30992 Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5

Delegations of Authority and

Organization; Reorganization and

Republication

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is revising its

regulation for its delegations of

authority, to improve information

retrieval, ensure consistency, clarify

redelegation statements, update the

legal citations and position and

organizational titles, and, in some

instances, redelegate authorities to

additional agency officials and

employees. This action is necessary to

ensure the continued accuracy of the

regulations.

DATES: This rule is effective April 2,

2001.

FOR FURTHER INFORMATION CONTACT:

Donna Page or Robin Phipps, Division

of Management Programs (HFA–340),

Food and Drug Administration, 301–

827–4816 or 301–827–4806,

respectively.

SUPPLEMENTARY INFORMATION: FDA is

revising its regulations for delegation of

authority and organization in part 5 (21

CFR part 5) to improve information

retrieval by agency officials and

employees, the public, and affected

industries; to ensure the accuracy of the

regulation by removing or correcting

obsolete references to legislation,

organizational and position titles; and to

improve consistency in the display of

the information. This regulation

includes revisions to § 5.10 to clarify

that the authority of the Secretary of

Health and Human Services (the

Secretary) is delegated directly to the

Commissioner of Food and Drugs (the

Commissioner), as well as to correct or

remove outdated statutory citations. In

21 CFR, subpart B has been

substantially reorganized, made into

additional subparts, and updated.

Prior to November 1995, the

Commissioner had reported to the

Assistant Secretary for Health (ASH),

and the Commissioner exercised

authority delegated from the Secretary

through the ASH. In November 1995,

the Secretary designated U.S. Public

Health Service agencies, including FDA,

as Operating Divisions within the

Department of Health and Human

Services that report directly to the

Secretary, and deleted the Office of the

ASH (60 FR 56605, November 9, 1995).

In this revision, we have therefore

modified the introductory language of

§ 5.10(a) to indicate that the delegations

are from the Secretary directly to the

Commissioner, and we have moved the

delegations formerly listed in § 5.10(c),

(d), and (f) into § 5.10(a).

In this revision, we have also removed

or corrected obsolete citations to

legislation in § 5.10 and in the agency

delegations. Following are the legal

citations that we removed or corrected,

as appropriate:

(1) In § 5.10(a)(1) and in § 5.32

(formerly § 5.35), we removed references

to the Tea Importation Act, which

Congress repealed by Public Law 104–

128, section 2.

(2) We removed § 5.10(a)(3), which

pertained to electronic product

radiation control under the PHS Act

(PHS Act), because Congress transferred

these provisions from the PHS Act to

the Federal Food, Drug and Cosmetic

Act (the act) by Public Law 101–629,

section 19(a). Additionally in §§ 5.800,

5.601, 5.602, 5.603, 5.604, 5.605, and

5.606 (formerly §§ 5.45, 5.87, 5.88, 5.89,

5.90, 5.91, and 5.92), we revised

citations for electronic product radiation

control to the act instead of the PHS

Act.

(3) In § 5.10(a)(19) (formerly

§ 5.10(a)(20)), we updated the reference

to the acceptance of gifts, which was

formerly codified under the PHS Act (at

42 U.S.C. 219) and is now codified at 42

U.S.C. 238 by Public Law 103–43, title

XX, section 2010(a)(1)–(3).

(4) We removed § 5.10(a)(22), which

pertained to waiving matching

requirements on state and local

governments under title X of the Public

Works and Economic Development Act

of 1965 (42 U.S.C. 3246b(b)(3)), because

Congress repealed section 1003(b)(3),

title X, of that act by Public Law 105–

393, title I, section 102(c).

(5) In § 5.10(a)(22) (formerly

§ 5.10(a)(24)), we removed the reference

to section 1704(6) of the PHS Act,

because Congress repealed it by Public

Law 98–551, section 2(b).

(6) We removed § 5.10(a)(28), which

pertained to a registry for cardiac

pacemaker devices and leads 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)) because

Congress repealed section 1862(h) (42

U.S.C. 1395y(h)) by Public Law 104–

224, section 1. Additionally, we

removed former § 5.28, regarding

payments for cardiac pacemaker devices

and pacemaker leads, because Congress

repealed the statutory provision.

(7) In § 5.10(a)(26) (formerly

§ 5.10(a)(29)), we updated citations

under the Stevenson-Wydler

Technology Innovation Act of 1980,

because Congress placed what had been

section 11(b)(3) into 11(b)(3)(D) and

what had been section 11(b)(4) into

11(b)(3)(C) by Public Law 104–113,

section 4.

At the end of each section of the

reorganized §§ 5.20 through 5.1000, we

have added the appropriate redelegation

statements. Although the officials under

§ 5.20(b) (the Deputy Commissioner;

Senior Associate Commissioner; Deputy

Commissioner for International and

Constituent Relations; Senior Associate

Commissioner for Management and

Systems; Senior Associate

Commissioner for Policy, Planning, and

Legislation; and the Associate

Commissioner for Regulatory Affairs)

have all the authorities of the

Commissioner, their titles appear in

other sections of the reorganized §§ 5.21

through 5.1000, generally to indicate

that they are the agency officials who

would principally exercise the

authority. Further, in some instances,

the Commissioner has delegated

authorities to additional agency officials

to ensure more efficient operations.

For the convenience of the user, we

have established additional subparts to

categorize the information about

delegations within FDA by functional

areas. In this revision, the subparts are

Subpart B, General Redelegations of

Authority; Subpart C, Human Drugs,

Redelegations of Authority; Subpart D,

Biologics, Redelegations of Authority;

Subpart E, Food and Cosmetics,

Redelegations of Authority; Subpart F,

Medical Devices, Redelegations of

Authority; Subpart G, Animal Drugs,

Redelegations of Authority; Subpart H,

Radiation Control, Redelegations of

Authority; Subpart I, Product

Designation, Redelegations of Authority;

Subpart J, Imports and Exports,

Redelegations of Authority; Subpart K,

Orphan Products, Redelegations of

Authority; Subpart L, Mammography

Facilities, Redelegations of Authority;

and Subpart M, Organization. We have

cross-referenced (in the attached

Appendix) the former subparts and

sections to the new subparts and

sections; and we are displaying the

entire text of the revised part 5.

The agency is issuing this rule as a

final rule without publishing a general

notice of proposed rulemaking because

such notice is not required for this rule

of agency organization, procedure, or

practice under 5 U.S.C. 533(b)(A).

The agency has determined under 21

CFR 25.30 that this action is of a type

that does not individually or

Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations 30993

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

FDA has analyzed this final rule in

accordance with the principles set forth

in Executive Order 13132. FDA has

determined that the rule does not

contain policies that have substantial

direct effects on the States, on the

relationship between the National

Government and the States, or on the

distribution of power and

responsibilities among the various

levels of government. Accordingly, the

agency has concluded that the rule does

not contain policies that have

federalism implications as defined in

the order and, consequently, a

federalism summary impact statement is

not required.

FDA has examined the impacts of this

final rule under Executive Order 12866.

Executive Order 12866 directs agencies

to assess all costs and benefits of

available regulatory alternatives and,

when regulation is necessary, to select

regulatory approaches that maximize

net benefits (including potential

economic, environmental, public health

and safety, and other advantages;

distributive impacts; and equity).

Executive Order 12866 classifies a rule

as significant if it meets any one of a

number of specified conditions,

including having an annual effect on the

economy of $100 million or more, or

adversely affecting in a material way a

sector of the economy, competition, or

jobs, or if it raises novel legal or policy

issues. The agency finds that this final

rule, which reorganizes, updates, and

clarifies the agency’s internal

delegations, is not a significant rule as

defined by Executive Order 12866. No

analysis is required under the

Regulatory Flexibility Act (5 U.S.C.

601–612) because the agency is issuing

it without publishing a general notice of

proposed rulemaking, as explained

previously in this document.

This final rule contains no collections

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

The agency plans to migrate to an

Intra/Internet-based system for

publishing the delegations of authority

and eventually remove them from part

5. The agency will publish a notice to

make that change effective and provide

the Internet website address.

The Commissioner hereby ratifies and

affirms any actions taken by the

delegates and their subordinates, which

in effect, involved the exercise of the

authorities delegated herein prior to the

effective date of this notice.

List of Subjects in 21 CFR Part 5

Authority delegations (Government

agencies), Imports, Organization and

functions (Government agencies).

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under the

authority delegated to the Commissioner

of Food and Drugs, title 21 CFR part 5

is revised to read as follows:

PART 5—DELEGATIONS OF

AUTHORITY AND ORGANIZATION

1. Part 5 is revised in its entirety to

read as follows:

PART 5—DELEGATIONS OF

AUTHORITY AND ORGANIZATION

Subpart A—Delegations of Authority to the

Commissioner of Food and Drugs

Sec.

5.10 Delegations from the Secretary for

Health and Human Services to the

Commissioner of Food and Drugs.

5.11 Reservation of authority.

Subpart B—General Redelegations of

Authority

Sec.

5.20 General redelegations of authority from

the Commissioner to other officers of the

Food and Drug Administration.

5.21 Emergency functions.

5.22 Certification of true copies and use of

Department seal.

5.23 Disclosure of official records and

authorization of testimony.

5.24 Authority relating to technology

transfer.

5.25 Research, investigation, and testing

programs and health information and

promotion programs.

5.26 Service fellowships.

5.27 Patent term extensions for human drug

products, medical devices, and food and

color additives; and authority to perform

due diligence determinations and

informal hearings.

5.28 Hearings.

5.29 Petitions under part 10.

5.30 Authority to select temporary voting

members for advisory committees and

authority to sign conflict of interest

waivers.

5.31 Enforcement activities.

5.32 Certification following inspections.

5.33 Issuance of reports of minor violations.

5.34 Issuance of notices relating to

proposals and orders for debarment and

denial of an application to terminate

debarment.

5.35 Officials authorized to make

certification under 5 U.S.C. 605(b) for

any proposed and final rules.

Subpart C—Human Drugs; Redelegations of

Authority

Sec.

5.100 Issuance of notices implementing the

provisions of the Drug Amendments of

1962.

5.101 Termination of exemptions for new

drugs for investigational use in human

beings.

5.102 Authority to approve and to

withdraw approval of a charge for

investigational new drugs.

5.103 Approval of new drug applications

and their supplements.

5.104 Responses to Drug Enforcement

Administration temporary scheduling

notices.

5.105 Issuance of notices relating to

proposals to refuse approval or to

withdraw approval of new drug

applications and their supplements.

5.106 Submission of and effective approval

dates for abbreviated new drug

applications and certain new drug

applications.

5.107 Extensions or stays of effective dates

for compliance with certain labeling

requirements for human prescription

drugs.

5.108 Authority relating to waivers or

reductions of prescription drug user fees.

5.109 Issuance of written notices

concerning patent information, current

good manufacturing practices and false

or misleading labeling of new drugs.

Subpart D—Biologics; Redelegations of

Authority

Sec.

5.200 Functions pertaining to safer

vaccines.

5.201 Redelegation of the Center for

Biologics Evaluation and Research

Director’s program authorities.

5.202 Issuance of notices of opportunity for

a hearing on proposals for denial of

approval of applications for licenses,

suspension of licenses, or revocation of

licenses and certain notices of revocation

of licenses.

5.203 Issuance and revocation of licenses

for the propagation or manufacture and

preparation of biological products.

5.204 Notification of release for distribution

of biological products.

Subpart E—Foods and Cosmetics;

Redelegations of Authority

Sec.

5.300 Food standards, food additives,

generally recognized as safe (GRAS)

substances, color additives, nutrient

content claims, and health claims.

5.301 Issuance of initial emergency permit

orders and notices of confirmation of

effective date of final regulations on food

for human and animal consumption.

5.302 Detention of meat, poultry, eggs, and

related products.

5.303 Establishing standards and approving

accrediting bodies under the National

Laboratory Accreditation Program.

5.304 Approval of schools providing foodprocessing instruction.

Subpart F—Medical Devices and

Radiological Health; Redelegations of

Authority

Sec.

5.400 Issuance of Federal Register

documents to recognize or to withdraw

recognition of a standard to meet

premarket submission requirements.

30994 Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations

5.401 Issuance of Federal Register

documents pertaining to exemptions

from premarket notification.

5.402 Detention of adulterated or

misbranded medical devices.

5.403 Authorization to use alternative

evidence for determination of the

effectiveness of medical devices.

5.404 Notification of petitioners of

determinations made on petitions for

reclassification of medical devices.

5.405 Determination of classification of

devices.

5.406 Notification to sponsors of

deficiencies in petitions for

reclassification of medical devices.

5.407 Approval, disapproval, or withdrawal

of approval of product development

protocols and applications for premarket

approval for medical devices.

5.408 Determinations concerning the type

of valid scientific evidence submitted in

a premarket approval application.

5.409 Determinations that medical devices

present unreasonable risk of substantial

harm.

5.410 Orders to repair or replace, or make

refunds for, medical devices.

5.411 Medical device recall authority.

5.412 Temporary suspension of a medical

device application.

5.413 Approval, disapproval, or withdrawal

of approval of applications and entering

into agreements for investigational

device exemptions.

5.414 Postmarket surveillance.

5.415 Authority relating to medical device

reporting procedures.

5.416 Medical device tracking.

5.417 Authority pertaining to accreditation

functions for medical devices.

Subpart G—Animal Drugs; Redelegations of

Authority.

Sec.

5.500 Issuance of Federal Register

documents pertaining to the

determination of safe levels, notice of

need for development of an analytical

method, notice of availability of a

developed analytical method, and

prohibition of certain extralabel drug

use.

5.501 Approval of new animal drug

applications, medicated feed mill license

applications and their supplements.

5.502 Issuance of notices, proposals, and

orders relating to new animal drugs and

medicated feed mill license applications.

5.503 Submission of and effective approval

dates for abbreviated new animal drug

applications and certain new animal

drug applications.

5.504 Issuance of written notices

concerning patent information, current

good manufacturing practices and false

or misleading labeling of new animal

drugs and feeds bearing or containing

new animal drugs.

5.505 Termination of exemptions for new

drugs for investigational use in animals.

Subpart H—Radiation Control;

Redelegations of Authority

Sec.

5.600 Variances from performance

standards for electronic products.

5.601 Exemption of electronic products

from performance standards and

prohibited acts.

5.602 Testing programs and methods of

certification and identification for

electronic products.

5.603 Notification of defects in, and repair

or replacement of, electronic products.

5.604 Manufacturers requirement to

provide date to ultimate purchasers of

electronic products.

5.605 Dealer and distributor direction to

provide data to manufacturers of

electronic products.

5.606 Acceptance of assistance from State

and Local authorities for enforcement of

radiation control legislation and

regulations.

Subpart I—Product Designation;

Redelegations of Authority

Sec.

5.700 Authority relating to determination of

product primary jurisdiction.

5.701 Premarket approval of a product that

is or contains a biologic, a device, or a

drug.

Subpart J—Imports and Exports;

Redelegations of Authority

Sec.

5.800 Imports and exports.

5.801 Export of unapproved drugs.

5.802 Manufacturer’s resident import

agents.

Subpart K—Orphan Products;

Redelegations of Authority

Sec. 5.900 Orphan products.

Subpart L—Mammography Facilities;

Redelegations of Authority

Sec.

5.1000 Authority to ensure that

mammography facilities meet quality

standards.

Subpart M—Organization

Sec.

5.1100 Headquarters.

5.1105 Chief Counsel, Food and Drug

Administration.

5.1110 Food and Drug Administration

Public Information Offices.

5.1115 Field Structure.

Authority: 5 U.S.C. 504, 552, App. 2 605;

7 U.S.C. 138a, 2217; 15 U.S.C. 638, 1261–

1282, 1451–1461, 3701–3711a; 21 U.S.C., 61–

63, 141–149, 301–394, 467f, 679(b), 801–886,

1031–1309, 1401–1403; 35 U.S.C. 156; 42

U.S.C. 238, 241, 242, 242a, 242l, 242n, 242o,

243, 262, 263, 264, 265, 300u–300u–5,

300aa–1, 300ar–25–28, 300cc, 300ff, 1395y,

4332, 4831(a), 10007–10008; E.O. 11921, 41

FR 24294, 3 CFR, 1977 Comp., p. 124–131;

E.O. 12591, 52 FR 13414, 3 CFR, 1988 Comp.,

p. 220–223.

Subpart A—Delegations of Authority to

the Commissioner of Food and Drugs

§ 5.10 Delegations from the Secretary of

Health and Human Services to the

Commissioner of Food and Drugs.

(a) The Secretary of Health and

Human Services (the Secretary) has

redelegated to the Commissioner of

Food and Drugs (Commissioner), with

authority to redelegate (except when

specifically prohibited), all authority as

follows:

(1) Functions vested in the Secretary

under the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 301 et seq.), as

amended, the Filled Milk Act (21 U.S.C.

61–63), the Federal Import Milk Act (21

U.S.C. 141 et seq.), the Federal Caustic

Poison Act (44 Stat. 1406; see also

Public Law 86–613, section 19, formerly

section 18) and The Fair Packaging and

Labeling Act (15 U.S.C. 1451 et seq.),

under section 12 of Reorganization Plan

No. IV and Reorganization Plan No. 1 of

1953, including authority to administer

oaths vested in the Secretary of

Agriculture by 7 U.S.C. 2217.

(2) Functions vested in the Secretary

under section 301 (Research and

Investigations); section 307

(International Cooperation); and section

311 (Federal-State Cooperation) of the

Public Health Service Act (the PHS Act)

(42 U.S.C. 241, 242l, 243), as amended,

which relate to the functions of the

Food and Drug Administration.

(3) Functions vested in the Secretary

under section 361 of the PHS Act (42

U.S.C. 264), as amended, which relate to

the law enforcement functions of the

Food and Drug Administration

concerning the following products and

activities: Biologicals (including blood

and blood products); interstate travel

sanitation (except interstate

transportation of etiologic agents under

42 CFR part 72); food (including milk

and food service sanitation and shellfish

sanitation); and drugs, devices,

cosmetics, electronic products, and

other items or products regulated by the

Food and Drug Administration.

(4) Functions vested in the Secretary

under sections 351 and 352 of part F,

subpart 1 of the PHS Act (42 U.S.C. 262

and 263), as amended (Biological

Products), insofar as they relate to the

functions assigned to the Food and Drug

Administration.

(5) Functions vested in the Secretary

under section 302(a) of the PHS Act (42

U.S.C. 242(a)), as amended, which relate

to the determination and reporting

requirements with respect to the

medicinal and scientific requirements of

the United States for controlled

substances.

(6) Functions vested in the Secretary

under section 303 of the PHS Act (42

U.S.C. 242a), as amended, which relate

to the authorization of persons engaged

in research on the use and effect of

drugs to protect the identity of their

research subjects with respect to drugs

scheduled under Public Law 91–513 for

which an investigational new drug

Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations 30995

application is filed with the Food and

Drug Administration and with respect to

all drugs not scheduled under Public

Law 91–513.

(7) Functions vested in the Secretary

pertaining to section 4 of the

Comprehensive Drug Abuse Prevention

and Control Act of 1970 (Public Law

91–513, 84 Stat. 1241) which relate to

the determination of the safety and

effectiveness of drugs or to approve new

drugs to be used in the treatment of

narcotic addicts.

(8) Functions vested in the Secretary

pertaining to section 303(f) of the

Controlled Substances Act (21 U.S.C.

823(f)), which relate to the merits of the

research protocol and to the

determination of the qualifications and

competency of practitioners wishing to

conduct research with controlled

substances listed in Schedule I of the

Act.

(9) Functions vested in the Secretary

pertaining to provisions of the

Controlled Substances Act (21 U.S.C.

801 et seq.), which relate to

administration of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 301

et seq.).

(10) Functions vested in the Secretary

under section 409(b) of the Federal Meat

Inspection Act (21 U.S.C. 679(b)), which

relate to the detention of any carcass,

part thereof, meat, or meat product of

cattle, sheep, swine, goats, or equines.

(11) Functions vested in the Secretary

under section 24(b) of the Poultry

Products Inspection Act (21 U.S.C.

467f(b)), which relate to the detention of

any poultry carcass, part thereof, or

poultry product.

(12) Functions vested in the Secretary

under the Egg Products Inspection Act

(21 U.S.C. 1031 et seq.).

(13) Functions vested in the Secretary

by amendments to the foregoing statutes

subsequent to Reorganization Plan No. 1

of 1953.

(14) Function of issuing all

regulations of the Food and Drug

Administration, except as provided in

§ 5.11. The reservation of authority

contained in Chapter 2–000 of the

Department Organization Manual shall

not apply.

(15) Functions vested in the Secretary

under section 1103 of Executive Order

11490, as amended by Executive Order

11921, which relate to emergency health

functions as they pertain to the

operations and functional

responsibilities assigned to the agency.

This authority shall be exercised in

accordance with section 102 and

pertinent sections of part 30 of

Executive Order 11490 and guidelines

issued by the Federal Preparedness

Agency of the General Services

Administration and the Office of the

Secretary.

(16) Function vested in the Secretary

of authorizing and approving

miscellaneous and emergency expenses

of enforcement activities.

(17) Functions vested in the Secretary

under the Federal Advisory Committee

Act, Public Law 92–463, to:

(i) Renew, recharter, amend and

terminate established Federal Advisory

Committees;

(ii) Authority to approve waivers to

appoint committee members to

established Federal Advisory

Committees;

(iii) Authority to close review

meetings following approval by the

Office of the General Counsel based on

a determination that the Advisory

Committee meeting or a portion thereof

may be closed to the public under the

provisions of 5 U.S.C. 552b(c) and

section 10(d) of the Federal Advisory

Committee Act. These authorities are to

be exercised in accordance with the

requirements of 5 U.S.C. 552b; the

Federal Advisory Committee Act (Public

Law 92–463); Departmental regulations

(45 CFR part 11, superseded by 41 CFR

part 101–6); and any other applicable

statutes and regulations. These

authorities may be redelegated.

(18) Functions vested in the Secretary

under the second sentence of section

310(a) and under section 310(b) (Health

Conferences and Health Education

Information) of the PHS Act (42 U.S.C.

242o), as amended, to call for a

conference and invite as many health

authorities and officials of State or local

public or private agencies or

organizations as deemed necessary or

proper on subjects related to the

functions of the Food and Drug

Administration, and to issue

information related to health for the use

of the public and other pertinent health

information for the use of persons and

institutions concerned with health

services when such information is

related to the functions of the Food and

Drug Administration.

(19) Functions vested in the Secretary

under section 2701 of the PHS Act (42

U.S.C. 238), as amended, to accept offers

of gifts, excluding the acceptance of gifts

of real property. Only the authority to

accept unconditional gifts of personal

property valued at $5,000 or less may be

redelegated.

(20) Functions vested in the Secretary

under section 362 of the PHS Act (42

U.S.C. 265), as amended, which relate to

the prohibition of the introduction of

foods, drugs, devices, cosmetics,

electronic products, and other items or

products regulated by the Food and

Drug Administration into the United

States when it is determined that it is

required in the interest of public health

when such functions relate to the law

enforcement functions of the Food and

Drug Administration.

