this section.
(g) These officials may not further redelegate these authorities.
Sec. 5.104 Responses to Drug Enforcement Administration temporary
scheduling notices.
The Director, Center for Drug Evaluation and Research (CDER) and the
Director, Executive Operations Staff, Office of the Center Director,
CDER, are authorized to provide responses to the Drug Enforcement
Administration's temporary scheduling notices under section 201(h)(4) of
the Controlled Substances Act, as amended (21 U.S.C. 811(h)(4)). The
delegation excludes the authority to submit reports to Congress. These
officials may not further redelegate this authority.
Sec. 5.105 Issuance of notices relating to proposals to refuse approval
or to withdraw approval of new drug applications and their supplements.
(a) The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, Center for Drug
Evaluation and Research (CDER), are authorized to issue notices of an
opportunity for a hearing on proposals to refuse approval or to withdraw
approval of new drug applications and abbreviated new drug applications
and supplements thereto on drugs for human use, except for those drugs
listed in Sec. 314.440(b) of this chapter, that have been submitted
under section 505 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 355) and subpart B of part 314 of this chapter and to issue
notices refusing approval
[[Page 71]]
or withdrawing approval when opportunity for hearing has been waived.
(b) The Director and Deputy Directors, Center for Biologics
Evaluation and Research, for those drugs listed in Sec. 314.440(b) of
this chapter, are authorized to issue notices of an opportunity for a
hearing on proposals to refuse approval or to withdraw approval of new
drug applications and abbreviated new drug applications and supplements
thereto on drugs for human use that have been submitted under section
505 of the act and subpart B of part 314 of this chapter and to issue
notices refusing approval or withdrawing approval when opportunity for
hearing has been waived.
(c) These officials may not further redelegate these authorities.
Sec. 5.106 Submission of and effective approval dates for abbreviated
new drug applications and certain new drug applications.
(a) The following officials are authorized to perform all of the
functions of the Commissioner of Food and Drugs with regard to decisions
made under section 505(c)(3)(D), (j)(4)(B)(iv), and (j)(4)(D) and
section 505A of the Federal Food, Drug and Cosmetic Act (the act) (21
U.S.C. 355(c)(3)(D), (j)(4)(B)(ii) and (j)(4)(D) and 355a) concerning
the date of submission or the date of effective approval of abbreviated
new drug applications including supplements thereto submitted under
section 505(j) of the act (21 U.S.C. 355(j)) and of new drug
applications including supplements thereto submitted under section
505(b)(1) (21 U.S.C. 355(b)(1)) of the act and described under section
505(b)(2) of the act (21 U.S.C. 355(b)(2)):
(1) The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, Center for Drug
Evaluation and Research (CDER).
(2) The Director and Deputy Director, Office of Generic Drugs,
Office of Pharmaceutical Science, CDER.
(b) These officials may not further redelegate this authority.
Sec. 5.107 Extensions or stays of effective dates for compliance with
certain labeling requirements for human prescription drugs.
(a) The following officials are authorized to extend or stay an
effective date in Sec. 201.59 of this chapter for compliance with
certain labeling requirements for human prescription drugs.
(1) For drugs assigned to their organizations:
(i) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER).
(ii) The Directors and Deputy Directors, Office of Blood Research
and Review (OBRR), Office of Vaccines Research and Review (OVRR), and
Office of Therapeutics Research and Review (OTRR), CBER.
(iii) The Directors and Deputy Directors of the Divisions in OBRR,
OVRR, and OTRR, CBER.
(2) For drugs assigned to their organizations:
(i) The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, Center for Drug
Evaluation and Research (CDER).
(ii) The Directors and Deputy Directors of the Offices of Drug
Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(iii) The Directors and Deputy Directors of the divisions in the
Offices of Drug Evaluation I, II, III, IV, and V, Office of Review
Management, CDER.
(b) These officials may not further redelegate this authority.
Sec. 5.108 Authority relating to waivers or reductions of prescription
drug user fees.
The Director, Center for Drug Evaluation and Research (CDER), and
the Associate Director for Regulatory Policy, CDER, are authorized to
perform all the functions of the Commissioner of Food and Drugs relating
to waivers or reductions of prescription drug user fees under the
Prescription Drug User Fee Act of 1992, as originally enacted and as
reauthorized by the Food and Drug Administration Modernization Act of
1997, except for the functions under section 736(d)(1)(C) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379h(d)(1)(C)) that
pertain to
[[Page 72]]
situations where ``the fees will exceed the anticipated present and
future costs,'' on behalf of CDER, the Center for Biologics Evaluation
and Research, and any other Food and Drug Administration Center. This
authority pertains to waivers requested under the public health waiver
provision (21 U.S.C. 379h(d)(1)(A)); the barrier to innovation waiver
provision (21 U.S.C. 379h(d)(1)(B)); the applications submitted under
section 505(b)(1) and (b)(2) of the Federal Food, Drug, and Cosmetic Act
waiver provision (21 U.S.C. 379h(d)(1)(D)); the small business waiver
provision (21 U.S.C. 379h(d)(1)(E)); and to requests for refunds of fees
if an application or supplement is withdrawn after filing (21 U.S.C.
379h(a)(1)(G)); as well as waivers, reductions, or refunds requested on
any other basis except fees exceeding the cost. (See Sec. 5.20(h)(1)
for the authority to reconsider any user fee decisions made by the Chief
Mediator and Ombudsman, the Deputy Chief Mediator and Ombudsman, and/or
the former Deputy User Fee Waiver Officer prior to July 1, 1999.) These
officials may not further redelegate this authority.
Sec. 5.109 Issuance of written notices concerning patent information,
current good manufacturing practices and false or misleading labeling
of new drugs.
(a) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs under Sec. 505(e) of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e))
regarding the issuance of written notices.
(1) The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, Center for Drug
Evaluation and Research (CDER).
(2) The Director and Deputy Director, Office of Compliance, CDER.
(3) The Director and Deputy Director, Division of Labeling and
Nonprescription Drug Compliance, Office of Compliance, CDER.
(4) The Director and Deputy Director, Division of Manufacturing and
Product Quality, Office of Compliance, CDER.
(5) The Director and Deputy Director, Division of Prescription Drug
Compliance and Surveillance, Office of Compliance, CDER.
(6) The Associate Director for Medical Policy, and the Director and
Deputy Director, Division of Scientific Investigations, Office of
Medical Policy, CDER.
(7) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER), the Director and Deputy Directors,
Office of Compliance and Biologics Quality (OCBQ), CBER, and the
Directors, Division of Case Management, Division of Inspections and
Surveillance, and Division of Manufacturing and Product Quality, OCBQ,
CBER.
(8) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH), and the Director and Deputy Directors of the Office of Device
Evaluation, CDRH.
(9) Regional Food and Drug Directors.
(10) District Directors.
(b) These officials may not further redelegate this authority.
Subpart D_Biologics; Redelegations of Authority
Sec. 5.200 Functions pertaining to safer vaccines.
(a) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER) are authorized to perform the functions
of the Commissioner of Food and Drugs (Commissioner) under part C,
subtitle 2 of title XXI of the PHS Act (42 U.S.C. 300aa-25 et seq.), as
amended, and the National Childhood Vaccine Injury Act of 1986 (42
U.S.C. 300aa-1 note), as amended hereafter, as follows:
(1) Section 2125 of the PHS Act (42 U.S.C. 300aa-25)-Recording and
reporting of information.
(2) Section 2127 of the PHS Act (42 U.S.C. 300aa-27)-Mandate for
safer childhood vaccines.
(3) Section 2128 of the PHS Act (42 U.S.C. 300aa-28)-Manufacturer
recordkeeping and reporting.
(4) Section 312 of the National Childhood Vaccine Injury Act of
1986-Related studies (42 U.S.C. 300aa-1 note), except that the authority
to provide for notice and opportunity for public
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hearing on the review of vaccines and related illnesses and conditions
under sections 312(a) and (d) of the National Childhood Vaccine Injury
Act of 1986 is not redelegated by the Commissioner.
(5) Section 313 of the National Childhood Vaccine Injury Act of
1986-Study of other vaccine risks (42 U.S.C. 300aa-1 note), except that
the authority to provide for notice and opportunity for public hearing
on the establishment of guidelines regarding the risks to children of
certain vaccines under section 313(a)(1)(B) and (b) of the National
Childhood Vaccine Injury Act of 1986 is not redelegated by the
Commissioner.
(6) Section 314 of the National Childhood Vaccine Injury Act of
1986-Review of warnings, use instructions, and precautionary information
(42 U.S.C. 300aa-1 note).
(b) These officials may not further redelegate these authorities.
Sec. 5.201 Redelegation of the Center for Biologics Evaluation and
Research Director's program authorities.
(a) The following officials are authorized to perform all the
functions of the Director, Center for Biologics Evaluation and Research
(CBER) with regard to program authorities for their respective areas:
(1) Deputy Directors, CBER.
(2) Associate Directors, CBER.
(3) Office Directors, CBER.
(4) Division Directors, CBER.
(b) These officials may not further redelegate these authorities.
Sec. 5.202 Issuance of notices of opportunity for a hearing on proposals
for denial of approval of applications for licenses, suspension of licenses,
or revocation of licenses and certain notices of revocation of
licenses.
(a) The Director and Deputy Directors, Center for Biologics
Evaluation and Research are authorized to issue:
(1) Notices of opportunity for a hearing on proposals to deny
approval or filing of applications for biologics licenses under Sec.
601.4(b) of this chapter.
(2) Notices of opportunity for a hearing on proposals to revoke
biologics licenses under Sec. 601.5(b) of this chapter.
(3) Notices of revocation, at the manufacturer's request, of
biologics licenses under Sec. Sec. 601.5(a) and 601.8 of this chapter.
(4) Notices of revocation when the manufacturer has waived the
opportunity for hearing under Sec. 601.7(a) of this chapter.
(5) Notice of biologics license suspensions under Sec. 601.6 of
this chapter.
(b) These officials may not further redelegate these authorities.
Sec. 5.203 Issuance and revocation of licenses for the propagation or
manufacture and preparation of biological products.
(a) The following officials are authorized to issue licenses under
section 351 of the PHS Act (42 U.S.C. 262) for the propagation or
manufacture and preparation of biological products as specified in the
PHS Act, and to revoke such licenses at the manufacturer's request:
(1) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER).
(2) Directors and Deputy Directors, Office of Blood Research and
Review, Office of Vaccines Research and Review, Office of Therapeutics
Research and Review, and Office of Compliance and Biologics Quality,
CBER.
(b) These officials may not further redelegate this authority.
Sec. 5.204 Notification of release for distribution of biological
products.
(a) The following officials are authorized to issue written notices
of release for distribution of licensed biological products under
subchapter F (parts 600 through 680.31) of this chapter:
(1) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER).
(2) The Director and Deputy Directors, Office of Compliance and
Biologics Quality (OCBQ), CBER.
(3) The Director and Deputy Director, Division of Manufacturing and
Product Quality, OCBQ, CBER.
(b) These officials may not further redelegate this authority.
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Subpart E_Food and Cosmetics; Redelegations of Authority
Sec. 5.300 Food standards, food additives, generally recognized as
safe (GRAS) substances, color additives, nutrient content claims,
and health claims.
(a)(1) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs (Commissioner) under
sections 409 and 721 of the act (21 U.S.C. 348 and 379e) regarding the
issuance of notices of filing (including notices of extension of, or
reopening of, the comment period), and of voluntary withdrawal, of
petitions on food additives, generally recognized as safe (GRAS)
substances, and color additives that relate to the assigned functions of
the respective Center:
(i) The Director and Deputy Director, Center for Food Safety and
Applied Nutrition (CFSAN).
(ii) The Director of Regulations and Policy, CFSAN.
(iii) The Director, Office of Premarket Approval, CFSAN
(iv) The Director and Deputy Director, Center for Veterinary
Medicine (CVM).
(2) The Director, Deputy Director, and Director of Regulations and
Policy, CFSAN are authorized to perform all the functions of the
Commissioner under section 401 of the act (21 U.S.C. 341) regarding the
issuance of proposed rulemaking (including notices of extension of, or
reopening of, the comment period) pertaining to food standards.
(b)(1) The Director, Deputy Director, and Director of Regulations
and Policy, CFSAN are authorized to perform all of the functions of the
Commissioner under section 409 and 721 of the act (21 U.S.C. 348 and
379e) regarding the approval of the use of food additives under section
409(e) of the act (21 U.S.C. 348(e)) and the listing of color additives
under section 721(d)(1) of the act (21 U.S.C. 379e) where the listing
does not involve novel or controversial issues and does not involve any
questions about the applicability of the Delaney Anti-Cancer Clause.
(2) The following officials are authorized to perform all of the
functions of the Commissioner under section 401 of the act (21 U.S.C.
341) regarding the issuance of notices of temporary permits for foods
varying from standards of identity under Sec. 130.17 of this chapter:
(i) The Director and Deputy Director, CFSAN.
(ii) The Director of Regulations and Policy, CFSAN.
(iii) The Director, Office of Nutritional Products, Labeling, and
Dietary Supplements, CFSAN.
(3) The Director and Deputy Director, CVM, are authorized to perform
all the functions of the Commissioner regarding approvals of the use of
food additives under section 409(e) of the act (21 U.S.C. 348(e)), where
these approvals do not involve novel or controversial issues, including
any question about the applicability of the Delaney Anti-Cancer Clause.
(c)(1) The following officials are authorized to issue 90-day
letters to food additive petitioners under section 409(c)(2) of the act
(21 U.S.C. 348(c)(2)) or to color additive petitions under section
721e(d)(1) (21 U.S.C. 379e(d)(1)) of the act that relate to the assigned
functions of the Center:
(i) The Director and Deputy Director, CFSAN.
(ii) The Director of Regulations and Policy, CFSAN.
(iii) The Director, Office of Premarket Approval, CFSAN.
(iv) The Director, Division of Product Policy, Office of Premarket
Approval, CFSAN.
(v) The Director, Division of Petition Control, Office of Premarket
Approval, CFSAN.
(2) The following officials are authorized to issue 90-day letters
to food additive petitioners under section 409(c)(2) of the act (21
U.S.C. 348(c)(2)) that relate to the assigned functions of the Center:
(i) The Director and Deputy Director, CVM.
(ii) The Director and Deputy Director, Office of Surveillance and
Compliance, CVM.
(iii) The Director and Deputy Director, Division of Animal Feeds,
Office of Surveillance and Compliance, CVM.
(d) The following officials are authorized to certify batches of
color additives under section 721 of the act (21 U.S.C. 379e):
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(1) The Director and Deputy Director, CFSAN.
(2) The Director of Regulations and Policy, CFSAN.
(3) The Director, Office of Cosmetics and Colors, CFSAN.
(e) The following officials are authorized to issue advance notices
of proposed rulemaking pertaining to Codex Alimentarius food standards
and notices terminating consideration of such standards when comments
fail to support the desirability and need for proposing their adoption,
under Sec. 130.6 of this chapter:
(1) The Director and Deputy Director, CFSAN.
(2) The Director of Regulations and Policy, CFSAN.
(3) The Director, Office of Nutritional Products, Labeling, and
Dietary Supplements, CFSAN.
(f) The following officials are authorized to issue notices of
proposed rulemaking and issue or amend regulations affirming GRAS status
of food substances under Sec. Sec. 170.35 or 570.35 of this chapter
where the affirmations relate to the assigned functions of the
respective Center and do not involve novel or controversial issues:
(1) The Director, Deputy Director, and Director of Regulations and
Policy, CFSAN.
(2) The Director and Deputy Director, CVM.
(g)(1) The following officials are authorized to perform all of the
functions of the Commissioner under section 403(r)(4) of the act (21
U.S.C. 343(r)(4)) regarding the issuance of decisions to grant or deny
petitions for nutrient content claims and health claims that do not
present controversial issues and regarding the issuance of any notices
of proposed rulemaking that result from such action:
(i) The Director and Deputy Director, CFSAN.
(ii) The Director of Regulations and Policy, CFSAN.
(2) The following officials are authorized to perform all of the
functions of the Commissioner under section 403(r)(4) of the act (21
U.S.C. 343(r)(4)) regarding the issuing of letters of filing in response
to petitions for nutrient content claims and health claims:
(i) The Director and Deputy Director, CFSAN.
(ii) The Director of Regulations and Policy, CFSAN.
(iii) The Director, Office of Nutritional Products, Labeling, and
Dietary Supplements, CFSAN.
(h) The following officials are authorized to issue letters
concerning substances determined to be below the ``threshold of
regulation'' under Sec. 170.39 of this chapter:
(1) The Director and Deputy Director, CFSAN.
(2) The Director of Regulations and Policy, CFSAN.
(3) The Director, Office of Premarket Approval, CFSAN.
(4) The Directors of the Divisions of Petition Control and Product
Policy, Office of Premarket Approval, CFSAN.
(i) The following officials are authorized to perform all of the
functions of the Commissioner under section 409(h) of the act (21 U.S.C.
348(h)), excluding the duties to set out in section 409(h)(5) of the act
(21 U.S.C. 348(h)(5)), regarding premarket notification of food-contact
substances:
(1) The Director and Deputy Director, CFSAN.
(2) The Director of Regulations and Policy, CFSAN.
(3) The Director, Office of Premarket Approval, CFSAN.
(j) These officials may not further redelegate these authorities.
Sec. 5.301 Issuance of initial emergency permit orders and notices of
confirmation of effective date of final regulations on food for human
and animal consumption.
(a) The Director and Deputy Director, Center for Food Safety and
Applied Nutrition (CFSAN), the Director, Office of Field Programs,
CFSAN, and the Director, Division of Enforcement and Programs, Office of
Field Programs, CFSAN, are authorized to issue initial emergency permit
orders under Sec. 108.5 of this chapter.
(b) The following officials are authorized to issue notices of
confirmation of effective date of final regulations on food matters
issued under section 701(e) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 371(e)):
(1) The Director and Deputy Director, CFSAN.
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(2) The Director of Regulations and Policy, CFSAN.
(3) The Director, Office of Nutritional Products, Labeling, and
Dietary Supplements, CFSAN.
(4) The Director, Office of Plant and Dairy Foods and Beverages,
CFSAN.
(5) The Director, Office of Seafood, CFSAN.
(6) The Director, Office of Field Programs, CFSAN.
(7) The Director, Office of Premarket Approval, CFSAN.
(c) These officials may not further redelegate these authorities.
Sec. 5.302 Detention of meat, poultry, eggs, and related products.
The Regional Food and Drug Directors and District Directors are
authorized to perform and to designate other officials to perform all of
the functions of the Commissioner of Food and Drugs under:
(a) Section 409(b) of the Federal Meat Inspection Act (21 U.S.C.
679(b)), that relates to the detention of any carcass, part thereof,
meat, or meat product of cattle, sheep, swine, goats, or equines.
(b) Section 24(b) of the Poultry Products Inspection Act (21 U.S.C.
467f(b)) that relates to the detention of any poultry carcass, part
thereof, or poultry product.
(c) The Egg Products Inspection Act (21 U.S.C. 1031 et seq.).
Sec. 5.303 Establishing standards and approving accrediting bodies
under the National Laboratory Accreditation Program.
The Director, Deputy Director, and Director of Regulations and
Policy, Center for Food Safety and Applied Nutrition, are authorized to
perform all the functions of the Commissioner of Food and Drugs under
sections 1322(b) and (c) of the Food, Agriculture, Conservation, and
Trade Act of 1990 (the National Laboratory Accreditation Program) (7
U.S.C. 138a), as amended hereafter, which relate to setting standards
for the National Laboratory Accreditation Program and approving State
agencies or private, nonprofit entities as accrediting bodies to
implement certification and quality assurance programs in accordance
with the requirements of these sections. The delegation excludes the
authority to submit reports to the Congress. These officials may not
further redelegate this authority.
Sec. 5.304 Approval of schools providing food-processing instruction.
(a) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs (Commissioner) under
Sec. 113.10 of this chapter regarding the approval of schools giving
instruction in retort operations, processing systems operations, aseptic
processing and packaging system operations, and container closure
inspections:
(1) The Director and Deputy Director, Center for Food Safety and
Applied Nutrition (CFSAN).
(2) The Director of Regulations and Policy, CFSAN.
(3) The Director, Office of Plant and Dairy Foods and Beverages,
CFSAN.
(b) These officials may not further redelegate this authority.
Subpart F_Medical Devices and Radiological Health; Redelegations of
Authority
Sec. 5.400 Issuance of Federal Register documents to recognize or to
withdraw recognition of a standard to meet premarket submission
requirements.
(a) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health; and
the Director and Deputy Directors, Center for Biologics Evaluation and
Research, are authorized to issue Federal Register documents under
section 514(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 360d(c)) recognizing or withdrawing recognition of a standard for
which a person may submit a declaration of conformity in order to meet a
premarket submission requirement.
(b) These officials may not further redelegate this authority.
Sec. 5.401 Issuance of Federal Register documents pertaining to
exemptions from premarket notification.
(a) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health; and
the Directors
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and Deputy Directors, Center for Biologics Evaluation and Research, are
authorized to make determinations and issue Federal Register notices and
rules under section 510(m) of the act (21 U.S.C. 360(m)) concerning
exemptions from premarket notification.
(b) These officials may not further redelegate this authority.
Sec. 5.402 Detention of adulterated or misbranded medical devices.
(a) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs pertaining to detention,
under section 304(g) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 334(g)) and in accordance with Sec. 800.55 of this chapter, of
medical devices that may be adulterated or misbranded:
(1) For medical devices assigned to their respective organizations:
(i) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH).
(ii) The Director and Deputy Director, Office of Compliance, CDRH.
(iii) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER).
(iv) The Director and Deputy Directors, Office of Compliance and
Biologics Quality, CBER.
(2) Regional Food and Drug Directors.
(3) District Directors.
(4) The Director, St. Louis Branch.
(b) These officials may not further redelegate this authority.
Sec. 5.403 Authorization to use alternative evidence for determination
of the effectiveness of medical devices.
(a) The following officials, for medical devices assigned to their
respective organizations, may authorize under section 513(a)(3)(B) of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
360c(a)(3)(B)) the use of valid scientific evidence (other than that
prescribed by section 513(a)(3)(A) of the act) for determining the
effectiveness of medical devices for the purposes of sections 513, 514,
and 515 of the act (21 U.S.C. 360c, 360d, and 360e):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH), and the Director and Deputy Directors, Office of Device
Evaluation, CDRH.
(2) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER), and the Directors and Deputy Director,
Office of Blood Research and Review (OBRR), Office of Vaccines Research
and Review (OVRR), and Office of Therapeutics Research and Review
(OTRR), CBER.
(b) These officials may not further redelegate this authority.
Sec. 5.404 Notification to petitioners of determinations made on
petitions for reclassification of medical devices.
(a) The following officials, for medical devices assigned to their
respective organizations, are authorized to notify petitioners of
determinations made on petitions for reclassification of medical devices
that are classified in class III (premarket approval) by sections 513(f)
and 520(l) of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 360c(f) and 360 j(1)) and denials of petitions for
reclassification of medical devices that are submitted under section
513(e) of the act (21 U.S.C. 360c(e)) (except for petitions submitted in
response to Federal Register notices initiating standard-setting under
section 514(b) of the act (21 U.S.C. 360d(b)) or premarket approval
under section 515(b) of the act (21 U.S.C. 360e(b)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH) and the Director and Deputy Directors, Office of Device
Evaluation.
(2) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER), and the Directors and Deputy Directors,
Office of Blood Research and Review, Office of Vaccines Research and
Review, and Office of Therapeutics Research and Review, CBER.
(b) These officials may not further redelegate this authority.
[[Page 78]]
Sec. 5.405 Determination of classification of devices.
(a) The following officials, for devices assigned to their
respective organizations, are authorized to determine the classification
of a medical device in commercial distribution prior to May 28, 1976,
under section 513(d) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360c(d)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH) and the Director and Deputy Directors, Office of Device
Evaluation (ODE), CDRH.
(2) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER), and the Director and Deputy Directors of
the Office of Blood Research and Review (OBRR), the Office of Vaccines
Research and Review (OVRR), and the Office of Therapeutics Research and
Review (OTRR), CBER.
(b) The following officials, for devices assigned to their
respective organizations, are authorized to determine the classification
of a medical device first intended for commercial distribution after May
28, 1976, under section 513(f)(1)(A) of the act (21 U.S.C.
360c(f)(1)(A)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH, and the Director, Deputy Directors,
Division and Deputy Division Directors, Associate Division Directors,
Branch Chiefs, and Chief, Premarket Notification Section, ODE, CDRH.
