[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[From the U.S. Government Publishing Office]
21
Food and Drugs
[[Page i]]
PARTS 1 TO 99
Revised as of April 1, 1996
CONTAINING
A CODIFICATION OF DOCUMENTS
OF GENERAL APPLICABILITY
AND FUTURE EFFECT
AS OF APRIL 1, 1996
With Ancillaries
Published by
the Office of the Federal Register
National Archives and Records
Administration
as a Special Edition of
the Federal Register
[[Page ii]]
U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 1996
For sale by U.S. Government Printing Office
Superintendent of Documents, Mail Stop: SSOP, Washington, DC 20402-9328
[[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.......... 405
Table of CFR Titles and Chapters.......................... 407
Alphabetical List of Agencies Appearing in the CFR........ 423
List of CFR Sections Affected............................. 433
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Cite this Code: CFR
To cite the regulations in this volume use title, part
and section number. Thus, 21 CFR 1.1 refers to title
21, part 1, section 1.
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[[Page v]]
EXPLANATION
The Code of Federal Regulations is a codification of the general and
permanent rules published in the Federal Register by the Executive
departments and agencies of the Federal Government. The Code is divided
into 50 titles which represent broad areas subject to Federal
regulation. Each title is divided into chapters which usually bear the
name of the issuing agency. Each chapter is further subdivided into
parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year
and issued on a quarterly basis approximately as follows:
Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1
The appropriate revision date is printed on the cover of each
volume.
LEGAL STATUS
The contents of the Federal Register are required to be judicially
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie
evidence of the text of the original documents (44 U.S.C. 1510).
HOW TO USE THE CODE OF FEDERAL REGULATIONS
The Code of Federal Regulations is kept up to date by the individual
issues of the Federal Register. These two publications must be used
together to determine the latest version of any given rule.
To determine whether a Code volume has been amended since its
revision date (in this case, April 1, 1996), consult the ``List of CFR
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative
List of Parts Affected,'' which appears in the Reader Aids section of
the daily Federal Register. These two lists will identify the Federal
Register page number of the latest amendment of any given rule.
EFFECTIVE AND EXPIRATION DATES
Each volume of the Code contains amendments published in the Federal
Register since the last revision of that volume of the Code. Source
citations for the regulations are referred to by volume number and page
number of the Federal Register and date of publication. Publication
dates and effective dates are usually not the same and care must be
exercised by the user in determining the actual effective date. In
instances where the effective date is beyond the cut-off date for the
Code a note has been inserted to reflect the future effective date. In
those instances where a regulation published in the Federal Register
states a date certain for expiration, an appropriate note will be
inserted following the text.
OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires
Federal agencies to display an OMB control number with their information
collection request. Many agencies have begun publishing numerous OMB
control numbers as
[[Page vi]]
amendments to existing regulations in the CFR. These OMB numbers are
placed as close as possible to the applicable recordkeeping or reporting
requirements.
OBSOLETE PROVISIONS
Provisions that become obsolete before the revision date stated on
the cover of each volume are not carried. Code users may find the text
of provisions in effect on a given date in the past by using the
appropriate numerical list of sections affected. For the period before
January 1, 1986, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, or 1973-1985, published in seven separate volumes. For
the period beginning January 1, 1986, a ``List of CFR Sections
Affected'' is published at the end of each CFR volume.
INCORPORATION BY REFERENCE
What is incorporation by reference? Incorporation by reference was
established by statute and allows Federal agencies to meet the
requirement to publish regulations in the Federal Register by referring
to materials already published elsewhere. For an incorporation to be
valid, the Director of the Federal Register must approve it. The legal
effect of incorporation by reference is that the material is treated as
if it were published in full in the Federal Register (5 U.S.C. 552(a)).
This material, like any other properly issued regulation, has the force
of law.
What is a proper incorporation by reference? The Director of the
Federal Register will approve an incorporation by reference only when
the requirements of 1 CFR part 51 are met. Some of the elements on which
approval is based are:
(a) The incorporation will substantially reduce the volume of
material published in the Federal Register.
(b) The matter incorporated is in fact available to the extent
necessary to afford fairness and uniformity in the administrative
process.
(c) The incorporating document is drafted and submitted for
publication in accordance with 1 CFR part 51.
Properly approved incorporations by reference in this volume are
listed in the Finding Aids at the end of this volume.
What if the material incorporated by reference cannot be found? If
you have any problem locating or obtaining a copy of material listed in
the Finding Aids of this volume as an approved incorporation by
reference, please contact the agency that issued the regulation
containing that incorporation. If, after contacting the agency, you find
the material is not available, please notify the Director of the Federal
Register, National Archives and Records Administration, Washington DC
20408, or call (202) 523-4534.
CFR INDEXES AND TABULAR GUIDES
A subject index to the Code of Federal Regulations is contained in a
separate volume, revised annually as of January 1, entitled CFR Index
and Finding Aids. This volume contains the Parallel Table of Statutory
Authorities and Agency Rules (Table I), and Acts Requiring Publication
in the Federal Register (Table II). 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.
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REPUBLICATION OF MATERIAL
There are no restrictions on the republication of material appearing
in the Code of Federal Regulations.
INQUIRIES
For a legal interpretation or explanation of any regulation in this
volume, contact the issuing agency. The issuing agency's name appears at
the top of odd-numbered pages.
For inquiries concerning CFR reference assistance, call 202-523-5227
or write to the Director, Office of the Federal Register, National
Archives and Records Administration, Washington, DC 20408.
SALES
The Government Printing Office (GPO) processes all sales and
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Richard L. Claypoole,
Director,
Office of the Federal Register.
April 1, 1996.
[[Page viii]]
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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, 1996.
The Table of Exempt Prescription Products to part 1308 appears in
the volume containing part 1300-end.
Redesignation tables for Chapter I--Food and Drug Administration
appear in the Finding Aids section for the volumes containing parts 170-
199 and 500-599.
For this volume, Ann Elise Maso was Chief Editor. The Code of
Federal Regulations publication program is under the direction of
Frances D. McDonald, assisted by Alomha S. Morris.
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[GRAPHIC] [TIFF OMITTED] TFRORDR.FRM
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H N
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: See Meat and Poultry Inspection, 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.
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CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
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SUBCHAPTER A--GENERAL
Part Page
1 General enforcement regulations............. 5
2 General administrative rulings and decisions 16
3 Product jurisdiction........................ 22
5 Delegations of authority and organization... 26
7 Enforcement policy.......................... 70
10 Administrative practices and procedures..... 80
12 Formal evidentiary public hearing........... 113
13 Public hearing before a public board of
inquiry................................. 131
14 Public hearing before a public advisory
committee............................... 135
15 Public hearing before the Commissioner...... 162
16 Regulatory hearing before the Food and Drug
Administration.......................... 165
17 Civil money penalties hearings.............. 170
19 Standards of conduct and conflicts of
interest................................ 183
20 Public information.......................... 185
21 Protection of privacy....................... 213
25 Environmental impact considerations......... 230
50 Protection of human subjects................ 250
56 Institutional Review Boards................. 257
58 Good laboratory practice for nonclinical
laboratory studies...................... 265
60 Patent term restoration..................... 279
70 Color additives............................. 286
71 Color additive petitions.................... 294
73 Listing of color additives exempt from
certification........................... 300
74 Listing of color additives subject to
certification........................... 344
80 Color additive certification................ 383
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81 General specifications and general
restrictions for provisional color
additives for use in foods, drugs, and
cosmetics............................... 389
82 Listing of certified provisionally listed
colors and specifications............... 396
83-99 [Reserved]
Editorial Note: For nomenclature changes to chapter I see 59 FR 14366,
Mar. 28, 1994.
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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.
1.31 Package size savings.
1.35 ``Cents-off,'' or other savings representations.
Subparts C--D [Reserved]
Subpart E--Imports and Exports
1.83 Definitions.
1.90 Notice of sampling.
1.91 Payment for samples.
1.94 Hearing on refusal of admission.
1.95 Application for authorization to relabel and recondition.
1.96 Granting of authorization to relabel and recondition.
1.97 Bonds.
1.99 Costs chargeable in connection with relabeling and reconditioning
inadmissible imports.
Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act (15
U.S.C. 1453, 1454, 1455); secs. 201, 403, 502, 505, 512, 602, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 343, 352, 355,
360b, 362, 371); sec. 215 of the Public Health Service Act (42 U.S.C.
216).
Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.
Subpart A--General Provisions
Sec. 1.1 General.
(a) The provisions of regulations promulgated under the Federal
Food, Drug, and Cosmetic Act with respect to the doing of any act shall
be applicable also to the causing of such act to be done.
(b) The definitions and interpretations of terms contained in
section 201 of the Federal Food, Drug, and Cosmetic Act shall be
applicable also to such terms when used in regulations promulgated under
that act.
(c) The definition of package in Sec. 1.20 and of principal display
panel in Secs. 101.1, 201.60, 501.1, 701.10 and 801.60 of this chapter;
and the requirements pertaining to uniform location, lack of
qualification, and separation of the net quantity declaration in
Secs. 101.105(f), 201.62(e), 501.105(f), 701.13(f) and 801.62(e) of this
chapter to type size requirements for net quantity declaration in
Secs. 101.105(i), 201.62(h), 501.105(i), 701.13(i) and 801.62(h) of this
chapter, to initial statement of ounces in the dual declaration of net
quantity in Secs. 101.105(j) and (m), 201.62(i) and (k), 501.105(j) and
(m), 701.13(j) and (m) and 801.62(i) and (k) of this chapter, to initial
statement of inches in declaration of net quantity in Secs. 201.62(m),
701.13(o) and 801.62(m) of this chapter, to initial statement of square
inches in declaration of net quantity in Secs. 201.62(n), 701.13(p) and
801.62(n) of this chapter, to prohibition of certain supplemental net
quantity statements in Secs. 101.105(o), 201.62(o), 501.105(o),
701.13(q) and 801.62(o) of this chapter, and to servings representations
in Sec. 501.8 of this chapter are provided for solely by the Fair
Packaging and Labeling Act. The other requirements of this part are
issued under both the Fair Packaging and Labeling Act and the Federal
Food, Drug, and Cosmetic Act, or by the latter act solely, and are not
limited in their application by section 10 of the Fair Packaging and
Labeling Act.
[42 FR 15553, Mar. 22, 1977, as amended at 58 FR 17085, Apr. 1, 1993]
Sec. 1.3 Definitions.
(a) Labeling includes all written, printed, or graphic matter
accompanying an article at any time while such article is in interstate
commerce or held for sale after shipment or delivery in interstate
commerce.
(b) Label means any display of written, printed, or graphic matter
on the
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immediate container of any article, or any such matter affixed to any
consumer commodity or affixed to or appearing upon a package containing
any consumer commodity.
Sec. 1.4 Authority citations.
(a) For each part of its regulations, the Food and Drug
Administration includes a centralized citation of all of the statutory
provisions that provide authority for any regulation that is included in
that part.
(b) The agency may rely on any one or more of the authorities that
are listed for a particular part in implementing or enforcing any
section in that part.
(c) All citations of authority in this chapter will list the
applicable sections in the organic statute if the statute is the Federal
Food, Drug, and Cosmetic Act, the Public Health Service Act, or the Fair
Packaging and Labeling Act. References to an act or a section thereof
include references to amendments to that act or section. These citations
will also list the corresponding United States Code (U.S.C.) sections.
For example, a citation to section 701 of the Federal Food, Drug, and
Cosmetic Act would be listed: Sec. 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371).
(d) If the organic statute is one other than those specified in
paragraph (c) of this section, the citations of authority in this
chapter generally will list only the applicable U.S.C. sections. For
example, a citation to section 552 of the Administrative Procedure Act
would be listed: 5 U.S.C. 552. The agency may, where it determines that
such measures are in the interest of clarity and public understanding,
list the applicable sections in the organic statute and the
corresponding U.S.C. section in the same manner set out in paragraph (c)
of this section. References to an act or a section thereof include
references to amendments to that act or section.
(e) Where there is no U.S.C. provision, the agency will include a
citation to the U.S. Statutes at Large. Citations to the U.S. Statutes
at Large will refer to volume and page.
(f) The authority citations will include a citation to executive
delegations (i.e., Executive Orders), if any, necessary to link the
statutory authority to the agency.
[54 FR 39630, Sept. 27, 1989]
Subpart B--General Labeling Requirements
Sec. 1.20 Presence of mandatory label information.
The term package means any container or wrapping in which any food,
drug, device, or cosmetic is enclosed for use in the delivery or display
of such commodities to retail purchasers, but does not include:
(a) Shipping containers or wrappings used solely for the
transportation of any such commodity in bulk or in quantity to
manufacturers, packers, processors, or wholesale or retail distributors;
(b) Shipping containers or outer wrappings used by retailers to ship
or deliver any such commodity to retail 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
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and the unit containers are not intended to be sold separately, the net
weight placement requirement of Sec. 101.105(f) applicable to such unit
containers is waived if the units are in compliance with all the other
requirements of this part.
Sec. 1.21 Failure to reveal material facts.
(a) Labeling of a food, drug, device, or cosmetic shall be deemed to
be misleading if it fails to reveal facts that are:
(1) Material in light of other representations made or suggested by
statement, word, design, device or any combination thereof; or
(2) Material with respect to consequences which may result from use
of the article under: (i) The conditions prescribed in such labeling or
(ii) such conditions of use as are customary or usual.
(b) Affirmative disclosure of material facts pursuant to paragraph
(a) of this section may be required, among other appropriate regulatory
procedures, by
(1) Regulations in this chapter promulgated pursuant to section
701(a) of the act; or
(2) Direct court enforcement action.
(c) Paragraph (a) of this section does not:
(1) Permit a statement of differences of opinion with respect to
warnings (including contraindications, precautions, adverse reactions,
and other information relating to possible product hazards) required in
labeling for food, drugs, devices, or cosmetics under the act.
(2) Permit a statement of differences of opinion with respect to the
effectiveness of a drug unless each of the opinions expressed is
supported by substantial evidence of effectiveness as defined in
sections 505(d) and 512(d) of the act.
Sec. 1.23 Procedures for requesting variations and exemptions from required label statements.
Section 403(e) of the act (in this part 1, the term act means the
Federal Food, Drug, and Cosmetic Act) provides for the establishment by
regulation of reasonable variations and exemptions for small packages
from the required declaration of net quantity of contents. Section
403(i) of the act provides for the establishment by regulation of
exemptions from the required declaration of ingredients where such
declaration is impracticable, or results in deception or unfair
competition. Section 502(b) of the act provides for the establishment by
regulation of reasonable variations and exemptions for small packages
from the required declaration of net quantity of contents. Section
602(b) of the act provides for the establishment by regulation of
reasonable variations and exemptions for small packages from the
required declaration of net quantity of contents. Section 5(b) of the
Fair Packaging and Labeling Act provides for the establishment by
regulation of exemptions from certain required declarations of net
quantity of contents, identity of commodity, identity and location of
manufacturer, packer, or distributor, and from declaration of net
quantity of 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
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pound or per specified number of pounds, and total price shall be exempt
from the type size, dual declaration, and placement requirements of
Sec. 101.105 of this chapter if the accurate statement of net weight is
presented conspicuously on the principal display panel of the package.
In the case of food packed in random packages at one place for
subsequent shipment and sale at another, the price sections of the label
may be left blank provided they are filled in by the seller prior to
retail sale. This exemption shall also apply to uniform weight packages
of cheese and cheese products labeled in the same manner and by the same
type of equipment as random food packages exempted by this paragraph
(a)(2) except that the labels shall bear a declaration of price per
pound and not price per specified number of pounds.
(3) Individual serving-size packages of foods containing less than
\1/2\ ounce or less than \1/2\ fluid ounce for use in restaurants,
institutions, and passenger carriers, and not intended for sale at
retail, shall be exempt from the required declaration of net quantity of
contents specified in this part.
(4) Individually wrapped pieces of penny candy and other
confectionery of less than one-half ounce net weight per individual
piece shall be exempt from the labeling requirements of this part when
the container in which such confectionery is shipped is in conformance
with the labeling requirements of this part. Similarly, when such
confectionery items are sold in bags or boxes, such items shall be
exempt from the labeling requirements of this part, including the
required declaration of net quantity of contents specified in this part
when the declaration on the bag or box meets the requirements of this
part.
(5)(i) Soft drinks packaged in bottles shall be exempt from the
placement requirements for the statement of identity prescribed by
Sec. 101.3 (a) and (d) of this chapter if such statement appears
conspicuously on the bottle closure. When such soft drinks are marketed
in a multiunit retail package, the multiunit retail package shall be
exempt from the statement of identity declaration requirements
prescribed by Sec. 101.3 of this chapter if the statement of identity on
the unit container is not obscured by the multiunit retail package.
(ii) A multiunit retail package for soft drinks shall be exempt from
the declaration regarding name and place of business required by
Sec. 101.5 of this chapter if the package does not obscure the
declaration on unit containers or if it bears a statement that the
declaration can be found on the unit containers and the declaration on
the unit containers complies with Sec. 101.5 of this chapter. The
declaration required by Sec. 101.5 of this chapter may appear on the top
or side of the closure of bottled soft drinks if the statement is
conspicuous and easily legible.
(iii) Soft drinks packaged in bottles which display other required
label information only on the closure shall be exempt from the placement
requirements for the declaration of contents 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
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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, 200 C St. SW., Washington, DC 20204, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street NW., suite 700, Washington, DC.
(ii) The foods named in paragraph (a)(6)(i) of this section, when
measured by and packaged in 1-liquid pint, 1-liquid quart, and \1/2\-
gallon measure-containers, as defined in the ``Measure Container Code of
National Bureau of Standards Handbook 44,'' Specifications, Tolerances,
and Other Technical Requirements for Weighing and Measuring Devices,
Sec. 4.45 ``Measure-Containers,'' which is incorporated by reference,
are exempt from the dual net-contents declaration requirement of
Sec. 101.105(j) of this chapter. Copies are available from the Center
for Food Safety and Applied Nutrition (HFS-150), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street NW., suite 700, Washington, DC.
(iii) The foods named in paragraph (a)(6)(i) of this section, when
measured by and packaged in \1/2\-liquid pint, 1-liquid pint, 1-liquid
quart, \1/2\-gallon, and 1-gallon measured-containers, as defined in the
``Measure Container Code of National Bureau of Standards Handbook 44,''
Specifications, Tolerances, and Other Technical Requirements for
Weighing and Measuring Devices, Sec. 4.45 ``Measure-Containers,'' which
is incorporated by reference, are exempt from the requirement of
Sec. 101.105(f) of this chapter that the declaration of net contents be
located within the bottom 30 percent of the principal display panel.
Copies are available from the Center for Food Safety and Applied
Nutrition (HFS-150), Food and Drug Administration, 200 C St. SW.,
Washington, DC 20204, or available for inspection at the Office of the
Federal Register, 800 North Capitol Street NW., suite 700, Washington,
DC.
(7)(i) Milk, cream, light cream, coffee or table cream, whipping
cream, light whipping cream, heavy or heavy whipping cream, sour or
cultured sour cream, half-and-half, sour or cultured half-and-half,
reconstituted or recombined milk and milk products, concentrated milk
and milk products, skim or skimmed milk, vitamin D milk and milk
products, fortified milk and milk products, homogenized milk, flavored
milk and milk products, buttermilk, cultured buttermilk, cultured milk
or cultured whole buttermilk, low-fat milk (0.5 to 2.0 percent
butterfat), and acidified milk and milk products, when packaged in
containers of 8- and 64-fluid-ounce capacity, are exempt from the
requirements of Sec. 101.105(b)(2) of this chapter to the extent that
net contents of 8 fluid ounces and 64 fluid ounces (or 2 quarts) may be
expressed as \1/2\ pint and \1/2\ gallon, respectively.
(ii) The products listed in paragraph (a)(7)(i) of this section,
when packaged in glass or plastic containers of \1/2\-pint, 1-pint, 1-
quart, \1/2\-gallon, and 1-gallon capacities are exempt from the
placement requirement of Sec. 101.105(f) of this chapter that the
declaration of net contents be located within the bottom 30 percent of
the principal display panel, provided that other required label
information is conspicuously displayed on the cap or outside closure and
the required net quantity of contents declaration is conspicuously
blown, formed, or molded into or permanently applied to that part of the
glass or plastic container that is at or above the shoulder of the
container.
[[Page 10]]
(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 Secs. 137.105, 137.155,
137.160, 137.165, 137.170, 137.175, 137.180, 137.185, 137.200, and
137.205 of this chapter, packaged:
(i) In conventional 2-, 5-, 10-, 25-, 50-, and 100-pound packages
are exempt from the placement requirement of Sec. 101.105(f) of this
chapter that the declaration of net contents be located within the
bottom 30 percent of the area of the principal display panel of the
label; and
(ii) In conventional 2-pound packages are exempt from the dual net-
contents declaration requirement of Sec. 101.105(j) of this chapter
provided the quantity of contents is expressed in pounds.
(9)(i) Twelve shell eggs packaged in a carton designed to hold 1
dozen eggs and designed to permit the division of such carton by the
retail customer at the place of purchase into two portions of one-half
dozen eggs each are exempt from the labeling requirements of this part
with respect to each portion of such divided carton if the carton, when
undivided, is in conformance with the labeling requirements of this
part.
(ii) Twelve shell eggs packaged in a carton designed to hold 1 dozen
eggs are exempt from the placement requirements for the declaration of
contents prescribed by Sec. 101.105(f) of this chapter if the required
content declaration is otherwise placed on the principal display panel
of such carton and if, in the case of such cartons designed to permit
division by retail customers into two portions of one-half dozen eggs
each, the required content declaration is placed on the principal
display panel in such a manner that the context of the content
declaration is destroyed upon division of the carton.
(10) Butter as defined in 42 Stat. 1500 (excluding whipped butter):
(i) In 8-ounce and in 1-pound packages is exempt from the
requirements of Sec. 101.105(f) of this chapter that the net contents
declaration be placed within the bottom 30 percent of the area of the
principal display panel;
(ii) In 1-pound packages is exempt from the requirements of
Sec. 101.105(j)(1) of this chapter that such declaration be in terms of
ounces and pounds, to permit declaration of ``1-pound'' or ``one
pound''; and
(iii) In 4-ounce, 8-ounce, and 1-pound packages with continuous
label copy wrapping is exempt from the requirements of Secs. 101.3 and
101.105(f) of this chapter that the statement of identity and net
contents declaration appear in lines generally parallel to the base on
which the package rests as it is designed to be displayed, provided that
such statement and declaration are not so positioned on the label as to
be misleading or difficult to read as the package is customarily
displayed at retail.
(11) Margarine as defined in Sec. 166.110 of this chapter and
imitations thereof in 1-pound rectangular packages, except for packages
containing whipped or soft margarine or packages that contain more than
four sticks, are exempt from the requirement of Sec. 101.105(f) of this
chapter that the declaration of the net quantity of contents appear
within the bottom 30 percent of the principal display panel and from the
requirement of Sec. 101.105(j)(1) of this chapter that such declaration
be expressed both in ounces and in pounds to permit declaration of ``1-
pound'' or ``one pound,'' provided an accurate statement of net weight
appears conspicuously on the principal display panel of the package.
(12) Corn flour and related products, as they are defined by
Secs. 137.211, 137.215, and Secs. 137.230 through 137.290 of this
chapter, packaged in conventional 5-, 10-, 25-, 50-, and 100-pound bags
are exempt from the placement requirement of Sec. 101.105(f) of this
chapter that the declaration of net contents be located within the
bottom 30 percent of the area of the principal display panel of the
label.
(13)(i) Single strength and less than single strength fruit juice
beverages, imitations thereof, and drinking water when packaged in glass
or plastic containers of \1/2\-pint, 1-pint, 1-quart, \1/2\-gallon, and
1-gallon capacities are exempt from the placement requirement of
Sec. 101.105(f) of this chapter that the declaration of net contents be
located within the bottom 30 percent of the
[[Page 11]]
principal display panel: Provided, That other required label information
is conspicuously displayed on the cap or outside closure and the
required net quantity of contents declaration is conspicuously blown,
formed, or molded into or permanently applied to that part of the glass
or plastic container that is at or above the shoulder of the container.
(ii) Single strength and less than single strength fruit juice
beverages, imitations thereof, and drinking water when packaged in
glass, plastic, or paper (fluid milk type) containers of 1-pint, 1-
quart, and \1/2\-gallon capacities are exempt from the dual net-contents
declaration requirement of Sec. 101.105(j) of this chapter.
(iii) Single strength and less than single strength fruit juice
beverages, imitations thereof, and drinking water when packaged in
glass, plastic, or paper (fluid milk type) containers of 8- and 64-
fluid-ounce capacity, are exempt from the requirements of
Sec. 101.105(b)(2) of this chapter to the extent that net contents of 8
fluid ounces and 64 fluid ounces (or 2 quarts) may be expressed as \1/2\
pint (or half pint) and \1/2\ gallon (or half gallon), respectively.
(14) The unit containers in a multiunit or multicomponent retail
food package shall be exempt from regulations of section 403 (e)(1),
(g)(2), (i)(2), (k), and (q) of the act with respect to the requirements
for label declaration of the name and place of business of the
manufacturer, packer, or distributor; label declaration of ingredients;
and nutrition information when:
(i) The multiunit or multicomponent retail food package labeling
meets all the requirements of this part;
(ii) The unit containers are securely enclosed within and not
intended to be separated from the retail package under conditions of
retail sale; and
(iii) Each unit container is labeled with the statement ``This Unit
Not Labeled For Retail Sale'' in type size not less than one-sixteenth
of an inch in height. The word ``Individual'' may be used in lieu of or
immediately preceding the word ``Retail'' in the statement.
(b) Drugs. Liquid over-the-counter veterinary preparations intended
for injection shall be exempt from the declaration of net quantity of
contents in terms of the U.S. gallon of 231 cubic inches and quart,
pint, and fluid-ounce subdivisions thereof as required by Sec. 201.62
(b), (i), and (j) of this chapter, and from the dual declaration
requirements of Sec. 201.62(i) of this chapter, if such declaration of
net quantity of 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]
Sec. 1.31 Package size savings.
Any food, drug, cosmetic, or device that bears on the label or
labeling a representation that the consumer commodity is being offered
at a lower price per unit of weight, measure, or count because of
economy resulting from the size of the container or quantity of its
contents is subject to the following conditions:
(a) The container may bear a representation of economy by virtue of
its size (for example, ``economy size,'' ``economy pack,'' ``big
value,'' ``thrifty pack,'' ``bargain size,'' ``budget pack,'' etc.) only
if:
(1) The sponsor of the economy size promotion at the same time
offers the same brand of that commodity in at least one other packaged
size or labeled form.
[[Page 12]]
(2) Only one packaged or labeled form of that brand of commodity is
labeled with an ``economy size'' representation.
(3) The sponsor of the economy size promotion and all subsequent
levels of commerce sell the commodity labeled with an ``economy size''
representation at a price per unit of weight, volume, measure, or count
which is substantially reduced (i.e., at least 5 percent) from the
actual price of all other packaged or labeled units of the same brand of
that commodity offered simultaneously.
(b) The sponsor of the economy size promotion and all subsequent
levels of commerce such as wholesalers and jobbers shall maintain for at
least 1 year invoices or other records showing that the wholesale price
per unit of weight, measure, or count in the economy size package is
such that the retailers can sell the economy size container at a
significantly lower price per unit.
Sec. 1.35 ``Cents-off,'' or other savings representations.
Any food, drug, cosmetic, or device that bears on the label or
labeling a representation that the consumer commodity is being offered
for retail at a reduction in retail price is subject to the following
conditions: Provided, however, That such conditions do not apply to any
such savings representations initiated by persons who do not
manufacture, package, or import such commodities and who do not
prescribe or specify by any means the manner in which such commodities
are packaged or labeled by a manufacturer, packager, or importer:
(a) A ``cents-off,'' or other savings representation that states or
implies a reduction in the ordinary and customary retail price may be
used by a manufacturer, packer, distributor, or retailer, hereinafter
known as the sponsor, initiating such promotion only if:
(1) An ordinary and customary selling price of such consumer
commodity has been established at the retail level,
(2) The sponsor's selling price and the selling price at all
subsequent levels of commerce such as wholesalers and jobbers has been
reduced by at least the savings differential represented on the package
or labeling, and
(3) The sponsor and all subsequent levels of commerce keep and
maintain invoices or other records for each promotion and for all
successive promotions which occur within a 12-month period for at least
1 year subsequent to the end of the year (calendar, fiscal, or market)
in which the promotion occurs in order to show that the invoice cost to
the retailer has been reduced in an amount sufficient to enable the
retailer to pass the savings on to the purchaser.
(b)(1) Each ``cents-off'' price reduction representation imprinted
on the package or label shall be limited to a phrase which reflects that
the price marked by the retailer represents the savings in the amount of
the ``cents-off'' the retailer's regular price, e.g., ``Price Marked Is
---- Cents Off the Regular Price,'' ``Price Marked Is ---- Cents-Off the
Regular Price of This Package'': Provided, The package or label may in
addition bear in the usual pricing spot a form reflecting a space for
the regular price, the represented ``cents-off,'' and a space for the
price to be paid by the consumer. The sponsor who sells the commodity at
retail shall display the regular price, clearly and conspicuously
designated as ``regular price,'' on the package or label of the
commodity or on a sign, placard, or shelf-marker placed in a position
contiguous to the retail display of the ``cents-off'' marked commodity.
The sponsor who does not sell at retail shall provide the retailer with
a sign, placard, shelf-marker, or other device for the purpose of
clearly and conspicuously displaying the retailer's regular price,
designated as ``regular price,'' in a position contiguous to the
``cents-off'' marked commodity.
(2) Other savings representations which appear on the label or
labeling of a package, e.g., ``bonus offer,'' ``two-for-one sales,''
``one-cent sales,'' etc., are subject to the provisions of this section.
Due to the infinite variety and scope of such promotions, the label
format of such representations may differ from that set forth in
paragraph (b)(1) of this section for ``cents-off'' promotions; however,
such representations shall include all material facts relative
[[Page 13]]
to the offer and shall in no way be misleading
(3) For the purposes of this section, the terms ordinary and
customary and regular when used with the term price mean the price at
which a consumer commodity has been openly and actively sold in the most
recent and regular course of business in a particular retail outlet or a
trade area for a reasonably substantial period of time (at least 30
days). For consumer commodities that fluctuate in price, the ordinary
and customary price shall be the lowest price at which any substantial
sales were made during said 30 days.
(c) Shipments of consumer commodities bearing ``cents-off,'' or
other savings representations to a given geographic trade area made by
the sponsor initiating such promotion shall be in no greater volume than
50 percent of the total units of that identical consumer commodity
distributed in the same geographic trade area during any period of 12
consecutive months comprising a calendar, fiscal, or market year.
(d) The ``cents-off,'' or other savings promotion may not be
employed by a sponsor on consumer commodities for distribution to a
specific geographic trade area until after 1 month has elapsed since
their last distribution of that identical consumer commodity bearing a
savings representation to the same geographic trade area. The number of
such promotions for that identical consumer commodity that may occur
within a 12-month period comprising a calendar, fiscal, or market year
shall not exceed a total of six with no more than three of any one type
or kind (e.g., ``cents-off,'' ``bonus offer,'' ``two-for-one sale,''
``1-cent sale,'' etc.), and the total period of time for all such
promotions shall not exceed 6 months within that 12-month period.
(e) A newly developed consumer commodity, one which has been changed
in a functionally significant respect, or one which is newly introduced
into a given geographic trade area may be the subject of an
``introductory offer'' type promotion. Such offers are not considered
subject to the provisions of paragraphs (a) through (d) of this section,
provided:
(1) Each such labeled offer is clearly and conspicuously qualified
with the phrase ``Introductory Offer,'' and
(2) If the introductory offer promotion is in the form of a ``cents-
off'' representation, each such labeled offer shall include clearly and
conspicuously in immediate conjunction therewith the phrase ``---- Cents
Off the After-Introductory -Offer Price''; and
(3) Labeled representations do not exceed a period of 6 months
duration.
Any subsequent price reduction promotion of the consumer commodity is
subject to the provisions of paragraphs (a) through (d) of this section
and shall be preceded by the 30-day period required for a determination
of the ordinary and customary selling price in that retail
establishment. At the time of making the introductory offer promotion,
the sponsor must intend in good faith to offer the commodity alone,
immediately following the introductory offer promotion, for a reasonably
substantial period of time (at least 30 days) at the anticipated after-
introductory-offer price. The sponsor of the introductory offer
promotion and all subsequent levels of commerce shall sell the commodity
at a reduction from their anticipated after-introductory-offer price
which reduction shall be at least equal to the savings differential
represented on the package or labeling. The sponsor and all subsequent
levels of commerce shall maintain invoices and records for at least 1
year subsequent to the end of the year (calendar, fiscal, or market) in
which such introductory offer occurs.
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).
[[Page 14]]
(b) The term district director means the director of the district of
the Food and Drug Administration having jurisdiction over the port of
entry through which an article is imported or offered for import, or
such officer of the district as he may designate to act in his behalf in
administering and enforcing the provisions of section 801 (a), (b), and
(c).
Sec. 1.90 Notice of sampling.
When a sample of an article offered for import has been requested by
the district director, the collector of customs having jurisdiction over
the article shall give to the owner or consignee prompt notice of
delivery of, or intention to deliver, such sample. Upon receipt of the
notice, the owner or consignee shall hold such article and not
distribute it until further notice from the district director or the
collector of customs of the results of examination of the sample.
Sec. 1.91 Payment for samples.
The Food and Drug Administration will pay for all import samples
which are found to be in compliance with the requirements of the Federal
Food, Drug, and Cosmetic Act. Billing for reimbursement should be made
by the owner or consignee to the Food and Drug Administration district
headquarters in whose territory the shipment was offered for import.
Payment for samples will not be made if the article is found to be in
violation of the act, even though subsequently brought into compliance
under the terms of an authorization to bring the article into compliance
or rendered not a food, drug, device, or cosmetic as set forth in
Sec. 1.95.
Sec. 1.94 Hearing on refusal of admission.
(a) If it appears that the article may be subject to refusal of
admission, the district director shall give the owner or consignee a
written notice to that effect, stating the reasons therefor. The notice
shall specify a place and a period of time during which the owner or
consignee shall have an opportunity to introduce testimony. Upon timely
request giving reasonable grounds therefor, such time and place may be
changed. Such testimony shall be confined to matters relevant to the
admissibility of the article, and may be introduced orally or in
writing.
(b) If such owner or consignee submits or indicates his intention to
submit an application for authorization to relabel or perform other
action to bring the article into compliance with the act or to render it
other than a food, drug, device, or cosmetic, such testimony shall
include evidence in support of such application. If such application is
not submitted at or prior to the hearing, the district director 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
[[Page 15]]
grounds therefor, the district director may grant such additional time
as he deems necessary.
(c) An authorization may be amended upon a showing of reasonable
grounds therefor and the filing of an amended application for
authorization with the district director.
(d) If ownership of an article covered by an authorization changes
before the operations specified in the authorization have been
completed, the original owner will be held responsible, unless the new
owner has executed a bond and obtained a new authorization. Any
authorization granted under this section shall supersede and nullify any
previously granted authorization with respect to the article.
[42 FR 15553, Mar. 22, 1977, as amended at 54 FR 9033, Mar. 3, 1989]
Sec. 1.97 Bonds.
(a) The bonds required under section 801(b) of the act may be
executed by the owner or consignee on the appropriate form of a customs
single-entry or term bond, containing a condition for the redelivery of
the merchandise or any part thereof upon demand of the collector of
customs and containing a provision for the performance of conditions as
may legally be imposed for the relabeling or other action necessary to
bring the article into compliance with the act or rendering it other
than a food, drug, device, or cosmetic, in such manner as is prescribed
for such bond in the customs regulations in force on the date of request
for authorization. The bond shall be filed with the collector of
customs.
(b) The collector of customs may cancel the liability for liquidated
damages incurred under the above-mentioned provisions of such a bond, if
he receives an application for relief therefrom, upon the payment of a
lesser amount or upon such other terms and conditions as shall be deemed
appropriate under the law and in view of the circumstances, but the
collector shall not act under this regulation in any case unless the
district director is in full agreement with the action.
Sec. 1.99 Costs chargeable in connection with relabeling and reconditioning inadmissible imports.
The cost of supervising the relabeling or other action in connection
with an import of food, drugs, devices, or cosmetics which fails to
comply with the Federal Food, Drug, and Cosmetic Act shall be paid by
the owner or consignee who files an application requesting such action
and executes a bond, pursuant to section 801(b) of the act, as amended.
The cost of such supervision shall include, but not be restricted to,
the following:
(a) Travel expenses of the supervising officer.
(b) Per diem in lieu of subsistence of the supervising officer when
away from his home station, as provided by law.
(c) The charge for the services of the supervising officer, which
shall include administrative support, shall be computed at a rate per
hour equal to 266 percent of the hourly rate of regular pay of a grade
GS-11/4 employee, except that such services performed by a customs
officer and subject to the provisions of the act of February 13, 1911,
as amended (sec. 5, 36 Stat. 901, as amended (19 U.S.C. 267)), shall be
calculated as provided in that act.
(d) The charge for the service of the analyst, which shall include
administrative and laboratory support, shall be computed at a rate per
hour equal to 266 percent of the hourly rate of regular pay of a grade
GS-12/4 employee. The rate per hour equal to 266 percent of the
equivalent hourly rate of regular pay of the supervising officer (GS-11/
4) and the analyst (GS-12/4) is computed as follows:
------------------------------------------------------------------------
Hours
------------------------------------------------------------------------
Gross number of working hours in 52 40-hr weeks................ 2,080
Less:
9 legal public holidays--New Years Day, Washington's
Birthday, Memorial Day, Independence Day, Labor Day,
Columbus Day, Veterans Day, Thanksgiving Day, and Christmas
Day......................................................... 72
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
employee retirement, life insurance, and health benefits
computed at 8\1/2\ pct. of annual rate of pay of employee..... 176
--------
[[Page 16]]
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
Drug appropriation...................................... 4,512
------------------------------------------------------------------------
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.
PART 2--GENERAL ADMINISTRATIVE RULINGS AND DECISIONS--Table of Contents
Subpart A--General Provisions
Sec.
2.5 Imminent hazard to the public health.
2.10 Examination and investigation samples.
2.19 Methods of analysis.
Subpart B--Human and Animal Foods
2.25 Grain seed treated with poisonous substances; color identification
to prevent adulteration of human and animal food.
2.35 Use of secondhand containers for the shipment or storage of food
and animal feed.
Subparts C--E [Reserved]
Subpart F--Caustic Poisons
2.110 Definition of ammonia under Federal Caustic Poison Act.
Subpart G--Provisions Applicable to Specific Products Subject to the
Federal Food, Drug, and Cosmetic Act
2.125 Use of chlorofluorocarbon propellants in self-pressurized
containers.
Authority: Secs. 201, 301, 305, 402, 408, 409, 501, 502, 505, 507,
512, 601, 701, 702, 704 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321, 331, 335, 342, 346a, 348, 351, 352, 355, 357, 360b, 361,
371, 372, 374); 15 U.S.C. 402, 409.
Source: 42 FR 15559, Mar. 22, 1977, unless otherwise noted.
Subpart A--General Provisions
Sec. 2.5 Imminent hazard to the public health.
(a) Within the meaning of the Federal Food, Drug, and Cosmetic Act
an imminent hazard to the public health is considered to exist when the
evidence is sufficient to show that a product or practice, posing a
significant threat of danger to health, creates a public health
situation (1) that should be corrected immediately to prevent injury and
(2) that should not be permitted to continue while a hearing or other
formal proceeding is being held. The imminent hazard may be declared at
any point in the chain of events which may ultimately result in harm to
the public health. The occurrence of the final anticipated injury is not
essential to establish that an imminent hazard of such occurrence
exists.
(b) In exercising his judgment on whether an imminent hazard exists,
the Commissioner will consider the number of injuries anticipated and
the nature, severity, and duration of the anticipated injury.
Sec. 2.10 Examination and investigation samples.
(a)(1) When any officer or employee of the Department collects a
sample of a food, drug, or cosmetic for analysis under the act, the
sample shall be designated as an official sample if records or other
evidence is obtained by him or any other officer or employee of the
Department indicating that the shipment or other lot of the article from
which such sample was collected was introduced or delivered for
introduction into interstate commerce, or was in or was received in
interstate commerce, or was manufactured within a Territory. Only
samples so designated by an officer or employee of the Department shall
be considered to be official samples.
(2) For the purpose of determining whether or not a sample is
collected for analysis, the term analysis includes examinations and
tests.
(3) The owner of a food, drug, or cosmetic of which an official
sample is collected is the person who owns the shipment or other lot of
the article from which the sample is collected.
[[Page 17]]
(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 $50.
(3) The sample cannot by diligent use of practicable preservation
techniques available to the Food and Drug Administration be kept in a
state in which it could be readily and meaningfully analyzed in the same
manner and for the same purposes as the Food and Drug Administration's
analysis.
(4) The sample is collected from a shipment or other lot which is
being imported or offered for import into the United States.
(5) The sample is collected from a person named on the label of the
article or his agent, and such person is also the owner of the article.
(6) The sample is collected from the owner of the article, or his
agent, and such article bears no label or, if it bears a label, no
person is named thereon.
In addition to the quantity of sample set forth in this paragraph, the
officer or employee shall, if practicable, collect such further amount
as he estimates will be sufficient for use as trial exhibits.
(c) After the Food and Drug Administration has completed such
analysis of an official sample of a food, drug, or cosmetic as it
determines, in the course of analysis and interpretation of analytical
results, to be adequate to establish the respects, if any, in which the
article is adulterated or misbranded within the meaning of the act, or
otherwise subject to the prohibitions of the act, and has reserved an
amount of the article it estimates to be adequate for use as exhibits in
the trial of any case that may arise under the act based on the sample,
a part of the sample, if any remains available, shall be provided for
analysis, upon written request, by any person named on the label of the
article, or the owner thereof, or the attorney or agent of such person
or owner, except when:
(1) After collection, the sample or remaining part thereof has
become decomposed or otherwise unfit for analysis, or
(2) The request is not made within a reasonable time before the
trial of any case under the act, based on the sample to which such
person or owner is a party. The person, owner, attorney, or agent who
requests the part of sample shall specify the amount desired. A request
from an owner shall be accompanied by a showing of ownership, and a
request from an attorney or agent by a showing of authority from such
person or owner to receive the part of sample. When two or more requests
for parts of the same sample are received the requests shall be complied
with in the order in which they were received so long as any part of the
sample remains available therefor.
(d) When an official sample of food, drug, or cosmetic is the basis
of a notice given under section 305 of the act, or of a case under the
act, and the person to whom the notice was given, or any person who is a
party to the case, has no right under paragraph (c) of this section to a
part of the sample, such person or his attorney or agent may obtain a
part of the sample upon request accompanied by a written waiver of right
under such paragraph (c) from each person named on the label of the
article and owner thereof, who has not 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
[[Page 18]]
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.
Sec. 2.19 Methods of analysis.