(21) Functions vested in the Secretary

under section 401(a) of the Lead-Based

Paint Poisoning Prevention Act, as

amended by Public Law 94–317 (42

U.S.C. 4831(a)), relating to the

prohibition of the application of leadbased paint to cooking, drinking, or

eating utensils.

(22) Functions vested in the Secretary

for the health information and health

promotion program under title XVII of

the PHS Act (42 U.S.C. 300u et seq.), as

amended, insofar as the authorities

pertain to functions assigned to the

Food and Drug Administration. The

delegation includes, but is not limited

to, the authorities under: Section

1702(a)(1) and (3) and section 1704(1)

and (2) (42 U.S.C. 300u–1(a) and (3) and

300u–3(1) and (2)). The delegation

excludes the authority to select all

Senior Executive Service, supergrade

and equivalent, and Schedule C (GS–12

and above) positions; issue regulations;

and submit reports to the President.

(23) To administer a Small Business

Innovation Research Program under

section 9 of the Small Business Act (15

U.S.C. 638), as amended. The delegation

excludes the authority to issue

regulations, establish advisory councils

and committees, appoint members to

advisory councils and committees, and

submit reports to Congress.

(24) Functions vested in the Secretary

under sections 982 and 983 of the

Consumer-Patient Radiation Health and

Safety Act of 1981 (the Act) (42 U.S.C.

10007 and 10008), as amended. The

delegation excludes the authority to

issue regulations and submit reports to

Congress. The authority delegated under

section 983 of the Act may only be

exercised as it relates to functions

assigned to the Food and Drug

Administration.

(25) Functions vested in the Secretary

under section 156 of title 35 of the U.S.

Code (35 U.S.C. 156), as amended,

which allows for the extension of patent

terms for human drug products, medical

devices, food additives, and color

additives subject to the Federal Food,

Drug, and Cosmetic Act (the act). These

authorities may be redelegated, except

the authority to make due diligence

determinations under section

156(d)(2)(B), which may not be

redelegated to an Office below the

Office of the Commissioner of Food and

Drugs.

(26) Functions vested in the Secretary

under the Stevenson-Wydler

Technology Innovation Act of 1980 (15

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U.S.C. 3701 et seq.) (the Act), as

amended, and under Executive Order

12591 of April 10, 1987, as they pertain

to the functions of the Food and Drug

Administration. The delegation

excludes the authority to issue

regulations and submit reports to

Congress; under section 11(a)(2) of the

Act (15 U.S.C. 3710a(a)(2)) to approve

agreements and contracts with

invention management organizations;

and under section 11(c)(3)(B) of the Act

(15 U.S.C. 3710a(c)(3)(B)) to propose

necessary statutory changes regarding

conflict of interest.

(i) The authorities under 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 by the head of the

laboratory concerned, and to transmit

written explanation of such disapproval

or modification to the head of the

laboratory concerned, may be

redelegated only to a senior official in

the immediate Office of the

Commissioner.

(ii) The following authorities may not

be redelegated: The authority under

section 11(b)(3)(D) of the Act (15 U.S.C.

3710a(b)(3)(D)) to waive a right of

ownership which the Federal

Government may have to an invention

made under a cooperative research and

development agreement; the authority

under section 11(b)(3)(C) of the Act (15

U.S.C. 3710a(b)(3)(C)) to permit

employees or former employees to

participate in efforts to commercialize

inventions they made while in the

service of the United States; the

authority under section 11(c)(3)(A) of

the Act (15 U.S.C. 3710a(c)(3)(A)) to

review employee standards of conduct

for resolving potential conflicts of

interest; the authority under section

13(a)(1) of the Act (15 U.S.C.

3710c(a)(1)) to retain any royalties or

other income, except as provided in

section 13(a)(2) of the Act (15 U.S.C.

3710c(a)2)); and the authority under

section 13(a)(1)(A)(i) of the Act (15

U.S.C. 3710c(a)(1)(A)(i)) to pay royalties

or other income the agency receives on

account of an invention to the inventor

if the inventor was an employee of the

agency at the time the invention was

made.

(iii) Any authorities under paragraph

(a)(26) of this section delegated by the

Commissioner may not be further

redelegated.

(27) Functions vested in the Secretary

under sections 4702, 4703, and 4704 of

the Pesticide Monitoring Improvements

Act of 1988 (21 U.S.C. 1401–1403) that

relate to pesticide monitoring and

enforcement information, foreign

pesticide information, and pesticide

analytical methods. The delegation

excludes the authority to submit reports

to Congress.

(28) Functions vested in the Secretary

under sections 2312(a)(1) and (2)(B), (b),

and (c) (Use of Investigational New

Drugs with Respect to Acquired

Immunodeficiency Syndrome); 2314(c)

(Scientific and Ethical Guidelines for

Certain Treatments); and 2317(d) and (e)

(Information Services) of title XXIII of

the PHS Act (42 U.S.C. 300cc–12(a)(1)

and (2)(B), (b) and (c), 300cc–14(c) and

300cc–17 (d) and (e)), as amended,

insofar as these authorities pertain to

the functions assigned to the Food and

Drug Administration. The delegation

excludes the authority to issue

regulations, submit reports to the

Congress, establish advisory committees

or national commissions, and appoint

members to such committees or

commissions.

(29) Functions vested in the Secretary

under section 2672(a)(1) (A) and (B)

(Provisions Relating to Blood Banks)

and section 2672(a)(2) (Information and

Training Programs) of the PHS Act (42

U.S.C. 300ff–72(a)(1)(A) and (B) and

(a)(2) et seq.), as amended, insofar as

these authorities pertain to the functions

assigned to the Food and Drug

Administration. The delegations

exclude the authority to issue

regulations, submit reports to the

Congress, establish advisory committees

or national commissioners, and appoint

members to such committees or

commissions.

(30) Functions vested in the Secretary

under sections 1322(b) and (c) of the

Food, Agriculture, Conservation, and

Trade Act of 1990 (the National

Laboratory Accreditation Program) (7

U.S.C. 138a), as amended hereafter,

which relate to setting standards for the

National Laboratory Accreditation

Program and approving State agencies

or private, nonprofit entities as

accrediting bodies to implement

certification and quality assurance

programs in accordance with the

requirements of this section. The

delegation excludes the authority to

submit reports to Congress.

(31) Functions vested in the Secretary

under part C, subtitle 2 of title XXI of

the PHS Act (42 U.S.C. 300aa–25 et

seq.), as amended, and the National

Childhood Vaccine Injury Act of 1986

(42 U.S.C. 300aa–1 note), as amended

hereafter, as follows:

(i) Section 2125 of the PHS Act (42

U.S.C. 300aa–25)—Recording and

reporting of information.

(ii) Section 2127 of the PHS Act (42

U.S.C. 300aa–27)—-Mandate for safer

childhood vaccines.

(iii) Section 2128 of the PHS Act (42

U.S.C. 300aa–28)—Manufacturer

recordkeeping and reporting.

(iv) Section 312 of the National

Childhood Vaccine Injury Act of 1986—

Related studies (42 U.S.C. 300aa–1

note).

(v) Section 313 of the National

Childhood Vaccine Injury Act of 1986—

Study of other vaccine risks (42 U.S.C.

300aa–1 note).

(vi) Section 314 of the National

Childhood Vaccine Injury Act of 1986—

Review of warnings, use instructions,

and precautionary information (42

U.S.C. 300aa–1 note).

(vii) The delegation excludes the

authority to issue regulations and

submit reports to Congress.

(32) Functions vested in the Secretary

under section 201(h)(4) of the

Controlled Substances Act (Title II of

the Comprehensive Drug Abuse

Prevention and Control Act of 1970, as

amended) (21 U.S.C. 811(h)(4)) to

provide responses to the Drug

Enforcement Administration’s

temporary scheduling notices. The

delegation excludes the authority to

submit reports to Congress.

(33) Functions vested in the Secretary

under the Safe Medical Devices Act of

1990 (Pub. L. 101–629), as amended

hereafter (e.g., 21 U.S.C. 360c note, 360i

note, and 360j note). The delegation

excludes the authority to submit reports

to Congress.

(34) Functions vested in the Secretary

under section 601 of Effective

Medication Guides of the Agriculture,

Rural Development, Food and Drug

Administration, and Related Agencies

Appropriations Act of 1997 (Public Law

104–180), as amended hereafter. The

delegation excludes the authority to

issue reports to Congress.

(35) The Secretary has redelegated to

the Commissioner of Food and Drugs, or

his designee, the authority to take final

action on matters pertaining to section

203 of the Equal Access to Justice Act

(5 U.S.C. 504), and to develop

procedures and regulations where

necessary to supplement the

Department’s regulations, 45 CFR part

13.

(36) The Secretary has delegated to

the Commissioner, the authority to

administer and make decisions

regarding the invention and patent

program as they pertain to the functions

of the Food and Drug Administration

and to make determinations of rights in

inventions and patents in which the

Department has an interest. This

delegation excludes the authority to

Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations 30997

submit reports to Congress and further,

it excludes those authorities under the

Stevenson-Wydler Technology

Innovation Act of 1980, as amended by

the Federal Technology Transfer Act of

1986 and the National Technology

Transfer and Advancement Act of 1995,

which are governed by a separate

delegation (under § 5.10(a)(26)). All

authorities other than the authority

under 35 U.S.C. section 203 (March-In

Rights) may be redelegated.

(37) Functions vested in the Secretary

under title III, Section 354, of the PHS

Act (42 U.S.C. 262 et seq.), as amended.

The authority pertains to the Food and

Drug Administration’s oversight of

mammography facilities.

(38) The Deputy Assistant Secretary

for Health Management Operations,

Public Health Service, has redelegated

to the Commissioner of Food and Drugs,

with authority to redelegate, the

authority to certify true copies of any

books, records, or other documents on

file within the Food and Drug

Administration, or extracts from such;

to certify that true copies are true copies

of the entire file of the Administration;

to certify the complete original record or

to certify the nonexistence of records on

file within the Administration; and to

cause the Seal of the Department to be

affixed to such certifications and to

agreements, awards, citations, diplomas,

and similar documents.

(39) The Secretary of Health and

Human Services has redelegated to the

Commissioner, of Food and Drugs,

under 45 CFR 5b.8 regulations, appeal

authority to take final action upon an

individual’s appeal of a refusal to

correct or amend the individual’s record

when the appeal has been made by the

individual under Privacy Act

regulations (part 21 of this chapter and

45 CFR part 5b). The authority may not

be redelegated.

(b) The Chief Counsel of the Food and

Drug Administration has been

authorized to report apparent violations

to the Department of Justice for the

institution of criminal proceedings,

under section 305 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 335),

section 4 of the Federal Import Milk Act

(21 U.S.C. 144), and section 9(b) of the

Federal Caustic Poison Act.

§ 5.11 Reservation of authority.

(a) Notwithstanding provisions of

§ 5.10 or any previous delegations of

authority to the contrary, the Secretary

of Health and Human Services

(Secretary) reserves the authority to

approve regulations of the Food and

Drug Administration, except regulations

to which sections 556 and 557 of title

5 U.S.C. apply, which:

(1) Establish procedural rules

applicable to a general class of foods,

drugs, cosmetics, medical devices, or

other subjects of regulation; or

(2) Present highly significant public

issues involving the quality, availability,

marketability, or cost of one or more

foods, drugs, cosmetics, medical

devices, or other subjects of regulation.

(b) Nothing in this section precludes

the Secretary from approving a

regulation, or being notified in advance

of an action, to which sections 556 and

557 of title 5 U.S.C. apply, which meets

one of the criteria in paragraph (a) of

this section.

(c) This reservation of authority is

intended only to improve the internal

management of the Department of

Health and Human Services, and it is

not intended to create any right or

benefit, substantive or procedural,

enforceable at law by a party against the

United States, the Department of Health

and Human Services, the Food and Drug

Administration, any agency, officer, or

employee of the United States, or any

person. Regulations issued by the Food

and Drug Administration without the

approval of the Secretary are to be

conclusively viewed as falling outside

the scope of this reservation of

authority.

Subpart B—General Redelegations of

Authority

§ 5.20 General redelegations of authority

from the Commissioner to other officers of

the Food and Drug Administration.

(a) Final authority of the

Commissioner of Food and Drugs

(Commissioner) is redelegated as set

forth in these subparts. The

Commissioner may continue to exercise

all authority delegated in subparts B

through L.

(b) The following officials are

authorized to perform all of the

functions of the Commissioner. These

officials may not further redelegate this

authority, or any part of this authority,

except as elsewhere specified:

(1) Deputy Commissioner;

(2) Associate Commissioner for

Regulatory Affairs;

(3) Senior Associate Commissioner;

(4) Senior Associate Commissioner for

Management and Systems;

(5) Senior Associate Commissioner for

Policy, Planning, and Legislation; and

(6) Deputy Commissioner for

International and Constituent Relations.

(c)(1) During the absence or disability

of the Commissioner or in the event of

a vacancy in that position, the first

official who is available in the following

positions, or who has been designated

by the Commissioner to act in such

position, shall act as Commissioner:

(i) Deputy Commissioner;

(ii) Associate Commissioner for

Regulatory Affairs; or

(iii) Senior Associate Commissioner.

(2) These officials may not further

redelegate this authority. However, for a

planned period of absence, the

Commissioner (or someone ‘‘acting’’ on

his/her behalf) may specify a different

order of succession.

(d) Authority delegated to a position

by title may be exercised by a person

officially designated to serve in that

position in an acting capacity or on a

temporary basis, unless prohibited by a

restriction in the document designating

him/her as ‘‘acting’’ or unless not legally

permissible.

(e)(1) The Senior Associate

Commissioner is authorized to make

determinations that advisory committee

meetings are concerned with matters

listed in 5 U.S.C. 552(b) and therefore

may be closed to the public in

accordance with 5.10(a)(17).

(2) The Senior Associate

Commissioner is authorized to perform

other associated advisory committee

functions (e.g., establishing technical

and scientific review groups (advisory

committees)); appointing and paying

members; approving waivers to appoint

members to established advisory

committees; renewing and rechartering

of established advisory committees;

amending charters of established

advisory committees; and terminating

established advisory committees.

(3) The Senior Associate

Commissioner is authorized to approve

conflict of interest waivers for special

Government employees serving on

advisory committees in accordance with

18 U.S.C. 208(b)(3), as amended.

(4) The Senior Associate

Commissioner is authorized to select

temporary members to advisory

committees if such voting members are

serving on an advisory committee

managed by another center.

(5) The Senior Associate

Commissioner may not further

redelegate these authorities.

(f)(1) The Senior Associate

Commissioner for Policy, Planning, and

Legislation (SACPPL) and the Associate

Commissioner for Policy (ACP) are

authorized to perform any of the

functions of the Commissioner with

respect to the issuance of Federal

Register notices and proposed and final

regulations of the Food and Drug

Administration. These officials may not

further redelegate this authority.

(2) The SACPPL and the ACP are

authorized to issue responses to the

following matters under part 10 of this

chapter as follows and these officials

30998 Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations

may not further redelegate this

authority:

(i) Requests for waiver, suspension, or

modification of procedural requirements

under § 10.19 of this chapter;

(ii) Citizen petitions under § 10.30 of

this chapter;

(iii) Petitions for reconsideration

under § 10.33 of this chapter;

(iv) Petitions for stay under § 10.35 of

this chapter; or

(v) Requests for advisory opinions

under § 10.85 of this chapter.

(3) With respect to any matter

delegated to the SACPPL and the ACP

under this paragraph, the SACPPL and

the ACP are authorized to perform the

function of the Commissioner under

§§ 10.40, 10.45, 10.50, 10.55, 10.60,

10.65, 10.80, 10.90, and 10.95 of this

chapter and of the Deputy

Commissioner under § 10.206(g) and (h)

of this chapter. These officials may not

further redelegate this authority.

(4) The SACPPL and the ACP are

authorized under the Regulatory

Flexibility Act (5 U.S.C. 605(b)) to

certify that a proposed or final rule, if

issued, will not have a significant

economic impact on a substantial

number of small entities. The SACPPL

and the ACP may further redelegate this

authority.

(g) The following officials are

authorized to perform all the functions

of the officials under them in their

respective offices and they may not

further redelegate this authority:

(1) Senior Associate Commissioner;

(2) Deputy Commissioner for

International and Constituent Relations;

(3) Senior Associate Commissioner for

Management and Systems; or

(4) Senior Associate Commissioner for

Policy, Planning, and Legislation.

(h)(1) The Chief Mediator and

Ombudsman and the Deputy Chief

Mediator and Ombudsman are

authorized to act upon requests for

reconsideration of any user fee

decisions under section 735 of the

Federal Food, Drug and Cosmetic Act

(the act) (21 U.S.C. 379h) made by such

officers and the former Deputy User Fee

Waiver Officer prior to July 1, 1999.

These officials may not further

redelegate this authority. (See subpart C,

§ 5.108 for the user fee-related

redelegation to officials within the

Center for Drug Evaluation and

Research.)

(2) The Senior Associate

Commissioner for Management and

Systems and the Director, Office of

Financial Management, are authorized

to perform the functions of the

Commissioner under section

736(d)(1)(c) of the act (21 U.S.C.

379h(d)(1)(C)), as amended, to waive or

reduce prescription drug user fees in

situation where he or she finds that ‘‘the

fees will exceed the anticipated present

and future costs.’’ These officials may

not further redelegate this authority.

(3) The Deputy Commissioner, or in

the event of a vacancy in that position,

the Senior Associate Commissioner,

Office of the Commissioner, is

designated as the User Fee Appeals

Officer. The User Fee Appeals Officer is

authorized to hear and decide user fee

waiver appeals. The decision of the User

Fee Appeals Officer will constitute final

agency action on such matters. The User

Fee Appeals Officer may not further

redelegate this authority.

(i) The Senior Associate

Commissioner for Management and

Systems is authorized to perform all of

the administrative authorities (i.e.,

financial, personnel, facilities

management, property management,

etc.) of the Commissioner. These

authorities may be further redelegated,

except when specifically prohibited.

(j) Unless specifically noted, the

persons to whom the Commissioner has

delegated authority in subparts B

through L of this part may not further

redelegate that authority.

§ 5.21 Emergency functions.

(a) Each Regional Food and Drug

Director is authorized, during any

period when normal channels of

direction are disrupted between the

Food and Drug Administration

headquarters and his or her region to:

(1) Fully represent the Food and Drug

Administration within his or her region

in cooperation with the Department of

Health and Human Services regional

emergency plans, and

(2) Exercise the authority of the

Commissioner of Food and Drugs for

supervision of and direction to all Food

and Drug Administration activities and

use of resources within his or her region

for continuity and for Federal

Emergency Health Service operations.

(b) These same officials are authorized

to provide in Regional Emergency Plans

for the delegation of Food and Drug

Administration regional authorities to

heads of field activities when such

activities are cut off from national and

regional headquarters. These officials

may not further redelegate this

authority.

§ 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 Commissioner, the

Senior Associate Commissioner, the

Deputy Commissioner for International

and Constituent Relations, the Senior

Associate Commissioner for

Management and Systems, and the

Senior Associate Commissioner for

Policy, Planning, and Legislation.

(2) The Associate and Deputy

Associate Commissioners and the Chief

Counsel and Deputy Chief Counsels.

(3) The Director, Office of the

Executive Secretariat, Office of the

Senior Associate Commissioner, Office

of the Commissioner (OC).

(4) The Director, Office of Executive

Operations, Office of the Senior

Associate Commissioner, OC.

(5)(i) The Director and Deputy

Director, Office of Enforcement, Office

of Regulatory Affairs (ORA).

(ii) The Director and Deputy Director,

Office of Regional Operations, ORA.

(iii) The Director and Deputy Director,

Office of Resource Management (ORM),

ORA.

(iv) The Director, Division of

Management Operations, ORM, ORA.

(v) Team Leader, FDA History Staff,

ORM, ORA.

(6)(i) The Director, Office of Human

Resources and Management Services

(OHRMS), Office of Management and

Systems (OMS), OC.

(ii) The Director, Division of

Management Programs (DMP), OHRMS,

OMS, OC.

(iii) The Chief, Dockets Management

Branch, DMP, OHRMS, OMS, OC.

(7) The Associate Commissioner for

Public Affairs, Office of Public Affairs

(OPA), Office of the Senior Associate

Commissioner (OSAC), OC.

(8)(i) The Chief Information Officer,

Office of Information Resources

Management (OIRM), Office of

Management and Systems (OMS), OC.

(ii) The Director, Freedom of

Information Staff, OIRM, OMS, OC.

(9)(i) The Director and Deputy

Directors, Center for Biologics

Evaluation and Research (CBER).

(ii) The Director, Office of

Management, CBER.

(iii) The Director and Deputy

Directors of the Office of Compliance

and Biologics Quality, CBER.

(iv) The Director and Deputy Director,

Office of Communication, Training, and

Manufacturer’s Assistance, CBER.

(v) The Director and Branch Chiefs,

Division of Case Management, Office of

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Compliance and Biologics Quality

(OCBQ), CBER; and the Consumer

Safety Officers, OCBQ, CBER.

(10)(i) The Director and Deputy

Director, Center for Food Safety and

Applied Nutrition (CFSAN).

(ii) The Director of Regulations and

Policy, CFSAN.

(iii) The Director, Office of

Management Systems, CFSAN.

(iv) The Director, Office of Cosmetics

and Colors, CFSAN.

(v) The Director, Office of Plant and

Dairy Foods and Beverages, CFSAN.

(vi) The Director, Office of Seafood,

CFSAN.

(vii) The Director, Office of

Nutritional Products, Labeling, and

Dietary Supplements, CFSAN.

(viii) The Director, Office of Special

Research Skills, CFSAN.

(ix) The Director, Office of

Constituent Operations, CFSAN.

(x) The Director, Office of Field

Programs, CFSAN.

(xi) The Director, Office of Premarket

Approval, CFSAN.

(xii) The Director, Office of Scientific

Analysis and Support, CFSAN.

(11)(i) The Director and Deputy

Directors, Center for Devices and

Radiological Health (CDRH).

(ii) The Associate Director and Deputy

Associate Director for Management and

Systems, CDRH.

(iii) The Director and Deputy Director,

Office of Compliance, CDRH.

(iv) For medical devices assigned to

their respective divisions, the Division

Directors, Office of Compliance, CDRH.

(v) The Director and Deputy Director,

Office of Surveillance and Biometrics

(OSB), CDRH, and the Director and

Deputy Director, Division of

Surveillance Systems (DSS), OSB,

CDRH.

(vi) The Director, Office of Systems

and Management, CDRH.

(vii) Freedom of Information Officers,

CDRH.

(12)(i) The Director and Deputy

Director, Center for Veterinary Medicine

(CVM).

(ii) The Director and Deputy Director,

Office of Management and

Communications, CVM.

(iii) The Director and Deputy Director,

Office of Surveillance and Compliance,

CVM.

(iv) The Director, Division of

Compliance, Office of Surveillance and

Compliance, CVM.

(13)(i) The Director and Deputy

Director for Washington Operations,

National Center for Toxicological

Research (NCTR).

(ii) The Deputy Center Director, Office

of Management (OM), NCTR, and the

Associate Director, Office of

Management Services, OM, NCTR.

(iii) The Deputy Center Director,

Office of Research, NCTR.