(2) The Director and Deputy Directors, CBER, and the Directors and
Deputy Directors of the OBRR, OVRR, and OTRR, CBER.
(c) The following officials are authorized to make determinations
and issue orders classifying devices under section 513(f)(2)(b):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Directors, ODE, CDRH.
(3) The Director and Deputy Directors, CBER, and the Directors and
Deputy Directors of the OBRR, OVRR, and OTRR, CBER.
(d) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH, and the Director and Deputy Directors,
CBER, and the Directors and Deputy Directors of the OBRR, OVRR, and
OTRR, CBER, are authorized to issue Federal Register notices under
section 513(f)(2)(C) of the act (21 U.S.C. 360c(f)(2)(C)) announcing
classification of devices under section 513(f)(2)(B) of the act (21
U.S.C. 360c(f)(2)(B)).
(e) These officials may not further redelegate those authorities.
Sec. 5.406 Notification to sponsors of deficiencies in petitions for
reclassification of medical devices.
(a) The following officials, for medical devices assigned to their
respective organizations, are authorized to notify sponsors of
deficiencies in petitions for reclassification of medical devices
submitted under sections 513(f) and 520(l) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360c(f) and 360j(l)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH), and the Director and Deputy Directors, Office of Device
Evaluation, CDRH.
(2) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER), and the Directors and Deputy Directors
of the Office of Blood Research and Review, Office of Vaccines Research
and Review, and Office of Therapeutics Research and Review, CBER.
(b) These officials may not further redelegate this authority.
Sec. 5.407 Approval, disapproval, or withdrawal of approval of product
development protocols and applications for premarket approval for medical
devices.
(a) The following officials, for medical devices assigned to their
respective organizations, are authorized to approve, disapprove, declare
as complete or incomplete, or revoke product development protocols for
medical devices submitted under section 515(f) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(f)):
(1) The Director and Deputy Directors for Science and for
Regulations
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and Policy, Center for Devices and Radiological Health (CDRH), the
Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH,
and the Division Directors, ODE, CDRH.
(2) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER), and the Director and Deputy Directors,
Office of Blood Research and Review (OBRR), Office of Vaccines Research
and Review (OVRR), and Office of Therapeutics Research and Review
(OTRR), CBER.
(b)(1) The following officials, for medical devices assigned to
their respective organizations, are authorized to approve, disapprove,
or withdraw approval of applications for premarket approval for medical
devices submitted under sections 515 and 520(l) of the act (21 U.S.C.
360e and 360j(l)):
(i) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH, the Director and Deputy Directors, ODE,
CDRH, and the Division Directors, ODE, CDRH.
(ii) The Director and Deputy Directors, CBER, and the Directors and
Deputy Directors, OBRR, OVRR, and OTRR, CBER.
(2) For medical devices assigned to their respective division, the
Division Directors, Office of Device Evaluation, CDRH, are authorized to
approve, disapprove, or withdraw approval of supplemental premarket
applications.
(c) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH, for medical devices assigned to their
organization, are authorized to issue notices to announce the approval,
disapproval, or withdrawal of approval of a device, and to make publicly
available a detailed summary of the information on which the decision
was based, under sections 515(d), (e), and (g) and 520(h)(1) of the act
(21 U.S.C. (d), (e), and (g) and 360j(h)(1)).
(d) These officials may not further redelegate these authorities.
Sec. 5.408 Determinations concerning the type of valid scientific
evidence submitted in a premarket approval application.
(a) The following officials are authorized to make determinations
under section 513(a)(3)(D) of the act (21 U.S.C. 360c(a)(3)(D))
concerning the type of valid scientific evidence to be submitted in a
premarket approval application that will provide a reasonable assurance
that a device is effective under the conditions of use proposed by such
person:
(i) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(ii) The Director and Deputy Directors, Office of Device Evaluation
(ODE), CDRH.
(iii) The Director, Program Operations Staff, ODE, CDRH.
(iv) For devices assigned to their respective Divisions: the
Division Directors and Deputy Division Directors, ODE, CDRH.
(b) These officials may may not further redelegate this authority.
Sec. 5.409 Determinations that medical devices present unreasonable
risk of substantial harm.
(a) The following officials, for medical devices assigned to their
respective organizations, are authorized to determine that medical
devices present an unreasonable risk of substantial harm to the public
health, and to order adequate notification thereof, under section 518(a)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(a)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH), and the Director and Deputy Director, Office of Compliance,
CDRH.
(2) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER), and the Director and Deputy Director,
Office of Compliance and Biologics Quality, CBER.
(3) The Director, the Deputy Director, and the Directors, Office of
Review Management and Pharmaceutical Science, Center for Drug Evaluation
and Research (CDER); and the Director and Deputy Director, Office of
Compliance, CDER.
(b) These officials may not further redelegate this authority.
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Sec. 5.410 Orders to repair or replace, or make refunds for, medical
devices.
(a) The following officials, for medical devices assigned to their
respective organizations, are authorized to order repair or replacement
of, or refund for, medical devices under section 518(b) and (c) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(b) and (c)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH), and the Director and Deputy Director, Office of Compliance,
CDRH.
(2) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER), and the Director and Deputy Directors,
Office of Compliance and Biologics Quality, CBER.
(3) The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, Center for Drug
Evaluation and Research (CDER); and the Director and Deputy Director,
Office of Compliance, CDER.
(b) These officials may not further redelegate this authority.
Sec. 5.411 Medical device recall authority.
(a) The following officials, for medical devices assigned to their
respective organizations, are authorized to perform all of the recall
functions under section 518(e) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360h(e)), which have been delegated to the Commissioner
of Food and Drugs:
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH).
(2) The Director and Deputy Director, Office of Compliance, CDRH.
(3) The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, Center for Drug
Evaluation and Research (CDER); and the Director and Deputy Director,
Office of Compliance, CDER.
(4) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER), and the Director and Deputy Directors,
Office of Compliance and Biologics Quality, CBER.
(b) These officials may not further redelegate this authority.
Sec. 5.412 Temporary suspension of a medical device application.
(a) The following officials for medical devices assigned to their
respective organizations are authorized under section 515(e) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(e)), to determine
that there is reasonable probability that continuation of the
distribution of a device under an approved application would cause
serious adverse health consequences or death, and upon making such a
determination, to issue an order to temporarily suspend the approval of
an application:
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH).
(2) The Director and Deputy Director, Office of Compliance, CDRH.
(3) The Director and Deputy Directors, Office of Device Evaluation,
CDRH.
(4) The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, Center for Drug
Evaluation and Research (CDER); the Directors of the Offices of Drug
Evaluation I, II, III, IV, and V, Office of Review Management, CDER; the
Director and Deputy Director, Office of Generic Drugs, Office of
Pharmaceutical Science, CDER; and the Director and Deputy Director,
Office of Compliance, CDER.
(5) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER), and the Director and Deputy Directors,
Office of Compliance and Biologics Quality, CBER.
(b) These officials may not further redelegate this authority.
Sec. 5.413 Approval, disapproval, or withdrawal of approval of
applications and entering into agreements for investigational device
exemptions.
(a) For medical devices assigned to their respective organizations,
the following officials are authorized to approve, disapprove, or
withdraw approval of applications for investigational device exemptions
submitted under section 520(g) of the Federal
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Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH), the Director and Deputy Directors, Office of Device Evaluation,
CDRH, and the Director and Deputy Director, Office of Compliance, CDRH.
(2) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER), and the Directors and Deputy Directors,
Office of Blood Research and Review (OBRR), Office of Vaccines Research
and Review (OVRR), and Office of Therapeutics Research and Review
(OTRR), CBER.
(b) For medical devices assigned to their respective divisions, the
Division Directors, Office of Device Evaluation, CDRH, are authorized to
approve, disapprove, or withdraw approval of applications for
investigational device exemptions submitted under section 520(g) of the
act (21 U.S.C. 360j(y)).
(c) The following officials are authorized to enter into written
agreements concerning investigational device exemption protocols under
section 520(g)(7) of the act (21 U.S.C. 360j(g)(7)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Directors, Office of Device Evaluation
(ODE), CDRH.
(3) The Director, Program Operations Staff, ODE, CDRH.
(4) The Chief, Investigational Device Exemption Section, ODE, CDRH.
(5) For medical devices assigned to their respective Divisions: The
Division Directors and Deputy Division Directors, ODE, CDRH.
(6) The Director and Deputy Directors, CBER, and the Director and
Deputy Directors of the OBRR, OVRR, and OTRR, CBER.
(d) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH and the Director and Deputy Directors, ODE,
CDRH, the Director and Deputy Directors, CBER, and the Director and
Deputy Directors of the OBRR, OVRR, and OTRR, CBER, are authorized to
make decisions under section 520(g)(7) of the act (21 U.S.C. 360j(g)(7))
with respect to an agreement on an investigational plan, that a
substantial scientific issue essential to determining the safety and
effectiveness of the device involved has been identified.
(e) These officials may not further redelegate these authorities.
Sec. 5.414 Postmarket surveillance.
(a) For any class II or class III device (including any device that
is or contains a drug or biologic), the failure of which would be
reasonably likely to have serious adverse health consequences, or which
is intended to be implanted in the human body for more than 1 year, or a
life supporting or life sustaining device used outside a user facility,
any of the following officials is authorized to require a manufacturer
of such device to conduct postmarket surveillance:
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH).
(2) The Director and Deputy Director, Office of Surveillance and
Biometrics, CDRH.
(3) The Director and Deputy Director, Division of Postmarket
Surveillance, Office of Surveillance and Biometrics (OSB), and the
Director, Issues Management Staff, OSB, CDRH.
(4) The Director and Deputy Directors, Office of Device Evaluation,
CDRH.
(5) The Director and Deputy Director, Office of Science and
Technology, CDRH.
(6) The Director and Deputy Director, Office of Health and Industry
Programs, CDRH.
(7) The Director and Deputy Director, Office of Compliance, CDRH.
(8) The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, Center for Drug
Evaluation and Research (CDER).
(9) The Directors of the Offices of Drug Evaluation I, II, III, IV,
and V, Office of Review Management, CDER.
(10) The Director and Deputy Director, Office of Compliance, CDER.
(11) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER).
[[Page 82]]
(12) The Director and Deputy Director, Office of Compliance and
Biologics Quality, CBER.
(13) The Directors and Deputy Directors, Office of Blood Research
and Review, Office of Vaccines Research and Review, and Office of
Therapeutics Research and Review, CBER.
(b) These officials may not further redelegate these authorities.
Sec. 5.415 Authority relating to medical device reporting procedures.
(a) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH), the Director and Deputy Director, Office of Surveillance and
Biometrics (OSB), CDRH, and the Director and Deputy Director, Division
of Surveillance Systems (DSS), OSB, CDRH, are authorized to approve
electronic reporting under Sec. 803.14 of this chapter.
(b) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH, the Director and Deputy Director, OSB,
CDRH, and the Director and Deputy Director, DSS, OSB, CDRH are
authorized to request the submission of additional information under
Sec. 803.15 of this chapter.
(c) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH, the Director and Deputy Director, OSB,
CDRH, and the Director and Deputy Director, DSS, OSB, CDRH are
authorized to grant or revoke exemptions and variances from reporting
requirements under Sec. 803.19 of this chapter.
(d) These officials may not further redelegate these authorities.
Sec. 5.416 Medical device tracking.
(a) The following officials are authorized to issue orders under
section 519(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360i(e)) requiring manufacturers to adopt methods of tracking devices:
(1) The Director and Deputy Directors, Center for Devices and
Radiological Health (CDRH).
(2) The Director and Deputy Director, Office of Compliance, CDRH.
(b) These officials may not further redelegate this authority.
Sec. 5.417 Authority pertaining to accreditation functions for medical
devices.
(a) The following officials are authorized under section 523(a)(1)
and (b)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 360m(a)(1) and (b)(2)(A)) to respond to a request for
accreditation and to accredit persons for the purpose of reviewing
reports submitted under section 510(k) of the act (21 U.S.C. 360(k)) and
making recommendations regarding the initial classification of devices:
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH).
(2) The Director and Deputy Director, Office of Health and Industry
Programs (OHIP), CDRH.
(3) The Director and Deputy Director, Division of Small
Manufacturers Assistance (DSMA), OHIP, CDRH.
(b) The following officials are authorized under section
523(a)(2)(B) and (C) of the act (21 U.S.C. 360m(a)(2)(B) and (C)) to
make a determination with respect to the recommendation of an initial
classification of a device; and to change the initial classification
under section 513(f)(1) of the act (21 U.S.C. 360c(f)(1)) that is
recommended by an accredited person to provide to such person, and the
person who submitted the report under section 510(k) of the act (21
U.S.C. 360(k)) for the device, a statement explaining in detail the
reasons for the change:
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Directors, Office of Device Evaluation
(ODE), CDRH.
(3) The Division Directors and Deputy Division Directors, ODE, CDRH.
(c) The following officials are authorized under section
523(b)(2)(B) of the act (21 U.S.C. 360m(b)(2)(B)) to suspend or withdraw
accreditation of any person accredited to review reports and to make
recommendations under section 523 of the act (21 U.S.C. 360m):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
[[Page 83]]
(3) The Director and Deputy Director, DSMA, OHIP, CDRH.
(d) The following officials are authorized under section
523(b)(2)(C) of the act (21 U.S.C. 360m(b)(2)(c)) to implement the
measures described in that section to ensure that persons accredited
under section 523 of the act (21 U.S.C. 360m) will continue to meet the
standards of accreditation:
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, Office of Compliance, CDRH.
(e) These officials may not further redelegate these authorities.
Subpart G_Animal Drugs; Redelegations of Authority
Sec. 5.500 Issuance of Federal Register documents pertaining to the
determination of safe levels, notice of need for development of an
analytical method, notice of availability of a developed analytical
method, and prohibition of certain extralabel drug use.
The Director and Deputy Director, Center for Veterinary Medicine
(CVM) are authorized to issue Federal Register documents pertaining to
the determination of safe levels, notice of need for development of an
analytical method, notice of availability of a developed analytical
method, and prohibition of certain extralabel drug use related to
implementation of section 512(a)(4) and (5) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360b(a)(4) and (5)). These officials may
further redelegate this authority.
Sec. 5.501 Approval of new animal drug applications, medicated feed
mill license applications and their supplements.
(a) The Director and Deputy Director, Center for Veterinary Medicine
(CVM), are authorized to perform all the functions of the Commissioner
of Food and Drugs (Commissioner) with regard to the approval of new
animal drug applications, and supplements thereto, for new animal drugs
submitted under section 512 of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360b).
(b) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs with regard to the
approval of supplemental applications to approved new animal drugs
submitted under section 512 of the act (21 U.S.C. 360b):
(1) The Director, the Deputy Director for Human Food Safety and
Consultative Services, and the Deputy Director for Therapeutic and
Production Drug Review, Office of New Animal Drug Evaluation, CVM.
(2) The Director and Deputy Director, Office of Surveillance and
Compliance, CVM.
(c) The following officials are authorized to perform all the
functions of the Commissioner with regard to the approval of
supplemental applications to new animal drug applications that are
described by Sec. 514.8(a)(4)(iii), (iv), and (v), and (d)(3) of this
chapter.
(1) The Director, Division of Manufacturing Technologies, Office of
New Animal Drug Evaluation, CVM.
(2) The Director, Division of Epidemiology and Surveillance, Office
of Surveillance and Compliance, CVM.
(d) The following officials are authorized to perform all the
functions of the Commissioner with regard to the approval of medicated
feed mill license applications for the manufacture of animal feeds
containing new animal drugs under section 512(m) of the act (21 U.S.C.
360b(m), as amended by the Animal Drug Availability Act of 1996 (Public
Law 104-250):
(1) The Director and Deputy Director, CVM.
(2) The Director, Division of Animal Feeds, Office of Surveillance
and Compliance, CVM.
(3) The Leader, Medicated Feeds Team, Division of Animal Feeds,
Office of Surveillance and Compliance, CVM.
(4) The Medicated Feeds Specialist, Medicated Feeds Team, Division
of Animal Feeds, Office of Surveillance and Compliance, CVM.
(e) These officials may not further redelegate these authorities.
[[Page 84]]
Sec. 5.502 Issuance of notices, proposals, and orders relating to new
animal drugs and medicated feed mill license applications.
(a) The Director and Deputy Director, Center for Veterinary Medicine
(CVM), are authorized to:
(1) Issue notices of opportunity for a hearing on proposals to
refuse approval or to withdraw approval of new animal drug applications,
and supplements thereto, for drugs for animal use and proposals to
refuse approval or to revoke approval of medicated feed mill license
applications, and supplements thereto, submitted under section 512(m) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(m)), as amended
by the Animal Drug Availability Act of 1996 (Public Law 104-250);
(2) Issue notices refusing or withdrawing approval when opportunity
for hearing has been waived; and
(3) Issue proposals and orders to revoke and amend regulations for
new animal drugs for drugs for animal use and medicated feed mill
licenses, corresponding to said act on such applications.
(b) The Director and Deputy Director, CVM, are authorized to issue
notices of availability of Public Master Files containing data
acceptable for use in applications for new animal drugs for drugs for
animal use and feeds bearing or containing new animal drugs.
(c) These officials may not further redelegate these authorities.
Sec. 5.503 Submission of and effective approval dates for abbreviated
new animal drug applications and certain new animal drug applications.
(a) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs (Commissioner) with
regard to decisions made under section 512(c)(2)(D)(iv) and (c)(2)(F) of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
360b(c)(2)(D)(iv) and (c)(2)(F) concerning the date of submission and
the date of effective approval of abbreviated new animal drug
applications including supplements thereto, submitted under section
512(b)(2) of the act (21 U.S.C. 360b(b)(2)), and of new animal drug
applications including supplements thereto, submitted under section
512(b)(1) of the act (21 U.S.C. 360b(b)(1)):
(1) The Director and Deputy Director, Center for Veterinary Medicine
(CVM).
(2) The Director and Deputy Director, Office of New Animal Drug
Evaluation, CVM.
(b) These officials may not further redelegate this authority.
Sec. 5.504 Issuance of written notices concerning patent information,
current good manufacturing practices and false or misleading labeling
of new animal drugs and feeds bearing or containing new animal drugs.
(a) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs (Commissioner) under
section 512(e), (m)(4)(B)(ii), and (m)(4)(B)(iii) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360b(e), (m)(4)(B)(ii), and
(m)(4)(B)(iii)) regarding the issuance of written notices:
(1) The Director and Deputy Director, Center for Veterinary Medicine
(CVM).
(2) The Director and Deputy Director, Office of Surveillance and
Compliance, CVM.
(3) The Director, Division of Compliance, Office of Surveillance and
Compliance, CVM.
(4) Regional Food and Drug Directors.
(5) District Directors.
(b) These officials may not further redelegate this authority.
Sec. 5.505 Termination of exemptions for new drugs for investigational
use in animals.
(a) The following officials are authorized to perform all functions
of the Commissioner of Food and Drugs with regard to the termination of
new animal drugs for investigational use in animals under Sec. 511.1 of
this chapter:
(1) The Director and Deputy Director, Center for Veterinary Medicine
(CVM).
(2) The Director and Deputy Director, Office of New Animal Drug
Evaluation, CVM.
(b) These officials may not further redelegate this authority.
[[Page 85]]
Subpart H_Radiation Control; Redelegations of Authority
Sec. 5.600 Variances from performance standards for electronic products.
(a) The following officials are authorized to grant and withdraw
variances and issue notices of availability of any approved variance or
any amendment or extension thereof, from the provisions of performance
standards for electronic products established in subchapter J of this
chapter:
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH).
(2) The Director and Deputy Director, Office of Compliance, CDRH.
(b) These officials may not further redelegate this authority.
Sec. 5.601 Exemption of electronic products from performance standards
and prohibited acts.
(a) The following officials are authorized to exempt from
performance standards any electronic product intended for use by
departments or agencies of the United States under section 534(a)(5) of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
360kk(a)(5)) and to exempt an electronic product or class of products
from all or part of the provisions of section 538(a) of the act (21
U.S.C. 360oo(a)) under section 538(b) of the act (21 U.S.C. 360oo(b)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH).
(2) The Director and Deputy Director, Office of Compliance, CDRH.
(b) These officials may not further redelegate this authority.
Sec. 5.602 Testing programs and methods of certification and
identification for electronic products.
(a) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH), and the Director and Deputy Director, Office of Compliance,
CDRH, are authorized to review and evaluate industry testing programs
under section 534(g) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360kk(g)) and to approve or disapprove alternate methods
of certification and identification and to disapprove testing programs
upon which certification is based under section 534(h) of the act (21
U.S.C. 360kk(h)).
(b) These officials may not further redelegate this authority.
Sec. 5.603 Notification of defects in, and repair or replacement of,
electronic products.
(a) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH), and the Director and Deputy Director, Office of Compliance,
CDRH, are authorized to perform all functions of the Commissioner of
Food and Drugs (Commissioner), relating to notification of defects in,
noncompliance of, and repair or replacement of or refund for, electronic
products under section 534 of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360kk) and under Sec. Sec. 1003.11, 1003.22,
1003.31, 1004.2, 1004.3, 1004.4, and 1004.6 of this chapter; and
Regional Food and Drug Directors, District Directors, and the Director,
St. Louis Branch, are authorized to perform all such functions relating
to:
(1) Assemblers of diagnostic x-ray systems, as defined in Sec.
1020.30(b) of this chapter.
(2) Manufacturers of sunlamp products and ultraviolet lamps intended
for use in any sunlamp product, as defined in Sec. 1040.20(b) of this
chapter.
(b) The Director and Deputy Director, Office of Compliance, CDRH,
and the Division Directors, Office of Compliance, CDRH, are authorized
to notify manufacturers of defects in, and noncompliance of, electronic
products under section 535(e) of the act (21 U.S.C. 360ll(e)) and under
Sec. 1003.11(a) of this chapter; and the chiefs of District Compliance
Branches are authorized to perform all such functions relating to:
(1) Assemblers of diagnostic x-ray systems, as defined in Sec.
1020.30(b) of this chapter.
(2) Manufacturers of sunlamp products and ultraviolet lamps intended
for use in any sunlamp products, as defined in Sec. 1040.20(b) of this
chapter.
[[Page 86]]
(c) These officials may not further redelegate these authorities.
Sec. 5.604 Manufacturers requirement to provide data to ultimate
purchasers of electronic products.
(a) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health, are
authorized to require manufacturers to provide performance and technical
data to the ultimate purchaser of electronic products under section
537(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360nn(c)).
(b) These officials may not further redelegate these authorities.
Sec. 5.605 Dealer and distributor direction to provide data to
manufacturers of electronic products.
(a) The Director and Deputy Director for Science and for Regulations
and Policy, Center for Devices and Radiological Health (CDRH), the
Director and Deputy Director, Office of Compliance, CDRH, and the
Division Directors, Office of Compliance, CDRH, are authorized to direct
dealers and distributors of electronic products to furnish information
on first purchasers of such products to the manufacturer of the product
under section 537(f) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360nn(f)).
(b) These officials may not further redelegate these authorities.
Sec. 5.606 Acceptance of assistance from State and Local authorities
for enforcement of radiation control legislation and regulations.
(a) The Director and Deputy Directors, Center for Devices and
Radiological Health, are authorized to accept assistance from State and
Local authorities engaged in activities related to health or safety or
consumer protection on a reimbursable basis or otherwise, under section
541 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360rr).
(b) These officials may not further redelegate these authorities.
Subpart I_Product Designation; Redelegations of Authority
Sec. 5.700 Authority relating to determination of product primary
jurisdiction.
The Chief Mediator and Ombudsman, Office of the Ombudsman, Office of
the Senior Associate Commissioner, Office of the Commissioner, as
product jurisdiction officer is authorized to make a determination under
section 563 of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 360bbb-2) respecting the classification of a product as a drug,
biological product, device, or a combination product subject to section
503(g) of the act (21 U.S.C. 353(g)), and to assign primary
responsibility respecting the organizational component of the Food and
Drug Administration that will regulate the product. This official may
not further redelegate this authority.
Sec. 5.701 Premarket approval of a product that is or contains a
biologic, a device, or a drug.
(a) For a product that is or contains a biologic, a device, or a
drug, the following officials in the Center for Biologics Evaluation and
Research, Center for Devices and Radiological Health, or Center for Drug
Evaluation and Research who currently hold delegated premarket approval
authority for biologics, devices, or drugs, respectively, are hereby
delegated all the authorities necessary for premarket approval of any
product that is a biologic, a device, or a drug, or any combination of
two or more of these products:
(1) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER) and the Directors of the Office of Blood
Research and Review, Office of Vaccines Research and Review, Office of
Therapeutics Research and Review, and Office of Compliance and Biologics
Quality, CBER.