Where the method of analysis is not prescribed in a regulation, it
is the policy of the Food and Drug Administration in its enforcement
programs to utilize the methods of analysis of the Association of
Official Analytical Chemists (AOAC) as published in the latest edition
(13th Ed., 1980) of their publication ``Official Methods of Analysis of
the Association of Official Analytical Chemists,'' and the supplements
thereto (``Changes in Methods'' as published in the March issues of the
``Journal of the Association of Official Analytical Chemists''), which
are incorporated by reference, when available and applicable. Copies are
available from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street NW., suite 700, Washington, DC. In the absence of an AOAC method,
the Commissioner will furnish a copy of the particular method, or a
reference to the published method, that the Food and Drug Administration
will use in its enforcement program. Other methods may be used for
quality control, specifications, contracts, surveys, and similar
nonregulatory functions, but it is expected that they will be calibrated
in terms of the method which the Food and Drug Administration uses in
its enforcement program. Use of an AOAC method does not relieve the
practioner of the responsibility to demonstrate that he can perform the
method properly through the use of positive and negative controls and
recovery and reproducibility studies.
[42 FR 15559, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 54
FR 9034, Mar. 3, 1989]
Subpart B--Human and Animal Foods
Sec. 2.25 Grain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food.
(a) In recent years there has developed increasing use of poisonous
treatments on seed for fungicidal and other purposes. Such treated seed,
if consumed, presents a hazard to humans and livestock. It is not
unusual for stocks of such treated food seeds to remain on hand after
the planting season has passed. Despite the cautions required by the
Federal Seed Act (53 Stat. 1275, as amended 72 Stat. 476, 7 U.S.C. 1551
et seq.) in the labeling of the treated seed, the Food and Drug
Administration has encountered many cases where such surplus stocks of
treated wheat, corn, oats, rye, barley, and sorghum seed had been mixed
with untreated seed and sent to market for food or feed use. This has
resulted in livestock injury and in legal actions under the Federal
Food, Drug, and Cosmetic Act against large quantities of food
adulterated through such admixture of poisonous treated seeds with good
food. Criminal cases were brought against some firms and individuals.
Where the treated seeds are prominently colored, buyers and users or
processors of agricultural food seed for food purposes are able to
detect the admixture of the poisonous seed and thus reject the lots; but
most such buyers, users, and processors do not have the facilities or
scientific equipment to determine the presence of the poisonous chemical
at the time crops are delivered, in cases where the treated seeds have
not been so colored. A suitable color for this use is one that is in
sufficient contrast to the natural color of the food seed as to make
admixture of treated, denatured seeds with good food easily apparent,
and is so applied that it is not readily removed.
[[Page 19]]
(b) On and after December 31, 1964, the Food and Drug Administration
will regard as adulterated any interstate shipment of the food seeds
wheat, corn, oats, rye, barley, and sorghum bearing a poisonous
treatment in excess of a recognized tolerance or treatment for which no
tolerance or exemption from tolerance is recognized in regulations
promulgated pursuant to section 408 of the Federal Food, Drug, and
Cosmetic Act, unless such seeds have been adequately denatured by a
suitable color to prevent their subsequent inadvertent use as food for
man or feed for animals.
(c) Attention is called to the labeling requirements of the Federal
Hazardous Substances Act, where applicable to denatured seeds in
packages suitable for household use.
Sec. 2.35 Use of secondhand containers for the shipment or storage of food and animal feed.
(a) Investigations by the Food and Drug Administration, the National
Communicable Disease Center of the U.S. Public Health Service, the
Consumer and Marketing Service of the U.S. Department of Agriculture,
and by various State public health agencies have revealed practices
whereby food and animal feed stored or shipped in secondhand containers
have been rendered dangerous to health. Such contamination has been the
result of the original use of these containers for the storage and
shipment of articles containing or bearing disease organisms or
poisonous or deleterious substances.
(b) The Commissioner concludes that such dangerous or potentially
dangerous practices include, but are not limited to, the following:
(1) Some vegetable growers and packers employ used poultry crates
for shipment of fresh vegetables, including cabbage and celery.
Salmonella organisms are commonly present on dressed poultry and in
excreta and fluid exudates from dressed birds. Thus wooden crates in
which dressed poultry has been iced and packed are potential sources of
Salmonella or other enteropathogenic microorganisms that may contaminate
fresh vegetables which are frequently consumed without heat treatment.
(2) Some potato growers and producers of animal feeds use secondhand
bags for shipment of these articles. Such bags may have originally been
used for shipping or storing pesticide-treated seed or other articles
bearing or containing poisonous substances. Thus these secondhand bags
are potential sources of contamination of the food or animal feed stored
or shipped therein.
(c) In a policy statement issued April 11, 1968, the Food and Drug
Administration declared adulterated within the meaning of section 402(a)
of the Federal Food, Drug, and Cosmetic Act shipments of vegetables or
other edible food in used crates or containers that may render the
contents injurious to health. This policy statement is extended so that
the Food and Drug Administration will regard as adulterated within the
meaning of section 402(a) of the act shipments of vegetables, other
edible food, or animal feed in used crates, bags, or other containers
that may render the contents injurious to health.
Subparts C--E [Reserved]
Subpart F--Caustic Poisons
Sec. 2.110 Definition of ammonia under Federal Caustic Poison Act.
For the purpose of determining whether an article containing ammonia
is subject to the Federal Caustic Poison Act, the ammonia content is to
be calculated as NH3.
Subpart G--Provisions Applicable to Specific Products Subject to the
Federal Food, Drug, and Cosmetic Act
Sec. 2.125 Use of chlorofluorocarbon propellants in self-pressurized containers.
(a) As used in this section:
(1) Chlorofluorocarbon means any fully halogenated
chlorofluoroalkane.
(2) Propellant means a liquefied or compressed gas that is used in
whole or in part to expel from the same self-pressurized container or
from a
[[Page 20]]
separate container a liquid or solid material different from the
propellant, but the term does not include the use of a
chlorofluorocarbon as an aerating agent for foamed or sprayed food
products.
(b) Chlorofluorocarbons are widely used in products subject to the
Federal Food, Drug, and Cosmetic Act, with the principal use being as
propellants in self-pressurized containers. Information recently
developed indicates that chlorofluorocarbons may reduce the amount of
ozone in the stratosphere and thus increase the amount of ultraviolet
radiation reaching the earth. An increase in ultraviolet radiation may
increase the incidence of skin cancer, change the climate, and produce
other effects of unknown magnitude on humans, animals, and plants.
Chlorofluorocarbons may also affect the climate by increasing infrared
absorption in the atmosphere.
(c) Except as provided in paragraph (e) of this section, any food,
drug, device, or cosmetic in a self-pressurized container that contains
a chlorofluorocarbon propellant is adulterated and/or misbranded in
violation of the act, and any drug product in a self-pressurized
container that contains a chlorofluorocarbon propellant is a new drug or
a new animal drug.
(d) The use of a chlorofluorocarbon as a propellant in a self-
pressurized container of a drug product will not result in the drug
product being adulterated and/or misbranded provided a new drug
application, a new animal drug application, or in the case of a
certifiable antibiotic an antibiotic application for the drug product
has been approved, a petition has been filed as provided by paragraph
(f) of this section, and paragraph (e) of this section has been amended
to specify the use as essential.
(e) The adulteration and misbranding provisions of paragraph (c) of
this section shall not apply to the following essential uses of
chlorofluorocarbons:
(1) Metered-dose steriod human drugs for nasal inhalation,
(2) Metered-dose steriod human drugs for oral inhalation,
(3) Metered-dose adrenergic bronchodilator human drugs for oral
inhalation,
(4) Contraceptive vaginal foams for human use, and
(5) Metered-dose ergotamine tartrate drug products administered by
oral inhalation for use in humans.
(6) Intrarectal hydrocortisone acetate for human use.
(7) Polymyxin B sulfate-bacitracin zinc-neomycin sulfate soluble
antibiotic powder without excipients, for topical use on humans.
(8) Anesthetic drugs for topical use on accessible mucous membranes
of humans where a cannula is used for application.
(9) Metered-dose nitroglycerin human drugs administered to the oral
cavity.
(10) Metered-dose cromolyn sodium human drugs administered by oral
inhalation.
(11) Metered-dose ipratropium bromide for oral inhalation.
(12) Metered-dose atropine sulfate aerosol human drugs administered
by oral inhalation.
(13) Metered-dose nedocromil sodium human drugs administered by oral
inhalation.
(f) Any person may file a petition in accordance with part 10 of
this chapter to amend paragraph (e) of this section to specify a use of
chlorofluorocarbons in a product as not being subject to the
adulteration and misbranding provisions in paragraph (c) of this
section. The petition must be supported by an adequate showing that:
(1) There are no technically feasible alternatives to the use of a
chlorofluorocarbon in the product,
(2) The product provides a substantial health benefit, environmental
benefit, or other public benefit that would not be obtainable without
the use of the chlorofluorocarbon, and
(3) The use does not involve a significant release of
chlorofluorocarbons into the atmosphere or that the release is warranted
in view of the consequence if the use were not permitted.
(g) Any holder of an approved new drug application or new animal
drug application for a drug product containing a chlorofluorocarbon in a
self-pressurized container, except those drug products listed in
paragraph (e) of this section, shall submit to the Food and Drug
Administration on or before October 1, 1978, either a supplemental
[[Page 21]]
application providing for a revised formulation complying with the
requirements of Sec. 314.70 or Sec. 514.8 of this chapter or a letter
requesting that a new drug application or a new animal drug application
for the drug product containing chlorofluorocarbon be withdrawn and that
the right to a hearing on the withdrawal of the application is waived.
(h)(1) Each manufacturer of a drug product listed in paragraph (e)
of this section that is not covered by an approved new drug application
shall submit a new drug application in accord with Sec. 314.50 of this
chapter on or before June 15, 1978.
(2) An abbreviated new drug application conforming to Sec. 314.94 of
this chapter is acceptable in lieu of a full new drug application for
any product included in the classes of products in paragraph (e) of this
section if the product is one that is described under Sec. 314.92 of
this chapter. A finding has been made that an abbreviated new drug
application may be submitted for the following products included in the
classes of products listed in paragraph (e) of this section:
(i) Ergotamine tartrate supplied in a metered-dose aerosol form
suitable for oral inhalation for the treatment of migraine headaches.
Each measured dose must deliver a dose of the active ingredient
equivalent to that contained in the product that has been the subject of
a separate finding that an abbreviated new drug application is suitable.
(ii) Isoproterenol hydrochloride supplied in a metered-dose aerosol
form suitable for oral inhalation for use as an adrenergic
bronchodilator. Each measured dose must deliver a dose of the active
ingredient equivalent to that contained in the products that have been
the subject of a separate finding that an abbreviated new drug
application is suitable.
(iii) Epinephrine, epinephrine bitartrate, or epinephrine
hydrochloride (racemic) in a metered-dose aerosol form suitable for oral
inhalation for use as an adrenergic bronchodilator. Each measured dose
must deliver a dose of the active ingredient equivalent to that
specified in an OTC proposed or final monograph issued under the
provisions of 21 CFR part 330.
(iv) Nonoxynol 9 in an aerosol foam suitable for vaginal
administration as a contraceptive foam. The aerosol foam must contain 8
to 12.5 percent of nonoxynol 9.
(i) Any sponsor of an ``Investigational New Drug Application'' (IND)
or ``Notice of Claimed Exemption for a New Animal Drug'' (INAD) for a
drug product containing a chlorofluorocarbon shall:
(1) Amend the IND or INAD on or before December 15, 1978, to revise
the formulation removing the chlorofluorocarbon.
(2) Submit the information required under paragraph (f) of this
section to amend paragraph (e) of this section to show that the use of
chlorofluorocarbon is essential, or
(3) Submit the information required under paragraph (j) of this
section requesting that studies with the drug product containing a
chlorofluorocarbon propellant be allowed to be performed.
(j) Any sponsor of an IND or INAD who wishes to initiate or continue
a study beyond December 15, 1978 on a drug product containing a
chlorofluorocarbon shall submit a petition in accordance with part 10 of
this chapter requesting that studies be permitted to collect the data to
show that the use of the chlorofluorocarbon is an essential use. The
petitions must be supported by the following:
(1) A description of the drug product,
(2) An explanation why a chlorofluorocarbon propellant is used in
the product rather than another propellant or another dosage form of the
product, and
(3) The benefit that the investigational product is believed to have
and that the sponsor hopes to demonstrate by the studies.
(k) The Commissioner will initiate action to withdraw approval of an
application or terminate an IND or INAD notice in accordance with the
applicable provisions of section 505 of the act and parts 312 and 314 of
this chapter, or section 512 of the act and parts 511 and 514 of this
chapter upon failure of a
[[Page 22]]
holder of an approved new drug application or approved new animal drug
application or sponsor of an IND or INAD notice to comply with the
applicable provisions of this section.
(l) Food, drug, device, or cosmetic products manufactured or
packaged on or after December 15, 1978, and finished products initially
introduced into interstate commerce on or after April 15, 1979, shall
comply with this regulation.
[43 FR 11316, Mar. 17, 1978, as amended at 44 FR 3961, Jan. 19, 1979; 44
FR 30334, May 26, 1979; 45 FR 22902, April 4, 1980; 51 FR 4591, Feb. 6,
1986; 52 FR 15717, Apr. 30, 1987; 54 FR 9034, Mar. 3, 1989; 55 FR 39267,
Sept. 26, 1990; 57 FR 17980, Apr. 28, 1992; 58 FR 6088, Jan. 26, 1993]
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: Secs. 201, 501, 502, 503, 505, 506, 507, 510, 513-516,
518-520, 530-542, 701(a), 721, 801, 903 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 351, 352, 353, 355, 356, 357, 360, 360c-
360f, 360h-360j, 360gg-360ss, 371(a), 379e, 381, 394); secs. 215, 351 of
the Public Health Service Act (42 U.S.C. 216, 262).
Source: 56 FR 58756, Nov. 21, 1991, unless otherwise noted.
Subpart A--Assignment of Agency Component for Review of Premarket
Applications
Sec. 3.1 Purpose.
This regulation relates to agency management and organization and
has two purposes. The first is to implement section 503(g) of the act,
as added by section 16 of the Safe Medical Devices Act of 1990 (Pub. L.
101-629), by specifying how FDA will determine the organizational
component within FDA designated to have primary jurisdiction for the
premarket review and regulation of products that are comprised of any
combination of a drug and a device; a device and a biological; a
biological and a drug; or a drug, a device and a biological. This
determination will eliminate, in most cases, the need to receive
approvals from more than one FDA component for such combination
products. The second purpose of this regulation is to enhance the
efficiency of agency management and operations by providing procedures
for determining which agency component will have primary jurisdiction
for any drug, device, or biological product where such jurisdiction is
unclear or in dispute. Nothing in this section prevents FDA from using
any agency resources it deems necessary to ensure adequate review of the
safety and effectiveness of any product, or the substantial equivalence
of any device to a predicate device.
Sec. 3.2 Definitions.
For the purpose of this part:
(a) Act means the Federal Food, Drug, and Cosmetic Act.
(b) Agency component means the Center for Biologics Evaluation and
Research, the Center for Devices and Radiological Health, or the Center
for Drug Evaluation and Research.
(c) Applicant means any person who submits or plans to submit an
application to the Food and Drug Administration for premarket review.
For purposes of this section, the terms ``sponsor'' and ``applicant''
have the same meaning.
(d) Biological product has the meaning given the term in section
351(a) of the Public Health Service Act (42 U.S.C. 262(a)).
(e) Combination product includes:
(1) A product comprised of two or more regulated components, i.e.,
drug/device, biologic/device, drug/biologic, or drug/device/biologic,
that are physically, chemically, or otherwise combined or mixed and
produced as a single entity;
(2) Two or more separate products packaged together in a single
package
[[Page 23]]
or as a unit and comprised of drug and device products, device and
biological products, or biological and drug products;
(3) A drug, device, or biological product packaged separately that
according to its investigational plan or proposed labeling is intended
for use only with an approved individually specified drug, device, or
biological product where both are required to achieve the intended use,
indication, or effect and where upon approval of the proposed product
the labeling of the approved product would need to be changed, e.g., to
reflect a change in intended use, dosage form, strength, route of
administration, or significant change in dose; or
(4) Any investigational drug, device, or biological product packaged
separately that according to its proposed labeling is for use only with
another individually specified investigational drug, device, or
biological product where both are required to achieve the intended use,
indication, or effect.
(f) Device has the meaning given the term in section 201(h) of the
act.
(g) Drug has the meaning given the term in section 201(g)(1) of the
act.
(h) FDA means Food and Drug Administration.
(i) Letter of designation means the written notice issued by the
product jurisdiction officer specifying the agency component with
primary jurisdiction for a combination product.
(j) Letter of request means an applicant's written submission to the
product jurisdiction officer seeking the designation of the agency
component with primary jurisdiction.
(k) Premarket review includes the examination of data and
information in an application for premarket review described in sections
505, 507, 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), antibiotic
application, biological product or establishment 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)).
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
[[Page 24]]
the Center for Drug Evaluation and Research have entered into agreements
clarifying product jurisdictional issues. These guidance documents are
on display in the Dockets Management Branch (HFA-305), Food and Drug
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, and
are entitled ``Intercenter Agreement Between the Center for Drug
Evaluation and Research and the Center for Devices and Radiological
Health;'' ``Intercenter Agreement Between the Center for Devices and
Radiological Health and the Center for Biologics Evaluation and
Research;'' ``Intercenter Agreement Between the Center for Drug
Evaluation and Research and the Center for Biologics Evaluation and
Research.'' The availability of any amendments to these intercenter
agreements will be announced by Federal Register notice.
(2) These guidance documents describe the allocation of
responsibility for categories of products or specific products. These
intercenter agreements, and any amendments thereto, are nonbinding
determinations designed to provide useful guidance to the public.
(3) The sponsor of a premarket application or required
investigational filing for a combination or other product covered by
these guidance documents may contact the designated agency component
identified in the intercenter agreement before submitting an application
of premarket review or to confirm coverage and to discuss the
application process.
(b) For a combination product not covered by a guidance document or
for a product where the agency component with primary jurisdiction is
unclear or in dispute, the sponsor of an application for premarket
review should follow the procedures set forth in Sec. 3.7 to request a
designation of the agency component with primary jurisdiction before
submitting the application.
Sec. 3.6 Product jurisdiction officer.
FDA Ombudsman (HF-7), Food and Drug Administration, rm. 14-84, 5600
Fishers Lane, Rockville, MD 20857, 301-443-1306, is the designated
product jurisdiction officer.
Sec. 3.7 Request for designation.
(a) Who should file: the sponsor of:
(1) Any combination product the sponsor believes is not covered by
an intercenter agreement; or
(2) Any product where the agency component with primary jurisdiction
is unclear or in dispute.
(b) When to file: a sponsor should file a request for designation
before filing any application for premarket review, whether an
application for marketing approval or a required investigational notice.
Sponsors are encouraged to file a request for designation as soon as
there is sufficient information for the agency to make a determination.
(c) What to file: an original and two copies of the request for
designation must be filed. The request for designation must not exceed
15 pages, including attachments, and must set forth:
(1) The identity of the sponsor, including company name and address,
establishment registration number, company contact person and telephone
number.
(2) A description of the product, including:
(i) Classification, name of the product and all component products,
if applicable;
(ii) Common, generic, or usual name of the product and all component
products;
(iii) Proprietary name of the product;
(iv) Identification of any component of the product that already has
received premarket approval, is marketed as not being subject to
premarket approval, or has received an investigational exemption, the
identity of the sponsors, and the status of any discussions or
agreements between the sponsors regarding the use of this product as a
component of a new combination product.
(v) Chemical, physical, or biological composition;
(vi) Status and brief reports of the results of developmental work,
including animal testing;
(vii) Description of the manufacturing processes, including the
sources of all components;
(viii) Proposed use or indications;
(ix) Description of all known modes of action, the sponsor's
identification
[[Page 25]]
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.''
Sec. 3.8 Letter of designation.
(a) Each request for designation will be reviewed for completeness
within 5 working days of receipt. Any request for designation determined
to be incomplete will be returned to the applicant with a request for
the missing information. The sponsor of an accepted request for
designation will be notified of the filing date.
(b) Within 60 days of the filing date of a request for designation,
the product jurisdiction officer will issue a letter of designation to
the sponsor, with copies to the centers, specifying the agency component
designated to have primary jurisdiction for the premarket review and
regulation of the product at issue, and any consulting agency
components. The product jurisdiction officer may request a meeting with
the sponsor during the review period to discuss the request for
designation. If the product jurisdiction officer has not issued a letter
of designation within 60 days of the filing date of a request for
designation, the sponsor's recommendation of the center with primary
jurisdiction, in accordance with Sec. 3.7(c)(3), shall become the
designated agency component.
(c) Request for reconsideration by sponsor: If the sponsor disagrees
with the designation, it may request the product jurisdiction officer to
reconsider the decision by filing, within 15 days of receipt of the
letter of designation, a written request for reconsideration not
exceeding 5 pages. No new information may be included in a request for
reconsideration. The product jurisdiction officer shall review and act
on the request in writing within 15 days of its receipt.
Sec. 3.9 Effect of letter of designation.
(a) The letter of designation constitutes an agency determination
that is subject to change only as provided in paragraph (b) of this
section.
(b) The product jurisdiction officer may change the designated
agency component with the written consent of the sponsor, or without its
consent to protect the public health or for other compelling reasons. A
sponsor shall be given 30 days written notice of any proposed
nonconsensual change in designated agency component. The sponsor may
request an additional 30 days to submit written objections, not to
exceed 15 pages, to the proposed change, and shall be granted, upon
request, a timely meeting with the product jurisdiction officer and
appropriate center officials. Within 30 days of receipt of the sponsor's
written objections, the product jurisdiction officer shall issue to the
sponsor, with copies to appropriate center officials, a written
determination setting forth a statement of reasons for the proposed
change in designated agency component. A nonconsensual change in the
designated agency component requires the concurrence of the Deputy
Commissioner for Operations or the Deputy Commissioner for Policy.
Sec. 3.10 Stay of review time.
Any filing with or review by the product jurisdiction officer stays
the review clock or other established time periods for agency action for
an application for marketing approval or required investigational notice
during the pendency of the review by the product jurisdiction officer.
[[Page 26]]
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, the Assistant Secretary for
Health, and Public Health Service Officials.
5.11 Reservation of authority.
Subpart B--Redelegations of Authority from the Commissioner of Food and
Drugs
5.20 General redelegations of authority from the Commissioner to other
officers of the Food and Drug Administration.
5.21 Emergency functions.
5.22 Certification of true copies and use of Department seal.
5.23 Disclosure of official records.
5.24 Authority relating to technology transfer.
5.25 Research, investigation, and testing programs and health
information and health promotion programs.
5.26 Service fellowships.
5.27 Patent term extensions for human drug products, medical devices,
and food and color additives.
5.28 Cardiac pacemaker devices and pacemaker leads.
5.29 Functions pertaining to safer vaccines.
5.30 Hearings.
5.31 Petitions under part 10.
5.32 Authority relating to determination of product primary
jurisdiction.
5.33 Premarket approval of a product that is or contains a biologic, a
device, or a drug.
5.34 Authority to select temporary voting members for advisory
committees and authority to sign conflict of interest waivers.
5.35 Enforcement activities.
5.36 Certification following inspections.
5.37 Issuance of reports of minor violations.
5.38 Issuance of written notices concerning patent information, current
good manufacturing practices and false or misleading labeling
of new drugs, new animal drugs, and feeds bearing or
containing new animal drugs.
5.39 Redelegation of the Center for Biologics Evaluation and Research
Director's program authorities.
5.44 Export of unapproved drugs.
5.45 Imports and exports.
5.46 Manufacturer's resident import agents.
5.47 Detention of adulterated or misbranded medical devices.
5.49 Authorization to use alternative evidence for determination of the
effectiveness of medical devices.
5.50 Notification to petitioners of determinations made on petitions
for reclassification of medical devices.
5.51 Determination of classification of devices.
5.52 Notification to sponsors of deficiencies in petitions for
reclassification of medical devices.
5.53 Approval, disapproval, or withdrawal of approval of product
development protocols and applications for premarket approval
for medical devices.
5.54 Determinations that medical devices present unreasonable risk of
substantial harm.
5.55 Orders to repair or replace, or make refunds for, medical devices.
5.56 Recall authority.
5.57 Temporary suspension of a medical device application.
5.58 Orphan products.
5.59 Approval, disapproval, or withdrawal of approval of applications
for investigational device exemptions.
5.60 Required and discretionary postmarket surveillance.
5.61 Food standards, food additives, generally recognized as safe
(GRAS) substances, color additives, nutrient content claims,
and health claims.
5.62 Issuance of initial emergency permit orders and notices of
confirmation of effective date of final regulations on food
for human and animal consumption.
5.63 Detention of meat, poultry, eggs, and related products.
5.64 Establishing standards and approving accrediting bodies under the
National Laboratory Accreditation Program.
5.66 Approval of schools providing food-processing instruction.
5.67 Issuance of notices of opportunity for a hearing on proposals for
denial of approval of applications for licenses or revocation
of licenses and certain notices of revocation of licenses.
5.68 Issuance and revocation of licenses for the propagation or
manufacture and preparation of biological products.
5.69 Notification of release for distribution of biological products.
5.70 Issuance of notice implementing the provisions of the Drug
Amendments of 1962.
5.71 Termination of exemptions for new drugs for investigational use in
human beings and in animals.
5.72 Authority to approve and to withdraw approval of a charge for
investigational new drugs.
5.73 Certification of insulin.
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5.74 Issuance, amendment, or repeal of regulations pertaining to drugs
containing insulin.
5.75 Designation of official master and working standards for
antibiotic drugs.
5.76 Certification of antibiotic drugs.
5.78 Issuance, amendment, or repeal of regulations pertaining to
antibiotic drugs.
5.80 Approval of new drug applications and their supplements.
5.81 Responses to Drug Enforcement Administration temporary scheduling
notices.
5.82 Issuance of notices relating to proposals to refuse approval or to
withdraw approval of new drug applications and their
supplements.
5.83 Approval of new animal drug applications and their supplements.
5.84 Issuance of notices, proposals, and orders relating to new animal
drugs and feeds bearing or containing new animal drugs.
5.85 Authority to ensure that mammography facilities meet quality
standards.
5.86 Variances from performance standards for electronic products.
5.87 Exemption of electronic products from performance standards and
prohibited acts.
5.88 Testing programs and methods of certification and identification
for electronic products.
5.89 Notification of defects in, and repair or replacement of,
electronic products.
5.90 Manufacturers requirement to provide data to ultimate purchasers
of electronic products.
5.91 Dealer and distributor direction to provide data to manufacturers
of electronic products.
5.92 Acceptance of assistance from State and local authorities for
enforcement of radiation control legislation and regulations.
5.93 Submission of and effective approval dates for abbreviated new
drug applications and certain new drug applications.
5.94 Extensions or stays of effective dates for compliance with certain
labeling requirements for human prescription drugs.
5.95 Submission of and effective approval dates for abbreviated new
animal drug applications and certain new animal drug
applications.
5.98 Authority relating to medical device reporting procedures.
5.99 Issuance of notices relating to proposals and orders for debarment
and denial of an application to terminate debarment.
Subpart C--Organization
5.100 Headquarters.
5.105 Chief Counsel, Food and Drug Administration.
5.110 FDA Public Information Offices.
5.115 Field structure.
Authority: 5 U.S.C. 504, 552, App. 2; 7 U.S.C. 138a, 2271; 15 U.S.C.
638, 1261-1282, 3701-3711a; secs. 2-12 of the Fair Packaging and
Labeling Act (15 U.S.C. 1451-1461); 21 U.S.C. 41-50, 61-63, 141-149,
467f, 679(b), 801-886, 1031-1309; secs. 201-903 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321-394); 35 U.S.C. 156; secs. 301,
302, 303, 307, 310, 311, 351, 352, 354, 361, 362, 1701-1706, 2101, 2125,
2127, 2128 of the Public Health Service Act (42 U.S.C. 241, 242, 242a,
242l, 242n, 243, 262, 263, 263b, 264, 265, 300u-300u-5, 300aa-1, 300aa-
25, 300aa-27, 300aa-28); 42 U.S.C. 1395y, 3246b, 4332, 4831(a), 10007-
10008; E.O. 11490, 11921, and 12591; secs. 312, 313, 314 of the National
Childhood Vaccine Injury Act of 1986, Pub. L. 99-660 (42 U.S.C. 300aa-1
note).
Source: 42 FR 15560, Mar. 22, 1977, unless otherwise noted.
Subpart A--Delegations of Authority to the Commissioner of Food and
Drugs
Sec. 5.10 Delegations from the Secretary, the Assistant Secretary for Health, and Public Health Service Officials.
(a) The Assistant Secretary for Health has redelegated to the
Commissioner of Food and Drugs, with authority to redelegate except when
specifically prohibited, all authority delegated to the Assistant
Secretary for Health by the Secretary of Health and Human Services, as
follows:
(1) Functions vested in the Secretary under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.), the Filled Milk Act (21 U.S.C.
61-63), the Federal Import Milk Act (21 U.S.C. 141 et seq.), the Tea
Importation Act (21 U.S.C. 41 et seq.), the Federal Caustic Poison Act
(44 Stat. 1406), and The Fair Packaging and Labeling Act (15 U.S.C. 1451
et seq.), pursuant to section 12 of Reorganization Plan No. IV and
Reorganization Plan No. 1 of 1953, including authority to administer
oaths vested in the Secretary of Agriculture by 7 U.S.C. 2217.
(2) Functions vested in the Secretary under section 301 (Research
and Investigations); section 307 (International Cooperation); and
section 311 (Federal-State Cooperation) of the Public Health Service Act
(42 U.S.C. 241, 242l, 243), as amended, which relate to the
[[Page 28]]
functions of the Food and Drug Administration.
(3) Functions vested in the Secretary under sections 354 through
360F of the Public Health Service Act (42 U.S.C. 263b through 263n), as
amended, which relate to electronic product radiation control.
(4) Functions vested in the Secretary under section 361 of the
Public Health Service Act (42 U.S.C. 264), as amended, which relate to
the law enforcement functions of the Food and Drug Administration
concerning the following products and activities: biologicals (including
blood and blood products); interstate travel sanitation (except
interstate transportation of etiologic agents under 42 CFR 72); food
(including milk and food service sanitation and shellfish sanitation);
and drugs, devices, cosmetics, electronic products, and other items or
products regulated by the Food and Drug Administration.
(5) Functions vested in the Secretary under sections 351 and 352 of
part F, subpart 1 of the Public Health Service Act (42 U.S.C. 262 and
263), as amended, Biological Products, insofar as they relate to the
functions assigned to the Food and Drug Administration.
(6) Functions vested in the Secretary under section 302(a) of the
Public Health Service Act (42 U.S.C. 242(a)), as amended, which relate
to the determination and reporting requirements with respect to the
medicinal and scientific requirements of the United States for
controlled substances.
(7) Functions vested in the Secretary under section 303 of the
Public Health Service Act (42 U.S.C. 242a), as amended, which relate to
the authorization of persons engaged in research on the use and effect
of drugs to protect the identity of their research subjects with respect
to drugs scheduled under Pub. L. 91-513 for which an investigational new
drug application is filed with the Food and Drug Administration and with
respect to all drugs not scheduled under Pub. L. 91-513.
(8) Functions vested in the Secretary pertaining to section 4 of the
Comprehensive Drug Abuse Prevention and Control Act of 1970 (84 Stat.
1241) which relate to the determination of the safety and effectiveness
of drugs or to approve new drugs to be used in the treatment of narcotic
addicts.
(9) Functions vested in the Secretary pertaining to section 303(f)
of the Controlled Substances Act (21 U.S.C. 823(f)) which relate to the
determination of the qualifications and competency of practitioners
wishing to conduct research with controlled substances listed in
Schedule I of the Act, and the merits of the research protocol.
(10) Functions vested in the Secretary pertaining to provisions of
the Controlled Substances Act (21 U.S.C. 801 et seq.) which relate to
administration of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.).
(11) Functions vested in the Secretary under section 409(b) of the
Federal Meat Inspection Act (21 U.S.C. 679(b)) which relate to the
detention of any carcass, part thereof, meat, or meat product of cattle,
sheep, swine, goats, or equines.
(12) Functions vested in the Secretary under section 24(b) of the
Poultry Products Inspection Act (21 U.S.C. 467f(b)) which relate to the
detention of any poultry carcass, part thereof, or poultry product.
(13) Functions vested in the Secretary under the Egg Products
Inspection Act (21 U.S.C. 1031 et seq.).
(14) Functions vested in the Secretary by amendments to the
foregoing statutes subsequent to Reorganization Plan No. 1 of 1953.
(15) Function of issuing all regulations of the Food and Drug
Administration, except as provided in Sec. 5.11. The reservation of
authority contained in Chapter 2-000 of the Department Organization
Manual shall not apply.
(16) Functions vested in the Secretary under section 1103 of
Executive Order 11490, as amended by Executive Order 11921, which relate
to emergency health functions as they pertain to the operations and
functional responsibilities assigned to the agency. This authority shall
be exercised in accordance with section 102 and pertinent sections of
part 30 of Executive Order 11490 and guidelines promulgated by the
Federal Preparedness Agency of the General Services Administration;
Office of the Secretary, HHS; and Office of the Assistant Secretary for
Health.
[[Page 29]]
(17) Function vested in the Secretary of authorizing and approving
miscellaneous and emergency expenses of enforcement activities.
(18) Functions vested in the Secretary under the Federal Advisory
Committee Act, Public Law 92-463, to make determinations that advisory
committee meetings are concerned with matters listed in 5 U.S.C. 552(b)
and therefore may be closed to the public for those committees under the
administrative jurisdiction of the Commissioner of Food and Drugs. This
authority may be redelegated to a single official who reports directly
to the Commissioner of Food and Drugs. This authority is to be exercised
in accordance with the requirements of the Federal Advisory Committee
Act and only with respect to the following:
(i) Meetings, to the extent that they directly involve review,
discussion or consideration of records of the Department which are
exempt from disclosure under 5 U.S.C. 552(b) (4), (6), and (7), namely,
(a) records containing trade secrets and commercial or financial
information obtained from a person and privileged or confidential; (b)
personnel, medical and similar files the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy; and (c)
investigatory files compiled for law enforcement purposes;
(ii) Meetings to the extent that they involve the review,
discussion, and evaluation of specific drugs and devices regulated by
FDA which are intended to result in recommendations for regulatory
decisions under the Federal Food, Drug, and Cosmetic Act and which are
concerned with matters listed in 5 U.S.C. 552(b) (4), (5), and (7);
(iii) Meetings held for the sole purpose of considering and
formulating advice which the committee will give or any final report it
will render, Provided:
(a) The meetings will involve solely the internal expression of
views and judgments of the members and it is essential to close the
meeting or portions thereof to protect the free exchange of such views
and avoid undue interference with agency or committee operations, and
such views if reduced to writing would be protected from mandatory
disclosure under 5 U.S.C. 552(b);
(b) The meeting is closed for the shortest time necessary,
summarizing the work of the committee during the closed session, and a
report, prepared by the executive secretary will be made available
promptly to the public.
(c) When feasible, the public is given a timely opportunity to
present relevant information and views to the committee; and
(d) Concurrence for closing the meetings for such purpose is
obtained from the Office of the General Counsel and the Office of Public
Affairs.
(19) Functions vested in the Secretary under the second sentence of
section 310(a) and under section 310(b) (Health Conferences and Health
Education Information) of the Public Health Service Act (42 U.S.C.
242o), as amended, to call for a conference and invite as many health
authorities and officials of State or local public or private agencies
or organizations as deemed necessary or proper on subjects related to
the functions of the Food and Drug Administration, and to issue
information related to health for the use of the public and other
pertinent health information for the use of persons and institutions
concerned with health services when such information is related to the
functions of the Food and Drug Administration.
(20) Functions vested in the Secretary under section 2101 of the
Public Health Service Act (42 U.S.C. 219) as amended, to accept offers
of gifts, excluding the acceptance of gifts of real property. Only the
authority to accept unconditional gifts of personal property valued at
$5,000 or less may be redelegated.
(21) Functions vested in the Secretary under section 362 of the
Public Health Service Act (42 U.S.C. 265), as amended, which relate to
the prohibition of the introduction of foods, drugs, devices, cosmetics,
electronic products, and other items or products regulated by the Food
and Drug Administration into the United States when it is determined
that it is required in the interest of public health when such functions
relate to the law enforcement functions of the Food and Drug
Administration.
[[Page 30]]
(22) Functions vested in the Secretary under section 1003(b)(3),
title X, of the Public Works and Economic Development Act of 1965 (42
U.S.C. 3246b(b)(3)) to waive any matching requirements for programs or
projects of State and local governments funded under title X of that act
where it is determined that State or local governments concerned cannot
reasonably obtain any non-Federal contributions.
(23) Functions vested in the Secretary under section 401(a) of the
Lead-Based Paint Poisoning Prevention Act, as amended by Pub. L. 94-317
(42 U.S.C. 4831(a)) relating to the prohibition of the application of
lead-based paint to cooking, drinking, or eating utensils.
(24) Functions vested in the Secretary for the health information
and health promotion program under title XVII of the Public Health
Service Act (42 U.S.C. 300u et seq.), as amended, insofar as the
authorities pertain to functions assigned to the Food and Drug
Administration. The delegation includes, but is not limited to, the
authorities under: section 1702(a) (1) and (3) and section 1704 (1),
(2), and (6). The delegation excludes the authority to select all Senior
Executive Service, supergrade and equivalent, and Schedule C (GS-12 and
above) positions; promulgate regulations; and submit reports to the
President.
(25) To administer a Small Business Innovation Research Program
under section 9 of the Small Business Act (15 U.S.C. 638), as amended.
The delegation excludes the authority to promulgate regulations,
establish advisory councils and committees, appoint members to advisory
councils and committees, and submit reports to Congress.
(26) Functions vested in the Secretary under sections 982 and 983 of
the Consumer-Patient Radiation Health and Safety Act of 1981 (42 U.S.C.
10007 and 10008), as amended. The delegation excludes the authority to
promulgate regulations and submit reports to Congress. The authority
delegated under section 983 of the Act may only be exercised as it
relates to functions assigned to the Food and Drug Administration.
(27) Functions vested in the Secretary under section 156 of title 35
of the U.S. Code (35 U.S.C. 156), as amended, which allows for the
extension of patent terms for human drug products, medical devices, food
additives, and color additives subject to the Federal Food, Drug, and
Cosmetic Act. These authorities may be redelegated except the authority
to make due diligence determinations under section 156(d)(2)(B), which
may not be redelegated to an Office below the Office of the Commissioner
of Food and Drugs.
(28) Functions vested in the Secretary under section 1862(h) (1),
(2)(A), and (3) of the Social Security Act (42 U.S.C. 1395y (h)(1),
(2)(A), and (3)), as amended, which provides for a registry of all
cardiac pacemaker devices and pacemaker leads for which payment was made
under this title. The approval and issuance of regulations under that
section are reserved to the Secretary, as provided in 21 CFR 5.11.
(29) Functions vested in the Secretary under the Stevenson-Wydler
Technology Innovation Act of 1980 (15 U.S.C. 3701 et seq.) (the Act), as
amended, and under Executive Order No. 12591 of April 10, 1987, as they
pertain to the functions of the Food and Drug Administration. The
delegation excludes the authority to promulgate regulations and submit
reports to Congress; under section 11(a)(2) of the Act (15 U.S.C.
3710a(a)(2)) to approve agreements and contracts with invention
management organizations; and under section 11(c)(3)(B) of the Act (15
U.S.C. 3710a(c)(3)(B)) to propose necessary statutory changes regarding
conflict of interest.
(i) The authorities under sections 11(c)(5) (A) and (B) of the Act
(15 U.S.C. 3710a(c)(5) (A) and (B)) to disapprove or require the
modification of cooperative research and development agreements and
licensing agreements after the agreement is presented to the
Commissioner of Food and Drugs by the head of the laboratory concerned,
and to transmit written explanation of such disapproval or modification
to the head of the laboratory concerned, may be redelegated only to a
senior official in the immediate office of the Commissioner.
(ii) The following authorities may not be redelegated: the authority
under section 11(b)(3) of the Act (15 U.S.C. 3710a(b)(3)) to waive a
right of
[[Page 31]]
ownership which the Federal Government may have to an invention made
under a cooperative research and development agreement; the authority
under section 11(b)(4) of the Act (15 U.S.C. 3710a(b)(4)) to permit
employees or former employees to participate in efforts to commercialize
inventions they made while in the service of the United States; the
authority under section 11(c)(3)(A) of the Act (15 U.S.C.
3710a(c)(3)(A)) to review employee standards of conduct for resolving
potential conflicts of interest; the authority under section 13(a)(1) of
the Act (15 U.S.C. 3710c(a)(1)) to retain any royalties or other income,
except as provided in section 13(a)(2) of the Act (15 U.S.C.
3710c(a)2)); and the authority under section 13(a)(1)(A)(i) of the Act
(15 U.S.C. 3710c(a)(1)(A)(i)) to pay royalties or other income the
agency receives on account of an invention to the inventor if the
inventor was an employee of the agency at the time the invention was
made.
(iii) Any authorities under paragraph (a)(29) of this section
delegated by the Commissioner of Food and Drugs may not be further
redelegated.
(30) Functions vested in the Secretary under sections 4702, 4703,
and 4704 of the Pesticide Monitoring Improvements Act of 1988 (21 U.S.C.
1401-1403) which relate to pesticide monitoring and enforcement
information, foreign pesticide information, and pesticide analytical
methods. The delegation excludes the authority to submit reports to
Congress.
(31) Functions vested in the Secretary under the Government Patent
Policy Act of 1980 as amended by the Federal Court Reorganization Act of
1984, as they pertain to the functions of the Food and Drug
Administration (FDA). The delegated authorities, to be exercised in
compliance with all existing rules and regulations regarding patent and
invention rights and responsibilities, are restricted to the extent that
35 U.S.C. 203, as amended, may not be redelegated and that under 35
U.S.C. 207(a), the Assistant Secretary for Health is to be notified of
any significant invention, patent, or license, so that the Assistant
Secretary for Health may decide whether or not documentation concerning
any such invention, patent, or license should be submitted to the
Assistant Secretary for Health for signature. All other authorities may
be redelegated to officials at the level equivalent to bureau and
institute directors.
(i) Disposition of rights, 35 U.S.C. 202(c)(7), as amended: The
authority to permit a nonprofit organization to assign the rights to a
subject invention in the United States to organizations which do not
have as one of their primary functions the management of inventions.
(ii) Disposition of rights, 35 U.S.C. 202(d), as amended: The
authority to permit a contractor to grant requests for retention of
rights by the inventor.
(iii) Disposition of rights, 35 U.S.C. 202(e), as amended: The
authority to transfer or assign whatever rights FDA may acquire in the
subject invention in any case when an agency employee is a coinventor of
any invention made under a funding agreement with a nonprofit
organization or small business firm. Such rights may be transferred or
assigned from the FDA employee to the contractor subject to the
conditions set forth in this chapter.
(iv) March-in-rights, 35 U.S.C. 203, as amended: The authority to
require the contractor to grant nonexclusive, partially exclusive, or
exclusive licenses to responsible applicant(s), or the authority for FDA
to grant such licenses, provided such action would be in the best
interest of FDA, in accordance with all provisions of this section.
(v) Preference for United States industry, 35 U.S.C. 204, as
amended: The authority to waive the preference for U.S. industry
requirement.