(14)(i) The Director and Deputy

Director, the Directors, Office of Review

Management and Office of

Pharmaceutical Science, the Associate

Director for Regulatory Policy, and the

Associate Director for Medical Policy,

Center for Drug Evaluation and Research

(CDER).

(ii) The Director and Deputy Director,

Office of Management, CDER.

(iii) The Director and Deputy Director,

Office of Compliance, CDER.

(iv) The Directors and Deputy

Directors of the Offices of Drug

Evaluation I, II, III, IV, and V, and the

Director and Deputy Director of the

Office of Biostatistics, Office of Review

Management, CDER.

(v) The Directors and Deputy

Directors of the Offices of Testing and

Research, Generic Drugs, New Drug

Chemistry, and Clinical Pharmacology

and Biopharmaceutics, Office of

Pharmaceutical Science, CDER.

(vi) The Director, Office of Training

and Communications (OTCOM), and the

Director, Division of Information

Disclosure Policy, Office of Regulatory

Policy, CDER.

(vii) The Directors of the Divisions of

Labeling and Non-prescription Drug

Compliance, Prescription Drug

Compliance and Surveillance, and

Manufacturing and Product Quality,

Office of Compliance, CDER.

(15)(i) Regional Food and Drug

Directors.

(ii) District Directors.

(iii) The Director, St. Louis Branch.

(iv) The Director, Northeast Regional

Laboratory, Northeast Region.

(v) The Director, Southeast Regional

Laboratory, Southeast Region.

(vi) The Director, National Forensic

Chemistry Center.

(vii) The Director, Arkansas Regional

Laboratory.

(viii) The Director, Winchester

Engineering Analytical Center.

(b) The following officials are

authorized to cause the seal of the

Department to be affixed to agreements,

awards, citations, diplomas, and similar

documents:

(1) Deputy Commissioner; the Senior

Associate Commissioner; the Deputy

Commissioner for International and

Constituent Relations; the Senior

Associate Commissioner for

Management and Systems; and the

Senior Associate Commissioner for

Policy, Planning, and Legislation.

(2) The Associate and Deputy

Associate Commissioners and the Chief

Counsel and Deputies.

(3) The Director and Deputy Directors,

CBER; the Director and Deputy Director,

CFSAN; the Director and Deputy

Directors, CDRH; the Director and

Deputy Director, CVM; the Director and

Deputy Directors, CDER; and the

Director, NCTR, the Deputy Director for

Washington Operations, NCTR, and the

Deputy Center Directors, Offices of

Management and Research, respectively,

NCTR.

(4) The Director, Office of Executive

Operations, Office of the Senior

Associate Commissioner (OSAC), OC;

Director, Office of Management, CBER;

Director, Office of Management, CDER;

Director, Office of Management

Systems, CFSAN; Director, Office of

Systems and Management, CDRH;

Director, Office of Management and

Communications, CVM; Associate

Director, Office of Management

Services, NCTR; and the Director, Office

of Resource Management, ORA.

(5) The Director, Office of Human

Resources and Management Services

(OHRMS), Office of Management and

Systems (OMS), OC.

(c) The following officials may further

redelegate the authorities under

paragraphs (a) and (b) of this section the

Deputy Commissioner; the Senior

Associate Commissioner; the Deputy

Commissioner for International and

Constituent Relations; the Senior

Associate Commissioner for

Management and Systems; the Senior

Associate Commissioner for Policy,

Planning, and Legislation; the Associate

and Deputy Associate Commissioners;

the Chief Counsel and Deputy Chief

Counsels; the Directors and Deputy

Directors for CBER, CFSAN, CDRH,

CVM, CDER, and NCTR; the Director,

Office of Executive Operations, OSAC,

OC; the Directors of the Offices of

Management, CBER and CDER; the

Director, Office of Management

Systems, CFSAN; the Director, Office of

Systems and Management, CDRH; the

Director, Office of Management and

Communications, CVM; the Associate

Director, Office of Management

Services, NCTR; the Director, Office of

Resource Management, ORA; and the

Director, OHRMS, OMS, OC. The other

officials delegated authority by this

section may not further redelegate it.

(d) The Chief, Regulations Editorial

Section (RES), Regulations Policy and

Management Staff (RPMS), Office of

Policy, Planning, and Legislation

(OPPL), OC, and his or her alternates are

authorized to certify true copies of

Federal Register documents. The Chief,

RES, RPMS, OPPL, OC may designate

alternates as required.

31000 Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations

§ 5.23 Disclosure of official records and

authorization of testimony.

(a) The following officials are

authorized to make determinations to

disclose official records and information

under part 20 of this chapter, except

that only the officials, listed in

paragraphs (a)(2) through (a)(8) of this

section, have the authority under

specific sections of part 20 of this

chapter.

(1)(i) Deputy Commissioner, the

Senior Associate Commissioner, the

Deputy Commissioner for International

and Constituent Relations, the Senior

Associate Commissioner for

Management and Systems, the Senior

Associate Commissioner for Policy,

Planning, and Legislation, and the

Associate and Deputy Associate

Commissioners.

(ii) The Director, Office of Executive

Operations, Office of the Senior

Associate Commissioner, Office of the

Commissioner (OC).

(iii) The Director, Office of the

Executive Secretariat, Office of the

Senior Associate Commissioner, OC.

(iv) The Director, Office of Human

Resources and Management Services

(OHRMS), Office of Management and

Systems (OMS), OC; the Director,

Division of Management Programs

(DMP), OHRMS, OMS, OC; and the

Chief, Dockets Management Branch,

DMP, OHRMS, OMS, OC.

(v) Program officials at all

organizational levels down to and

including branch level for all

Headquarters organizations.

(vi) Regional Food and Drug Directors

and District Directors.

(vii) Director, Winchester Engineering

and Analytical Center.

(viii) Chiefs of branches Field/District

Offices and Centers.

(ix) Freedom of Information Officers

and other employees engaged in

Freedom of Information activities.

(x) The Director, Office of

Enforcement (OE), Office of Regulatory

Affairs (ORA); Deputy Director, OE,

ORA; and Director, Division of

Compliance Policy, OE, ORA.

(xi) The Director and Deputy

Directors, Center for Biologics

Evaluation and Research (CBER); and

the Director and Deputy Director, Office

of Communication, Training, and

Manufacturer’s Assistance (OCTMA),

CBER.

(xii) The Director and Deputy

Director, the Directors, Office of Review

Management and Office of

Pharmaceutical Science, the Associate

Director for Medical Policy, and the

Associate Director for Regulatory Policy,

Center for Drug Evaluation and Research

(CDER).

(xiii) The Director, Center for Devices

and Radiological Health (CDRH), the

Deputy Director for Regulations and

Policy, and the Deputy Director for

Science, CDRH.

(xiv) The Director and Deputy

Director, Center for Food Safety and

Applied Nutrition (CFSAN).

(xv) The Director and Deputy

Director, Center for Veterinary Medicine

(CVM).

(xvi) The Director, National Center for

Toxicological Research (NCTR); the

Deputy Center Directors, Offices of

Research and Management, respectively,

NCTR; and the Deputy Director for

Washington Operations, NCTR.

(xvii) These officials may not further

redelegate this authority.

(2) The Deputy Associate

Commissioner for Regulatory Affairs

(Deputy ACRA), ORA; the Director and

Deputy Director, Office of Enforcement

OE, ORA; and the Director, Division of

Compliance Policy, OE, ORA are

delegated the authority to grant requests

for testimony or to authorize the giving

of testimony under § 20.1 of this

chapter. These officials may not further

redelegate this authority.

(3) The Associate and Deputy

Associate Commissioners are delegated

the authority to disclose official records

and information under § 20.82 of this

chapter. These officials may not further

redelegate this authority.

(4) The Associate and Deputy

Associate Commissioners; the Director

and Deputy Director, OE, ORA; and the

Director, Division of Compliance Policy,

OE, ORA are delegated the authority to

disclose official records and information

under § 20.85 of this chapter. These

officials may not further redelegate this

authority

(5) The following officials are

delegated the authority to disclose

confidential commercial information to

State government officials under

§ 20.88(d) of this chapter and the ACRA

and the Center Directors may further

redelegate this authority.

(i) The ACRA, the Deputy ACRA,

ORA and the Director, OE, ORA.

(ii) The Director and Deputy

Directors, Center for Biologics

Evaluation and Research (CBER); and

the Director and Deputy Director, Office

of Communication, Training, and

Manufacturer’s Assistance (OCTMA),

CBER.

(iii) The Director and Deputy Director,

CDER; the Directors, Office of Review

Management and Office of

Pharmaceutical Science, CDER; the

Associate Director for Regulatory Policy,

CDER.

(iv) The Director, CDRH, the Deputy

Director for Regulations and Policy, the

Deputy Director for Science, and the

Director, Office of Health and Industry

Programs, CDRH.

(v) The Director and Deputy Director,

CFSAN.

(vi) The Director and Deputy Director,

CVM.

(vii) The Director, the Deputy Center

Directors, Offices of Research and

Management, respectively, NCTR, and

the Deputy Director for Washington

Operations, NCTR.

(6) The following officials are

delegated the authority to disclose

nonpublic, predecisional documents to

State and foreign government officials

under §§ 20.88(e) and 20.89(d) of this

chapter and they may not further

redelegate this authority.

(i) The Associate Commissioner for

Policy, Office of Policy, Planning and

Legislation (OPPL); and the Director,

Office of International Programs, Office

of International and Constituent

Relations (OICR).

(ii) For level 2 nonpublic,

predecisional guidance documents, any

Center Director or Deputy Director, and

any Director for an OC office having

program responsibilities.

(7) The Associate Commissioner for

Policy, OPPL; and the Director, Office of

International Programs, OICR are

delegated the authority to receive

nonpublic, predecisional documents

from State and foreign government

officials under §§ 20.88(e) and 20.89(d)

of this chapter. These officials may not

further redelegate this authority.

(8) The following officials are

authorized to disclose confidential

commercial information to foreign

government officials under § 20.89(c) of

this chapter; and they may not further

redelegate it:

(i) The Deputy ACRA, ORA; and the

Director, OE, ORA.

(ii) The Director and Deputy

Directors, Center for Biologics

Evaluation and Research (CBER); and

the Director and Deputy Director, Office

of Communication, Training, and

Manufacturer’s Assistance (OCTMA),

CBER.

(iii) The Director and Deputy Director,

CDER; the Directors, Office of Review

Management and Office of

Pharmaceutical Science, CDER; the

Associate Director for Medical Policy,

CDER; the Associate Director for

Regulatory Policy, CDER, and the

Director, Division of Information

Disclosure Policy, Office of Regulatory

Policy, CDER.

(iv) The Director, CDRH, the Deputy

Director for Regulations and Policy and

the Deputy Director for Science, CDRH.

(v) The Director and Deputy Director,

CFSAN.

Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations 31001

(vi) The Director and Deputy Director,

CVM.

(vii) The Director, the Deputy Center

Directors, Offices of Research and

Management, respectively, and the

Deputy Director for Washington

Operations, NCTR.

(b) The Chief, Information

Management Team, Division of Data

Management and Services, Office of

Information Technology, CDER, is

authorized to sign affidavits regarding

the presence or absence of records of

Registration of Drug Establishments.

This official may not further redelegate

this authority.

(c) The following officials are

authorized to sign affidavits regarding

the presence or absence of medical

device establishment registration

records and these officials may not

further redelegate this authority:

(1) The Director, the Deputy Director

for Regulations and Policy, and the

Deputy Director for Science, CDRH.

(2) The Director and Deputy Director,

Office of Compliance, CDRH.

(3) The Director and Deputy Director,

Division of Program Operations, Office

of Compliance, CDRH.

(4) The Chief, Information Processing

and Office Automation Branch, Division

of Program Operations, Office of

Compliance, CDRH.

(d) The Director, Office of Resource

Management, Office of Regulatory

Affairs is authorized to sign affidavits

regarding the presence or absence of

records in the files of that office and this

official may not further redelegate this

authority

(e) The Director and Deputy Directors,

CBER, the Director and Deputy Director,

Office of Blood Research and Review

(OBRR), and the Director and Deputy

Director, Division of Blood

Applications, OBRR, CBER, are

authorized to sign affidavits regarding

the presence or absence of records of

registration of blood product

establishments. These officials may not

further redelegate this authority.

§ 5.24 Authority relating to technology

transfer.

(a) The Associate Commissioner for

Regulatory Affairs is authorized to

perform the functions of the

Commissioner of Food and Drugs as

requested by the Commissioner

regarding the authority to disapprove or

require modification of cooperative

research and development agreements

and licensing agreements and transmit

written explanation of such approval or

disapproval to the head of the laboratory

concerned under section 11(c)(5) (A)

and (B) of the Stevenson-Wydler

Technology Innovation Act of 1980 (the

Act) (15 U.S.C. 3710a(c)(5) (A) and (B)),

as amended.

(b) The following officials are

authorized to perform the functions of

the Commissioner of Food and Drugs

(Commissioner) requested by the

Commissioner under the Act (15 U.S.C.

3701 et seq.), as amended, and

Executive Order 12591 of April 10, 1987

(except to the extent that redelegation of

those functions is specifically limited in

§ 5.10(a)(26)), as they pertain to the

functions of their respective

organizations, including the authority to

perform the functions of laboratory

directors under the Act as the heads of

their respective Federal laboratories,

subject to the discretion of the

Commissioner to require that

agreements entered into under section

11(a) of the Act (15 U.S.C. 3710a(a))

include provisions in accordance with

section 11(c)(5)(A) of the Act (15 U.S.C.

3710a(c)(5)(A):

(1) The Director, Center for Biologics

Evaluation and Research.

(2) The Director, Center for Devices

and Radiological Health.

(3) The Director, Center for Drug

Evaluation and Research.

(4) The Director, Center for Food

Safety and Applied Nutrition.

(5) The Director, Center for Veterinary

Medicine.

(6) The Director, National Center for

Toxicological Research.

(7) The Associate Commissioner for

Regulatory Affairs.

(c) These officials may not further

redelegate these authorities.

§ 5.25 Research, investigation, and testing

programs and health information and

promotion programs.

(a) The following officials are

authorized under sections 301, 307, 311,

1701, 1702, 1703, and 1704 of the Public

Health Service Act (the PHS Act) (42

U.S.C. 241, 242l, 243, 300u, 300u–1,

300u–2, 300u–3) to establish research,

investigation, and testing programs and

health information and health

promotion programs, which relate to

their assigned functions, and to approve

grants for conducting such programs:

(1) The Director, the Deputy Director

for Washington Operations, and the

Deputy Center Directors, Offices of

Research and Management, respectively,

National Center for Toxicological

Research (NCTR).

(2) The Director and Deputy Directors

for Science and for Regulations and

Policy, Centers for Devices and

Radiological Health (CDRH).

(3) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER).

(4) The Director and Deputy Director,

Center for Food Safety and Applied

Nutrition (CFSAN).

(5) The Director and Deputy Director,

Center for Veterinary Medicine (CVM).

(6) The Director and Deputy Director,

the Directors, Office of Review

Management and Office of

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER).

(7) The Director, Office of Orphan

Products Development (OPD), Office of

the Senior Associate Commissioner

(OSAC), Office of the Commissioner

(OC).

(b) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH, are authorized to

establish an electronic product radiation

control program and to approve grants

for conducting the program under

section 532 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 360ii).

(c) The Senior Associate

Commissioner for Management and

Systems, Office of Management and

Systems (OMS), OC; the Director and

Deputy Director, Office of Facilities,

Acquisitions, and Central Services

(OFACS), OMS, OC; the Director,

Division of Contracts and Procurement

Management (DCPM), OFACS, OMS,

OC; and the Chief Grants Management

Officer and the Grants Management

Officer, DCPM, OFACS, OMS, OC are

authorized to sign and issue all notices

of grant awards and amendments

thereto and sign and issue notices of

suspension and termination thereof for

grants approved under the authority

delegated in paragraphs (a) and (b) of

this section.

(d) The Director, NCTR, is authorized

under section 301 of the PHS Act (42

U.S.C. 241), as amended by Public Law

95–622, to make available to

educational institutions, for biomedical

and behavioral research, laboratory

animals bred for research purposes of

the Center that are not required to

support Center research programs.

(e) The Senior Associate

Commissioner for Management and

Systems may further redelegate the

authorities in paragraph (c) of this

section. With the exception for

paragraph (c) of this section, these

officials may not further redelegate

these authorities.

§ 5.26 Service fellowships.

(a) Under authority of sections 207(g)

and 208(f) of the PHS Act (42 U.S.C.

209(g) and 210(f)), and within the limits

of an approved service fellowship plan,

the following officials are authorized to

designate persons to receive service

fellowships, appoint service fellows,

and determine specific stipend rates for

31002 Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations

individual actions within the ranges

established under an approved service

fellowship plan:

(1) The Deputy Commissioner; the

Senior Associate Commissioner; the

Deputy Commissioner for International

and Constituent Relations; the Senior

Associate Commissioner for

Management and Systems; the Senior

Associate Commissioner for Policy,

Planning, and Legislation; the Chief

Counsel and Deputy Chief Counsels;

and the Associate Commissioners and

their Deputies.

(2) The Director, the Deputy Director

for Washington Operations, the Deputy

Center Directors for Research and

Management, respectively, and the

Associate Director, Office of

Management Services, National Center

for Toxicological Research (NCTR).

(3) The Director, the Deputy Directors

for Science and for Regulations and

Policy, and the Director, Office of

Systems and Management, Center for

Devices and Radiological Health

(CDRH).

(4) The Director, the Deputy Directors,

the Associate Director for Research, the

Office Directors, and the Director, Office

of Management, Center for Biologics

Evaluation and Research (CBER).

(5) The Director, the Deputy Director,

and Director, Office of Management

Systems, Center for Food Safety and

Applied Nutrition (CFSAN).

(6) The Director, the Deputy Director,

and the Director, Office of Management

and Communications, Center for

Veterinary Medicine (CVM).

(7) The Director and Deputy Director,

the Directors, Office of Review

Management and Office of

Pharmaceutical Science, and the

Director and Deputy Director, Office of

Management, Center for Drug

Evaluation and Research (CDER).

(8) The Director, Office of Executive

Operations, Office of the Senior

Associate Commissioner, Office of the

Commissioner and the Director, Office

of Resource Management, ORA.

(9) Director, Office of Human

Resources and Management Services,

Office of Management and Systems,

Office of the Commissioner.

(b) These officials may further

redelegate this authority, with the

limitation that the Director, Office of

Human Resources and Management

Services, OMS, OC, is delegated the

authority to approve service fellowship

plans and exceptions to the approved

plans, and this official may not further

redelegate this authority.

§ 5.27 Patent term extensions for human

drug products, medical devices, and food

and color additives; and authority to

perform due diligence determinations and

informal hearings.

(a) The Deputy Commissioner is

authorized to perform the due diligence

determinations and informal hearings

functions under section 156(d)(2)(B)(ii)

of title 35 U.S.C. (35 U.S.C. 156), as

amended, relative to patent term

extensions.

(b) The Director, Center for Drug

Evaluation and Research (CDER) and the

Associate Director for Regulatory Policy,

CDER, are authorized to perform the

functions delegated to the

Commissioner under title 35 U.S.C. 156,

as amended, except for making due

diligence determinations and holding of

informal hearings under title 35 U.S.C.

156(d)(2)(B).

(c) The Chief Mediator and

Ombudsman, Office of the Ombudsman,

Office of the Senior Associate

Commissioner, Office of the

Commissioner, is authorized to perform

the functions delegated to the

Commissioner to make due diligence

determinations under title 35 U.S.C. 156

(d)(2)(B), as amended, except for

holding of informal hearings under title

35 U.S.C. 156(d)(2)(B)(ii).

(d) These officials may not further

redelegate this authority.

§ 5.28 Hearings.

(a) The following officials are

authorized to designate officials to hold

informal hearings that relate to their

assigned functions under sections 305,

404(b), and 801(a) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 335,

344(b), and 381(a)); section 6 of the Fair

Packaging and Labeling Act (15 U.S.C.

1455) (21 U.S.C. 145); section 9(b) of the

Federal Caustic Poison Act (44 Stat.

1406; see also Public Law 86–613,

section 19 formerly section 18); and

section 5 of the Federal Import Milk

Act. Officials so designated are

delegated authority vested in the

Secretary of Agriculture by 7 U.S.C.

2217 (43 Stat. 803) to administer to take

from any person an oath, affirmation,

affidavit, or deposition for use in any

prosecution or proceeding under, or in

enforcement of, any law as cited in this

part:

(1) The Director and Deputy Director,

Center for Food Safety and Applied

Nutrition (CFSAN); and the Director of

Regulations and Policy, CFSAN.

(2) The Director and Deputy Director,

the Directors, Office of Review

Management and Office of

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER); the

Associate Director for Regulatory Policy

and the Associate Director for Medical

Policy, CDER; the Directors of the

Offices of Drug Evaluation I, II, III, IV,

and V, Office of Review Management,

CDER; and the Director and Deputy

Director, Office of Compliance, CDER.

(3) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH).

(4) The Director and Deputy Director,

Center for Veterinary Medicine (CVM).

(5) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER), and the Directors and

Deputy Directors, Office of Blood

Research and Review, Office of Vaccines

Research and Review, Office of

Therapeutics Research and Review, and

Office of Compliance and Biologics

Quality, CBER.

(6) Regional Food and Drug Directors.

(7) District Directors.

(8) The Director, St. Louis Branch.

(b) The Director and Deputy Directors

for Science and for Regulations Policy,

CDRH, are authorized to hold hearings,

and to designate other officials to hold

informal hearings, under section 360(a)

of the PHS Act.

(c) The following officials are

authorized to serve as the presiding

officer, and to designate other Food and

Drug Administration employees to serve

as the presiding officer, at a regulatory

hearing and to conduct such a hearing

under the provisions of part 16 of this

chapter. An official can serve as the

presiding officer in a particular hearing

only if he or she satisfies the

requirements of § 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 Chief Mediator and

Ombudsman, Office of the Ombudsman,

Office of the Senior Associate

Commissioner, Office of the

Commissioner of Food and Drugs

(Commissioner).

(2) The Director and Deputy Director,

CFSAN.

(3) The Director and Deputy Director,

Center for Drug Evaluation and Research

(CDER); the Directors, Office of Review

Management and Office of

Pharmaceutical Science, CDER; the

Associate Director for Regulatory Policy

and the Associate Director for Medical

Policy, CDER, the Directors of the

Offices of Drug Evaluation I, II, III, IV,

and V, Office of Review Management,

Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations 31003

CDER; and the Director and Deputy

Director, Office of Compliance, CDER.

(4) The Director and Deputy Directors

for Science and for Regulations Policy,

CDRH.

(5) The Director and Deputy Director,

CVM.

(6) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER), and the Directors and

Deputy Directors, Office of Blood

Research and Review, Office of Vaccines

Research and Review, Office of

Therapeutics Research and Review, and

Office of Compliance and Biologics

Quality, CBER.

(7) Regional Food and Drug Directors.

(8) District Directors.

(9) The Director, St. Louis Branch.

(10) Such other FDA official as is

designated by the Commissioner by

memorandum in the proceeding.