(2) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH), and the Director, Office of Device Evaluation, CDRH.
(3) The Director, the Deputy Director, and the Directors, Office of
Review
[[Page 87]]
Management and Office of Pharmaceutical Science, Center for Drug
Evaluation and Research (CDER); and the Directors of the Offices of Drug
Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(b) These officials may not further redelegate this authority.
Subpart J_Imports and Exports; Redelegations of Authority
Sec. 5.800 Imports and exports.
(a) The Regional Food and Drug Directors, District Directors, and
the Director, St. Louis Branch, are authorized, under section 801 of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381), to
perform the following functions or to designate officials to:
(1) Request from the Secretary of the Treasury samples of food,
drugs (including biological products), devices, or cosmetics imported or
offered for import.
(2) Determine whether such articles are in compliance with the act.
(3) Authorize relabeling or other compliance actions to bring
articles into compliance under the act.
(4) Supervise such compliance actions.
(b) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH); the Director and Deputy Director, Office of Compliance, CDRH;
Regional Food and Drug Directors; District Directors; and the Director,
St. Louis Branch, are authorized, under section 536 of the act (21
U.S.C. 360mm), to perform the following functions or to designate
officials to:
(1) Request from the Secretary of the Treasury samples of electronic
products imported or offered for import to determine whether such
products are in compliance with section 534 of the act (21 U.S.C.
360kk).
(2) Refuse admission of noncomplying products and notify the
Secretary of the Treasury of such refusal.
(3) Supervise operations to bring noncomplying products into
compliance under section 534 of the act (21 U.S.C. 360kk).
(4) Refuse or grant permission and time extensions to bring
noncomplying products into compliance with section 534 of the act (21
U.S.C. 360kk) in accordance with a corrective action plan approved by
the Directors, Offices of Compliance Surveillance and Biometrics, CDRH.
(c) The following officials are authorized, under section 538(b) of
the act (21 U.S.C. 360oo(b)), to exempt persons from issuing a
certification, as required by section 534(h) of the act (21 U.S.C.
360kk(h)) for electronic products imported into the United States for
testing, evaluation, demonstrations, or training, which will not be
introduced into commerce and upon completion of their function will be
destroyed or exported in accord with U.S. Customs Service's regulations:
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, Office of Compliance, CDRH.
(3) Regional Food and Drug Directors.
(4) District Directors.
(5) The Director, St. Louis Branch.
(d) The Regional Food and Drug Directors, District Directors, and
the Director, St. Louis Branch, are authorized to exercise all of the
functions of the Commissioner of Food and Drugs (Commissioner) under
section 362 of the Public Health Service Act (42 U.S.C. 265) that relate
to the prohibition of the introduction of foods, drugs, devices,
cosmetics, and electronic products, and other items or products
regulated by the Food and Drug Administration into the United States
when it is determined that it is required in the interest of public
health, and such functions relate to the law enforcement functions of
the Food and Drug Administration.
(e) The following officials are authorized to perform all the
functions of the Commissioner pertaining to exportation of medical
devices under section 801(e) of the act (21 U.S.C. 381(e)):
(1) For medical devices assigned to their respective organization:
(i) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(ii) The Director and Deputy Director, Office of Compliance, CDRH.
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(iii) The Director and Deputy Director, Division of Program
Operations, Office of Compliance, CDRH.
(iv) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER).
(v) The Director and Deputy Directors, Office of Compliance and
Biologics Quality, CBER.
(2) Regional Food and Drug Directors.
(3) District Directors.
(4) The Director, St. Louis Branch.
(f) The following officials are authorized to perform the functions
of the Commissioner for drugs under their jurisdiction, pertaining to
authorizing the reimportation of prescription drugs under section
801(d)(2) of the act (21 U.S.C. 381(d)(2)) for emergency medical care:
(1) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER) and the Director, Office of Compliance
and Biologics Quality, CBER.
(2) The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, Center for Drug
Evaluation and Research (CDER) and the Director and Deputy Director,
Office of Compliance, CDER.
(g) These officials may not further redelegate these authorities.
Sec. 5.801 Export of unapproved drugs.
(a) The following officials are authorized, under section 802(b)(2)
and (b)(3) of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 382(b)(2) and (b)(3)), to grant or deny petitions to export
unapproved new drugs and biological products and to issue notices of
receipt of such petitions for human drugs assigned to their respective
organizations:
(1) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER).
(2) The Director and Deputy Directors, Office of Compliance and
Biologics Quality, CBER.
(3) The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, Center for Drug
Evaluation and Research (CDER).
(4) The Director and Deputy Director, Office of Compliance, CDER.
(b) The following officials are authorized, under section 802(e) of
the act (21 U.S.C. 382(e)), to approve or disapprove an application to
export a drug (including a biological product) to be used in the
prevention or treatment of a tropical disease or another disease as
described in section 802(e) for human drugs assigned to their respective
organizations:
(1) The Director and Deputy Directors, CBER.
(2) The Director and Deputy Directors, Office of Compliance and
Biologics Quality, CBER.
(3) The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, CDER.
(4) The Director and Deputy Director, Office of Compliance, CDER.
(c) The following officials are authorized, under section 351(h) of
the Public Health Service Act (42 U.S.C. 262(h)), to approve or
disapprove an application to export a partially processed biological
product:
(1) The Director and Deputy Directors, CBER.
(2) The Director and Deputy Directors, Office of Compliance and
Biologics Quality, CBER.
(d) These officials may not further redelegate these authorities.
Sec. 5.802 Manufacturer's resident import agents.
The Director and Deputy Directors for Science and for Regulations
and Policy, Center for Devices and Radiological Health (CDRH) and the
Director and Deputy Director, Office of Compliance, CDRH, are authorized
to reject manufacturer's designation of import agents under Sec.
1005.25(b) of this chapter. These officials may not further redelegate
this authority.
Subpart K_Orphan Products; Redelegations of Authority
Sec. 5.900 Orphan products.
(a) The Director, Office of Orphan Products Development (OPD),
Office of the Senior Associate Commissioner (OSAC), Office of the
Commissioner (OC), is authorized to issue notices, and
[[Page 89]]
amendments thereto, inviting sponsorship for orphan products (human and
animal drugs, biological products, and medical devices) and submission
of:
(1) Notices of claimed investigational exemption for a new drug or
new drug applications;
(2) Notices of claimed investigational exemption for a new animal
drug or new animal drug applications;
(3) Applications for biologics licenses for biological products; or
(4) Applications for an investigational device exemption or
premarket approval applications for medical devices, as appropriate.
(b) The Director, OPD, OSAC, OC, is authorized:
(1) To determine whether there is reason to believe that a drug is a
drug for a disease or condition that is rare in the United States under
section 525(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 360aa(a)) and to designate such drug as a drug for a rare disease
or condition under section 526(a) of the act (21 U.S.C. 360bb(a)).
(2) To issue holders of approved applications or licenses notice and
opportunity for the submission of views under section 527(b)(1) of the
act (21 U.S.C. 360cc(b)(1)).
(3) To encourage sponsors of an investigational new drug for a rare
disease or condition to design protocols for clinical investigations to
permit the addition to the investigation of persons with the disease or
condition under section 528 of the act (21 U.S.C. 360dd).
(c) The following officials are authorized to provide sponsors,
under section 525(a) of the act (21 U.S.C. 360aa(a)), with
recommendations for nonclinical or clinical investigations believed to
be necessary for a drug for a rare disease or condition to be approved
or licensed:
(1) For drugs under their jurisdiction:
(i) The Director, the Deputy Director, and the Directors, Office of
Review Management and Office of Pharmaceutical Science, Center for Drug
Evaluation and Research (CDER).
(ii) The Directors and Deputy Directors of the Offices of Drug
Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
(iii) The Directors and Deputy Directors of the divisions in the
Offices of Drug Evaluation I, II, III, IV, and V, Office of Review
Management, CDER.
(2) For biological products under their jurisdiction:
(i) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER).
(ii) The Directors and Deputy Directors, Office of Blood Research
and Review (OBRR), Office of Vaccines Research and Review (OVRR), Office
of Therapeutics Research and Review (OTRR), CBER.
(iii) The Directors and Deputy Directors of the Divisions in OBRR,
OVRR, and OTRR, CBER.
(d) These officials may not further redelegate these authorities.
Subpart L_Mammography Facilities; Redelegations of Authority
Sec. 5.1000 Authority to ensure that mammography facilities meet
quality standards.
(a) The following officials are authorized to ensure mammography
facilities obtain certificates under section 354(b) of the Public Health
Service Act (the PHS Act) (42 U.S.C. 263b(b)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, Center for Devices and Radiological Health
(CDRH).
(2) The Director and Deputy Director, Office of Health and Industry
Programs (OHIP), CDRH.
(3) The Director and Deputy Director, Division of Mammography
Quality and Radiation Programs (DMQRP), OHIP, CDRH.
(b) The following officials are authorized to issue, renew and
extend certificates to mammography facilities under section 354(c) of
the PHS Act (42 U.S.C. 263b(c)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(c) The following officials are authorized to accept an application
for a certificate under section 354(d)(1) of the PHS Act (42 U.S.C.
263b(d)(1)):
[[Page 90]]
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(d) The following officials are authorized to approve accreditation
bodies to accredit mammography facilities under section 354(e)(1)(A) of
the PHS Act (42 U.S.C. 263b(e)(1)(A)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(e) The following officials are authorized to ensure accreditation
bodies provide satisfactory assurances of compliance under section
354(e)(1)(C) of the PHS Act (42 U.S.C. 263b(e)(1)(c)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(f) The Director, CDRH is authorized to issue regulations under
which the Director may withdraw approval of accreditation bodies under
section 354(e)(2)(A) of the PHS Act (42 U.S.C. 263b(e)(2)(A)).
(g) The following officials are authorized to determine the
expiration date of a certificate of a facility accredited by an
accreditation body after the body's approval is withdrawn, or a State's
certification authority has been withdrawn, or a facility's
accreditation has been revoked by an accreditation body under sections
354(e)(2)(B) and 354(e)(5) of the PHS Act (42 U.S.C. 263b(e)(2)(B) and
(e)(5)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(h) The following officials are authorized to determine the
applicable standards for a facility for accreditation under section
354(e)(3) of the PHS Act (42 U.S.C. 263b(e)(3)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(i) The following officials are authorized to ensure accreditation
bodies make on site visits and to determine whether other measures are
appropriate under section 354(e)(4) of the PHS Act (42 U.S.C.
263b(e)(4)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(j) The following officials are authorized to evaluate annually the
performance of each approved accreditation body as provided by section
354(e)(6)(A) of the PHS Act (41 U.S.C. 263b(e)(6)(A)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(k) The following officials are authorized to determine the
compliance of certified facilities with established standards through
annual facility inspections as provided by section 354(g) of the PHS Act
(42 U.S.C. 263b(g)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(l) The following officials are authorized to promote voluntary
compliance with established standards instead of taking actions under
section 354(i) of the PHS Act (42 U.S.C. 263b(i)) by imposing directed
plans of correction and/or payment of the cost of onsite monitoring
under section 354(h)(1) of the PHS Act (42 U.S.C. 263b(h)(l)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
[[Page 91]]
(m) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH are authorized to impose sanctions under
section 354(h)(2) of the PHS Act (42 U.S.C. 263b(h)(2)).
(n) The following officials are authorized to develop and implement
the procedures for determining when and how to impose sanctions as
provided by section 354(h)(3) of the PHS Act (42 U.S.C. 263b(h)(3)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(o) The following officials are authorized to suspend or revoke
individual facility certificates under section 354(i)(1) and (i)(2) of
the PHS Act (42 U.S.C. 263b(i)(1) and (i)(2)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(p) The following officials are authorized under section 354(i)(3)
of the PHS Act (42 U.S.C. 263b(i)(3)) to ensure that no person who owned
or operated a facility at the time the cause of revocation occurred may,
within 2 years of the revocation of the certificate, own or operate a
mammography facility:
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(q) The following officials are authorized to compile and make
available to physicians and the general public information determined to
be useful in evaluating the performance of mammography facilities as
provided by section 354(l) of the PHS Act (42 U.S.C. 263b(l):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(r) The following officials are authorized to ensure that
appropriate Federal agencies are consulted in the development of
standards, regulations, evaluations, procedures for compliance and
oversight as provided by section 354(o) of the PHS Act (42 U.S.C.
263b(o)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(3) The Director and Deputy Director, DMQRP, OHIP, CDRH.
(s) The following officials may authorize a State to carry out
certification program requirements and implement quality standards under
section 354(q)(1) and (q)(2) of the PHS Act (42 U.S.C. 263b(g)(1) and
(g)(2)):
(1) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH.
(2) The Director and Deputy Director, OHIP, CDRH.
(t) The Director and Deputy Directors for Science and for
Regulations and Policy, CDRH are authorized, after providing notice and
opportunity for corrective action, to withdraw the approval of a State's
authority to carry out certification requirements and implement quality
standards under section 354(q)(4) of the PHS Act (42 U.S.C. 263b(g)(4)).
(u) These officials may not further redelegate these authorities.
Subpart M_Organization
Sec. 5.1100 Headquarters.
The central organization of the Food and Drug Administration
consists of the following:
Office of the Commissioner.\1\
---------------------------------------------------------------------------
\1\ Mailing address: 5600 Fishers Lane, Rockville, MD 20857.
---------------------------------------------------------------------------
Office of the Chief Counsel.
Office of Equal Opportunity.
Office of the Administrative Law Judge.
Office of the Senior Associate Commissioner.
Office of Executive Secretariat.
Office of Public Affairs.
Office of the Ombudsman.
[[Page 92]]
Office of Orphan Products Development.
Office of Internal Affairs.
Office of Executive Operations.
Office of Science Coordination and Communication.
Office of Human Research Trials.
Office of International and Constituent Relations.
Office of International Programs.
Office of Consumer Affairs.
Office of Women's Health.
Office of Special Health Issues.
Office of Policy, Planning, and Legislation.
Office of Policy.
Office of Planning.
Office of Legislation.
Office of Management and Systems.
Office of Human Resources and Management Services.
Office of Information Resources Management.
Office of Financial Management.
Office of Facilities, Acquisitions, and Central Services.\2\
---------------------------------------------------------------------------
\2\ Mailing address: 5630 Fishers Lane, Rockville, MD 20857.
Center for Biologics Evaluation and Research.\3\
---------------------------------------------------------------------------
\3\ Mailing address: 1401 Rockville Pike, Rockville, MD 20852-1448.
---------------------------------------------------------------------------
Office of the Center Director.
Scientific Advisors and Consultants Staff.
Equal Employment Opportunity and Workforce Diversity Staff.
Quality Assurance Staff.
Regulations and Policy Staff.
Veterinary Services Staff.
Office of Management.
Regulatory Information Management Staff.
Division of Planning, Evaluation, and Budget.
Division of Management Services.
Office of Information Technology Management.
Division of Information Technology Operations.
Division of Information Technology Development.
Division of Information Technology Infrastructure.
Office of Compliance and Biologics Quality.
Division of Case Management.
Division of Manufacturing and Product Quality.
Division of Inspections and Surveillance.
Office of Blood Research and Review.
Human Tissue Staff.
Policy and Publications Staff.
Division of Emerging and Transfusion Transmitted Diseases.
Division of Hematology.
Division of Blood Applications.
Office of Therapeutics Research and Review.
Division of Cellular and Gene Therapies.
Division of Therapeutic Proteins.
Division of Monoclonal Antibodies.
Division of Clinical Trial Design and Analysis.
Division of Application Review and Policy.
Office of Vaccines Research and Review.
Division of Bacterial, Parasitic, and Allergenic Products.
Division of Viral Products.
Division of Vaccines and Related Products Applications.
Office of Communication, Training, and Manufacturers Assistance.
Division of Disclosure and Oversight Management.
Division of Manufacturers Assistance and Training.
Division of Communication and Consumer Affairs.
Office of Biostatistics and Epidemiology.
Division of Biostatistics.
Division of Epidemiology.
Center for Food Safety and Applied Nutrition.\4\
---------------------------------------------------------------------------
\4\ Mailing address: 5100 Paint Branch Pkwy., College Park, MD
20740.
---------------------------------------------------------------------------
Office of the Center Director.
Food Safety Initiatives Staff.
Office of Science
Quality Assurance Staff.
[[Page 93]]
CFSAN Staff College.
Microbial Research and Risk Assessment Staff.
JIFSAN Liaison Staff.
CFSAN Food Advisory Committee Staff.
Office of Applied Research and Safety Assessment.
Muirkirk Technical Operations Staff.
Division of Molecular Biology.
Division of Virulence Assessment.
Division of Toxicology and Nutritional Product Studies.
Division of In Vitro and Biochemical Toxicology.
Office of Regulations and Policy.
Regulations Coordination Staff.
Office of Constituent Operations.
Consumer Education Staff.
Industry Activities Staff.
International Activities Staff.
Office of Management Systems.
Safety Management Systems.
Division of Information Resources Management.
Division of Planning and Financial Resources Management.
Division of Management Operations.
Division of Administrative Services Management.
Office of Operations.
Equal Employment Opportunity Staff.
Executive Operations Staff.
Office of Cosmetics and Colors.
Division of Programs and Enforcement Policy.
Division of Science and Applied Technology.
Office of Nutritional Products, Labeling and Dietary Supplements.
Division of Compliance and Enforcement.
Division of Standards and Labeling Regulations.
Division of Nutrition Science Policy.
Office of Premarket Approval.
Division of Product Policy.
Division of Petition Control.
Division of Health Effects Evaluation.
Division of Product Manufacture and Use.
Office of Plant and Dairy Foods and Beverages.
Division of Pesticides and Industrial Chemicals.
Division of Natural Products.
Division of Food Processing and Packaging.
Division of Plant Product Safety.
Division of Dairy and Egg Safety.
Division of Risk Assessment.
Division of Microbiological Studies.
Office of Seafood.
Division of Special Programs.
Division of Programs and Enforcement Policy.
Division of Science and Applied Technology.
Office of Field Programs.
Division of Enforcement and Programs.
Division of HACCP Programs.
Division of Cooperative Programs.
Office of Scientific Analysis and Support.
Division of General Scientific Support.
Division of Mathematics.
Division of Market Studies.
Center for Drug Evaluation and Research.\1\
Office of the Center Director.
Equal Employment Opportunity Staff.
Executive Operations Staff.
Office of Regulatory Policy.
Division of Regulatory Policy I.
Division of Regulatory Policy II.
Division of Information Disclosure Policy.
Office of Management.\1\
Strategic Planning Staff.\1\
Division of Management and Budget.\5\
---------------------------------------------------------------------------
\5\ Mailing address: 7500 Standish Pl., Rockville, MD 20855.
---------------------------------------------------------------------------
Division of Management Services.\1\
Office of Training and Communication.\1\
Medwatch Staff.
Division of Library and Information Services.
Division of Training and Development.
Division of Public Affairs.
Division of Drug Information.
[[Page 94]]
Office of Compliance.\6\
---------------------------------------------------------------------------
\6\ Mailing address: 7520 Standish Pl., Rockville, MD 20855.
---------------------------------------------------------------------------
Division of Manufacturing and Product Quality.
Division of Prescription Drug Compliance and Surveillance.
Division of Labeling and Non-Prescription Drug Compliance.
Office of Information Technology.\1\
Quality Assurance Staff.
Technology Support Services Staff.
Division of Data Management and Services.
Division of Applications Development and Services.
Division of Infrastructure Management and Services.
Office of Medical Policy.\1\
Division of Drug Marketing, Advertising and Communication.\1\
Division of Scientific Investigations.\5\
Office of Review Management.\1\
Advisors and Consultants Staff.\2\
Office of Drug Evaluation I.\1\
Division of Cardio-Renal Drug Products.
Division of Neuropharmacological Drug Products.
Division of Oncology Drug Products.
Office of Drug Evaluation II.\1\
Division of Metabolic and Endocrine Drug Products.
Division of Pulmonary and Allergy Drug Products.
Division of Anesthetic, Critical Care and Addiction Drug Products.
Office of Drug Evaluation III.\1\
Division of Gastrointestinal and Coagulation Drug Products.
Division of Medical Imaging and Radiopharmaceutical Drug Products.
Division of Reproductive and Urologic Drug Products.
Office of Drug Evaluation IV.\1\
Division of Anti-Infective Drug Products.
Division of Anti-Viral Drug Products.
Division of Special Pathogen and Immunologic Drug Products.
Office of Drug Evaluation V.\1\
Division of Anti-Inflammatory, Analgesic and Opthalmologic Drug
Products.
Division of Dermatologic and Dental Drug Products.
Division of Over-The-Counter Drug Products.
Office of Biostatistics.\1\
Quantitative Methods Research Staff.
Division of Biometrics I.
Division of Biometrics II.
Division of Biometrics III.
Office of Post-Marketing Drug Risk Assessment.\1\
Extramural Programs Staff.
Information Technology Staff.
Division of Drug Risk Evaluation I.
Division of Drug Risk Evaluation II.
Office of Pharmaceutical Science.\1\
Quality Implementation Staff.\1\
Operations Staff.\1\
Office of Clinical Pharmacology and Biopharmaceutics.
Pharmacometrics Staff.
Division of Pharmaceutical Evaluation I.\1\
Division of Pharmaceutical Evaluation II.\1\
Division of Pharmaceutical Evaluation III.\1\
Office of Generic Drugs.\6\
Division of Bioequivalence.
Division of Chemistry I.
Division of Chemistry II.
Division of Labeling and Program Support.
Office of New Drug Chemistry.\1\
Division of New Drug Chemistry I.\1\
Division of New Drug Chemistry II.\1\
Division of New Drug Chemistry III.\1\
Office of Testing and Research.\1\
Informatics and Computational Safety Analysis Staff.
Laboratory of Clinical Pharmacology.\1\
Division of Applied Pharmacology Research.\7\
---------------------------------------------------------------------------
\7\ Mailing address: 8301 Muirkirk Rd., Laurel, MD 20708.
Division of Pharmaceutical Analysis.\8\
---------------------------------------------------------------------------
\8\ Mailing address: 1114 Market St., St. Louis, MO 63101.
---------------------------------------------------------------------------
[[Page 95]]
---------------------------------------------------------------------------
Division of Product Quality Research.\1\
Office of Regulatory Affairs.\1\
Equal Employment Opportunity Staff.
Office of Resource Management.
Strategic Initiatives Staff.
Division of Planning, Evaluation, and Management.
Division of Information Systems.
Division of Human Resource Development.
Division of Management Operations.
Division of Personnel Operations.
Office of Enforcement.
Division of Compliance Management and Operations.
Division of Compliance Policy.
Division of Compliance Information and Quality Assurance.
Office of Regional Operations.
Division of Federal-State Relations.
Division of Field Science.
Division of Emergency and Investigational Operations.
Division of Import Operations and Policy.
Office of Criminal Investigations.
Mid-Atlantic Area Office.\9\
---------------------------------------------------------------------------
\9\ Mailing address: 900 U.S. Customhouse, Second Chestnut St.,
Philadelphia, PA 19106.
Midwest Area Office. \10\
---------------------------------------------------------------------------
\10\ Mailing address: 901 Warrenville Rd., suite 360, Lisle, IL
60532.
Northeast Area Office.\11\
---------------------------------------------------------------------------
\11\ Mailing address: 158-15 Liberty Ave., Jamaica, NY 11433.
Pacific Area Office.\12\
---------------------------------------------------------------------------
\12\ Mailing address: 13301 Clay St., Oakland CA 94512.
Southeast Area Office.\13\
---------------------------------------------------------------------------
\13\ Mailing address: 60 Eighth St. NE, Atlanta, GA 30309.
Southwest Area Office.\14\
---------------------------------------------------------------------------
\14\ Mailing address: 7920 Elmbrook Rd., Dallas, TX 75247.
Center for Veterinary Medicine.\15\
---------------------------------------------------------------------------
\15\ Mailing address: 7500 Standish Pl., MPN-2, Rockville, MD 20855.
---------------------------------------------------------------------------
Office of the Center Director.
Office of Management and Communications.
Administrative Staff.
Communications Staff.
Information Resources Management Staff.
Office of New Animal Drug Evaluation.
Division of Therapeutic Drugs for Food Animals.
Division of Biometics and Production Drugs
Division of Therapeutic Drugs for Nonfood Animals.
Division of Manufacturing Technologies.
Division of Human Food Safety.
Office of Surveillance and Compliance.
Division of Surveillance.
Division of Animal Feeds.
Division of Compliance.