(vi) Domestic and foreign protection of federally owned inventions,
35 U.S.C. 207(a) as amended, the authority to:
(A) Apply for, obtain, and maintain patents or other forms of
protection in the United States and in foreign countries on inventions
in which the Federal Government owns a right, title, or interest;
(B) Grant nonexclusive, exclusive, or partially exclusive licenses
under federally owned patent applications, patents, or other forms of
protection obtained, royalty-free or for royalties or other
consideration, and on such terms and conditions, including the grant to
[[Page 32]]
the licensee of the right of enforcement pursuant to the provisions of
chapter 29 of title 35 as determined appropriate in the public interest;
(C) Undertake all other suitable and necessary steps to protect and
administer rights to federally owned inventions on behalf of the Federal
Government either directly or through contract; and
(D) Transfer custody and administration, in whole or in part, to
another Federal agency, of the right, title, or interest in any
federally owned invention.
(vii) Determination as to domestic rights and notice to employee of
determination, 45 CFR 7.3 and 7.7, as amended, authority to:
(A) Leave title to invention in the FDA employee inventor where the
Government has insufficient interest in an invention to obtain the
entire domestic right, title, and interest therein; and
(B) Notify the FDA employee inventor of the determination in
writing.
(32) Functions vested in the Secretary under sections 2312(a)(1) and
(2)(B), (b), and (c) (Use of Investigational New Drugs with Respect to
Acquired Immunodeficiency Syndrome); 2314(c) (Scientific and Ethical
Guidelines for Certain Treatments); and 2317 (d) and (e) (Information
Services) of title XXIII of the Public Health Service Act (42 U.S.C.
300cc-12(a)(1) and (2)(B), (b) and (c), 300cc-14(c) and 300cc-17 (d) and
(e), as amended, insofar as these authorities pertain to the functions
assigned to the Food and Drug Administration. The delegation excludes
the authority to promulgate regulations, submit reports to the Congress,
establish advisory committees or national commissions, and appoint
members to such committees or commissions.
(33) Functions vested in the Secretary under section 2672(a)(1) (A)
and (B) (Provisions Relating to Blood Banks) and section 2672(a)(2)
(Information and Training Programs) of the Public Health Service Act (42
U.S.C. 300ff et seq.), as amended, insofar as these authorities pertain
to the functions assigned to the Food and Drug Administration. The
delegations exclude the authority to promulgate regulations, submit
reports to the Congress, establish advisory committees or national
commissioners, and appoint members to such committees or commissions.
(34) Functions vested in the Secretary under sections 1322(b) and
(c) of the Food, Agriculture, Conservation, and Trade Act of 1990 (the
National Laboratory Accreditation Program) (7 U.S.C. 138a), as amended
hereafter, which relate to setting standards for the National Laboratory
Accreditation Program and approving State agencies or private, nonprofit
entities as accrediting bodies to implement certification and quality
assurance programs in accordance with the requirements of this section.
The delegation excludes the authority to submit reports to Congress.
(35) Functions vested in the Secretary under part C, subtitle 2 of
title XXI of the Public Health Service Act (42 U.S.C. 300aa-25 et seq.),
as amended, and the National Childhood Vaccine Injury Act of 1986 (42
U.S.C. 300aa-1 note), as amended hereafter, as follows:
(i) Section 2125 of the Public Health Service Act (42 U.S.C. 300aa-
25)--Recording and reporting of information.
(ii) Section 2127 of the Public Health Service Act (42 U.S.C. 300aa-
27)--Mandate for safer childhood vaccines.
(iii) Section 2128 of the Public Health Service Act (42 U.S.C.
300aa-28)--Manufacturer recordkeeping and reporting.
(iv) Section 312 of the National Childhood Vaccine Injury Act of
1986--Related studies.
(v) Section 313 of the National Childhood Vaccine Injury Act of
1986--Study of other vaccine risks.
(vi) Section 314 of the National Childhood Vaccine Injury Act of
1986--Review of warnings, use instructions, and precautionary
information.
(vii) The delegation excludes the authority to issue regulations and
submit reports to Congress.
(36) Functions vested in the Secretary under section 354(b) through
(l) and (n), (o), (q), and (r) of the Public Health Service Act (section
2 of the Mammography Quality Standards Act of 1992 (Pub. L. 102-539)),
as amended, which deal with the certification of mammography facilities.
The delegation excludes the authority to submit reports to Congress.
[[Page 33]]
(37) Functions vested in the Secretary under section 811(h)(4) of
the Controlled Substances Act (Title II of the Comprehensive Drug Abuse
Prevention and Control Act of 1970, as amended) to provide responses to
the Drug Enforcement Administration's temporary scheduling notices. The
delegation excludes the authority to submit reports to Congress.
(b) The Chief Counsel of the Food and Drug Administration, i.e., the
Associate General Counsel in charge of the Food and Drug Division, has
been authorized to report apparent violations to the Department of
Justice for the institution of criminal proceedings, pursuant to section
305 of the Federal Food, Drug, and Cosmetic Act, section 4 of the
Federal Import Milk Act, and section 9(b) of the Federal Caustic Poison
Act.
(c) The Director, Office of Management, Public Health Service, has
redelegated to the Commissioner of Food and Drugs, with authority to
redelegate, the authority to certify true copies of any books, records,
or other documents on file within the Food and Drug Administration or
extracts from such; to certify that true copies are true copies of the
entire file of the Administration; to certify the complete original
record or to certify the nonexistence of records on file within the
Administration; and to cause the Seal of the Department of be affixed to
such certifications and to agreements, awards, citations, diplomas, and
similar documents.
(d) The Executive Officer, Public Health Service, has redelegated to
the Commissioner of Food and Drugs appeal authority to take final action
upon an individual's appeal of a refusal to correct or amend the
individual's record when the appeal has been made by the individual
under Privacy Act regulations (part 21 of this chapter and 45 CFR part
5b). The authority may not be redelegated.
(e) [Reserved]
(f) The Secretary of Health and Human Services has redelegated to
the Commissioner of Food and Drugs, or his designee, the authority to
take final action on matters pertaining to section 203 of the Equal
Access to Justice Act (5 U.S.C. 504), and to develop procedures and
regulations where necessary to supplement the Department's regulations,
45 CFR part 13.
[42 FR 15560, Mar. 22, 1977]
Editorial Note: For Federal Register citations affecting Sec. 5.10,
see the List of CFR Sections Affected in the Finding Aids section of
this volume.
Sec. 5.11 Reservation of authority.
(a) Notwithstanding provisions of Sec. 5.10 or any previous
delegations of authority to the contrary, the Secretary reserves the
authority to approve regulations of the Food and Drug Administration,
except regulations to which sections 556 and 557 of title 5 U.S.C.
apply, which:
(1) Establish procedural rules applicable to a general class of
foods, drugs, cosmetics, medical devices, or other subjects of
regulation; or
(2) Present highly significant public issues involving the quality,
availability, marketability, or cost of one or more foods, drugs,
cosmetics, medical devices, or other subjects of regulation.
(b) Nothing in this section precludes the Secretary from approving a
regulation, or being notified in advance of an action, to which sections
556 and 557 of title 5 U.S.C. apply, which meets one of the criteria in
paragraph (a) of this section.
(c) This reservation of authority is intended only to improve the
internal management of the Department of Health and Human Services, and
is not intended to create any right or benefit, substantive or
procedural, enforceable at law by a party against the United States, the
Department of Health and Human Services, the Food and Drug
Administration, any agency, officer, or employee of the United States,
or any person. Regulations issued by the Food and Drug Administration
without the approval of the Secretary are to be conclusively viewed as
falling outside the scope of this reservation of authority.
[47 FR 16318, Apr. 16, 1982]
[[Page 34]]
Subpart B--Redelegations of Authority from the Commissioner of Food and
Drugs
Sec. 5.20 General redelegations of authority from the Commissioner to other officers of the Food and Drug Administration.
(a) Final authority of the Commissioner of Food and Drugs is
redelegated as set forth in this subpart.
(b) The Deputy Commissioner and the Associate Commissioner for
Regulatory Affairs are authorized to perform all of the functions of the
Commissioner of Food and Drugs.
(c) 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:
(1) Deputy Commissioner.
(2) Associate Commissioner for Regulatory Affairs.
(3) Associate Commissioner for Management and Operations.
For a planned period of absence, the Commissioner may specify a
different order of succession.
(d) Authority delegated to a position by title may be exercised by a
person officially designated to serve in that position in an acting
capacity or on a temporary basis, unless prohibited by a restriction in
the document designating him as ``acting'' or unless not legally
permissible.
(e) The Deputy Commissioner for Operations is authorized to make
determinations that advisory committee meetings are concerned with
matters listed in 5 U.S.C. 552(b) and may be closed to the public in
accordance with Sec. 5.10(a)(18).
(f)(1) The Deputy Commissioner for Policy and the Associate
Commissioner for Policy Coordination are authorized to perform any of
the functions of the Commissioner of Food and Drugs with respect to the
issuance of Federal Register notices and proposed and final regulations
of the Food and Drug Administration.
(2) The Deputy Commissioner for Policy is authorized to issue
responses to the following matters under part 10 of this chapter as
follows:
(i) Requests for waiver, suspension, or modification of procedural
requirements under Sec. 10.19;
(ii) Citizen petitions under Sec. 10.30;
(iii) Petitions for reconsideration under Sec. 10.33;
(iv) Petitions for stay under Sec. 10.35; or
(v) Requests for advisory opinions under Sec. 10.85.
(3) With respect to any matter delegated to the Deputy Commissioner
for Policy under this paragraph, the Deputy Commissioner for Policy is
authorized to perform the functions of the Commissioner under
Secs. 10.40, 10.45, 10.50, 10.55, 10.60, 10.65, 10.80, 10.90, and 10.95
and of the Deputy Commissioner under Sec. 10.206 (g) and (h) of this
chapter.
(g) The following officials are authorized to perform all the
functions of the officials under them in their respective offices:
(1) Deputy Commissioner for Operations.
(2) Deputy Commissioner for Policy.
(3) Deputy Commissioner for External Affairs.
(4) Deputy Commissioner for Management and Systems.
(h) The Chief Mediator and Ombudsman is designated as User Fee
Waiver Officer and is authorized to perform all of the functions of the
Commissioner under the Prescription Drug User Fee Act of 1992 (21 U.S.C.
379h(d)), as amended hereafter, relating to waiver or reduction of user
fees. The User Fee Waiver Officer's authority may be redelegated to the
Deputy, Chief Mediator and Ombudsman, without further redelegation. The
Deputy Commissioner for Operations is designated as User Fee Appeals
Officer and 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.
(i) Authority delegated in the following sections of this subpart
may not be redelegated.
[43 FR 20487, May 12, 1978, as amended at 48 FR 43300, Sept. 23, 1983;
56 FR 36001, July 30, 1991; 57 FR 12875, Apr. 14, 1992; 58 FR 17095,
Apr. 1, 1993; 59 FR 14549, Mar. 29, 1994; 61 FR 2414, Jan. 26, 1996]
Sec. 5.21 Emergency functions.
Each Regional Food and Drug Director is authorized, during any
period
[[Page 35]]
when normal channels of direction are disrupted between the Food and
Drug Administration headquarters and his region, to fully represent the
Food and Drug Administration within his region in consonance with the
Department of Health and Human Services regional emergency plans and to
exercise the authority of the Commissioner for supervision of and
direction to all Food and Drug Administration activities and use of
resources within his region for continuity and for Federal Emergency
Health Service operations. These same officials are authorized to
provide in Regional Emergency Plans for the delegation of Food and Drug
Administration regional authorities to heads of field activities when
such activities are cut off from national and regional headquarters.
Sec. 5.22 Certification of true copies and use of Department seal.
(a) The following officials are authorized to certify true copies of
or extracts from any books, records, papers, or other documents on file
within the Food and Drug Administration, to certify that copies are true
copies of the entire file, to certify the complete original record, or
to certify the nonexistence of records on file within the Food and Drug
Administration, and to cause the seal of the Department to be affixed to
such certifications:
(1) The Deputy Commissioners.
(2) The Associate and Deputy Associate Commissioners.
(3)(i) The Director, Office of Executive Operations.
(ii) The Director, Executive Secretariat.
(iii) The Director, Program Management Staff.
(4) The Executive Assistant to the Commissioner, Office of the
Commissioner.
(5)(i) The Director and Deputy Director, Office of Enforcement,
Office of Regulatory Affairs (ORA).
(ii) The Director and Deputy Director, Office of Regional
Operations, ORA.
(iii) The Director and Deputy Director, Office of Resource
Management, ORA.
(iv) The Director, Division of Management Operations, and Chief,
Administrative Management Branch, Office of Resource Management, ORA.
(v) The Director, FDA History Staff, ORA.
(6)(i) The Director, Division of Management Systems and Policy,
Office of Management (OM).
(ii) The Chief, Dockets Management Branch, Division of Management
Systems and Policy, OM.
(7) The Director, Freedom of Information Staff, Office of Public
Affairs.
(8)(i) The Director and Deputy Directors, Center for Biologics
Evaluation and Research (CBER).
(ii) The Director, Office of Management, CBER.
(iii) The Directors and Deputy Directors of the Office of
Compliance, CBER.
(iv) The Director of Congressional and Public Affairs Staff, Office
of the Center Director, CBER.
(v) The Chief, Surveillance and Policy Branch and Consumer Safety
Officers, Office of Compliance, CBER.
(9)(i) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition (CFSAN).
(ii) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(iii) The Director, Office of Management Systems, CFSAN.
(iv) The Director, Office of Cosmetics and Colors, CFSAN.
(v) The Director, Office of Plant and Dairy Foods Beverages, CFSAN.
(vi) The Director, Office of Seafood, CFSAN.
(vii) The Director, Office of Special Nutritional, CFSAN.
(viii) The Director, Office of Special Research Skills, CFSAN.
(ix) The Director, Office of Constituent Operations, CFSAN.
(x) The Director, Office of Field Programs, CFSAN.
(xi) The Director, Office of Premarket Approval, CFSAN.
(xii) The Director, Office of Scientific Analysis and Support,
CFSAN.
(xiii) The Director, Office of Food Labeling, CFSAN.
(10)(i) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH).
(ii) The Director, Office of Management Services, CDRH.
[[Page 36]]
(iii) The Director and Deputy Director, Office of Compliance, CDRH.
(iv) The Director and Deputy Director, Division of Compliance
Programs, CDRH.
(v) The Director and Deputy Director, Office of Standards and
Regulations, CDRH.
(11)(i) The Director and Deputy Directors, Center for Veterinary
Medicine (CVM).
(ii) The Director and Deputy Director, Office of Management, CVM.
(iii) The Director and Deputy Director, Office of Surveillance and
Compliance, CVM.
(iv) The Director, Division of Compliance, Office of Surveillance
and Compliance, CVM.
(v) The Chief, Case Guidance Branch, Division of Compliance, Office
of Surveillance and Compliance, CVM.
(12)(i) The Director and Deputy Director, National Center for
Toxicological Research (NCTR).
(ii) The Director, Office of Research Support, NCTR.
(13)(i) The Director and Deputy Director, Center for Drug Evaluation
and Research (CDER).
(ii) The Directors and Deputy Directors of the Offices of
Management, Epidemiology and Biostatistics, Compliance, Drug Evaluation
I, Drug Evaluation II, Research Resources, Generic Drugs, and Over-the-
Counter Drug Evaluation, CDER.
(iii) The Chief and Freedom of Information Officers, Freedom of
Information Staff, Office of Management, CDER.
(iv) The Director, Division of Management and Budget, Office of
Management, CDER.
(v) The Directors of the Divisions of Drug Labeling Compliance, Drug
Quality Evaluation, Manufacturing and Product Quality, and Scientific
Investigations, Office of Compliance, CDER.
(14)(i) Regional Food and Drug Directors.
(ii) District Directors.
(iii) The Director, St. Louis Branch.
(iv) The Director, New York Laboratory Division, Northeast Region.
(v) The Director, Southeast Regional Laboratory, Southeast Region.
(vi) The Director, National Forensic Chemistry Center.
(b) The following officials are authorized to cause the seal of the
Department to be affixed to agreements, awards, citations, diplomas, and
similar documents:
(1) Deputy Commissioners.
(2) The Associate and Deputy Associate Commissioners.
(3) The Director, Office of Human Resources Management, Office of
Management.
(c) The Chief, Regulations Editorial Section and his/her alternates,
Regulations Policy and Management Staff, Office of Policy, Office of the
Commissioner are authorized to certify true copies of Federal Register
documents.
[50 FR 4858, Feb. 4, 1985, as amended at 58 FR 17095, Apr. 1, 1993; 60
FR 26826, May 19, 1995; 61 FR 9639, Mar. 11, 1996]
Sec. 5.23 Disclosure of official records.
(a) The following officials are authorized to make determinations to
disclose official records and information under part 20 of this chapter,
except that only the officials listed in paragraph (a)(1) of this
section may disclose official records and information under Secs. 20.82
and 20.85 of this chapter, and only officials listed in paragraph
(a)(10) of this section may disclose information under Sec. 20.89(c) of
this chapter.
(1) Associate and Deputy Associate Commissioners.
(2)(i) The Director, Office of the Executive Assistant.
(ii) The Director, Executive Secretariat.
(iii) The Director, Program Management Staff.
(3) Executive Officer, Office of the Commissioner.
(4) The Chief, Dockets Management Branch, Division of Management
Systems and Policy, Office of Management and Operations.
(5) Program officials at all organizational levels down to and
including branch level for all Headquarters organizations.
(6) Regional Food and Drug Directors and District Directors.
(7) Director, Winchester Engineering and Analytical Center.
(8) Chiefs of branches Field/District Offices and Centers.
[[Page 37]]
(9) Freedom of Information Officers and other employees engaged in
Freedom of Information activities.
(10)(i) The Associate Commissioner for Regulatory Affairs, Deputy
Associate Commissioner for Regulatory Affairs, and Director, Office of
Enforcement, FDA.
(ii) The Director, Deputy Director, and Associate Director for
Policy Coordination and Public Affairs, Center for Biologics Evaluation
and Research (CBER), and Director, Division of Congressional and Public
Affairs, CBER.
(iii) The Director, Deputy Directors, and Associate Director for
Science and Medical Affairs, Center for Drug Evaluation and Research
(CDER).
(iv) The Director and Deputy Director for Regulations and Policy,
Center for Devices and Radiological Health (CDRH).
(v) The Director, Center for Food Safety and Applied Nutrition
(CFSAN), and Deputy Director for Systems and Support, CFSAN.
(vi) The Director and Deputy Director, Center for Veterinary
Medicine (CVM).
(vii) The Director, Deputy Director, and Associate Director for
Scientific Coordination, National Center for Toxicological Research
(NCTR).
(b) The Chief, Drug Listing Branch, Division of Drug Labeling
Compliance, Office of Compliance, Center for Drug Evaluation and
Research (CDER), is authorized to sign affidavits regarding the presence
or absence of records of Registration of Drug Establishments.
(c) The following officials are authorized to sign affidavits
regarding the presence or absence of medical device establishment
registration records:
(1) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH).
(2) The Director and Deputy Director, Office of Compliance and
Surveillance, CDRH.
(3) The Director, Division of Product Surveillance, Office of
Compliance and Surveillance, CDRH.
(4) The Chief, Device Registration and Listing Branch, Division of
Product Surveillance, Office of Compliance and Surveillance, CDRH.
(d) The Chief of the Records Section of the Administrative Services
Branch, Division of Management Services, Office of Management and
Operations, is authorized to sign affidavits regarding the presence or
absence of records in the files of that section.
(e) The Director and Deputy Director, Division of Product
Certification, Office of Biological Product Review, Center for Biologics
Evaluation and Research, are authorized to sign affidavits regarding the
presence or absence of records of registration of blood product
establishments.
[43 FR 29286, July 7, 1978, as amended at 48 FR 56946, Dec. 27, 1983; 49
FR 14932, Apr. 16, 1984; 50 FR 4859, Feb. 4, 1985; 51 FR 11428, Apr. 3,
1986; 54 FR 8315, Feb. 28, 1989; 55 FR 47053, Nov. 9, 1990; 57 FR 40318,
Sept. 3, 1992; 59 FR 37419, July 22, 1994]
Sec. 5.24 Authority relating to technology transfer.
(a) The Associate Commissioner for Regulatory Affairs is authorized
to perform the functions of the Commissioner of Food and Drugs as
requested by the Commissioner regarding the authority to disapprove or
require modification of cooperative research and development agreements
and licensing agreements and transmit written explanation of such
approval or disapproval to the head of the laboratory concerned under
sections 11(c)(5) (A) and (B) of the Stevenson-Wydler Technology
Innovation Act of 1980 (the Act) (15 U.S.C. 3710a(c)(5) (A) and (B)), as
amended.
(b) The following officials are authorized to perform the functions
of the Commissioner of Food and Drugs as requested by the Commissioner
under the Stevenson-Wydler Technology Innovation Act of 1980 (15 U.S.C.
3701 et seq.), as amended, and Executive Order 12591 of April 10, 1987,
except to the extent that redelegation of those functions is
specifically limited in Sec. 5.10(a)(29) of this part, as they pertain
to the functions of their respective organizations, including the
authority to perform the functions of laboratory directors under the Act
as the heads of their respective Federal laboratories, subject to the
discretion of the Commissioner of Food and Drugs to require that
agreements entered into under section 11(a) of the Act (15 U.S.C.
3710a(a)) include provisions in accordance with section
[[Page 38]]
11(c)(5)(A) of the Act (15 U.S.C. 3710a(c)(5)(A):
(1) The Director, Center for Biologics Evaluation and Research.
(2) The Director, Center for Devices and Radiological Health.
(3) The Director, Center for Drug Evaluation and Research.
(4) The Director, Center for Food Safety and Applied Nutrition.
(5) The Director, Center for Veterinary Medicine.
(6) The Director, National Center for Toxicological Research.
(7) The Associate Commissioner for Regulatory Affairs.
[53 FR 26049, July 11, 1988]
Sec. 5.25 Research, investigation, and testing programs and health information and health promotion programs.
(a) The following officials are authorized under sections 301, 307,
311, 1701, 1702, 1703, and 1704 of the Public Health Service Act (the
act) to establish research, investigation, and testing programs and
health information and health promotion programs, which relate to their
assigned functions, and to approve grants for conducting such programs:
(1) The Director and Deputy Director, National Center for
Toxicological Research.
(2) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH).
(3) The Director and Deputy Director, Center for Biologics
Evaluation and Research.
(4) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition.
(5) The Director and Deputy Director, Center for Veterinary
Medicine.
(6) The Director and Deputy Director, Center for Drug Evaluation and
Research.
(7) The Director, Office of Orphan Products Development.
(b) The Director and Deputy Director, CDRH, are authorized to
establish an electronic product radiation control program and to approve
grants for conducting the program under section 356 of the act.
(c) The Associate and Deputy Associate Commissioner for Management
and Operations, the Director and Deputy Director of the Division of
Contracts and Grants Management of the Office of Management and
Operations, the Chief of the State Contracts and Assistance Agreements
Branch, and the Chief of the Grants and Assistance Agreements Section of
that Division and Office are authorized to sign and issue all notices of
grant awards and amendments thereto and sign and issue notices of
suspension and termination thereof for grants approved under the
authority delegated in paragraphs (a) and (b) of this section.
(d) The Director of the National Center for Toxicological Research
is authorized under section 301, as amended by Pub. L. 95--622, of the
Public Health Service Act to make available to educational institutions,
for biomedical and behavioral research, laboratory animals bred for
research purposes of the Center which are not required to support Center
research programs.
[45 FR 7783, Feb. 5, 1980, as amended at 45 FR 27924, Apr. 25, 1980; 46
FR 17758, Mar. 20, 1981; 48 FR 56946, Dec. 27, 1983; 49 FR 14932, 14936,
Apr. 16, 1984; 50 FR 4859, Feb. 4, 1985; 54 FR 8316, Feb. 28, 1989; 57
FR 45295, Oct. 1, 1992; 59 FR 42491, Aug. 18, 1994]
Sec. 5.26 Service fellowships.
Under authority of sections 207(g) and 208(f) of the Public Health
Service Act (42 U.S.C. 209(g) and 210(f)), and within the limits of an
approved service fellowship plan, the following officials are authorized
to designate persons to receive service fellowships, appoint service
fellows, and determine specific stipend rates for individual actions
within the ranges established under an approved service fellowship plan:
(a) Deputy Commissioners.
(b) The Director and Deputy Director, National Center for
Toxicological Research (NCTR), and the Director, Office of Management,
NCTR.
(c) The Director, Center for Devices and Radiological Health (CDRH),
the Deputy Director for Science, CDRH, the Deputy Director for
Regulations and Policy, CDRH, and the Director, Office of Management
Services, CDRH.
(d) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER), the Associate
[[Page 39]]
Director for Research, CBER, and Office Directors.
(e) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition (CFSAN), and Director, Office of Management Systems,
CFSAN.
(f) The Director and Deputy Director, Center for Veterinary Medicine
(CVM), and the Director, Office of Management, CVM.
(g) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER), and the Director and Deputy Director, Office of
Management, CDER.
(h) The Director, Office of Resource Management, Office of
Regulatory Affairs.
(i) The Director, Office of Human Resources Management, Office of
Management and Systems.
[48 FR 56946, Dec. 27, 1983, as amended at 49 FR 14932, 14936, Apr. 16,
1984; 50 FR 4859, Feb. 4, 1985; 54 FR 8316, Feb. 28, 1989; 59 FR 5317,
Feb. 4, 1994; 59 FR 42491, Aug. 18, 1994]
Sec. 5.27 Patent term extensions for human drug products, medical devices, and food and color additives.
The Associate Commissioner for Health Affairs is authorized to
perform the functions delegated to the Commissioner under section 156 of
title 35 U.S. Code (35 U.S.C. 156), except for the holding of informal
hearings pursuant to 35 U.S.C. 156(d)(2)(B)(ii).
[50 FR 9424, Mar. 8, 1985]
Sec. 5.28 Cardiac pacemaker devices and pacemaker leads.
The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH), are authorized to perform all the functions
of the Commissioner of Food and Drugs with regard to a registry of all
cardiac pacemaker devices and pacemaker leads for which payment was made
under the Social Security Act (42 U.S.C. 1395y(h)(1), (2)(A), and (3)),
as amended.
[51 FR 25883, July 17, 1986]
Sec. 5.29 Functions pertaining to safer vaccines.
The Director, Center for Biologics Evaluation and Research (CBER),
and the Associate Director for Policy Coordination and Public Affairs,
CBER, are authorized to perform the functions of the Commissioner of
Food and Drugs under part C, subtitle 2 of title XXI of the Public
Health Service Act (42 U.S.C. 300aa-25 et seq.), as amended, and the
National Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1 note),
as amended hereafter, as follows:
(a) Section 2125 of the Public Health Service Act (42 U.S.C. 300aa-
25)--Recording and reporting of information.
(b) Section 2127 of the Public Health Service Act (42 U.S.C. 300aa-
27)--Mandate for safer childhood vaccines.
(c) Section 2128 of the Public Health Service Act (42 U.S.C. 300aa-
28)--Manufacturer recordkeeping and reporting.
(d) Section 312 of the National Childhood Vaccine Injury Act of
1986--Related studies, except that the authority to provide for notice
and opportunity for public hearing on the review of vaccines and related
illnesses and conditions under sections 312(a) and 312(d) of the
National Childhood Vaccine Injury Act of 1986 is not redelegated by the
Commissioner.
(e) Section 313 of the National Childhood Vaccine Injury Act of
1986--Study of other vaccine risks, except that the authority to provide
for notice and opportunity for public hearing on the establishment of
guidelines regarding the risks to children of certain vaccines under
section 313(a)(1)(B) and (b) of the National Childhood Vaccine Injury
Act of 1986 is not redelegated by the Commissioner.
(f) Section 314 of the National Childhood Vaccine Injury Act of
1986--Review of warnings, use instructions, and precautionary
information.
[58 FR 17106, Apr. 1, 1993]
Sec. 5.30 Hearings.
(a) The following officials are authorized to designate officials to
hold informal hearings that relate to their assigned functions under
sections 305, 404(b), and 801(a) of the Federal Food, Drug, and Cosmetic
Act; section 6 of the Fair Packaging and Labeling Act; section 9(b) of
the Federal Caustic Poison Act; and section 5 of the Federal Import Milk
Act. Officials so designated are delegated authority vested in the
Secretary of Agriculture by 7 U.S.C. 2217 (43 Stat. 803) to administer
[[Page 40]]
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 Directors, Center for Food Safety and
Applied Nutrition (CFSAN), and the Director, Office of Policy, Planning,
and Strategic Initiatives, CFSAN.
(2) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER), and the Directors and Deputy Directors of the Offices
of Drug Evaluation I, Drug Evaluation II, and Compliance, CDER.
(3) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH).
(4) The Director and Deputy Director, Center for Veterinary Medicine
(CVM).
(5) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER), and the Directors and Deputy Directors
of the Offices of Biological Product Review, Biologics Research, and
Compliance, CBER.
(6) Regional Food and Drug Directors.
(7) District Directors.
(8) The Director, St. Louis Branch.
(b) The Director and Deputy Director, CDRH, are authorized to hold
hearings, and to designate other officials to hold informal hearings,
under section 360(a) of the Public Health Service Act.
(c) The following officials are authorized to serve as the presiding
officer, and to designate other Food and Drug Administration employees
to serve as the presiding officer, at a regulatory hearing and to
conduct such a hearing pursuant to the provisions of part 16 of this
chapter. An official can serve as the presiding officer in a particular
hearing only if he or she satisfies the requirements of Sec. 16.42(b) of
this chapter with respect to the action that is the subject of the
hearing. Such officials are delegated authority vested in the Secretary
of Agriculture by 7 U.S.C. 2217 (43 Stat. 803) to administer or to take
from any person an oath, affirmation, or deposition for use in any
prosecution or proceeding under, or in enforcement of, any law as cited
in this part:
(1) The Associate Commissioner for Health Affairs.
(2) The Director and Deputy Directors, CFSAN.
(3) The Director and Deputy Director, CDER, and the Directors and
Deputy Directors of the Offices of Drug Evaluation I, Drug Evaluation
II, and Compliance.
(4) The Director and Deputy Director, CDRH.
(5) The Director and Deputy Director, CVM.
(6) The Director and Deputy Director, CBER, and the Directors and
Deputy Directors of the Offices of Biological Product Review, Biologics
Research, and Compliance, CBER.
(7) Regional Food and Drug Directors.
(8) District Directors.
(9) The Director, St. Louis Branch.
(10) Such other FDA official as is designated by the Commissioner by
memorandum in the proceeding.
[48 FR 8440, Mar. 1, 1983, as amended at 48 FR 56946, Dec. 27, 1983; 49
FR 14932, 14936, Apr. 16, 1984; 51 FR 32452, Sept. 12, 1986; 54 FR 8316,
Feb. 28, 1989; 54 FR 9034, Mar. 3, 1989; 59 FR 42491, Aug. 18, 1994]
Sec. 5.31 Petitions under part 10.
(a) For drugs assigned to their organizations, the following
officials are authorized to grant or deny citizen petitions submitted
under Sec. 10.30 of this chapter for a stay of an effective date in
Sec. 201.59 of this chapter for compliance with certain labeling
requirements for human prescription drugs.
(1)(i) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER).
(ii) The Directors and Deputy Directors of the Offices of Biological
Product Review and Biologics Research, CBER.
(iii) The Directors and Deputy Directors of the divisions in the
Offices of Biological Product Review and Biologics Research, CBER.
(2)(i) The Director and Deputy Director, Center for Drug Evaluation
and Research (CDER).
(ii) The Directors and Deputy Directors of the Offices of Drug
Evaluation I and Drug Evaluation II, CDER.
(iii) The Directors and Deputy Directors of the divisions in the
Offices of Drug Evaluation I and Drug Evaluation II, CDER.
[[Page 41]]
(iv) The Director and supervisory consumer safety officers, Pilot
Drug Evaluation Staff, Office of the Center Director, CDER.
(b) The following officials are authorized to grant or deny citizen
petitions submitted under Sec. 10.30 of this chapter requesting in vitro
test modifications under Sec. 331.29 of this chapter:
(1) The Director and Deputy Director, CDER.
(2) The Director and Deputy Director, Office of Drug Standards,
CDER.
(3) The Director and Deputy Director, Division of OTC Drug
Evaluation, Office of Drug Standards, CDER.
(c) The following officials are authorized to grant or deny citizen
petitions submitted under Sec. 10.30 of this chapter for a stay of an
effective date or for an exemption from the tamper-resistant packaging
and labeling requirements set forth in Sec. 211.132, Sec. 700.25, or
Sec. 800.12 of this chapter for certain over-the-counter human drug and
cosmetic products and medical devices which relate to the assigned
functions of the respective organizations:
(1) The Director and Deputy Director, CDER, and the Director and
Deputy Director, Office of Compliance, CDER.
(2) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition (CFSAN), and the Director, Office of Policy, Planning,
and Strategic Initiatives, CFSAN.
(3) The Director and Deputy Director, Center for Devices and
Radiological Health.
(d) The following officials are authorized to grant or deny citizen
petitions submitted under Sec. 10.30 of this chapter requesting
exemption from the general pregnancy-nursing warning for over-the-
counter (OTC) drugs required under Sec. 201.63 of this chapter,
requesting exemption from a general overdose warning required under
Sec. 330.1(g) of this chapter, and requesting exemption from OTC drug
administrative procedures under Sec. 330.10 of this chapter:
(1) The Director and Deputy Director, CDER.
(2) The Director and Deputy Director, Office of OTC Drug Evaluation,
CDER.
(e)(1) The following officials are authorized to issue 180-day
tentative responses to citizen petitions on food and cosmetic matters
under Sec. 10.30(e)(2)(iii) of this chapter that relate to the assigned
functions of that Center:
(i) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition (CFSAN).
(ii) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(iii) The Director, Office of Cosmetics and Colors, CFSAN.
(iv) The Director, Office of Food Labeling, CFSAN.
(v) The Director, Office of Premarket Approval, CFSAN.
(vi) The Director, Office of Plant and Dairy Foods and Beverages,
CFSAN.
(vii) The Director, Office of Seafood, CFSAN.
(viii) The Director, Office of Special Nutritionals, CFSAN.
(2) The Director and Deputy Director, Center for Veterinary Medicine
(CVM), are authorized to issue 180-day tentative responses to citizen
petitions on animal food and drug matters under Sec. 10.30(e)(2)(iii) of
this chapter that relate to the assigned functions of that Center.
(3) The Director and Deputy Director, CBER, are authorized to issue
180-day tentative responses to citizen petitions on biological product
matters under Sec. 10.30(e)(2)(iii) of this chapter that relate to the
assigned functions of that Center.
(4) The Director and Deputy Director, CDER, are authorized to issue
180-day tentative responses to citizen petitions on drug product matters
under Sec. 10.30(e)(2)(iii) of this chapter that relate to the assigned
functions of that Center.
(5) The Director and Deputy Director, CDRH, are authorized to issue
180-day tentative responses to citizen petitions on medical device
matters under Sec. 10.30(e)(2)(iii) of this chapter that relate to the
assigned functions of that Center.
(f)(1) The Director and Deputy Director, CBER, are authorized to
grant or deny citizen petitions submitted under Sec. 10.30 of this
chapter on drug and biological product matters in program areas where
they have been delegated final approval authority in the following
sections of this part:
(i) Section 5.68 Issuance and revocation of licenses for the
propagation or
[[Page 42]]
manufacture and preparation of biological products;
(ii) Section 5.69 Notification of release for distribution of
biological products;
(iii) Section 5.71 Termination of exemptions for new drugs for
investigational use in human beings or in animals;
(iv) Section 5.80 Approval of new drug applications and their
supplements; and
(v) Section 5.82 Issuance of notices relating to proposals to refuse
approval or to withdraw approval of new drug applications and their
supplements.
(vi) Section 5.99 Issuance of notices relating to proposals and
orders for debarment and denial of an application to terminate
debarment.
(2) The Director and Deputy Director, CDER, are authorized to grant
or deny citizen petitions submitted under Sec. 10.30 of this chapter on
drug product matters in program areas where they have been delegated
final approval authority in the following sections of this part:
(i) Section 5.70 Issuance of notices implementing the provisions of
the Drug Amendments of 1962 (DESI);
(ii) Section 5.71 Termination of exemptions for new drugs for
investigational use in human beings or in animals;
(iii) Section 5.73 Certification of insulin;
(iv) Section 5.74 Issuance, amendment, or repeal of regulations
pertaining to drugs containing insulin;
(v) Section 5.75 Designation of official master and working
standards for antibiotic drugs;
(vi) Section 5.76 Certification of antibiotic drugs;
(vii) Section 5.78 Issuance, amendment, or repeal of regulations
pertaining to antibiotic drugs;
(viii) Section 5.80 Approval of new drug applications and their
supplements; and
(ix) Section 5.82 Issuance of notices relating to proposals to
refuse approval or to withdraw approval of new drug applications and
their supplements.
(x) Section 5.99 Issuance of notices relating to proposals and
orders for debarment and denial of an application to terminate
debarment.
(3) The Director and Deputy Director (Bioequivalence), Office of
Generic Drugs, CDER, except for those drug products listed in
Sec. 314.440(b) of this chapter, are authorized to issue responses to
citizen petitions submitted under Sec. 10.30 of this chapter seeking a
determination of the suitability of an abbreviated new drug application
for a drug product.
(4) The Director and Deputy Director, Office of Biological Product
Review, CBER, for those drug products listed in Sec. 314.440(b) of this
chapter, are authorized to issue responses to citizen petitions
submitted under Sec. 10.30 of this chapter seeking a determination of
the suitability of an abbreviated new drug application for a drug
product.
(5) For drugs assigned to their organization, the following
officials are authorized to issue responses to citizen petitions
submitted under Sec. 10.30 of this chapter from sponsors of an
investigational new drug application who request approval to ship in
interstate commerce, in accordance with Sec. 2.125(j) of this chapter,
an investigational new drug for human use containing a
chlorofluorocarbon.
(i) The Director and Deputy Director, CBER.
(ii) The Director and Deputy Director, 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 of this chapter
concerning actions they are authorized to take under Sec. 5.99 Issuance
of notices relating to proposals and orders for debarment and denial of
an application to terminate debarment.
(g) The Director and Deputy Directors, CDRH, and the Director,
Office of Compliance, CDRH, are authorized to grant or deny citizen
petitions
[[Page 43]]
submitted under Secs. 10.30 and 821.2(b) of this chapter, requesting an
exemption or variance from medical device tracking requirements in part
821 of this chapter.
[47 FR 38480, Aug. 31, 1982]
Editorial Note: For Federal Register citations affecting Sec. 5.31,
see the List of CFR Sections Affected in the Finding Aids section of
this volume.
Sec. 5.32 Authority relating to determination of product primary jurisdiction.
The FDA ombudsman as product jurisdiction officer is authorized to
determine whether the Center for Biologics Evaluation and Research
(CBER), the Center for Devices and Radiological Health (CDRH), or the
Center for Drug Evaluation and Research (CDER) has primary
responsibility for premarket review and regulation of a product that
constitutes a combination of a drug, device, or biological product under
section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act or that is
a drug, device or biologic product where the center with primary
jurisdiction is unclear or in dispute.
[56 FR 58758, Nov. 21, 1991]
Sec. 5.33 Premarket approval of a product that is or contains a biologic, a device, or a drug.
For a product that is or contains a biologic, a device, or a drug,
the following officials in the Center for Biologics Evaluation and
Research, Center for Devices and Radiological Health, or Center for Drug
Evaluation and Research who currently hold delegated premarket approval
authority for biologics, devices, or drugs, respectively, are hereby
delegated all the authorities necessary for premarket approval of any
product that is a biologic, a device, or a drug, or any combination of
two or more of these products:
(a) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER) and the Director, Office of Biological
Product Review, CBER.
(b) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH) and the Director, Office of Device
Evaluation, CDRH.
(c) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER); the Director, Pilot Drug Evaluation Staff, CDER; and
the Directors of the Offices of Drug Evaluation I and Drug Evaluation
II, CDER.
[56 FR 58759, Nov. 21, 1991]
Sec. 5.34 Authority to select temporary voting members for advisory committees and authority to sign conflict of interest waivers.
(a) Each center director is authorized to select members of, and
consultants to, scientific and technical FDA advisory committees under
that center's management to serve temporarily as voting members on
another advisory committee under that center's management when expertise
is required that is 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 or his designee.
(b) Each center director is authorized, under 18 U.S.C. 208(b)(1),
to sign conflict of interest waivers for special government employees
without substantial interest to serve as consultants to advisory
committees or in any other capacity within the centers except as
advisory committee members.
[58 FR 39142, July 22, 1993]
Sec. 5.35 Enforcement activities.
(a) Designated officers and employees of the Food and Drug
Administration who have been issued the Food and Drug Administration
official credentials consisting of Form FDA-200A, Identification Record,
and Form FDA-200B, Specification of General Authority, are authorized:
[[Page 44]]
(1) To conduct examinations, inspections, and investigations; to
collect and obtain samples; to have access to and to copy and verify
records as authorized by law; to make seizures of items under section
702(e)(5) of the Federal Food, Drug, and Cosmetic Act (the act); and to
supervise compliance operations for the enforcement of the act, the Fair
Packaging and Labeling Act, the Federal Caustic Poison Act, the Import
Milk Act, the Filled Milk Act, the Tea Importation Act, and sections 351
and 354 through 361 of the Public Health Service Act.
(2) To administer oaths and affirmations under section 1 of the act
of January 31, 1925 (Ch. 124, 43 Stat. 803); sections 12 to 15 of
Reorganization Plan No. IV, effective June 30, 1940; and Reorganization
Plan No. 1 of 1953, effective April 11, 1953.
(b) Any officer or employee of the Food and Drug Administration who
has been designated by the Commissioner to conduct examinations,
investigations, or inspections under the act relating to counterfeit
drugs and issued the Food and Drug Administration Official Credential
consisting of Form FDA-200D, Special Authority for Criminal
Investigators, is authorized to do the following:
(1) As set forth under section 702(e)(1) through (e)(5) of the act:
(i) Carry firearms;
(ii) Serve and execute search warrants and arrest warrants;
(iii) Execute seizure by process issued pursuant to libel under
section 304 of the act;
(iv) Make arrests without warrant for an offense under the act with
respect to counterfeit drugs if the offense is committed in the presence
of the criminal investigator or, in the case of a felony, if the
investigator has probable cause to believe that the person so arrested
has committed, or is committing, such offense; and
(v) Make, prior to the institution of libel proceedings under
section 304(a)(2) of the act, seizures of drugs or containers or of
equipment, punches, dies, plates, stones, labeling, or other things, if
they are, or the criminal investigator has reasonable grounds to believe
that they are, subject to seizure and condemnation under section
304(a)(2) of the act.
(2) Perform such other functions under the act, or any other law, as
the Commissioner of Food and Drugs may prescribe.
(3) To administer oaths and affirmations under section 1 of the act
of January 31, 1925 (Ch. 124, 43 Stat. 803); sections 12 to 15 of
Reorganization Plan No. IV, effective June 30, 1940; and Reorganization
Plan No. 1 of 1953, effective April 11, 1953.
(c) Any officer or employee of the Food and Drug Administration who
has been designated by the Commissioner to provide specialized law
enforcement support involving criminal investigations under the Federal
Food, Drug, and Cosmetic Act (the act), and other duties as assigned by
the Commissioner, and issued the Food and Drug Administration Official
Credential consisting of Form FDA-200E, Special Authority for Criminal
Investigative Specialists, is authorized to receive information as to
all matters relating to such act and regulations promulgated under the
act.
(d) The Food and Drug Administration's official credentials referred
to in paragraphs (a), (b), and (c) of this section are described as
follows:
(1) Form FDA-200A entitled ``Identification Record'' bears a color
photograph, a description, and the signature of the holder, an
identification number, an expiration date, the Department of Health and
Human Services' seal with blue imprint, on the left of the photograph,
and the Food and Drug Administration's symbol, on the right of the
photograph.