(d) These officials may not further

redelegate this authority.

§ 5.29 Petitions under part 10.

(a) For drugs assigned to their

organizations, the following officials are

authorized to grant or deny citizen

petitions submitted under § 10.30 of this

chapter for a stay of an effective date in

§ 201.59 of this chapter for compliance

with certain labeling requirements for

human prescription drugs:

(1)(i) The Director and Deputy

Directors, Center for Biologics

Evaluation and Research (CBER).

(ii) The Directors and Deputy

Directors, Office of Blood Research and

Review (OBRR), Office of Vaccines

Research and Review (OVRR), and

Office of Therapeutics Research and

Review (OTRR), CBER.

(iii) The Directors and Deputy

Directors of the Divisions in OBRR,

OVRR, and OTRR, CBER.

(2)(i) The Director, the Deputy

Director, and the Directors, Office of

Review Management and Office of

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER).

(ii) The Directors and Deputy

Directors of the Offices of Drug

Evaluation I, II, III, IV, and V, Office of

Review Management, CDER.

(iii) The Directors and Deputy

Directors of the divisions in the Offices

of Drug Evaluation I, II, III, IV, and V,

Office of Review Management, CDER.

(b) The following officials are

authorized to grant or deny citizen

petitions submitted under § 10.30 of this

chapter requesting in vitro test

modifications under § 331.29 of this

chapter:

(1) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Office of

Pharmaceutical Science, CDER.

(2) The Director, Office of Drug

Evaluation V, Office of Review

Management, CDER.

(3) The Director and Deputy Director,

Division of Over-the-Counter Drug

Products, Office of Drug Evaluation V,

Office of Review Management, CDER.

(c) The following officials are

authorized to grant or deny citizen

petitions submitted under § 10.30 of this

chapter for a stay of an effective date or

for an exemption from the tamperresistant packaging and labeling

requirements set forth in §§ 211.132,

700.25, or 800.12 of this chapter for

certain over-the-counter human drug

and cosmetic products and medical

devices which relate to the assigned

functions of the respective

organizations:

(1) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Office of

Pharmaceutical Science, CDER.

(2) The Director and Deputy Director,

Center for Food Safety and Applied

Nutrition (CFSAN); and the Director of

Regulations and Policy, CFSAN.

(3) The Director and the Deputy

Directors for Science and for

Regulations and Policy, Center for

Devices and Radiological Health

(CDRH).

(d) The following officials are

authorized to grant or deny citizen

petitions submitted under § 10.30 of this

chapter requesting exemption from the

general pregnancy-nursing warning for

over-the-counter (OTC) drugs required

under § 201.63 of this chapter,

requesting exemption from a general

overdose warning required under

§ 330.1(g) of this chapter, and requesting

exemption from OTC drug

administrative procedures under

§ 330.10 of this chapter:

(1) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Office of

Pharmaceutical Science, CDER.

(2) The Director, Office of Drug

Evaluation V, Office of Review

Management, CDER.

(3) The Director and Deputy Director,

Division of Over-the-Counter Drug

Products, Office of Drug Evaluation V,

Office of Review Management, CDER.

(e)(1) The following officials are

authorized to issue 180-day tentative

responses to citizen petitions on food

and cosmetic matters under

§ 10.30(e)(2)(iii) of this chapter that

relate to the assigned functions of that

Center:

(i) The Director and Deputy Director,

CFSAN.

(ii) The Director of Regulations and

Policy, CFSAN.

(iii) The Director, Office of Cosmetics

and Colors, CFSAN.

(iv) The Director, Office of Nutritional

Products, Labeling and Dietary

Supplements, CFSAN.

(v) The Director, Office of Premarket

Approval, CFSAN.

(vi) The Director, Office of Plant and

Dairy Foods and Beverages, CFSAN.

(vii) The Director, Office of Seafood,

CFSAN.

(viii) The Director, Office of Field

Programs, CFSAN.

(2) The Director and Deputy Director,

Center for Veterinary Medicine (CVM),

are authorized to issue 180-day tentative

responses to citizen petitions on animal

food and drug matters under

§ 10.30(e)(2)(iii) of this chapter that

relate to the assigned functions of that

Center.

(3) The Director and Deputy Directors,

CBER, are authorized to issue 180-day

tentative responses to citizen petitions

on biological product matters under

§ 10.30(e)(2)(iii) of this chapter that

relate to the assigned functions of that

Center.

(4) The Director, the Deputy Director,

and the Associate Director for

Regulatory Policy, CDER, are authorized

to issue 180-day tentative responses to

citizen petitions on drug product

matters under § 10.30(e)(2)(iii) of this

chapter that relate to the assigned

functions of that Center.

(5) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH, are authorized to issue

180-day tentative responses to citizen

petitions on medical device matters

under § 10.30(e)(2)(iii) of this chapter

that relate to the assigned functions of

that Center.

(f)(1) The Director and Deputy

Directors, CBER, are authorized to grant

or deny citizen petitions submitted

under § 10.30 of this chapter on drug

and biological product matters in

program areas where they have been

delegated final approval authority in the

following sections of this chapter:

(i) Section 5.203 Issuance and

revocation of licenses for the

propagation or manufacture and

preparation of biological products;

(ii) Section 5.204 Notification of

release for distribution of biological

products;

(iii) Section 5.101 Termination of

exemptions for new drugs for

investigational use in human beings or

in animals;

(iv) Section 5.103 Approval of new

drug applications and their

supplements.

(v) Section 5.105 Issuance of notices

relating to proposals to refuse approval

31004 Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations

or to withdraw approval of new drug

applications and their supplements.

(vi) Section 5.34 Issuance of notices

relating to proposals and orders for

debarment and denial of an application

to terminate debarment.

(2) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Office of

Pharmaceutical Science, CDER, are

authorized to grant or deny citizen

petitions submitted under § 10.30 of this

chapter on drug product matters in

program areas where they have been

delegated final approval authority in the

following sections of this chapter:

(i) Section 5.100 Issuance of notices

implementing the provisions of the Drug

Amendments of 1962;

(ii) Section 5.101 Termination of

exemptions for new drugs for

investigational use in human beings or

in animals;

(iii) Section 5.103 Approval of new

drug applications and their

supplements.

(iv) Section 5.105 Issuance of notices

relating to proposals to refuse approval

or to withdraw approval of new drug

applications and their supplements.

(v) Section 5.34 Issuance of notices

relating to proposals and orders for

debarment and denial of an application

to terminate debarment.

(3) The Director and Deputy Director,

Office of Generic Drugs, Office of

Pharmaceutical Science, CDER, except

for those drug products listed in

§ 314.440(b) of this chapter, are

authorized to issue responses to citizen

petitions submitted under § 10.30 of this

chapter seeking a determination of the

suitability of an abbreviated new drug

application for a drug product.

(4) The Directors and Deputy

Directors of OBRR, OVRR, and OTRR,

CBER, for those drug products listed in

§ 314.440(b) of this chapter, are

authorized to issue responses to citizen

petitions submitted under § 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 § 10.30 of this

chapter from sponsors of an

investigational new drug application

who request approval to ship in

interstate commerce, in accordance with

§ 2.125(j) of this chapter, an

investigational new drug for human use

containing a chlorofluorocarbon.

(i) The Director and Deputy Directors,

CBER.

(ii) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Office of

Pharmaceutical Science, CDER.

(6) The Director and Deputy Director,

CVM, are authorized to issue responses

to citizen petitions submitted under

§ 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 § 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

§ 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

§ 10.30 of this chapter concerning

actions they are authorized to take

under § 5.34 Issuance of notices relating

to proposals and orders for debarment

and denial of an application to

terminate debarment.

(g) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH, and the Director, Office

of Compliance, CDRH, are authorized to

grant or deny citizen petitions

submitted under §§ 10.30 and 821.2(b)

of this chapter, requesting an exemption

or variance from medical device

tracking requirements in part 821 of this

chapter.

(h) These officials may not further

redelegate this authority.

§ 5.30 Authority to select temporary voting

members for advisory committees and

authority to sign conflict of interest waivers.

(a) Each Center director is authorized

to select members of, and consultants to,

scientific and technical FDA advisory

committees under that Center’s

management to serve temporarily as

voting members on another advisory

committee under that Center’s

management when expertise is required

that is not available among current

voting standing members of a committee

or to comprise a quorum when, because

of unforeseen circumstances, a quorum

is or will be lacking. When additional

voting members are added to a

committee to provide needed expertise

not available among current voting

standing members of a committee, a

quorum will be based on the total of

regular and added members. Authority

to select temporary voting members to

advisory committees, if such voting

members are serving on an advisory

committee managed by another Center,

has not been redelegated. This authority

will continue to be exercised by the

Commissioner of Food and Drugs

(Commissioner) or the Senior Associate

Commissioner, Office of the

Commissioner.

(b) Each Center director is authorized,

under 18 U.S.C. 208(b)(1), to sign

conflict of interest waivers for special

Government employees without

substantial interest to serve as

consultants to advisory committees or in

any other capacity within the Centers

except as advisory committee members.

(c) These officials may not further

redelegate this authority.

§ 5.31 Enforcement activities.

(a) Designated officers and employees

of the Food and Drug Administration

who have been issued the Food and

Drug Administration official credentials

consisting of Form FDA–200A,

Identification Record, and Form FDA–

200B, Specification of General

Authority, are authorized:

(1) To conduct examinations,

inspections, and investigations; to

collect and obtain samples; to have

access to and to copy and verify records

as authorized by law; to make seizures

of items under section 702(e)(5) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 372 (e) (5)); and to

supervise compliance operations for the

enforcement of the act, the Fair

Packaging and Labeling Act (15 U.S.C.

1451–1461), the Federal Caustic Poison

Act (44 Stat. 140b; see also Public Law

86–613, section 19, formerly section 18),

the Import Milk Act (21 U.S.C. 141–

149), the Filled Milk Act (21 U.S.C. 61–

64), and sections 351 and 361 of the

PHS Act (42 U.S.C. 262 and 264).

(2) To administer oaths and

affirmations under section 1 of the act

of January 31, 1925 (Ch. 124, 43 Stat.

803); sections 12 to 15 of Reorganization

Plan No. IV, effective June 30, 1940; and

Reorganization Plan No. 1 of 1953,

effective April 11, 1953.

(b) Any officer or employee of the

Food and Drug Administration who has

been designated by the Commissioner of

Food and Drugs (Commissioner) to

conduct examinations, investigations, or

inspections under the act relating to

counterfeit drugs and issued the Food

and Drug Administration Official

Credential consisting of Form FDA–

200D, Special Authority for Criminal

Investigators, is authorized to do the

following:

(1) As set forth under section 702(e)(1)

through (e)(5) of the act (21 U.S.C. 372

(e)(1)–(e)(5)):

(i) Carry firearms;

(ii) Serve and execute search warrants

and arrest warrants;

Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations 31005

(iii) Execute seizure by process issued

under libel under section 304 of the act

(21 U.S.C. 334);

(iv) Make arrests without warrant for

an offense under the act with respect to

counterfeit drugs if the offense is

committed in the presence of the

criminal investigator or, in the case of

a felony, if the investigator has probable

cause to believe that the person so

arrested has committed, or is

committing, such offense; and

(v) Make, prior to the institution of

libel proceedings under section

304(a)(2) of the act (21 U.S.C. 334(a)(2)),

seizures of drugs or containers or of

equipment, punches, dies, plates,

stones, labeling, or other things, if they

are, or the criminal investigator has

reasonable grounds to believe that they

are, subject to seizure and

condemnation under section 304(a)(2) of

the act.

(2) Perform such other functions

under the act, or any other law, as the

Commissioner may prescribe.

(3) To administer oaths and

affirmations under section 1 of the act

of January 31, 1925 (Ch. 124, 43 Stat.

803); sections 12 to 15 of Reorganization

Plan No. IV, effective June 30, 1940; and

Reorganization Plan No. 1 of 1953,

effective April 11, 1953.

(c) Any officer or employee of the

Food and Drug Administration who has

been designated by the Commissioner to

provide specialized law enforcement

support involving criminal

investigations under the act, and other

duties as assigned by the Commissioner,

and issued the Food and Drug

Administration Official Credential

consisting of Form FDA–200E, Special

Authority for Criminal Investigative

Specialists, is authorized to receive

information as to all matters relating to

such act and regulations issued under

the act.

(d) These officials may not further

redelegate these authorities.

§ 5.32 Certification following inspections.

Regional Food and Drug Directors and

District Directors are authorized to issue

certificates of sanitation under § 1240.20

of this chapter. These officials may not

further redelegate this authority.

§ 5.33 Issuance of reports of minor

violations.

(a) The following officials are

authorized to perform all the functions

of the Commissioner of Food and Drugs

(Commissioner) under section 309 of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 336) (the act) regarding the

issuance of written notices or warnings:

(1)(i) The Director and Deputy

Directors, Center for Biologics

Evaluation and Research (CBER).

(ii) The Director and Deputy

Directors, Office of Compliance and

Biologics Quality, CBER.

(2)(i) The Director and Deputy

Directors for Science and for

Regulations and Policy, Center for

Devices and Radiological Health

(CDRH).

(ii) The Director and Deputy Director,

Office of Compliance, CDRH.

(iii) For medical devices assigned to

their respective divisions, the Division

Directors, Office of Compliance, CDRH.

(iv) The Director and Deputy Director,

Office of Surveillance and Biometrics

(OSB), CDRH, and the Director and

Deputy Director, Division of

Surveillance Systems (DSS), OSB,

CDRH.

(3)(i) The Director and Deputy

Director, Center for Food Safety and

Applied Nutrition, (CFSAN).

(ii) The Director of Regulations and

Policy, CFSAN.

(iii) The Director, Office of Field

Programs, CFSAN.

(iv) The Director, Division of

Enforcement and Programs, Office of

Field Programs, CFSAN.

(4)(i) The Director and Deputy

Director, Center for Veterinary Medicine

(CVM).

(ii) The Director and Deputy Director,

Office of Surveillance and Compliance,

CVM.

(iii) The Director, Division of

Compliance, Office of Surveillance and

Compliance, CVM.

(5)(i) The Director, the Deputy

Director, the Associate Director for

Regulatory Policy, and the Directors,

Office of Review Management and

Office of Pharmaceutical Science,

Center for Drug Evaluation and Research

(CDER).

(ii) The Director and Deputy Director,

Office of Compliance, CDER.

(iii) The Associate Director for

Medical Policy, CDER.

(iv) The Director, Division of Drug

Marketing, Advertising, and

Communications, Office of Medical

Policy, CDER.

(6)(i) Regional Food and Drug

Directors.

(ii) District Directors.

(iii) Chiefs of District Compliance

Branches.

(iv) The Director, St. Louis Branch.

(v) The Director, Northeast Regional

Laboratory, Northeast Region.

(vi) The Director, Southeast Regional

Laboratory, Southeast Region.

(vii) The Director, Winchester

Engineering and Analytical Center.

(viii) The Director, National Forensic

Chemistry Center.

(ix) The Director, Arkansas Regional

Laboratory.

(b) The following officials are

authorized to perform all the functions

of the Commissioner under section

539(d) of the act (21 U.S.C. 360pp(d))

regarding the issuance of written notices

or warnings:

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH).

(2) The Director and Deputy Director,

Office of Compliance, CDRH.

(3) For medical devices assigned to

their respective divisions, the Division

Directors, Office of Compliance, CDRH.

(4) The Director and Deputy Director,

Office of Surveillance and Biometrics

(OSB), CDRH, and the Director and

Deputy Director, Division of

Surveillance Systems (DSS), OSB,

CDRH.

(5) Regional Food and Drug Directors;

District Directors; the Director, St. Louis

Branch; the Director, Northeast Regional

Laboratory, Northeast Region; the

Director, Southeast Regional Laboratory,

Southeast Region; the Director,

Winchester Engineering and Analytical

Center; the Director, National Forensic

Chemistry Center, and the Director,

Arkansas Regional Laboratory when

such functions relate to:

(i) Assemblers of diagnostic x-ray

systems, as defined in § 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 § 1040.20(b) of this chapter.

(c) These officials may not further

redelegate these authorities.

§ 5.34 Issuance of notices relating to

proposals and orders for debarment and

denial of an application to terminate

debarment.

(a) The Director, the Deputy Director,

and the Associate Director for

Regulatory Policy, Center for Drug

Evaluation and Research, the Director

and Deputy Director, Center for

Veterinary Medicine, and the Director

and Deputy Directors, Center for

Biologics Evaluation and Research are

authorized to issue the following notices

and make all findings required in

relation to these notices under section

306 of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 335a)

which relate to the assigned functions of

their organizations:

(1) Notices of opportunity for hearing

on proposals for mandatory or

permissive debarment.

(2) Notices ordering debarment when

opportunity for a hearing has been

waived.

(3) Notices ordering debarment where

the person notifies the agency that the

31006 Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations

person consents to debarment under

section 306(c)(2)(B) of the act (21 U.S.C.

335a(c)(2)(B)).

(4) Notices of opportunity for hearing

on proposals denying an application to

terminate debarment under section

306(d)(3) of the act (21 U.S.C.

335u(d)(3)).

(5) Orders denying an application to

terminate debarment under section

306(d)(3) of the act (21 U.S.C.

335u(d)(3)) when opportunity for a

hearing has been waived.

(b) These officials may not further

redelegate these authorities.

§ 5.35 Officials authorized to make

certification under 5 U.S.C. 605(b) for any

proposed and final rules.

(a) The following officials are

authorized to perform all the functions

of the Commissioner of Food and Drugs

with regard to decisions made under the

Regulatory Flexibility Act (5 U.S.C.

605(b)), to certify that a proposed or

final rule, if issued, will not have a

significant economic impact on a

substantial number of small entities:

(1) The Associate Commissioner for

Regulatory Affairs.

(2) The Director, Center for Biologics

Evaluation and Research.

(3) The Director, Center for Drug

Evaluation and Research.

(4) The Director, Center for Devices

and Radiological Health.

(5) The Director, Center for Food

Safety and Applied Nutrition.

(6) The Director, Center for Veterinary

Medicine.

(7) Other Food and Drug

Administration Officials authorized to

issue Federal Register documents.

(b) These officials may not further

redelegate this authority.

Subpart C—Human Drugs;

Redelegations of Authority

§ 5.100 Issuance of notices implementing

the provisions of the Drug Amendments of

1962.

The Director, the Deputy Director, and

the Directors, Office of Review

Management and Office of

Pharmaceutical Science, Center for Drug

Evaluation and Research; and the

Director, the Deputy Directors for

Regulations and Policy and for Science,

and the Director and Deputy Directors,

Office of Device Evaluation, Center for

Devices and Radiological Health, are

authorized to issue notices and

amendments thereto implementing

section 107(c)(3) of the Drug

Amendments of 1962 (Pub. L. 87–781)

by announcing new or revised efficacy

findings on human drugs that are or

were subject to the provisions of section

506 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 355). These

officials may not further redelegate this

authority.

§ 5.101 Termination of exemptions for new

drugs for investigational use in human

beings.

(a) The following officials, for drugs

under their jurisdiction, are authorized

to perform all the functions of the

Commissioner of Food and Drugs on the

termination of exemptions for new

drugs (including those that are

biological products which are subject to

the licensing provisions of the Public

Health Service Act) for investigational

use in human beings under § 312.44 of

this chapter and in animals under

§ 312.160 of this chapter:

(1) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER).

(2) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Pharmaceutical

Science, Center for Drug Evaluation and

Research (CDER).

(3) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH).

(b) The following officials, for drugs

under their jurisdiction, are authorized

to terminate exemptions for new drugs

for investigational use when sponsors

fail to submit an annual progress report

under § 312.44(b)(1)(viii) of this chapter:

(1) The Directors and Deputy

Directors of the Offices of Drug

Evaluation I, II, III, IV, and V, Office of

Review Management, CDER.

(2) The Directors and Deputy

Directors of the divisions in the Offices

of Drug Evaluation I, II, III, IV, and V,

Office of Review Management, CDER.

(3) The Directors and Deputy

Directors, Office of Blood Research and

Review (OBRR), OVRR, and Office of

Therapeutics Research and Review

(OTRR), CBER.

(4) The Directors and Deputy

Directors of the Division of Blood

Applications, OBRR, the Division of

Vaccines and Related Products

Applications, OVRR, and the Division of

Application Review and Policy, OTRR,

CBER.

(5) The Director and Deputy Directors,

Office of Device Evaluation (ODE),

CDRH.

(c) The following officials, for drugs

under their jurisdiction, are authorized

to make the findings set forth in

§ 312.44(b) of this chapter and to notify

sponsors and invite correction before

termination action on such exemptions:

(1) The Directors and Deputy

Directors of the Offices of Drug

Evaluation I, II, III, IV, and V, Office of

Review Management, CDER.

(2) The Directors and Deputy

Directors of the divisions in the Offices

of Drug Evaluation I, II, III, IV, and V,

Office of Review Management, CDER.

(3) The Directors and Deputy

Directors, Office of Blood Research and

Review (OBRR), Office of Vaccines

Research and Review (OVRR), and

Office of Therapeutics Research and

Review (OTRR), CBER.

(4) The Directors and Deputy

Directors of the Division of Blood

Applications, OBRR, the Division of

Vaccines and Related Products

Applications, OVRR, and the Division of

Application Review and Policy, OTRR,

CBER.

(5) The Director and Deputy Directors,

ODE, CDRH.

(d) These officials may not further

redelegate these authorities.

§ 5.102 Authority to approve and to

withdraw approval of a charge for

investigational new drugs.

(a) The following officials, for drugs

under their jurisdiction, are authorized

to perform all the functions of the

Commissioner of Food and Drugs to

approve a charge and to withdraw

approval to charge for investigational

drugs in a clinical trial under an

investigational new drug application

under § 312.7(d)(1) of this chapter:

(1) The Director, the Deputy Director,

and the Directors, Office of Review

Management and the Office of

Pharmaceutical Science, Center for Drug

Evaluation and Research.

(2) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research.

(b) These officials may not further

redelegate this authority.

§ 5.103 Approval of new drug applications

and their supplements.

(a)(1) The following officials are

authorized to perform all the functions

of the Commissioner of Food and Drugs

(Commissioner) with regard to approval

of new drug applications and

supplements thereto on drugs for

human use, except for those drugs listed

in § 314.440(b) of this chapter, that have

been submitted under section 505 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 355):

(i) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Office of

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER).

(ii) The Directors and Deputy

Directors of the Offices of Drug

Evaluation I, II, III, IV, and V, Office of

Review Management, CDER, for drugs

under their jurisdiction.

(2) The Director and Deputy Directors,

Center for Biologics Evaluation and

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Research, for drugs listed in § 314.440(b)

of this chapter, are authorized to

perform all the functions of the

Commissioner with regard to approval

of new drug applications and

supplements thereto on drugs for

human use that have been submitted

under section 505 of the act.

(b) The Directors and Deputy

Directors of the divisions in the Offices

of Drug Evaluation I, II, III, IV, and V,

Office of Review Management, CDER,

for drugs under their jurisdiction, are

authorized to perform all functions of

the Commissioner with regard to

approval of supplemental applications

to approved new drug applications for

drugs for human use that have been

submitted under § 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 § 5.10(a) and paragraph (a)

of this section.