Division of Epidemiology.
Office of Research.
Administrative Staff.
Division of Residue Chemistry.
Division of Animal Research.
Division of Animal and Food Microbiology.
Center for Devices and Radiological Health.\16\
---------------------------------------------------------------------------
\16\ Mailing address: 9200 Corporate Blvd., Rockville, MD 20850.
---------------------------------------------------------------------------
Office of the Center Director.
Equal Employment Opportunity Staff.
Office of Systems and Management.
Integrity Committee and Conference Management Staff.
Division of Management Operations.
Division of Information Dissemination.
Division of Information Technology Management.
Division of Planning, Analysis and Finance.
Office of Compliance.
Promotion and Advertising Policy Staff.
Division of Bioresearch Monitoring.
Division of Program Operations.
Division of Enforcement I.
Division of Enforcement II.
Division of Enforcement III.
Office of Device Evaluation.
Program Management Staff.
Program Operations Staff.
Division of Cardiovascular and Respiratory Devices.
[[Page 96]]
Division of Reproductive, Abdominal and Radiological Devices.
Division of General, Restorative and Neurological Devices.
Division of Clinical Laboratory Devices.
Division of Ophthalmic, Ear, Nose, and Throat Devices.
Division of Dental, Infection Control, and General Hospital Devices.
Office of Science and Technology.
Division of Mechanics and Materials Science.
Division of Life Sciences.
Division of Physical Sciences.
Division of Electronics and Computer Sciences.
Division of Management Information and Support Services.
Office of Health and Industry Programs.
Program Operations Staff.
Regulations Staff.
Staff College.
Division of Device User Programs and Systems Analysis.
Division of Small Manufacturers Assistance.
Division of Mammography Quality and Radiation Programs.
Division of Communication Media.
Office of Surveillance and Biometrics.
Issues Management Staff.
Division of Biostatistics.
Division of Postmarket Surveillance.
Division of Surveillance Systems.
National Center for Toxicological Research.\17\
---------------------------------------------------------------------------
\17\ Mailing address: 3900 NCTR Dr., Jefferson, AR 72079.
---------------------------------------------------------------------------
Office of the Center Director.
Environmental Health and Program Assurance Staff.
Office of Research.
Technology Advancement Staff.
Division of Biochemical Toxicology.
Division of Genetic and Reproductive Toxicology.
Division of Biometry and Risk Assessment.
Division of Microbiology.
Division of Chemistry.
Division of Neurotoxicology.
Division of Veterinary Services.
Division of Molecular Epidemiology.
Office of Management.
Office of Management Services.
Division of Facilities, Engineering and Maintenance.
Division of Administrative Services.
Division of Contracts and Acquisitions.
Office of Planning, Finance and Information Technology.
Division of Planning.
Division of Financial Management.
Division of Information Technology.
[66 FR 30993, June 8, 2001, as amended at 66 FR 56035, Nov. 6, 2001]
Sec. 5.1105 Chief Counsel, Food and Drug Administration.
The Office of the Chief Counsel's mailing address is 5600 Fishers
Lane, rm. 6-57, Rockville, MD 20857.
Sec. 5.1110 Food and Drug Administration Public Information Offices.
(a) Division of Dockets Management (HFA-305). The Division of
Dockets Management Public Room is located in rm. 1061, 5630 Fishers
Lane, Rockville, MD 20852. Telephone: 301-827-6860.
(b) Freedom of Information Staff (HFI-35). The Freedom of
Information Public Room is located in rm. 12A-30, Parklawn Bldg., 5600
Fishers Lane, Rockville, MD 20857. Telephone: 301-827-6567.
(c) Press Relations Staff (HFI-40). Press Offices are located in rm.
15-05, Parklawn Bldg, 5600 Fishers Lane, Rockville, MD 20857. Telephone:
301-827-6242; and in rm. 3807, FB-8, 5100 Paint Branch Pkwy., College
Park, MD 20740. Telephone 202-205-4144.
[66 FR 30993, June 8, 2001, as amended at 66 FR 56035, Nov. 6, 2001]
Sec. 5.1115 Field structure.
NORTHEAST REGION
Regional Field Office: 158-15 Liberty Ave., Jamaica, NY 11433.
Northeast Regional Laboratory: 158-15 Liberty Ave., Jamaica, NY 11433.
New York District Office: 158-15 Liberty Ave., Jamaica, NY 11433.
[[Page 97]]
New England District Office: One Montvale Ave., Stoneham, MA 02180.
Winchester Engineering and Analytical Center: 109 Holton St.,
Winchester, MA 01890.
CENTRAL REGION
Regional Field Office: U.S. Customhouse, Second and Chestnut Sts., rm.
900, Philadelphia, PA 19106.
Philadelphia District Office: U.S. Customhouse, Second and Chestnut
Sts., rm. 900, Philadelphia, PA 19106.
Baltimore District Office: 900 Madison Ave., Baltimore, MD 21201-2199.
Cincinnati District Office: 6751 Steger Dr., Cincinnati, OH 45237-3097.
Forensic Chemistry Center: 6751 Steger Dr., Cincinnati, OH 45237-3097.
New Jersey District Office: Waterview Corporate Center, 10 Waterview
Blvd., 3d Floor, Parsippany, NJ 07054.
Chicago District Office: 300 South Riverside Plaza, suite 550, South
Chicago, IL 60606.
Detroit District Office: 1560 East Jefferson Ave., Detroit, MI 48207-
3179.
Minneapolis District Office: 240 Hennepin Ave., Minneapolis, MN 55401-
1912.
SOUTHEAST REGION
Regional Field Office: 60 Eighth St. NE., Atlanta, GA 30309.
Southeast Regional Laboratory: 60 Eighth St. NE., Atlanta, GA 30309.
Atlanta District Office: 60 Eighth St. NE., Atlanta, GA 30309.
New Orleans District Office: Textron Bldg., 6600 Plaza Dr., suite 400,
New Orleans, LA 70127.
Nashville Branch of NOL-DO: 297 Plus Park Blvd., Nashville, TN 37217.
Florida District Office: 555 Winderley, suite 200, Maitland, FL 32751.
San Juan District Office: 466 Fernandez Juncos Ave., San Juan, PR 00901-
3223.
SOUTHWEST REGION
Regional Field Office: 7920 Elmwood Rd., suite 102, Dallas, TX 75247-
4982.
Dallas District Office: 3310 Live Oak St., Dallas, TX 75204.
Denver District Office: Bldg. 20, Denver Federal Center, Sixth and
Kipling Sts., P.O. Box 25087, Denver, CO 80225-0087.
Kansas City District Office: 11630 West 80th St., Lenexa, KS 66214-3338.
St. Louis Branch: 12 Sunnen Dr., suite 122, St. Louis, MO 63143-3800.
Arkansas Regional Laboratory: 3900 NCTR Rd., Bldg. 14-T, rm. 104,
Jefferson, AR 72079-9502.
PACIFIC REGION
Regional Field Office: 1301 Clay St., suite 1180-N, Oakland, CA 94612-
5217.
San Francisco District Office: 1431 Harbor Bay Pkwy., Alameda, CA 94502-
7070.
Los Angeles District Office: 19900 Mac Arthur Blvd., suite 300, Irvine,
CA 92715.
Seattle District Office: P.O. Box 3012, Bothell, WA 98021-3012.
Pacific Regional Laboratory, SW: 1521 West Pico Blvd., Los Angeles, CA
90015-2488.
Pacific Regional Laboratory, NW: 22201 23rd Dr. SE., Bothell, WA 98021-
4421.
PART 7_ENFORCEMENT POLICY--Table of Contents
Subpart A_General Provisions
Sec.
7.1 Scope.
7.3 Definitions.
7.12 Guaranty.
7.13 Suggested forms of guaranty.
Subpart B [Reserved]
Subpart C_Recalls (Including Product Corrections)_Guidance on Policy,
Procedures, and Industry Responsibilities
7.40 Recall policy.
7.41 Health hazard evaluation and recall classification.
7.42 Recall strategy.
7.45 Food and Drug Administration-requested recall.
7.46 Firm-initiated recall.
7.49 Recall communications.
7.50 Public notification of recall.
7.53 Recall status reports.
7.55 Termination of a recall.
7.59 General industry guidance.
Subpart D [Reserved]
Subpart E_Criminal Violations
7.84 Opportunity for presentation of views before report of criminal
violation.
[[Page 98]]
7.85 Conduct of a presentation of views before report of criminal
violation.
7.87 Records related to opportunities for presentation of views
conducted before report of criminal violation.
Authority: 21 U.S.C. 321-393; 42 U.S.C. 241, 262, 263b-263n, 264.
Source: 42 FR 15567, Mar. 22, 1977, unless otherwise noted.
Subpart A_General Provisions
Sec. 7.1 Scope.
This part governs the practices and procedures applicable to
regulatory enforcement actions initiated by the Food and Drug
Administration pursuant to the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) and other laws that it administers. This part also
provides guidance for manufacturers and distributors to follow with
respect to their voluntary removal or correction of marketed violative
products. This part is promulgated to clarify and explain the regulatory
practices and procedures of the Food and Drug Administration, enhance
public understanding, improve consumer protection, and assure uniform
and consistent application of practices and procedures throughout the
agency.
[43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19, 2000]
Sec. 7.3 Definitions.
(a) Agency means the Food and Drug Administration.
(b) Citation or cite means a document and any attachments thereto
that provide notice to a person against whom criminal prosecution is
contemplated of the opportunity to present views to the agency regarding
an alleged violation.
(c) Respondent means a person named in a notice who presents views
concerning an alleged violation either in person, by designated
representative, or in writing.
(d) Responsible individual includes those in positions of power or
authority to detect, prevent, or correct violations of the Federal Food,
Drug, and Cosmetic Act.
(e) [Reserved]
(f) Product means an article subject to the jurisdiction of the Food
and Drug Administration, including any food, drug, and device intended
for human or animal use, any cosmetic and biologic intended for human
use, and any item subject to a quarantine regulation under part 1240 of
this chapter. Product does not include an electronic product that emits
radiation and is subject to parts 1003 and 1004 of this chapter.
(g) Recall means a firm's removal or correction of a marketed
product that the Food and Drug Administration considers to be in
violation of the laws it administers and against which the agency would
initiate legal action, e.g., seizure. Recall does not include a market
withdrawal or a stock recovery.
(h) Correction means repair, modification, adjustment, relabeling,
destruction, or inspection (including patient monitoring) of a product
without its physical removal to some other location.
(i) Recalling firm means the firm that initiates a recall or, in the
case of a Food and Drug Administration-requested recall, the firm that
has primary responsibility for the manufacture and marketing of the
product to be recalled.
(j) Market withdrawal means a firm's removal or correction of a
distributed product which involves a minor violation that would not be
subject to legal action by the Food and Drug Administration or which
involves no violation, e.g., normal stock rotation practices, routine
equipment adjustments and repairs, etc.
(k) Stock recovery means a firm's removal or correction of a product
that has not been marketed or that has not left the direct control of
the firm, i.e., the product is located on premises owned by, or under
the control of, the firm and no portion of the lot has been released for
sale or use.
(l) Recall strategy means a planned specific course of action to be
taken in conducting a specific recall, which addresses the depth of
recall, need for public warnings, and extent of effectiveness checks for
the recall.
(m) Recall classification means the numerical designation, i.e., I,
II, or III, assigned by the Food and Drug Administration to a particular
product recall to indicate the relative degree of
[[Page 99]]
health hazard presented by the product being recalled.
(1) Class I is a situation in which there is a reasonable
probability that the use of, or exposure to, a violative product will
cause serious adverse health consequences or death.
(2) Class II is a situation in which use of, or exposure to, a
violative product may cause temporary or medically reversible adverse
health consequences or where the probability of serious adverse health
consequences is remote.
(3) Class III is a situation in which use of, or exposure to, a
violative product is not likely to cause adverse health consequences.
(n) Consignee means anyone who received, purchased, or used the
product being recalled.
[42 FR 15567, Mar. 22, 1977, as amended at 43 FR 26218, June 16, 1978;
44 FR 12167, Mar. 6, 1979]
Sec. 7.12 Guaranty.
In case of the giving of a guaranty or undertaking referred to in
section 303(c)(2) or (3) of the act, each person signing such guaranty
or undertaking shall be considered to have given it.
Sec. 7.13 Suggested forms of guaranty.
(a) A guaranty or undertaking referred to in section 303(c)(2) of
the act may be:
(1) Limited to a specific shipment or other delivery of an article,
in which case it may be a part of or attached to the invoice or bill of
sale covering such shipment or delivery, or
(2) General and continuing, in which case, in its application to any
shipment or other delivery of an article, it shall be considered to have
been given at the date such article was shipped or delivered by the
person who gives the guaranty or undertaking.
(b) The following are suggested forms of guaranty or undertaking
under section 303(c)(2) of the act:
(1) Limited form for use on invoice or bill of sale.
(Name of person giving the guaranty or undertaking) hereby
guarantees that no article listed herein is adulterated or misbranded
within the meaning of the Federal Food, Drug, and Cosmetic Act, or is an
article which may not, under the provisions of section 404, 505, or 512
of the act, be introduced into interstate commerce.
(Signature and post-office address of person giving the guaranty or
undertaking.)
(2) General and continuing form.
The article comprising each shipment or other delivery hereafter
made by (name of person giving the guaranty or undertaking) to, or in
the order of (name and post-office address of person to whom the
guaranty or undertaking is given) is hereby guaranteed, as of the date
of such shipment or delivery, to be, on such date, not adulterated or
misbranded within the meaning of the Federal Food, Drug, and Cosmetic
Act, and not an article which may not, under the provisions of section
404, 505, or 512 of the act, be introduced into interstate commerce.
(Signature and post-office address of person giving the guaranty of
undertaking.)
(c) The application of a guaranty or undertaking referred to in
section 303(c)(2) of the act to any shipment or other delivery of an
article shall expire when such article, after shipment or delivery by
the person who gave such guaranty or undertaking, becomes adulterated or
misbranded within the meaning of the act, or becomes an article which
may not, under the provisions of section 404, 505, or 512 of the act, be
introduced into interstate commerce.
(d) A guaranty or undertaking referred to in section 303(c)(3) of
the act shall state that the shipment or other delivery of the color
additive covered thereby was manufactured by a signer thereof. It may be
a part of or attached to the invoice or bill of sale covering such
color. If such shipment or delivery is from a foreign manufacturer, such
guaranty or undertaking shall be signed by such manufacturer and by an
agent of such manufacturer who resides in the United States.
(e) The following are suggested forms of guaranty or undertaking
under section 303(c)(3) of the act:
(1) For domestic manufacturers:
(Name of manufacturer) hereby guarantees that all color additives
listed herein were manufactured by him, and (where color additive
regulations require certification) are from batches certified in
accordance with the applicable regulations promulgated under the Federal
Food, Drug, and Cosmetic Act.
(Signature and post-office address of manufacturer.)
[[Page 100]]
(2) For foreign manufacturers:
(Name of manufacturer and agent) hereby severally guarantee that all
color additives listed herein were manufactured by (name of
manufacturer), and (where color additive regulations require
certification) are from batches certified in accordance with the
applicable regulations promulgated under the Federal Food, Drug, and
Cosmetic Act.
(Signature and post-office address of manufacturer.)
(Signature and post-office address of agent.)
(f) For the purpose of a guaranty or undertaking under section
303(c)(3) of the act the manufacturer of a shipment or other delivery of
a color additive is the person who packaged such color.
(g) A guaranty or undertaking, if signed by two or more persons,
shall state that such persons severally guarantee the article to which
it applies.
(h) No representation or suggestion that an article is guaranteed
under the act shall be made in labeling.
Subpart B [Reserved]
Subpart C_Recalls (Including Product Corrections)_Guidance on Policy,
Procedures, and Industry Responsibilities
Source: 43 FR 26218, June 16, 1978, unless otherwise noted.
Sec. 7.40 Recall policy.
(a) Recall is an effective method of removing or correcting consumer
products that are in violation of laws administered by the Food and Drug
Administration. Recall is a voluntary action that takes place because
manufacturers and distributors carry out their responsibility to protect
the public health and well-being from products that present a risk of
injury or gross deception or are otherwise defective. This section and
Sec. Sec. 7.41 through 7.59 recognize the voluntary nature of recall by
providing guidance so that responsible firms may effectively discharge
their recall responsibilities. These sections also recognize that recall
is an alternative to a Food and Drug Administration-initiated court
action for removing or correcting violative, distributed products by
setting forth specific recall procedures for the Food and Drug
Administration to monitor recalls and assess the adequacy of a firm's
efforts in recall.
(b) Recall may be undertaken voluntarily and at any time by
manufacturers and distributors, or at the request of the Food and Drug
Administration. A request by the Food and Drug Administration that a
firm recall a product is reserved for urgent situations and is to be
directed to the firm that has primary responsibility for the manufacture
and marketing of the product that is to be recalled.
(c) Recall is generally more appropriate and affords better
protection for consumers than seizure, when many lots of product have
been widely distributed. Seizure, multiple seizure, or other court
action is indicated when a firm refuses to undertake a recall requested
by the Food and Drug Administration, or where the agency has reason to
believe that a recall would not be effective, determines that a recall
is ineffective, or discovers that a violation is continuing.
[43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19, 2000]
Sec. 7.41 Health hazard evaluation and recall classification.
(a) An evaluation of the health hazard presented by a product being
recalled or considered for recall will be conducted by an ad hoc
committee of Food and Drug Administration scientists and will take into
account, but need not be limited to, the following factors:
(1) Whether any disease or injuries have already occurred from the
use of the product.
(2) Whether any existing conditions could contribute to a clinical
situation that could expose humans or animals to a health hazard. Any
conclusion shall be supported as completely as possible by scientific
documentation and/or statements that the conclusion is the opinion of
the individual(s) making the health hazard determination.
(3) Assessment of hazard to various segments of the population,
e.g., children, surgical patients, pets, livestock, etc., who are
expected to be exposed to the product being considered, with particular
attention paid to the hazard to
[[Page 101]]
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 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;
[[Page 102]]
(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 his designee under Sec.
5.20 of this chapter may request a firm to initiate a recall when the
following determinations have been made:
(1) That a product that has been distributed presents a risk of
illness or injury or gross consumer deception.
(2) That the firm has not initiated a recall of the product.
(3) That an agency action is necessary to protect the public health
and welfare.
(b) The Commissioner or his designee will notify the firm of this
determination and of the need to begin immediately a recall of the
product. Such notification will be by letter or telegram to a
responsible official of the firm, but may be preceded by oral
communication or by a visit from an authorized representative of the
local Food and Drug Administration district office, with formal, written
confirmation from the Commissioner or his designee afterward. The
notification will specify the violation, the health hazard
classification of the violative product, the recall strategy, and other
appropriate instructions for conducting the recall.
(c) Upon receipt of a request to recall, the firm may be asked to
provide the Food and Drug Administration any or all of the information
listed in Sec. 7.46(a). The firm, upon agreeing to the recall request,
may also provide other information relevant to the agency's
determination of the need for the recall or how the recall should be
conducted.
Sec. 7.46 Firm-initiated recall.
(a) A firm may decide of its own volition and under any
circumstances to remove or correct a distributed product. A firm that
does so because it believes the product to be violative is requested to
notify immediately the appropriate Food and Drug Administration district
office listed in Sec. 5.115 of this chapter. Such removal or correction
will be considered a recall only if the Food and Drug Administration
regards the product as involving a violation that is subject to legal
action, e.g., seizure. In such cases, the firm will be asked to provide
the Food and Drug Administration the following information:
(1) Identity of the product involved.
(2) Reason for the removal or correction and the date and
circumstances under which the product deficiency or possible deficiency
was discovered.
(3) Evaluation of the risk associated with the deficiency or
possible deficiency.
(4) Total amount of such products produced and/or the timespan of
the production.
(5) Total amount of such products estimated to be in distribution
channels.
(6) Distribution information, including the number of direct
accounts and, where necessary, the identity of the direct accounts.
(7) A copy of the firm's recall communication if any has issued, or
a proposed communication if none has issued.
(8) Proposed strategy for conducting the recall.
(9) Name and telephone number of the firm official who should be
contacted concerning the recall.
(b) The Food and Drug Administration will review the information
submitted, advise the firm of the assigned recall classification,
recommend any appropriate changes in the firm's strategy for the recall,
and advise the firm that its recall will be placed in the weekly FDA
Enforcement Report. Pending this review, the firm need not delay
initiation of its product removal or correction.
[[Page 103]]
(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 certain drugs and
devices where the
[[Page 104]]
agency determines that public notification may cause unnecessary and
harmful anxiety in patients and that initial consultation between
patients and their physicians is essential. The report will not include
a firm's product removals or corrections which the agency determines to
be market withdrawals or stock recoveries. The report, which also
includes other Food and Drug Administration regulatory actions, e.g.,
seizures that were effected and injunctions and prosecutions that were
filed, is available upon request from the Office of Public Affairs (HFI-
1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857.
Sec. 7.53 Recall status reports.
(a) The recalling firm is requested to submit periodic recall status
reports to the appropriate Food and Drug Administration district office
so that the agency may assess the progress of the recall. The frequency
of such reports will be determined by the relative urgency of the recall
and will be specified by the Food and Drug Administration in each recall
case; generally the reporting interval will be between 2 and 4 weeks.
(b) Unless otherwise specified or inappropriate in a given recall
case, the recall status report should contain the following information:
(1) Number of consignees notified of the recall, and date and method
of notification.
(2) Number of consignees responding to the recall communication and
quatity of products on hand at the time it was received.
(3) Number of consignees that did not respond (if needed, the
identity of nonresponding consignees may be requested by the Food and
Drug Administration).
(4) Number of products returned or corrected by each consignee
contacted and the quantity of products accounted for.
(5) Number and results of effectiveness checks that were made.
(6) Estimated time frames for completion of the recall.
(c) Recall status reports are to be discontinued when the recall is
terminated by the Food and Drug Administration.
Sec. 7.55 Termination of a recall.
(a) A recall will be terminated when the Food and Drug
Administration determines that all reasonable efforts have been made to
remove or correct the product in accordance with the recall strategy,
and when it is reasonable to assume that the product subject to the
recall has been removed and proper disposition or correction has been
made commensurate with the degree of hazard of the recalled product.
Written notification that a recall is terminated will be issued by the
appropriate Food and Drug Administration district office to the
recalling firm.
(b) A recalling firm may request termination of its recall by
submitting a written request to the appropriate Food and Drug
Adminstration district office stating that the recall is effective in
accordance with the criteria set forth in paragraph (a) of this section,
and by accompanying the request with the most current recall status
report and a description of the disposition of the recalled product.
Sec. 7.59 General industry guidance.
A recall can be disruptive of a firm's operation and business, but
there are several steps a prudent firm can take in advance to minimize
this disruptive effect. Notwithstanding similar specific requirements
for certain products in other parts of this chapter, the following is
provided by the Food and Drug Administration as guidance for a firm's
consideration:
(a) Prepare and maintain a current written contingency plan for use
in initiating and effecting a recall in accordance with Sec. Sec. 7.40
through 7.49, 7.53, and 7.55.
(b) Use sufficient coding of regulated products to make possible
positive lot identification and to facilitate effective recall of all
violative lots.
(c) Maintain such product distribution records as are necessary to
facilitate location of products that are being recalled. Such records
should be maintained for a period of time that exceeds the shelf life
and expected use of the product and is at least the length of
[[Page 105]]
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 106]]
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 107]]
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.
10.33 Administrative reconsideration of action.
10.35 Administrative stay of action.
10.40 Promulgation of regulations for the efficient enforcement of the
law.
10.45 Court review of final administrative action; exhaustion of
administrative remedies.
10.50 Promulgation of regulations and orders after an opportunity for a
formal evidentiary public hearing.
10.55 Separation of functions; ex parte communications.
10.60 Referral by court.
10.65 Meetings and correspondence.
10.70 Documentation of significant decisions in administrative file.
10.75 Internal agency review of decisions.
10.80 Dissemination of draft Federal Register notices and regulations.
10.85 Advisory opinions.
10.90 Food and Drug Administration regulations, recommendations, and
agreements.
10.95 Participation in outside standard-setting activities.
10.100 Public calendar.
10.105 Representation by an organization.
10.110 Settlement proposals.
[[Page 108]]
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 that the
Commissioner of Food and Drugs administers under Sec. 5.10.
(b) If a requirement in another part of title 21 differs from a
requirement in this part, the requirements of this part apply to the
extent that they do not conflict with the other requirements.
(c) References in this part and parts 12, 13, 14, 15, and 16 to
regulatory sections of the Code of Federal Regulations are to chapter I
of title 21 unless otherwise noted.