(2) Form FDA-200B entitled ``Specification of General Authority''
bears the holder's name, his or her general authority, an identification
number, an expiration date, the Commissioner's signature, the names of
the Department of Health and Human Services, the Public Health Service,
and the Food and Drug Administration. The form is superimposed with the
Department's seal with blue imprint.
(3) Form FDA-200D, entitled ``Special Authority for Criminal
Investigators,'' is in two parts and bears the holder's name, a color
photograph, the signature of the holder, his or her special
[[Page 45]]
authority under 21 U.S.C. 334 and 372 and other duties as assigned by
the Commissioner, an identification number, the Commissioner's or his
designee's signature, the names of the Department of Health and Human
Services, the Public Health Service, and the Food and Drug
Administration. Part 1 of the form is superimposed with the symbol FDA
with blue imprint, and part 2 is superimposed with the FDA criminal
investigator's badge with blue imprint.
(4) Form FDA-200E, entitled ``Special Authority for Criminal
Investigative Specialists,'' is in two parts and bears the holder's
name, a color photograph, the signature of the holder, his or her
special authority under the act, and other duties under the law, as
assigned by the Commissioner, an identification number, the
Commissioner's or his designee's signature, the names of the Department
of Health and Human Services, the Public Health Service, and the Food
and Drug Administration. Part 1 of the form is superimposed with the
symbol FDA with blue imprint, and part 2 is superimposed with the FDA
criminal investigative specialist's badge with blue imprint.
[49 FR 19973, May 11, 1984, as amended at 53 FR 22293, June 15, 1988; 56
FR 23788, May 24, 1991; 58 FR 494, Jan. 6, 1993; 58 FR 42496, Aug. 10,
1993; 59 FR 47799, Sept. 19, 1994]
Sec. 5.36 Certification following inspections.
Regional Food and Drug Directors and District Directors are
authorized to issue certificates of sanitation under Sec. 1240.20 of
this chapter.
[60 FR 15871, Mar. 28, 1995]
Sec. 5.37 Issuance of reports of minor violations.
(a) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs under section 309 of the
Federal Food, Drug, and Cosmetic Act regarding the issuance of written
notices or warnings:
(1)(i) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER).
(ii) The Director and Deputy Director, Office of Compliance, CBER.
(2)(i) The Director and Deputy Director of the Center for Devices
and Radiological Health (CDRH).
(ii) The Director and Deputy Director, Office of Compliance and
Surveillance, CDRH.
(iii) The Director and Deputy Director, Division of Compliance
Operations, Office of Compliance and Surveillance, CDRH.
(iv) The Director, Division of Product Surveillance, Office of
Compliance and Surveillance, CDRH.
(3)(i) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition, (CFSAN).
(ii) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(iii) The Director, Office of Field Programs, CFSAN.
(iv) The Director, Division of Enforcement, Office of Field
Programs, CFSAN.
(4)(i) The Director and Deputy Director, Center for Veterinary
Medicine (CVM).
(ii) The Director and Deputy Director, Office of Surveillance and
Compliance, CVM.
(iii) The Director, Division of Compliance, Office of Surveillance
and Compliance, CVM.
(5)(i) The Director and Deputy Director, Center for Drug Evaluation
and Resarch (CDER).
(ii) The Director and Deputy Director, Office of Compliance, CDER.
(6)(i) Regional Food and Drug Directors.
(ii) District Directors.
(iii) Chiefs of District Compliance Branches.
(iv) The Director, St. Louis Branch.
(v) The Director, Northeast Regional Laboratory, Northeast Region.
(vi) The Director, Southeast Regional Laboratory, Southeast Region.
(vii) The Director, Winchester Engineering and Analytical Center.
(viii) The Director, National Forensic Chemistry Center.
(b) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs under section 539(d) of
the Federal Food, Drug, and Cosmetic Act regarding the issuance of
written notices or warnings:
[[Page 46]]
(1) The Director and Deputy Director of the Center for Devices and
Radiological Health (CDRH).
(2) The Director and Deputy Director, Office of Compliance and
Surveillance, CDRH.
(3) Director, Division of Compliance Operations, Office of
Compliance and Surveillance, CDRH.
(4) The Director, Division of Standards Enforcement, Office of
Compliance and Surveillance, CDRH.
(5) Regional Food and Drug Directors; District Directors; the
Director, St. Louis Branch; the Director, Northeast Regional Laboratory,
Northeast Region; the Director, Southeast Regional Laboratory, Southeast
Region; the Director, Winchester Engineering and Analytical Center; and
the Director, National Forensic Chemistry Center, when such functions
relate to:
(i) Assemblers of diagnostic x-ray systems, as defined in
Sec. 1020.30(b) of this chapter; and
(ii) Manufacturers of sunlamp products and ultraviolet lamps
intended for use in any sunlamp product as defined in Sec. 1040.20(b) of
this chapter.
[48 FR 8441, Mar. 1, 1983, as amended at 48 FR 56946, Dec. 27, 1983; 49
FR 14933, 14936, Apr. 16, 1984; 51 FR 32452, Sept. 12, 1986; 54 FR 8317,
Feb. 28, 1989; 55 FR 47053, Nov. 9, 1990; 57 FR 40318, Sept. 3, 1992; 59
FR 42491, Aug. 18, 1994; 60 FR 15871, Mar. 28, 1995]
Sec. 5.38 Issuance of written notices concerning patent information, current good manufacturing practices and false or misleading labeling of new drugs, new
animal drugs, and feeds bearing or containing new animal
drugs.
(a) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs under section 505(e) of
the Federal Food, Drug, and Cosmetic Act (the act) regarding the
issuance of written notices.
(1) The Director and Deputy Director, 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 Drug Labeling
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 Drug Quality
Evaluation, Office of Compliance, CDER.
(6) The Director and Deputy Director, Division of Scientific
Investigations, Office of Compliance, CDER.
(7) Regional Food and Drug Directors.
(8) District Directors.
(b) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs under sections 512(e)
and 512 (m)(4)(B)(ii) and (m)(4)(B)(iii) of the act regarding the
issuance of written notices.
(1) The Director and Deputy Director, Center for Veterinary Medicine
(CVM).
(2) The Director and Deputy Director, Office of Surveillance and
Compliance, CVM.
(3) The Director, Division of Compliance, Office of Surveillance and
Compliance, CVM.
(4) Regional Food and Drug Directors.
(5) District Directors.
[57 FR 18823, May 1, 1992]
Sec. 5.39 Redelegation of the Center for Biologics Evaluation and Research Director's program authorities.
The following officials are authorized to perform all the functions
of the Director, Center for Biologics Evaluation and Research (CBER)
with regard to program authorities for their respective areas:
(a) Associate Directors, CBER.
(b) Office Directors, CBER.
(c) Division Directors, CBER.
[58 FR 18346, Apr. 9, 1993]
Sec. 5.44 Export of unapproved drugs.
(a) The following officials are authorized, under section 802(b) of
the Federal Food, Drug, and Cosmetic Act, to approve or disapprove
applications to export unapproved new drugs and biological products and
to issue notices of receipt of such applications:
(1) For human drugs assigned to their respective organizations:
(i) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER).
(ii) The Director and Deputy Director, Office of Compliance, CBER.
[[Page 47]]
(iii) The Director and Deputy Director, Center for Drug Evaluation
and Research (CDER).
(iv) The Director and Deputy Director, Office of Compliance, CDER.
(2) For new animal drugs assigned to their respective organizations:
(i) The Director and Deputy Director, Center for Veterinary Medicine
(CVM).
(ii) The Director and Deputy Director, Office of New Animal Drug
Evaluation, CVM.
(b) The following officials are authorized, under section 802(f) of
the Federal Food, Drug, and Cosmetic Act, to approve or disapprove an
application to export a drug (including a biological product) to be used
in the prevention or treatment of a tropical disease:
(1) For human drugs assigned to their respective organizations:
(i) The Director and Deputy Director, CBER.
(ii) The Director and Deputy Director, Office of Compliance, CBER.
(iii) The Director and Deputy Director, CDER.
(iv) The Director and Deputy Director, Office of Compliance, CDER.
(2) For veterinary drugs subject to their jurisdiction:
(i) The Director and Deputy Director, CVM.
(ii) The Director and Deputy Director, Office of New Animal Drug
Evaluation, CVM.
(c) The following officials are authorized, under section 351(h) of
the Public Health Service Act, to approve or disapprove an application
to export a partially processed biological product:
(1) The Director and Deputy Director, CBER.
(2) The Director and Deputy Director, Office of Compliance, CBER.
[52 FR 7269, Mar. 10, 1987, as amended at 54 FR 8317, Feb. 28, 1989]
Sec. 5.45 Imports and exports.
(a) The Regional Food and Drug Directors, District Directors, and
the Director, St. Louis Branch, are authorized, under section 801 of the
Federal Food, Drug, and Cosmetic Act (FFDCA), to perform the following
functions or to designate officials to:
(1) Request from the Secretary of the Treasury samples of food,
drugs (including biological products), devices, or cosmetics imported or
offered for import.
(2) Determine whether such articles are in compliance with the
FFDCA.
(3) Authorize relabeling or other compliance actions to bring
articles into compliance under the FFDCA.
(4) Supervise such compliance actions.
(b) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH); the Director and Deputy Director, Office of
Compliance and Surveillance, CDRH; Regional Food and Drug Directors;
District Directors; and the Director, St. Louis Branch, are authorized,
under section 360 of the Public Health Service Act (PHSA), to perform
the following functions or to designate officials to:
(1) Request from the Secretary of the Treasury samples of electronic
products imported or offered for import to determine whether such
products are in compliance with the PHSA.
(2) Refuse admission of noncomplying products and notify the
Secretary of the Treasury of such refusal.
(3) Supervise operations to bring noncomplying products into
compliance under the PHSA.
(4) Refuse or grant permission and time extensions to bring
noncomplying products into compliance with the PHSA in accordance with a
corrective action plan approved by the Director, Office of Compliance
and Surveillance, CDRH.
(c) The following officials are authorized, under section 360B(b) of
the PHSA, to exempt persons from issuing a certification, as required by
section 358(h) of the PHSA, for electronic products imported into the
United States for testing, evaluation, demonstrations, or training,
which will not be introduced into commerce and upon completion of their
function will be destroyed or exported in accord with U.S. Customs
Service's regulations:
(1) The Director and Deputy Director, CDRH.
(2) The Director and Deputy Director, Office of Compliance and
Surveillance, CDRH.
(3) Regional Food and Drug Directors.
(4) District Directors.
(5) The Director, St. Louis Branch.
[[Page 48]]
(d) The Regional Food and Drug Directors, District Directors, and
the Director, St. Louis Branch, are authorized to exercise all of the
functions of the Commissioner of Food and Drugs under section 362 of the
PHSA that refers to the prohibition of the introduction of foods, drugs,
devices, cosmetics, and electronic products and other items or products
regulated by the Food and Drug Administration into the United States
when it is determined that it is required in the interest of public
health, and such functions relate to the law enforcement functions of
the Food and Drug Administration.
(e) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs pertaining to
exportation of medical devices under section 801(e) of the FFDCA:
(1) For medical devices assigned to their respective organization:
(i) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH).
(ii) The Director and Deputy Director, Office of Compliance and
Surveillance, CDRH.
(iii) The Director and Deputy Director, Division of Compliance
Operations, Office of Compliance and Surveillance, CDRH.
(iv) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER).
(v) The Director and Deputy Director, Office of Compliance, 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 of Food and Drugs, for drugs under their
jurisdiction, pertaining to authorizing the reimportation of
prescription drugs under section 801(d)(2) of the FFDCA for emergency
medical care:
(1) The Director, Center for Biologics Evaluation and Research
(CBER) and the Director, Office of Compliance, CBER.
(2) The Director, Center for Drug Evaluation and Research (CDER) and
the Director, Office of Compliance, CDER.
[48 FR 8441, Mar. 1, 1983, as amended at 48 FR 56946, Dec. 27, 1983; 49
FR 572, Jan. 5, 1984; 49 FR 14933, Apr. 16, 1984; 51 FR 32452, Sept. 12,
1986; 54 FR 6518, Feb. 13, 1989; 54 FR 8317, Feb. 28, 1989; 54 FR 9034,
Mar. 3, 1989; 55 FR 47053, Nov. 9, 1990; 57 FR 40318, Sept. 3, 1992]
Sec. 5.46 Manufacturer's resident import agents.
The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH) and the Director and Deputy Director, Office
of Compliance and Surveillance, CDRH, are authorized to reject
manufacturer's designations of import agents under Sec. 1005.25(b) of
this chapter.
[55 FR 47053, Nov. 9, 1990]
Sec. 5.47 Detention of adulterated or misbranded medical devices.
The following officials are authorized to perform all the functions
of the Commissioner of Food and Drugs pertaining to detention, under
section 304(g) of the Federal Food, Drug, and Cosmetic Act and in
accordance with Sec. 800.55 of this chapter, of medical devices that may
be adulterated or misbranded:
(a) For medical devices assigned to their respective organizations:
(1) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH).
(2) The Director and Deputy Director, Office of Compliance and
Surveillance, CDRH.
(3) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER).
(4) The Director and Deputy Director, Office of Compliance, CBER.
(b) Regional Food and Drug Directors.
(c) District Directors.
(d) The Director, St. Louis Branch.
[48 FR 8442, Mar. 1, 1983, as amended at 48 FR 56947, Dec. 27, 1983; 49
FR 14933, Apr. 16, 1984; 51 FR 32452, Sept. 12, 1986; 54 FR 8317, Feb.
28, 1989; 55 FR 47053, Nov. 9, 1990]
Sec. 5.49 Authorization to use alternative evidence for determination of the effectiveness of medical devices.
The following officials, for medical devices assigned to their
respective
[[Page 49]]
organizations, may authorize under section 513(a)(3)(B) of the Federal
Food, Drug, and Cosmetic Act (the act) the use of valid scientific
evidence (other than that prescribed by section 513(a)(3)(A) of the act)
for determining the effectiveness of medical devices for the purposes of
sections 513, 514, and 515 of the act:
(a) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH), and the Director, Deputy Director, and
Associate Director, Office of Device Evaluation, CDRH.
(b) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER), and the Director and Deputy Director,
Office of Biological Product Review, CBER.
[48 FR 56947, Dec. 27, 1983, as amended at 49 FR 14933, Apr. 16, 1984;
54 FR 8317, Feb. 28, 1989]
Sec. 5.50 Notification to petitioners of determinations made on petitions for reclassification of medical devices.
The following officials, for medical devices assigned to their
respective organizations, are authorized to notify petitioners of
determinations made on petitions for reclassification of medical devices
that are classified in class III (premarket approval) by sections 513(f)
and 520(l) of the Federal Food, Drug, and Cosmetic Act (the act) and
denials of petitions for reclassification of medical devices that are
submitted under section 513(e) of the act (except for petitions
submitted in response to Federal Register notices initiating standard-
setting under section 514(b) of the act or premarket approval under
section 515(b) of the act):
(a) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH), and the Director, Deputy Director, and
Associate Director, Office of Device Evaluation, CDRH.
(b) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER), and the Director and Deputy Director,
Office of Biological Product Review, CBER.
[48 FR 56947, Dec. 27, 1983, as amended at 49 FR 14933, Apr. 16, 1984;
54 FR 8317, Feb. 28, 1989; 54 FR 11866, Mar. 22, 1989]
Sec. 5.51 Determination of classification of devices.
(a) The following officials, for devices assigned to their
respective organizations, are authorized to determine the classification
of a medical device in commercial distribution prior to May 28, 1976,
pursuant to section 513(d) of the Federal Food, Drug, and Cosmetic Act
(the act):
(1) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH), and the Director, Deputy Director, and
Associate Director, Office of Device Evaluation, CDRH.
(2) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER).
(b) The following officials, for devices assigned to their
respective organizations, are authorized to determine the classification
of a medical device first intended for commercial distribution after May
28, 1976, pursuant to section 513 (f)(1)(A) of the act:
(1) The Director and Deputy Director, CDRH, and the Director, Deputy
Director, Associate Director, Chief of the Premarket Notification
Section, Division and Deputy Division Directors, Associate Division
Directors, and Branch Chiefs, Office of Device Evaluation, CDRH.
(2) The Director and Deputy Director, CBER.
[55 FR 6974, Feb. 27, 1990, as amended at 60 FR 2014, Jan. 6, 1995]
Sec. 5.52 Notification to sponsors of deficiencies in petitions for reclassification of medical devices.
The following officials, for medical devices assigned to their
respective organizations, are authorized to notify sponsors of
deficiencies in petitions for reclassification of medical devices
submitted under sections 513(f) and 520(l) of the Federal Food, Drug,
and Cosmetic Act:
(a) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH), and the Director, Deputy Director, and
Associate Director, Office of Device Evaluation, CDRH.
(b) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER), and the Director
[[Page 50]]
and Deputy Director, Office of Biological Product Review, CBER.
[48 FR 56947, Dec. 27, 1983, as amended at 49 FR 14933, Apr. 16, 1984;
54 FR 8317, Feb. 28, 1989]
Sec. 5.53 Approval, disapproval, or withdrawal of approval of product development protocols and applications for premarket approval for medical devices.
(a) The following officials, for medical devices assigned to their
respective organizations, are authorized to approve, disapprove, declare
as complete or incomplete, or revoke product development protocols for
medical devices submitted under section 515(f) of the Federal Food,
Drug, and Cosmetic Act (the act):
(1) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH), and the Director, Deputy Director, and
Associate Director, Office of Device Evaluation, CDRH.
(2) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER), and the Director and Deputy Director,
Office of Biological Product Review, CBER.
(b)(1) The following officials, for medical devices assigned to
their respective organizations, are authorized to approve, disapprove,
or withdraw approval of applications for premarket approval for medical
devices submitted under sections 515 and 520(l) of the act:
(i) The Director and Deputy Director, CDRH, and the Director, Deputy
Director, and Associate Director, Office of Device Evaluation, CDRH.
(ii) The Director and Deputy Director, CBER, and the Director and
Deputy Director, Office of Biological Product Review, CBER.
(2) For medical devices assigned to their respective division, the
Division Directors, Office of Device Evaluation, CDRH, are authorized to
approve, disapprove, or withdraw approval of supplemental premarket
applications.
(c) The Director and Deputy Director, CDRH, for medical devices
assigned to their organization, are authorized to issue notices to
announce the approval, disapproval, or withdrawal of approval of a
device, and to make publicly available a detailed summary of the
information on which the decision was based, under sections 515 (d),
(e), and (g) and 520(h)(1) of the act.
[48 FR 56947, Dec. 27, 1983, as amended at 49 FR 14933, Apr. 16, 1984;
49 FR 21708, May 23, 1984; 50 FR 9424, Mar. 8, 1985; 54 FR 8317, Feb.
28, 1989]
Sec. 5.54 Determinations that medical devices present unreasonable risk of substantial harm.
The following officials, for medical devices assigned to their
respective organizations, are authorized to determine that medical
devices present an unreasonable risk of substantial harm to the public
health, and to order adequate notification thereof, under section 518(a)
of the Federal Food, Drug, and Cosmetic Act:
(a) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH), and the Director and Deputy Director, Office
of Compliance and Surveillance, CDRH.
(b) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER), and the Director and Deputy Director,
Office of Compliance, CBER.
(c) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER), and the Director and Deputy Director, Office of
Compliance, CDER.
[48 FR 56947, Dec. 27, 1983, as amended at 49 FR 14933, Apr. 16, 1984;
57 FR 40316, Sept. 3, 1992]
Sec. 5.55 Orders to repair or replace, or make refunds for, medical devices.
The following officials, for medical devices assigned to their
respective organizations, are authorized to order repair or replacement
of, or refund for, medical devices under section 518 (b) and (c) of the
Federal Food, Drug, and Cosmetic Act:
(a) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH), and the Director and Deputy Director, Office
of Compliance and Surveillance, CDRH.
(b) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER), and the Director and Deputy Director,
Office of Compliance, CBER.
[[Page 51]]
(c) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER), and the Director and Deputy Director, Office of
Compliance, CDER.
[48 FR 56948, Dec. 27, 1983, as amended at 49 FR 14933, Apr. 16, 1984;
57 FR 40317, Sept. 3, 1992]
Sec. 5.56 Recall authority.
The following officials, for medical devices assigned to their
respective organizations, are authorized to perform all of the recall
functions under section 518(e) of the Federal Food, Drug, and Cosmetic
Act, which have been delegated to the Commissioner of Food and Drugs:
(a) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH).
(b) The Director and Deputy Director, Office of Compliance and
Surveillance, CDRH.
(c) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER), and the Director and Deputy Director, Office of
Compliance, CDER.
(d) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER), and the Director and Deputy Director,
Office of Compliance, CBER.
[56 FR 51170, Oct. 10, 1991, as amended at 57 FR 40317, Sept. 3, 1992]
Sec. 5.57 Temporary suspension of a medical device application.
The following officials for medical devices assigned to their
respective organizations are authorized under section 515(e) of the
Federal Food, Drug, and Cosmetic Act, to determine that there is
reasonable probability that continuation of the distribution of a device
under an approved application would cause serious adverse health
consequences or death, and upon making such a determination, to issue an
order to temporarily suspend the approval of an application:
(a) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH).
(b) The Director and Deputy Director, Office of Compliance and
Surveillance, CDRH.
(c) The Director, Deputy Director, and Associate Director, Office of
Device Evaluation, CDRH.
(d) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER); the Director, Pilot Drug Evaluation Staff, CDER; the
Directors and Deputy Directors of the Offices of Drug Evaluation I and
Drug Evaluation II, CDER; the Director and Deputy Director, Office of
Generic Drugs, CDER; and the Director and Deputy Director, Office of
Compliance, CDER.
(e) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER), and the Director and Deputy Director,
Office of Compliance, CBER.
[56 FR 51170, Oct. 10, 1991, as amended at 57 FR 40317, Sept. 3, 1992]
Sec. 5.58 Orphan products.
(a) The Director, Office of Orphan Products Development, Office of
the Commissioner, is authorized to issue notices, and amendments
thereto, inviting sponsorship for orphan products (human and animal
drugs, biological products, and medical devices) and submission of:
(1) Notices of claimed investigational exemption for a new drug or
new drug applications;
(2) Notices of claimed investigational exemption for a new animal
drug or new animal drug applications;
(3) Applications for establishment and product licenses for
biological products; or
(4) Applications for an investigational device exemption or
premarket approval applications for medical devices, as appropriate.
(b) The Director, Office of Orphans Products Development, Office of
the Commissioner, is authorized:
(1) To determine whether there is reason to believe that a drug is a
drug for a disease or condition that is rare in the United States under
section 525(a) of the Federal Food, Drug, and Cosmetic Act (the act) and
to designate such drug as a drug for a rare disease or condition under
section 526(a) of the act.
(2) To issue holders of approved applications or licenses notice and
[[Page 52]]
opportunity for the submission of views under section 527(b)(1) of the
act.
(3) To encourage sponsors of an investigational new drug for a rare
disease or condition to design protocols for clinical investigations to
permit the addition to the investigation of persons with the disease or
condition under section 528 of the act.
(c) The following officials are authorized to provide sponsors,
under section 525(a) of the act, with recommendations for nonclinical or
clinical investigations believed to be necessary for a drug for a rare
disease or condition to be approved or licensed:
(1) For drugs under their jurisdiction:
(i) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER).
(ii) The Directors and Deputy Directors of the Offices of Drug
Evaluation I and Drug Evaluation II, CDER.
(iii) The Division Directors of the divisions in the Offices of Drug
Evaluation I and Drug Evaluation II, CDER.
(iv) The Director and supervisory medical officers, Pilot Drug
Evaluation Staff, Office of the Center Director, CDER.
(2) For biological products under their jurisdiction:
(i) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER).
(ii) The Director and Deputy Director, Office of Biological Product
Review, CBER.
(iii) The Directors and Deputy Directors of the divisions in the
Office of Biological Product Review, CBER.
[48 FR 40703, Sept. 9, 1983, as amended at 49 FR 14933, Apr. 16, 1984;
49 FR 27489, July 5, 1984; 50 FR 19341, May 8, 1985; 54 FR 8318, Feb.
28, 1989; 55 FR 51688, Dec. 17, 1990]
Sec. 5.59 Approval, disapproval, or withdrawal of approval of applications for investigational device exemptions.
(a) For medical devices assigned to their respective organizations,
the following officials are authorized to approve, disapprove, or
withdraw approval of applications for investigational device exemptions
submitted under section 520(g) of the Federal Food, Drug, and Cosmetic
Act (the act):
(1) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH), the Director, Deputy Director, and Associate
Director, Office of Device Evaluation, CDRH, and the Director and Deputy
Director, Office of Compliance and Surveillance, CDRH.
(2) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER), and the Director and Deputy Director,
Office of Biological Product Review, CBER.
(b) For medical devices assigned to their respective divisions, the
Division Directors, Office of Device Evaluation, CDRH, are authorized to
approve, disapprove, or withdraw approval of applications for
investigational device exemptions submitted under section 520(g) of the
act.
[48 FR 56948, Dec. 27, 1983, as amended at 49 FR 14934, Apr. 16, 1984;
54 FR 8318, Feb. 28, 1989; 55 FR 47053, Nov. 9, 1990]
Sec. 5.60 Required and discretionary postmarket surveillance.
(a) For any device (including any device that is or contains a drug
or biologic) that was first introduced or delivered for introduction
into interstate commerce after January 1, 1991, and that is either a
permanent implant, the failure of which may cause serious adverse health
consequences or death, a life-sustaining or life-supporting device, or a
device that potentially presents a serious risk to human health, any of
the following officials is authorized to require a manufacturer of such
device to conduct postmarket surveillance:
(1) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH).
(2) The Director and Deputy Director, Office of Science and
Technology, CDRH.
(3) The Director and Deputy Director, Division of Biometric
Sciences, Office of Science and Technology, CDRH.
(4) The Director, Deputy Director, Associate Director, Division
Directors, and Associate Division Directors, Office of Device
Evaluation, CDRH.
(5) The Chief, Premarket Notification Section; Chief, Premarket
Approval Section; Director, Program Operations Staff, Office of Device
Evaluation, CDRH.
[[Page 53]]
(6) The Director and Deputy Director, Office of Compliance and
Surveillance, CDRH.
(7) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER).
(8) The Director, Pilot Drug Evaluation Staff, CDER.
(9) The Directors and Deputy Directors of the Offices of Drug
Evaluation I and Drug Evaluation II, CDER.
(10) The Director and Deputy Director, Office of Compliance, CDER.
(11) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER).
(12) The Director and Deputy Director, Office of Compliance, CBER.
(13) The Director and Deputy Director, Office of Biological Product
Review, CBER.
(b) For any device (including any device that is or contains a drug
or biologic), any of the following officials is authorized to require a
manufacturer of a device to conduct postmarket surveillance if the
official determines that postmarket surveillance of the device is
necessary to protect the public health or provide safety or
effectiveness data for the device:
(1) The Director and Deputy Director, CDRH.
(2) The Director and Deputy Director, Office of Science and
Technology, CDRH.
(3) The Director and Deputy Director, Division of Biometric
Sciences, Office of Science and Technology, CDRH.
(4) The Director, Deputy Director, and Associate Director, Office of
Device Evaluation, CDRH.
(5) The Director and Deputy Director, Office of Compliance and
Surveillance, CDRH.
(6) The Director and Deputy Director, CDER.
(7) The Director, Pilot Drug Evaluation Staff, CDER.
(8) The Directors and Deputy Directors of the Offices of Drug
Evaluation I and Drug Evaluation II, CDER.
(9) The Director and Deputy Director, Office of Compliance, CDER.
(10) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER).
(11) The Director and Deputy Director, Office of Compliance, CBER.
(12) The Director and Deputy Director, Office of Biological Product
Review, CBER.
[57 FR 40315, Sept. 3, 1992]
Sec. 5.61 Food standards, food additives, generally recognized as safe (GRAS) substances, color additives, nutrient content claims, and health claims.
(a)(1) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs under section 409 and
721 of the Federal Food, Drug, and Cosmetic Act (the act) regarding the
issuance of notices of filing (including notices of extension of, or
reopening of, the comment period), and of voluntary withdrawal, of
petitions on food additives, generally recognized as safe (GRAS)
substances, and color additives that relate to the assigned functions of
the respective Center:
(i) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition (CFSAN).
(ii) The Director, Office of Policy, Planning and Strategic
Initiatives, CFSAN.
(iii) The Director, Office of Premarket Approval, CFSAN.
(iv) The Director and Deputy Director, Center for Veterinary
Medicine (CVM).
(2) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition (CFSAN), and the Director, Office of Policy, Planning,
and Strategic Initiatives, CFSAN are authorized to perform all the
functions of the Commissioner of Food and Drugs under section 401 of the
act regarding the issuance of proposed rulemaking (including notices of
extension of, or reopening of, the comment period) pertaining to food
standards.
(b)(1) The Director and Deputy Directors, CFSAN, and the Director,
Office of Policy, Planning, and Strategic Initiatives, CFSAN are
authorized to perform all of the functions of the Commissioner of Food
and Drugs under sections 409 and 721 of the act regarding the approval
of the use of food additives under section 409(e) of the act and the
listing of color additives under section 721(d) of the act where the
listing does not involve novel or controversial
[[Page 54]]
issues and does not involve any questions about the applicability of the
Delaney Anti-Cancer Clause.
(2) The following officials are authorized to perform all of the
functions of the Commissioner of Food and Drugs under section 401 of the
act regarding the issuance of notices of temporary permits for foods
varying from standards of identity under Sec. 130.17 of this chapter:
(i) The Director and Deputy Directors, CFSAN.
(ii) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(iii) The Director, Office of Food Labeling, CFSAN.
(3) The Director and Deputy Director, CVM, are authorized to perform
all the functions of the Commissioner of Food and Drugs regarding
approvals of the use of food additives under section 409(e) of the act,
where these approvals do not involve novel or controversial issues,
including any question about the applicability of the Delaney Anti-
Cancer Clause.
(c)(1) The following officials are authorized to issue 90-day
letters to food additive petitioners under section 409(c)(2) of the act
or to color additive petitions under section 721(d)(1) of the act that
relate to the assigned functions of the Center:
(i) The Director and Deputy Directors, CFSAN.
(ii) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(iii) The Director, Office of Premarket Approval, CFSAN.
(iv) The Director, Division of Product Policy, Office of Premarket
Approval, CFSAN.
(v) The Director, Division of Petition Control, Office of Premarket
Approval, CFSAN.
(2) The following officials are authorized to issue 90-day letters
to food additive petitioners under section 409(c)(2) of the act that
relate to the assigned functions of the Center:
(i) The Director and Deputy Director, CVM.
(ii) The Director and Deputy Director, Office of Surveillance and
Compliance, CVM.
(iii) The Director and Deputy Director, Division of Animal Feeds,
Office of Surveillance and Compliance, CVM.
(d) The following officials are authorized to certify batches of
color additives under section 721 of the act:
(1) The Director and Deputy Directors, CFSAN.
(2) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(3) The Director, Office of Cosmetics and Colors, CFSAN.
(e) The following officials are authorized to issue advance notices
of proposed rulemaking pertaining to Codex Alimentarius food standards
and notices terminating consideration of such standards when comments
fail to support the desirability and need for proposing their adoption,
under Sec. 130.6 of this chapter:
(1) The Director and Deputy Directors, CFSAN.
(2) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(3) The Director, Office of Food Labeling, CFSAN.
(f) The following officials are authorized to issue notices of
proposed rulemaking and issue or amend regulations affirming generally
recognized as safe (GRAS) status of food substances under Sec. 170.35 or
Sec. 570.35 of this chapter where the affirmations relate to the
assigned functions of the respective Center and do not involve novel or
controversial issues:
(1) The Director and Deputy Directors, CFSAN, and the Director,
Office of Policy, Planning, and Strategic Initiatives, CFSAN.
(2) The Director and Deputy Director, CVM.
(g)(1) The following officials are authorized to perform all of the
functions of the Commissioner of Food and Drugs under section 403(r)(4)
of the act regarding the issuance of decisions to grant or deny
petitions for nutrient content claims and health claims that do not
present controversial issues and regarding the issuance of any notices
of proposed rulemaking that result from such action:
(i) The Director and Deputy Directors, CFSAN.
[[Page 55]]
(ii) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(2) The following officials are authorized to perform all of the
functions of the Commissioner of Food and Drugs under section 403(r)(4)
of the act regarding the issuing of letters of filing in response to
petitions for nutrient content claims and health claims:
(i) The Director and Deputy Directors, CFSAN.
(ii) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(iii) The Director, Office of Food Labeling, CFSAN.
(h) The following officials are authorized to issue letters
concerning substances determined to be below the ``threshold of
regulation'' under Sec. 170.39 of this chapter:
(1) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition (CFSAN).
(2) The Director, Office of Policy, Planning and Strategic
Initiatives, CFSAN.
(3) The Director, Office of Premarket Approval, CFSAN.
(4) The Directors of the Divisions of Petition Control and Product
Policy, Office of Premarket Approval, CFSAN.
[49 FR 14936, Apr. 16, 1984, as amended at 49 FR 48183, Dec. 11, 1984;
52 FR 5951, Feb. 27, 1987; 58 FR 2410, Jan. 6, 1993; 59 FR 42492, Aug.
18, 1994; 60 FR 36594, July 17, 1995]
Sec. 5.62 Issuance of initial emergency permit orders and notices of confirmation of effective date of final regulations on food for human and animal
consumption.
(a) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition (CFSAN), the Director, Office of Field Programs,
CFSAN, and the Director, Division of Enforcement, Office of Field
Programs, CFSAN, are authorized to issue initial emergency permit orders
under Sec. 108.5 of this chapter.
(b) The following officials are authorized to issue notices of
confirmation of effective date of final regulations on food matters
promulgated under section 701(e) of the Federal Food, Drug, and Cosmetic
Act:
(1) The Director and Deputy Directors, CFSAN.
(2) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(3) The Director, Office of Food Labeling, CFSAN.
(4) The Director, Office of Special Nutritionals, CFSAN.
(5) The Director, Office of Plant and Dairy Foods and Beverages,
CFSAN.
(6) The Director, Office of Seafood, CFSAN.
(7) The Director, Office of Field Programs, CFSAN.
(8) The Director, Office of Premarket Approval, CFSAN.
[59 FR 42492, Aug. 18, 1994]
Sec. 5.63 Detention of meat, poultry, eggs, and related products.
The Regional Food and Drug Directors and District Directors are
authorized to perform and to designate other officials to perform all of
the functions of the Commissioner of Food and Drugs under:
(a) Section 409(b) of the Federal Meat Inspection Act (21 U.S.C.
679(b)) which relate to the detention of any carcass, part thereof,
meat, or meat product of cattle, sheep, swine, goats, or equines.
(b) Section 24(b) of the Poultry Products Inspection Act (21 U.S.C.
467f(b)) which relate to the detention of any poultry carcass, part
thereof, or poultry product.
(c) The Egg Products Inspection Act (21 U.S.C. 1031 et seq.).
[48 FR 8442, Mar. 1, 1983, as amended at 54 FR 9034, Mar. 3, 1989; 60 FR
15871, Mar. 28, 1995]
Sec. 5.64 Establishing standards and approving accrediting bodies under the National Laboratory Accreditation Program.
The Director and Deputy Director, Center for Food Safety and Applied
Nutrition, are authorized to perform all the functions of the
Commissioner of Food and Drugs under sections 1322(b) and (c) of the
Food, Agriculture, Conservation, and Trade Act of 1990 (the National
Laboratory Accreditation Program) (7 U.S.C. 138a), as amended hereafter;
which relate to setting standards for the National Laboratory
Accreditation Program and approving State agencies or private, nonprofit
entities as accrediting bodies to implement certification and quality
[[Page 56]]
assurance programs in accordance with the requirements of these
sections. The delegation excludes the authority to submit reports to the
Congress.
[57 FR 43398, Sept. 21, 1992]
Sec. 5.66 Approval of schools providing food-processing instruction.
The following officials are authorized to perform all the functions
of the Commissioner of Food and Drugs under Sec. 113.10 of this chapter
regarding the approval of schools giving instruction in retort
operations, processing systems operations, aseptic processing and
packaging system operations, and container closure inspections:
(a) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition (CFSAN).
(b) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(c) The Director, Office of Plant and Dairy Foods and Beverages,
CFSAN.
[59 FR 42492, Aug. 18, 1994]
Sec. 5.67 Issuance of notices of opportunity for a hearing on proposals for denial of approval of applications for licenses or revocation of licenses and
certain notices of revocation of licenses.
The Director and Deputy Director, Center for Biologics Evaluation
and Research are authorized to issue:
(a) Notices of opportunity for a hearing on proposals to deny
approval or filing of applications for establishment or product licenses
under Sec. 601.4(b) of this chapter.
(b) Notices of opportunity for a hearing on proposals to revoke
establishment or product licenses under Sec. 601.5(b) of this chapter.
(c) Notices of revocation, at the manufacturer's request, of
establishment or product licenses under Secs. 601.5(a) and 601.8 of this
chapter.
(d) Notices of revocation when the manufacturer has waived the
opportunity for hearing under Sec. 601.7(a) of this chapter.
[50 FR 30697, July 29, 1985, as amended at 54 FR 8318, Feb. 28, 1989; 56
FR 25025, June 3, 1991]
Sec. 5.68 Issuance and revocation of licenses for the propagation or manufacture and preparation of biological products.
The following officials are authorized to issue licenses under
section 351 of the Public Health Service Act (42 U.S.C. 262) for the
propagation or manufacture and preparation of biological products as
specified in the act, and to revoke such licenses at the manufacturer's
request:
(a) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER).
(b) The Director and Deputy Director, Office of Biological Product
Review, CBER.
[49 FR 14934, Apr. 16, 1984, as amended at 54 FR 8318, Feb. 28, 1989]
Sec. 5.69 Notification of release for distribution of biological products.
The following officials are authorized to issue written notices of
release for distribution of licensed biological products under
subchapter F (parts 600 through 699) of this chapter:
(a) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER).
(b) The Director and Deputy Director, Office of Biological Product
Review, CBER.
(c) The Director and Deputy Director, Division of Product Quality
Control, Office of Biological Product Review, CBER.
[49 FR 14934, Apr. 16, 1984, as amended at 50 FR 19341, May 8, 1985; 54
FR 8318, Feb. 28, 1989]
Sec. 5.70 Issuance of notice implementing the provisions of the Drug Amendments of 1962.
The Director and Deputy Director, Center for Drug Evaluation and
Research, 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 sections 505 and 507 of
the Federal Food, Drug, and Cosmetic Act.
[54 FR 8318, Feb. 28, 1989]
[[Page 57]]
Sec. 5.71 Termination of exemptions for new drugs for investigational use in human beings and in animals.
(a) The following officials, for drugs under their jurisdiction, are
authorized to perform all the functions of the Commissioner of Food and
Drugs on the termination of exemptions for new drugs (including those
that are biological products which are subject to the licensing
provisions of the Public Health Service Act) for investigational use in
human beings under Sec. 312.44 of this chapter and in animals under
Sec. 312.160 of this chapter:
(1) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER).
(2) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER).
(b) The following officials, for drugs under their jurisdiction, are
authorized to terminate exemptions for new drugs for investigational use
when sponsors fail to submit an annual progress report under
Sec. 312.44(b)(1)(viii) of this chapter:
(1) The Directors and Deputy Directors of the Offices of Drug
Evaluation I and Drug Evaluation II, CDER.
(2) The Directors and Deputy Directors in the divisions in the
Offices of Drug Evaluation I and Drug Evaluation II and the Director and
supervisory medical officers, Pilot Drug Evaluation Staff, Office of the
Center Director, CDER.
(3) The Director and Deputy Director, Office of Biological Product
Review, CBER.
(4) The Director and Deputy Director, Division of Biological
Investigational New Drugs, Office of Biological Product Review.
(c) The following officials, for drugs under their jurisdiction, are
authorized to make the findings set forth in Sec. 312.44(b) of this
chapter and to notify sponsors and invite correction before termination
action on such exemptions:
(1) The Directors and Deputy Directors of the Offices of Drug
Evaluation I and Drug Evaluation II, CDER.
(2) The Directors and Deputy Directors in the divisions in the
Offices of Drug Evaluation I and Drug Evaluation II and the Director and
supervisory medical officers, Pilot Drug Evaluation Staff, Office of the
Center Director, CDER.
(3) The Director and Deputy Director, Office of Biological Product
Review, CBER.
(4) The Director and Deputy Director, Division of Biological
Investigational New Drugs, Office of Biological Product Review.
(d) The following officials are authorized to perform all functions
of the Commissioner of Food and Drugs with regard to the termination of
new animal drugs for investigational use in animals under Sec. 511.1 of
this chapter:
(1) The Director and Deputy Director, Center for Veterinary Medicine
(CVM).
(2) The Director and Deputy Director, Office of New Animal Drug
Evaluation, CVM.
[49 FR 14934, Apr. 16, 1984, as amended at 50 FR 14094, Apr. 10, 1985;
52 FR 7829, Mar. 13, 1987; 54 FR 8318, Feb. 28, 1989; 55 FR 51688, Dec.
17, 1990]
Sec. 5.72 Authority to approve and to withdraw approval of a charge for investigational new drugs.
The following officials, for drugs under their jurisdiction, are
authorized to perform all the functions of the Commissioner of Food and
Drugs to approve a charge and to withdraw approval to charge for
investigational drugs in a clinical trial under an investigational new
drug application under Sec. 312.7(d)(1) of this chapter:
(a) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER).
(b) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER).
[55 FR 5445, Feb. 15, 1990]
Sec. 5.73 Certification of insulin.
The following officials are authorized to certify or reject batches
of drugs containing insulin pursuant to section 506(a) of the Federal
Food, Drug, and Cosmetic Act:
(a) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER).
(b) The Director and Deputy Director, Office of Compliance, CDER.
[[Page 58]]
(c) The Director and Deputy Director, Division of Drug Quality
Evaluation, Office of Compliance, CDER.
(d) The Chief and Assistant Chief, Product Surveillance Branch,
Division of Drug Quality Evaluation, Office of Compliance, CDER.
[49 FR 14934, Apr. 16, 1984, as amended at 54 FR 8319, Feb. 28, 1989]
Sec. 5.74 Issuance, amendment, or repeal of regulations pertaining to drugs containing insulin.
The following officials are authorized to perform all the functions
of the Commissioner of Food and Drugs under section 506 of the Federal
Food, Drug, and Cosmetic Act regarding the issuance, amendment, or
repeal of regulations pertaining to drugs containing insulin:
(a) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER).
(b) The Director and Deputy Director, Office of Compliance, CDER.
[49 FR 14934, Apr. 16, 1984, as amended at 54 FR 8319, Feb. 28, 1989]
Sec. 5.75 Designation of official master and working standards for antibiotic drugs.
The following officials are authorized to designate official Food
and Drug Administration master and working standards for antibiotic
drugs under Sec. 430.5 of this chapter:
(a) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER).
(b) The Director and Deputy Director, Office of Research Resources,
CDER.
(c) The Director and Deputy Director, Division of Research and
Testing, Office of Research Resources, CDER.
[49 FR 27315, July 3, 1984, as amended at 54 FR 8319, Feb. 28, 1989]
Sec. 5.76 Certification of antibiotic drugs.