(c) The following officials are

authorized to perform all the functions

of the Commissioner with regard to

approval of abbreviated new drug

applications and supplements thereto

for drugs for human use and new drug

applications for drugs with a 5S

classification whose clinical safety and

efficacy may be supported by

appropriate literature citations in lieu of

submission of data from original

proprietary studies, or section 505(b)(2)

of the act (21 U.S.C. 355 (b)(2))

applications under their jurisdiction.

The applications to which this

authorization applies may, in

appropriate circumstances, continue to

be acted upon by the officials so

authorized in § 5.10(a) and paragraph (a)

of this section.

(1) For drugs submitted under

§§ 314.50, 314.70, and 314.94 of this

chapter, except for those drug products

listed in § 314.440(b):

(i) The Director and Deputy Director,

Office of Generic Drugs (OGD), Office of

Pharmaceutical Science, CDER, except

that the Director and Deputy Director,

OGD are not authorized to approve new

drug applications with a 5S

classification if clinical studies are

needed.

(ii) The Directors and Deputy

Directors of the divisions in Offices of

Drug Evaluation I, II, III, IV, and V,

Office of Review Management, CDER.

(2) For drug products listed in

§ 314.440(b) of this chapter and

submitted under §§ 314.50, 314.70, and

314.94 of this chapter: The Directors

and Deputy Directors, Office of Blood

Research and Review, Office of Vaccines

Research and Review, Office of

Therapeutics Research and Review, and

Office of Compliance and Biologics

Quality, CBER.

(d) The following officials are

authorized to perform all functions of

the Commissioner with respect to

approval of supplemental applications

to abbreviated new drug applications,

5S applications, or section 505(b)(2)

applications for drugs for human use

that are described in §§ 314.70(b)(1),

(b)(2)(ii) through (b)(2)(x), (c)(1), and

(c)(3) of this chapter. (Authority to

approve supplements that require in

vivo bioavailability studies or that

include in vivo bioavailability study

waiver requests are not included in this

paragraph.)

(1) The Director and Deputy Director,

Division of Chemistry I, Office of

Generic Drugs, Office of Pharmaceutical

Science, CDER.

(2) The Director and Deputy Director,

Division of Chemistry II, Office of

Generic Drugs, Office of Pharmaceutical

Science, CDER.

(3) Associate Director for Chemistry,

Office of New Drug Chemistry, Office of

Pharmaceutical Science, CDER.

(e) The Director, Division of Labeling

and Program Support, Office of Generic

Drugs, Office of Pharmaceutical Science,

CDER, are authorized to perform all the

functions of the Commissioner with

respect to approval of supplemental

applications to abbreviated new drug

applications, 5S applications, or section

505(b)(2) applications for drugs for

human use that are described in

§§ 314.70(b)(3) and (c)(2)(i) through

(c)(2)(iv) of this chapter. Authority to

approve supplements that require in

vivo bioavailability studies or in vivo

study waiver requests is not included in

this paragraph.

(f) The supervisory and team leader

chemists in the Divisions of New Drug

Chemistry I, II, and III, Office of New

Drug Chemistry, Office of

Pharmaceutical Science, CDER, are

authorized to perform all functions of

the Commissioner with respect to

approval of supplemental applications

to new drug applications for drugs for

human use that are described in

§§ 314(b)(1), (b)(2)(ii) through (b)(2)(x),

(c)(1), and (c)(3) of this chapter.

Authority to approve supplements that

require in vivo bioavailability

information or that require a change in

the labeling of the drug, except changes

that reflect only the use of a different

facility or establishment, are not

included in this paragraph. The

supplemental applications to which this

authorization applies may continue to

be acted upon by the officials so

authorized in § 5.10(a) and paragraphs

(a) and (b) of this section.

(g) These officials may not further

redelegate these authorities.

§ 5.104 Responses to Drug Enforcement

Administration temporary scheduling

notices.

The Director, Center for Drug

Evaluation and Research (CDER) and the

Director, Executive Operations Staff,

Office of the Center Director, CDER, are

authorized to provide responses to the

Drug Enforcement Administration’s

temporary scheduling notices under

section 201(h)(4) of the Controlled

Substances Act, as amended (21 U.S.C.

811(h)(4)). The delegation excludes the

authority to submit reports to Congress.

These officials may not further

redelegate this authority.

§ 5.105 Issuance of notices relating to

proposals to refuse approval or to withdraw

approval of new drug applications and their

supplements.

(a) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Office of

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER), are

authorized to issue notices of an

opportunity for a hearing on proposals

to refuse approval or to withdraw

approval of new drug applications and

abbreviated new drug applications and

supplements thereto on drugs for

human use, except for those drugs listed

in § 314.440(b) of this chapter, that have

been submitted under section 505 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 355) and subpart B

of part 314 of this chapter and to issue

notices refusing approval or

withdrawing approval when

opportunity for hearing has been

waived.

(b) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research, for those drugs listed in

§ 314.440(b) of this chapter, are

authorized to issue notices of an

opportunity for a hearing on proposals

to refuse approval or to withdraw

approval of new drug applications and

abbreviated new drug applications and

supplements thereto on drugs for

human use that have been submitted

under section 505 of the act and subpart

B of part 314 of this chapter and to issue

notices refusing approval or

withdrawing approval when

opportunity for hearing has been

waived.

(c) These officials may not further

redelegate these authorities.

31008 Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations

§ 5.106 Submission of and effective

approval dates for abbreviated new drug

applications and certain new drug

applications.

(a) The following officials are

authorized to perform all of the

functions of the Commissioner of Food

and Drugs with regard to decisions

made under section 505 (c)(3)(D),

(j)(4)(B)(iv), and (j)(4)(D) and section

505A of the Federal Food, Drug and

Cosmetic Act (the act) (21 U.S.C.

355(c)(3)(D), (j)(4)(B)(ii) and (j)(4)(D) and

355a) concerning the date of submission

or the date of effective approval of

abbreviated new drug applications

including supplements thereto

submitted under section 505(j) of the act

(21 U.S.C. 355(j)) and of new drug

applications including supplements

thereto submitted under section

505(b)(1) (21 U.S.C. 355 (b)(1)) of the act

and described under section 505(b)(2) of

the act (21 U.S.C. 355(b)(2)):

(1) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Office of

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER).

(2) The Director and Deputy Director,

Office of Generic Drugs, Office of

Pharmaceutical Science, CDER.

(b) These officials may not further

redelegate this authority.

§ 5.107 Extensions or stays of effective

dates for compliance with certain labeling

requirements for human prescription drugs.

(a) The following officials are

authorized to extend or stay an effective

date in § 201.59 of this chapter for

compliance with certain labeling

requirements for human prescription

drugs.

(1) For drugs assigned to their

organizations:

(i) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER).

(ii) The Directors and Deputy

Directors, Office of Blood Research and

Review (OBRR), Office of Vaccines

Research and Review (OVRR), and

Office of Therapeutics Research and

Review (OTRR), CBER.

(iii) The Directors and Deputy

Directors of the Divisions in OBRR,

OVRR, and OTRR, CBER.

(2) For drugs assigned to their

organizations:

(i) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Office of

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER).

(ii) The Directors and Deputy

Directors of the Offices of Drug

Evaluation I, II, III, IV, and V, Office of

Review Management, CDER.

(iii) The Directors and Deputy

Directors of the divisions in the Offices

of Drug Evaluation I, II, III, IV, and V,

Office of Review Management, CDER.

(b) These officials may not further

redelegate this authority.

§ 5.108 Authority relating to waivers or

reductions of prescription drug user fees.

The Director, Center for Drug

Evaluation and Research (CDER), and

the Associate Director for Regulatory

Policy, CDER, are authorized to perform

all the functions of the Commissioner of

Food and Drugs relating to waivers or

reductions of prescription drug user fees

under the Prescription Drug User Fee

Act of 1992, as originally enacted and as

reauthorized by the Food and Drug

Administration Modernization Act of

1997, except for the functions under

section 736(d)(1)(C) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 379h(d)(1)(C)) that pertain to

situations where ‘‘the fees will exceed

the anticipated present and future

costs,’’ on behalf of CDER, the Center for

Biologics Evaluation and Research, and

any other Food and Drug

Administration Center. This authority

pertains to waivers requested under the

public health waiver provision (21

U.S.C. 379h(d)(1)(A)); the barrier to

innovation waiver provision (21 U.S.C.

379h(d)(1)(B)); the applications

submitted under section 505(b)(1) and

(b)(2) of the Federal Food, Drug, and

Cosmetic Act waiver provision (21

U.S.C. 379h(d)(1)(D)); the small business

waiver provision (21 U.S.C.

379h(d)(1)(E)); and to requests for

refunds of fees if an application or

supplement is withdrawn after filing (21

U.S.C. 379h(a)(1)(G)); as well as waivers,

reductions, or refunds requested on any

other basis except fees exceeding the

cost. (See § 5.20(h)(1) for the authority

to reconsider any user fee decisions

made by the Chief Mediator and

Ombudsman, the Deputy Chief Mediator

and Ombudsman, and/or the former

Deputy User Fee Waiver Officer prior to

July 1, 1999.) These officials may not

further redelegate this authority.

§ 5.109 Issuance of written notices

concerning patent information, current

good manufacturing practices and false or

misleading labeling of new drugs.

(a) The following officials are

authorized to perform all the functions

of the Commissioner of Food and Drugs

under § 505(e) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 355(e)) regarding the issuance of

written notices.

(1) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Office of

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER).

(2) The Director and Deputy Director,

Office of Compliance, CDER.

(3) The Director and Deputy Director,

Division of Labeling and

Nonprescription Drug Compliance,

Office of Compliance, CDER.

(4) The Director and Deputy Director,

Division of Manufacturing and Product

Quality, Office of Compliance, CDER.

(5) The Director and Deputy Director,

Division of Prescription Drug

Compliance and Surveillance, Office of

Compliance, CDER.

(6) The Associate Director for Medical

Policy, and the Director and Deputy

Director, Division of Scientific

Investigations, Office of Medical Policy,

CDER.

(7) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER), the Director and

Deputy Directors, Office of Compliance

and Biologics Quality (OCBQ), CBER,

and the Directors, Division of Case

Management, Division of Inspections

and Surveillance, and Division of

Manufacturing and Product Quality,

OCBQ, CBER.

(8) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH), and the

Director and Deputy Directors of the

Office of Device Evaluation, CDRH.

(9) Regional Food and Drug Directors.

(10) District Directors.

(b) These officials may not further

redelegate this authority.

Subpart D—Biologics; Redelegations

of Authority

§ 5.200 Functions pertaining to safer

vaccines.

(a) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER) are authorized to

perform the functions of the

Commissioner of Food and Drugs

(Commissioner) under part C, subtitle 2

of title XXI of the PHS Act (42 U.S.C.

300aa–25 et seq.), as amended, and the

National Childhood Vaccine Injury Act

of 1986 (42 U.S.C. 300aa–1 note), as

amended hereafter, as follows:

(1) Section 2125 of the PHS Act (42

U.S.C. 300aa–25)–Recording and

reporting of information.

(2) Section 2127 of the PHS Act (42

U.S.C. 300aa–27)–Mandate for safer

childhood vaccines.

(3) Section 2128 of the PHS Act (42

U.S.C. 300aa–28)–Manufacturer

recordkeeping and reporting.

(4) Section 312 of the National

Childhood Vaccine Injury Act of 1986–

Related studies (42 U.S.C. 300aa–1

Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations 31009

note), 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 (d) of the

National Childhood Vaccine Injury Act

of 1986 is not redelegated by the

Commissioner.

(5) Section 313 of the National

Childhood Vaccine Injury Act of 1986–

Study of other vaccine risks (42 U.S.C.

300aa–1 note), except that the authority

to provide for notice and opportunity

for public hearing on the establishment

of guidelines regarding the risks to

children of certain vaccines under

section 313(a)(1)(B) and (b) of the

National Childhood Vaccine Injury Act

of 1986 is not redelegated by the

Commissioner.

(6) Section 314 of the National

Childhood Vaccine Injury Act of 1986–

Review of warnings, use instructions,

and precautionary information (42

U.S.C. 300aa–1 note).

(b) These officials may not further

redelegate these authorities.

§ 5.201 Redelegation of the Center for

Biologics Evaluation and Research

Director’s program authorities.

(a) The following officials are

authorized to perform all the functions

of the Director, Center for Biologics

Evaluation and Research (CBER) with

regard to program authorities for their

respective areas:

(1) Deputy Directors, CBER.

(2) Associate Directors, CBER.

(3) Office Directors, CBER.

(4) Division Directors, CBER.

(b) These officials may not further

redelegate these authorities.

§ 5.202 Issuance of notices of opportunity

for a hearing on proposals for denial of

approval of applications for licenses,

suspension of licenses, or revocation of

licenses and certain notices of revocation

of licenses.

(a) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research are authorized to issue:

(1) Notices of opportunity for a

hearing on proposals to deny approval

or filing of applications for biologics

licenses under § 601.4(b) of this chapter.

(2) Notices of opportunity for a

hearing on proposals to revoke biologics

licenses under § 601.5(b) of this chapter.

(3) Notices of revocation, at the

manufacturer’s request, of biologics

licenses under §§ 601.5(a) and 601.8 of

this chapter.

(4) Notices of revocation when the

manufacturer has waived the

opportunity for hearing under § 601.7(a)

of this chapter.

(5) Notice of biologics license

suspensions under § 601.6 of this

chapter.

(b) These officials may not further

redelegate these authorities.

§ 5.203 Issuance and revocation of

licenses for the propagation or manufacture

and preparation of biological products.

(a) The following officials are

authorized to issue licenses under

section 351 of the PHS Act (42 U.S.C.

262) for the propagation or manufacture

and preparation of biological products

as specified in the PHS Act, and to

revoke such licenses at the

manufacturer’s request:

(1) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER).

(2) Directors and Deputy Directors,

Office of Blood Research and Review,

Office of Vaccines Research and Review,

Office of Therapeutics Research and

Review, and Office of Compliance and

Biologics Quality, CBER.

(b) These officials may not further

redelegate this authority.

§ 5.204 Notification of release for

distribution of biological products.

(a) The following officials are

authorized to issue written notices of

release for distribution of licensed

biological products under subchapter F

(parts 600 through 680.31) of this

chapter:

(1) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER).

(2) The Director and Deputy Directors,

Office of Compliance and Biologics

Quality (OCBQ), CBER.

(3) The Director and Deputy Director,

Division of Manufacturing and Product

Quality, OCBQ, CBER.

(b) These officials may not further

redelegate this authority.

Subpart E—Food and Cosmetics;

Redelegations of Authority

§ 5.300 Food standards, food additives,

generally recognized as safe (GRAS)

substances, color additives, nutrient

content claims, and health claims.

(a)(1) The following officials are

authorized to perform all the functions

of the Commissioner of Food and Drugs

(Commissioner) under sections 409 and

721 of the act (21 U.S.C. 348 and 379e)

regarding the issuance of notices of

filing (including notices of extension of,

or reopening of, the comment period),

and of voluntary withdrawal, of

petitions on food additives, generally

recognized as safe (GRAS) substances,

and color additives that relate to the

assigned functions of the respective

Center:

(i) The Director and Deputy Director,

Center for Food Safety and Applied

Nutrition (CFSAN).

(ii) The Director of Regulations and

Policy, CFSAN.

(iii) The Director, Office of Premarket

Approval, CFSAN.

(iv) The Director and Deputy Director,

Center for Veterinary Medicine (CVM).

(2) The Director, Deputy Director, and

Director of Regulations and Policy,

CFSAN are authorized to perform all the

functions of the Commissioner under

section 401 of the act (21 U.S.C. 341)

regarding the issuance of proposed

rulemaking (including notices of

extension of, or reopening of, the

comment period) pertaining to food

standards.

(b)(1) The Director, Deputy Director,

and Director of Regulations and Policy,

CFSAN are authorized to perform all of

the functions of the Commissioner

under section 409 and 721 of the act (21

U.S.C. 348 and 379e) regarding the

approval of the use of food additives

under section 409(e) of the act (21

U.S.C. 348(e)) and the listing of color

additives under section 721(d)(1) of the

act (21 U.S.C. 379e) where the listing

does not involve novel or controversial

issues and does not involve any

questions about the applicability of the

Delaney Anti-Cancer Clause.

(2) The following officials are

authorized to perform all of the

functions of the Commissioner under

section 401 of the act (21 U.S.C. 341)

regarding the issuance of notices of

temporary permits for foods varying

from standards of identity under §

130.17 of this chapter:

(i) The Director and Deputy Director,

CFSAN.

(ii) The Director of Regulations and

Policy, CFSAN.

(iii) The Director, Office of Nutritional

Products, Labeling, and Dietary

Supplements, CFSAN.

(3) The Director and Deputy Director,

CVM, are authorized to perform all the

functions of the Commissioner

regarding approvals of the use of food

additives under section 409(e) of the act

(21 U.S.C. 348(e)), where these

approvals do not involve novel or

controversial issues, including any

question about the applicability of the

Delaney Anti-Cancer Clause.

(c)(1) The following officials are

authorized to issue 90-day letters to

food additive petitioners under section

409(c)(2) of the act (21 U.S.C. 348(c)(2))

or to color additive petitions under

section 721e(d)(1) (21 U.S.C. 379e(d)(1))

of the act that relate to the assigned

functions of the Center:

(i) The Director and Deputy Director,

CFSAN.

(ii) The Director of Regulations and

Policy, CFSAN.

31010 Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations

(iii) The Director, Office of Premarket

Approval, CFSAN.

(iv) The Director, Division of Product

Policy, Office of Premarket Approval,

CFSAN.

(v) The Director, Division of Petition

Control, Office of Premarket Approval,

CFSAN.

(2) The following officials are

authorized to issue 90-day letters to

food additive petitioners under section

409(c)(2) of the act (21 U.S.C. 348(c)(2))

that relate to the assigned functions of

the Center:

(i) The Director and Deputy Director,

CVM.

(ii) The Director and Deputy Director,

Office of Surveillance and Compliance,

CVM.

(iii) The Director and Deputy Director,

Division of Animal Feeds, Office of

Surveillance and Compliance, CVM.

(d) The following officials are

authorized to certify batches of color

additives under section 721 of the act

(21 U.S.C. 379e):

(1) The Director and Deputy Director,

CFSAN.

(2) The Director of Regulations and

Policy, CFSAN.

(3) The Director, Office of Cosmetics

and Colors, CFSAN.

(e) The following officials are

authorized to issue advance notices of

proposed rulemaking pertaining to

Codex Alimentarius food standards and

notices terminating consideration of

such standards when comments fail to

support the desirability and need for

proposing their adoption, under § 130.6

of this chapter:

(1) The Director and Deputy Director,

CFSAN.

(2) The Director of Regulations and

Policy, CFSAN.

(3) The Director, Office of Nutritional

Products, Labeling, and Dietary

Supplements, CFSAN.

(f) The following officials are

authorized to issue notices of proposed

rulemaking and issue or amend

regulations affirming GRAS status of

food substances under §§ 170.35 or

570.35 of this chapter where the

affirmations relate to the assigned

functions of the respective Center and

do not involve novel or controversial

issues:

(1) The Director, Deputy Director, and

Director of Regulations and Policy,

CFSAN.

(2) The Director and Deputy Director,

CVM.

(g)(1) The following officials are

authorized to perform all of the

functions of the Commissioner under

section 403(r)(4) of the act (21 U.S.C.

343(r)(4)) regarding the issuance of

decisions to grant or deny petitions for

nutrient content claims and health

claims that do not present controversial

issues and regarding the issuance of any

notices of proposed rulemaking that

result from such action:

(i) The Director and Deputy Director,

CFSAN.

(ii) The Director of Regulations and

Policy, CFSAN.

(2) The following officials are

authorized to perform all of the

functions of the Commissioner under

section 403(r)(4) of the act (21 U.S.C.

343(r)(4)) regarding the issuing of letters

of filing in response to petitions for

nutrient content claims and health

claims:

(i) The Director and Deputy Director,

CFSAN.

(ii) The Director of Regulations and

Policy, CFSAN.

(iii) The Director, Office of Nutritional

Products, Labeling, and Dietary

Supplements, CFSAN.

(h) The following officials are

authorized to issue letters concerning

substances determined to be below the

‘‘threshold of regulation’’ under §

170.39 of this chapter:

(1) The Director and Deputy Director,

CFSAN.

(2) The Director of Regulations and

Policy, CFSAN.

(3) The Director, Office of Premarket

Approval, CFSAN.

(4) The Directors of the Divisions of

Petition Control and Product Policy,

Office of Premarket Approval, CFSAN.

(i) The following officials are

authorized to perform all of the

functions of the Commissioner under

section 409(h) of the act (21 U.S.C.

348(h)), excluding the duties to set out

in section 409(h)(5) of the act (21 U.S.C.

348(h)(5)), regarding premarket

notification of food-contact substances:

(1) The Director and Deputy Director,

CFSAN.

(2) The Director of Regulations and

Policy, CFSAN.

(3) The Director, Office of Premarket

Approval, CFSAN.

(j) These officials may not further

redelegate these authorities.

§ 5.301 Issuance of initial emergency

permit orders and notices of confirmation

of effective date of final regulations on food

for human and animal consumption.

(a) The Director and Deputy Director,

Center for Food Safety and Applied

Nutrition (CFSAN), the Director, Office

of Field Programs, CFSAN, and the

Director, Division of Enforcement and

Programs, Office of Field Programs,

CFSAN, are authorized to issue initial

emergency permit orders under § 108.5

of this chapter.

(b) The following officials are

authorized to issue notices of

confirmation of effective date of final

regulations on food matters issued

under section 701(e) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

371(e)):

(1) The Director and Deputy Director,

CFSAN.

(2) The Director of Regulations and

Policy, CFSAN.

(3) The Director, Office of Nutritional

Products, Labeling, and Dietary

Supplements, CFSAN.

(4) The Director, Office of Plant and

Dairy Foods and Beverages, CFSAN.

(5) The Director, Office of Seafood,

CFSAN.

6) The Director, Office of Field

Programs, CFSAN.

(7) The Director, Office of Premarket

Approval, CFSAN.

(c) These officials may not further

redelegate these authorities.

§ 5.302 Detention of meat, poultry, eggs,

and related products.

The Regional Food and Drug Directors

and District Directors are authorized to

perform and to designate other officials

to perform all of the functions of the

Commissioner of Food and Drugs under:

(a) Section 409(b) of the Federal Meat

Inspection Act (21 U.S.C. 679(b)), that

relates to the detention of any carcass,

part thereof, meat, or meat product of

cattle, sheep, swine, goats, or equines.

(b) Section 24(b) of the Poultry

Products Inspection Act (21 U.S.C. 467f

(b)) that relates to the detention of any

poultry carcass, part thereof, or poultry

product.

(c) The Egg Products Inspection Act

(21 U.S.C. 1031 et seq.).

§ 5.303 Establishing standards and

approving accrediting bodies under the

National Laboratory Accreditation Program.