(d) References in this part and parts 12, 13, 14, 15, and 16 to
publication, or to the day or date of publication, or use of the phrase
to publish, refer to publication in the Federal Register unless
otherwise noted.
[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989]
Sec. 10.3 Definitions.
(a) The following definitions apply in this part and parts 12, 13,
14, 15, 16, and 19:
Act means the Federal Food, Drug, and Cosmetic Act unless otherwise
indicated.
Administrative action includes every act, including the refusal or
failure to act, involved in the administration of any law by the
Commissioner, except that it does not include the referral of apparent
violations to U.S. attorneys for the institution of civil or criminal
proceedings or an act in preparation of a referral.
Administrative file means the file or files containing all documents
pertaining to a particular administrative action, including internal
working memoranda, and recommendations.
Administrative record means the documents in the administrative file
of a particular administrative action on which the Commissioner relies
to support the action.
Agency means the Food and Drug Administration.
Chief Counsel means the Chief Counsel of the Food and Drug
Administration.
Commissioner means the Commissioner of Food and Drugs, Food and Drug
Administration, U.S. Department of Health and Human Services, or the
Commissioner's designee.
Department means the U.S. Department of Health and Human Services.
Division of Dockets Management means the Division of Dockets
Management, Office of Management and Operations of the Food and Drug
Administration, U.S. Department of Health and Human Services, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
Ex parte communication means an oral or written communication not on
the public record for which reasonable prior notice to all parties is
not given, but does not include requests for status reports on a matter.
FDA means the Food and Drug Administration.
Food and Drug Administration employee or Food and Drug
Administration representative includes members of the Food and Drug
Division of the office of the General Counsel of the Department of
Health and Human Services.
Formal evidentiary public hearing means a hearing conducted under
part 12.
[[Page 109]]
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 under Sec. 5.10.
(b) A term that is defined in section 201 of the Federal Food, Drug,
and Cosmetic Act or part 1 has the same definition in this part.
(c) Words in the singular form include the plural, words in the
masculine form include the feminine, and vice versa.
(d) Whenever a reference is made in this part to a person in FDA,
e.g., the director of a center, the reference includes all persons to
whom that person has delegated the specific function involved.
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 50
FR 8994, Mar. 6, 1985; 54 FR 6886, Feb. 15, 1989; 54 FR 9034, Mar. 3,
1989; 59 FR 14363, Mar. 28, 1994]
[[Page 110]]
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 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
[[Page 111]]
that it meets all applicable requirements or that it contains reasonable
grounds for the action requested or that the action requested is in
accordance with law.
(e) All submissions to the Division of Dockets Management will be
considered as submitted on the date they are postmarked or, if delivered
in person during regular business hours, on the date they are delivered,
unless a provision in this part, an applicable Federal Register notice,
or an order issued by an administrative law judge specifically states
that the documents must be received by a specified date, e.g., Sec.
10.33(g) relating to a petition for reconsideration, in which case they
will be considered submitted on the date received.
(f) All submissions are to be mailed or delivered in person to the
Division of Dockets Management, Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
(g) FDA ordinarily will not acknowledge or give receipt for
documents, except:
(1) Documents delivered in person or by certified or registered mail
with a return receipt requested; and
(2) Petitions for which acknowledgment of receipt of filing is
provided by regulation or by customary practice, e.g., Sec. 10.30(c)
relating to a citizen petition.
(h) Saturdays, Sundays, and Federal legal holidays are included in
computing the time allowed for the submission of documents, except that
when the time for submission expires on a Saturday, Sunday, or Federal
legal holiday, the period will be extended to include the next business
day.
(i) All submissions to the Division of Dockets Management are
representations that, to the best of the knowledge, information, and
belief of the person making the submission, the statements made in the
submission are true and accurate. All submissions are subject to the
False Reports to the Government Act (18 U.S.C. 1001) under which a
willfully false statement is a criminal offense.
(j) The availability for public examination and copying of
submissions to the Division of Dockets Management is governed by the
following rules:
(1) Except to the extent provided in paragraphs (j)(2) and (3) of
this section, the following submissions, including all supporting
material, will be on public display and will be available for public
examination between 9 a.m. and 4 p.m., Monday through Friday. Requests
for copies of submissions will be filed and handled in accordance with
subpart C of part 20:
(i) Petitions.
(ii) Comments on petitions, on documents published in the Federal
Register, and on similar public documents.
(iii) Objections and requests for hearings filed under part 12.
(iv) Material submitted at a hearing under Sec. 12.32(a)(2) and
parts 12, 13, and 15.
(v) Material placed on public display under the regulations in this
chapter, e.g., agency guidance documents developed under Sec. 10.115.
(2)(i) Material prohibited from public disclosure under Sec. 20.63
(clearly unwarranted invasion of personal privacy) and, except as
provided in paragraph (j)(3) of this section, material submitted with
objections and requests for hearing filed under part 12, or at a hearing
under part 12 or part 13, or an alternative form of public hearing
before a public advisory committee or a hearing under Sec. 12.32(a) (2)
or (3), of the following types will not be on public display, will not
be available for public examination, and will not be available for
copying or any other form of verbatim transcription unless it is
otherwise available for public disclosure under part 20:
(a) Safety and effectiveness information, which includes all studies
and tests of an ingredient or product on animals and humans and all
studies and tests on the ingredient or product for identity, stability,
purity, potency, bioavailability, performance, and usefulness.
(b) A protocol for a test or study.
(c) Manufacturing methods or processes, including quality control
procedures.
(d) Production, sales distribution, and similar information, except
any compilation of information aggregated and prepared in a way that
does not reveal confidential information.
[[Page 112]]
(e) Quantitative or semiquantitative formulas.
(f) Information on product design or construction.
(ii) Material submitted under paragraph (j)(2) of this section is to
be segregated from all other submitted material and clearly so marked. A
person who does not agree that a submission is properly subject to
paragraph (j)(2) may request a ruling from the Associate Commissioner
for Public Affairs whose decision is final, subject to judicial review
under Sec. 20.48.
(3) Material listed in paragraph (j)(2)(i) (a) and (b) of this
section may be disclosed under a protective order issued by the
administrative law judge or other presiding officer at a hearing
referenced in paragraph (j)(2)(i). The administrative law judge or
presiding officer shall permit disclosure of the data only in camera and
only to the extent necessary for the proper conduct of the hearing. The
administrative law judge or presiding officer shall direct to whom the
information is to be made available (e.g., to parties or participants,
or only to counsel for parties or participants), and persons not
specifically permitted access to the data will be excluded from the in
camera part of the proceeding. The administrative law judge or other
presiding officer may impose other conditions or safeguards. The limited
availability of material under this paragraph does not constitute prior
disclosure to the public as defined in Sec. 20.81, and no information
subject to a particular order is to be submitted to or received or
considered by FDA in support of a petition or other request from any
other person.
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 49
FR 7363, Feb. 29, 1984; 54 FR 9034, Mar. 3, 1989; 59 FR 14363, Mar. 28,
1994; 64 FR 69190, Dec. 10, 1999; 65 FR 56477, Sept. 19, 2000; 66 FR
56035, Nov. 6, 2001; 66 FR 66742, Dec. 27, 2001; 68 FR 25285, May 12,
2003]
Sec. 10.25 Initiation of administrative proceedings.
An administrative proceeding may be initiated in the following three
ways:
(a) An interested person may petition the Commissioner to issue,
amend, or revoke a regulation or order, or to take or refrain from
taking any other form of administrative action. A petition must be
either: (1) In the form specified in other applicable FDA regulations,
e.g., the form for a color additive petition in Sec. 71.1, for a food
additive petition in Sec. 171.1, for a new drug application in Sec.
314.50, for a new animal drug application in Sec. 514.1, or (2) in the
form for a citizen petition in Sec. 10.30.
(b) The Commissioner may initiate a proceeding to issue, amend, or
revoke a regulation or order or take or refrain from taking any other
form of administrative action. FDA has primary jurisdiction to make the
initial determination on issues within its statutory mandate, and will
request a court to dismiss, or to hold in abeyance its determination of
or refer to the agency for administrative determination, any issue which
has not previously been determined by the agency or which, if it has
previously been determined, the agency concluded should be reconsidered
and subject to a new administrative determination. The Commissioner may
utilize any of the procedures established in this part in reviewing and
making a determination on any matter initiated under this paragraph.
(c) The Commissioner will institute a proceeding to determine
whether to issue, amend, or revoke a regulation or order, or take or
refrain from taking any other form of administrative action whenever any
court, on its own initiative, holds in abeyance or refers any matter to
the agency for an administrative determination and the Commissioner
concludes that an administrative determination is feasible within agency
priorities and resources.
[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989]
Sec. 10.30 Citizen petition.
(a) This section applies to any petition submitted by a person
(including a person who is not a citizen of the United States) except to
the extent that other sections of this chapter apply different
requirements to a particular matter.
(b) A petition (including any attachments) must be submitted in
accordance with Sec. 10.20 and in the following form:
(Date)__________________________________________________________________
[[Page 113]]
________________________________________________________________________
Division of Dockets Management, Food and Drug Administration,
Department of Health and Human Services, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Citizen Petition
The undersigned submits this petition under ------ (relevant
statutory sections, if known) of the ------ (Federal Food, Drug, and
Cosmetic Act or the Public Health Service Act or any other statutory
provision for which authority has been delegated to the Commissioner of
Food and Drugs under 21 CFR 5.10) to request the Commissioner of Food
and Drugs to ------ (issue, amend, or revoke a regulation or order or
take or refrain from taking any other form of administrative action).
A. Action requested
((1) If the petition requests the Commissioner to issue, amend, or
revoke a regulation, the exact wording of the existing regulation (if
any) and the proposed regulation or amendment requested.)
((2) If the petition requests the Commissioner to issue, amend, or
revoke an order, a copy of the exact wording of the citation to the
existing order (if any) and the exact wording requested for the proposed
order.)
((3) If the petition requests the Commissioner to take or refrain
from taking any other form of administrative action, the specific action
or relief requested.)
B. Statement of grounds
(A full statement, in a well organized format, of the factual and
legal grounds on which the petitioner relies, including all relevant
information and views on which the petitioner relies, as well as
representative information known to the petitioner which is unfavorable
to the petitioner's position.)
C. Environmental impact
(A) Claim for categorical exclusion under Sec. Sec. 25.30, 25.31,
25.32, 25.33, or Sec. 25.34 of this chapter or an environmental
assessment under Sec. 25.40 of this chapter.)
D. Economic impact
(The following information is to be submitted only when requested by
the Commissioner following review of the petition: A statement of the
effect of requested action on: (1) Cost (and price) increases to
industry, government, and consumers; (2) productivity of wage earners,
businesses, or government; (3) competition; (4) supplies of important
materials, products, or services; (5) employment; and (6) energy supply
or demand.)
E. Certification
The undersigned certifies, that, to the best knowledge and belief of
the undersigned, this petition includes all information and views on
which the petition relies, and that it includes representative data and
information known to the petitioner which are unfavorable to the
petition.
(Signature)_____________________________________________________________
(Name of petitioner)____________________________________________________
(Mailing address)_______________________________________________________
(Telephone number)______________________________________________________
(c) A petition which appears to meet the requirements of paragraph
(b) of this section and Sec. 10.20 will be filed by the Division of
Dockets Management, stamped with the date of filing, and assigned a
docket number. The docket number identifies the file established by the
Division of Dockets Management for all submissions relating to the
petition, as provided in this part. Subsequent submissions relating to
the matter must refer to the docket number and will be filed in the
docket file. Related petitions may be filed together and given the same
docket number. The Division of Dockets Management will promptly notify
the petitioner in writing of the filing and docket number of a petition.
(d) An interested person may submit written comments to the Division
of Dockets Management on a filed petition, which comments become part of
the docket file. The comments are to specify the docket number of the
petition and may support or oppose the petition in whole or in part. A
request for alternative or different administrative action must be
submitted as a separate petition.
(e)(1) The Commissioner shall, in accordance with paragraph (e)(2),
rule upon each petition filed under paragraph (c) of this section,
taking into consideration (i) available agency resources for the
category of subject matter, (ii) the priority assigned to the petition
considering both the category of subject matter involved and the overall
work of the agency, and (iii) time requirements established by statute.
(2) Except as provided in paragraph (e)(4) of this section, the
Commissioner shall furnish a response to each petitioner within 180 days
of receipt of the petition. The response will either:
(i) Approve the petition, in which case the Commissioner shall
concurrently take appropriate action (e.g.,
[[Page 114]]
publication of a Federal Register notice) implementing the approval;
(ii) Deny the petition; or
(iii) Provide a tentative response, indicating why the agency has
been unable to reach a decision on the petition, e.g., because of the
existence of other agency priorities, or a need for additional
information. The tentative response may also indicate the likely
ultimate agency response, and may specify when a final response may be
furnished.
(3) The Commissioner may grant or deny such a petition, in whole or
in part, and may grant such other relief or take other action as the
petition warrants. The petitioner is to be notified in writing of the
Commissioner's decision. The decision will be placed in the public
docket file in the office of the Division of Dockets Management and may
also be in the form of a notice published in the Federal Register.
(4) The Commissioner shall furnish a response to each petitioner
within 90 days of receipt of a petition filed under section 505(j)(2)(C)
of the act. The response will either approve or disapprove the petition.
Agency action on a petition shall be governed by Sec. 314.93 of this
chapter.
(f) If a petition filed under paragraph (c) of this section requests
the Commissioner to issue, amend, or revoke a regulation, Sec. 10.40 or
Sec. 10.50 also apply.
(g) A petitioner may supplement, amend, or withdraw a petition in
writing without agency approval and without prejudice to resubmission at
anytime until the Commissioner rules on the petition, unless the
petition has been referred for a hearing under parts 12, 13, 14, or 15.
After a ruling or referral, a petition may be supplemented, amended, or
withdrawn only with the approval of the Commissioner. The Commissioner
may approve withdrawal, with or without prejudice against resubmission
of the petition.
(h) In reviewing a petition the Commissioner may use the following
procedures:
(1) Conferences, meetings, discussions, and correspondence under
Sec. 10.65.
(2) A hearing under parts 12, 13, 14, 15, or 16.
(3) A Federal Register notice requesting information and views.
(4) A proposal to issue, amend, or revoke a regulation, in
accordance with Sec. 10.40 or Sec. 12.20.
(5) Any other specific public procedure established in this chapter
and expressly applicable to the matter.
(i) The record of the administrative proceeding consists of the
following:
(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
[[Page 115]]
attorney for the initiation of court enforcement action and related
correspondence, or to requests, suggestions, and recommendations made
informally in routine correspondence received by FDA. Routine
correspondence does not constitute a petition within the meaning of this
section unless it purports to meet the requirements of this section.
Action on routine correspondence does not constitute final
administrative action subject to judicial review under Sec. 10.45.
(l) The Division of Dockets Management will maintain a chronological
list of each petition filed under this section and Sec. 10.85, but not
of petitions submitted elsewhere in the agency under Sec. 10.25(a)(1),
showing:
(1) The docket number;
(2) The date the petition was filed by the Division of Dockets
Management;
(3) The name of the petitioner;
(4) The subject matter involved; and
(5) The disposition of the petition.
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 50
16656, Apr. 26, 1985; 54 FR 9034, Mar. 3, 1989; 57 FR 17980, Apr. 28,
1992; 59 FR 14364, Mar. 28, 1994; 62 FR 40592, July 29, 1997; 66 FR
6467, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001]
Sec. 10.33 Administrative reconsideration of action.
(a) The Commissioner may at any time reconsider a matter, on the
Commissioner's own initiative or on the petition of an interested
person.
(b) An interested person may request reconsideration of part or all
of a decision of the Commissioner on a petition submitted under Sec.
10.25. Each request for reconsideration must be submitted in accordance
with Sec. 10.20 and in the following form no later than 30 days after
the date of the decision involved. The Commissioner may, for good cause,
permit a petition to be filed after 30 days. In the case of a decision
published in the Federal Register, the day of publication is the day of
decision.
(Date)__________________________________________________________________
Division of Dockets Management, Food and Drug Administration,
Department of Health and Human Services, rm. 1-23, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
Petition for Reconsideration
[Docket No.]
The undersigned submits this petition for reconsideration of the
decision of the Commissioner of Food and Drugs in Docket No. ----.
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.
[[Page 116]]
(e) A petition for reconsideration may not be based on information
and views not contained in the administrative record on which the
decision was made. An interested person who wishes to rely on
information or views not included in the administrative record shall
submit them with a new petition to modify the decision under Sec.
10.25(a).
(f) The decision on a petition for reconsideration is to be in
writing and placed on public display as part of the docket file on the
matter in the office of the Division of Dockets Management. A
determination to grant reconsideration will be published in the Federal
Register if the Commissioner's original decision was so published. Any
other determination to grant or deny reconsideration may also be
published in the Federal Register.
(g) The Commissioner may consider a petition for reconsideration
only before the petitioner brings legal action in the courts to review
the action, except that a petition may also be considered if the
Commissioner has denied a petition for stay of action and the petitioner
has petitioned for judicial review of the Commissioner's action and
requested the reviewing court to grant a stay pending consideration of
review. A petition for reconsideration submitted later than 30 days
after the date of the decision involved will be denied as untimely
unless the Commissioner permits the petition to be filed after 30 days.
A petition for reconsideration will be considered as submitted on the
day it is received by the Division of Dockets Management.
(h) The Commissioner may initiate the reconsideration of all or part
of a matter at any time after it has been decided or action has been
taken. If review of the matter is pending in the courts, the
Commissioner may request that the court refer the matter back to the
agency or hold its review in abeyance pending administrative
reconsideration. The administrative record of the proceeding is to
include all additional documents relating to such reconsideration.
(i) After determining to reconsider a matter, the Commissioner shall
review and rule on the merits of the matter under Sec. 10.30(e). The
Commissioner may reaffirm, modify, or overrule the prior decision, in
whole or in part, and may grant such other relief or take such other
action as is warranted.
(j) The Commissioner's reconsideration of a matter relating to a
petition submitted under Sec. 10.25(a)(2) is subject to Sec. 10.30 (f)
through (h), (j), and (k).
(k) The record of the administrative proceeding consists of the
following:
(1) The record of the original petition specified in Sec. 10.30(i).
(2) The petition for reconsideration, including all information on
which it relies, filed by the Division of Dockets Management.
(3) All comments received on the petition, including all information
submitted as a part of the comments.
(4) The Commissioner's decision on the petition under paragraph (f)
of this section, including all information identified or filed by the
Commissioner with the Division of Dockets Management as part of the
record supporting the decision.
(5) Any Federal Register notices or other documents resulting from
the petition.
(6) All documents filed with the Division of Dockets Management
under Sec. 10.65(h).
(7) If the Commissioner reconsiders the matter, the administrative
record relating to reconsideration specified in Sec. 10.30(i).
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 59
FR 14364, Mar. 28, 1994; 66 FR 6467, Jan. 22, 2001; 66 FR 12848, Mar. 1,
2001]
Sec. 10.35 Administrative stay of action.
(a) The Commissioner may at any time stay or extend the effective
date of an action pending or following a decision on any matter.
(b) An interested person may request the Commissioner to stay the
effective date of any administrative action. A stay may be requested for
a specific time period or for an indefinite time period. A request for
stay must be submitted in accordance with Sec. 10.20 and in the
following form no later than 30 days after the date of the decision
involved. The Commissioner may, for good cause, permit a petition to be
[[Page 117]]
filed after 30 days. In the case of a decision published in the Federal
Register, the day of publication is the date of decision.
(Date)__________________________________________________________________
Division of Dockets Management, Food and Drug Administration,
Department of Health and Human Services, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Petition for Stay of Action
The undersigned submits this petition requesting that the
Commissioner of Food and Drugs stay the effective date of the following
matter.
A. Decision involved
(The specific administrative action being taken by the Commissioner
for which a stay is requested, including the docket number or other
citation to the action involved.)
B. Action requested
(The length of time for which the stay is requested, which may be
for a specific or indefinite time period.)
C. Statement of grounds
(A full statement, in a well-organized format, of the factual and
legal grounds upon which the petitioner relies for the stay.)
(Signature)_____________________________________________________________
(Name of petitioner)____________________________________________________
(Mailing address)_______________________________________________________
(Telephone number)______________________________________________________
(c) A petition for stay of action relating to a petition submitted
under Sec. 10.25(a)(2) is subject to the requirements of Sec. 10.30
(c) and (d), except that it will be filed in the same docket file as the
petition to which it relates.
(d) Neither the filing of a petition for a stay of action nor action
taken by an interested person in accordance with any other
administrative procedure in this part or in any other section of this
chapter, e.g., the filing of a citizen petition under Sec. 10.30 or a
petition for reconsideration under Sec. 10.33 or a request for an
advisory opinion under Sec. 10.85, will stay or otherwise delay any
administrative action by the Commissioner, including enforcement action
of any kind, unless one of the following applies:
(1) The Commissioner determines that a stay or delay is in the
public interest and stays the action.
(2) A statute requires that the matter be stayed.
(3) A court orders that the matter be stayed.
(e) The Commissioner shall promptly review a petition for stay of
action. The Commissioner may grant or deny a petition, in whole or in
part; and may grant such other relief or take such other action as is
warranted by the petition. The Commissioner may grant a stay in any
proceeding if it is in the public interest and in the interest of
justice. The Commissioner shall grant a stay in any proceeding if all of
the following apply:
(1) The petitioner will otherwise suffer irreparable injury.
(2) The petitioner's case is not frivolous and is being pursued in
good faith.
(3) The petitioner has demonstrated sound public policy grounds
supporting the stay.
(4) The delay resulting from the stay is not outweighted by public
health or other public interests.
(f) The Commissioner's decision on a petition for stay of action is
to be in writing and placed on public display as part of the file on the
matter in the office of the Division of Dockets Management. A
determination to grant a stay will be published in the Federal Register
if the Commissioner's original decision was so published. Any other
determination to grant or to deny a stay may also be published in the
Federal Register.
(g) A petition for a stay of action submitted later than 30 days
after the date of the decision involved will be denied as untimely
unless the Commissioner permits the petition to be filed after 30 days.
A petition for a stay of action is considered submitted on the day it is
received by the Division of Dockets Management.
(h) The record of the administrative proceeding consists of the
following:
(1) The record of the proceeding to which the petition for stay of
action is directed.
(2) The petition for stay of action, including all information on
which it relies, filed by the Division of Dockets Management.
(3) All comments received on the petition, including all information
submitted as a part of the comments.
(4) The Commissioner's decision on the petition under paragraph (e)
of this
[[Page 118]]
section, including all information identified or filed by the
Commissioner with the Division of Dockets Management as part of the
record supporting the decision.
(5) Any Federal Register notices or other documents resulting from
the petition.
(6) All documents filed with the Division of Dockets Management
under Sec. 10.65(h).
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 54
FR 9034, Mar. 3, 1989; 59 FR 14364, Mar. 28, 1994; 66 FR 6468, Jan. 22,
2001; 66 FR 12848, Mar. 1, 2001]
Sec. 10.40 Promulgation of regulations for the efficient enforcement
of the law.
(a) The Commissioner may propose and promulgate regulations for the
efficient enforcement of the laws administered by FDA whenever it is
necessary or appropriate to do so. The issuance, amendment, or
revocation of a regulation may be initiated in any of the ways specified
in Sec. 10.25.
(1) This section applies to any regulation: (i) Not subject to Sec.
10.50 and part 12, or (ii) if it is subject to Sec. 10.50 and part 12,
to the extent that those provisions make this section applicable.
(2) A regulation proposed by an interested person in a petition
submitted under Sec. 10.25(a) will be published in the Federal Register
as a proposal if:
(i) The petition contains facts demonstrating reasonable grounds for
the proposal; and
(ii) The petition substantially shows that the proposal is in the
public interest and will promote the objectives of the act and the
agency.
(3) Two or more alternative proposed regulations may be published on
the same subject to obtain comment on the different alternatives.
(4) A regulation proposed by an interested person in a petition
submitted under Sec. 10.25(a) may be published together with the
Commissioner's preliminary views on the proposal and any alternative
proposal.
(b) Except as provided in paragraph (e) of this section, each
regulation must be the subject of a notice of proposed rulemaking
published in the Federal Register. (1) The notice will contain:
(i) The name of the agency;
(ii) The nature of the action, e.g., proposed rule, or notice;
(iii) A summary in the first paragraph describing the substance of
the 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.''