The following officials are authorized to certify or reject batches
of antibiotic drugs, or any derivative of these drugs, pursuant to
sections 507(a) and 512(n) of the Federal Food, Drug, and Cosmetic Act:
(a) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER).
(b) The Director and Deputy Director, Office of Compliance, CDER.
(c) The Director and Deputy Director, Division of Drug Quality
Evaluation, Office of Compliance, CDER.
(d) The Chief and Assistant Chief, Product Surveillance Branch,
Division of Drug Quality Evaluation, Office of Compliance, CDER.
[49 FR 14934, Apr. 16, 1984, as amended at 54 FR 8319, Feb. 28, 1989]
Sec. 5.78 Issuance, amendment, or repeal of regulations pertaining to antibiotic drugs.
(a) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs under section 507 of the
Federal Food, Drug, and Cosmetic Act (the act) regarding the issuance,
amendment, or repeal of regulations pertaining to antibiotic drugs for
human use:
(1) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER).
(2) The Director and Deputy Director, Office of Compliance, CDER.
(b) The Director and Deputy Director, Center for Devices and
Radiological Health, are authorized to perform all the functions of the
Commissioner of Food and Drugs under section 507 of the act regarding
the issuance, amendment, or repeal of regulations pertaining to
antibiotic drugs for human use contained in medical devices.
[48 FR 56948, Dec. 27, 1983, as amended at 49 FR 14935, Apr. 16, 1984;
54 FR 8319, Feb. 28, 1989]
Sec. 5.80 Approval of new drug applications and their supplements.
(a)(1) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs with regard to approval
of new drug applications and supplements thereto on drugs for human use,
except for those drugs listed in Sec. 314.440(b) of this chapter, that
have been submitted under section 505 of the Federal Food, Drug, and
Cosmetic Act:
(i) The Director and Deputy Director, and Deputy Director (Medical
and
[[Page 59]]
Scientific Affairs), Center for Drug Evaluation and Research (CDER).
(ii) The Directors and Deputy Directors of the Offices of Drug
Evaluation I and Drug Evaluation II, CDER, for drugs under their
jurisdiction.
(iii) The Director, Office of Over-the-Counter Drug Evaluation,
CDER, for drugs under the Director's jurisdiction.
(2) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER), for drugs listed in Sec. 314.440(b) of
this chapter, are authorized to perform all the functions of the
Commissioner of Food and Drugs with regard to approval of new drug
applications and supplements thereto on drugs for human use that have
been submitted under section 505 of the Federal Food, Drug, and Cosmetic
Act.
(b) The officials listed in paragraphs (b) (1) and (2) of this
section, for drugs under their jurisdiction, are authorized to perform
all functions of the Commissioner of Food and Drugs with regard to
approval of supplemental applications to approved new drug applications
for drugs for human use that have been submitted under Sec. 314.70 of
this chapter and of new drug applications for drug products other than
those that contain new molecular entities (new chemical entities). The
applications to which this authorization applies may, in appropriate
circumstances, continue to be acted upon by the officials so authorized
in Sec. 5.10(a) and paragraph (a) of this section.
(1) The Directors and Deputy Directors of the divisions in the
Office of Drug Evaluation I, CDER.
(2) The Directors and Deputy Directors of the divisions in the
Office of Drug Evaluation II, CDER.
(c) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs with regard to approval
of abbreviated new drug applications and supplements thereto for drugs
for human use and new drug applications for drugs with a 5S
classification whose clinical safety and efficacy may be supported by
appropriate literature citations in lieu of submission of data from
original proprietary studies, or 505(b)(2) applications under their
jurisdiction. The applications to which this authorization applies may,
in appropriate circumstances, continue to be acted upon by the officials
so authorized in Sec. 5.10(a) and paragraph (a) of this section.
(1) For drugs submitted under Secs. 314.50, 314.70, and 314.94 of
this chapter, except for those drug products listed in Sec. 314.440(b):
(i) The Director and Deputy Director, Office of Generic Drugs (OGD),
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 the
Office of Drug Evaluation I, CDER.
(iii) The Directors and Deputy Directors of the divisions in the
Office of Drug Evaluation II, CDER.
(iv) The Director, Pilot Drug Evaluation Staff, CDER.
(2)(i) For drug products listed in Sec. 314.440(b) and submitted
under Secs. 314.50, 314.70, and 314.94 of this chapter:
(ii) The Director and Deputy Director, Office of Biological Product
Review, CBER.
(d) The following officials are authorized to perform all functions
of the Commissioner of Food and Drugs with respect to approval of
supplemental applications to abbreviated new drug applications, 5S
applications, or 505(b)(2) applications for drugs for human use that are
described in 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 of the Division of Chemistry I,
OGD.
(2) The Director and Deputy Director of the Division of Chemistry
II, OGD.
(3) The Associate Director for Chemistry, OGD.
(e) The Director and Deputy Director, Division of Labeling and
Program Support, OGD, are authorized to perform all the functions of the
Commissioner of Food and Drugs with respect to approval of supplemental
applications to abbreviated new drug applications, 5S applications, or
505(b)(2) applications for drugs for human use that
[[Page 60]]
are described in 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 following officials are authorized to perform all functions
of the Commissioner of Food and Drugs with respect to approval of
supplemental applications to new drug applications for drugs for human
use that are described in 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 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.
(1) The supervisory chemists in the divisions in the Office of Drug
Evaluation I, CDER.
(2) The supervisory chemists in the divisions in the Office of Drug
Evaluation II, CDER.
[49 FR 14935, Apr. 16, 1984, as amended at 50 FR 30697, July 29, 1985;
50 FR 47207, Nov. 15, 1985; 52 FR 37764, Oct. 9, 1987; 54 FR 8319, Feb.
28, 1989; 55 FR 6247, Feb. 22, 1990; 55 FR 51688, Dec. 17, 1990; 57 FR
17980, Apr. 28, 1992; 58 FR 17094, Apr. 1, 1993; 59 FR 33431, June 29,
1994; 60 FR 57338, Nov. 15, 1995]
Sec. 5.81 Responses to Drug Enforcement Administration temporary scheduling notices.
The Associate Commissioner for Health Affairs is authorized to
provide responses to the Drug Enforcement Administration's temporary
scheduling notices under the Controlled Substances Act, as amended
(Title II of the Comprehensive Drug Abuse Prevention and Control Act of
1970, 21 U.S.C. 811(h)(4), as amended hereafter). The delegation
excludes the authority to submit reports to Congress.
[60 FR 54424, Oct. 24, 1995]
Sec. 5.82 Issuance of notices relating to proposals to refuse approval or to withdraw approval of new drug applications and their supplements.
(a) The Director and Deputy Director, Center for Drug Evaluation and
Research, are authorized to issue notices of an opportunity for a
hearing on proposals to refuse approval or to withdraw approval of new
drug applications and abbreviated new drug applications and supplements
thereto on drugs for human use, except for those drugs listed in
Sec. 314.440(b) of this chapter, that have been submitted under section
505 of the Federal Food, Drug, and Cosmetic Act and subpart B of part
314 of this chapter and to issue notices refusing approval or
withdrawing approval when opportunity for hearing has been waived.
(b) The Director and Deputy Director, Center for Biologics
Evaluation and Research, for those drugs listed in Sec. 314.440(b) of
this chapter, are authorized to issue notices of an opportunity for a
hearing on proposals to refuse approval or to withdraw approval of new
drug applications and abbreviated new drug applications and supplements
thereto on drugs for human use that have been submitted under section
505 of the Federal Food, Drug, and Cosmetic Act and subpart B of part
314 of this chapter and to issue notices refusing approval or
withdrawing approval when opportunity for hearing has been waived.
[54 FR 8319, Feb. 28, 1989]
Sec. 5.83 Approval of new animal drug applications and their supplements.
(a) The Director and Deputy Director, Center for Veterinary Medicine
(CVM), are authorized to perform all the functions of the Commissioner
of Food and Drugs with regard to the approval of new animal drug
applications, and supplements thereto, for new animal drugs submitted
pursuant to section 512 of the Federal Food, Drug, and Cosmetic Act (the
act).
(b) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs with regard to the
approval of supplemental applications to approved new animal drugs
submitted pursuant to section 512 of the act:
[[Page 61]]
(1) The Director, the Deputy Director for Human Food Safety and
Consultative Services, and the Deputy Director for Therapeutic and
Production Drug Review, Office of New Animal Drug Evaluation, CVM.
(2) The Director and Deputy Director, Office of Surveillance and
Compliance, CVM.
(c) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs with regard to the
approval of supplemental applications to new animal drug applications
that are described by Sec. 514.8(a)(4)(iii), (iv), and (v), and (d)(3)
of this chapter.
(1) The Director, Division of Chemistry, Office of New Animal Drug
Evaluation, CVM.
(2) The Director, Division of Surveillance, Office of Surveillance
and Compliance, CVM.
(d) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs with regard to the
approval of applications for animal feeds containing new animal drugs:
(1) The Director and Deputy Director, Division of Animal Feeds,
Office of Surveillance and Compliance, CVM.
(2) The Chief, Petition Review and Medicated Feeds Branch, Division
of Animal Feeds, Office of Surveillance and Compliance, CVM.
(3) The Medicated Feeds Specialist, Petition Review and Medicated
Feeds Branch, Division of Animal Feeds, Office of Surveillance and
Compliance, CVM.
[49 FR 14937, Apr. 16, 1984, as amended at 50 FR 14094, Apr. 10, 1985;
53 FR 2225, Jan. 27, 1988; 53 FR 17186, May 16, 1988; 53 FR 40055, Oct.
13, 1988]
Sec. 5.84 Issuance of notices, proposals, and orders relating to new animal drugs and feeds bearing or containing new animal drugs.
(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 feeds bearing or
containing new animal drugs, submitted pursuant to section 512 of the
Federal Food, Drug, and Cosmetic Act;
(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 feeds bearing or
containing new animal drugs, corresponding to said action on such
applications.
(b) The Director and Deputy Director, CVM, are authorized to issue
notices of availability of Public Master Files containing data
acceptable for use in applications for new animal drugs for drugs for
animal use and feeds bearing or containing new animal drugs.
[49 FR 17936, Apr. 26, 1984]
Sec. 5.85 Authority to ensure that mammography facilities meet quality standards.
(a) The following officials are authorized to issue, renew, and
extend certificates to mammography facilities under section 354(c) of
the Public Health Service Act (42 U.S.C. 263b):
(1) The Director and Deputy Director for Regulations and Policy,
Center for Devices and Radiological Health (CDRH).
(2) The Director, Office of Health and Industry Programs, CDRH.
(3) The Director, Division of Mammography Quality and Radiation
Programs, Office of Health and Industry Programs, CDRH.
(b) The following officials are authorized to accept an application
for a certificate under section 354(d)(1) of the Public Health Service
Act:
(1) The Director and Deputy Director for Regulations and Policy,
CDRH.
(2) The Director, Office of Health and Industry Programs, CDRH.
(3) The Director, Division of Mammography Quality and Radiation
Programs, Office of Health and Industry Programs, CDRH.
(c) The following officials are authorized to approve accreditation
bodies to accredit mammography facilities under section 354(e)(1)(A) of
the Public Health Service Act:
(1) The Director and Deputy Director for Regulations and Policy,
CDRH.
[[Page 62]]
(2) The Director, Office of Health and Industry Programs, CDRH.
(d) The following officials are authorized to ensure that
accreditation bodies provide satisfactory assurances of compliance under
section 354(e)(1)(C) of the Public Health Service Act:
(1) The Director and Deputy Director for Regulations and Policy,
CDRH.
(2) The Director, Office of Health and Industry Programs, CDRH.
(3) The Director, Division of Mammography Quality and Radiation
Programs, Office of Health and Industry Programs, CDRH.
(e) The Director, CDRH, is authorized to promulgate regulations
under which the Director may withdraw approval of accreditation bodies
under section 354(e)(2) of the Public Health Service Act.
(f) The following officials are authorized to determine the
applicable standards for a facility for accreditation under section
354(e)(3) of the Public Health Service Act:
(1) The Director and Deputy Director for Regulations and Policy,
CDRH.
(2) The Director, Office of Health and Industry Programs, CDRH.
(3) The Director, Division of Mammography Quality and Radiation
Programs, Office of Health and Industry Programs, CDRH.
(g) The following officials are authorized to ensure that
accreditation bodies make on site visits and to determine whether other
measures are appropriate under section 354(e)(4)(A) and (e)(4)(B) of the
Public Health Service Act:
(1) The Director and Deputy Director for Regulations and Policy,
CDRH.
(2) The Director, Office of Health and Industry Programs, CDRH.
(3) The Director, Division of Mammography Quality and Radiation
Programs, Office of Health and Industry Programs, CDRH.
(h) The following officials are authorized to evaluate annually the
performance of each approved accreditation body as provided by section
354(e)(6)(A) of the Public Health Service Act:
(1) The Director and Deputy Director for Regulations and Policy,
CDRH.
(2) The Director, Office of Health and Industry Programs, CDRH.
(3) The Director, Division of Mammography Quality and Radiation
Programs, Office of Health and Industry Programs, CDRH.
(i) The following officials are authorized to determine the
compliance of certified facilities with established standards through
facility inspections as provided by section 354(g) of the Public Health
Service Act:
(1) The Director and Deputy Director for Regulations and Policy,
CDRH.
(2) The Director, Office of Health and Industry Programs, CDRH.
(3) The Director, Division of Mammography Quality and Radiation
Programs, Office of Health and Industry Programs, CDRH.
(j) The Director and Deputy Director for Regulations and Policy,
CDRH, are authorized to impose sanctions under section 354(h)(1) and
(h)(2) of the Public Health Service Act.
(k) The Director and Deputy Director for Regulations and Policy,
CDRH, are authorized to suspend or revoke individual facility
certificates under section 354(i)(1) and (i)(2)(A) of the Public Health
Service Act.
(l) The Director and Deputy Director for Regulations Policy, CDRH,
are authorized to compile and make available to physicians and the
general public information the Director determines is useful in
evaluating the performance of mammography facilities as provided by
section 354(l) of the Public Health Service Act.
(m)(1) The following officials may authorize a State to carry out
certification program requirements and implement quality standards under
section 354(q)(1) and (q)(2) of the Public Health Service Act:
(i) The Director and Deputy Director for Regulations and Policy,
CDRH.
(ii) The Director, Office of Health and Industry Programs, CDRH.
(2) The Director, CDRH, is authorized, after providing notice and
opportunity for corrective action, to withdraw the approval of a State's
authority to carry out certification requirements and implement quality
standards under section 354(q)(4) of the Public Health Service Act.
[60 FR 47268, Sept. 12, 1995]
[[Page 63]]
Sec. 5.86 Variances from performance standards for electronic products.
The following officials are authorized to grant and withdraw
variances and issue notices of availability of any approved variance or
any amendment or extension thereof, from the provisions of performance
standards for electronic products established in subchapter J of this
chapter:
(a) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH).
(b) The Director and Deputy Director, Office of Compliance and
Surveillance, CDRH.
(c) The Director and Deputy Director, Office of Standards and
Regulations, CDRH.
[52 FR 29664, Aug. 11, 1987, as amended at 55 FR 47053, Nov. 9, 1990]
Sec. 5.87 Exemption of electronic products from performance standards and prohibited acts.
The following officials are authorized to exempt from performance
standards any electronic product intended for use by departments or
agencies of the United States under section 358(a)(5) of the Public
Health Service Act (the act) and to exempt an electronic product or
class of products from all or part of the provisions of section 360B(a)
of the act under section 360B(b) of that act:
(a) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH).
(b) The Director and Deputy Director, Office of Compliance and
Surveillance, CDRH.
(c) The Director and Deputy Director, Office of Standards and
Regulations, CDRH.
[52 FR 29664, Aug. 11, 1987, as amended at 55 FR 47053, Nov. 9, 1990]
Sec. 5.88 Testing programs and methods of certification and identification for electronic products.
The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH), and the Director and Deputy Director, Office
of Compliance and Surveillance, CDRH, are authorized to review and
evaluate industry testing programs under section 358(g) of the Public
Health Service Act (the act), and to approve or disapprove alternate
methods of certification and identification and to disapprove testing
programs upon which certification is based under section 358(h) of the
act.
[55 FR 47054, Nov. 9, 1990]
Sec. 5.89 Notification of defects in, and repair or replacement of, electronic products.
(a) The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH), and the Director and Deputy Director, Office
of Compliance and Surveillance, CDRH, are authorized to perform all
functions of the Commissioner of Food and Drugs, relating to
notification of defects in, noncompliance of, and repair or replacement
of or refund for, electronic products under section 359 of the Public
Health Service Act (the act) and under Secs. 1003.11, 1003.22, 1003.31,
1004.2, 1004.3, 1004.4, and 1004.6 of this chapter; and Regional Food
and Drug Directors, District Directors, and the Director, St. Louis
Branch, are authorized to perform all such functions relating to:
(1) Assemblers of diagnostic x-ray systems, as defined in
Sec. 1020.30(b) of this chapter.
(2) Manufacturers of sunlamp products and ultraviolet lamps intended
for use in any sunlamp product, as defined in Sec. 1040.20(b) of this
chapter.
(b) The Director and Deputy Director, Office of Compliance and
Surveillance, CDRH, and the Director, Division of Standards Enforcement,
Office of Compliance and Surveillance, CDRH, are authorized to notify
manufacturers of defects in, and noncompliance of, electronic products
under section 359(e) of the act and under Sec. 1003.11(a) of this
chapter; and the chiefs of District Compliance Branches are authorized
to perform all such functions relating to:
(1) Assemblers of diagnostic x-reay systems, as defined in
Sec. 1020.30(b) of this chapter.
(2) Manufacturers of sunlamp products and ultraviolet lamps intended
for use in any sunlamp products, as defined in Sec. 1040.20(b) of this
chapter.
[48 FR 56948, Dec. 27, 1983, as amended at 51 FR 32452, Sept. 12, 1986;
55 FR 47054, Nov. 9, 1990]
[[Page 64]]
Sec. 5.90 Manufacturers requirement to provide data to ultimate purchasers of electronic products.
The Director and Deputy Director, Center for Devices and
Radiological Health, are authorized to require manufacturers to provide
performance and technical data to the ultimate purchaser of electronic
products under section 360A(c) of the Public Health Service Act.
[48 FR 56948, Dec. 27, 1983]
Sec. 5.91 Dealer and distributor direction to provide data to manufacturers of electronic products.
The Director and Deputy Director, Center for Devices and
Radiological Health (CDRH), the Director and Deputy Director, Office of
Compliance and Surveillance, CDRH, and the Director, Division of
Standards Enforcement, Office of Compliance and Surveillance, CDRH, are
authorized to direct dealers and distributors of electronic products to
furnish information on first purchasers of such products to the
manufacturer of the product under section 360A(f) of the Public Health
Service Act.
[55 FR 47054, Nov. 9, 1990]
Sec. 5.92 Acceptance of assistance from State and local authorities for enforcement of radiation control legislation and regulations.
The Director and Deputy Director, Center for Devices and
Radiological Health, are authorized to accept assistance from State and
local authorities engaged in activities related to health or safety or
consumer protection on a reimbursable basis or otherwise, under section
360E of the Public Health Service Act.
[48 FR 56949, Dec. 27, 1983]
Sec. 5.93 Submission of and effective approval dates for abbreviated new drug applications and certain new drug applications.
The following officials are authorized to perform all of the
functions of the Commissioner of Food and Drugs with regard to decisions
made under section 505(c)(3)(D), (j)(4)(B)(iv), and (j)(4)(D) of the
Federal Food, Drug and Cosmetic Act (the act) concerning the date of
submission or the date or effective approval of abbreviated new drug
applications including supplements thereto submitted under section
505(j) of the act and of new drug applications including supplements
thereto submitted under section 505(b)(1) of the act and described under
section 505(b)(2) of the act:
(a) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER).
(b) The Director and Deputy Director (Bioequivalence), Office of
Generic Drugs, CDER.
[53 FR 18274, May 23, 1988, as amended at 55 FR 6247, Feb. 22, 1990]
Sec. 5.94 Extensions or stays of effective dates for compliance with certain labeling requirements for human prescription drugs.
The following officials are authorized to extend or stay an
effective date in Sec. 201.59 of this chapter for compliance with
certain labeling requirements for human prescription drugs.
(a) For drugs assigned to their organizations:
(1) The Director and Deputy Director, Center for Biologics
Evaluation and Research (CBER).
(2) The Director and Deputy Director, Office of Biological Product
Review, CBER.
(3) The Directors and Deputy Directors of the divisions in the
Office of Biological Product Review, CBER.
(b) For drugs assigned to their organizations:
(1) The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER).
(2) The Directors and Deputy Directors of the Office of Drug
Evaluation I and Drug Evaluation II, CDER.
(3) The Directors and Deputy Directors of the divisions in the
Office of Drug Evaluation I and Drug Evaluation II, CDER.
(4) The Director and supervisory consumer safety officers, Pilot
Drug Evaluation Staff, Office of the Center Director, CDER.
[52 FR 2514, Jan. 23, 1987, as amended at 54 FR 8320, Feb. 28, 1989; 55
FR 51688, Dec. 17, 1990]
[[Page 65]]
Sec. 5.95 Submission of and effective approval dates for abbreviated new animal drug applications and certain new animal drug applications.
The following officials are authorized to perform all the functions
of the Commissioner of Food and Drugs with regard to decisions made
under section 512(c)(2)(D)(iv) and (c)(2)(F) of the Federal, Food, Drug,
and Cosmetic Act (the act) concerning the date of submission and the
date of effective approval of abbreviated new animal drug applications
including supplements thereto, submitted under section 512(b)(2) of the
act, and of new animal drug applications including supplements thereto,
submitted under section 512(b)(1) of the act:
(a) The Director and Deputy Director, Center for Veterinary Medicine
(CVM).
(b) The Director and Deputy Director, Office of New Animal Drug
Evaluation, CVM.
[56 FR 6263, Feb. 15, 1991]
Sec. 5.98 Authority relating to medical device reporting procedures.
(a) The Director and Deputy Directors, Center for Devices and
Radiological Health (CDRH), and the Director and Deputy Director, Office
of Surveillance and Biometrics, CDRH, are authorized to approve
electronic reporting under Sec. 803.14 of this chapter.
(b) The Director and Deputy Directors, Center for Devices and
Radiological Health (CDRH), and the Director and Deputy Director, Office
of Surveillance and Biometrics, CDRH, are authorized to request the
submission of additional information under Sec. 803.15 of this chapter.
(c) The Director and Deputy Directors, Center for Devices and
Radiological Health (CDRH), and the Director and Deputy Director, Office
of Surveillance and Biometrics, CDRH, are authorized to grant or revoke
exemptions and variances from reporting requirements under Sec. 803.19
of this chapter.
[60 FR 63607, Dec. 11, 1995]
Sec. 5.99 Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment.
The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER), the Director and Deputy Director, Center for Veterinary
Medicine (CVM), and the Director and Associate Director for Policy
Coordination and Public Relations, Center for Biologics Evaluation and
Research (CBER) are authorized to issue the following notices under
section 306 of the Federal Food, Drug, and Cosmetic Act (the act) which
relate to the assigned functions of their organizations:
(a) Notices of opportunity for hearing on proposals for mandatory or
permissive debarment.
(b) Notices ordering debarment when opportunity for a hearing has
been waived.
(c) Notices ordering debarment where the person notifies the agency
that the person acquiesces to debarment under section 306(c)(2)(B) of
the act.
(d) Notices of opportunity for hearing on proposals denying an
application to terminate debarment under section 306(d)(3) of the act.
(e) Orders denying an application to terminate debarment under
section 306(d)(3) of the act when opportunity for a hearing has been
waived.
[61 FR 8215, Mar. 4, 1996; 61 FR 11545, Mar. 21, 1996; 61 FR 14375, Apr.
1, 1996]
Subpart C--Organization
Sec. 5.100 Headquarters.
The central organization of the Food and Drug Administration
consists of the following:
[[Page 66]]
Office of the Commissioner \1\
---------------------------------------------------------------------------
\1\ Mailing address: 5600 Fishers Lane, Rockville, MD 20857.
---------------------------------------------------------------------------
Immediate Office
Office of the Administrative Law Judge.
Office of Executive Operations.
Office of Equal Employment Opportunity and Civil Rights.
Office of Chief Counsel.
Office of Internal Affairs.
Office of External Affairs
Office of AIDS and Special Health Issues.
Office of Consumer Affairs.
Office of Health Affairs.
Office of Legislative Affairs.
Office of Public Affairs.
Office of Women's Health.
Office of Management and Systems
Office of Planning and Evaluation.
Office of Management.
Office of Information Resources Management.
Office of Policy
Regulations Policy and Management Staff.
Policy Development and Coordination Staff.
Policy Research Staff.
International Policy Staff.
Office of Operations
Office of Biotechnology
Office of Orphan Products Development
National Center for Toxicological Research \2\
---------------------------------------------------------------------------
\2\ Mailing address: Jefferson, AR 72079-9502.
---------------------------------------------------------------------------
Office of the Center Director
Environmental Health and Program Assurance Staff.
Scientific Coordination Staff.
Equal Employment Opportunity Staff.
Technology Advancement Staff.
Office of Planning and Resource Management
Planning Staff.
Financial Management Staff.
Evaluation Staff.
Office of Research
Division of Reproductive and Developmental Toxicology.
Division of Genetic Toxicology.
Division of Biochemical Toxicology.
Division of Nutritional Toxicology.
Division of Biometry and Risk Assessment.
Division of Chemistry.
Division of Microbiology.
Division of Neurotoxicology.
Office of Research Support
Veterinary Services Staff.
Information Technology Staff.
Division of Administrative Services.
Division of Facilities Engineering and Maintenance.
Office of Regulatory Affairs
Office of the Associate Commissioner
Contaminants Policy Coordination Staff.
Equal Employment Opportunity Staff.
Strategic Initiatives Staff.
Office of Resource Management
Division of Planning, Evaluation, and Management.
Division of Information Systems.
Division of Human Resource Development.
Division of Management Operations.
Office of Enforcement
Division of Compliance Management and Operations.
Division of Compliance Policy.
Division of Medical Products Quality Assurance.
Office of Regional Operations
Division of Federal-State Relations.
Division of Field Science.
Division of Field Investigations.
Division of Emergency and Epidemiological Operations.
Division of Import Operations and Policy.
Office of Criminal Investigations \3\
---------------------------------------------------------------------------
\3\ Mailing address: 7500 Standish Pl., rm. 250N, Rockville, MD
20855.
---------------------------------------------------------------------------
Northeast Area Office.\4\
---------------------------------------------------------------------------
\4\ Mailing address: 10 Exchange Pl., 18th floor, Jersey City, NJ
07302.
---------------------------------------------------------------------------
Mid-Atlantic Area Office.3
Southeast Area Office.\5\
---------------------------------------------------------------------------
\5\ Mailing address: 8525 NW 53d Terrace, suite 204, Miami, FL
33166.
---------------------------------------------------------------------------
Midwest Area Office.\6\
---------------------------------------------------------------------------
\6\ Mailing address: 3 Arboretum 801 Warrenville Rd., suite 550,
Lisle, IL 60532.
---------------------------------------------------------------------------
Southwest Area Office.\7\
---------------------------------------------------------------------------
\7\ Mailing address: 10901 West 84th Terrace, suite 201, Lenexa, KS
66214-3338.
---------------------------------------------------------------------------
Pacific Area Office.\8\
---------------------------------------------------------------------------
\8\ Mailing address: 4365 Executive Dr., suite 230, San Diego, CA
92122.
---------------------------------------------------------------------------
Center for Biologics Evaluation and Research \9\
---------------------------------------------------------------------------
\9\ Mailing address: 1401 Rockville Pike, suite 200N, Rockville, MD
20852-1448.
---------------------------------------------------------------------------
Office of the Center Director
Equal Employment and Minority Recruitment Staff.
Congressional and Public Affairs Staff.
Scientific Advisors and Consultants Staff.
[[Page 67]]
Office of Management
Division of Management and Budget.
Division of Scientific and Management Information Systems.
Division of Administrative Management.
Office of Compliance
Division of Case Management.
Division of Bioresearch Monitoring and Regulations.
Division of Inspection and Surveillance.
Office of Therapeutics Research and Review
Division of Cytokine Biology.
Division of Cellular and Gene Therapies.
Division of Hematologic Products.
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 Allergenic Products and Parasitology.
Division of Bacterial Products.
Division of Viral Products.
Division of Vaccines and Related Products Applications.
Office of Establishment Licensing and Product Surveillance
Division of Product Quality Control.
Division of Veterinary Services.
Division of Biostatistics and Epidemiology.
Division of Establishment Licensing.
Office of Blood Research and Review
Division of Blood Applications.
Division of Transfusion Transmitted Diseases.
Division of Hematology.
Center for Drug Evaluation and Research 1
Office of the Center Director
Pilot Drug Evaluation Staff.
Advisors and Consultants Staff.
Professional Development Staff.
CDER Executive Secretariat Staff.
Equal Employment Opportunity Staff.
Office of Management
Division of Drug Information Resources.
Division of Information Systems Design.
Medical Library.
Division of Management and Budget.
Office of Compliance
Division of Drug Quality Evaluation.
Division of Drug Labeling Compliance.
Division of Manufacturing and Product Quality.
Division of Scientific Investigations.
Division of Regulatory Affairs.
Office of Drug Evaluation I
Division of Cardio-Renal Drug Products.
Division of Oncology and Pulmonary Drug Products.
Division of Neuropharmacological Drug Products.
Division of Medical Imaging, Surgical, and Dental Drug Products.
Division of Gastrointestinal and Coagulation Drug Products.
Office of Drug Evaluation II
Division of Anti-Infective Drug Products.
Division of Metabolism and Endocrine Drug Products.
Division of Anti-Viral Drug Products.
Division of Topical Drug Products.
Office of Drug Standards
Division of Drug Marketing, Advertising, and Communications.
Office of Epidemiology and Biostatistics
Division of Epidemiology and Surveillance.
Division of Biometrics.
Office of Generic Drugs \10\
---------------------------------------------------------------------------
\10\ Mailing address: 7500 Standish Pl., rm. 150, Rockville, MD
20855.
---------------------------------------------------------------------------
Division of Chemistry I.
Division of Chemistry II.
Division of Bioequivalence.
Division of Labeling and Program Support.
Office of Over-the-Counter Drug Evaluation
Monograph Review Staff.
OTC Drug Policy Staff.
Medical Review Staff.
Office of Research Resources
Division of Research and Testing.
Division of Biopharmaceutics.
Division of Drug Analysis.
Division of Clinical Pharmacology.
Center for Devices and Radiological Health\11\
---------------------------------------------------------------------------
\11\ Mailing address: 2094 Gaither Rd., Rockville, MD 20850.
---------------------------------------------------------------------------
Office of the Center Director
Office of Management Services
Division of Planning, Evaluation, and Information Services.
Division of Resource Management.
[[Page 68]]
Office of Health Physics11
Office of Health and Industry Programs\12\
---------------------------------------------------------------------------
\12\ Mailing address: 9200 Corporate Blvd., Rockville, MD 20850.
---------------------------------------------------------------------------
Office of Standards and Regulations11
Office of Information Systems\13\
---------------------------------------------------------------------------
\13\ Mailing address: 2098 Gaither Rd., Rockville, MD 20850.
---------------------------------------------------------------------------
Division of Computer Services.
Division of Information Resources.
Office of Compliance 11
Division of Program Operations.
Division of Bioresearch Monitoring.
Division of Enforcement 1.
Division of Enforcement 2.
Division of Enforcement 3.
Office of Device Evaluation 12
Division of Cardiovascular, Respiratory and Neurological Devices.
Division of Reproductive, Abdominal, Ear, Nose, and Throat, and
Radiological Devices.
Division of General and Restorative Devices.
Division of Clinical Laboratory Devices.\17\
---------------------------------------------------------------------------
\17\ See footnote 13.
---------------------------------------------------------------------------
Division of Ophthalmic Devices.
Office of Science and Technology 1
Division of Mechanics and Materials Science.
Division of Life Sciences.
Division of Physical Sciences.
Division of Electronics and Computer Science.
Division of Management, Information, and Support Services.
Office of Health and Industry Programs
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 Biometrics12
Division of Biostatistics.\14\
---------------------------------------------------------------------------
\14\ Mailing address: 9200 Corporate Blvd., Rockville, MD 20850.
---------------------------------------------------------------------------
Division of Postmarket Surveillance.
Division of Surveillance Systems.
Center for Food Safety and Applied Nutrition \15\
---------------------------------------------------------------------------
\15\ Mailing address: 200 C St. SW., Washington, DC 20204.
---------------------------------------------------------------------------
Office of the Center Director
Office of Policy, Planning, and Strategic Initiatives.
Office of Programs
Office of Cosmetics and Colors
Division of Programs and Enforcement Policy.
Division of Science and Applied Technology.
Office of Food Labeling
Division of Programs and Enforcement Policy.
Division of Technical Evaluation.
Division of Science and Applied Technology.
Office of Pre-Market Approval
Division of Product Policy.
Division of Petition Control.
Division of Health Effects Evaluation.
Division of Molecular Biological Research and Evaluation.
Division of Product Manufacture and Use.
Office of Plant and Dairy Foods and Beverages
Division of Programs and Enforcement Policy.
Division of Microanalytical Evaluations.
Division of Virulence Assessment.
Division of Pesticides and Industrial Chemicals.
Division of Natural Products.
Division of Food Processing and Packaging.
Office of Seafood
Division of Special Programs.
Division of Programs and Enforcement Policy.
Division of Science and Applied Technology.
Office of Special Nutritionals
Division of Programs and Enforcement Policy.
Division of Science and Applied Technology.
Office of Special Research Skills
Division of Toxicological Research.
Division of Microbiological Studies.
Office of Systems and Support
Quality Assurance Staff.
Office of Constituent Operations
Consumer Education Staff.
Legislative Activities Staff.
Industry Activities Staff.
International Activities Staff.
Office of Field Programs
Division of Enforcement.
Division of HACCP Programs.
Division of Cooperative Programs.
Division of Field Program Planning and Evaluation.
[[Page 69]]
Office of Management Systems
Division of Management Services and Policy.
Division of Planning and Financial Management.
Division of Information Resources Management.
Division of Administrative Services.
Office of Scientific Analysis and Support
Division of Mathematics.
Division of General Scientific Support.
Division of Market Studies.
Center for Veterinary Medicine \16\
---------------------------------------------------------------------------
\16\ Mailing address: 7500 Standish Pl., Rockville, MD 20855.
---------------------------------------------------------------------------
Office of the Center Director
Office of Management
Division of Program and Information Systems.
Division of Program Communications and Administrative Management.
Office of Surveillance and Compliance
Division of Compliance.
Division of Animal Feeds.
Division of Surveillance.
Division of Voluntary Compliance and Hearings Development.
Office of New Animal Drug Evaluation
Division of Biometrics and Production Drugs.
Division of Chemistry.
Division of Therapeutic Drugs for Food Animals.
Division of Therapeutic Drugs for Non-Food Animals.
Division of Toxicology and Environmental Sciences.
Office of Science
Division of Residue Chemistry.
Division of Animal Research.
[60 FR 16568, Mar. 31, 1995, as amended at 61 FR 8472, Mar. 5, 1996]
Sec. 5.105 Chief Counsel, Food and Drug Administration.
The Chief Counsel to the Commissioner of Food and Drugs is the
Associate General Counsel, Food and Drug Division, Office of the General
Counsel, Department of Health and Human Services, Room 6-57, 5600
Fishers Lane, Rockville, MD 20857.
[46 FR 8455, Jan. 27, 1981, as amended at 56 FR 8709, Mar. 1, 1991]
Sec. 5.110 FDA Public Information Offices.
(a) Dockets Management Branch (HFA-305). The Dockets Management
Branch Public Room is located in rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857. Telephone: 301-443-1753.
(b) Freedom of Information Staff (HFI-35). The Freedom of
Information Public Room is located in Room 12A-30, Parklawn Building,
5600 Fishers Lane, Rockville, MD 20857. Telephone: 301-443-6310.
(c) Press Relations Staff (HFI-40). Press Offices are located in
Room 15-05, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.
Telephone: 301-443-3285; and in Room 3807, FB-8, 200 C Street SW.,
Washington, DC 20204. Telephone: 202-245-1144.
[46 FR 8455, Jan. 27, 1981, as amended at 54 FR 9034, Mar. 3, 1989; 59
FR 14363, Mar. 28, 1994]
Sec. 5.115 Field structure.
NORTHEAST REGION
Regional Field Office: 830 Third Ave., Brooklyn, NY 11232.
Northeast Regional Laboratory: 850 Third Ave., Brooklyn , NY 11232.
New York District Office: 850 Third Ave., Brooklyn, NY 11232.
Boston District Office: One Montvale Ave., Stoneham, MA 02180.
Buffalo District Office: 599 Delaware Ave., Buffalo, NY 14202.
MID-ATLANTIC REGION
Regional Field Office: 900 U.S. Customhouse, Second and Chestnut Sts.,
Philadelphia, PA 19106.
Philadelphia District Office: 900 U.S. Customhouse, Second and Chestnut
Sts., Philadelphia, PA 19106.
Baltimore District Office: 900 Madison Ave., Baltimore, MD 21201.
Cincinnati District Office: 1141 Central Pkwy., Cincinnati, OH 45202-
1097.
Newark District Office: Waterview Corporate Center, 10 Waterview Blvd.,
3d floor, Parsippany, NJ 07054.
[[Page 70]]
SOUTHEAST REGION
Regional Field Office: 60 Eighth St. NE., Atlanta, GA 30309.
Southeast Regional Laboratory: 60 Eighth St. NE., Atlanta, GA 30309.
Atlanta District Office: 60 Eighth St. NE., Atlanta, GA 30309.
Nashville District Office: 297 Plus Park Blvd., Nashville, TN 37217.
New Orleans District Office: 4296 Elysian Fields Ave., New Orleans, LA
70122.
Orlando District Office: 7200 Lake Ellenor Dr., suite 120, Orlando, FL
32809.
San Juan District Office: 466 Fernandez Juncos Ave., San Juan, PR 00901-
3223.
MIDWEST REGION
Regional Field Office: 20 North Michigan Ave., rm. 510, Chicago, IL
60602.
Chicago District Office: 300 South Riverside Plaza, suite 550, South
Chicago, IL 60606.
Detroit District Office: 1560 East Jefferson Ave., Detroit, MI 48207.
Minneapolis District Office: 240 Hennepin Ave., Minneapolis, MN 55401.
SOUTHWEST REGION
Regional Field Office: 3032 Bryan St., Dallas, TX 75204.
Dallas District Office: 3032 Bryan 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 66214-3340.
St. Louis Branch: 808 North Collins Alley, St. Louis, MO 63102.
PACIFIC REGION
Regional Field Office: Federal Office Bldg., rm. 568, 50 U.N. Plaza, San
Francisco, CA 94102.
San Francisco District Office: Federal Office Bldg., rm. 526, 50 U.N.
Plaza, San Francisco, CA 94102.
Los Angeles District Office: 1521 West Pico Blvd., Los Angeles, CA
90015-2486.
Seattle District Office: 22201 23d Dr. SE., Bothell, WA 98021-4421.
[60 FR 16570, Mar. 31, 1995]
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)--Guidelines on
Policy, Procedures, and Industry Responsibilities
7.40 Recall policy.
7.41 Health hazard evaluation and recall classification.
7.42 Recall strategy.
7.45 Food and Drug Administration-requested recall.
7.46 Firm-initiated recall.
7.49 Recall communications.
7.50 Public notification of recall.
7.53 Recall status reports.
7.55 Termination of a recall.
7.59 General industry guidance.
Subpart D--[Reserved]
Subpart E--Criminal Violations
7.84 Opportunity for presentation of views before report of criminal
violation.
7.85 Conduct of a presentation of views before report of criminal
violation.
7.87 Records related to opportunities for presentation of views
conducted before report of criminal violation.
Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321-393); secs. 301, 351, 354-360F, 361 of the Public Health
Service Act (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 guidelines 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]
[[Page 71]]
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 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:
[[Page 72]]
(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.)
(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)--Guidelines on
Policy, Procedures, and Industry Responsibilities
Source: 43 FR 26218, June 16, 1978, unless otherwise noted.
[[Page 73]]
Sec. 7.40 Recall policy.
(a) Recall is an effective method of removing or correcting consumer
products that are in violation of laws administered by the Food and Drug
Administration. Recall is a voluntary action that takes place because
manufacturers and distributors carry out their responsibility to protect
the public health and well-being from products that present a risk of
injury or gross deception or are otherwise defective. This section and
Secs. 7.41 through 7.59 recognize the voluntary nature of recall by
providing guidelines 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.
Sec. 7.41 Health hazard evaluation and recall classification.
(a) An evaluation of the health hazard presented by a product being
recalled or considered for recall will be conducted by an ad hoc
committee of Food and Drug Administration scientists and will take into
account, but need not be limited to, the following factors:
(1) Whether any disease or injuries have already occurred from the
use of the product.
(2) Whether any existing conditions could contribute to a clinical
situation that could expose humans or animals to a health hazard. Any
conclusion shall be supported as completely as possible by scientific
documentation and/or statements that the conclusion is the opinion of
the individual(s) making the health hazard determination.
(3) Assessment of hazard to various segments of the population,
e.g., children, surgical patients, pets, livestock, etc., who are
expected to be exposed to the product being considered, with particular
attention paid to the hazard to those individuals who may be at greatest
risk.
(4) Assessment of the degree of seriousness of the health hazard to
which the populations at risk would be exposed.
(5) Assessment of the likelihood of occurrence of the hazard.
(6) Assessment of the consequences (immediate or long-range) of
occurrence of the hazard.
(b) On the basis of this determination, the Food and Drug
Administration will assign the recall a classification, i.e., Class I,
Class II, or Class III, to indicate the relative degree of health hazard
of the product being recalled or considered for recall.
Sec. 7.42 Recall strategy.
(a) General. (1) A recall strategy that takes into account the
following factors will be developed by the agency for a Food and Drug
Administration-requested recall and by the recalling firm for a firm-
initiated recall to suit the individual circumstances of the particular
recall:
(i) Results of health hazard evaluation.
(ii) Ease in identifying the product.
(iii) Degree to which the product's deficiency is obvious to the
consumer or user.
(iv) Degree to which the product remains unused in the market-place.
(v) Continued availability of essential products.
[[Page 74]]
(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 Dockets Management Branch (HFA-305), Food and Drug
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. The
recalling firm will ordinarily be responsible for conducting
effectiveness checks, but the Food and Drug Administration will assist
in this task where necessary and appropriate. The recall strategy will
specify the method(s) to be used for and the level of effectiveness
checks that will be conducted, as follows:
(i) Level A--100 percent of the total number of consignees to be
contacted;
(ii) Level B--Some percentage of the total number of consignees to
be contacted, which percentage is to be determined on a case-by-case
basis, but is greater that 10 percent and less than 100 percent of the
total number of consignees;
(iii) Level C--10 percent of the total number of consignees to be
contacted;
(iv) Level D--2 percent of the total number of consignees to be
contacted; or
(v) Level E--No effectiveness checks.
[43 FR 26218, June 16, 1978, as amended at 46 FR 8455, Jan. 27, 1981; 59
FR 14363, Mar. 28, 1994]
Sec. 7.45 Food and Drug Administration-requested recall.