The Director, Deputy Director, and

Director of Regulations and Policy,

Center for Food Safety and Applied

Nutrition, are authorized to perform all

the functions of the Commissioner of

Food and Drugs under sections 1322(b)

and (c) of the Food, Agriculture,

Conservation, and Trade Act of 1990

(the National Laboratory Accreditation

Program) (7 U.S.C. 138a), as amended

hereafter, which relate to setting

standards for the National Laboratory

Accreditation Program and approving

State agencies or private, nonprofit

entities as accrediting bodies to

implement certification and quality

assurance programs in accordance with

the requirements of these sections. The

delegation excludes the authority to

submit reports to the Congress. These

officials may not further redelegate this

authority.

Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations 31011

§ 5.304 Approval of schools providing

food-processing instruction.

(a) The following officials are

authorized to perform all the functions

of the Commissioner of Food and Drugs

(Commissioner) under § 113.10 of this

chapter regarding the approval of

schools giving instruction in retort

operations, processing systems

operations, aseptic processing and

packaging system operations, and

container closure inspections:

(1) The Director and Deputy Director,

Center for Food Safety and Applied

Nutrition (CFSAN).

(2) The Director of Regulations and

Policy, CFSAN.

(3) The Director, Office of Plant and

Dairy Foods and Beverages, CFSAN.

(b) These officials may not further

redelegate this authority.

Subpart F—Medical Devices and

Radiological Health; Redelegations of

Authority

§ 5.400 Issuance of Federal Register

documents to recognize or to withdraw

recognition of a standard to meet premarket

submission requirements.

(a) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health; and the Director

and Deputy Directors, Center for

Biologics Evaluation and Research, are

authorized to issue Federal Register

documents under section 514(c) of the

Federal Food, Drug and Cosmetic Act

(the act) (21 U.S.C. 360d(c)) recognizing

or withdrawing recognition of a

standard for which a person may submit

a declaration of conformity in order to

meet a premarket submission

requirement.

(b) These officials may not further

redelegate this authority.

§ 5.401 Issuance of Federal Register

documents pertaining to exemptions from

premarket notification.

(a) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health; and the Directors

and Deputy Directors, Center for

Biologics Evaluation and Research, are

authorized to make determinations and

issue Federal Register notices and rules

under § 510(m) of the act (21 U.S.C.

360(m)) concerning exemptions from

premarket notification.

(b) These officials may not further

redelegate this authority.

§ 5.402 Detention of adulterated or

misbranded medical devices.

(a) The following officials are

authorized to perform all the functions

of the Commissioner of Food and Drugs

pertaining to detention, under section

304(g) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 334(g)) and in

accordance with § 800.55 of this

chapter, of medical devices that may be

adulterated or misbranded:

(1) For medical devices assigned to

their respective organizations:

(i) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH).

(ii) The Director and Deputy Director,

Office of Compliance, CDRH.

(iii) The Director and Deputy

Directors, Center for Biologics

Evaluation and Research (CBER).

(iv) The Director and Deputy

Directors, Office of Compliance and

Biologics Quality, CBER.

(2) Regional Food and Drug Directors.

(3) District Directors.

(4) The Director, St. Louis Branch.

(b) These officials may not further

redelegate this authority.

§ 5.403 Authorization to use alternative

evidence for determination of the

effectiveness of medical devices.

(a) The following officials, for medical

devices assigned to their respective

organizations, may authorize under

section 513(a)(3)(B) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 360c(a)(3)(B)) the use of valid

scientific evidence (other than that

prescribed by section 513(a)(3)(A) of the

act) for determining the effectiveness of

medical devices for the purposes of

sections 513, 514, and 515 of the act (21

U.S.C. 360c, 360d, and 360e):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH), and the

Director and Deputy Directors, Office of

Device Evaluation, CDRH.

(2) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER), and the Directors and

Deputy Director, Office of Blood

Research and Review (OBRR), Office of

Vaccines Research and Review (OVRR),

and Office of Therapeutics Research and

Review (OTRR), CBER.

(b) These officials may not further

redelegate this authority.

§ 5.404 Notification to petitioners of

determinations made on petitions for

reclassification of medical devices.

(a) The following officials, for medical

devices assigned to their respective

organizations, are authorized to notify

petitioners of determinations made on

petitions for reclassification of medical

devices that are classified in class III

(premarket approval) by sections 513(f)

and 520(l) of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

360c(f) and 360 j(1)) and denials of

petitions for reclassification of medical

devices that are submitted under section

513(e) of the act (21 U.S.C. 360c(e))

(except for petitions submitted in

response to Federal Register notices

initiating standard-setting under

§ 514(b) of the act (21 U.S.C. 360d(b)) or

premarket approval under section

515(b) of the act (21 U.S.C. 360e(b)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH) and the

Director and Deputy Directors, Office of

Device Evaluation.

(2) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER), and the Directors and

Deputy Directors, Office of Blood

Research and Review, Office of Vaccines

Research and Review, and Office of

Therapeutics Research and Review,

CBER.

(b) These officials may not further

redelegate this authority.

§ 5.405 Determination of classification of

devices.

(a) The following officials, for devices

assigned to their respective

organizations, are authorized to

determine the classification of a medical

device in commercial distribution prior

to May 28, 1976, under section 513(d)

of the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 360c(d)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH) and the

Director and Deputy Directors, Office of

Device Evaluation (ODE), CDRH.

(2) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER), and the Director and

Deputy Directors of the Office of Blood

Research and Review (OBRR), the Office

of Vaccines Research and Review

(OVRR), and the Office of Therapeutics

Research and Review (OTRR), CBER.

(b) The following officials, for devices

assigned to their respective

organizations, are authorized to

determine the classification of a medical

device first intended for commercial

distribution after May 28, 1976, under

section 513 (f)(1)(A) of the act (21 U.S.C.

360c(f)(1)(A)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH, and the Director, Deputy

Directors, Division and Deputy Division

Directors, Associate Division Directors,

Branch Chiefs, and Chief, Premarket

Notification Section, ODE, CDRH.

(2) The Director and Deputy Directors,

CBER, and the Directors and Deputy

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Directors of the OBRR, OVRR, and

OTRR, CBER.

(c) The following officials are

authorized to make determinations and

issue orders classifying devices under

section 513(f)(2)(b):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Directors,

ODE, CDRH.

(3) The Director and Deputy Directors,

CBER, and the Directors and Deputy

Directors of the OBRR, OVRR, and

OTRR, CBER.

(d) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH, and the Director and

Deputy Directors, CBER, and the

Directors and Deputy Directors of the

OBRR, OVRR, and OTRR, CBER, are

authorized to issue Federal Register

notices under section 513(f)(2)(C) of the

act (21 U.S.C. 360c(f)(2)(C)) announcing

classification of devices under section

513(f)(2)(B) of the act (21 U.S.C.

360c(f)(2)(B)).

(e) These officials may not further

redelegate those authorities.

§ 5.406 Notification to sponsors of

deficiencies in petitions for reclassification

of medical devices.

(a) The following officials, for medical

devices assigned to their respective

organizations, are authorized to notify

sponsors of deficiencies in petitions for

reclassification of medical devices

submitted under sections 513(f) and

520(l) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 360c(f) and

360j(l)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH), and the

Director and Deputy Directors, Office of

Device Evaluation, CDRH.

(2) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER), and the Directors and

Deputy Directors of the Office of Blood

Research and Review, Office of Vaccines

Research and Review, and Office of

Therapeutics Research and Review,

CBER.

(b) These officials may not further

redelegate this authority.

§ 5.407 Approval, disapproval, or

withdrawal of approval of product

development protocols and applications for

premarket approval for medical devices.

(a) The following officials, for medical

devices assigned to their respective

organizations, are authorized to

approve, disapprove, declare as

complete or incomplete, or revoke

product development protocols for

medical devices submitted under

section 515(f) of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

360e(f)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH), the

Director and Deputy Directors, Office of

Device Evaluation (ODE), CDRH, and

the Division Directors, ODE, CDRH.

(2) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER), and the Director and

Deputy Directors, Office of Blood

Research and Review (OBRR), Office of

Vaccines Research and Review (OVRR),

and Office of Therapeutics Research and

Review (OTRR), CBER.

(b)(1) The following officials, for

medical devices assigned to their

respective organizations, are authorized

to approve, disapprove, or withdraw

approval of applications for premarket

approval for medical devices submitted

under sections 515 and 520(l) of the act

(21 U.S.C. 360e and 360j(l)):

(i) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH, the Director and Deputy

Directors, ODE, CDRH, and the Division

Directors, ODE, CDRH.

(ii) The Director and Deputy

Directors, CBER, and the Directors and

Deputy Directors, OBRR, OVRR, and

OTRR, CBER.

(2) For medical devices assigned to

their respective division, the Division

Directors, Office of Device Evaluation,

CDRH, are authorized to approve,

disapprove, or withdraw approval of

supplemental premarket applications.

(c) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH, for medical devices

assigned to their organization, are

authorized to issue notices to announce

the approval, disapproval, or

withdrawal of approval of a device, and

to make publicly available a detailed

summary of the information on which

the decision was based, under sections

515(d), (e), and (g) and 520(h)(1) of the

act (21 U.S.C. (d), (e), and (g) and

360j(h)(1)).

(d) These officials may not further

redelegate these authorities.

§ 5.408 Determinations concerning the

type of valid scientific evidence submitted

in a premarket approval application.

(a) The following officials are

authorized to make determinations

under section 513(a)(3)(D) of the act (21

U.S.C. 360c(a)(3)(D)) concerning the

type of valid scientific evidence to be

submitted in a premarket approval

application that will provide a

reasonable assurance that a device is

effective under the conditions of use

proposed by such person:

(i) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(ii) The Director and Deputy

Directors, Office of Device Evaluation

(ODE), CDRH.

(iii) The Director, Program Operations

Staff, ODE, CDRH.

(iv) For devices assigned to their

respective Divisions: the Division

Directors and Deputy Division Directors,

ODE, CDRH.

(b) These officials may may not

further redelegate this authority.

§ 5.409 Determinations that medical

devices present unreasonable risk of

substantial harm.

(a) The following officials, for medical

devices assigned to their respective

organizations, are authorized to

determine that medical devices present

an unreasonable risk of substantial harm

to the public health, and to order

adequate notification thereof, under

section 518(a) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 360h(a)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH), and the

Director and Deputy Director, Office of

Compliance, CDRH.

(2) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER), and the Director and

Deputy Director, Office of Compliance

and Biologics Quality, CBER.

(3) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Pharmaceutical

Science, Center for Drug Evaluation and

Research (CDER); and the Director and

Deputy Director, Office of Compliance,

CDER.

(b) These officials may not further

redelegate this authority.

§ 5.410 Orders to repair or replace, or

make refunds for, medical devices.

(a) The following officials, for medical

devices assigned to their respective

organizations, are authorized to order

repair or replacement of, or refund for,

medical devices under section 518(b)

and (c) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 360h(b) and

(c)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH), and the

Director and Deputy Director, Office of

Compliance, CDRH.

(2) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER), and the Director and

Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations 31013

Deputy Directors, Office of Compliance

and Biologics Quality, CBER.

(3) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Office of

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER); and

the Director and Deputy Director, Office

of Compliance, CDER.

(b) These officials may not further

redelegate this authority.

§ 5.411 Medical device recall authority.

(a) The following officials, for medical

devices assigned to their respective

organizations, are authorized to perform

all of the recall functions under section

518(e) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 360h(e)), which

have been delegated to the

Commissioner of Food and Drugs:

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH).

(2) The Director and Deputy Director,

Office of Compliance, CDRH.

(3) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Office of

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER); and

the Director and Deputy Director, Office

of Compliance, CDER.

(4) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER), and the Director and

Deputy Directors, Office of Compliance

and Biologics Quality, CBER.

(b) These officials may not further

redelegate this authority.

§ 5.412 Temporary suspension of a

medical device application.

(a) The following officials for medical

devices assigned to their respective

organizations are authorized under

section 515(e) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 360e(e)), to

determine that there is reasonable

probability that continuation of the

distribution of a device under an

approved application would cause

serious adverse health consequences or

death, and upon making such a

determination, to issue an order to

temporarily suspend the approval of an

application:

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH).

(2) The Director and Deputy Director,

Office of Compliance, CDRH.

(3) The Director and Deputy Directors,

Office of Device Evaluation, CDRH.

(4) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Office of

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER); the

Directors of the Offices of Drug

Evaluation I, II, III, IV, and V, Office of

Review Management, CDER; the

Director and Deputy Director, Office of

Generic Drugs, Office of Pharmaceutical

Science, CDER; and the Director and

Deputy Director, Office of Compliance,

CDER.

(5) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER), and the Director and

Deputy Directors, Office of Compliance

and Biologics Quality, CBER.

(b) These officials may not further

redelegate this authority.

§ 5.413 Approval, disapproval, or

withdrawal of approval of applications and

entering into agreements for investigational

device exemptions.

(a) For medical devices assigned to

their respective organizations, the

following officials are authorized to

approve, disapprove, or withdraw

approval of applications for

investigational device exemptions

submitted under section 520(g) of the

Federal Food, Drug, and Cosmetic Act

(the act) ( 21 U.S.C. 360j(g)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH), the

Director and Deputy Directors, Office of

Device Evaluation, CDRH, and the

Director and Deputy Director, Office of

Compliance, CDRH.

(2) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER), and the Directors and

Deputy Directors, Office of Blood

Research and Review (OBRR), Office of

Vaccines Research and Review (OVRR),

and Office of Therapeutics Research and

Review (OTRR), CBER.

(b) For medical devices assigned to

their respective divisions, the Division

Directors, Office of Device Evaluation,

CDRH, are authorized to approve,

disapprove, or withdraw approval of

applications for investigational device

exemptions submitted under section

520(g) of the act (21 U.S.C. 360j(y)).

(c) The following officials are

authorized to enter into written

agreements concerning investigational

device exemption protocols under

section 520(g)(7) of the act (21 U.S.C.

360j(g)(7)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Directors,

Office of Device Evaluation (ODE),

CDRH.

(3) The Director, Program Operations

Staff, ODE, CDRH.

(4) The Chief, Investigational Device

Exemption Section, ODE, CDRH.

(5) For medical devices assigned to

their respective Divisions: The Division

Directors and Deputy Division Directors,

ODE, CDRH.

(6) The Director and Deputy Directors,

CBER, and the Director and Deputy

Directors of the OBRR, OVRR, and

OTRR, CBER.

(d) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH and the Director and

Deputy Directors, ODE, CDRH, the

Director and Deputy Directors, CBER,

and the Director and Deputy Directors of

the OBRR, OVRR, and OTRR, CBER, are

authorized to make decisions under

section 520(g)(7) of the act (21 U.S.C.

360j(g)(7)) with respect to an agreement

on an investigational plan, that a

substantial scientific issue essential to

determining the safety and effectiveness

of the device involved has been

identified.

(e) These officials may not further

redelegate these authorities.

§ 5.414 Postmarket surveillance.

(a) For any class II or class III device

(including any device that is or contains

a drug or biologic), the failure of which

would be reasonably likely to have

serious adverse health consequences, or

which is intended to be implanted in

the human body for more than 1 year,

or a life supporting or life sustaining

device used outside a user facility, any

of the following officials is authorized to

require a manufacturer of such device to

conduct postmarket surveillance:

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH).

(2) The Director and Deputy Director,

Office of Surveillance and Biometrics,

CDRH.

(3) The Director and Deputy Director,

Division of Postmarket Surveillance,

Office of Surveillance and Biometrics

(OSB), and the Director, Issues

Management Staff, OSB, CDRH.

(4) The Director and Deputy Directors,

Office of Device Evaluation, CDRH.

(5) The Director and Deputy Director,

Office of Science and Technology,

CDRH.

(6) The Director and Deputy Director,

Office of Health and Industry Programs,

CDRH.

(7) The Director and Deputy Director,

Office of Compliance, CDRH.

(8) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Office of

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER).

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(9) The Directors of the Offices of

Drug Evaluation I, II, III, IV, and V,

Office of Review Management, CDER.

(10) The Director and Deputy

Director, Office of Compliance, CDER.

(11) The Director and Deputy

Directors, Center for Biologics

Evaluation and Research (CBER).

(12) The Director and Deputy

Director, Office of Compliance and

Biologics Quality, CBER.

(13) The Directors and Deputy

Directors, Office of Blood Research and

Review, Office of Vaccines Research and

Review, and Office of Therapeutics

Research and Review, CBER.

(b) These officials may not further

redelegate these authorities.

§ 5.415 Authority relating to medical

device reporting procedures.

(a) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH), the

Director and Deputy Director, Office of

Surveillance and Biometrics (OSB),

CDRH, and the Director and Deputy

Director, Division of Surveillance

Systems (DSS), OSB, CDRH, are

authorized to approve electronic

reporting under § 803.14 of this chapter.

(b) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH, the Director and Deputy

Director, OSB, CDRH, and the Director

and Deputy Director, DSS, OSB, CDRH

are authorized to request the submission

of additional information under § 803.15

of this chapter.

(c) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH, the Director and Deputy

Director, OSB, CDRH, and the Director

and Deputy Director, DSS, OSB, CDRH

are authorized to grant or revoke

exemptions and variances from

reporting requirements under § 803.19

of this chapter.

(d) These officials may not further

redelegate these authorities.

§ 5.416 Medical device tracking.

(a) The following officials are

authorized to issue orders under section

519(e) of the Federal Food Drug and

Cosmetic Act (21 U.S.C. 360i(e))

requiring manufacturers to adopt

methods of tracking devices:

(1) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH).

(2) The Director and Deputy Director,

Office of Compliance, CDRH.

(b) These officials may not further

redelegate this authority.

§ 5.417 Authority pertaining to

accreditation functions for medical devices.

(a) The following officials are

authorized under section 523(a)(1) and

(b)(2)(A) of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C.

360m(a)(1) and (b)(2)(A)) to respond to

a request for accreditation and to

accredit persons for the purpose of

reviewing reports submitted under

section 510(k) of the act (21 U.S.C.

360(k)) and making recommendations

regarding the initial classification of

devices:

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH).

(2) The Director and Deputy Director,

Office of Health and Industry Programs

(OHIP), CDRH.

(3) The Director and Deputy Director,

Division of Small Manufacturers

Assistance (DSMA), OHIP, CDRH.

(b) The following officials are

authorized under section 523(a)(2)(B)

and (C) of the act (21 U.S.C.

360m(a)(2)(B) and (C)) to make a

determination with respect to the

recommendation of an initial

classification of a device; and to change

the initial classification under section

513(f)(1) of the act (21 U.S.C. 360c(f)(1))

that is recommended by an accredited

person to provide to such person, and

the person who submitted the report

under section 510(k) of the act (21

U.S.C. 360(k)) for the device, a

statement explaining in detail the

reasons for the change:

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Directors,

Office of Device Evaluation (ODE),

CDRH.

(3) The Division Directors and Deputy

Division Directors, ODE, CDRH.

(c) The following officials are

authorized under section 523(b)(2)(B) of

the act (21 U.S.C. 360m(b)(2)(B)) to

suspend or withdraw accreditation of

any person accredited to review reports

and to make recommendations under

section 523 of the act (21 U.S.C. 360m):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Director,

OHIP, CDRH.

(3) The Director and Deputy Director,

DSMA, OHIP, CDRH.

(d) The following officials are

authorized under section 523(b)(2)(C) of

the act (21 U.S.C. 360m(b)(2)(c)) to

implement the measures described in

that section to ensure that persons

accredited under section 523 of the act

(21 U.S.C. 360m) will continue to meet

the standards of accreditation:

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Director,

Office of Compliance, CDRH.

(e) These officials may not further

redelegate these authorities.

Subpart G—Animal Drugs;

Redelegations of Authority

§ 5.500 Issuance of FEDERAL REGISTER

documents pertaining to the determination

of safe levels, notice of need for

development of an analytical method,

notice of availability of a developed

analytical method, and prohibition of

certain extralabel drug use.

The Director and Deputy Director,

Center for Veterinary Medicine (CVM)

are authorized to issue Federal Register

documents pertaining to the

determination of safe levels, notice of

need for development of an analytical

method, notice of availability of a

developed analytical method, and

prohibition of certain extralabel drug

use related to implementation of section

512(a)(4) and (5) of the Federal Food,

Drug and Cosmetic Act (21 U.S.C.

360b(a)(4) and (5)). These officials may

further redelegate this authority.

§ 5.501 Approval of new animal drug

applications, medicated feed mill license

applications and their supplements.

(a) The Director and Deputy Director,

Center for Veterinary Medicine (CVM),

are authorized to perform all the

functions of the Commissioner of Food

and Drugs (Commissioner) with regard

to the approval of new animal drug

applications, and supplements thereto,

for new animal drugs submitted under

section 512 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

360b).

(b) The following officials are

authorized to perform all the functions

of the Commissioner of Food and Drugs

with regard to the approval of

supplemental applications to approved

new animal drugs submitted under

section 512 of the act (21 U.S.C. 360b):

(1) The Director, the Deputy Director

for Human Food Safety and

Consultative Services, and the Deputy

Director for Therapeutic and Production

Drug Review, Office of New Animal

Drug Evaluation, CVM.

(2) The Director and Deputy Director,

Office of Surveillance and Compliance,

CVM.

(c) The following officials are

authorized to perform all the functions

of the Commissioner with regard to the

approval of supplemental applications

to new animal drug applications that are

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described by section 514.8(a)(4)(iii), (iv),

and (v), and (d)(3) of this chapter.

(1) The Director, Division of

Manufacturing Technologies, Office of

New Animal Drug Evaluation, CVM.

(2) The Director, Division of

Epidemiology and Surveillance, Office

of Surveillance and Compliance, CVM.

(d) The following officials are

authorized to perform all the functions

of the Commissioner with regard to the

approval of medicated feed mill license

applications for the manufacture of

animal feeds containing new animal

drugs under section 512(m) of the act

(21 U.S.C. 360b(m), as amended by the

Animal Drug Availability Act of 1996

(Public Law 104–250):

(1) The Director and Deputy Director,

CVM.

(2) The Director, Division of Animal

Feeds, Office of Surveillance and

Compliance, CVM.

(3) The Leader, Medicated Feeds

Team, Division of Animal Feeds, Office

of Surveillance and Compliance, CVM.

(4) The Medicated Feeds Specialist,

Medicated Feeds Team, Division of

Animal Feeds, Office of Surveillance

and Compliance, CVM.

(e) These officials may not further

redelegate these authorities.

§ 5.502 Issuance of notices, proposals,

and orders relating to new animal drugs

and medicated feed mill license

applications.

(a) The Director and Deputy Director,

Center for Veterinary Medicine (CVM),

are authorized to:

(1) Issue notices of opportunity for a

hearing on proposals to refuse approval

or to withdraw approval of new animal

drug applications, and supplements

thereto, for drugs for animal use and

proposals to refuse approval or to

revoke approval of medicated feed mill

license applications, and supplements

thereto, submitted under section 512(m)

of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 360b(m)), as amended by

the Animal Drug Availability Act of

1996 (Public Law 104–250);

(2) Issue notices refusing or

withdrawing approval when

opportunity for hearing has been

waived; and

(3) Issue proposals and orders to

revoke and amend regulations for new

animal drugs for drugs for animal use

and medicated feed mill licenses,

corresponding to said act on such

applications.