[[Page 119]]
(i) A request must discuss the reason comments could not feasibly be
submitted within the time permitted, or that important new information
will shortly be available, or that sound public policy otherwise
supports an extension of the time for comment. The Commissioner may
grant or deny the request or may grant an extension for a time period
different from that requested. An extension may be limited to specific
persons who have made and justified the request, but will ordinarily
apply to all interested persons.
(ii) A comment time extension of 30 days or longer will be published
in the Federal Register and will be applicable to all interested
persons. A comment time extension of less than 30 days will be the
subject either of a letter or memorandum filed with the Division of
Dockets Management or of a notice published in the Federal Register.
(4) A notice of proposed rulemaking will request that four copies of
all comments be submitted to the Division of Dockets Management, except
that individuals may submit single copies. Comments will be stamped with
the date of receipt and will be numbered chronologically.
(5) Persons submitting comments critical of a proposed regulation
are encouraged to include their preferred alternative wording.
(c) After the time for comment on a proposed regulation has expired,
the Commissioner will review the entire administrative record on the
matter, including all comments and, in a notice published in the Federal
Register, will terminate the proceeding, issue a new proposal, or
promulgate a final regulation.
(1) The quality and persuasiveness of the comments will be the basis
for the Commissioner's decision. The number or length of comments will
not ordinarily be a significant factor in the decision unless the number
of comments is material where the degree of public interest is a
legitimate factor for consideration.
(2) The decision of the Commissioner on the matter will be based
solely upon the administrative record.
(3) A final regulation published in the Federal Register will have a
preamble stating: (i) The name of the agency, (ii) the nature of the
action e.g., final rule, notice, (iii) a summary first paragraph
describing the substance of the document in easily understandable terms,
(iv) relevant dates, 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
[[Page 120]]
modified or revoked. A subsequent notice based on those comments may,
but need not, provide additional opportunity for public comment.
(2) Food additive and color additive petitions, which are subject to
the provisions of Sec. 12.20(b)(2).
(3) New animal drug regulations, which are promulgated under section
512(i) of the act.
(f) In addition to the notice and public procedure required under
paragraph (b) of this section, the Commissioner may also subject a
proposed or final regulation, before or after publication in the Federal
Register, to the following additional procedures:
(1) Conferences, meetings, discussions, and correspondence under
Sec. 10.65.
(2) A hearing under parts 12, 13, 14, or 15.
(3) A notice published in the Federal Register requesting
information and views before the Commissioner determines whether to
propose a regulation.
(4) A draft of a proposed regulation placed on public display in the
office of the Division of Dockets Management. If this procedure is used,
the Commissioner shall publish an appropriate notice in the Federal
Register stating that the document is available and specifying the time
within which comments on the draft proposal may be submitted orally or
in writing.
(5) A revised proposal published in the Federal Register, which
proposal is subject to all the provisions in this section relating to
proposed regulations.
(6) A tentative final regulation or tentative revised final
regulation placed on public display in the office of the Division of
Dockets Management and, if deemed desirable by the Commissioner,
published in the Federal Register. If the tentative regulation is placed
on display only, the Commissioner shall publish an appropriate notice in
the Federal Register stating that the document is available and
specifying the time within which comments may be submitted orally or in
writing on the tentative final regulation. The Commissioner shall mail a
copy of the tentative final regulation and the Federal Register notice
to each person who submitted comments on the proposed regulation if one
has been published.
(7) A final regulation published in the Federal Register that
provides an opportunity for the submission of further comments, in
accordance with paragraph (e)(1) of this section.
(8) Any other public procedure established in this chapter and
expressly applicable to the matter.
(g) The record of the administrative proceeding consists of all of
the following:
(1) If the regulation was initiated by a petition, the
administrative record specified in Sec. 10.30(i).
(2) If a petition for reconsideration or for a stay of action is
filed, the administrative record specified in Sec. Sec. 10.33(k) and
10.35(h).
(3) The proposed rule published in the Federal Register, including
all information identified or filed by the Commissioner with the
Division of Dockets Management on the proposal.
(4) All comments received on the proposal, including all information
submitted as a part of the comments.
(5) The notice promulgating the final regulation, including all
information identified or filed by the Commissioner with the Division of
Dockets Management as part of the administrative record of the final
regulation.
(6) The transcripts, minutes of meetings, reports, Federal Register
notices, and other documents resulting from the procedures specified in
paragraph (f) of this section, but not the transcript of a closed
portion of a public advisory committee meeting.
(7) All documents submitted to the Division of Dockets Management
under Sec. 10.65(h).
(h) The record of the administrative proceeding closes on the date
of publication of the final regulation in the Federal Register unless
some other date is specified. Thereafter, any interested person may
submit a petition for reconsideration under Sec. 10.33 or a petition
for stay of action under Sec. 10.35. A person who wishes to rely upon
information or views not included in the administrative record shall
submit it to the Commissioner with a new petition to modify the final
regulation.
(i) The Division of Dockets Management shall maintain a
chronological
[[Page 121]]
list of all regulations proposed and promulgated under this section and
Sec. 10.50 (which list will not include regulations resulting from
petitions filed and assigned a docket number under Sec. 10.30)
showing--
(1) The docket number (for a petition submitted directly to a
center, the list also includes the number or other designation assigned
by the center, e.g., the number assigned to a food additive petition);
(2) The name of the petitioner, if any;
(3) The subject matter involved; and
(4) The disposition of the petition.
[44 FR 22323, Apr. 13, 1979, as amended at 52 FR 36401, Sept. 29, 1987;
54 FR 9034, Mar. 3, 1989; 56 FR 13758, Apr. 4, 1991; 62 FR 40592, July
29, 1997; 66 FR 6468, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001]
Sec. 10.45 Court review of final administrative action; exhaustion of
administrative remedies.
(a) This section applies to court review of final administrative
action taken by the Commissioner, including action taken under
Sec. Sec. 10.25 through 10.40 and Sec. 16.1(b), except action subject
to Sec. 10.50 and part 12.
(b) A request that the Commissioner take or refrain from taking any
form of administrative action must first be the subject of a final
administrative decision based on a petition submitted under Sec.
10.25(a) or, where applicable, a hearing under Sec. 16.1(b) before any
legal action is filed in a court complaining of the action or failure to
act. If a court action is filed complaining of the action or failure to
act before the submission of the decision on a petition under Sec.
10.25(a) or, where applicable, a hearing under Sec. 16.1(b), the
Commissioner shall request dismissal of the court action or referral to
the agency for an initial administrative determination on the grounds of
a failure to exhaust administrative remedies, the lack of final agency
action as required by 5 U.S.C. 701 et seq., and the lack of an actual
controversy as required by 28 U.S.C. 2201.
(c) A request that administrative action be stayed must first be the
subject of an administrative decision based upon a petition for stay of
action submitted under Sec. 10.35 before a request is made that a court
stay the action. If a court action is filed requesting a stay of
administrative action before the Commissioner's decision on a petition
submitted in a timely manner pursuant to Sec. 10.35, the Commissioner
shall request dismissal of the court action or referral to the agency
for an initial determination on the grounds of a failure to exhaust
administrative remedies, the lack of final agency action as required by
5 U.S.C. 701 et seq., and the lack of an actual controversy as required
by 28 U.S.C. 2201. If a court action is filed requesting a stay of
administrative action after a petition for a stay of action is denied
because it was submitted after expiration of the time period provided
under Sec. 10.35, or after the time for submitting such a petition has
expired, the Commissioner will request dismissal of the court action on
the ground of a failure to exhaust administrative remedies.
(d) The Commissioner's final decision constitutes final agency
action (reviewable in the courts under 5 U.S.C. 701 et seq. and, where
appropriate, 28 U.S.C. 2201) on a petition submitted under Sec.
10.25(a), on a petition for reconsideration submitted under Sec. 10.33,
on a petition for stay of action submitted under Sec. 10.35, on an
advisory opinion issued under Sec. 10.85, on a matter involving
administrative action which is the subject of an opportunity for a
hearing under Sec. 16.1(b) of this chapter, or on the issuance of a
final regulation published in accordance with Sec. 10.40, except that
the agency's response to a petition filed under section 505(j)(2)(C) of
the act and Sec. 314.93 of this chapter will not constitute final
agency action until any petition for reconsideration submitted by the
petitioner is acted on by the Commissioner.
(1) It is the position of FDA except as otherwise provided in
paragraph (d)(2) of this section, that:
(i) Final agency action exhausts all administrative remedies and is
ripe for preenforcement judicial review as of the date of the final
decision, unless applicable law explicitly requires that the petitioner
take further action before judicial review is available;
(ii) An interested person is affected by, and thus has standing to
obtain judicial review of final agency action; and
[[Page 122]]
(iii) It is not appropriate to move to dismiss a suit for
preenforcement judicial review of final agency action on the ground that
indispenable parties are not joined or that it is an unconsented suit
against the United States if the defect could be cured by amending the
complaint.
(2) The Commissioner shall object to judicial review of a matter if:
(i) The matter is committed by law to the discretion of the
Commissioner, e.g., a decision to recommend or not to recommend civil or
criminal enforcement action under sections 302, 303, and 304 of the act;
or
(ii) Review is not sought in a proper court.
(e) An interested person may request judicial review of a final
decision of the Commissioner in the courts without first petitioning the
Commissioner for reconsideration or for a stay of action, except that in
accordance with paragraph (c) of this section, the person shall request
a stay by the Commissioner under Sec. 10.35 before requesting a stay by
the court.
(f) The Commissioner shall take the position in an action for
judicial review under 5 U.S.C. 701 et seq., whether or not it includes a
request for a declaratory judgment under 28 U.S.C. 2201, or in any other
case in which the validity of administrative action is properly
challenged, that the validity of the action must be determined solely on
the basis of the administrative record specified in Sec. Sec. 10.30(i),
10.33(k), 10.35(h), 10.40(g), and 16.80(a) or the administrative record
applicable to any decision or action under the regulations referenced in
Sec. 16.1(b), and that additional information or views may not be
considered. An interested person who wishes to rely upon information or
views not included in the administrative record shall submit them to the
Commissioner with a new petition to modify the action under Sec.
10.25(a).
(g) The Commissioner requests that all petitions for judicial review
of a particular matter be filed in a single U.S. District court. If
petitions are filed in more than one jurisdiction, the Commissioner will
take appropriate action to prevent a multiplicity of suits in various
jurisdictions, such as:
(1) A request for transfer of one or more suits to consolidate
separate actions, under 28 U.S.C. 1404(a) or 28 U.S.C. 2112(a);
(2) A request that actions in all but one jurisdiction be stayed
pending the conclusion of one proceeding;
(3) A request that all but one action be dismissed pending the
conclusion of one proceeding, with the suggestion that the other
plaintiffs intervene in that one suit; or
(4) A request that one of the suits be maintained as a class action
in behalf of all affected persons.
(h)(1) For the purpose of 28 U.S.C. 2112(a), a copy of any petition
filed in any U.S. Court of Appeals challenging a final action of the
Commissioner shall be sent by certified mail, return receipt requested,
or by personal delivery to the Chief Counsel of FDA. The petition copy
shall be time-stamped by the clerk of the court when the original is
filed with the court. The petition copy should be addressed to: Office
of the Chief Counsel (GCF-1), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. The Chief Counsel requests that the purpose
of all petitions mailed or delivered to the Office of Chief Counsel to
satisfy 28 U.S.C. 2112(a) be clearly identified in a cover letter.
(2) If the Chief Counsel receives two or more petitions filed in two
or more U.S. Courts of Appeals for review of any agency action within 10
days of the effective date of that action for the purpose of judicial
review, the Chief Counsel will notify the U.S. Judicial Panel on
Multidistrict Litigation of any petitions that were received within the
10-day period, in accordance with the applicable rule of the panel.
(3) For the purpose of determining whether a petition for review has
been received within the 10-day period under paragraph (h)(2) of this
section, the petition shall be considered to be received on the date of
delivery, if personally delivered. If the delivery is accomplished by
mail, the date of receipt shall be the date noted on the return receipt
card.
(i) Upon judicial review of administrative action under this
section:
(1) If a court determines that the administrative record is
inadequate to
[[Page 123]]
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]
Sec. 10.50 Promulgation of regulations and orders after an opportunity
for a formal evidentiary public hearing.
(a) The Commissioner shall promulgate regulations and orders after
an opportunity for a formal evidentiary public hearing under part 12
whenever all of the following apply:
(1) The subject matter of the regulation or order is subject by
statute to an opportunity for a formal evidentiary public hearing.
(2) The person requesting the hearing has a right to an opportunity
for a hearing and submits adequate justification for the hearing as
required by Sec. Sec. 12.20 through 12.22 and other applicable
provisions in this chapter, e.g., Sec. Sec. 314.200, 514.200, and
601.7(a).
(b) The Commissioner may order a formal evidentiary public hearing
on any matter whenever it would be in the public interest to do so.
(c) The provisions of the act, and other laws, that afford a person
who would be adversely affected by administrative action an opportunity
for a formal evidentiary public hearing as listed below. The list
imparts no right to a hearing where the statutory section provides no
opportunity for a hearing.
(1) Section 401 on any action for the amendment or repeal of any
definition and standard of identity for any dairy product (including
products regulated under parts 131, 133, and 135 of this chapter) or
maple sirup (regulated under Sec. 168.140 of this chapter).
(2) Section 403(j) on regulations for labeling of foods for special
dietary uses.
(3) Section 404(a) on regulations for emergency permit control.
(4) Section 406 on tolerances for poisonous substances in food.
(5) Section 409 (c), (d), and (h) on food additive regulations.
(6) Section 501(b) on tests or methods of assay for drugs described
in official compendia.
(7) [Reserved]
(8) Section 502(h) on regulations designating requirements for drugs
liable to deterioration.
(9) Section 502(n) on prescription drug advertising regulations.
(10) [Reserved]
(11) Section 507(f) on regulations for antibiotic drug
certification.
(12) Section 512(n)(5) on regulations for animal antibiotic drugs
and certification requirements.
(13) Section 721 (b) and (c) on regulations for color additive
listing and certification.
(14) Section 4(a) of the Fair Packaging and Labeling Act on food,
drug, device, and cosmetic labeling.
[[Page 124]]
(15) Section 5(c) of the Fair Packaging and Labeling Act on
additional economic regulations for food, drugs, devices, and cosmetics.
(16) Section 505 (d) and (e) on new drug applications.
(17) Section 512 (d), (e) and (m) (3) and (4) on new animal drug
applications.
(18) Section 515(g) on device premarket approval applications and
product development protocols.
(19) Section 351(a) of the Public Health Service Act on a biologics
license for a biological product.
(20) Section 306 on debarment, debarment period and considerations,
termination of debarment under section 306(d)(3), suspension, and
termination of suspension.
[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989; 58
FR 49190, Sept. 22, 1993; 60 FR 38626, July 27, 1995; 63 FR 26697, May
13, 1998; 64 FR 398, Jan. 5, 1999; 64 FR 56448, Oct. 20, 1999; 67 FR
4906, Feb. 1, 2002]
Sec. 10.55 Separation of functions; ex parte communications.
(a) This section applies to any matter subject by statute to an
opportunity for a formal evidentiary public hearing, as listed in Sec.
10.50(c), and any matter subject to a hearing before a Public Board of
Inquiry under part 13.
(b) In the case of a matter listed in Sec. 10.50(c) (1) through
(10) and (12) through (15):
(1) An interested person may meet or correspond with any FDA
representative concerning a matter prior to publication of a notice
announcing a formal evidentiary public hearing or a hearing before a
Public Board of Inquiry on the matter; the provisions of Sec. 10.65
apply to the meetings and correspondence; and
(2) Upon publication of a notice announcing a formal evidentiary
public hearing or a hearing before a Public Board of Inquiry, the
following separation of functions apply:
(i) The center responsible for the matter is, as a party to the
hearing, responsible for all investigative functions and for
presentation of the position of the center at the hearing and in any
pleading or oral argument before the Commissioner. Representatives of
the center may not participate or advise in any decision except as
witness or counsel in public proceedings. There 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
[[Page 125]]
the advice and participation of anyone in FDA other than representatives
of the involved center and those members of the office of General
Counsel designated to assist in the center's functions in the hearing.
(c) In a matter listed in Sec. 10.50(c) (11) and (16) through (19),
the provisions relating to separation of functions set forth in
Sec. Sec. 314.200(f), 514.200, and 601.7(a) are applicable before
publication of a notice announcing a formal evidentiary public hearing
or a hearing before a Public Board of Inquiry. Following publication of
the notice of hearing, the rules in paragraph (b)(2) of this section
apply.
(d) Except as provided in paragraph (e) of this section, between the
date that separation of functions applies under paragraph (b) or (c) of
this section and the date of the Commissioner's decision on the matter,
communication concerning the matter involved in the hearing will be
restricted as follows:
(1) No person outside the agency may have an ex parte communication
with the presiding officer or any person representing the office of the
Commissioner concerning the matter in the hearing. Neither the presiding
officer nor any person representing the office of the Commissioner may
have any ex parte communication with a person outside the agency
concerning the matter in the hearing. All communications are to be
public communications, as witness or counsel, under the applicable
provisions of this part.
(2) A participant in the hearing may submit a written communication
to the office of the Commissioner with respect to a proposal for
settlement. These communications are to be in the form of pleadings,
served on all other participants, and filed with the Division of Dockets
Management like any other pleading.
(3) A written communication contrary to this section must be
immediately served on all other participants and filed with the Division
of Dockets Management by the presiding officer at the hearing, or by the
Commissioner, depending on who received the communication. An oral
communication contrary to this section must be immediately recorded in a
written memorandum and similarly served on all 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
[[Page 126]]
and expressly applicable to the matter under those provisions.
(d) If the Commissioner's review of the matter results in a proposed
rule, the provisions of Sec. 10.40 or Sec. 10.50 also apply.
Sec. 10.65 Meetings and correspondence.
(a) In addition to public hearings and proceedings established under
this part and other sections of this chapter, meetings may be held and
correspondence may be exchanged between representatives of FDA and an
interested person outside FDA on a matter within the jurisdiction of the
laws administered by the Commissioner. Action on meetings and
correspondence does not constitute final administrative action subject
to judicial review under Sec. 10.45.
(b) The Commissioner may conclude that it would be in the public
interest to hold an open public meeting to discuss a matter (or class of
matters) pending before FDA, in which any interested person may
participate.
(1) The Commissioner shall inform the public of the time and place
of the meeting and of the matters to be discussed.
(2) The meeting will be informal, i.e., any interested person may
attend and participate in the discussion without prior notice to the
agency unless the notice of the meeting specifies otherwise.
(c) Every person outside the Federal Government may request a
private meeting with a representative of FDA in agency offices to
discuss a matter. FDA will make reasonable efforts to accommodate such
requests.
(1) The person requesting a meeting may be accompanied by a
reasonable number of employees, consultants, or other persons with whom
there is a commercial arrangement within the meaning of Sec. 20.81(a)
of this chapter. Neither FDA nor any other person may require the
attendance of a person who is not an employee of the executive branch of
the Federal Government without the agreement of the person requesting
the meeting. Any person may attend by mutual consent of the person
requesting the meeting and FDA.
(2) FDA will determine which representatives of the agency will
attend the meeting. The person requesting the meeting may request, but
not require 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
[[Page 127]]
any matter concerning the laws administered by the Commissioner. Unless
otherwise required by law, meetings may be public or private at FDA's
discretion.
(h) A meeting of an advisory committee is subject to the
requirements of part 14 of this chapter.
[66 FR 6468, Jan. 22, 2001]
Sec. 10.70 Documentation of significant decisions in administrative file.
(a) This section applies to every significant FDA decision on any
matter under the laws administered by the Commissioner, whether it is
raised formally, for example, by a petition or informally, for example,
by correspondence.
(b) FDA employees responsible for handling a matter are responsible
for insuring the completeness of the administrative file relating to it.
The file must contain:
(1) Appropriate documentation of the basis for the decision,
including relevant evaluations, reviews, memoranda, letters, opinions of
consultants, minutes of meetings, and other pertinent written documents;
and
(2) The recommendations and decisions of individual employees,
including supervisory personnel, responsible for handling the matter.
(i) The recommendations and decisions are to reveal significant
controversies or differences of opinion and their resolution.
(ii) An agency employee working on a matter and, consistent with the
prompt completion of other assignments, an agency employee who has
worked on a matter may record individual views on that matter in a
written memorandum, which is to be placed in the file.
(c) A written document placed in an administrative file must:
(1) Relate to the factual, scientific, legal or related issues under
consideration;
(2) Be dated and signed by the author;
(3) Be directed to the file, to appropriate supervisory personnel,
and to other appropriate employees, and show all persons to whom copies
were sent;
(4) Avoid defamatory language, intemperate remarks, undocumented
charges, or irrelevant matters (e.g., personnel complaints);
(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
[[Page 128]]
section 515(g)(2)(B) of the act. The reason(s) for any denial of a
request for such review shall be briefly set forth in writing to the
requester. Persons who receive a Center denial of their request under
this section may submit a request for review of the denial. The request
should be sent to the Chief Mediator and Ombudsman.
(c) An interested person outside the agency may request internal
agency review of a decision through the established agency channels of
supervision or review. Personal review of these matters by center
directors or the office of the Commissioner will occur for any of the
following purposes:
(1) To resolve an issue that cannot be resolved at lower levels
within the agency (e.g., between two parts of a center or other
component of the agency, between two centers or other components of the
agency, or between the agency and an interested person outside the
agency).
(2) To review policy matters requiring the attention of center or
agency management.
(3) In unusual situations requiring an immediate review in the
public interest.
(4) As required by delegations of authority.
(d) Internal agency review of a decision must be based on the
information in the administrative file. If an interested person presents
new information not in the file, the matter will be returned to the
appropriate lower level in the agency for reevaluation based on the new
information.
[44 FR 22323, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 63
FR 63982, Nov. 18, 1998]
Sec. 10.80 Dissemination of draft Federal Register notices and regulations.
(a) A representative of FDA may discuss orally or in writing with an
interested person ideas and recommendations for notices or regulations.
FDA welcomes assistance in developing ideas for, and in gathering the
information to support, notices and regulations.
(b) Notices and proposed regulations. (1) Once it is determined that
a notice or proposed regulation will be prepared, the general concepts
may be discussed by a representative of FDA with an interested person.
Details of a draft of a notice or proposed regulation may be discussed
with a person outside the executive branch only with the specific
permission of the Commissioner. The permission must be in writing and
filed with the 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.
[[Page 129]]
(ii) If additional technical information from a person outside the
executive branch is necessary to draft the final notice or regulation or
its preamble, it will be requested by FDA in general terms and furnished
directly to the Division of Dockets Management to be included as part of
the administrative record.
(iii) If direct discussion by FDA of a draft of a final notice or
regulation or its preamble is required with a person outside the
executive branch, appropriate protective procedures will be undertaken
to make certain that a full and impartial administrative record is
established. Such procedures may include either:
(a) The scheduling of an open public meeting under Sec. 10.65(b) at
which interested persons may participate in review of and comment on the
draft document; or
(b) The preparation of a tentative final regulation or tentative
revised final regulation under Sec. 10.40(f)(6), on which interested
persons will be given an additional period of time for oral and written
comment.
(e) After a final regulation is published, an FDA representative may
discuss any aspect of it with an interested person.
(f) In addition to the requirements of this section, the provisions
of Sec. 10.55 apply to the promulgation of a regulation subject to
Sec. 10.50 and part 12.
(g) A draft of a final food additive color additive, or new animal
drug regulation may be furnished to the petitioner for comment on the
technical accuracy of the regulation. Every meeting with a petitioner
relating to the draft will be recorded in a written memorandum, and all
memoranda and correspondence will be filed with the Division of Dockets
Management as part of the administrative record of the regulation under
the provisions of Sec. 10.65.
(h) In accordance with 42 U.S.C 263f, the Commissioner shall consult
with interested persons and with the Technical Electronic Product
Radiation Safety Standards Committee (TEPRSSC) before prescribing any
performance standard for an electronic product. Accordingly, the
Commissioner shall publish in the Federal Register an announcement when
a proposed or final performance standard, including any amendment, is
being considered for an electronic product, and any draft of any
proposed or final standard will be furnished to an interested person
upon request and may be discussed in detail.
(i) The provisions of Sec. 10.65 apply to meetings and
correspondence relating to draft notices and regulations.
(j) The provisions of this section restricting discussion and
disclosure of draft notices and regulations do not apply to situations
covered by Sec. Sec. 20.83 through 20.89.
[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64
FR 398, Jan. 5, 1999]
Sec. 10.85 Advisory opinions.
(a) An interested person may request an advisory opinion from the
Commissioner on a matter of general applicability.
(1) The request will be granted whenever feasible.