(a) The Commissioner of Food and Drugs or his designee under
Sec. 5.20 of this chapter may request a firm to initiate a recall when
the following determinations have been made:
(1) That a product that has been distributed presents a risk of
illness or injury or gross consumer deception.
(2) That the firm has not initiated a recall of the product.
(3) That an agency action is necessary to protect the public health
and welfare.
(b) The Commissioner or his designee will notify the firm of this
determination and of the need to begin immediately a recall of the
product. Such notification will be by letter or telegram to a
responsible official of the
[[Page 75]]
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.
(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.
[[Page 76]]
(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 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
[[Page 77]]
quatity of products on hand at the time it was received.
(3) Number of consignees that did not respond (if needed, the
identity of nonresponding consignees may be requested by the Food and
Drug Administration).
(4) Number of products returned or corrected by each consignee
contacted and the quantity of products accounted for.
(5) Number and results of effectiveness checks that were made.
(6) Estimated time frames for completion of the recall.
(c) Recall status reports are to be discontinued when the recall is
terminated by the Food and Drug Administration.
Sec. 7.55 Termination of a recall.
(a) A recall will be terminated when the Food and Drug
Administration determines that all reasonable efforts have been made to
remove or correct the product in accordance with the recall strategy,
and when it is reasonable to assume that the product subject to the
recall has been removed and proper disposition or correction has been
made commensurate with the degree of hazard of the recalled product.
Written notification that a recall is terminated will be issued by the
appropriate Food and Drug Administration district office to the
recalling firm.
(b) A recalling firm may request termination of its recall by
submitting a written request to the appropriate Food and Drug
Adminstration district office stating that the recall is effective in
accordance with the criteria set forth in paragraph (a) of this section,
and by accompanying the request with the most current recall status
report and a description of the disposition of the recalled product.
Sec. 7.59 General industry guidance.
A recall can be disruptive of a firm's operation and business, but
there are several steps a prudent firm can take in advance to minimize
this disruptive effect. Notwithstanding similar specific requirements
for certain products in other parts of this chapter, the following is
provided by the Food and Drug Administration as guidance for a firm's
consideration:
(a) Prepare and maintain a current written contingency plan for use
in initiating and effecting a recall in accordance with Secs. 7.40
through 7.49, 7.53, and 7.55.
(b) Use sufficient coding of regulated products to make possible
positive lot identification and to facilitate effective recall of all
violative lots.
(c) Maintain such product distribution records as are necessary to
facilitate location of products that are being recalled. Such records
should be maintained for a period of time that exceeds the shelf life
and expected use of the product and is at least the length of 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
[[Page 78]]
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 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
[[Page 79]]
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 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
[[Page 80]]
been concluded, or when the statute of limitations has run.
(c) Before disclosure of any record specifically reflecting
consideration of a possible recommendation for criminal prosecution of
any individual, all names and other information that would identify an
individual whose prosecution was considered but not recommended, or who
was not prosecuted, shall be deleted, unless the Commissioner concludes
that there is a compelling public interest in the disclosure of the
names.
(d) Names and other information that would identify a Food and Drug
Administration employee shall be deleted from records related to a
section 305 presentation of views before public disclosure only under
Sec. 20.32 of this chapter.
[44 FR 12168, Mar. 6, 1979]
PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES--Table of Contents
Subpart A--General Provisions
Sec.
10.1 Scope.
10.3 Definitions.
10.10 Summaries of administrative practices and procedures.
10.19 Waiver, suspension, or modification of procedural requirements.
Subpart B--General Administrative Procedures
10.20 Submission of documents to Dockets Management Branch; computation
of time; availability for public disclosure.
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, guidelines,
recommendations, and agreements.
10.95 Participation in outside standard setting activities.
10.100 Public calendars.
10.105 Representation by an organization.
10.110 Settlement proposals.
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: Secs. 201-903 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321-394); 21 U.S.C. 41-50, 141-149, 467f, 679, 821, 1034;
secs. 2, 351, 354, 361 of the Public Health Service Act (42 U.S.C. 201,
262, 263b, 264); secs. 2-12 of the Fair Packaging and Labeling Act (15
U.S.C. 1451-1461); 5 U.S.C. 551-558, 701-721; 28 U.S.C. 2112.
Source: 44 FR 22323, Apr. 13, 1979, unless otherwise noted.
Subpart A--General Provisions
Sec. 10.1 Scope.
(a) Part 10 governs practices and procedures for petitions,
hearings, and other administrative proceedings and activities conducted
by the Food and Drug Administration under the Federal Food, Drug, and
Cosmetic Act, the Public Health Service Act, and other laws that the
Commissioner of Food and Drugs administers under Sec. 5.10.
(b) If a requirement in another part of title 21 differs from a
requirement in this part, the requirements of this part apply to the
extent that they do not conflict with the other requirements.
(c) References in this part and parts 12, 13, 14, 15, and 16 to
regulatory sections of the Code of Federal Regulations are to chapter I
of title 21 unless otherwise noted.
(d) References in this part and parts 12, 13, 14, 15, and 16 to
publication, or to the day or date of publication, or use of the phrase
to publish, refer to
[[Page 81]]
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.
Dockets Management Branch means the Dockets Management Branch,
Office of Management and Operations of the Food and Drug Administration,
U.S. Department of Health and Human Services, rm. 1-23, 12420 Parklawn
Dr., Rockville, MD 20857.
Ex parte communication means an oral or written communication not on
the public record for which reasonable prior notice to all parties is
not given, but does not include requests for status reports on a matter.
FDA means the Food and Drug Administration.
Food and Drug Administration employee or Food and Drug
Administration representative includes members of the Food and Drug
Division of the office of the General Counsel of the Department of
Health and Human Services.
Formal evidentiary public hearing means a hearing conducted under
part 12.
Interested person or any person who will be adversely affected means
a person who submits a petition or comment or objection or otherwise
asks to participate in an informal or formal administrative proceeding
or court action.
Meeting means any oral discussion, whether by telephone or in
person.
Office of the Commissioner includes the offices of the Associate
Commissioners but not the centers or the regional or district offices.
Order means the final agency disposition, other than the issuance of
a regulation, in a proceeding concerning any matter and includes action
on a new drug application, new animal drug application, or biological
license.
Participant means any person participating in any proceeding,
including each party and any other interested person.
Party means the center of the Food and Drug Administration
responsible for a matter involved and every person who either has
exercised a right to request or has been granted the right by the
Commissioner to have a hearing under part 12 or part 16 or who has
waived the right to a hearing to obtain the establishment of a Public
Board of Inquiry under part 13 and as a result of whose action a hearing
or a Public Board of Inquiry has been established.
Person includes an individual, partnership, corporation,
association, or other legal entity.
Petition means a petition, application, or other document requesting
the Commissioner to establish, amend, or revoke a regulation or order,
or to take or not to take any other form of administrative action, under
the laws administered by the Food and Drug Administration.
Presiding officer means the Commissioner or the Commissioner's
designee or an administrative law judge appointed as provided in 5
U.S.C. 3105.
[[Page 82]]
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]
Sec. 10.10 Summaries of administrative practices and procedures.
To encourage public participation in all agency activities, the
Commissioner will prepare for public distribution summaries of FDA
administrative practices and procedures in readily understandable terms.
Sec. 10.19 Waiver, suspension, or modification of procedural requirements.
The Commissioner or a presiding officer may, either voluntarily or
at the request of a participant, waive, suspend, or modify any provision
in parts 12 through 16 applicable to the conduct of a public hearing by
announcement at the hearing or by notice in advance of the hearing if no
participant will be prejudiced, the ends of justice will thereby be
served, and the action is in accordance with law.
Subpart B--General Administrative Procedures
Sec. 10.20 Submission of documents to Dockets Management Branch; computation of time; availability for public disclosure.
(a) A submission to the Dockets Management Branch of a petition,
comment, objection, notice, compilation of information, or any other
document is to be filed in four copies except as otherwise specifically
provided in a relevant Federal Register notice or in another section of
this chapter. The Dockets Management Branch is the agency custodian of
these documents.
(b) A submission is to be signed by the person making it, or by an
attorney or other authorized representative of that person. Submissions
by trade associations are also subject to the requirements of
Sec. 10.105(b).
(c) Information referred to or relied upon in a submission is to be
included in full and may not be incorporated by
[[Page 83]]
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;
(iv) A recognized medical or scientific textbook that is readily
available to the agency; or
(v) A designated journal listed in Sec. 510.95.
(2) If a part of the material submitted is in a foreign language, it
must be accompanied by an English translation verified to be complete
and accurate, together with the name, address, and a brief statement of
the qualifications of the person making the translation. A translation
of literature or other material in a foreign language is to be
accompanied by copies of the original publication.
(3) Where relevant information is contained in a document also
containing irrelevant information, the irrelevant information is to be
deleted and only the relevant information is to be submitted.
(4) Under Sec. 20.63 (a) and (b), the names and other information
that would identify patients or research subjects are to be deleted from
any record before it is submitted to the Dockets Management Branch in
order to preclude a clearly unwarranted invasion of personal privacy.
(5) Defamatory, scurrilous, or intemperate matter is to be deleted
from a record before it is submitted to the Dockets Management Branch.
(6) The failure to comply with the requirements of this part or with
Sec. 12.80 or Sec. 13.20 will result in rejection of the submission for
filing or, if it is filed, in exclusion from consideration of any
portion that fails to comply. If a submission fails to meet any
requirement of this section and the deficiency becomes known to the
Dockets Management Branch, the Dockets Management Branch shall not file
the submission but return it with a copy of the applicable regulations
indicating those provisions not complied with. A deficient submission
may be corrected or supplemented and subsequently filed. The office of
the Dockets Management Branch does not make decisions regarding the
confidentiality of submitted documents. Persons wishing to voluntarily
submit information considered confidential shall follow the
presubmission review requirements of Sec. 20.44.
(d) The filing of a submission means only that the Dockets
Management Branch has identified no technical deficiencies in the
submission. The filing of a petition does not mean or imply that it
meets all applicable requirements or that it contains reasonable grounds
for the action requested or that the action requested is in accordance
with law.
(e) All submissions to the Dockets Management Branch will be
considered as submitted on the date they are postmarked or, if delivered
in person during regular business hours, on the date they are delivered,
unless a provision in this part, an applicable Federal Register notice,
or an order issued by an administrative law judge specifically states
that the documents must be received by a specified date, e.g.,
Sec. 10.33(g) relating to a petition for reconsideration, in which case
they will be considered submitted on the date received.
(f) All submissions are to be mailed or delivered in person to the
Dockets Management Branch, Food and Drug Administration, rm. 1-23, 12420
Parklawn Dr., Rockville, MD 20857, except that a submission which is
required to be received by the Branch by a specified date may be
delivered in person to the FDA building in Washington (Room 6819, 200 C
Street SW., Washington, DC 20204) and will be considered as received by
the Branch on the date on which it is delivered.
(g) FDA ordinarily will not acknowledge or give receipt for
documents, except:
(1) Documents delivered in person or by certified or registered mail
with a return receipt requested; and
(2) Petitions for which acknowledgment of receipt of filing is
provided by regulation or by customary practice, e.g., Sec. 10.30(c)
relating to a citizen petition.
[[Page 84]]
(h) Saturdays, Sundays, and Federal legal holidays are included in
computing the time allowed for the submission of documents, except that
when the time for submission expires on a Saturday, Sunday, or Federal
legal holiday, the period will be extended to include the next business
day.
(i) All submissions to the Dockets Management Branch are
representations that, to the best of the knowledge, information, and
belief of the person making the submission, the statements made in the
submission are true and accurate. All submissions are subject to the
False Reports to the Government Act (18 U.S.C. 1001) under which a
willfully false statement is a criminal offense.
(j) The availability for public examination and copying of
submissions to the Dockets Management Branch is governed by the
following rules:
(1) Except to the extent provided in paragraphs (j)(2) and (3) of
this section, the following submissions, including all supporting
material, will be on public display and will be available for public
examination between 9 a.m. and 4 p.m., Monday through Friday. Requests
for copies of submissions will be filed and handled in accordance with
subpart C of part 20:
(i) Petitions.
(ii) Comments on petitions, on documents published in the Federal
Register, and on similar public documents.
(iii) Objections and requests for hearings filed under part 12.
(iv) Material submitted at a hearing under Sec. 12.32(a)(2) and
parts 12, 13, and 15.
(v) Material placed on public display under the regulations in this
chapter, e.g., agency guidelines filed under Sec. 10.90(b).
(2)(i) Material prohibited from public disclosure under Sec. 20.63
(clearly unwarranted invasion of personal privacy) and, except as
provided in paragraph (j)(3) of this section, material submitted with
objections and requests for hearing filed under part 12, or at a hearing
under part 12 or part 13, or an alternative form of public hearing
before a public advisory committee or a hearing under Sec. 12.32(a) (2)
or (3), of the following types will not be on public display, will not
be available for public examination, and will not be available for
copying or any other form of verbatim transcription unless it is
otherwise available for public disclosure under part 20:
(a) Safety and effectiveness information, which includes all studies
and tests of an ingredient or product on animals and humans and all
studies and tests on the ingredient or product for identity, stability,
purity, potency, bioavailability, performance, and usefulness.
(b) A protocol for a test or study.
(c) Manufacturing methods or processes, including quality control
procedures.
(d) Production, sales distribution, and similar information, except
any compilation of information aggregated and prepared in a way that
does not reveal confidential information.
(e) Quantitative or semiquantitative formulas.
(f) Information on product design or construction.
(ii) Material submitted under paragraph (j)(2) of this section is to
be segregated from all other submitted material and clearly so marked. A
person who does not agree that a submission is properly subject to
paragraph (j)(2) may request a ruling from the Associate Commissioner
for Public Affairs whose decision is final, subject to judicial review
under Sec. 20.46.
(3) Material listed in paragraph (j)(2)(i) (a) and (b) of this
section may be disclosed under a protective order issued by the
administrative law judge or other presiding officer at a hearing
referenced in paragraph (j)(2)(i). The administrative law judge or
presiding officer shall permit disclosure of the data only in camera and
only to the extent necessary for the proper conduct of the hearing. The
administrative law judge or presiding officer shall direct to whom the
information is to be made available (e.g., to parties or participants,
or only to counsel for parties or participants), and persons not
specifically permitted access to the data will be excluded from the in
camera part of the proceeding. The administrative law judge or other
presiding officer may impose other conditions or safeguards. The limited
availability of material
[[Page 85]]
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]
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)__________________________________________________________________
Dockets Management Branch, Food and Drug Administration, Department
of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville,
MD 20857.
Citizen Petition
The undersigned submits this petition under ------ (relevant
statutory sections, if known) of the ------ (Federal Food, Drug, and
Cosmetic Act or the Public Health Service Act or any other statutory
provision for which authority has been delegated to the Commissioner of
Food and Drugs under 21 CFR 5.10) to request the Commissioner of Food
and Drugs to ------ (issue, amend, or revoke a regulation or order or
take or refrain from taking any other form of administrative action).
A. Action requested
((1) If the petition requests the Commissioner to issue, amend, or
revoke a regulation, the exact wording of the existing regulation (if
any) and the proposed regulation or amendment requested.)
((2) If the petition requests the Commissioner to issue, amend, or
revoke an order, a copy of the exact wording of the citation to the
existing order (if any) and the exact wording requested for the proposed
order.)
((3) If the petition requests the Commissioner to take or refrain
from taking any other form of administrative action, the specific action
or relief requested.)
B. Statement of grounds
(A full statement, in a well organized format, of the factual and
legal grounds on which the petitioner relies, including all relevant
information and views on which the petitioner relies, as well as
representative information known to the petitioner which is unfavorable
to the petitioner's position.)
[[Page 86]]
C. Environmental impact
(A claim for categorical exclusion under Sec. 25.24 of this chapter
or an environmental assessment under Sec. 25.31 of this chapter.)
D. Economic impact
(The following information is to be submitted only when requested by
the Commissioner following review of the petition: A statement of the
effect of requested action on: (1) Cost (and price) increases to
industry, government, and consumers; (2) productivity of wage earners,
businesses, or government; (3) competition; (4) supplies of important
materials, products, or services; (5) employment; and (6) energy supply
or demand.)
E. Certification
The undersigned certifies, that, to the best knowledge and belief of
the undersigned, this petition includes all information and views on
which the petition relies, and that it includes representative data and
information known to the petitioner which are unfavorable to the
petition.
(Signature)_____________________________________________________________
(Name of petitioner)____________________________________________________
(Mailing address)_______________________________________________________
(Telephone number)______________________________________________________
(c) A petition which appears to meet the requirements of paragraph
(b) of this section and Sec. 10.20 will be filed by the Dockets
Management Branch, stamped with the date of filing, and assigned a
docket number. The docket number identifies the file established by the
Dockets Management Branch for all submissions relating to the petition,
as provided in this part. Subsequent submissions relating to the matter
must refer to the docket number and will be filed in the docket file.
Related petitions may be filed together and given the same docket
number. The Dockets Management Branch will promptly notify the
petitioner in writing of the filing and docket number of a petition.
(d) An interested person may submit written comments to the Dockets
Management Branch on a filed petition, which comments become part of the
docket file. The comments are to specify the docket number of the
petition and may support or oppose the petition in whole or in part. A
request for alternative or different administrative action must be
submitted as a separate petition.
(e)(1) The Commissioner shall, in accordance with paragraph (e)(2),
rule upon each petition filed under paragraph (c) of this section,
taking into consideration (i) available agency resources for the
category of subject matter, (ii) the priority assigned to the petition
considering both the category of subject matter involved and the overall
work of the agency, and (iii) time requirements established by statute.
(2) Except as provided in paragraph (e)(4) of this section, the
Commissioner shall furnish a response to each petitioner within 180 days
of receipt of the petition. The response will either:
(i) Approve the petition, in which case the Commissioner shall
concurrently take appropriate action (e.g., publication of a Federal
Register notice) implementing the approval;
(ii) Deny the petition; or
(iii) Provide a tentative response, indicating why the agency has
been unable to reach a decision on the petition, e.g., because of the
existence of other agency priorities, or a need for additional
information. The tentative response may also indicate the likely
ultimate agency response, and may specify when a final response may be
furnished.
(3) The Commissioner may grant or deny such a petition, in whole or
in part, and may grant such other relief or take other action as the
petition warrants. The petitioner is to be notified in writing of the
Commissioner's decision. The decision will be placed in the public
docket file in the office of the Dockets Management Branch and may also
be in the form of a notice published in the Federal Register.
(4) The Commissioner shall furnish a response to each petitioner
within 90 days of receipt of a petition filed under section 505(j)(2)(C)
of the act. The response will either approve or disapprove the petition.
Agency action on a petition shall be governed by Sec. 314.93 of this
chapter.
(f) If a petition filed under paragraph (c) of this section requests
the Commissioner to issue, amend, or revoke a regulation, Sec. 10.40 or
Sec. 10.50 also apply.
(g) A petitioner may supplement, amend, or withdraw a petition in
writing without agency approval and without prejudice to resubmission at
anytime until the Commissioner rules on
[[Page 87]]
the petition, unless the petition has been referred for a hearing under
parts 12, 13, 14, or 15. After a ruling or referral, a petition may be
supplemented, amended, or withdrawn only with the approval of the
Commissioner. The Commissioner may approve withdrawal, with or without
prejudice against resubmission of the petition.
(h) In reviewing a petition the Commissioner may use the following
procedures:
(1) Conferences, meetings, discussions, and correspondence under
Sec. 10.65.
(2) A hearing under parts 12, 13, 14, 15, or 16.
(3) A Federal Register notice requesting information and views.
(4) A proposal to issue, amend, or revoke a regulation, in
accordance with Sec. 10.40 or Sec. 12.20.
(5) Any other specific public procedure established in this chapter
and expressly applicable to the matter.
(i) The record of the administrative proceeding consists of the
following:
(1) The petition, including all information on which it relies,
filed by the Dockets Management Branch.
(2) All comments received on the petition, including all information
submitted as a part of the comments.
(3) If the petition resulted in a proposal to issue, amend, or
revoke a regulation, all of the documents specified in Sec. 10.40(g).
(4) The record, consisting of any transcripts, minutes of meetings,
reports, Federal Register notices, and other documents resulting from
the optional procedures specified in paragraph (h) of this section,
except a transcript of a closed portion of a public advisory committee
meeting.
(5) The Commissioner's decision on the petition, including all
information identified or filed by the Commissioner with the Dockets
Management Branch as part of the record supporting the decision.
(6) All documents filed with the Dockets Management Branch under
Sec. 10.65(h).
(7) If a petition for reconsideration or for a stay of action is
filed under paragraph (j) of this section, the administrative record
specified in Sec. 10.33(k) or Sec. 10.35(h).
(j) The administrative record specified in paragraph (i) of this
section is the exclusive record for the Commissioner's decision. The
record of the administrative proceeding closes on the date of the
Commissioner's decision unless some other date is specified. Thereafter
any interested person may submit a petition for reconsideration under
Sec. 10.33 or a petition for stay of action under Sec. 10.35. A person
who wishes to rely upon information or views not included in the
administrative record shall submit them to the Commissioner with a new
petition to modify the decision in accordance with this section.
(k) This section does not apply to the referral of a matter to a
United States attorney for the initiation of court enforcement action
and related correspondence, or to requests, suggestions, and
recommendations made informally in routine correspondence received by
FDA. Routine correspondence does not constitute a petition within the
meaning of this section unless it purports to meet the requirements of
this section. Action on routine correspondence does not constitute final
administrative action subject to judicial review under Sec. 10.45.
(l) The Dockets Management Branch will maintain a chronological list
of each petition filed under this section and Sec. 10.85, but not of
petitions submitted elsewhere in the agency under Sec. 10.25(a)(1),
showing:
(1) The docket number;
(2) The date the petition was filed by the Dockets Management
Branch;
(3) The name of the petitioner;
(4) The subject matter involved; and
(5) The disposition of the petition.
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 50
16656, Apr. 26, 1985; 54 FR 9034, Mar. 3, 1989; 57 FR 17980, Apr. 28,
1992; 59 FR 14364, Mar. 28, 1994]
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
[[Page 88]]
in accordance with Sec. 10.20 and in the following form no later than 30
days after the date of the decision involved. The Commissioner may, for
good cause, permit a petition to be filed after 30 days. In the case of
a decision published in the Federal Register, the day of publication is
the day of decision.
(Date)__________________________________________________________________
Dockets Management Branch, Food and Drug Administration, Department
of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville,
MD 20857.
Petition for Reconsideration
[Docket No.]
The undersigned submits this petition for reconsideration of the
decision of the Commissioner of Food and Drugs in Docket No. ------.
A. Decision involved
(A concise statement of the decision of the Commissioner which the
petitioner wishes to have reconsidered.)
B. Action requested
(The decision which the petitioner requests the Commissioner to make
upon reconsideration of the matter.)
C. Statement of grounds
(A full statement, in a well-organized format, of the factual and
legal grounds upon which the petitioner relies. The grounds must
demonstrate that relevant information and views contained in the
administrative record were not previously or not adequately considered
by the Commissioner.
(No new information or views may be included in a petition for
reconsideration.)
(Signature)_____________________________________________________________
(Name of petitioner)____________________________________________________
(Mailing address)_______________________________________________________
(Telephone number)______________________________________________________
(c) A petition for reconsideration relating to a petition submitted
under Sec. 10.25(a)(2) is subject to the requirements of Sec. 10.30 (c)
and (d), except that it is filed in the same docket file as the petition
to which it relates.
(d) The Commissioner shall promptly review a petition for
reconsideration. The Commissioner may grant the petition when the
Commissioner determines it is in the public interest and in the interest
of justice. The Commissioner shall grant a petition for reconsideration
in any proceeding if the Commissioner determines all of the following
apply:
(1) The petition demonstrates that relevant information or views
contained in the administrative record were not previously or not
adequately considered.
(2) The petitioner's position is not frivolous and is being pursued
in good faith.
(3) The petitioner has demonstrated sound public policy grounds
supporting reconsideration.
(4) Reconsideration is not outweighed by public health or other
public interests.
(e) A petition for reconsideration may not be based on information
and views not contained in the administrative record on which the
decision was made. An interested person who wishes to rely on
information or views not included in the administrative record shall
submit them with a new petition to modify the decision under
Sec. 10.25(a).
(f) The decision on a petition for reconsideration is to be in
writing and placed on public display as part of the docket file on the
matter in the office of the Dockets Management Branch. A determination
to grant reconsideration will be published in the Federal Register if
the Commissioner's original decision was so published. Any other
determination to grant or deny reconsideration may also be published in
the Federal Register.
(g) The Commissioner may consider a petition for reconsideration
only before the petitioner brings legal action in the courts to review
the action, except that a petition may also be considered if the
Commissioner has denied a petition for stay of action and the petitioner
has petitioned for judicial review of the Commissioner's action and
requested the reviewing court to grant a stay pending consideration of
review. A petition for reconsideration submitted later than 30 days
after the date of the decision involved will be denied as untimely
unless the Commissioner permits the petition to be filed after 30 days.
A petition for reconsideration will be considered as submitted on the
day it is received by the Dockets Management Branch.
(h) The Commissioner may initiate the reconsideration of all or part
of a
[[Page 89]]
matter at any time after it has been decided or action has been taken.
If review of the matter is pending in the courts, the Commissioner may
request that the court refer the matter back to the agency or hold its
review in abeyance pending administrative reconsideration. The
administrative record of the proceeding is to include all additional
documents relating to such reconsideration.
(i) After determining to reconsider a matter, the Commissioner shall
review and rule on the merits of the matter under Sec. 10.30(e). The
Commissioner may reaffirm, modify, or overrule the prior decision, in
whole or in part, and may grant such other relief or take such other
action as is warranted.
(j) The Commissioner's reconsideration of a matter relating to a
petition submitted under Sec. 10.25(a)(2) is subject to Sec. 10.30 (f)
through (h), (j), and (k).
(k) The record of the administrative proceeding consists of the
following:
(1) The record of the original petition specified in Sec. 10.30(i).
(2) The petition for reconsideration, including all information on
which it relies, filed by the Dockets Management Branch.
(3) All comments received on the petition, including all information
submitted as a part of the comments.
(4) The Commissioner's decision on the petition under paragraph (f)
of this section, including all information identified or filed by the
Commissioner with the Dockets Management Branch as part of the record
supporting the decision.
(5) Any Federal Register notices or other documents resulting from
the petition.
(6) All documents filed with the Dockets Management Branch under
Sec. 10.65(h).
(7) If the Commissioner reconsiders the matter, the administrative
record relating to reconsideration specified in Sec. 10.30(i).
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 59
FR 14364, Mar. 28, 1994]
Sec. 10.35 Administrative stay of action.
(a) The Commissioner may at any time stay or extend the effective
date of an action pending or following a decision on any matter.
(b) An interested person may request the Commissioner to stay the
effective date of any administrative action. A stay may be requested for
a specific time period or for an indefinite time period. A request for
stay must be submitted in accordance with Sec. 10.20 and in the
following form no later than 30 days after the date of the decision
involved. The Commissioner may, for good cause, permit a petition to be
filed after 30 days. In the case of a decision published in the Federal
Register, the day of publication is the date of decision.
(Date)__________________________________________________________________
Dockets Management Branch, Food and Drug Administration, Department
of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville,
MD 20857.
Petition for Stay of Action
The undersigned submits this petition requesting that the
Commissioner of Food and Drugs stay the effective date of the following
matter.
A. Decision involved
(The specific administrative action being taken by the Commissioner
for which a stay is requested, including the docket number or other
citation to the action involved.)
B. Action requested
(The length of time for which the stay is requested, which may be
for a specific or indefinite time period.)
C. Statement of grounds
(A full statement, in a well-organized format, of the factual and
legal grounds upon which the petitioner relies for the stay.)
(Signature)_____________________________________________________________
(Name of petitioner)____________________________________________________
(Mailing address)_______________________________________________________
(Telephone number)______________________________________________________
(c) A petition for stay of action relating to a petition submitted
under Sec. 10.25(a)(2) is subject to the requirements of Sec. 10.30 (c)
and (d), except that it will be filed in the same docket file as the
petition to which it relates.
(d) Neither the filing of a petition for a stay of action nor action
taken by an interested person in accordance with any other
administrative procedure in this part or in any other section of this
chapter, e.g., the filing of a citizen
[[Page 90]]
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 Dockets Management Branch. A determination
to grant a stay will be published in the Federal Register if the
Commissioner's original decision was so published. Any other
determination to grant or to deny a stay may also be published in the
Federal Register.
(g) A petition for a stay of action submitted later than 30 days
after the date of the decision involved will be denied as untimely
unless the Commissioner permits the petition to be filed after 30 days.
A petition for a stay of action is considered submitted on the day it is
received by the Dockets Management Branch.
(h) The record of the administrative proceeding consists of the
following:
(1) The record of the proceeding to which the petition for stay of
action is directed.
(2) The petition for stay of action, including all information on
which it relies, filed by the Dockets Management Branch.
(3) All comments received on the petition, including all information
submitted as a part of the comments.
(4) The Commissioner's decision on the petition under paragraph (e)
of this section, including all information identified or filed by the
Commissioner with the Dockets Management Branch as part of the record
supporting the decision.
(5) Any Federal Register notices or other documents resulting from
the petition.
(6) All documents filed with the Dockets Management Branch under
Sec. 10.65(h).
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 54
FR 9034, Mar. 3, 1989; 59 FR 14364, Mar. 28, 1994]
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
[[Page 91]]
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 Dockets
Management Branch), and cites the authority under which the regulation
is proposed;
(viii) either the terms or substance of the proposed regulation or a
description of the subjects and issues involved;
(ix) a reference to the existence or lack of need for an
environmental impact statement under Sec. 25.42(b)(3) (ii) or (iii); and
(x) the docket number of the matter, which identifies the docket
file established by the Dockets Management Branch for all relevant
submissions.
(2) The proposal will provide 60 days for comment, although the
Commissioner may shorten or lengthen this time period for good cause. In
no event is the time for comment to be less than 10 days.
(3) After publication of the proposed rule, any interested person
may request the Commissioner to extend the comment period for an
additional specified period by submitting a written request to the
Dockets Management Branch stating the grounds for the request. The
request is submitted under Sec. 10.35 but should be headed ``REQUEST FOR
EXTENSION OF COMMENT PERIOD.''
(i) A request must discuss the reason comments could not feasibly be
submitted within the time permitted, or that important new information
will shortly be available, or that sound public policy otherwise
supports an extension of the time for comment. The Commissioner may
grant or deny the request or may grant an extension for a time period
different from that requested. An extension may be limited to specific
persons who have made and justified the request, but will ordinarily
apply to all interested persons.
(ii) A comment time extension of 30 days or longer will be published
in the Federal Register and will be applicable to all interested
persons. A comment time extension of less than 30 days will be the
subject either of a letter or memorandum filed with the Dockets
Management Branch or of a notice published in the Federal Register.
(4) A notice of proposed rulemaking will request that four copies of
all comments be submitted to the Dockets Management Branch, except that
individuals may submit single copies. Comments will be stamped with the
date of receipt and will be numbered chronologically.
(5) Persons submitting comments critical of a proposed regulation
are encouraged to include their preferred alternative wording.
(c) After the time for comment on a proposed regulation has expired,
the Commissioner will review the entire administrative record on the
matter, including all comments and, in a notice published in the Federal
Register, will terminate the proceeding, issue a new proposal, or
promulgate a final regulation.
(1) The quality and persuasiveness of the comments will be the basis
for the Commissioner's decision. The number
[[Page 92]]
or length of comments will not ordinarily be a significant factor in the
decision unless the number of comments is material where the degree of
public interest is a legitimate factor for consideration.
(2) The decision of the Commissioner on the matter will be based
solely upon the administrative record.
(3) A final regulation published in the Federal Register will have a
preamble stating: (i) The name of the agency, (ii) the nature of the
action e.g., final rule, notice, (iii) a summary first paragraph
describing the substance of the document in easily understandable terms,
(iv) relevant dates, e.g., the rule's effective date and comment closing
date, if an opportunity for comment is provided, (v) the name, business
address, and phone number of an agency contact person who can provide
further information to the public about the notice, (vi) an address for
the submission of written comments when they are permitted, (vii)
supplementary information about the regulation in the body of the
preamble that contains references to prior notices relating to the same
matter and a summary of each type of comment submitted on the proposal
and the Commissioner's conclusions with respect to each. The preamble is
to contain a thorough and comprehensible explanation of the reasons for
the Commissioner's decision on each issue.
(4) The effective date of a final regulation may not be less than 30
days after the date of publication in the Federal Register, except for:
(i) A regulation that grants an exemption or relieves a restriction;
or
(ii) A regulation for which the Commissioner finds, and states in
the notice good cause for an earlier effective date.
(d) The provisions for notice and comment in paragraphs (b) and (c)
of this section apply only to the extent required by the Administrative
Procedure Act (5 U.S.C. 551, 552, and 553). As a matter of discretion,
however, the Commissioner may voluntarily follow those provisions in
circumstances in which they are not required by the Administrative
Procedure Act.
(e) The requirements of notice and public procedure in paragraph (b)
of this section do not apply in the following situations:
(1) When the Commissioner determines for good cause that they are
impracticable, unnecessary, or contrary to the public interest. In these
cases, the notice promulgating the regulation will state the reasons for
the determination, and provide an opportunity for comment to determine
whether the regulation should subsequently be modified or revoked. A
subsequent notice based on those comments may, but need not, provide
additional opportunity for public comment.
(2) Food additive and color additive petitions, which are subject to
the provisions of Sec. 12.20(b)(2).
(3) New animal drug regulations, which are promulgated under section
512(i) of the act.
(f) In addition to the notice and public procedure required under
paragraph (b) of this section, the Commissioner may also subject a
proposed or final regulation, before or after publication in the Federal
Register, to the following additional procedures:
(1) Conferences, meetings, discussions, and correspondence under
Sec. 10.65.
(2) A hearing under parts 12, 13, 14, or 15.
(3) A notice published in the Federal Register requesting
information and views before the Commissioner determines whether to
propose a regulation.
(4) A draft of a proposed regulation placed on public display in the
office of the Dockets Management Branch. If this procedure is used, the
Commissioner shall publish an appropriate notice in the Federal Register
stating that the document is available and specifying the time within
which comments on the draft proposal may be submitted orally or in
writing.
(5) A revised proposal published in the Federal Register, which
proposal is subject to all the provisions in this section relating to
proposed regulations.
(6) A tentative final regulation or tentative revised final
regulation placed on public display in the office of the Dockets
Management Branch and, if deemed desirable by the Commissioner,
published in the Federal Register. If the tentative regulation is placed
on display only, the
[[Page 93]]
Commissioner shall publish an appropriate notice in the Federal Register
stating that the document is available and specifying the time within
which comments may be submitted orally or in writing on the tentative
final regulation. The Commissioner shall mail a copy of the tentative
final regulation and the Federal Register notice to each person who
submitted comments on the proposed regulation if one has been published.
(7) A final regulation published in the Federal Register that
provides an opportunity for the submission of further comments, in
accordance with paragraph (e)(1) of this section.
(8) Any other public procedure established in this chapter and
expressly applicable to the matter.
(g) The record of the administrative proceeding consists of all of
the following:
(1) If the regulation was initiated by a petition, the
administrative record specified in Sec. 10.30(i).
(2) If a petition for reconsideration or for a stay of action is
filed, the administrative record specified in Secs. 10.33(k) and
10.35(h).
(3) The proposed rule published in the Federal Register, including
all information identified or filed by the Commissioner with the Dockets
Management Branch on the proposal.
(4) All comments received on the proposal, including all information
submitted as a part of the comments.
(5) The notice promulgating the final regulation, including all
information identified or filed by the Commissioner with the Dockets
Management Branch as part of the administrative record of the final
regulation.
(6) The transcripts, minutes of meetings, reports, Federal Register
notices, and other documents resulting from the procedures specified in
paragraph (f) of this section, but not the transcript of a closed
portion of a public advisory committee meeting.
(7) All documents submitted to the Dockets Management Branch under
Sec. 10.65(h).
(h) The record of the administrative proceeding closes on the date
of publication of the final regulation in the Federal Register unless
some other date is specified. Thereafter, any interested person may
submit a petition for reconsideration under Sec. 10.33 or a petition for
stay of action under Sec. 10.35. A person who wishes to rely upon
information or views not included in the administrative record shall
submit it to the Commissioner with a new petition to modify the final
regulation.
(i) The Dockets Management Branch shall maintain a chronological
list of all regulations proposed and promulgated under this section and
Sec. 10.50 (which list will not include regulations resulting from
petitions filed and assigned a docket number under Sec. 10.30) showing--
(1) The docket number (for a petition submitted directly to a
center, the list also includes the number or other designation assigned
by the center, e.g., the number assigned to a food additive petition);
(2) The name of the petitioner, if any;
(3) The subject matter involved; and
(4) The disposition of the petition.
[44 FR 22323, Apr. 13, 1979, as amended at 52 FR 36401, Sept. 29, 1987;
54 FR 9034, Mar. 3, 1989; 56 FR 13758, Apr. 4, 1991]
Sec. 10.45 Court review of final administrative action; exhaustion of administrative remedies.
(a) This section applies to court review of final administrative
action taken by the Commissioner, including action taken under
Secs. 10.25 through 10.40 and Sec. 16.1(b), except action subject to
Sec. 10.50 and part 12.
(b) A request that the Commissioner take or refrain from taking any
form of administrative action must first be the subject of a final
administrative decision based on a petition submitted under
Sec. 10.25(a) or, where applicable, a hearing under Sec. 16.1(b) before
any legal action is filed in a court complaining of the action or
failure to act. If a court action is filed complaining of the action or
failure to act before the submission of the decision on a petition under
Sec. 10.25(a) or, where applicable, a hearing under Sec. 16.1(b), the
Commissioner shall request dismissal of the court action or referral to
the agency for an initial administrative determination on the grounds of
a failure to exhaust administrative remedies, the lack of final agency
action as required by 5 U.S.C. 701 et seq., and the lack of
[[Page 94]]
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 guideline issued
under Sec. 10.90, on a matter involving administrative action which is
the subject of an opportunity for a hearing under Sec. 16.1(b) of this
chapter, or on the issuance of a final regulation published in
accordance with Sec. 10.40, except that the agency's response to a
petition filed under section 505(j)(2)(C) of the act and Sec. 314.93 of
this chapter will not constitute final agency action until any petition
for reconsideration submitted by the petitioner is acted on by the
Commissioner.
(1) It is the position of FDA except as otherwise provided in
paragraph (d)(2) of this section, that:
(i) Final agency action exhausts all administrative remedies and is
ripe for preenforcement judicial review as of the date of the final
decision, unless applicable law explicitly requires that the petitioner
take further action before judicial review is available;
(ii) An interested person is affected by, and thus has standing to
obtain judicial review of final agency action; and
(iii) It is not appropriate to move to dismiss a suit for
preenforcement judicial review of final agency action on the ground that
indispenable parties are not joined or that it is an unconsented suit
against the United States if the defect could be cured by amending the
complaint.
(2) The Commissioner shall object to judicial review of a matter if:
(i) The matter is committed by law to the discretion of the
Commissioner, e.g., a decision to recommend or not to recommend civil or
criminal enforcement action under sections 302, 303, and 304 of the act;
or
(ii) Review is not sought in a proper court.
(e) An interested person may request judicial review of a final
decision of the Commissioner in the courts without first petitioning the
Commissioner for reconsideration or for a stay of action, except that in
accordance with paragraph (c) of this section, the person shall request
a stay by the Commissioner under Sec. 10.35 before requesting a stay by
the court.
(f) The Commissioner shall take the position in an action for
judicial review under 5 U.S.C. 701 et seq., whether or not it includes a
request for a declaratory judgment under 28 U.S.C. 2201, or in any other
case in which the validity of administrative action is properly
challenged, that the validity of the action must be determined solely on
the basis of the administrative record specified in Secs. 10.30(i),
10.33(k), 10.35(h), 10.40(g), and 16.80(a) or the administrative record
applicable to any decision or action under the regulations referenced in
Sec. 16.1(b), and that additional information or views may not be
considered. An interested person who wishes to rely upon information or
views not included in the administrative record shall submit them to the
Commissioner with a new petition to modify the action under
Sec. 10.25(a).
[[Page 95]]
(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 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]
[[Page 96]]
Sec. 10.50 Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.
(a) The Commissioner shall promulgate regulations and orders after
an opportunity for a formal evidentiary public hearing under part 12
whenever all of the following apply:
(1) The subject matter of the regulation or order is subject by
statute to an opportunity for a formal evidentiary public hearing.
(2) The person requesting the hearing has a right to an opportunity
for a hearing and submits adequate justification for the hearing as
required by Secs. 12.20 through 12.22 and other applicable provisions in
this chapter, e.g., Secs. 314.200, 314.300, 514.200, and 601.7(a).
(b) The Commissioner may order a formal evidentiary public hearing
on any matter whenever it would be in the public interest to do so.
(c) The provisions of the act, and other laws, that afford a person
who would be adversely affected by administrative action an opportunity
for a formal evidentiary public hearing as listed below. The list
imparts no right to a hearing where the statutory section provides no
opportunity for a hearing.
(1) Section 401 on any action for the amendment or repeal of any
definition and standard of identity for any dairy product (including
products regulated under parts 131, 133, and 135 of this chapter) or
maple sirup (regulated under Sec. 168.140 of this chapter).
(2) Section 403(j) on regulations for labeling of foods for special
dietary uses.
(3) Section 404(a) on regulations for emergency permit control.
(4) Section 406 on tolerances for poisonous substances in food.
(5) Section 409 (c), (d), and (h) on food additive regulations.
(6) Section 501(b) on tests or methods of assay for drugs described
in official compendia.
(7) Section 502(d) on regulations designating habit forming drugs.
(8) Section 502(h) on regulations designating requirements for drugs
liable to deterioration.
(9) Section 502(n) on prescription drug advertising regulations.
(10) Section 506(c) on insulin regulations.
(11) Section 507(f) on regulations for antibiotic drug
certification.
(12) Section 512(n)(5) on regulations for animal antibiotic drugs
and certification requirements.
(13) Section 721 (b) and (c) on regulations for color additive
listing and certification.
(14) Section 4(a) of the Fair Packaging and Labeling Act on food,
drug, device, and cosmetic labeling.
(15) Section 5(c) of the Fair Packaging and Labeling Act on
additional economic regulations for food, drugs, devices, and cosmetics.
(16) Section 505 (d) and (e) on new drug applications.
(17) Section 512 (d), (e) and (m) (3) and (4) on new animal drug
applications.
(18) Section 515(g) on device premarket approval applications and
product development protocols.
(19) Section 351(a) of the Public Health Service Act on plant and
product licenses for a biologic.
(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]
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
[[Page 97]]
Board of Inquiry, the following separation of functions apply:
(i) The center responsible for the matter is, as a party to the
hearing, responsible for all investigative functions and for
presentation of the position of the center at the hearing and in any
pleading or oral argument before the Commissioner. Representatives of
the center may not participate or advise in any decision except as
witness or counsel in public proceedings. There is to be no other
communication between representatives of the center and representatives
of the office of the Commissioner concerning the matter before the
decision of the Commissioner. The Commissioner may, however, designate
representatives of a center to advise the office of the Commissioner, or
designate members of that office to advise a center. The designation
will be in writing and filed with the Dockets Management Branch no later
than the time specified in paragraph (b)(2) of this section for the
application of separation of functions. All members of FDA other than
representatives of the involved center (except those specifically
designated otherwise) shall be available to advise and participate with
the office of the Commissioner in its functions relating to the hearing
and the final decision.