(b) The Director and Deputy Director,

CVM, are authorized to issue notices of

availability of Public Master Files

containing data acceptable for use in

applications for new animal drugs for

drugs for animal use and feeds bearing

or containing new animal drugs.

(c) These officials may not further

redelegate these authorities.

§ 5.503 Submission of and effective

approval dates for abbreviated new animal

drug applications and certain new animal

drug applications.

(a) The following officials are

authorized to perform all the functions

of the Commissioner of Food and Drugs

(Commissioner) with regard to decisions

made under section 512(c)(2)(D)(iv) and

(c)(2)(F) of the Federal, Food, Drug, and

Cosmetic Act (the act) (21 U.S.C.

360b(c)(2)(D)(iv) and (c)(2)(F)

concerning the date of submission and

the date of effective approval of

abbreviated new animal drug

applications including supplements

thereto, submitted under section

512(b)(2) of the act (21 U.S.C.

360b(b)(2)), and of new animal drug

applications including supplements

thereto, submitted under section

512(b)(1) of the act (21 U.S.C.

360b(b)(1)):

(1) The Director and Deputy Director,

Center for Veterinary Medicine (CVM).

(2) The Director and Deputy Director,

Office of New Animal Drug Evaluation,

CVM.

(b) These officials may not further

redelegate this authority.

§ 5.504 Issuance of written notices

concerning patent information, current

good manufacturing practices and false or

misleading labeling of new animal drugs

and feeds bearing or containing new animal

drugs.

(a) The following officials are

authorized to perform all the functions

of the Commissioner of Food and Drugs

(Commissioner) under sections 512(e)

and 512 (m)(4)(B)(ii) and (m)(4)(B)(iii) of

the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 360b(e), (m)(4)(B)(ii), and

(m)(4)(B)(iii)) regarding the issuance of

written notices:

(1) The Director and Deputy Director,

Center for Veterinary Medicine (CVM).

(2) The Director and Deputy Director,

Office of Surveillance and Compliance,

CVM.

(3) The Director, Division of

Compliance, Office of Surveillance and

Compliance, CVM.

(4) Regional Food and Drug Directors.

(5) District Directors.

(b) These officials may not further

redelegate this authority.

§ 5.505 Termination of exemptions for new

drugs for investigational use in animals.

(a) The following officials are

authorized to perform all functions of

the Commissioner of Food and Drugs

with regard to the termination of new

animal drugs for investigational use in

animals under § 511.1 of this chapter:

(1) The Director and Deputy Director,

Center for Veterinary Medicine (CVM).

(2) The Director and Deputy Director,

Office of New Animal Drug Evaluation,

CVM.

(b) These officials may not further

redelegate this authority.

Subpart H—Radiation Control;

Redelegations of Authority

§ 5.600 Variances from performance

standards for electronic products.

(a) The following officials are

authorized to grant and withdraw

variances and issue notices of

availability of any approved variance or

any amendment or extension thereof,

from the provisions of performance

standards for electronic products

established in subchapter J of this

chapter:

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH).

(2) The Director and Deputy Director,

Office of Compliance, CDRH.

(b) These officials may not further

redelegate this authority.

§ 5.601 Exemption of electronic products

from performance standards and prohibited

acts.

(a) The following officials are

authorized to exempt from performance

standards any electronic product

intended for use by departments or

agencies of the United States under

section 534 (a)(5) of the Federal Food,

Drug and Cosmetic Act (the act) (21

U.S.C. 360kk(a)(5)) and to exempt an

electronic product or class of products

from all or part of the provisions of

section 538(a) of the act (21 U.S.C.

360oo(a)) under section 538(b) of the act

(21 U.S.C. 360oo(b)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH).

(2) The Director and Deputy Director,

Office of Compliance, CDRH.

(b) These officials may not further

redelegate this authority.

§ 5.602 Testing programs and methods of

certification and identification for electronic

products.

(a) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH), and the

Director and Deputy Director, Office of

Compliance, CDRH, are authorized to

review and evaluate industry testing

programs under section 534(g) of the

Federal Food, Drug and Cosmetic Act

the act (21 U.S.C. 360kk(g)) and to

approve or disapprove alternate

31016 Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations

methods of certification and

identification and to disapprove testing

programs upon which certification is

based under section 534(h) of the act (21

U.S.C. 360kk(h)).

(b) These officials may not further

redelegate this authority.

§ 5.603 Notification of defects in, and

repair or replacement of, electronic

products.

(a) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH), and the

Director and Deputy Director, Office of

Compliance, CDRH, are authorized to

perform all functions of the

Commissioner of Food and Drugs

(Commissioner), relating to notification

of defects in, noncompliance of, and

repair or replacement of or refund for,

electronic products under section 534 of

the Federal Food, Drug and Cosmetic

Act (the act) (21 U.S.C. 360kk) and

under §§ 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 § 1020.30(b) of

this chapter.

(2) Manufacturers of sunlamp

products and ultraviolet lamps intended

for use in any sunlamp product, as

defined in § 1040.20(b) of this chapter.

(b) The Director and Deputy Director,

Office of Compliance, CDRH, and the

Division Directors, Office of

Compliance, CDRH, are authorized to

notify manufacturers of defects in, and

noncompliance of, electronic products

under section 535(e) of the act (21

U.S.C. 360ll(e)) and under § 1003.11(a)

of this chapter; and the chiefs of District

Compliance Branches are authorized to

perform all such functions relating to:

(1) Assemblers of diagnostic x-ray

systems, as defined in § 1020.30(b) of

this chapter.

(2) Manufacturers of sunlamp

products and ultraviolet lamps intended

for use in any sunlamp products, as

defined in § 1040.20(b) of this chapter.

(c) These officials may not further

redelegate these authorities.

§ 5.604 Manufacturers requirement to

provide data to ultimate purchasers of

electronic products.

(a) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health, are authorized to

require manufacturers to provide

performance and technical data to the

ultimate purchaser of electronic

products under section 537(c) of the

Federal Food, Drug and Cosmetic Act

(21 U.S.C. 360nn(c)).

(b) These officials may not further

redelegate these authorities.

§ 5.605 Dealer and distributor direction to

provide data to manufacturers of electronic

products.

(a) The Director and Deputy Director

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH), the

Director and Deputy Director, Office of

Compliance, CDRH, and the Division

Directors, Office of Compliance, CDRH,

are authorized to direct dealers and

distributors of electronic products to

furnish information on first purchasers

of such products to the manufacturer of

the product under section 537(f) of the

Federal Food, Drug and Cosmetic Act

(21 U.S.C. 360nn(f)).

(b) These officials may not further

redelegate these authorities.

§ 5.606 Acceptance of assistance from

State and Local authorities for enforcement

of radiation control legislation and

regulations.

(a) The Director and Deputy Directors,

Center for Devices and Radiological

Health, are authorized to accept

assistance from State and Local

authorities engaged in activities related

to health or safety or consumer

protection on a reimbursable basis or

otherwise, under section 541 of the

Federal Food, Drug and Cosmetic Act

(21 U.S.C. 360rr).

(b) These officials may not further

redelegate these authorities.

Subpart I—Product Designation;

Redelegations of Authority

§ 5.700 Authority relating to determination

of product primary jurisdiction.

The Chief Mediator and Ombudsman,

Office of the Ombudsman, Office of the

Senior Associate Commissioner, Office

of the Commissioner, as product

jurisdiction officer is authorized to

make a determination under section 563

of the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 360bbb–2)

respecting the classification of a product

as a drug, biological product, device, or

a combination product subject to section

503(g) of the act (21 U.S.C. 353(g)), and

to assign primary responsibility

respecting the organizational

component of the Food and Drug

Administration that will regulate the

product. This official may not further

redelegate this authority.

§ 5.701 Premarket approval of a product

that is or contains a biologic, a device, or

a drug.

(a) For a product that is or contains a

biologic, a device, or a drug, the

following officials in the Center for

Biologics Evaluation and Research,

Center for Devices and Radiological

Health, or Center for Drug Evaluation

and Research who currently hold

delegated premarket approval authority

for biologics, devices, or drugs,

respectively, are hereby delegated all

the authorities necessary for premarket

approval of any product that is a

biologic, a device, or a drug, or any

combination of two or more of these

products:

(1) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER) and the Directors of

the Office of Blood Research and

Review, Office of Vaccines Research and

Review, Office of Therapeutics Research

and Review, and Office of Compliance

and Biologics Quality, CBER.

(2) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH), and the

Director, Office of Device Evaluation,

CDRH.

(3) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Office of

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER); and

the Directors of the Offices of Drug

Evaluation I, II, III, IV, and V, Office of

Review Management, CDER.

(b) These officials may not further

redelegate this authority.

Subpart J—Imports and Exports;

Redelegations of Authority

§ 5.800 Imports and exports.

(a) The Regional Food and Drug

Directors, District Directors, and the

Director, St. Louis Branch, are

authorized, under section 801 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 381), to perform the

following functions or to designate

officials to:

(1) Request from the Secretary of the

Treasury samples of food, drugs

(including biological products), devices,

or cosmetics imported or offered for

import.

(2) Determine whether such articles

are in compliance with the act.

(3) Authorize relabeling or other

compliance actions to bring articles into

compliance under the Act.

(4) Supervise such compliance

actions.

(b) The Director and Deputy Directors

for Science and for Regulations and

Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations 31017

Policy, Center for Devices and

Radiological Health (CDRH); the

Director and Deputy Director, Office of

Compliance, CDRH; Regional Food and

Drug Directors; District Directors; and

the Director, St. Louis Branch, are

authorized, under section 536 of the act

(21 U.S.C. 360mm), to perform the

following functions or to designate

officials to:

(1) Request from the Secretary of the

Treasury samples of electronic products

imported or offered for import to

determine whether such products are in

compliance with section 534 of the act

(21 U.S.C. 360kk).

(2) Refuse admission of noncomplying

products and notify the Secretary of the

Treasury of such refusal.

(3) Supervise operations to bring

noncomplying products into

compliance under section 534 of the act

(21 U.S.C. 360kk).

(4) Refuse or grant permission and

time extensions to bring noncomplying

products into compliance with section

534 of the act (21 U.S.C. 360kk) in

accordance with a corrective action plan

approved by the Directors, Offices of

Compliance Surveillance and

Biometrics, CDRH.

(c) The following officials are

authorized, under section 538(b) of the

act (21 U.S.C. 360oo(b)), to exempt

persons from issuing a certification, as

required by section 534(h) of the act (21

U.S.C. 360kk(h)) for electronic products

imported into the United States for

testing, evaluation, demonstrations, or

training, which will not be introduced

into commerce and upon completion of

their function will be destroyed or

exported in accord with U.S. Customs

Service’s regulations:

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Director,

Office of Compliance, CDRH.

(3) Regional Food and Drug Directors.

(4) District Directors.

(5) The Director, St. Louis Branch.

(d) The Regional Food and Drug

Directors, District Directors, and the

Director, St. Louis Branch, are

authorized to exercise all of the

functions of the Commissioner of Food

and Drugs (Commissioner) under

section 362 of the Public Health Service

Act (42 U.S.C. 265) that relate to the

prohibition of the introduction of foods,

drugs, devices, cosmetics, and

electronic products, and other items or

products regulated by the Food and

Drug Administration into the United

States when it is determined that it is

required in the interest of public health,

and such functions relate to the law

enforcement functions of the Food and

Drug Administration.

(e) The following officials are

authorized to perform all the functions

of the Commissioner pertaining to

exportation of medical devices under

section 801(e) of the act (21 U.S.C.

381(e)):

(1) For medical devices assigned to

their respective organization:

(i) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(ii) The Director and Deputy Director,

Office of Compliance, CDRH.

(iii) The Director and Deputy Director,

Division of Program Operations, Office

of Compliance, CDRH.

(iv) The Director and Deputy

Directors, Center for Biologics

Evaluation and Research (CBER).

(v) The Director and Deputy Directors,

Office of Compliance and Biologics

Quality, CBER.

(2) Regional Food and Drug Directors.

(3) District Directors.

(4) The Director, St. Louis Branch.

(f) The following officials are

authorized to perform the functions of

the Commissioner for drugs under their

jurisdiction, pertaining to authorizing

the reimportation of prescription drugs

under section 801(d)(2) of the act (21

U.S.C. 381(d)(2)) for emergency medical

care:

(1) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER) and the Director,

Office of Compliance and Biologics

Quality, CBER.

(2) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Office of

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER) and the

Director and Deputy Director, Office of

Compliance, CDER.

(g) These officials may not further

redelegate these authorities.

§ 5.801 Export of unapproved drugs.

(a) The following officials are

authorized, under section 802(b)(2) and

(b)(3) of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C.

382(b)(2) and (b)(3)), to grant or deny

petitions to export unapproved new

drugs and biological products and to

issue notices of receipt of such petitions

for human drugs assigned to their

respective organizations:

(1) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER).

(2) The Director and Deputy Directors,

Office of Compliance and Biologics

Quality, CBER.

(3) The Director, the Deputy Director,

and the Directors, Office Review

Management and Office of

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER).

(4) The Director and Deputy Director,

Office of Compliance, CDER.

(b) The following officials are

authorized, under section 802(e) of the

act (21 U.S.C. 382(e)), to approve or

disapprove an application to export a

drug (including a biological product) to

be used in the prevention or treatment

of a tropical disease or another disease

as described in section 802(e) for human

drugs assigned to their respective

organizations:

(1) The Director and Deputy Directors,

CBER.

(2) The Director and Deputy Directors,

Office of Compliance and Biologics

Quality, CBER.

(3) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Office of

Pharmaceutical Science, CDER.

(4) The Director and Deputy Director,

Office of Compliance, CDER.

(c) The following officials are

authorized, under section 351(h) of the

Public Health Service Act (42 U.S.C.

262(h)), to approve or disapprove an

application to export a partially

processed biological product:

(1) The Director and Deputy Directors,

CBER.

(2) The Director and Deputy Directors,

Office of Compliance and Biologics

Quality, CBER.

(d) These officials may not further

redelegate these authorities.

§ 5.802 Manufacturer’s resident import

agents.

The Director and Deputy Directors for

Science and for Regulations and Policy,

Center for Devices and Radiological

Health (CDRH) and the Director and

Deputy Director, Office of Compliance,

CDRH, are authorized to reject

manufacturer’s designation of import

agents under § 1005.25(b) of this

chapter. These officials may not further

redelegate this authority.

Subpart K—Orphan Products;

Redelegations of Authority

§ 5.900 Orphan products.

(a) The Director, Office of Orphan

Products Development (OPD), Office of

the Senior Associate Commissioner

(OSAC), Office of the Commissioner

(OC), is authorized to issue notices, and

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;

31018 Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations

(2) Notices of claimed investigational

exemption for a new animal drug or

new animal drug applications;

(3) Applications for biologics licenses

for biological products; or

(4) Applications for an investigational

device exemption or premarket approval

applications for medical devices, as

appropriate.

(b) The Director, OPD, OSAC, OC, is

authorized:

(1) To determine whether there is

reason to believe that a drug is a drug

for a disease or condition that is rare in

the United States under section 525(a)

of the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 360aa(a)) and to

designate such drug as a drug for a rare

disease or condition under section

526(a) of the act (21 U.S.C. 360bb(a)).

(2) To issue holders of approved

applications or licenses notice and

opportunity for the submission of views

under section 527(b)(1) of the act (921

U.S.C. 360cc(b)(1)).

(3) To encourage sponsors of an

investigational new drug for a rare

disease or condition to design protocols

for clinical investigations to permit the

addition to the investigation of persons

with the disease or condition under

section 528 of the act (21 U.S.C. 360dd).

(c) The following officials are

authorized to provide sponsors, under

section 525(a) of the act (21 U.S.C.

360aa(a)), with recommendations for

nonclinical or clinical investigations

believed to be necessary for a drug for

a rare disease or condition to be

approved or licensed:

(1) For drugs under their jurisdiction:

(i) The Director, the Deputy Director,

and the Directors, Office of Review

Management and Office of

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER).

(ii) The Directors and Deputy

Directors of the Offices of Drug

Evaluation I, II, III, IV, and V, Office of

Review Management, CDER.

(iii) The Directors and Deputy

Directors of the divisions in the Offices

of Drug Evaluation I, II, III, IV, and V,

Office of Review Management, CDER.

(2) For biological products under their

jurisdiction:

(i) The Director and Deputy Directors,

Center for Biologics Evaluation and

Research (CBER).

(ii) The Directors and Deputy

Directors, Office of Blood Research and

Review (OBRR), Office of Vaccines

Research and Review (OVRR), Office of

Therapeutics Research and Review

(OTRR), CBER.

(iii) The Directors and Deputy

Directors of the Divisions in OBRR,

OVRR, and OTRR, CBER.

(d) These officials may not further

redelegate these authorities.

Subpart L—Mammography Facilities;

Redelegations of Authority

§ 5.1000 Authority to ensure that

mammography facilities meet quality

standards.

(a) The following officials are

authorized to ensure mammography

facilities obtain certificates under

section 354(b) of the Public Health

Service Act (the PHS Act) (42 U.S.C.

263b(b)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, Center for Devices and

Radiological Health (CDRH).

(2) The Director and Deputy Director,

Office of Health and Industry Programs

(OHIP), CDRH.

(3) The Director and Deputy Director,

Division of Mammography Quality and

Radiation Programs (DMQRP), OHIP,

CDRH.

(b) The following officials are

authorized to issue, renew and extend

certificates to mammography facilities

under section 354(c) of the PHS Act (42

U.S.C. 263b(c)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Director,

OHIP, CDRH.

(3) The Director and Deputy Director,

DMQRP, OHIP, CDRH.

(c) The following officials are

authorized to accept an application for

a certificate under section 354(d)(1) of

the PHS Act (42 U.S.C. 263b(d)(1)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Director,

OHIP, CDRH.

(3) The Director and Deputy Director,

DMQRP, OHIP, CDRH.

(d) The following officials are

authorized to approve accreditation

bodies to accredit mammography

facilities under section 354(e)(1)(A) of

the PHS Act (42 U.S.C. 263b(e)(1)(A)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Director,

OHIP, CDRH.

(e) The following officials are

authorized to ensure accreditation

bodies provide satisfactory assurances

of compliance under section

354(e)(1)(C) of the PHS Act (42 U.S.C.

263b(e)(1)(c)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Director,

OHIP, CDRH.

(3) The Director and Deputy Director,

DMQRP, OHIP, CDRH.

(f) The Director, CDRH is authorized

to issue regulations under which the

Director may withdraw approval of

accreditation bodies under section

354(e)(2)(A) of the PHS Act (42 U.S.C.

263b(e)(2)(A)).

(g) The following officials are

authorized to determine the expiration

date of a certificate of a facility

accredited by an accreditation body

after the body’s approval is withdrawn,

or a State’s certification authority has

been withdrawn, or a facility’s

accreditation has been revoked by an

accreditation body under sections

354(e)(2)(B) and 354(e)(5) of the PHS

Act (42 U.S.C. 263b(e)(2)(B) and (e)(5)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Director,

OHIP, CDRH.

(h) The following officials are

authorized to determine the applicable

standards for a facility for accreditation

under section 354(e)(3) of the PHS Act

(42 U.S.C. 263b(e)(3)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Director,

OHIP, CDRH.

(3) The Director and Deputy Director,

DMQRP, OHIP, CDRH.

(i) The following officials are

authorized to ensure accreditation

bodies make on site visits and to

determine whether other measures are

appropriate under section 354(e)(4) of

the PHS Act (42 U.S.C. 263b(e)(4)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Director,

OHIP, CDRH.

(3) The Director and Deputy Director,

DMQRP, OHIP, CDRH.

(j) The following officials are

authorized to evaluate annually the

performance of each approved

accreditation body as provided by

section 354(e)(6)(A) of the PHS Act (41

U.S.C. 263b(e)(6)(A)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Director,

OHIP, CDRH.

(3) The Director and Deputy Director,

DMQRP, OHIP, CDRH.

(k) The following officials are

authorized to determine the compliance

of certified facilities with established

standards through annual facility

inspections as provided by section

354(g) of the PHS Act (42 U.S.C.

263b(g)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations 31019

1Mailing address: 5600 Fishers Lane, Rockville,

MD 20857.

2Mailing address: 5630 Fishers Lane, Rockville,

MD 20857.

3Mailing address: 1401 Rockville Pike, Rockville,

MD 20852–1448.

(2) The Director and Deputy Director,

OHIP, CDRH.

(3) The Director and Deputy Director,

DMQRP, OHIP, CDRH.

(l) The following officials are

authorized to promote voluntary

compliance with established standards

instead of taking actions under section

354(i) of the PHS Act (42 U.S.C. 263b(i))

by imposing directed plans of correction

and/or payment of the cost of onsite

monitoring under section 354(h)(1) of

the PHS Act (42 U.S.C. 263b(h)(l)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Director,

OHIP, CDRH.

(3) The Director and Deputy Director,

DMQRP, OHIP, CDRH.

(m) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH are authorized to impose

sanctions under section 354(h)(2) of the

PHS Act (42 U.S.C. 263b(h)(2)).

(n) The following officials are

authorized to develop and implement

the procedures for determining when

and how to impose sanctions as

provided by section 354(h)(3) of the

PHS Act (42 U.S.C. 263b(h)(3)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Director,

OHIP, CDRH.

(3) The Director and Deputy Director,

DMQRP, OHIP, CDRH.

(o) The following officials are

authorized to suspend or revoke

individual facility certificates under

section 354(i)(1) and (i)(2) of the PHS

Act (42 U.S.C. 263b(i)(1) and (i)(2)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Director,

OHIP, CDRH.

(p) The following officials are

authorized under section 354(i)(3) of the

PHS Act (42 U.S.C. 263b(i)(3)) to ensure

that no person who owned or operated

a facility at the time the cause of

revocation occurred may, within 2 years

of the revocation of the certificate, own

or operate a mammography facility:

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Director,

OHIP, CDRH.

(3) The Director and Deputy Director,

DMQRP, OHIP, CDRH.

(q) The following officials are

authorized to compile and make

available to physicians and the general

public information determined to be

useful in evaluating the performance of

mammography facilities as provided by

section 354(l) of the PHS Act (42 U.S.C.

263b(l):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Director,

OHIP, CDRH.

(3) The Director and Deputy Director,

DMQRP, OHIP, CDRH.

(r) The following officials are

authorized to ensure that appropriate

Federal agencies are consulted in the

development of standards, regulations,

evaluations, procedures for compliance

and oversight as provided by section

354(o) of the PHS Act (42 U.S.C.

263b(o)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Director,

OHIP, CDRH.

(3) The Director and Deputy Director,

DMQRP, OHIP, CDRH.

(s) The following officials may

authorize a State to carry out

certification program requirements and

implement quality standards under

sections 354(q)(1) and (q)(2) of the PHS

Act (42 U.S.C. 263b(g)(1) and (g)(2)):

(1) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH.

(2) The Director and Deputy Director,

OHIP, CDRH.

(t) The Director and Deputy Directors

for Science and for Regulations and

Policy, CDRH are authorized, after

providing notice and opportunity for

corrective action, to withdraw the

approval of a State’s authority to carry

out certification requirements and

implement quality standards under

section 354(q)(4) of the PHS Act (42

U.S.C. 263b(g)(4)).