(2) The request may be denied if:
(i) The request contains incomplete information on which to base an
informed advisory opinion;
(ii) The Commissioner concludes that an advisory opinion cannot
reasonably be given on the matter involved;
(iii) The matter is adequately covered by a prior advisory opinion
or a regulation;
(iv) The request covers a particular product or ingredient or label
and does not raise a policy issue of broad applicability; or
(v) The Commissioner otherwise concludes that an advisory opinion
would not be in the public interest.
(b) A request for an advisory opinion is to be submitted in
accordance with Sec. 10.20, is subject to the provisions of Sec. 10.30
(c) through (l), and must be in the following form:
(Date)__________________________________________________________________
Division of Dockets Management, Food and Drug Administration,
Department of Health and Human Services, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Request for Advisory Opinion
The undersigned submits this request for an advisory opinion of the
Commissioner of Food and Drugs with respect to ------ (the general
nature of the matter involved).
[[Page 130]]
A. Issues involved.
(A concise statement of the issues and questions on which an opinion
is requested.)
B. Statement of facts and law.
(A full statement of all facts and legal points relevant to the
request.)
The undersigned certifies that, to the best of his/her knowledge and
belief, this request includes all data, information, and views relevant
to the matter, whether favorable or unfavorable to the position of the
undersigned, which is the subject of the request.
(Signature)_____________________________________________________________
(Person making request)_________________________________________________
(Mailing address)_______________________________________________________
(Telephone number)______________________________________________________
(c) The Commissioner may respond to an oral or written request to
the agency as a request for an advisory opinion, in which case the
request will be filed with the Division of Dockets Management and be
subject to this section.
(d) A statement of policy or interpretation made in the following
documents, unless subsequently repudiated by the agency or overruled by
a court, will constitute an advisory opinion:
(1) Any portion of a Federal Register notice other than the text of
a proposed or final regulation, e.g., a notice to manufacturers or a
preamble to a proposed or final regulation.
(2) Trade Correspondence (T.C. Nos. 1-431 and 1A-8A) issued by FDA
between 1938 and 1946.
(3) Compliance policy guides issued by FDA beginning in 1968 and
codified in the Compliance Policy Guides manual.
(4) Other documents specifically identified as advisory opinions,
e.g., advisory opinions on the performance standard for diagnostic X-ray
systems, issued before July 1, 1975, and filed in a permanent public
file for prior advisory opinions maintained by the Freedom of
Information Staff (HFI-35).
(e) An advisory opinion represents the formal position of FDA on a
matter and except as provided in paragraph (f) of this section,
obligates the agency to follow it until it is amended or revoked. The
Commissioner may not recommend legal action against a person or product
with respect to an action taken in conformity with an advisory opinion
which has not been amended or revoked.
(f) In unusual situations involving an immediate and significant
danger to health, the Commissioner may take appropriate civil
enforcement action contrary to an advisory opinion before amending or
revoking the opinion. This action may be taken only with the approval of
the Commissioner, who may not delegate this function. Appropriate
amendment or revocation of the advisory opinion involved will be
expedited.
(g) An advisory opinion may be amended or revoked at any time after
it has been issued. Notice of amendment or revocation will be given in
the same manner as notice of the advisory opinion was originally given
or in the Federal Register, and will be placed on public display as part
of the file on the matter in the office of the Division of Dockets
Management. The Division of Dockets Management shall maintain a separate
chronological index of all advisory opinions filed. The index will
specify the date of the request for the advisory opinion, the date of
the opinion, and identification of the appropriate file.
(h) Action undertaken or completed in conformity with an advisory
opinion which has subsequently been amended or revoked is acceptable to
FDA unless the Commissioner determines that substantial public interest
considerations preclude continued acceptance. Whenever possible, an
amended or revoked advisory opinion will state when action previously
undertaken or completed does not remain acceptable, and any transition
period that may be applicable.
(i) An interested person may submit written comments on an advisory
opinion or modified advisory opinion. Four copies of any comments are to
be sent to the Division of Dockets Management for inclusion in the
public file on the advisory opinion. Individuals may submit only one
copy. Comments will be considered in determining whether further
modification of an advisory opinion is warranted.
(j) An advisory opinion may be used in administrative or court
proceedings to illustrate acceptable and unacceptable procedures or
standards, but not as a legal requirement.
(k) A statement made or advice provided by an FDA employee
constitutes an advisory opinion only if it is issued
[[Page 131]]
in writing under this section. A statement or advice given by an FDA
employee orally, or given in writing but not under this section or Sec.
10.90, is an informal communication that represents the best judgment of
that employee at that time but does not constitute an advisory opinion,
does not necessarily represent the formal position of FDA, and does not
bind or otherwise obligate or commit the agency to the views expressed.
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 59
FR 14364, Mar. 28, 1994; 65 FR 56477, Sept. 19, 2000]
Sec. 10.90 Food and Drug Administration regulations, recommendations,
and agreements.
(a) Regulations. FDA regulations are promulgated in the Federal
Register under Sec. 10.40 or Sec. 10.50 and codified in the Code of
Federal Regulations. Regulations may contain provisions that will be
enforced as legal requirements, or which are intended only as guidelines
and recommendations, or both. The dissemination of draft notices and
regulations is subject to Sec. 10.80.
(b) [Reserved]
(c) Recommendations. In addition to the guidelines subject to
paragraph (b) of this section, FDA often formulates and disseminates
recommendations about matters which are authorized by, but do not
involve direct regulatory action under, the laws administered by the
Commissioner, e.g., model State and local ordinances, or personnel
practices for reducing radiation exposure, issued under 42 U.S.C. 243
and 263d(b). These recommendations may, in the discretion of the
Commissioner, be handled under the procedures established in paragraph
(b) of this section, except that the recommendations will be included in
a separate public file of recommendations established by the Division of
Dockets Management and will be separated from the guidelines in the
notice of availability published in the Federal Register, or be
published in the Federal Register as regulations under paragraph (a) of
this section.
(d) Agreements. Formal agreements, memoranda of understanding, or
other similar written documents executed by FDA and another person will
be included in the public file on agreements established by the Freedom
of Information Staff (HFI-35) under Sec. 20.108. A document not
included in the public file is deemed to be rescinded and has no force
or effect whatever.
[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 65
FR 56477, Sept. 19, 2000]
Sec. 10.95 Participation in outside standard-setting activities.
(a) General. This section applies to participation by FDA employees
in standard-setting activities outside the agency. Standard-setting
activities include matters such as the development of performance
characteristics, testing methodology, manufacturing practices, product
standards, scientific protocols, compliance criteria, ingredient
specifications, labeling, or other technical or policy criteria. FDA
encourages employee participation in outside standard-setting activities
that are in the public interest.
(b) Standard-setting activities by other Federal Government
agencies. (1) An FDA employee may participate in these activities after
approval of the activity under procedures specified in the current
agency Staff Manual Guide.
(2) Approval forms and all pertinent background information
describing the activity will be included in the public file on standard-
setting activities established by the Freedom of Information Staff.
(3) If a member of the public is invited by FDA to present views to,
or to accompany, the FDA employee at a meeting, the invitations will be
extended to a representative sampling of the public, including consumer
groups, industry associations, professional societies, and academic
institutions.
(4) An FDA employee appointed as the liaison representative to an
activity shall refer all requests for information about or participation
in the activity to the group or organization responsible for the
activity.
(c) Standard-setting activities by State and local government
agencies and by United Nations organizations and other international
organizations and foreign governments pursuant to treaty. (1) An FDA
employee may participate in these activities after approval of the
[[Page 132]]
activity under procedures specified in the current agency Staff Manual
Guide.
(2) Approval forms and all pertinent background information
describing the activity will be included in the public file on standard-
setting activities established by the Freedom of Information Staff (HFI-
35).
(3) The availability for public disclosure of records relating to
the activity will be governed by part 20.
(4) If a member of the public is invited by FDA to present views to,
or to accompany, the FDA employee at a meeting, the invitation will be
extended to a representative sampling of the public, including consumer
groups, industry associations, professional societies, and academic
institutions.
(5) An FDA employee appointed as the liaison representative to an
activity shall refer all requests for information about or participation
in the activity to the group or organization responsible for the
activity.
(d) Standard-setting activities by private groups and organizations.
(1) An FDA employee may engage in these activities after approval of the
activity under procedures specified in the current agency Staff Manual
Guide. A request for official participation must be made by the group or
organization in writing, must describe the scope of the activity, and
must demonstrate that the minimum standards set out in paragraph (d)(5)
of this section are met. Except as provided in paragraph (d)(7) of this
section, a request that is granted will be the subject of a letter from
the Commissioner or the center director to the organization stating--
(i) Whether participation by the individual will be as a voting or
nonvoting liaison representative;
(ii) That participation by the individual does not connote FDA
agreement with, or endorsement of, any decisions reached; and
(iii) That participation by the individual precludes service as the
deciding official on the standard involved if it should later come
before FDA. The deciding official is the person who signs a document
ruling upon the standard.
(2) The letter requesting official FDA participation, the approval
form, and the Commissioner's or center director's letter, together with
all pertinent background information describing the activities involved,
will be included in the public file on standard-setting activities
established by the Freedom of Information Staff (HFI-35).
(3) The availability for public disclosure of records relating to
the activities will be governed by part 20.
(4) An FDA employee appointed as the liaison representative to an
activity shall refer all requests for information about or participation
in the activity to the group or organization responsible for the
activity.
(5) The following minimum standards apply to an outside private
standard-setting activity in which FDA employees participate:
(i) The activity will be based upon consideration of sound
scientific and technological information, will permit revision on the
basis of new information, and will be designed to protect the public
against unsafe, ineffective, or deceptive products or practices.
(ii) The activity and resulting standards will not be designed for
the economic benefit of any company, group, or organization, will not be
used for such antitrust violations as fixing prices or hindering
competition, and will not involve establishment of certification or
specific approval of individual products or services.
(iii) The group or organization responsible for the standard-setting
activity must have a procedure by which an interested person will have
an opportunity to provide information and views on the activity and
standards involved, without the payment of fees, and the information and
views will be considered. How this is accomplished, including whether
the presentation will be in person or in writing, will be decided by the
group or organization responsible for the activity.
(6) Membership of an FDA employee in an organization that also
conducts a standard-setting activity does not invoke the provisions of
this section unless the employee participates in the standard-setting
activity. Participation in a standard-setting activity is subject to
this section.
(7) The Commissioner may determine in writing that, because direct
involvement by FDA in a particular standard-
[[Page 133]]
setting activity is in the public interest and will promote the
objectives of the act and the agency, the participation is exempt from
the requirements of paragraph (d)(1) (ii) and/or (iii) of this section.
This determination will be included in the public file on standard-
setting activities established by the Freedom of Information Staff and
in any relevant administrative file. The activity may include the
establishment and validation of analytical methods for regulatory use,
drafting uniform laws and regulations, and the development of
recommendations concerning public health and preventive medicine
practices by national and international organizations.
(8) Because of the close daily cooperation between FDA and the
associations of State and local government officials listed below in
this paragraph, and the large number of agency employees who are members
of or work with these associations, participation in the activities of
these associations is exempt from paragraphs (d)(1) through (7) of this
section, except that a list of the committees and other groups of these
associations will be included in the public file on standard-setting
activities established by the Freedom of Information Staff (HFI-35):
(i) American Association of Food Hygiene Veterinarians (AAFHV).
(ii) American Public Health Association (APHA).
(iii) Association of American Feed Control Officials, Inc. (AAFCO).
(iv) Association of Food and Drug Officials (AFDO).
(v) Association of Official Analytical Chemists (AOAC).
(vi) Association of State and Territorial Health Officials (ASTHO).
(vii) Conference for Food Protection (CFP).
(viii) Conference of State Health and Environmental Managers
(COSHEM).
(ix) Conference of Radiation Control Program Directors (CRCPD).
(x) International Association of Milk, Food, and Environmental
Sanitation, Inc. (IAMFES).
(xi) Interstate Shellfish Sanitation Conference (ISSC).
(xii) National Association of Boards of Pharmacy (NABP).
(xiii) National Association of Departments of Agriculture (NADA).
(xiv) National Conference on Interstate Milk Shipments (NCIMS).
(xv) National Conference of Local Environmental Health
Administrators (NCLEHA).
(xvi) National Conference on Weights and Measures (NCWW).
(xvii) National Environmental Health Association (NEHA).
(xviii) National Society of Professional Sanitarians (NSPS).
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 52
FR 35064, Sept. 17, 1987; 54 FR 9035, Mar. 3, 1989]
Sec. 10.100 Public calendar.
(a) Public calendar. A public calendar will be prepared and made
publicly available by FDA each week showing, to the extent feasible,
significant events of the previous week, including significant meetings
with persons outside the executive branch, that involve the
representatives of FDA designated under paragraph (c) of this section.
(1) Public calendar entries will include:
(i) Significant meetings with members of the judiciary,
representatives of Congress, or staffs of congressional committees when
the meeting relates to a pending court case, administrative hearing, or
other regulatory action or decision;
(ii) Significant meetings, conferences, seminars, and speeches; and
(iii) Social events sponsored by the regulated industry.
(2) The public calendar will not include reports of meetings that
would prejudice law enforcement activities (e.g., a meeting with an
informant) or invade privacy (e.g., a meeting with a candidate for
possible employment at FDA), meetings with members of the press, or
meetings with onsite contractors.
(b) Calendar entries. The calendar will specify for each entry the
date, person(s), and subject matter involved. If a large number of
persons are in attendance, the name of each individual need not be
specified. When more than one FDA representative is in attendance, the
most senior agency official will report the meeting on the public
calendar.
[[Page 134]]
(c) Affected persons. The following FDA representatives are subject
to the requirements of this section:
(1) Commissioner of Food and Drugs.
(2) Senior Associate Commissioners.
(3) Deputy Commissioners.
(4) Associate Commissioner for Regulatory Affairs.
(5) Center Directors.
(6) Chief Counsel for the Food and Drug Administration.
(d) Public display. The public calendar will be placed on public
display at the following locations:
(1) Division of Dockets Management.
(2) Office of the Associate Commissioner for Public Affairs.
(3) The FDA home page, to the extent feasible.
[66 FR 6468, Jan. 22, 2001]
Sec. 10.105 Representation by an organization.
(a) An organization may represent its members by filing petitions,
comments, and objections, and otherwise participating in an
administrative proceeding subject to this part.
(b) A petition, comment, objection, or other representation by an
organization will not abridge the right of a member to take individual
action of a similar type, in the member's own name.
(c) It is requested that each organization participating in FDA
administrative proceedings file annually with the Division of Dockets
Management a current list of all of the members of the organization.
(d) The filing by an organization of an objection or request for
hearing under Sec. Sec. 12.20 through 12.22 does not provide a member a
legal right with respect to the objection or request for hearing that
the member may individually exercise. A member of an organization
wishing to file an objection or request for hearing must do so
individually.
(e) In a court proceeding in which an organization participates, the
Commissioner will take appropriate legal measures to have the case
brought or considered as a class action or otherwise as binding upon all
members of the organization except those specifically excluded by name.
Regardless of whether the case is brought or considered as a class
action or as otherwise binding upon all members of the organization
except those specifically excluded by name, the Commissioner will take
the position in any subsequent suit involving the same issues and a
member of the organization that the issues are precluded from further
litigation by the member under the doctrines of collateral estoppel or
res judicata.
Sec. 10.110 Settlement proposals.
At any time in the course of a proceeding subject to this part, a
person may propose settlement of the issues involved. A participant in a
proceeding will have an opportunity to consider a proposed settlement.
Unaccepted proposals of settlement and related matters, e.g., proposed
stipulations not agreed to, will not be admissible in evidence in an FDA
administrative proceeding. FDA will oppose the admission in evidence of
settlement information 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.
[[Page 135]]
(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 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:
[[Page 136]]
(i) Before FDA prepares a draft of a Level 1 guidance document, FDA
can seek or accept early input from individuals or groups outside the
agency. For example, FDA can do this by participating in or holding
public meetings and workshops.
(ii) After FDA prepares a draft of a Level 1 guidance document, FDA
will:
(A) Publish a notice in the Federal Register announcing that the
draft guidance document is available;
(B) Post the draft guidance document on the Internet and make it
available in hard copy; and
(C) Invite your comment on the draft guidance document. Paragraph
(h) of this section tells you how to submit your comments.
(iii) After FDA prepares a draft of a Level 1 guidance document, FDA
also can:
(A) Hold public meetings or workshops; or
(B) Present the draft guidance document to an advisory committee for
review.
(iv) After providing an opportunity for public comment on a Level 1
guidance document, FDA will:
(A) Review any comments received and prepare the final version of
the guidance document that incorporates suggested changes, when
appropriate;
(B) Publish a notice in the Federal Register announcing that the
guidance document is available;
(C) Post the guidance document on the Internet and make it available
in hard copy; and
(D) Implement the guidance document.
(v) After providing an opportunity for comment, FDA may decide that
it should issue another draft of the guidance document. In this case,
FDA will follow the steps in paragraphs (g)(1)(ii), (g)(1)(iii), and
(g)(1)(iv) of this section.
(2) FDA will not seek your comment before it implements a Level 1
guidance document if the agency determines that prior public
participation is not feasible or appropriate.
(3) FDA will use the following procedures for developing and issuing
Level 1 guidance documents under the circumstances described in
paragraph (g)(2) of this section:
(i) After FDA prepares a guidance document, FDA will:
(A) Publish a notice in the Federal Register announcing that the
guidance document is available;
(B) Post the guidance document on the Internet and make it available
in hard copy;
(C) Immediately implement the guidance document; and
(D) Invite your comment when it issues or publishes the guidance
document. Paragraph (h) of this section tells you how to submit your
comments.
(ii) If FDA receives comments on the guidance document, FDA will
review those comments and revise the guidance document when appropriate.
(4) FDA will use the following procedures for developing and issuing
Level 2 guidance documents:
(i) After it prepares a guidance document, FDA will:
(A) Post the guidance document on the Internet and make it available
in hard copy;
(B) Immediately implement the guidance document, unless FDA
indicates otherwise when the document is made available; and
(C) Invite your comment on the Level 2 guidance document. Paragraph
(h) of this section tells you how to submit your comments.
(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.
[[Page 137]]
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.
(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
[[Page 138]]
Mediator and Ombudsman to become involved.
[65 FR 56477, Sept. 19, 2000]
Subpart C_Electronic Media Coverage of Public Administrative
Proceedings; Guideline on Policy and Procedures
Source: 49 FR 14726, Apr. 13, 1984, unless otherwise noted.
Sec. 10.200 Scope.
This guideline describes FDA's policy and procedures applicable to
electronic media coverage of agency public administrative proceedings.
It is a guideline intended to clarify and explain FDA's policy on the
presence and operation of electronic recording equipment at such
proceedings and to assure uniform and consistent application of
practices and procedures throughout the agency.
Sec. 10.203 Definitions.
(a) Public administrative proceeding as used in this guideline means
any FDA proceeding which the public has a right to attend. This includes
a formal evidentiary public hearing as set forth in part 12, a public
hearing before a Public Board of Inquiry as set forth in part 13, a
public hearing before a Public Advisory Committee as set forth in part
14, a public hearing before the Commissioner as set forth in part 15, a
regulatory hearing before FDA as set forth in part 16, consumer exchange
meetings, and Commissioner's public meetings with health professionals.
(b) Advance notice as used in this guideline means written or
telephone notification to FDA's Office of Public Affairs (Press
Relations Staff) of intent to electronically record an agency public
administrative proceeding.
(c) Electronic recording as used in this guideline means any visual
or audio recording made by videotape recording equipment or moving film
camera, and/or other electronic recording equipment.
[49 FR 14726, Apr. 13, 1984, as amended at 54 FR 9035, Mar. 3, 1989]
Sec. 10.204 General.
(a) FDA has for many years willingly committed itself to a policy of
openness. In many instances FDA has sought to make the open portions of
agency public administrative proceedings more accessible to public
participation. Similarly, FDA has sought, wherever possible, to allow
full written media access to its proceedings, so that members of the
press would have the opportunity to provide first-hand reports. However,
because electronic media coverage presents certain difficulties that are
easier to resolve with advance notice to the agency and all
participants, FDA believes that codification of its policy will
facilitate and further increase media access to its public
administrative proceedings. The agency intends to refer to this
guideline when notices of hearing, or individual advisory committee
meetings, are published in the Federal Register. Thus, all parties to a
proceeding will be on notice that the proceeding may be recorded
electronically and any person interested in videotaping or otherwise
recording the proceeding will be notified that there are established
procedures to be followed.
(b) The designated presiding officer of a public administrative
proceeding retains the existing discretionary authority set forth in
specific regulations pertaining to each type of administrative
proceeding to regulate the conduct 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
[[Page 139]]
presiding officers should ordinarily follow, but from which they may
depart in particular situations if necessary, subject to the presumption
of openness of public proceedings to electronic media coverage. The
presiding officer's discretion to establish additional procedures or to
limit electronic coverage is to be exercised only in the unusual
circumstances defined in this guideline. Even though a presiding officer
may establish additional procedures or limits as may be required in a
particular situation, he or she will be guided by the policy expressed
in this guideline in establishing these conditions. The presiding
officer may also be less restrictive, taking into account such factors
as the duration of a hearing and the design of the room.
(d) If a portion or all of a proceeding is closed to the public
because material is to be discussed that is not disclosable to the
public under applicable laws, the proceeding also will be closed to
electronic media coverage.
(e) The agency requests advance notice of intent to record a
proceeding electronically to facilitate the orderly conduct of the
proceeding. Knowledge of anticipated media coverage will allow the
presiding officer to make any special arrangements required by the
circumstances of the proceeding. The agency believes that this guideline
establishes sufficiently specific criteria to promote uniformity.
(f) The agency would like to allow all interested media
representatives to videotape a proceeding in which they have an
interest. However, should space limitations preclude a multitude of
cameras, the presiding officer may require pool sharing. In such a case,
pool sharing arrangements of the resulting videotape should be made
between those allowed to film and those who were excluded. Arrangements
for who is designated to present the pool and a method of distributing
the resulting film or tape may be determined by the established
networks' pooling system. However, the agency has a strong commitment to
ensuring that media representatives other than the major networks also
be able to obtain a copy of the tape at cost. FDA is concerned that if
the network pool representative wishes to record only a short portion of
a proceeding, but an excluded party wishes to record the entire
proceeding, confusion will result. The agency expects the interested
media representatives to negotiate a suitable agreement among themselves
before commencement of the proceeding. For example, the network pool
representatives might agree to record a portion of the proceeding up to
a break in the proceeding, at which time, while the network
representative is disassembling equipment, another media representative
might set up to continue recording. If an agreement cannot be reached
before the proceeding, the agency will use the time of receipt of any
advance notice to determine the representation for each category of
media, e.g., one network reporter, one independent reporter. The agency
recommends that parties intending to videotape provide as much advance
notice as possible, so that the agency may best respond to the needs of
the electronic media.
(g) To ensure the timely conduct of agency hearings and to prevent
disruptions, equipment is to be stationary during a proceeding and
should be set up and taken down when the proceeding is not in progress.
As noted previously, the presiding officer may, at his or her
discretion, be less restrictive if appropriate.
(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.
[[Page 140]]
Sec. 10.205 Electronic media coverage of public administrative
proceedings.
(a) A person may record electronically any open public
administrative proceeding, subject to the procedures specified in this
guideline. The procedures include a presumption that agency public
proceedings are open to the electronic media. Whenever possible, FDA
will permit all interested persons access to record agency public
administrative proceedings. Restrictions other than those listed in
Sec. 10.206 will be imposed only under exceptional circumstances.
(b) A videotape recording of an FDA public administrative proceeding
is not an official record of the proceeding. The only official record is
the written transcript of the proceeding, which is taken by the official
reporter.
Sec. 10.206 Procedures for electronic media coverage of agency public
administrative proceedings.
(a) To facilitate the agency's response to media needs, a person
intending to videotape an FDA public administrative proceeding should,
whenever possible, provide advance notice to the Press Relations Staff
(HFI-20), Office of Public Affairs, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, in writing or by telephone (telephone
301-443-4177), at least 48 hours in advance of the proceeding. The Press
Relations Staff will inform the presiding officer that the proceeding
will be attended by representatives of the electronic media, and
ascertain whether any special provisions in addition to those set forth
in this subpart are required by the presiding officer. If so, the Press
Relations Staff will function as a liaison between the presiding officer
and the person intending to record the proceeding in facilitating any
procedures in addition to those outlined in this subpart. The presiding
officer will not deny access for failure to provide a 48-hour advance
notice. Any advance notice may describe the intended length of recording
if known, the amount and type of equipment to be used, and any special
needs such as interviews.