(ii) The Chief Counsel for FDA shall designate members of the office
of General Counsel to advise and participate with the center in its
functions in the hearing and members who are to advise the office of the
Commissioner in its functions related to the hearing and the final
decision. The members of the office of General Counsel designated to
advise the center may not participate or advise in any decision of the
Commissioner except as counsel in public proceedings. The designation is
to be in the form of a memorandum filed with the Dockets Management
Branch and made a part of the administrative record in the proceeding.
There may be no other communication between those members of the office
of General Counsel designated to advise the office of the Commissioner
and any other persons in the office of General Counsel or in the
involved center with respect to the matter prior to the decision of the
Commissioner. The Chief Counsel may assign new attorneys to advise
either the center or the office of the Commissioner at any stage of the
proceedings. The Chief Counsel will ordinarily advise and participate
with the office of the Commissioner in its functions relating to the
hearing and the final decision.
(iii) The office of the Commissioner is responsible for the agency
review and final decision of the matter, with the advice and
participation of anyone in FDA other than representatives of the
involved center and those members of the office of General Counsel
designated to assist in the center's functions in the hearing.
(c) In a matter listed in Sec. 10.50(c) (11) and (16) through (19),
the provisions relating to separation of functions set forth in
Secs. 314.200(f), 314.300, 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
[[Page 98]]
Dockets Management Branch like any other pleading.
(3) A written communication contrary to this section must be
immediately served on all other participants and filed with the Dockets
Management Branch by the presiding officer at the hearing, or by the
Commissioner, depending on who received the communication. An oral
communication contrary to this section must be immediately recorded in a
written memorandum and similarly served on all other participants and
filed with the Dockets Management Branch. A person, including a
representative of a participant in the hearing, who is involved in an
oral communication contrary to this section, must, if possible, be made
available for cross-examination during the hearing with respect to the
substance of that conversation. Rebuttal testimony pertinent to a
written or oral communication contrary to this section will be
permitted. Cross-examination and rebuttal testimony will be transcribed
and filed with the Dockets Management Branch.
(e) The prohibitions specified in paragraph (d) of this section
apply to a person who knows of a notice of hearing in advance of its
publication from the time the knowledge is acquired.
(f) The making of a communication contrary to this section may,
consistent with the interests of justice and the policy of the
underlying statute, result in a decision adverse to the person knowingly
making or causing the making of such a communication.
[44 FR 22323, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54
FR 9035, Mar. 3, 1989]
Sec. 10.60 Referral by court.
(a) This section applies when a Federal, State, or local court holds
in abeyance, or refers to the Commissioner, any matter for an initial
administrative determination under Sec. 10.25(c) or Sec. 10.45(b).
(b) The Commissioner shall promptly agree or decline to accept a
court referral. Whenever feasible in light of agency priorities and
resources, the Commissioner shall agree to accept a referral and shall
proceed to determine the matter referred.
(c) In reviewing the matter, the Commissioner may use the following
procedures:
(1) Conferences, meetings, discussions, and correspondence under
Sec. 10.65.
(2) A hearing under parts 12, 13, 14, 15, or 16.
(3) A notice published in the Federal Register requesting
information and views.
(4) Any other public procedure established in other sections of this
chapter and expressly applicable to the matter under those provisions.
(d) If the Commissioner's review of the matter results in a proposed
rule, the provisions of Sec. 10.40 or Sec. 10.50 also apply.
Sec. 10.65 Meetings and correspondence.
(a) In addition to public hearings and proceedings established under
this part and other sections of this chapter, meetings may be held and
correspondence may be exchanged between representatives of FDA and an
interested person outside FDA on a matter within the jurisdiction of the
laws administered by the Commissioner. Action on meetings and
correspondence does not constitute final administrative action subject
to judicial review under Sec. 10.45.
(b) The Commissioner may conclude that it would be in the public
interest to hold an open public meeting to discuss a matter (or class of
matters) pending before FDA, at which any interested person may
participate.
(1) The Commissioner shall give public notice through the public
calendar described in Sec. 10.100(a) of the time and place of the
meeting and of the matters to be discussed, and may also publish notice
of the meeting.
(2) The meeting will be informal, i.e., any interested person may
attend and participate in the discussion without prior notice to the
agency unless the notice of the meeting specifies otherwise.
(3) No official transcript or recording of the meeting will be made
unless it appears to the agency that it will be useful. A written
memorandum summarizing the substance of the meeting will be prepared by
an FDA representative in all cases.
(c) A meeting with a person outside the Department, including a
person in
[[Page 99]]
the executive or legislative branch of the Federal Government,
concerning a pending court case, administrative hearing, or other
regulatory action or decision, which involves more than a brief
description of the matter, is to be summarized in a written memorandum,
which is filed in the administrative file on the matter.
(d) Every person outside the Federal Government may request and
obtain a private meeting with a representative of FDA in agency offices
to discuss a matter.
(1) The person requesting a meeting may be accompanied by a
reasonable number of employees, consultants, or other persons with whom
there is a commercial arrangement within the meaning of Sec. 20.81(a).
Neither FDA nor any other person may require the attendance of a person
who is not an employee of the executive branch of the Federal Government
without the agreement of the person requesting the meeting. Any person
may attend by mutual consent of the person requesting the meeting and
FDA.
(2) FDA will determine which representatives of the Agency will
attend the meeting. The person requesting the meeting may request but
not require or preclude the attendance of a specific FDA employee.
(3) Whenever appropriate (e.g., the meeting involves a matter
covered by paragraph (c) of this section or other important matter, a
decision on an issue, or statements or advice or conclusions to which
future reference may be desirable), a written memorandum summarizing the
substance of the meeting will be prepared by an FDA representative.
(4) A person who wishes to attend a private meeting, but who either
is not permitted to attend by the person requesting the meeting or by
FDA or who cannot attend because the meeting is conducted by telephone,
may obtain a separate meeting with FDA to discuss the same matter or an
additional matter.
(e) FDA employees have a responsibility to meet with all segments of
the public to promote the objectives of the laws administered by the
Agency. In pursuing this responsibility the following general policy
applies where agency employees are invited by persons outside the
Federal Government to attend or participate in meetings outside agency
offices as representatives of the Agency.
(1) A person outside the executive branch may invite an agency
representative to attend or participate in a meeting outside agency
offices. The agency representative is not obligated to attend or
participate, but may do so where it is in the public interest and will
promote the objectives of the act.
(2) The agency representative may request that the meeting be open
if that would be in the public interest. The agency representative may
decline to participate in a meeting held as a private meeting if that
will best serve the public interest.
(3) An agency representative may not knowingly participate in a
meeting which is closed on the basis of sex, race, or religion.
(4) A meeting, whether open or closed, is subject to paragraph
(d)(3) of this section with respect to memoranda summarizing the
substance of the meeting.
(f) Representatives of FDA may initiate a meeting or correspondence
with any person outside the Federal Government on any matter concerning
the laws administered by the Commissioner.
(1) A meeting initiated by FDA representatives which involves a
small number of interested persons, for example, a meeting with a
petitioner or with two manufacturers of a particular product which
requires additional testing or with a trade association employee to
discuss an industry labeling problem, may be a private meeting. A
meeting initiated by FDA representatives which involves a large number
of interested persons, for example, 10 manufacturers of an ingredient in
a discussion of appropriate testing or labeling, must be held as an open
conference or meeting under paragraph (b) of this section.
(2) Whenever appropriate (e.g., the meeting involves a matter
covered by paragraph (c) of this section or another important matter, a
decision on an issue, or statements or advice or conclusions to which
future reference may be desirable), a written memorandum
[[Page 100]]
summarizing the substance of the meeting will be prepared by an FDA
representative.
(g) A person who participates in a meeting described in paragraphs
(b) through (f) of this section may also prepare and submit to FDA for
inclusion in the administrative file a written memorandum summarizing
the substance of the meeting.
(h) Memoranda of meetings prepared by an FDA representative or by
any other person and all correspondence which relate to a matter pending
before the agency will promptly be filed in the administrative file of
the proceeding.
(i) A meeting with a representative of Congress relating to a
pending or potential investigation, inquiry, or hearing by a
congressional committee or a Member of Congress will be summarized in a
written memorandum which is to be forwarded to the Food and Drug
Administration, Office of Legislative Affairs. This provision does not
restrict the right of an agency employee to participate in the meeting.
(j) A meeting of an advisory committee is subject to the
requirements of part 14.
(k) Under 42 U.S.C. 263l(a)(8), a log or summary is to be made of
all meetings between representatives of FDA and industry and other
interested parties to implement the Radiation Control for Health and
Safety Act of 1968.
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.
[[Page 101]]
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) 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.
(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]
Sec. 10.80 Dissemination of draft Federal Register notices and regulations.
(a) A representative of FDA may discuss orally or in writing with an
interested person ideas and recommendations for notices or regulations.
FDA welcomes assistance in developing ideas for, and in gathering the
information to support, notices and regulations.
(b) Notices and proposed regulations. (1) Once it is determined that
a notice or proposed regulation will be prepared, the general concepts
may be discussed by a representative of FDA with an interested person.
Details of a draft of a notice or proposed regulation may be discussed
with a person outside the executive branch only with the specific
permission of the Commissioner. The permission must be in writing and
filed with the Dockets Management Branch.
(2) A draft of a notice or proposed regulation or its preamble, or a
portion of either, may be furnished to an interested person outside the
executive branch only if it is made available to all interested persons
by a notice published in the Federal Register. A draft of a notice or
proposed regulation made available in this manner may, without the prior
permission of the Commissioner, be discussed with an interested person
to clarify and resolve questions raised and concerns expressed about the
draft.
(c) After publication of a notice or proposed regulation in the
Federal Register, and before preparation of a draft of the final notice
or regulation, a representative of FDA may discuss the proposal with an
interested person as provided in paragraph (b)(2) of this section.
(d) Final notices and regulations. (1) Details of a draft of a final
notice or regulation may be discussed with an interested person outside
the executive branch only with the specific permission of the
Commissioner. The permission must be in writing and filed with the
Dockets Management Branch.
(2) A draft of a final notice or regulation or its preamble, or any
portion of either, may be furnished to an interested person outside the
executive branch only if it is made available to all interested persons
by a notice published in the Federal Register, except
[[Page 102]]
as otherwise provided in paragraphs (g) and (j) of this section. A draft
of a final notice or regulation made available to an interested person
in this manner may, without the prior permission of the Commissioner, be
discussed as provided in paragraph (b)(2) of this section.
(i) The final notice or regulation and its preamble will be prepared
solely on the basis of the administrative record.
(ii) If additional technical information from a person outside the
executive branch is necessary to draft the final notice or regulation or
its preamble, it will be requested by FDA in general terms and furnished
directly to the Dockets Management Branch to be included as part of the
administrative record.
(iii) If direct discussion by FDA of a draft of a final notice or
regulation or its preamble is required with a person outside the
executive branch, appropriate protective procedures will be undertaken
to make certain that a full and impartial administrative record is
established. Such procedures may include either:
(a) The scheduling of an open public meeting under Sec. 10.65(b) at
which interested persons may participate in review of and comment on the
draft document; or
(b) The preparation of a tentative final regulation or tentative
revised final regulation under Sec. 10.40(f)(6), on which interested
persons will be given an additional period of time for oral and written
comment.
(e) After a final regulation is published, an FDA representative may
discuss any aspect of it with an interested person.
(f) In addition to the requirements of this section, the provisions
of Sec. 10.55 apply to the promulgation of a regulation subject to
Sec. 10.50 and part 12.
(g) A draft of a final food additive color additive, or new animal
drug regulation or a proposed or final antibiotic regulation may be
furnished to the petitioner for comment on the technical accuracy of the
regulation. Every meeting with a petitioner relating to the draft will
be recorded in a written memorandum, and all memoranda and
correspondence will be filed with the Dockets Management Branch as part
of the administrative record of the regulation under the provisions of
Sec. 10.65.
(h) In accordance with 42 U.S.C 263f, the Commissioner shall consult
with interested persons and with the Technical Electronic Product
Radiation Safety Standards Committee (TEPRSSC) before prescribing any
performance standard for an electronic product. Accordingly, the
Commissioner shall publish in the Federal Register an announcement when
a proposed or final performance standard, including any amendment, is
being considered for an electronic product, and any draft of any
proposed or final standard will be furnished to an interested person
upon request and may be discussed in detail.
(i) The provisions of Sec. 10.65 apply to meetings and
correspondence relating to draft notices and regulations.
(j) The provisions of this section restricting discussion and
disclosure of draft notices and regulations do not apply to situations
covered by Secs. 20.83 through 20.89.
[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]
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
[[Page 103]]
Sec. 10.30 (c) through (l), and must be in the following form:
(Date)__________________________________________________________________
Dockets Management Branch, Food and Drug Administration, Department
of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville,
MD 20857.
Request for Advisory Opinion
The undersigned submits this request for an advisory opinion of the
Commissioner of Food and Drugs with respect to ------ (the general
nature of the matter involved).
A. Issues involved.
(A concise statement of the issues and questions on which an opinion
is requested.)
B. Statement of facts and law.
(A full statement of all facts and legal points relevant to the
request.)
The undersigned certifies that, to the best of his/her knowledge and
belief, this request includes all data, information, and views relevant
to the matter, whether favorable or unfavorable to the position of the
undersigned, which is the subject of the request.
(Signature)_____________________________________________________________
(Person making request)_________________________________________________
(Mailing address)_______________________________________________________
(Telephone number)______________________________________________________
(c) The Commissioner may respond to an oral or written request to
the agency as a request for an advisory opinion, in which case the
request will be filed with the Dockets Management Branch and be subject
to this section.
(d) A statement of policy or interpretation made in the following
documents, unless subsequently repudiated by the agency or overruled by
a court, will constitute an advisory opinion:
(1) Any portion of a Federal Register notice other than the text of
a proposed or final regulation, e.g., a notice to manufacturers or a
preamble to a proposed or final regulation.
(2) Trade Correspondence (T.C. Nos. 1-431 and 1A-8A) issued by FDA
between 1938 and 1946.
(3) Compliance policy guides issued by FDA beginning in 1968 and
codified in the Compliance Policy Guides manual.
(4) Other documents specifically identified as advisory opinions,
e.g., advisory opinions on the performance standard for diagnostic X-ray
systems, issued before July 1, 1975, and filed in a permanent public
file for prior advisory opinions maintained by the Freedom of
Information Staff (HFI-35).
(5) Guidelines issued by FDA under Sec. 10.90(b).
(e) An advisory opinion represents the formal position of FDA on a
matter and except as provided in paragraph (f) of this section,
obligates the agency to follow it until it is amended or revoked. The
Commissioner may not recommend legal action against a person or product
with respect to an action taken in conformity with an advisory opinion
which has not been amended or revoked.
(f) In unusual situations involving an immediate and significant
danger to health, the Commissioner may take appropriate civil
enforcement action contrary to an advisory opinion before amending or
revoking the opinion. This action may be taken only with the approval of
the Commissioner, who may not delegate this function. Appropriate
amendment or revocation of the advisory opinion involved will be
expedited.
(g) An advisory opinion may be amended or revoked at any time after
it has been issued. Notice of amendment or revocation will be given in
the same manner as notice of the advisory opinion was originally given
or in the Federal Register, and will be placed on public display as part
of the file on the matter in the office of the Dockets Management
Branch. The Dockets Management Branch shall maintain a separate
chronological index of all advisory opinions filed. The index will
specify the date of the request for the advisory opinion, the date of
the opinion, and identification of the appropriate file.
(h) Action undertaken or completed in conformity with an advisory
opinion which has subsequently been amended or revoked is acceptable to
FDA unless the Commissioner determines that substantial public interest
considerations preclude continued acceptance. Whenever possible, an
amended or revoked advisory opinion will state when action previously
undertaken or completed does not remain acceptable, and any transition
period that may be applicable.
(i) An interested person may submit written comments on an advisory
opinion or modified advisory opinion. Four copies of any comments are to
be sent to the Dockets Management Branch for
[[Page 104]]
inclusion in the public file on the advisory opinion. Individuals may
submit only one copy. Comments will be considered in determining whether
further modification of an advisory opinion is warranted.
(j) An advisory opinion may be used in administrative or court
proceedings to illustrate acceptable and unacceptable procedures or
standards, but not as a legal requirement.
(k) A statement made or advice provided by an FDA employee
constitutes an advisory opinion only if it is issued in writing under
this section. A statement or advice given by an FDA employee orally, or
given in writing but not under this section or Sec. 10.90, is an
informal communication that represents the best judgment of that
employee at that time but does not constitute an advisory opinion, does
not necessarily represent the formal position of FDA, and does not bind
or otherwise obligate or commit the agency to the views expressed.
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 59
FR 14364, Mar. 28, 1994]
Sec. 10.90 Food and Drug Administration regulations, guidelines, 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) Guidelines. FDA guidelines are included in the public file of
guidelines established by the Dockets Management Branch, under this
paragraph, unless they have been published as regulations under
paragraph (a) of this section.
(1) Guidelines establish principles or practices of general
applicability and do not include decisions or advice on particular
situations. Guidelines relate to performance characteristics,
preclinical and clinical test procedures, manufacturing practices,
product standards, scientific protocols, compliance criteria, ingredient
specifications, labeling, or other technical or policy criteria.
Guidelines state procedures or standards of general applicability that
are not legal requirements but are acceptable to FDA for a subject
matter which falls within the laws administered by the Commissioner.
(i) A person may rely upon a guideline with assurance that it is
acceptable to FDA, or may follow different procedures or standards. When
different procedures or standards are chosen, a person may, but is not
required to, discuss the matter in advance with FDA to prevent the
expenditure of money and effort on activity that may later be determined
to be unacceptable.
(ii) Use of testing guidelines established by FDA assures acceptance
of a test as scientifically valid, if properly conducted, but does not
assure approval of any ingredient or product so tested. Test results or
other available information may require disapproval or additional
testing.
(2) A guideline represents the formal position of FDA on a matter
and, except as provided in paragraph (b)(3) 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 a guideline issued under this
section that has not been amended or revoked.
(3) In unusual situations involving an immediate and significant
danger to health, the Commissioner may take appropriate civil
enforcement action contrary to a guideline before amending or revoking
the guideline as provided in paragraph (b)(5) of this section. This
action may be taken only with the approval of the Commissioner, who may
not delegate that function. Amendment or revocation of the guideline
involved will be expedited.
(4) A guideline will be included in the public file upon approval of
the guideline by the Commissioner or relevant center director and
publication of a notice of its availability. The notice will state (i)
the title of the guideline, (ii) the subject matter it covers, and (iii)
the office or individual responsible for maintaining the guideline.
(5) A guideline may be amended or revoked by the Commissioner or
relevant
[[Page 105]]
center director and publication of a notice of the amendment or
revocation. The notice will state (i) the title of the guideline, (ii)
the subject matter it covers, and (iii) the office or individual
responsible for maintaining the guideline. All original guidelines and
subsequent amendments will be retained in the public file permanently so
that a complete record of the development of each guideline is
available.
(6) Action undertaken or completed in conformity with a guideline
which has subsequently been amended or revoked will remain acceptable to
FDA unless the Commissioner determines that substantial public interest
considerations preclude continued acceptance. This determination may be
made at the time of or after amendment or revocation of the guideline.
Whenever possible, notice of an amended or revoked guideline will state
when it has been determined that action previously undertaken or
completed in conformity with a prior guideline does not remain
acceptable, and any transition period that may be applicable.
(7) The notice of a guideline or of an amended or revoked guideline
will state that an interested person may submit written comments on the
guideline. Four copies of comments are to be sent to the Dockets
Management Branch for inclusion in the public file on the guideline. The
comments will be considered in determining whether further amendments to
or reinstitution of a guideline are warranted.
(8) A guideline may be used in administrative or court proceedings
to illustrate acceptable and unacceptable procedures or standards, but
not as a legal requirement.
(9) A statement relating to acceptable procedures or standards given
by an FDA employee orally, or in writing but not under Sec. 10.85 of
this section, is an informal communication that represents the best
judgment of that employee at that time but does not constitute a
guideline, does not necessarily represent the formal position of FDA,
and does not bind or otherwise obligate the agency to the views
expressed.
(10) Because of the large number of analytical methods involved in
FDA activities, their length and complexity and the volume and frequency
of amendment, paragraph (b)(4) of this section does not apply to
analytical methods except to the extent that the Commissioner concludes
that particular analytical methods should be included in the public file
for a particular purpose. FDA analytical methods are available for
public disclosure under part 20.
(11) The dissemination of draft guidelines is subject to the same
provisions as the dissemination of draft notices and regulations under
Sec. 10.80.
(c) Recommendations. In addition to the guidelines subject to
paragraph (b) of this section, FDA often formulates and disseminates
recommendations about matters which are authorized by, but do not
involve direct regulatory action under, the laws administered by the
Commissioner, e.g., model State and local ordinances, or personnel
practices for reducing radiation exposure, issued under 42 U.S.C 243 and
263d(b). These recommendations may, in the discretion of the
Commissioner, be handled under the procedures established in paragraph
(b) of this section, except that the recommendations will be included in
a separate public file of recommendations established by the Dockets
Management Branch and will be separated from the guidelines in the
notice of availability published in the Federal Register, or be
published in the Federal Register as regulations under paragraph (a) of
this section.
(d) Agreements. Formal agreements, memoranda of understanding, or
other similar written documents executed by FDA and another person will
be included in the public file on agreements established by the Freedom
of Information Staff (HFI-35) under Sec. 20.108. A document not included
in the public file is deemed to be rescinded and has no force or effect
whatever.
[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]
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
[[Page 106]]
methodology, manufacturing practices, product standards, scientific
protocols, compliance criteria, ingredient specifications, labeling, or
other technical or policy criteria. FDA encourages employee
participation in outside standard-setting activities that are in the
public interest.
(b) Standard-setting activities by other Federal Government
agencies. (1) An FDA employee may participate in these activities after
approval of the activity under procedures specified in the current
agency Staff Manual Guide.
(2) Approval forms and all pertinent background information
describing the activity will be included in the public file on standard-
setting activities established by the Freedom of Information Staff.
(3) If a member of the public is invited by FDA to present views to,
or to accompany, the FDA employee at a meeting, the invitations will be
extended to a representative sampling of the public, including consumer
groups, industry associations, professional societies, and academic
institutions.
(4) An FDA employee appointed as the liaison representative to an
activity shall refer all requests for information about or participation
in the activity to the group or organization responsible for the
activity.
(c) Standard-setting activities by State and local government
agencies and by United Nations organizations and other international
organizations and foreign governments pursuant to treaty. (1) An FDA
employee may participate in these activities after approval of the
activity under procedures specified in the current agency Staff Manual
Guide.
(2) Approval forms and all pertinent background information
describing the activity will be included in the public file on standard-
setting activities established by the Freedom of Information Staff (HFI-
35).
(3) The availability for public disclosure of records relating to
the activity will be governed by part 20.
(4) If a member of the public is invited by FDA to present views to,
or to accompany, the FDA employee at a meeting, the invitation will be
extended to a representative sampling of the public, including consumer
groups, industry associations, professional societies, and academic
institutions.
(5) An FDA employee appointed as the liaison representative to an
activity shall refer all requests for information about or participation
in the activity to the group or organization responsible for the
activity.
(d) Standard-setting activities by private groups and organizations.
(1) an FDA employee may engage in these activities after approval of the
activity under procedures specified in the current agency Staff Manual
Guide. A request for official participation must be made by the group or
organization in writing, must describe the scope of the activity, and
must demonstrate that the minimum standards set out in paragraph (d)(5)
of this section are met. Except as provided in paragraph (d)(7) of this
section, a request that is granted will be the subject of a letter from
the Commissioner or the center director to the organization stating--
(i) Whether participation by the individual will be as a voting or
nonvoting liaison representative;
(ii) That participation by the individual does not connote FDA
agreement with, or endorsement of, any decisions reached; and
(iii) That participation by the individual precludes service as the
deciding official on the standard involved if it should later come
before FDA. The deciding official is the person who signs a document
ruling upon the standard.
(2) The letter requesting official FDA participation, the approval
form, and the Commissioner's or center director's letter, together with
all pertinent background information describing the activities involved,
will be included in the public file on standard-setting activities
established by the Freedom of Information Staff (HFI-35).
(3) The availability for public disclosure of records relating to
the activities will be governed by part 20.
(4) An FDA employee appointed as the liaison representative to an
activity shall refer all requests for information about or participation
in the activity to the group or organization responsible for the
activity.
(5) The following minimum standards apply to an outside private
standard-
[[Page 107]]
setting activity in which FDA employees participate:
(i) The activity will be based upon consideration of sound
scientific and technological information, will permit revision on the
basis of new information, and will be designed to protect the public
against unsafe, ineffective, or deceptive products or practices.
(ii) The activity and resulting standards will not be designed for
the economic benefit of any company, group, or organization, will not be
used for such antitrust violations as fixing prices or hindering
competition, and will not involve establishment of certification or
specific approval of individual products or services.
(iii) The group or organization responsible for the standard-setting
activity must have a procedure by which an interested person will have
an opportunity to provide information and views on the activity and
standards involved, without the payment of fees, and the information and
views will be considered. How this is accomplished, including whether
the presentation will be in person or in writing, will be decided by the
group or organization responsible for the activity.
(6) Membership of an FDA employee in an organization that also
conducts a standard-setting activity does not invoke the provisions of
this section unless the employee participates in the standard-setting
activity. Participation in a standard-setting activity is subject to
this section.
(7) The Commissioner may determine in writing that, because direct
involvement by FDA in a particular standard-setting activity is in the
public interest and will promote the objectives of the act and the
agency, the participation is exempt from the requirements of paragraph
(d)(1) (ii) and/or (iii) of this section. This determination will be
included in the public file on standard-setting activities established
by the Freedom of Information Staff and in any relevant administrative
file. The activity may include the establishment and validation of
analytical methods for regulatory use, drafting uniform laws and
regulations, and the development of recommendations concerning public
health and preventive medicine practices by national and international
organizations.
(8) Because of the close daily cooperation between FDA and the
associations of State and local government officials listed below in
this paragraph, and the large number of agency employees who are members
of or work with these associations, participation in the activities of
these associations is exempt from paragraphs (d)(1) through (7) of this
section, except that a list of the committees and other groups of these
associations will be included in the public file on standard-setting
activities established by the Freedom of Information Staff (HFI-35):
(i) American Association of Food Hygiene Veterinarians (AAFHV).
(ii) American Public Health Association (APHA).
(iii) Association of American Feed Control Officials, Inc. (AAFCO).
(iv) Association of Food and Drug Officials (AFDO).
(v) Association of Official Analytical Chemists (AOAC).
(vi) Association of State and Territorial Health Officials (ASTHO).
(vii) Conference for Food Protection (CFP).
(viii) Conference of State Health and Environmental Managers
(COSHEM).
(ix) Conference of Radiation Control Program Directors (CRCPD).
(x) International Association of Milk, Food, and Environmental
Sanitation, Inc. (IAMFES).
(xi) Interstate Shellfish Sanitation Conference (ISSC).
(xii) National Association of Boards of Pharmacy (NABP).
(xiii) National Association of Departments of Agriculture (NADA).
(xiv) National Conference on Interstate Milk Shipments (NCIMS).
(xv) National Conference of Local Environmental Health
Administrators (NCLEHA).
(xvi) National Conference on Weights and Measures (NCWW).
(xvii) National Environmental Health Association (NEHA).
(xviii) National Society of Professional Sanitarians (NSPS).
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 52
FR 35064, Sept. 17, 1987; 54 FR 9035, Mar. 3, 1989]
[[Page 108]]
Sec. 10.100 Public calendars.
(a) Prospective public calendar of public proceedings. (1) A public
calendar will be prepared and made publicly available each week showing,
to the extent feasible, for the following 4 weeks, the public meetings,
conferences, hearings, advisory committee meetings, seminars, and other
public proceedings of FDA, and other significant public events involving
FDA, e.g., congressional hearings.
(2) A copy of this public calendar will be placed on public display
in the following places: (i) Dockets Management Branch.
(ii) Office of the Associate Commissioner for Public Affairs.
(iii) A central place in each center.
(iv) A central place in each field office.
(v) A central place at the National Center for Toxicological
Research.
(b) Retrospective public calendar of meetings. (1) A public calendar
will be prepared and made publicly available each week showing for the
previous week meetings with persons outside the executive branch and
other significant events involving the representatives of FDA designated
under paragraph (b)(3) of this section, but telephone conversations will
be included on an optional basis and meetings with the working press,
except for ``house organs'' (i.e., publications of firms that
manufacture or distribute regulated products, or industry associations),
and with on-site contractors will not be included. Meetings with members
of the judiciary, representatives of Congress, or staffs of
congressional committees will be included when the meeting relates to a
pending court case, administrative hearing, or other regulatory action
or decision and involves more than a brief description of the matter.
(2) The calendar will include all meetings, conferences, seminars,
social events sponsored by the regulated industry, and speeches. The
calendar will specify the date and the person and subject matter
involved. When more than one FDA representative is in attendance, only
the presiding or head representative will report the meeting on the
public calendar. If a large number of persons is involved, the name of
each need not be specified. Meetings that would prejudice law
enforcement activities (e.g., a meeting with an informant) or invade
privacy (e.g., a meeting with a candidate for possible employment in
FDA) will not be reported.
(3) The following FDA representatives and their deputies are subject
to the requirements of paragraphs (b) (1) and (2) of this section:
(i) Commissioner of Food and Drugs.
(ii) Deputy Commissioner.
(iii) Associate Commissioners.
(iv) Executive and Special Assistants to the Commissioner.
(v) [Reserved]
(vi) Director, National Center for Toxicological Research.
(vii) Center Directors.
(viii) Chief Counsel for the Food and Drug Administration, or any
representative of that office attending on behalf of the Chief Counsel.
(4) A copy of the public calendar will be placed on public display
in the following places:
(i) Dockets Management Branch.
(ii) Office of the Associate Commissioner for Public Affairs.
(iii) A central place in each center.
(iv) A central place in each field office.
(v) A central place at the National Center for Toxicological
Research.
[44 FR 22323, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54
FR 9035, Mar. 3, 1989]
Sec. 10.105 Representation by an organization.
(a) An organization may represent its members by filing petitions,
comments, and objections, and otherwise participating in an
administrative proceeding subject to this part.
(b) A petition, comment, objection, or other representation by an
organization will not abridge the right of a member to take individual
action of a similar type, in the member's own name.
(c) It is requested that each organization participating in FDA
administrative proceedings file annually with the Dockets Management
Branch a current list of all of the members of the organization.
(d) The filing by an organization of an objection or request for
hearing under Secs. 12.20 through 12.22 does not
[[Page 109]]
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.
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
[[Page 110]]
agency intends to refer to this guideline when notices of hearing, or
individual advisory committee meetings, are published in the Federal
Register. Thus, all parties to a proceeding will be on notice that the
proceeding may be recorded electronically and any person interested in
videotaping or otherwise recording the proceeding will be notified that
there are established procedures to be followed.
(b) The designated presiding officer of a public administrative
proceeding retains the existing discretionary authority set forth in
specific regulations pertaining to each type of administrative
proceeding to regulate the conduct of the proceeding over which he or
she presides. The responsibilities of the presiding officer, established
elsewhere in parts 10 through 16, include an obligation to be concerned
with the timely conduct of a hearing, the limited availability of
certain witnesses, and reducing disruptions to the proceeding which may
occur. Each proceeding varies, and the presiding officer cannot
anticipate all that might occur. Discretionary authority to regulate
conduct at a proceeding has traditionally been granted to presiding
officers to enable them to fulfill their responsibility to maintain a
fair and orderly hearing conducted in an expeditious manner.
(c) This guideline provides the presiding officer with a degree of
flexibility in that it sets forth the agency's policy as well as the
procedures that presiding officers should ordinarily follow, but from
which they may depart in particular situations if necessary, subject to
the presumption of openness of public proceedings to electronic media
coverage. The presiding officer's discretion to establish additional
procedures or to limit electronic coverage is to be exercised only in
the unusual circumstances defined in this guideline. Even though a
presiding officer may establish additional procedures or limits as may
be required in a particular situation, he or she will be guided by the
policy expressed in this guideline in establishing these conditions. The
presiding officer may also be less restrictive, taking into account such
factors as the duration of a hearing and the design of the room.
(d) If a portion or all of a proceeding is closed to the public
because material is to be discussed that is not disclosable to the
public under applicable laws, the proceeding also will be closed to
electronic media coverage.
(e) The agency requests advance notice of intent to record a
proceeding electronically to facilitate the orderly conduct of the
proceeding. Knowledge of anticipated media coverage will allow the
presiding officer to make any special arrangements required by the
circumstances of the proceeding. The agency believes that this guideline
establishes sufficiently specific criteria to promote uniformity.
(f) The agency would like to allow all interested media
representatives to videotape a proceeding in which they have an
interest. However, should space limitations preclude a multitude of
cameras, the presiding officer may require pool sharing. In such a case,
pool sharing arrangements of the resulting videotape should be made
between those allowed to film and those who were excluded. Arrangements
for who is designated to present the pool and a method of distributing
the resulting film or tape may be determined by the established
networks' pooling system. However, the agency has a strong commitment to
ensuring that media representatives other than the major networks also
be able to obtain a copy of the tape at cost. FDA is concerned that if
the network pool representative wishes to record only a short portion of
a proceeding, but an excluded party wishes to record the entire
proceeding, confusion will result. The agency expects the interested
media representatives to negotiate a suitable agreement among themselves
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
[[Page 111]]
independent reporter. The agency recommends that parties intending to
videotape provide as much advance notice as possible, so that the agency
may best respond to the needs of the electronic media.
(g) To ensure the timely conduct of agency hearings and to prevent
disruptions, equipment is to be stationary during a proceeding and
should be set up and taken down when the proceeding is not in progress.
As noted previously, the presiding officer may, at his or her
discretion, be less restrictive if appropriate.
(h) The agency recognizes that electronic media representatives may
desire only short footage of a proceeding, a facsimile of the
proceeding, and/or interview opportunities and may be unnecessarily
restricted by requirements for setting up before a proceeding and then
waiting until a break in the proceeding before being permitted to take
down their equipment. To accommodate this possibility, FDA's Press
Relations Staff will attempt to make arrangements to respond to such
needs by, for example, requesting that the presiding officer provide a
break shortly after commencement of the proceeding to permit take down
of equipment.
(i) The agency is making a full commitment to allowing, whenever
possible, electronic coverage of its public administrative proceedings
subject to the limited restrictions established in this guideline.
Sec. 10.205 Electronic media coverage of public administrative proceedings.
(a) A person may record electronically any open public
administrative proceeding, subject to the procedures specified in this
guideline. The procedures include a presumption that agency public
proceedings are open to the electronic media. Whenever possible, FDA
will permit all interested persons access to record agency public
administrative proceedings. Restrictions other than those listed in
Sec. 10.206 will be imposed only under exceptional circumstances.
(b) A videotape recording of an FDA public administrative proceeding
is not an official record of the proceeding. The only official record is
the written transcript of the proceeding, which is taken by the official
reporter.
Sec. 10.206 Procedures for electronic media coverage of agency public administrative proceedings.
(a) To facilitate the agency's response to media needs, a person
intending to videotape an FDA public administrative proceeding should,
whenever possible, provide advance notice to the Press Relations Staff
(HFI-20), Office of Public Affairs, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, in writing or by telephone (telephone
301-443-4177), at least 48 hours in advance of the proceeding. The Press
Relations Staff will inform the presiding officer that the proceeding
will be attended by representatives of the electronic media, and
ascertain whether any special provisions in addition to those set forth
in this subpart are required by the presiding officer. If so, the Press
Relations Staff will function as a liaison between the presiding officer
and the person intending to record the proceeding in facilitating any
procedures in addition to those outlined in this subpart. The presiding
officer will not deny access for failure to provide a 48-hour advance
notice. Any advance notice may describe the intended length of recording
if known, the amount and type of equipment to be used, and any special
needs such as interviews.
(b) Cameras should be completely set up before a proceeding is
scheduled to begin or during a break in the proceeding and should remain
standing in the area designated for electronic media equipment. Cameras
may be taken down only during breaks or after the hearing is over.
Roving cameras will not be permitted during the proceeding. Any
artificial lighting should be unobtrusive. Microphones, like cameras,
should be in place before the start of a proceeding and may be taken
down as indicated in this paragraph.
(c) When space in the hearing room is limited, the presiding officer
may restrict the number of cameras or the equipment present. Should such
a restriction become necessary, the pool arrangements are the
responsibility of the participating media. The agency encourages the
network pool to make
[[Page 112]]
copies of the tape, film, or other product available at cost to nonpool
participants. However, if this is not possible, the agency may need to
use the time of receipt of any advance notice to determine the
representation for each category, e.g., one network reporter, one
independent reporter, etc.
(d) Off the record portions of a proceeding may not be videotaped.
(e) Before or during the proceeding, the presiding officer may
establish other conditions specific to the proceeding for which the
request is being made. These conditions may be more or less restrictive
than those stated in this guideline, except that the presiding officer
shall observe the agency's presumption of openness of its public
proceedings to the electronic media. Only a substantial and clear threat
to the agency's interests in order, fairness, and timeliness authorizes
the presiding officer to impose additional restrictions. This threat
must outweigh the public interest in electronic media coverage of agency
proceedings. Additional restrictions shall be narrowly drawn to the
particular circumstances. The following factors are listed to assist
presiding officers in determining whether the agency's interest is
sufficiently compelling to call for the unusual step of imposing
additional restrictions. Generally this step is justified when one of
the following factors is met:
(1) Electronic recording would result in a substantial likelihood of
disruption that clearly cannot be contained by the procedures
established in paragraphs (a) through (d) of this section.
(2) Electronic recording would result in a substantial likelihood of
prejudicial impact on the fairness of the proceeding or the substantive
discussion in a proceeding.
(3) There is a substantial likelihood that a witness' ability to
testify may be impaired due to unique personal circumstances such as the
age or psychological state of the witness or the particularly personal
or private nature of the witness' testimony, if the witness' testimony
were electronically recorded.
(f) Before the proceeding, the Press Relations Staff will, upon
request, provide written copies of any additional conditions imposed by
the presiding officer (as described in paragraph (e) of this section) to
requesting members of the media. Any appeals should be made in
accordance with paragraph (h) of this section.
(g) The presiding officer retains authority to restrict or
discontinue videotaping or other recording of a proceeding, or parts of
a proceeding, should such a decision become necessary. The presiding
officer's responsibility to conduct the hearing includes the right and
duty to remove a source of substantial disruption. In exercising his or
her authority, the presiding officer shall observe the presumption that
agency public proceedings are open to the electronic media. The
presiding officer shall exercise his or her discretion to restrict or
discontinue electronic coverage of a public proceeding, or portions of a
public proceeding, only if he or she determines that the agency's
interest in the fair and orderly administrative process is substantially
threatened. A clear and substantial threat to the integrity of agency
proceedings must clearly outweigh the public interest in electronic
media coverage of the proceedings before additional restrictions are
imposed on the electronic media during the course of the proceedings.
The factors noted in paragraph (e) of this section indicate the kind of
substantial threat to the agency interests that may require imposing
additional restrictions during the course of the proceedings. If
additional requirements are established during the hearing, the
presiding officer shall notify immediately the Deputy Commissioner of
Food and Drugs of that fact by telephone and submit a written
explanation of the circumstances that necessitated such an action within
24 hours or sooner if requested by the Deputy Commissioner. In the
absence or unavailability of the Deputy Commissioner, the presiding
officer shall notify the Associate Commissioner for Regulatory Affairs.
(h) A decision by a presiding officer, made either before the
proceeding or during the course of a proceeding, to establish
requirements in addition to the minimum standards set forth in this
guideline may be appealed by any adversely affected person who intends
[[Page 113]]
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 12--FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents
Subpart A--General Provisions
Sec.
12.1 Scope.
Subpart B--Initiation of Proceedings
12.20 Initiation of a hearing involving the issuance, amendment, or
revocation of a regulation.
12.21 Initiation of a hearing involving the issuance, amendment, or
revocation of an order.
12.22 Filing objections and requests for a hearing on a regulation or
order.
12.23 Notice of filing of objections.
12.24 Ruling on objections and requests for hearing.
12.26 Modification or revocation of regulation or order.
12.28 Denial of hearing in whole or in part.
12.30 Judicial review after waiver of hearing on a regulation.
12.32 Request for alternative form of hearing.
12.35 Notice of hearing; stay of action.
12.37 Effective date of a regulation.
12.38 Effective date of an order.
Subpart C--Appearance and Participation
12.40 Appearance.
12.45 Notice of participation.
12.50 Advice on public participation in hearings.
Subpart D--Presiding Officer
12.60 Presiding officer.
12.62 Commencement of functions.
12.70 Authority of presiding officer.
12.75 Disqualification of presiding officer.
12.78 Unavailability of presiding officer.
Subpart E--Hearing Procedures
12.80 Filing and service of submissions.
12.82 Petition to participate in forma pauperis.
12.83 Advisory opinions.
12.85 Disclosure of data and information by the participants.
12.87 Purpose; oral and written testimony; burden of proof.
12.89 Participation of nonparties.
12.90 Conduct at oral hearings or conferences.
12.91 Time and place of prehearing conference.
12.92 Prehearing conference procedure.
12.93 Summary decisions.
12.94 Receipt of evidence.
12.95 Official notice.
12.96 Briefs and argument.
12.97 Interlocutory appeal from ruling of presiding officer.
12.98 Official transcript.
12.99 Motions.
Subpart F--Administrative Record
12.100 Administrative record of a hearing.
12.105 Examination of record.
Subpart G--Initial and Final Decisions
12.120 Initial decision.
12.125 Appeal from or review of initial decision.
12.130 Decision by Commissioner on appeal or review of initial
decision.
12.139 Reconsideration and stay of action.
Subpart H--Judicial Review
12.140 Review by the courts.
12.159 Copies of petitions for judicial review.
Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321-393); 21 U.S.C. 41-50, 141-149, 467f, 679, 821, 1034;
secs. 2, 351, 354-360F, 361 of the Public Health Service Act (42 U.S.C.
201, 262, 263b-263n, 264); secs. 2-12 of the Fair Packaging and Labeling
Act (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
[[Page 114]]
(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), 507(f), 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 for an antibiotic petition
in Sec. 431.50; or
(ii) If no form is specified, by a petition under Sec. 10.30.
(b) If the Commissioner receives a petition under paragraph (a)(2)
of this section, the Commissioner will--
(1) If it involves any matter subject to section 701(e) of the act
or section 4 or 5 of the Fair Packaging and Labeling Act, and meets the
requirements for filing, follow the provisions of Sec. 10.40 (b) through
(f);
(2) If it involves a color additive or food additive, and meets the
requirements for filing in Secs. 71.1 and 71.2, or in Secs. 171.1,
171.6, 171.7, and 171.100, publish a notice of filing of the petition
within 30 days after the petition is filed instead of a notice of
proposed rulemaking.
(c) The Commissioner may issue, amend, or revoke an antibiotic
regulation without the requirements of notice and public procedure in
Sec. 10.40(b) or delayed effective date in Sec. 10.40(c)(4), on the
Commissioner's own initiative or as a result of a petition containing
the required evidence of safety and effectiveness in the circumstances
described in Sec. 10.40(e)(1).
(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.
Sec. 12.21 Initiation of a hearing involving the issuance, amendment, or revocation of an order.