(b) Cameras should be completely set up before a proceeding is
scheduled to begin or during a break in the proceeding and should remain
standing in the area designated for electronic media equipment. Cameras
may be taken down only during breaks or after the hearing is over.
Roving cameras will not be permitted during the proceeding. Any
artificial lighting should be unobtrusive. Microphones, like cameras,
should be in place before the start of a proceeding and may be taken
down as indicated in this paragraph.
(c) When space in the hearing room is limited, the presiding officer
may restrict the number of cameras or the equipment present. Should such
a restriction become necessary, the pool arrangements are the
responsibility of the participating media. The agency encourages the
network pool to make copies of the tape, film, or other product
available at cost to nonpool participants. However, if this is not
possible, the agency may need to use the time of receipt of any advance
notice to determine the representation for each category, e.g., one
network reporter, one independent reporter, etc.
(d) Off the record portions of a proceeding may not be videotaped.
(e) Before or during the proceeding, the presiding officer may
establish other conditions specific to the proceeding for which the
request is being made. These conditions may be more or 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
[[Page 141]]
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 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.
[[Page 142]]
Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.
Source: 62 FR 13464, Mar. 20, 1997, unless otherwise noted.
Subpart A_General Provisions
Sec. 11.1 Scope.
(a) The regulations in this part set forth the criteria under which
the agency considers electronic records, electronic signatures, and
handwritten signatures executed to electronic records to be trustworthy,
reliable, and generally equivalent to paper records and handwritten
signatures executed on paper.
(b) This part applies to records in electronic form that are
created, modified, maintained, archived, retrieved, or transmitted,
under any records requirements set forth in agency regulations. This
part also applies to electronic records submitted to the agency under
requirements of the Federal Food, Drug, and Cosmetic Act and the Public
Health Service Act, even if such records are not specifically identified
in agency regulations. However, this part does not apply to paper
records that are, or have been, transmitted by electronic means.
(c) Where electronic signatures and their associated electronic
records meet the requirements of this part, the agency will consider the
electronic signatures to be equivalent to full handwritten signatures,
initials, and other general signings as required by agency regulations,
unless specifically excepted by regulation(s) effective on or after
August 20, 1997.
(d) Electronic records that meet the requirements of this part may
be used in lieu of paper records, in accordance with Sec. 11.2, unless
paper records are specifically required.
(e) Computer systems (including hardware and software), controls,
and attendant documentation maintained under this part shall be readily
available for, and subject to, FDA inspection.
Sec. 11.2 Implementation.
(a) For records required to be maintained but not submitted to the
agency, persons may use electronic records in lieu of paper records or
electronic signatures in lieu of traditional signatures, in whole or in
part, provided that the requirements of this part are met.
(b) For records submitted to the agency, persons may use electronic
records in lieu of paper records or electronic signatures in lieu of
traditional signatures, in whole or in part, provided that:
(1) The requirements of this part are met; and
(2) The document or parts of a document to be submitted have been
identified in public docket No. 92S-0251 as being the type of submission
the agency accepts in electronic form. This docket will identify
specifically what types of documents or parts of documents are
acceptable for submission in electronic form without paper records and
the agency receiving unit(s) (e.g., specific center, office, division,
branch) to which such submissions may be made. Documents to agency
receiving unit(s) not specified in the public docket will not be
considered as official if they are submitted in electronic form; paper
forms of such documents will be 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
[[Page 143]]
for the content of electronic records that are on the system.
(5) Digital signature means an electronic signature based upon
cryptographic methods of originator authentication, computed by using a
set of rules and a set of parameters such that the identity of the
signer and the integrity of the data can be verified.
(6) Electronic record means any combination of text, graphics, data,
audio, pictorial, or other information representation in digital form
that is created, modified, maintained, archived, retrieved, or
distributed by a computer system.
(7) Electronic signature means a computer data compilation of any
symbol or series of symbols executed, adopted, or authorized by an
individual to be the legally binding equivalent of the individual's
handwritten signature.
(8) Handwritten signature means the scripted name or legal mark of
an individual handwritten by that individual and executed or adopted
with the present intention to authenticate a writing in a permanent
form. The act of signing with a writing or marking instrument such as a
pen or stylus is preserved. The scripted name or legal mark, while
conventionally applied to paper, may also be applied to other devices
that capture the name or mark.
(9) Open system means an environment in which system access is not
controlled by persons who are responsible for the content of electronic
records that are on the system.
Subpart B_Electronic Records
Sec. 11.10 Controls for closed systems.
Persons who use closed systems to create, modify, maintain, or
transmit electronic records shall employ procedures and controls
designed to ensure the authenticity, integrity, and, when appropriate,
the confidentiality of electronic records, and to ensure that the signer
cannot readily repudiate the signed record as not genuine. Such
procedures and controls shall include the following:
(a) Validation of systems to ensure accuracy, reliability,
consistent intended performance, and the ability to discern invalid or
altered records.
(b) The ability to generate accurate and complete copies of records
in both human readable and electronic form suitable for inspection,
review, and copying by the agency. Persons should contact the agency if
there are any questions regarding the ability of the agency to perform
such review and copying of the electronic records.
(c) Protection of records to enable their accurate and ready
retrieval throughout the records retention period.
(d) Limiting system access to authorized individuals.
(e) Use of secure, computer-generated, time-stamped audit trails to
independently record the date and time of operator entries and actions
that create, modify, or delete electronic records. Record changes shall
not obscure previously recorded information. Such audit trail
documentation shall be retained for a period at least as long as that
required for the subject electronic records and shall be available for
agency review and copying.
(f) Use of operational system checks to enforce permitted sequencing
of steps and events, as appropriate.
(g) Use of authority checks to ensure that only authorized
individuals can use the system, electronically sign a record, access the
operation or computer system input or output device, alter a record, or
perform the operation at hand.
(h) Use of device (e.g., terminal) checks to determine, as
appropriate, the validity of the source of data input or operational
instruction.
(i) Determination that persons who develop, maintain, or use
electronic record/electronic signature systems have the education,
training, and experience to perform their assigned tasks.
(j) The establishment of, and adherence to, written policies that
hold individuals accountable and responsible for actions initiated under
their electronic signatures, in order to deter record and signature
falsification.
(k) Use of appropriate controls over systems documentation
including:
(1) Adequate controls over the distribution of, access to, and use
of documentation for system operation and maintenance.
[[Page 144]]
(2) Revision and change control procedures to maintain an audit
trail that documents time-sequenced development and modification of
systems documentation.
Sec. 11.30 Controls for open systems.
Persons who use open systems to create, modify, maintain, or
transmit electronic records shall employ procedures and controls
designed to ensure the authenticity, integrity, and, as appropriate, the
confidentiality of electronic records from the point of their creation
to the point of their receipt. Such procedures and controls shall
include those identified in Sec. 11.10, as appropriate, and additional
measures such as document encryption and use of appropriate digital
signature standards to ensure, as necessary under the circumstances,
record authenticity, integrity, and confidentiality.
Sec. 11.50 Signature manifestations.
(a) Signed electronic records shall contain information associated
with the signing that clearly indicates all of the following:
(1) The printed name of the signer;
(2) The date and time when the signature was executed; and
(3) The meaning (such as review, approval, responsibility, or
authorship) associated with the signature.
(b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of
this section shall be subject to the same controls as for electronic
records and shall be included as part of any human readable form of the
electronic record (such as electronic display or printout).
Sec. 11.70 Signature/record linking.
Electronic signatures and handwritten signatures executed to
electronic records shall be linked to their respective electronic
records to ensure that the signatures cannot be excised, copied, or
otherwise transferred to falsify an electronic record by ordinary means.
Subpart C_Electronic Signatures
Sec. 11.100 General requirements.
(a) Each electronic signature shall be unique to one individual and
shall not be reused by, or reassigned to, anyone else.
(b) Before an organization establishes, assigns, certifies, or
otherwise sanctions an individual's electronic signature, or any element
of such electronic signature, the organization shall verify the identity
of the individual.
(c) Persons using electronic signatures shall, prior to or at the
time of such use, certify to the agency that the electronic signatures
in their system, used on or after August 20, 1997, are intended to be
the legally binding equivalent of traditional handwritten signatures.
(1) The certification shall be submitted in paper form and signed
with a traditional handwritten signature, to the Office of Regional
Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.
(2) Persons using electronic signatures shall, upon agency request,
provide additional certification or testimony that a specific electronic
signature is the legally binding equivalent of the signer's handwritten
signature.
Sec. 11.200 Electronic signature components and controls.
(a) Electronic signatures that are not based upon biometrics shall:
(1) Employ at least two distinct identification components such as
an identification code and password.
(i) When an individual executes a series of signings during a
single, continuous period of controlled system access, the first signing
shall be executed using all electronic signature components; subsequent
signings shall be executed using at least one electronic signature
component that is only executable by, and designed to be used only by,
the individual.
(ii) When an individual executes one or more signings not performed
during a single, continuous period of controlled system access, each
signing shall be executed using all of the electronic signature
components.
(2) Be used only by their genuine owners; and
(3) Be administered and executed to ensure that attempted use of an
individual's electronic signature by anyone other than its genuine owner
requires
[[Page 145]]
collaboration of two or more individuals.
(b) Electronic signatures based upon biometrics shall be designed to
ensure that they cannot be used by anyone other than their genuine
owners.
Sec. 11.300 Controls for identification codes/passwords.
Persons who use electronic signatures based upon use of
identification codes in combination with passwords shall employ controls
to ensure their security and integrity. Such controls shall include:
(a) Maintaining the uniqueness of each combined identification code
and password, such that no two individuals have the same combination of
identification code and password.
(b) Ensuring that identification code and password issuances are
periodically checked, recalled, or revised (e.g., to cover such events
as password aging).
(c) Following loss management procedures to electronically
deauthorize lost, stolen, missing, or otherwise potentially compromised
tokens, cards, and other devices that bear or generate identification
code or password information, and to issue temporary or permanent
replacements using suitable, rigorous controls.
(d) Use of transaction safeguards to prevent unauthorized use of
passwords and/or identification codes, and to detect and report in an
immediate and urgent manner any attempts at their unauthorized use to
the system security unit, and, as appropriate, to organizational
management.
(e) Initial and periodic testing of devices, such as tokens or
cards, that bear or generate identification code or password information
to ensure that they function properly and have not been altered in an
unauthorized manner.
PART 12_FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents
Subpart A_General Provisions
Sec.
12.1 Scope.
Subpart B_Initiation of Proceedings
12.20 Initiation of a hearing involving the issuance, amendment, or
revocation of a regulation.
12.21 Initiation of a hearing involving the issuance, amendment, or
revocation of an order.
12.22 Filing objections and requests for a hearing on a regulation or
order.
12.23 Notice of filing of objections.
12.24 Ruling on objections and requests for hearing.
12.26 Modification or revocation of regulation or order.
12.28 Denial of hearing in whole or in part.
12.30 Judicial review after waiver of hearing on a regulation.
12.32 Request for alternative form of hearing.
12.35 Notice of hearing; stay of action.
12.37 Effective date of a regulation.
12.38 Effective date of an order.
Subpart C_Appearance and Participation
12.40 Appearance.
12.45 Notice of participation.
12.50 Advice on public participation in hearings.
Subpart D_Presiding Officer
12.60 Presiding officer.
12.62 Commencement of functions.
12.70 Authority of presiding officer.
12.75 Disqualification of presiding officer.
12.78 Unavailability of presiding officer.
Subpart E_Hearing Procedures
12.80 Filing and service of submissions.
12.82 Petition to participate in forma pauperis.
12.83 Advisory opinions.
12.85 Disclosure of data and information by the participants.
12.87 Purpose; oral and written testimony; burden of proof.
12.89 Participation of nonparties.
12.90 Conduct at oral hearings or conferences.
12.91 Time and place of prehearing conference.
12.92 Prehearing conference procedure.
12.93 Summary decisions.
12.94 Receipt of evidence.
12.95 Official notice.
12.96 Briefs and argument.
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.
[[Page 146]]
Subpart G_Initial and Final Decisions
12.120 Initial decision.
12.125 Appeal from or review of initial decision.
12.130 Decision by Commissioner on appeal or review of initial decision.
12.139 Reconsideration and stay of action.
Subpart H_Judicial Review
12.140 Review by the courts.
12.159 Copies of petitions for judicial review.
Authority: 21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 42
U.S.C. 201, 262, 263b-263n, 264; 15 U.S.C. 1451-1461; 5 U.S.C. 551-558,
701-721; 28 U.S.C. 2112.
Source: 44 FR 22339, Apr. 13, 1979, unless otherwise noted.
Subpart A_General Provisions
Sec. 12.1 Scope.
The procedures in this part apply when--
(a) A person has a right to an opportunity for a hearing under the
laws specified in Sec. 10.50; or
(b) The Commissioner concludes that it is in the public interest to
hold a formal evidentiary public hearing on any matter before FDA.
Subpart B_Initiation of Proceedings
Sec. 12.20 Initiation of a hearing involving the issuance, amendment,
or revocation of a regulation.
(a) A proceeding under section 409(f), 502(n), 512(n)(5), 701(e), or
721(d) of the act or section 4 or 5 of the Fair Packaging and Labeling
Act may be initiated--
(1) By the Commissioner on the Commissioner's own initiative, e.g.,
as provided in Sec. 170.15 for food additives; or
(2) By a petition--
(i) In the form specified elsewhere in this chapter, e.g., the form
for a color additive petition in Sec. 71.1; or
(ii) If no form is specified, by a petition under Sec. 10.30.
(b) If the Commissioner receives a petition under paragraph (a)(2)
of this section, the Commissioner will--
(1) If it involves any matter subject to section 701(e) of the act
or section 4 or 5 of the Fair Packaging and Labeling Act, and meets the
requirements for filing, follow the provisions of Sec. 10.40 (b)
through (f);
(2) If it involves a color additive or food additive, and meets the
requirements for filing in Sec. Sec. 71.1 and 71.2, or in
Sec. Sec. 171.1, 171.6, 171.7, and 171.100, publish a notice of filing
of the petition within 30 days after the petition is filed instead of a
notice of proposed rulemaking.
(c) [Reserved]
(d) The notice promulgating the regulation will describe how to
submit objections and requests for hearing.
(e) On or before the 30th day after the date of publication of a
final regulation, or of a notice withdrawing a proposal initiated by a
petition under Sec. 10.25(a), a person may submit to the Commissioner
written objections and a request for a hearing. The 30-day period may
not be extended except that additional information supporting an
objection may be received after 30 days upon a showing of inadvertent
omission and hardship, and if review of the objection and request for
hearing will not thereby be impeded. If, after a final color additive
regulation is published, a petition or proposal relating to the
regulation is referred to an advisory committee in accordance with
section 721(b)(5)(C) of the act, objections and requests for a hearing
may be submitted on or before the 30th day after the date on which the
order confirming or modifying the Commissioner's previous order is
published.
[44 FR 22339, Apr. 13, 1979, as amended at 64 FR 399, Jan. 5, 1999]
Sec. 12.21 Initiation of a hearing involving the issuance, amendment,
or revocation of an order.
(a) A proceeding under section 505 (d) or (e), 512 (d), (e), (m) (3)
or (4), of section 515(g)(1) of the act, or section 351(a) of the Public
Health Service Act, may be initiated--
(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.
[[Page 147]]
(b) A notice of opportunity for hearing on a proposal to deny or
revoke approval of all or part of an order will be published together
with an explanation of the grounds for the proposed action. The notice
will describe how to submit requests for hearing. A person subject to
the notice has 30 days after its issuance to request a hearing. The 30-
day period may not be extended.
(c) The Commissioner may use an optional procedure specified in
Sec. 10.30(h) to consider issuing, amending, or revoking an order.
(d) In a proceeding under sections 505(e), 512(e) or (m), or 515(e)
of the act in which a party wishes to apply for reimbursement of certain
expenses under the Equal Access to Justice Act (5 U.S.C. 504 and 504
note), FDA will follow the Department of Health and Human Services'
regulations in 45 CFR part 13.
[44 FR 22339, Apr. 13, 1979, as amended at 47 FR 25734, June 15, 1982;
54 FR 9035, Mar. 3, 1989]
Sec. 12.22 Filing objections and requests for a hearing on a regulation
or order.
(a) Objections and requests for a hearing under Sec. 12.20(d) must
be submitted to the Division of Dockets Management and will be accepted
for filing if they meet the following conditions:
(1) They are submitted within the time specified in Sec. 12.20(e).
(2) Each objection is separately numbered.
(3) Each objection specifies with particularity the provision of the
regulation or proposed order objected to.
(4) Each objection on which a hearing is requested specifically so
states. Failure to request a hearing on an objection constitutes a
waiver of the right to a hearing on that objection.
(5) Each objection for which a hearing is requested includes a
detailed description and analysis of the factual information to be
presented in support of the objection. Failure to include a description
and analysis for an objection constitutes a waiver of the right to a
hearing on that objection. The description and analysis may be used only
for the purpose of determining whether a hearing has been justified
under Sec. 12.24, and do not limit the evidence that may be presented
if a hearing is granted.
(i) A copy of any report, article, survey, or other written document
relied upon must be submitted, except if the document is--
(a) An FDA document that is routinely publicly available; or
(b) A recognized medical or scientific textbook that is readily
available to the agency.
(ii) A summary of the nondocumentary testimony to be presented by
any witnesses relied upon must be submitted.
(b) Requests for hearing submitted under Sec. 12.21 will be
submitted to the Division of Dockets Management and will be accepted for
filing if they meet the following conditions:
(1) They are submitted on or before the 30th day after the date of
publication of the notice of opportunity for hearing.
(2) They comply with Sec. Sec. 314.200, 514.200, or 601.7(a).
(c) If an objection or request for a public hearing fails to meet
the requirements of this section and the deficiency becomes known to the
Division of Dockets Management, the Division of Dockets Management shall
return it with a copy of the applicable regulations, indicating those
provisions not complied with. A deficient objection or request for a
hearing may be supplemented and subsequently filed if submitted within
the 30-day time period specified in Sec. 12.20(e) or Sec. 12.21(b).
(d) If another person objects to a regulation issued in response to
a petition submitted under Sec. 12.20(a)(2), the petitioner may submit
a written reply to the Division of Dockets Management.
[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64
FR 69190, Dec. 10, 1999]
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
[[Page 148]]
parts of the regulation that have been stayed by the filing of proper
objections and, if no objections have been filed, stating that fact. The
notice does not constitute a determination that a hearing is justified
on any objections or requests for hearing that have been filed. When to
do so will cause no undue delay, the notice required by this section may
be combined with the notices described in Sec. Sec. 12.28 and 12.35.
Sec. 12.24 Ruling on objections and requests for hearing.
(a) As soon as possible the Commissioner will review all objections
and requests for hearing filed under Sec. 12.22 and determine--
(1) Whether the regulation should be modified or revoked under Sec.
12.26;
(2) Whether a hearing has been justified; and
(3) Whether, if requested, a hearing before a Public Board of
Inquiry under part 13 or before a public advisory committee under part
14 or before the Commissioner under part 15 has been justified.
(b) A request for a hearing will be granted if the material
submitted shows the following:
(1) There is a genuine and substantial issue of fact for resolution
at a hearing. A hearing will not be granted on issues of policy or law.
(2) The factual issue can be resolved by available and specifically
identified reliable evidence. A hearing will not be granted on the basis
of mere allegations or denials or general descriptions of positions and
contentions.
(3) The data and information submitted, if established at a hearing,
would be adequate to justify resolution of the factual issue in the way
sought by the person. A hearing will be denied if the Commissioner
concludes that the data and information submitted are insufficient to
justify the factual determination urged, even if accurate.
(4) Resolution of the factual issue in the way sought by the person
is adequate to justify the action requested. A hearing will not be
granted on factual issues that are not determinative with respect to the
action requested, e.g., if the Commissioner concludes that the action
would be the same even if the factual issue were resolved in the way
sought, or if a request is made that a final regulation include a
provision not reasonably encompassed by the proposal. A hearing will be
granted upon proper objection and request when a food standard or other
regulation is shown to have the effect of excluding or otherwise
affecting a product or ingredient.
(5) The action requested is not inconsistent with any provision in
the act or any regulation in this chapter particularizing statutory
standards. The proper procedure in those circumstances is for the person
requesting the hearing to petition for an amendment or waiver of the
regulation involved.
(6) The requirements in other applicable regulations, e.g.,
Sec. Sec. 10.20, 12.21, 12.22, 314.200, 514.200, and 601.7(a), and in
the notice promulgating the final regulation or the notice of
opportunity for hearing are met.
(c) In making the determination in paragraph (a) of this section,
the Commissioner may use any of the optional procedures specified in
Sec. 10.30(h) or in other applicable regulations, e.g., Sec. Sec.
314.200, 514.200, and 601.7(a).
(d) If it is uncertain whether a hearing has been justified under
the principles in paragraph (b) of this section, and the Commissioner
concludes that summary decision against the person requesting a hearing
should be considered, the Commissioner may serve upon the person by
registered mail a proposed order denying a hearing. The person has 30
days after receipt of the proposed order to demonstrate that the
submission justifies a hearing.
[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64
FR 399, Jan. 5, 1999]
Sec. 12.26 Modification or revocation of regulation or order.
If the Commissioner determines upon review of an objection or
request for hearing that the regulation or order should be modified or
revoked, the Commissioner will promptly take such action by notice in
the Federal Register. Further objections to or requests for hearing on
the modification or revocation may be submitted under Sec. Sec. 12.20
through 12.22 but no further issue may be taken with other provisions in
the regulation or order. Objections and requests for hearing that are
[[Page 149]]
not affected by the modification or revocation will remain on file and
be acted upon in due course.
Sec. 12.28 Denial of hearing in whole or in part.
If the Commissioner determines upon review of the objections or
requests for hearing that a hearing is not justified, in whole or in
part, a notice of the determination will be published.
(a) The notice will state whether the hearing is denied in whole or
in part. If the hearing is denied in part, the notice will be combined
with the notice of hearing required by Sec. 12.35, and will specify the
objections and requests for hearing that have been granted and denied.
(1) Any denial will be explained. A denial based on an analysis of
the information submitted to justify a hearing will explain the
inadequacy of the information.
(2) The notice will confirm or modify or stay the effective date of
the regulation or order involved.
(b) The record of the administrative proceeding relating to denial
of a public hearing in whole or in part on an objection or request for
hearing consists of the following:
(1) If the proceeding involves a regulation--
(i) The documents specified in Sec. 10.40(g);
(ii) The objections and requests for hearing filed by the Division
of Dockets Management;
(iii) If the proceeding involves a color additive regulation
referred to an advisory committee in accordance with section
721(b)(5)(C) of the act, the committee's report and the record of the
committee's proceeding; and
(iv) The notice denying a formal evidentiary public hearing.
(2) If the proceeding involves an order--
(i) The notice of opportunity for hearing;
(ii) The requests for hearing filed by the Division of Dockets
Management;
(iii) The transcripts, minutes of meetings, reports, Federal
Register notices, and other documents constituting the record of any of
the optional procedures specified in Sec. 12.24(c) used by the
Commissioner, but not the transcript of a closed portion of a public
advisory committee meeting; and
(iv) The notice denying the hearing.
(c) The record specified in paragraph (b) of this section is the
exclusive record for the Commissioner's decision on the complete or
partial denial of a hearing. The record of the proceeding will be closed
as of the date of the Commissioner's decision unless another date is
specified. A person who requested and was denied a hearing may submit a
petition for reconsideration under Sec. 10.33 or a petition for stay of
action under Sec. 10.35. A person who wishes to rely upon information
or views not included in the administrative record shall submit them to
the Commissioner with a petition under Sec. 10.25(a) to modify the
final regulation or order.
(d) Denial of a request for a hearing in whole or in part is final
agency action reviewable in the courts, under the statutory provisions
governing the matter involved, as of the date of publication of the
denial in the Federal Register.
(1) Before requesting a court for a stay of action pending review, a
person shall first submit a petition for a stay of action under Sec.
10.35.
(2) Under 28 U.S.C. 2112(a), FDA will request consolidation of all
petitions on a particular matter.
(3) The time for filing a petition for judicial review of a denial
of a hearing on an objection or issue begins on the date the denial is
published in the Federal Register, (i) When an objection or issues
relates to a regulation, if a hearing is denied on all objections and
issues concerning a part of the proposal the effectiveness of which has
not been deferred pending a hearing on other parts of the proposal; or
(ii) when an issue relates to an order, if a hearing is 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
[[Page 150]]
whether a hearing has been granted on other objections and issues.