(a) A proceeding under section 505 (d) or (e), 512 (d), (e), (m) (3)
or (4), of section 515(g)(1) of the act, or section 351(a) of the Public
Health Service Act, may be initiated--
(1) By the Commissioner on the Commissioner's own initiative;
(2) By a petition in the form specified elsewhere in this chapter,
e.g., Sec. 314.50 for new drug applications, Sec. 514.1 for new animal
drug applications, Sec. 514.2 for applications for animal feeds, or
Sec. 601.3 for licenses for biologic products; or
(3) By a petition under Sec. 10.30.
(b) A notice of opportunity for hearing on a proposal to deny or
revoke approval of all or part of an order will be published together
with an explanation of the grounds for the proposed action. The notice
will describe how to submit requests for hearing. A person subject to
the notice has 30 days after its issuance to request a hearing. The 30-
day period may not be extended.
(c) The Commissioner may use an optional procedure specified in
Sec. 10.30(h) to consider issuing, amending, or revoking an order.
(d) In a proceeding under sections 505(e), 512(e) or (m), or 515(e)
of the act in which a party wishes to apply for reimbursement of certain
expenses under the Equal Access to Justice Act (5
[[Page 115]]
U.S.C. 504 and 504 note), FDA will follow the Department of Health and
Human Services' regulations in 45 CFR part 13.
[44 FR 22339, Apr. 13, 1979, as amended at 47 FR 25734, June 15, 1982;
54 FR 9035, Mar. 3, 1989]
Sec. 12.22 Filing objections and requests for a hearing on a regulation or order.
(a) Objections and requests for a hearing under Sec. 12.20(d) must
be submitted to the Dockets Management Branch and will be accepted for
filing if they meet the following conditions:
(1) They are submitted within the time specified in Sec. 12.20(e).
(2) Each objection is separately numbered.
(3) Each objection specifies with particularity the provision of the
regulation or proposed order objected to.
(4) Each objection on which a hearing is requested specifically so
states. Failure to request a hearing on an objection constitutes a
waiver of the right to a hearing on that objection.
(5) Each objection for which a hearing is requested includes a
detailed description and analysis of the factual information to be
presented in support of the objection. Failure to include a description
and analysis for an objection constitutes a waiver of the right to a
hearing on that objection. The description and analysis may be used only
for the purpose of determining whether a hearing has been justified
under Sec. 12.24, and do not limit the evidence that may be presented if
a hearing is granted.
(i) A copy of any report, article, survey, or other written document
relied upon must be submitted, except if the document is--
(a) An FDA document that is routinely publicly available;
(b) A recognized medical or scientific textbook that is readily
available to the agency; or
(c) A designated journal listed in Sec. 510.95.
(ii) A summary of the nondocumentary testimony to be presented by
any witnesses relied upon must be submitted.
(b) Requests for hearing submitted under Sec. 12.21 will be
submitted to the Dockets Management Branch and will be accepted for
filing if they meet the following conditions:
(1) They are submitted on or before the 30th day after the date of
publication of the notice of opportunity for hearing.
(2) They comply with Secs. 314.200, 514.200, or 601.7(a).
(c) If an objection or request for a public hearing fails to meet
the requirements of this section and the deficiency becomes known to the
Dockets Management Branch, the Dockets Management Branch shall return it
with a copy of the applicable regulations, indicating those provisions
not complied with. A deficient objection or request for a hearing may be
supplemented and subsequently filed if submitted within the 30-day time
period specified in Sec. 12.20(e) or Sec. 12.21(b).
(d) If another person objects to a regulation issued in response to
a petition submitted under Sec. 12.20(a)(2), the petitioner may submit a
written reply to the Dockets Management Branch.
[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]
Sec. 12.23 Notice of filing of objections.
As soon as practicable after the expiration of the time for filing
objections to and requests for hearing on agency action involving the
issuance, amendment, or revocation of a regulation under sections
502(n), 701(e), or 721(d) of the act or sections 4 or 5 of the Fair
Packaging and Labeling Act, the Commissioner shall publish a notice in
the Federal Register specifying those parts of the regulation that have
been stayed by the filing of proper objections and, if no objections
have been filed, stating that fact. The notice does not constitute a
determination that a hearing is justified on any objections or requests
for hearing that have been filed. When to do so will cause no undue
delay, the notice required by this section may be combined with the
notices described in Secs. 12.28 and 12.35.
Sec. 12.24 Ruling on objections and requests for hearing.
(a) As soon as possible the Commissioner will review all objections
and requests for hearing filed under Sec. 12.22 and determine--
[[Page 116]]
(1) Whether the regulation should be modified or revoked under
Sec. 12.26;
(2) Whether a hearing has been justified; and
(3) Whether, if requested, a hearing before a Public Board of
Inquiry under part 13 or before a public advisory committee under part
14 or before the Commissioner under part 15 has been justified.
(b) A request for a hearing will be granted if the material
submitted shows the following:
(1) There is a genuine and substantial issue of fact for resolution
at a hearing. A hearing will not be granted on issues of policy or law.
(2) The factual issue can be resolved by available and specifically
identified reliable evidence. A hearing will not be granted on the basis
of mere allegations or denials or general descriptions of positions and
contentions.
(3) The data and information submitted, if established at a hearing,
would be adequate to justify resolution of the factual issue in the way
sought by the person. A hearing will be denied if the Commissioner
concludes that the data and information submitted are insufficient to
justify the factual determination urged, even if accurate.
(4) Resolution of the factual issue in the way sought by the person
is adequate to justify the action requested. A hearing will not be
granted on factual issues that are not determinative with respect to the
action requested, e.g., if the Commissioner concludes that the action
would be the same even if the factual issue were resolved in the way
sought, or if a request is made that a final regulation include a
provision not reasonably encompassed by the proposal. A hearing will be
granted upon proper objection and request when a food standard or other
regulation is shown to have the effect of excluding or otherwise
affecting a product or ingredient.
(5) The action requested is not inconsistent with any provision in
the act or any regulation in this chapter particularizing statutory
standards. The proper procedure in those circumstances is for the person
requesting the hearing to petition for an amendment or waiver of the
regulation involved.
(6) The requirements in other applicable regulations, e.g.,
Secs. 10.20, 12.21, 12.22, 314.200, 314.300, 514.200, and 601.7(a), and
in the notice promulgating the final regulation or the notice of
opportunity for hearing are met.
(c) In making the determination in paragraph (a) of this section,
the Commissioner may use any of the optional procedures specified in
Sec. 10.30(h) or in other applicable regulations, e.g., Secs. 314.200,
314.300, 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]
Sec. 12.26 Modification or revocation of regulation or order.
If the Commissioner determines upon review of an objection or
request for hearing that the regulation or order should be modified or
revoked, the Commissioner will promptly take such action by notice in
the Federal Register. Further objections to or requests for hearing on
the modification or revocation may be submitted under Secs. 12.20
through 12.22 but no further issue may be taken with other provisions in
the regulation or order. Objections and requests for hearing that are
not affected by the modification or revocation will remain on file and
be acted upon in due course.
Sec. 12.28 Denial of hearing in whole or in part.
If the Commissioner determines upon review of the objections or
requests for hearing that a hearing is not justified, in whole or in
part, a notice of the determination will be published.
(a) The notice will state whether the hearing is denied in whole or
in part. If the hearing is denied in part, the notice will be combined
with the notice of hearing required by Sec. 12.35, and will specify the
objections and requests for
[[Page 117]]
hearing that have been granted and denied.
(1) Any denial will be explained. A denial based on an analysis of
the information submitted to justify a hearing will explain the
inadequacy of the information.
(2) The notice will confirm or modify or stay the effective date of
the regulation or order involved.
(b) The record of the administrative proceeding relating to denial
of a public hearing in whole or in part on an objection or request for
hearing consists of the following:
(1) If the proceeding involves a regulation--
(i) The documents specified in Sec. 10.40(g);
(ii) The objections and requests for hearing filed by the Dockets
Management Branch;
(iii) If the proceeding involves a color additive regulation
referred to an advisory committee in accordance with section
721(b)(5)(C) of the act, the committee's report and the record of the
committee's proceeding; and
(iv) The notice denying a formal evidentiary public hearing.
(2) If the proceeding involves an order--
(i) The notice of opportunity for hearing;
(ii) The requests for hearing filed by the Dockets Management
Branch;
(iii) The transcripts, minutes of meetings, reports, Federal
Register notices, and other documents constituting the record of any of
the optional procedures specified in Sec. 12.24(c) used by the
Commissioner, but not the transcript of a closed portion of a public
advisory committee meeting; and
(iv) The notice denying the hearing.
(c) The record specified in paragraph (b) of this section is the
exclusive record for the Commissioner's decision on the complete or
partial denial of a hearing. The record of the proceeding will be closed
as of the date of the Commissioner's decision unless another date is
specified. A person who requested and was denied a hearing may submit a
petition for reconsideration under Sec. 10.33 or a petition for stay of
action under Sec. 10.35. A person who wishes to rely upon information or
views not included in the administrative record shall submit them to the
Commissioner with a petition under Sec. 10.25(a) to modify the final
regulation or order.
(d) Denial of a request for a hearing in whole or in part is final
agency action reviewable in the courts, under the statutory provisions
governing the matter involved, as of the date of publication of the
denial in the Federal Register.
(1) Before requesting a court for a stay of action pending review, a
person shall first submit a petition for a stay of action under
Sec. 10.35.
(2) Under 28 U.S.C. 2112(a), FDA will request consolidation of all
petitions on a particular matter.
(3) The time for filing a petition for judicial review of a denial
of a hearing on an objection or issue begins on the date the denial is
published in the Federal Register, (i) When an objection or issues
relates to a regulation, if a hearing is denied on all objections and
issues concerning a part of the proposal the effectiveness of which has
not been deferred pending a hearing on other parts of the proposal; or
(ii) when an issue relates to an order, if a hearing is denied on all
issues relating to a particular new drug application, new animal drug
application, device premarket approval application or product
development protocol, or biologics license. The failure to file a
petition for judicial review within the period established in the
statutory provision governing the matter involved constitutes a waiver
of the right to judicial review of the objection or issue, regardless
whether a hearing has been granted on other objections and issues.
Sec. 12.30 Judicial review after waiver of hearing on a regulation.
(a) A person with a right to submit objections and a request for
hearing under Sec. 12.20(d) may submit objections and waive the right to
a hearing. The waiver may be either an explicit statement, or a failure
to request a hearing, as provided in 12.22(a)(4).
(b) If a person waives the right to a hearing, the Commissioner will
rule upon the person's objections under Secs. 12.24 through 12.28. As a
matter of discretion, the Commissioner may also
[[Page 118]]
order a hearing on the matter under any of the provisions of this part.
(c) If the Commissioner rules adversely on a person's objection, the
person may petition for judicial review in a U.S. Court of Appeals under
the act.
(1) The record for judicial review is the record designated in
Sec. 12.28(b)(1).
(2) The time for filing a petition for judicial review begins as of
the date of publication of the Commissioner's ruling on the objections.
Sec. 12.32 Request for alternative form of hearing.
(a) A person with a right to request a hearing may waive that right
and request one of the following alternatives:
(1) A hearing before a Public Board of Inquiry under part 13.
(2) A hearing before a public advisory committee under part 14.
(3) A hearing before the Commissioner under part 15.
(b) The request--
(1) May be on the person's own initiative or at the suggestion of
the Commissioner.
(2) Must be submitted in the form of a citizen petition under
Sec. 10.30 before publication of a notice of hearing under Sec. 12.35 or
a denial of hearing under Sec. 12.28; and
(3) Must be--
(i) In lieu of a request for a hearing under this part; or
(ii) If submitted after or with a request for hearing, in the form
of a waiver of the right to request a hearing conditioned on an
alternative form of hearing. Upon acceptance by the Commissioner, the
waiver becomes binding and may be withdrawn only by waiving any right to
any form of hearing unless the Commissioner determines otherwise.
(c) When more than one person requests and justifies a hearing under
this part, an alternative form of hearing may by used only if all the
persons concur and waive their right to request a hearing under this
part.
(d) The Commissioner will determine whether an alternative form of
hearing should be used, and if so, which alternative is acceptable,
after considering the requests submitted and the appropriateness of the
alternatives for the issues raised in the objections. The Commissioner's
acceptance is binding unless, for good cause, the Commissioner
determines otherwise.
(e) The Commissioner will publish a notice of an alternative form of
hearing setting forth the following information:
(1) The regulation or order that is the subject of the hearing.
(2) A statement specifying any part of the regulation or order that
has been stayed by operation of law or in the Commissioner's discretion.
(3) The time, date, and place of the hearing, or a statment that
such information will be contained in a later notice.
(4) The parties to the hearing.
(5) The issues at the hearing. The statement of issues determines
the scope of the hearing.
(6) If the hearing will be conducted by a Public Board of Inquiry,
the time within which--
(i) The parties should submit nominees for the Board under
Sec. 13.10(b);
(ii) A notice of participation under Sec. 12.45 should be filed; and
(iii) Participants should submit written information under
Sec. 13.25. The notice will list the contents of the portions of the
administrative record relevant to the issues at the hearing before the
Board. The portions listed will be placed on public display in the
office of the Dockets Management Branch before the notice is published.
Additional copies of material already submitted under Sec. 13.25 need
not be included with any later submissions.
(f)(1) The decision of a hearing before a Public Board of Inquiry or
a public advisory committee under this section has legal status of and
will be handled as an initial decision under Sec. 12.120.
(2) The decision of a public hearing before the Commissioner under
this section will be issued as a final order. The final order will have
the same content as an initial decision, as specified in Sec. 12.120 (b)
and (c).
(3) Thereafter, the participants in the proceeding may pursue the
administrative and court remedies specified in Secs. 12.120 through
12.159.
(g) If a hearing before a public advisory committee or a hearing
before the Commissioner is used as an alternative
[[Page 119]]
form of hearing, all submissions will be made to the Dockets Management
Branch, and Sec. 10.20(j) governs their availability for public
examination and copying.
(h) This section does not affect the right to an opportunity for a
hearing before a public advisory committee under section 515(g)(2) of
the act regarding device premarket approval applications and product
development protocols. Advisory committee hearing procedures are found
in part 14.
Sec. 12.35 Notice of hearing; stay of action.
(a) If the Commissioner determines upon review of the objections and
requests for hearing that a hearing is justified on any issue, the
Commissioner will publish a notice setting forth the following:
(1) The regulation or order that is the subject of the hearing.
(2) A statement specifying any part of the regulation or order that
has been stayed by operation of law or in the Commissioner's discretion.
(3) The parties to the hearing.
(4) The issues of fact on which a hearing has been justified.
(5) A statement of any objections or requests for hearing for which
a hearing has not been justified, which are subject to Sec. 12.28.
(6) The presiding officer, or a statement that the presiding officer
will be designated in a later notice.
(7) The time within which notices of participation should be filed
under Sec. 12.45.
(8) The date, time, and place of the prehearing conference, or a
statement that the date, time, and place will be announced in a later
notice. The pre-hearing conference may not commence until after the time
expires for filing the notice of participation required by
Sec. 12.45(a).
(9) The time within which participants should submit written
information and views under Sec. 12.85. The notice will list the
contents of the portions of the administrative record relevant to the
issues at the hearing. The portions listed will be placed on public
display in the office of the Dockets Management Branch before the notice
is published. Additional copies of material already submitted under
Sec. 12.85 need not be included with any later submissions.
(b) The statement of the issues determines the scope of the hearing
and the matters on which evidence may be introduced. The issues may be
revised by the presiding officer. A participant may obtain interlocutory
review by the Commissioner of a decision by the presiding officer to
revise the issues to include an issue on which the Commissioner has not
granted a hearing or to eliminate an issue on which a hearing has been
granted.
(c) A hearing is deemed to begin on the date of publication of the
notice of hearing.
[44 FR 22339, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982]
Sec. 12.37 Effective date of a regulation.
(a) If no objections are filed and no hearing is requested on a
regulation under Sec. 12.20(e), the regulation is effective on the date
specified in the regulation as promulgated.
(b) The Commissioner shall publish a confirmation of the effective
date of the regulation. The Federal Register document confirming the
effective date of the regulation may extend the time for compliance with
the regulation.
Sec. 12.38 Effective date of an order.
(a) If a person who is subject to a notice of opportunity for
hearing under Sec. 12.21(b) does not request a hearing, the Commissioner
will--
(1) Publish a final order denying or withdrawing approval of an NDA,
NADA, device premarket approval application, or biologics license, in
whole or in part, or revoking a device product development protocol or
notice of completion, or declaring that such a protocol has not been
completed, and stating the effective date of the order; and
(2) If the order involves withdrawal of approval of an NADA,
forthwith revoke, in whole or in part, the applicable regulation, under
section 512(i) of the act.
(b) If a person who is subject to a notice of opportunity for
hearing under Sec. 12.21(b) requests a hearing and others do not, the
Commissioner may issue a final order covering all the drug or device
products at once or may issue
[[Page 120]]
more than one final order covering different drug or device products at
different times.
Subpart C--Appearance and Participation
Sec. 12.40 Appearance.
(a) A person who has filed a notice of participation under
Sec. 12.45 may appear in person or by counsel or other representative in
any hearing and, subject to Sec. 12.89, may be heard concerning all
relevant issues.
(b) The presiding officer may strike a person's appearance for
violation of the rules of conduct in Sec. 12.90.
Sec. 12.45 Notice of participation.
(a) Within 30 days after publication of the notice of hearing under
Sec. 12.35, a person desiring to participate in a hearing is to file
with the Dockets Management Branch under Sec. 10.20 a notice of
participation in the following form:
(Date)
Dockets Management Branch, Food and Drug Administration, Department
of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville,
MD 20857.
Notice of Participation
Docket No. ----
Under 21 CFR part 12, please enter the participation of:
(Name)____________________________________________________________
(Street address)__________________________________________________
(City and State)__________________________________________________
(Telephone number)________________________________________________
Service on the above will be accepted by:
(Name)____________________________________________________________
(Street address)__________________________________________________
(City and State)__________________________________________________
(Telephone number)________________________________________________
The following statements are made as part of this notice of
participation:
A. Specific interests. (A statement of the specific interest of the
person in the proceeding, including the specific issues of fact
concerning which the person desires to be heard. This part need not be
completed by a party to the proceeding.)
B. Commitment to participate. (A statement that the person will
present documentary evidence or testimony at the hearing and will comply
with the requirements of 21 CFR 12.85, or, in the case of a hearing
before a Public Board of Inquiry, with the requirements of 21 CFR
13.25.)
(Signed)__________________________________________________________
(b) An amendment to a notice of participation should be filed with
the Dockets Management Branch and served on all participants.
(c) No person may participate in a hearing who has not filed a
written notice of participation or whose participation has been stricken
under paragraph (e) of this section.
(d) The presiding officer may permit the late filing of a notice of
participation upon a showing of good cause.
(e) The presiding officer may strike the participation of a person
for nonparticipation in the hearing or failure to comply with any
requirement of this subpart, e.g., disclosure of information as required
by Sec. 12.85 or the prehearing order issued under Sec. 12.92. Any
person whose participation is stricken may petition the Commissioner for
interlocutory review.
[44 FR 22339, Apr. 13, 1979, as amended at 46 FR 8456, Jan. 27, 1981; 59
FR 14364, Mar. 28, 1994]
Sec. 12.50 Advice on public participation in hearings.
(a) Designated agency contact. All inquiries from the public about
scheduling, location, and general procedures should be addressed to the
Deputy Commissioner for Policy (HF-22), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, or telephone 301-443-3480. The
staff of the Associate Commissioner for Regulatory Affairs will attempt
to respond promptly to all inquiries from members of the public, as well
as to simple requests for information from participants in hearings.
(b) Hearing schedule changes. Requests by hearing participants for
changes in the schedule of a hearing or for filing documents, briefs, or
other pleadings should be made in writing directly to the Administrative
Law Judge (HF-3), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857.
(c) Legal advice to individuals. FDA does not have the resources to
provide legal advice to members of the public concerning participation
in hearings.
[[Page 121]]
Furthermore, to do so would compromise the independence of the
Commissioner's office and invite charges of improper interference in the
hearing process. Accordingly, the Deputy Commissioner for Policy (HF-22)
will not answer questions about the strengths or weaknesses of a party's
position at a hearing, litigation strategy, or similar matters.
(d) Role of the office of the Chief Counsel. Under no circumstances
will the office of the Chief Counsel of FDA directly provide advice
about a hearing to any person who is participating or may participate in
the hearing. In every hearing, certain attorneys in the office are
designated to represent the center or centers whose action is the
subject of the hearing. Other members of the office, including
ordinarily the Chief Counsel, are designated to advise the Commissioner
on a final decision in the matter. It is not compatible with these
functions, nor would it be professionally responsible, for the attorneys
in the office of the Chief Counsel also to advise other participants in
a hearing, or for any attorney who may be called on to advise the
Commissioner to respond to inquiries from other participants in the
hearing, for such participants may be urging views contrary to those of
the center involved or to what may ultimately be the final conclusions
of the Commissioner. Accordingly, members of the office of the Chief
Counsel, other than the attorneys responsible for representing the
center whose action is the subject of the hearing, will not answer
questions about the hearing from any participant or potential
participant.
(e) Communication between participants and attorneys. Participants
in a hearing may communicate with the attorneys responsible for
representing the center whose action is the subject of the hearing, in
the same way that they may communicate with counsel for any other party
in interest about the presentation of matters at the hearing. It would
be inappropriate to bar discussion of such matters as stipulations of
fact, joint presentation of witnesses, or possible settlement of hearing
issues. Members of the public, including participants at hearings, are
advised, however, that all such communications, including those by
telephone, will be recorded in memoranda that can be filed with the
Dockets Management Branch.
[44 FR 22329, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54
FR 9035, Mar. 3, 1989; 58 FR 17096, Apr. 1, 1993]
Subpart D--Presiding Officer
Sec. 12.60 Presiding officer.
The presiding officer in a hearing will be the Commissioner, a
member of the Commissioner's office to whom the responsibility for the
matter involved has been delegated, or an administrative law judge
qualified under 5 U.S.C. 3105.
Sec. 12.62 Commencement of functions.
The functions of the presiding officer begin upon designation and
end upon the filing of the initial decision.
Sec. 12.70 Authority of presiding officer.
The presiding officer has all powers necessary to conduct a fair,
expeditious, and orderly hearing, including the power to--
(a) Specify and change the date, time, and place of oral hearings
and conferences;
(b) Establish the procedures for use in developing evidentiary
facts, including the procedures in Sec. 12.92(b) and to rule on the need
for oral testimony and cross-examination under Sec. 12.87(b);
(c) Prepare statements of the areas of factual disagreement among
the participants;
(d) Hold conferences to settle, simplify, or determine the issues in
a hearing or to consider other matters that may expedite the hearing;
(e) Administer oaths and affirmations;
(f) Control the course of the hearing and the conduct of the
participants;
(g) Examine witnesses and strike their testimony if they fail to
respond fully to proper questions;
(h) Rule on, admit, exclude, or limit evidence;
(i) Set the time for filing pleadings;
(j) Rule on motions and other procedural matters;
(k) Rule on motions for summary decision under Sec. 12.93;
[[Page 122]]
(l) Conduct the hearing in stages if the number of parties is large
or the issues are numerous and complex;
(m) Waive, suspend, or modify any rule in this subpart under
Sec. 10.19 if the presiding officer determines that no party will be
prejudiced, the ends of justice will be served, and the action is in
accordance with law;
(n) Strike the participation of any person under Sec. 12.45(e) or
exclude any person from the hearing under Sec. 12.90, or take other
reasonable disciplinary action; and
(o) Take any action for the fair, expeditious, and orderly conduct
of the hearing.
Sec. 12.75 Disqualification of presiding officer.
(a) A participant may request the presiding officer to disqualify
himself/herself and withdraw from the proceeding. The ruling on any such
request may be appealed in accordance with Sec. 12.97(b).
(b) A presiding officer who is aware of grounds for disqualification
shall withdraw from the proceeding.
Sec. 12.78 Unavailability of presiding officer.
(a) If the presiding officer is unable to act for any reason, the
Commissioner will assign the powers and duties to another presiding
officer. The substitution will not affect the hearing, except as the new
presiding officer may order.
(b) Any motion based on the substitution must be made within 10
days.
Subpart E--Hearing Procedures
Sec. 12.80 Filing and service of submissions.
(a) Submissions, including pleadings in a hearing, are to be filed
with the Dockets Management Branch under Sec. 10.20 except that only two
copies need be filed. To determine compliance with filing deadlines in a
hearing, a submission is considered submitted on the date it is actually
received by the Dockets Management Branch. When this part allows a
response to a submission and prescribes a period of time for the filing
of the response, an additional 3 days are allowed for the filing of the
response if the submission is served by mail.
(b) The person making a submission shall serve copies of it on the
other participants. Submissions of documentary data and information are
not required to be served on each participant, but any accompanying
transmittal letter, pleading, summary, statement of position,
certification under paragraph (d) of this section, or similar document
must be served on each participant.
(c) Service is accomplished by mailing a submission to the address
shown in the notice of participation or by personal delivery.
(d) All submissions are to be accompanied by a certificate of
service, or a statement that service is not required.
(e) No written submission or other portion of the administrative
record may be held in confidence, except as provided in Sec. 12.105.
Sec. 12.82 Petition to participate in forma pauperis.
(a) A participant who believes that compliance with the filing and
service requirements of this section constitutes an unreasonable
financial burden may submit to the Commissioner a petition to
participate in forma pauperis.
(b) The petition will be in the form specified in Sec. 10.30 except
that the heading will be ``Request to Participate in Forma Pauperis,
Docket No. ----.'' Filing and service requirements for the petition are
described in paragraph (c) of this section, whether or not the petition
is granted. The petition must demonstrate that either: (1) The person is
indigent and a strong public interest justifies participation, or (2)
the person's participation is in the public interest because it can be
considered of primary benefit to the general public.
(c) The Commissioner may grant or deny the petition. If the petition
is granted, the participant need file only one copy of each submission
with the Dockets Management Branch. The Dockets Management Branch will
make sufficient additional copies for the administrative record, and
serve a copy on each other participant.
[[Page 123]]
Sec. 12.83 Advisory opinions.
Before or during a hearing, a person may, under Sec. 10.85, request
the Commissioner for an advisory opinion on whether any regulation or
order under consideration in the proceeding applies to a specific
situation.
Sec. 12.85 Disclosure of data and information by the participants.
(a) Before the notice of hearing is published under Sec. 12.35, the
director of the center responsible for the matters involved in the
hearing shall submit the following to the Dockets Management Branch:
(1) The relevant portions of the administrative record of the
proceeding. Portions of the administrative record not relevant to the
issues in the hearing are not part of the administrative record.
(2) All documents in the director's files containing factual
information, whether favorable or unfavorable to the director's
position, which relate to the issues involved in the hearing. Files
means the principal files in the center in which documents relating to
the issues in the hearing are ordinarily kept, e.g., the food additive
master file and the food additive petition in the case of issues
concerning a food additive, or the new drug application in the case of
issues concerning a new drug. Internal memoranda reflecting the
deliberative process, and attorney work product and material prepared
specifically for use in connection with the hearing, are not required to
be submitted.
(3) All other documentary data and information relied upon.
(4) A narrative position statement on the factual issues in the
notice of hearing and the type of supporting evidence the director
intends to introduce.
(5) A signed statement that, to the director's best knowledge and
belief, the submission complies with this section.
(b) Within 60 days of the publication of the notice of hearing or,
if no participant will be prejudiced, within another period of time set
by the presiding officer, each participant shall submit to the Dockets
Management Branch all data and information specified in paragraph (a)(2)
through (5) of this section, and any objections that the administrative
record filed under paragraph (a)(1) of this section is incomplete. With
respect to the data and information specified in paragraph (a)(2) of
this section, participants shall exercise reasonable diligence in
identifying documents in files comparable to those described in that
paragraph.
(c) Submissions required by paragraphs (a) and (b) of this section
may be supplemented later in the proceeding, with the approval of the
presiding officer, upon a showing that the material contained in the
supplement was not reasonably known or available when the submission was
made or that the relevance of the material contained in the supplement
could not reasonably have been forseen.
(d) A participant's failure to comply substantially and in good
faith with this section constitutes a waiver of the right to participate
further in the hearing; failure of a party to comply constitutes a
waiver of the right to a hearing.
(e) Participants may reference each other's submissions. To reduce
duplicative submissions, participants are encouraged to exchange and
consolidate lists of documentary evidence. If a particular document is
bulky or in limited supply and cannot reasonably be reproduced, and it
constitutes relevant evidence, the presiding officer may authorize
submission of a reduced number of copies.
(f) The presiding officer will rule on questions relating to this
section.
[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]
Sec. 12.87 Purpose; oral and written testimony; burden of proof.
(a) The objective of a formal evidentiary hearing is the fair
determination of relevant facts consistent with the right of all
interested persons to participate and the public interest in promptly
settling controversial matters affecting the public health and welfare.
(b) Accordingly, the evidence at a hearing is to be developed to the
maximum extent through written submissions, including written direct
testimony, which may be in narrative or in question-and-answer form.
[[Page 124]]
(1) In a hearing, the issues may have general applicability and
depend on general facts that do not concern particular action of a
specific party, e.g., the safety or effectiveness of a class of drug
products, the safety of a food or color additive, or a definition and
standard of identity for a food; or the issues may have specific
applicability to past action and depend upon particular facts concerning
only that party, e.g., the applicability of a grandfather clause to a
particular brand of a drug or the failure of a particular manufacturer
to meet required manufacturing and processing specifications or other
general standards.
(i) If the proceeding involves general issues, direct testimony will
be submitted in writing, except on a showing that written direct
testimony is insufficient for a full and true disclosure of relevant
facts and that the participant will be prejudiced if unable to present
oral direct testimony. If the proceeding involves particular issues,
each party may determine whether, and the extent to which, each wishes
to present direct testimony orally or in writing.
(ii) Oral cross-examination of witnesses will be permitted if it
appears that alternative means of developing the evidence are
insufficient for a full and true disclosure of the facts and that the
party requesting oral cross-examination will be prejudiced by denial of
the request or that oral cross-examination is the most effective and
efficient means to clarify the matters at issue.
(2) Witnesses shall give testimony under oath.
(c) Except as provided in paragraph (d) of this section, in a
hearing involving issuing, amending, or revoking a regulation or order,
the originator of the proposal or petition or of any significant
modification will be, within the meaning of 5 U.S.C. 556(d), the
proponent of the regulation or order, and will have the burden of proof.
A participant who proposes to substitute a new provision for a provision
objected to has the burden of proof in relation to the new provision.
(d) At a hearing involving issuing, amending, or revoking a
regulation or order relating to the safety or effectiveness of a drug,
antibiotic, device, food additive, or color additive, the participant
who is contending that the product is safe or effective or both and who
is requesting approval or contesting withdrawal of approval has the
burden of proof in establishing safety or effectiveness or both and thus
the right to approval. The burden of proof remains on that participant
in an amendment or revocation proceeding.
Sec. 12.89 Participation of nonparties.
(a) A nonparty participant may--
(1) Attend all conferences (including the prehearing conference),
oral proceedings, and arguments;
(2) Submit written testimony and documentary evidence for inclusion
in the record;
(3) File written objections, briefs, and other pleadings; and
(4) Present oral argument.
(b) A nonparty participant may not--
(1) Submit written interrogatories; and
(2) Conduct cross-examination.
(c) A person whose petition is the subject of the hearing has the
same right as a party.
(d) A nonparty participant will be permitted additional rights if
the presiding officer concludes that the participant's interests would
not be adequately protected otherwise or that broader participation is
required for a full and true disclosure of the facts, but the rights of
a nonparty participant may not exceed the rights of a party.
[44 FR 22339, Apr. 13, 1979, as amended at 48 FR 51770, Nov. 14, 1983]
Sec. 12.90 Conduct at oral hearings or conferences.
All participants in a hearing will conduct themselves with dignity
and observe judicial standards of practice and ethics. They may not
indulge in personal attacks, unseemly wrangling, or intemperate
accusations or characterizations. Representatives of parties shall, to
the extent possible, restrain clients from improprieties in connection
with any proceeding. Disrespectful, disorderly, or contumacious language
or conduct, refusal to comply with directions, use of dilatory tactics,
or refusal to adhere to reasonable
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standards of orderly and ethical conduct during any hearing, constitute
grounds for immediate exclusion from the proceeding by the presiding
officer.
Sec. 12.91 Time and place of prehearing conference.
A prehearing conference will commence at the date, time, and place
announced in the notice of hearing, or in a later notice, or as
specified by the presiding officer in a notice modifying a prior notice.
At that conference the presiding officer will establish the methods and
procedures to be used in developing the evidence, determine reasonable
time periods for the conduct of the hearing, and designate the times and
places for the production of witnesses for direct and cross-examination
if leave to conduct oral examination is granted on any issue, as far as
practicable at that time.
Sec. 12.92 Prehearing conference procedure.
(a) Participants in a hearing are to appear at the prehearing
conference prepared to discuss and resolve all matters specified in
paragraph (b) of this section.
(1) To expedite the hearing, participants are encouraged to prepare
in advance for the prehearing conference. Participants should cooperate
with each other, and request information and begin preparation of
testimony at the earliest possible time. Failure of a participant to
appear at the prehearing conference or to raise matters that could
reasonably be anticipated and resolved at that time will not delay the
progress of the hearing, and constitutes a waiver of the rights of the
participant regarding such matters as objections to the agreements
reached, actions taken, or rulings issued by the presiding officer and
may be grounds for striking the participation under Sec. 12.45.
(2) Participants shall bring to the prehearing conference the
following specific information, which will be filed with the Dockets
Management Branch under Sec. 12.80:
(i) Any additional information to supplement the submission filed
under Sec. 12.85, which may be filed if approved under Sec. 12.85(c).
(ii) A list of all witnesses whose testimony will be offered, orally
or in writing, at the hearing, with a full curriculum vitae for each.
Additional witnesses may later be identified, with the approval of the
presiding officer, on a showing that the witness was not reasonably
available at the time of the prehearing conference or the relevance of
the witness' views could not reasonably have been foreseen at that time.
(iii) All prior written statements including articles and any
written statement signed or adopted, or a recording or transcription of
an oral statement made, by persons identified as witnesses if--
(a) The statement is available without making request of the witness
or any other person;
(b) The statement relates to the subject matter of the witness'
testimony; and
(c) The statement either was made before the time the person agreed
to become a witness or has been made publicly available by the person.
(b) The presiding officer will conduct a prehearing conference for
the following purposes:
(1) To determine the areas of factual disagreement to be considered
at the hearing. The presiding officer may hold conferences off the
record in an effort to reach agreement on disputed factual questions.
(2) To identify the most appropriate techniques for developing
evidence on issues in controversy and the manner and sequence in which
they will be used, including, where oral examination is to be conducted,
the sequence in which witnesses will be produced for, and the time and
place of, oral examination. The presiding officer may consider--
(i) Submission of narrative statements of position on factual issues
in controversy;
(ii) Submission of evidence or identification of previously
submitted evidence to support such statements, such as affidavits,
verified statements of fact, data, studies, and reports;
(iii) Exchange of written interrogatories directed to particular
witnesses;
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(iv) Written requests for the production of additional
documentation, data, or other relevant information;
(v) Submission of written questions to be asked by the presiding
officer of a specific witness; and
(vi) Identification of facts for which oral examination and/or
cross-examination is appropriate.
(3) To group participants with substantially like interests for
presenting evidence, making motions and objections, including motions
for summary decision, filing briefs, and presenting oral argument.
(4) To hear and rule on objections to admitting into evidence
information submitted under Sec. 12.85.
(5) To obtain stipulations and admissions of facts.
(6) To take other action that may expedite the hearing.
(c) The presiding officer shall issue, orally or in writing, a
prehearing order reciting the actions taken at the prehearing conference
and setting forth the schedule for the hearing. The order will control
the subsequent course of the hearing unless modified by the presiding
officer for good cause.
Sec. 12.93 Summary decisions.
(a) After the hearing commences, a participant may move, with or
without supporting affidavits, for a summary decision on any issue in
the hearing. Any other participant may, within 10 days after service of
the motion, which time may be extended for an additional 10 days for
good cause, serve opposing affidavits or countermove for summary
decision. The presiding officer may set the matter for argument and call
for the submission of briefs.
(b) The presiding officer will grant the motion if the objections,
requests for hearing, other pleadings, affidavits, and other material
filed in connection with the hearing, or matters officially noticed,
show that there is no genuine issue as to any material fact and that a
participant is entitled to summary decision.
(c) Affidavits should set forth facts that would be admissible in
evidence and show affirmatively that the affiant is competent to testify
to the matters stated. When a properly supported motion for summary
decision is made, a participant opposing the motion may not rest upon
mere allegations or denials or general descriptions of positions and
contentions; affidavits or other responses must set forth specific facts
showing that there is a genuine issue of fact for the hearing.
(d) Should it appear from the affidavits of a participant opposing
the motion that for sound reasons stated, facts essential to justify the
opposition cannot be presented by affidavit, the presiding officer may
deny the motion for summary decision, order a continuance to permit
affidavits or additional evidence to be obtained, or issue other just
order.
(e) If on motion under this section a summary decision is not
rendered upon the whole case or for all the relief asked. and
evidentiary facts need to be developed, the presiding officer will issue
an order specifying the facts that appear without substantial
controversy and directing further evidentiary proceedings. The facts so
specified will be deemed established.
(f) A participant may obtain interlocutory review by the
Commissioner of a summary decision of the presiding officer.
Sec. 12.94 Receipt of evidence.
(a) A hearing consists of the development of evidence and the
resolution of factual issues as set forth in this subpart and in the
prehearing order.
(b) All orders, transcripts, written statements of position, written
direct testimony, written interrogatories and responses, and any other
written material submitted in the proceeding is a part of the
administrative record of the hearing, and will be promptly placed on
public display in the office of the Dockets Management Branch, except as
provided in Sec. 12.105.
(c) Written evidence, identified as such, is admissible unless a
participant objects and the presiding officer excludes it on objection
of a participant or on the presiding officer's own initiative.
(1) The presiding officer may exclude written evidence as
inadmissible only if--
(i) The evidence is irrelevant, immaterial, unreliable, or
repetitive;
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(ii) Exclusion of part or all of the written evidence of a
participant is necessary to enforce the requirements of this subpart; or
(iii) The evidence was not submitted as required by Sec. 12.85.
(2) Items of written evidence are to be submitted as separate
documents, sequentially numbered, except that a voluminous document may
be submitted in the form of a cross-reference to the documents filed
under Sec. 12.85.
(3) Written evidence excluded by the presiding officer as
inadmissible remains a part of the administrative record, as an offer of
proof, for judicial review.
(d) Testimony, whether on direct or on cross-examination, is
admissible as evidence unless a participant objects and the presiding
officer excludes it.
(1) The presiding officer may exclude oral evidence as inadmissible
only if--
(i) The evidence is irrelevant, immaterial, unreliable, or
repetitive; or
(ii) Exclusion of part or all of the evidence is necessary to
enforce the requirements of this part.
(2) If oral evidence is excluded as inadmissible, the participant
may take written exception to the ruling in a brief to the Commissioner,
without taking oral exception at the hearing. Upon review, the
Commissioner may reopen the hearing to permit the evidence to be
admitted if the Commissioner determines that its exclusion was erroneous
and prejudicial.
(e) The presiding officer may schedule conferences as needed to
monitor the program of the hearing, narrow and simplify the issues, and
consider and rule on motions, requests, and other matters concerning the
development of the evidence.
(f) The presiding officer will conduct such proceedings as are
necessary for the taking of oral testimony, for the oral examination of
witnesses by the presiding officer on the basis of written questions
previously submitted by the parties, and for the conduct of cross-
examination of witnesses by the parties. The presiding officer shall
exclude irrelevant or repetitious written questions and limit oral
cross-examination to prevent irrelevant or repetitious examination.
(g) The presiding officer shall order the proceedings closed for the
taking of oral testimony relating to matters specified in
Sec. 10.20(j)(2)(i)(a) and (b). Such closed proceedings will be
conducted in accordance with Sec. 10.20(j)(3). Participation in closed
proceedings will be limited to the witness, the witness' counsel, and
Federal Government executive branch employees and special government
employees. Closed proceedings will be permitted only for, and will be
limited to, oral testimony directly relating to matters specified in
Sec. 10.20(j)(3).
Sec. 12.95 Official notice.
(a) Official notice may be taken of such matters as might be
judicially noticed by the courts of the United States or of any other
matter peculiarly within the general knowledge of FDA as an expert
agency.
(b) If official notice is taken of a material fact not appearing in
the evidence of record, a participant, on timely request, will be
afforded an opportunity to show the contrary.
Sec. 12.96 Briefs and arguments.
(a) Promptly after the taking of evidence is completed, the
presiding officer will announce a schedule for the filing of briefs.
Briefs are to be filed ordinarily within 45 days of the close of the
hearing. Briefs must include a statement of position on each issue, with
specific and complete citations to the evidence and points of law relied
on. Briefs must contain proposed findings of fact and conclusions of
law.
(b) The presiding officer may, as a matter of discretion, permit
oral argument after the briefs are filed.
(c) Briefs and oral argument are to refrain from disclosing specific
details of written and oral testimony and documents relating to matters
specified in Sec. 10.20(j)(2)(i)(a) and (b), except as specifically
authorized in a protective order issued under Sec. 10.20(j)(3).
Sec. 12.97 Interlocutory appeal from ruling of presiding officer.
(a) Except as provided in paragraph (b) of this section and in
Secs. 12.35(b), 12.45(e), 12.93(f), and 12.99(d), when an interlocutory
appeal is specifically authorized by this subpart, rulings of the
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presiding officer may not be appealed to the Commissioner before the
Commissioner's consideration of the entire record of the hearing.
(b) A ruling of the presiding officer is subject to interlocutory
appeal to the Commissioner if the presiding officer certifies on the
record or in writing that immediate review is necessary to prevent
exceptional delay, expense, or prejudice to any participant, or
substantial harm to the public interest.
(c) When an interlocutory appeal is made to the Commissioner, a
participant may file a brief with the Commissioner only if specifically
authorized by the presiding officer or the Commissioner, and if such
authorization is granted, within the period the Commissioner directs. If
a participant is authorized to file a brief, any other participant may
file a brief in opposition, within the period the Commissioner directs.
If no briefs are authorized, the appeal will be presented as an oral
argument to the Commissioner. The oral argument will be transcribed. If
briefs are authorized, oral argument will be heard only at the
discretion of the Commissioner.
Sec. 12.98 Official transcript.
(a) The presiding officer will arrange for a verbatim stenographic
transcript of oral testimony and for necessary copies of the transcript.
(b) One copy of the transcript will be placed on public display in
the office of the Dockets Management Branch upon receipt.
(c) Except as provided in Sec. 12.105, copies of the transcript may
be obtained by application to the official reporter and payment of costs
thereof or under part 20.
(d) Witnesses, participants, and counsel have 30 days from the time
the transcript becomes available to propose corrections in the
transcript of oral testimony. Corrections are permitted only for
transcription errors. The presiding officer shall promptly order
justified corrections.
Sec. 12.99 Motions.
(a) A motion on any matter relating to the proceeding is to be filed
under Sec. 12.80, and must include a draft order, except one made in the
course of an oral hearing before the presiding officer.
(b) A response may be filed within 10 days of service of a motion.
The time may be shortened or extended by the presiding officer for good
cause shown.
(c) The moving party has no right to reply, except as permitted by
the presiding officer.
(d) The presiding officer shall rule upon the motion and may certify
that ruling to the Commissioner for interlocutory review.
Subpart F--Administrative Record