(u) These officials may not further

redelegate these authorities.

Subpart M—Organization

§ 5.1100 Headquarters.

The central organization of the Food

and Drug Administration consists of the

following:

Office of the Commissioner.1

Office of the Chief Counsel.

Office of Equal Opportunity.

Office of the Administrative Law Judge.

Office of the Senior Associate

Commissioner.

Office of Executive Secretariat.

Office of Public Affairs.

Office of the Ombudsman.

Office of Orphan Products

Development.

Office of Internal Affairs.

Office of Executive Operations.

Office of Science Coordination and

Communication.

Office of Human Research Trials.

Office of International and Constituent

Relations.

Office of International Programs.

Office of Consumer Affairs.

Office of Women’s Health.

Office of Special Health Issues.

Office of Policy, Planning, and

Legislation.

Office of Policy.

Office of Planning.

Office of Legislation.

Office of Management and Systems.

Office of Human Resources and

Management Services.

Office of Information Resources

Management.

Office of Financial Management.

Office of Facilities, Acquisitions, and

Central Services.2

Center for Biologics Evaluation and

Research.3

Office of the Center Director.

Scientific Advisors and Consultants

Staff.

Equal Employment Opportunity and

Workforce Diversity Staff.

Quality Assurance Staff.

Regulations and Policy Staff.

Veterinary Services Staff.

Office of Management.

Regulatory Information Management

Staff.

Division of Planning, Evaluation, and

Budget.

Division of Management Services.

Office of Information Technology

Management.

Division of Information Technology

Operations.

Division of Information Technology

Development.

Division of Information Technology

Infrastructure.

Office of Compliance and Biologics

Quality.

Division of Case Management.

Division of Manufacturing and Product

Quality.

Division of Inspections and

Surveillance.

Office of Blood Research and Review.

Human Tissue Staff.

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4Mailing address: 200 C St. SW., Washington, DC

20204.

5Mailing address: 7500 Standish Pl., Rockville,

MD 20855.

6Mailing address: 7520 Standish Pl., Rockville,

MD 20855.

Policy and Publications Staff.

Division of Emerging and Transfusion

Transmitted Diseases.

Division of Hematology.

Division of Blood Applications.

Office of Therapeutics Research and

Review.

Division of Cellular and Gene

Therapies.

Division of Therapeutic Proteins.

Division of Monoclonal Antibodies.

Division of Clinical Trial Design and

Analysis.

Division of Application Review and

Policy.

Office of Vaccines Research and Review.

Division of Bacterial, Parasitic, and

Allergenic Products.

Division of Viral Products.

Division of Vaccines and Related

Products Applications.

Office of Communication, Training, and

Manufacturers Assistance.

Division of Disclosure and Oversight

Management.

Division of Manufacturers Assistance

and Training.

Division of Communication and

Consumer Affairs.

Office of Biostatistics and Epidemiology.

Division of Biostatistics.

Division of Epidemiology.

Center for Food Safety and Applied

Nutrition.4

Office of the Center Director.

Food Safety Initiatives Staff.

Office of Science

Quality Assurance Staff.

CFSAN Staff College.

Microbial Research and Risk

Assessment Staff.

JIFSAN Liaison Staff.

CFSAN Food Advisory Committee Staff.

Office of Applied Research and Safety

Assessment.

Muirkirk Technical Operations Staff.

Division of Molecular Biology.

Division of Virulence Assessment.

Division of Toxicology and Nutritional

Product Studies.

Division of In Vitro and Biochemical

Toxicology.

Office of Regulations and Policy.

Regulations Coordination Staff.

Office of Constituent Operations.

Consumer Education Staff.

Industry Activities Staff.

International Activities Staff.

Office of Management Systems.

Safety Management Systems.

Division of Information Resources

Management.

Division of Planning and Financial

Resources Management.

Division of Management Operations.

Division of Administrative Services

Management.

Office of Operations.

Equal Employment Opportunity Staff.

Executive Operations Staff.

Office of Cosmetics and Colors.

Division of Programs and Enforcement

Policy.

Division of Science and Applied

Technology.

Office of Nutritional Products, Labeling

and Dietary Supplements.

Division of Compliance and

Enforcement.

Division of Standards and Labeling

Regulations.

Division of Nutrition Science Policy.

Office of Premarket Approval.

Division of Product Policy.

Division of Petition Control.

Division of Health Effects Evaluation.

Division of Product Manufacture and

Use.

Office of Plant and Dairy Foods and

Beverages.

Division of Pesticides and Industrial

Chemicals.

Division of Natural Products.

Division of Food Processing and

Packaging.

Division of Plant Product Safety.

Division of Dairy and Egg Safety.

Division of Risk Assessment.

Division of Microbiological Studies.

Office of Seafood.

Division of Special Programs.

Division of Programs and Enforcement

Policy.

Division of Science and Applied

Technology.

Office of Field Programs.

Division of Enforcement and Programs.

Division of HACCP Programs.

Division of Cooperative Programs.

Office of Scientific Analysis and

Support.

Division of General Scientific Support.

Division of Mathematics.

Division of Market Studies.

Center for Drug Evaluation and

Research.1

Office of the Center Director.

Equal Employment Opportunity Staff.

Executive Operations Staff.

Office of Regulatory Policy.

Division of Regulatory Policy I.

Division of Regulatory Policy II.

Division of Information Disclosure

Policy.

Office of Management.1

Strategic Planning Staff.1

Division of Management and Budget.5

Division of Management Services.1

Office of Training and Communication.1

Medwatch Staff.

Division of Library and Information

Services.

Division of Training and Development.

Division of Public Affairs.

Division of Drug Information.

Office of Compliance.6

Division of Manufacturing and Product

Quality.

Division of Prescription Drug

Compliance and Surveillance.

Division of Labeling and NonPrescription Drug Compliance.

Office of Information Technology.1

Quality Assurance Staff.

Technology Support Services Staff.

Division of Data Management and

Services.

Division of Applications Development

and Services.

Division of Infrastructure Management

and Services.

Office of Medical Policy.1

Division of Drug Marketing, Advertising

and Communication.1

Division of Scientific Investigations.5

Office of Review Management.1

Advisors and Consultants Staff.2

Office of Drug Evaluation I.1

Division of Cardio-Renal Drug Products.

Division of Neuropharmacological Drug

Products.

Division of Oncology Drug Products.

Office of Drug Evaluation II.1

Division of Metabolic and Endocrine

Drug Products.

Division of Pulmonary and Allergy Drug

Products.

Division of Anesthetic, Critical Care and

Addiction Drug Products.

Office of Drug Evaluation III.1

Division of Gastrointestinal and

Coagulation Drug Products.

Division of Medical Imaging and

Radiopharmaceutical Drug Products.

Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations 31021

7Mailing address: 8301 Muirkirk Rd., Laurel, MD

20708.

8Mailing address: 1114 Market St., St. Louis, MO

63101.

9Mailing address: 900 U.S. Customhouse, Second

Chestnut St., Philadelphia, PA 19106.

10Mailing address: 901 Warrenville Rd., suite

360, Lisle, IL 60532.

11Mailing address: 158–15 Liberty Ave., Jamaica,

NY 11433.

12Mailing address: 13301 Clay St., Oakland CA

94512.

13Mailing address: 60 Eighth St. NE, Atlanta, GA

30309.

14Mailing address: 7920 Elmbrook Rd., Dallas,

TX 75247.

15Mailing address: 7500 Standish Pl., MPN–2,

Rockville, MD 20855.

16Mailing address: 9200 Corporate Blvd.,

Rockville, MD 20850.

Division of Reproductive and Urologic

Drug Products.

Office of Drug Evaluation IV.1

Division of Anti-Infective Drug

Products.

Division of Anti-Viral Drug Products.

Division of Special Pathogen and

Immunologic Drug Products.

Office of Drug Evaluation V.1

Division of Anti-Inflammatory,

Analgesic and Opthalmologic Drug

Products.

Division of Dermatologic and Dental

Drug Products.

Division of Over-The-Counter Drug

Products.

Office of Biostatistics.1

Quantitative Methods Research Staff.

Division of Biometrics I.

Division of Biometrics II.

Division of Biometrics III.

Office of Post-Marketing Drug Risk

Assessment.1

Extramural Programs Staff.

Information Technology Staff.

Division of Drug Risk Evaluation I.

Division of Drug Risk Evaluation II.

Office of Pharmaceutical Science.1

Quality Implementation Staff.1

Operations Staff.1

Office of Clinical Pharmacology and

Biopharmaceutics.

Pharmacometrics Staff.

Division of Pharmaceutical Evaluation

I.1

Division of Pharmaceutical Evaluation

II.1

Division of Pharmaceutical Evaluation

III.1

Office of Generic Drugs.6

Division of Bioequivalence.

Division of Chemistry I.

Division of Chemistry II.

Division of Labeling and Program

Support.

Office of New Drug Chemistry.1

Division of New Drug Chemistry I.1

Division of New Drug Chemistry II.1

Division of New Drug Chemistry III.1

Office of Testing and Research.1

Informatics and Computational Safety

Analysis Staff.

Laboratory of Clinical Pharmacology.1

Division of Applied Pharmacology

Research.7

Division of Pharmaceutical Analysis.8

Division of Product Quality Research.1

Office of Regulatory Affairs.1

Equal Employment Opportunity Staff.

Office of Resource Management.

Strategic Initiatives Staff.

Division of Planning, Evaluation, and

Management.

Division of Information Systems.

Division of Human Resource

Development.

Division of Management Operations.

Division of Personnel Operations.

Office of Enforcement.

Division of Compliance Management

and Operations.

Division of Compliance Policy.

Division of Compliance Information and

Quality Assurance.

Office of Regional Operations.

Division of Federal-State Relations.

Division of Field Science.

Division of Emergency and

Investigational Operations.

Division of Import Operations and

Policy.

Office of Criminal Investigations.

Mid-Atlantic Area Office.9

Midwest Area Office. 10

Northeast Area Office.11

Pacific Area Office.12

Southeast Area Office.13

Southwest Area Office.14

Center for Veterinary Medicine.15

Office of the Center Director.

Office of Management and

Communications.

Administrative Staff.

Communications Staff.

Information Resources Management

Staff.

Office of New Animal Drug Evaluation.

Division of Therapeutic Drugs for Food

Animals.

Division of Biometics and Production

Drugs

Division of Therapeutic Drugs for

Nonfood Animals.

Division of Manufacturing

Technologies.

Division of Human Food Safety.

Office of Surveillance and Compliance.

Division of Surveillance.

Division of Animal Feeds.

Division of Compliance.

Division of Epidemiology.

Office of Research.

Administrative Staff.

Division of Residue Chemistry.

Division of Animal Research.

Division of Animal and Food

Microbiology.

Center for Devices and Radiological

Health.16

Office of the Center Director.

Equal Employment Opportunity Staff.

Office of Systems and Management.

Integrity Committee and Conference

Management Staff.

Division of Management Operations.

Division of Information Dissemination.

Division of Information Technology

Management.

Division of Planning, Analysis and

Finance.

Office of Compliance.

Promotion and Advertising Policy Staff.

Division of Bioresearch Monitoring.

Division of Program Operations.

Division of Enforcement I.

Division of Enforcement II.

Division of Enforcement III.

Office of Device Evaluation.

Program Management Staff.

Program Operations Staff.

Division of Cardiovascular and

Respiratory Devices.

Division of Reproductive, Abdominal

and Radiological Devices.

Division of General, Restorative and

Neurological Devices.

Division of Clinical Laboratory Devices.

Division of Ophthalmic, Ear, Nose, and

Throat Devices.

Division of Dental, Infection Control,

and General Hospital Devices.

Office of Science and Technology.

Division of Mechanics and Materials

Science.

Division of Life Sciences.

Division of Physical Sciences.

Division of Electronics and Computer

Sciences.

Division of Management Information

and Support Services.

Office of Health and Industry Programs.

Program Operations Staff.

31022 Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations

17Mailing address: 3900 NCTR Dr., Jefferson, AR

72079.

Regulations Staff.

Staff College.

Division of Device User Programs and

Systems Analysis.

Division of Small Manufacturers

Assistance.

Division of Mammography Quality and

Radiation Programs.

Division of Communication Media.

Office of Surveillance and Biometrics.

Issues Management Staff.

Division of Biostatistics.

Division of Postmarket Surveillance.

Division of Surveillance Systems.

National Center for Toxicological

Research.17

Office of the Center Director.

Environmental Health and Program

Assurance Staff.

Office of Research.

Technology Advancement Staff.

Division of Biochemical Toxicology.

Division of Genetic and Reproductive

Toxicology.

Division of Biometry and Risk

Assessment.

Division of Microbiology.

Division of Chemistry.

Division of Neurotoxicology.

Division of Veterinary Services.

Division of Molecular Epidemiology.

Office of Management.

Office of Management Services.

Division of Facilities, Engineering and

Maintenance.

Division of Administrative Services.

Division of Contracts and Acquisitions.

Office of Planning, Finance and

Information Technology.

Division of Planning.

Division of Financial Management.

Division of Information Technology.

§ 5.1105 Chief Counsel, Food and Drug

Administration.

The Office of the Chief Counsel’s

mailing address is 5600 Fishers Lane,

rm. 6–57, Rockville, MD 20857.

§ 5.1110 Food and Drug Administration

Public Information Offices.

(a) Dockets Management Branch

(HFA–305). The Dockets Management

Branch Public Room is located in rm.

1061, 5630 Fishers Lane, Rockville, MD

20852. Telephone: 301–827–6860.

(b) Freedom of Information Staff

(HFI–35). The Freedom of Information

Public Room is located in rm. 12A–30,

Parklawn Bldg., 5600 Fishers Lane,

Rockville, MD 20857. Telephone: 301–

827–6567.

(c) Press Relations Staff (HFI–40).

Press Offices are located in rm. 15–05,

Parklawn Bldg, 5600 Fishers Lane,

Rockville, MD 20857. Telephone: 301–

827–6242; and in rm. 3807, FB–8, 200

C St. SW., Washington, DC 20204.

Telephone 202–205–4144.

§ 5.1115 Field structure.

NORTHEAST REGION

Regional Field Office: 158–15 Liberty

Ave., Jamaica, NY 11433.

Northeast Regional Laboratory: 158–15

Liberty Ave., Jamaica, NY 11433.

New York District Office: 158–15 Liberty

Ave., Jamaica, NY 11433.

New England District Office: One

Montvale Ave., Stoneham, MA 02180.

Winchester Engineering and Analytical

Center: 109 Holton St., Winchester, MA

01890

CENTRAL REGION

Regional Field Office: U.S.

Customhouse, Second and Chestnut

Sts., rm. 900, Philadelphia, PA 19106.

Philadelphia District Office: U.S.

Customhouse, Second and Chestnut

Sts., rm. 900, Philadelphia, PA 19106.

Baltimore District Office: 900 Madison

Ave., Baltimore, MD 21201–2199.

Cincinnati District Office: 6751 Steger

Dr., Cincinnati, OH 45237–3097.

Forensic Chemistry Center: 6751 Steger

Dr., Cincinnati, OH 45237–3097.

New Jersey District Office: Waterview

Corporate Center, 10 Waterview Blvd.,

3d Floor, Parsippany, NJ 07054.

Chicago District Office: 300 South

Riverside Plaza, suite 550, South

Chicago, IL 60606.

Detroit District Office: 1560 East

Jefferson Ave., Detroit, MI 48207–3179.

Minneapolis District Office: 240

Hennepin Ave., Minneapolis, MN

55401–1912.

SOUTHEAST REGION

Regional Field Office: 60 Eighth St. NE.,

Atlanta, GA 30309.

Southeast Regional Laboratory: 60

Eighth St. NE., Atlanta, GA 30309.

Atlanta District Office: 60 Eighth St.

NE., Atlanta, GA 30309.

New Orleans District Office: Textron

Bldg., 6600 Plaza Dr., suite 400, New

Orleans, LA 70127.

Nashville Branch of NOL-DO: 297 Plus

Park Blvd., Nashville, TN 37217.

Florida District Office: 555 Winderley,

suite 200, Maitland, FL 32751.

San Juan District Office: 466 Fernandez

Juncos Ave., San Juan, PR 00901–3223.

SOUTHWEST REGION

Regional Field Office: 7920 Elmwood

Rd., suite 102, Dallas, TX 75247–4982.

Dallas District Office: 3310 Live Oak St.,

Dallas, TX 75204.

Denver District Office: Bldg. 20, Denver

Federal Center, Sixth and Kipling Sts.,

P.O. Box 25087, Denver, CO 80225–

0087.

Kansas City District Office: 11630 West

80th St., Lenexa, KS 66214–3338.

St. Louis Branch: 12 Sunnen Dr., suite

122, St. Louis, MO 63143–3800.

Arkansas Regional Laboratory: 3900

NCTR Rd., Bldg. 14–T, rm. 104,

Jefferson, AR 72079–9502.

PACIFIC REGION

Regional Field Office: 1301 Clay St.,

suite 1180–N, Oakland, CA 94612–5217.

San Francisco District Office: 1431

Harbor Bay Pkwy., Alameda, CA 94502–

7070.

Los Angeles District Office: 19900 Mac

Arthur Blvd., suite 300, Irvine, CA

92715.

Seattle District Office: P.O. Box 3012,

Bothell, WA 98021–3012.

Pacific Regional Laboratory, SW: 1521

West Pico Blvd., Los Angeles, CA

90015–2488.

Pacific Regional Laboratory, NW: 22201

23rd Dr. SE., Bothell, WA 98021–4421.

Dated: May 30, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

Note: This appendix will not appear in

the Code of Federal Regulations.

Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations 31023

APPENDIX A—PART 5; CORRESPONDING FORMER AND NEW SUBPARTS, SECTION NUMBERS, AND SUBJECTS

Former CFR Subpart, Section No., and Subject New CFR Subpart, Section No., and Subject

Subpart A, § 5.10–Delegations from the Secretary, the Assistant

Secretary for Health, and Public Health Service Officials.

Subpart A, § 5.10–Delegations from the Secretary for Health and

Human Services to the Commissioner of Food and Drugs

Subpart A, § 5.11–Reservation of Authority ............................................. Subpart A, § 5.11–(same subject)

Subpart B, § 5.20–General Redelegations of Authority from the

Commissioner to other officers of FDA..

Subpart B, § 5.20–(same subject)

Subpart B, § 5.21–Emergency functions .................................................. Subpart B, § 5.21–(same subject)

Subpart B, § 5.22–Certification of true copies and use of Department

seal.

Subpart B, § 5.22–(same subject)

Subpart B, § 5.23–Disclosure of official records ....................................... Subpart B, § 5.23–Disclosure of official records and authorization of

testimony

Subpart B, § 5.24–Authority relating to technology transfer ..................... Subpart B, § 5.24–(same subject)

Subpart B, § 5.25–Research, investigation, and testing programs and

health information and health promotion programs.

Subpart B, § 5.25–Research, investigation, and testing programs and

health information and promotion programs

Subpart B, § 5.26–Service fellowships ..................................................... Subpart B, § 5.26–(same subject)

Subpart B, § 5.27–Patent term extensions for human drug products,

medical devices, and food and color additives.

Subpart B, § 5.27–Patent term extensions for human drug products,

medical devices, and food and color additives; and authority to

perform due diligence determinations and informal hearings

Subpart B, § 5.28–Cardiac pacemaker devices and pacemaker leads ... Deleted because the Social Security Act was repealed.

Subpart B, § 5.29–Functions pertaining to safer vaccines ....................... Subpart D, § 5.200–(same subject)

Subpart B, § 5.30–Hearings ...................................................................... Subpart B, § 5.28–(same subject)

Subpart B, § 5.31–Petitions under part 10 ............................................... Subpart B, § 5.29–(same subject)

Subpart B, § 5.32–Authority relating to determination of product primary

jurisdiction.

Subpart I, § 5.700–(same subject)

Subpart B, § 5.33–Premarket approval of a product that is or contains a

biologic, a device, or a drug.

Subpart I, § 5.701–(same subject)

Subpart B, § 5.34–Authority to select temporary voting members for

advisory committees and authority to sign conflict of interest waivers.

Subpart B, § 5.30–(same subject)

Subpart B, § 5.35–Enforcement activities ................................................. Subpart B, § 5.31–(same subject)

Subpart B, § 5.36–Certification following inspections ............................... Subpart B, § 5.32–(same subject)

Subpart B, § 5.37–Issuance of reports of minor violations ....................... Subpart B, § 5.33–(same subject)

Subpart B, § 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.

Subpart C, § 5.109–Issuance of written notices concerning patent

information, current good manufacturing practices and false or

misleading labeling of new drugs.

................................................................................................................... Subpart G, § 5.504–Issuance of written notices concerning patent information, current good manufacturing practices and false or misleading labeling of new animal drugs and feeds bearing or containing new animal drugs.

Subpart B, § 5.39–Redelegation of the Center for Biologics Evaluation

and Research Director’s program authorities.

Subpart D, § 5.201–(same subject)

Subpart B, § 5.40–Issuance of FEDERAL REGISTER documents pertaining

to the determination of safe levels, notice of need for development of

an analytical method, notice of availability of a developed analytical

method, and prohibition of certain extralabel drug use.

Subpart G, § 5.500–(same subject)

Subpart B, § 5.44–Export of unapproved drugs ....................................... Subpart J, § 5.801–(same subject)

Subpart B, § 5.45–Imports and exports .................................................... Subpart J, § 5.800–(same subject)

Subpart B, § 5.46–Manufacturer’s resident import agents ....................... Subpart J, § 5.802–(same subject)

Subpart B, § 5.47–Detention of adulterated or misbranded medical

devices.

Subpart F, § 5.402–(same subject)

Subpart B, § 5.49–Authorization to use alternative evidence for

determination of the effectiveness of medical devices.

Subpart F, § 5.403–(same subject)

Subpart B, § 5.50–Notification to petitioners of determinations made on

petitions for reclassification of medical devices.

Subpart F, § 5.404–(same subject)

Subpart B, § 5.51–Determination of classification of devices .................. Subpart F, § 5.405–(same subject)

Subpart B, § 5.52–Notification to sponsors of deficiencies in petitions

for reclassification of medical devices.

Subpart F, § 5.406–(same subject)

Subpart B, § 5.53–Approval, disapproval, or withdrawal of approval of

product development protocols and applications for premarket

approval for medical devices.

Subpart F, § 5.407–(same subject)

Subpart B, § 5.54–Determinations that medical devices present

unreasonable risk of substantial harm.

Subpart F, § 5.409–(same subject)

Subpart B, § 5.55–Orders to repair or replace, or make refunds for,

medical devices.

Subpart F, § 5.410–(same subject)

Subpart B, § 5.56–Recall authority ........................................................... Subpart F, § 5.411–Medical device recall authority

Subpart B, § 5.57–Temporary suspension of a medical device

application.

Subpart F, § 5.412–(same subject)

Subpart B, § 5.58–Orphan products ......................................................... Subpart K, § 5.900–(same subject)

Subpart B, § 5.59–Approval, disapproval, or withdrawal of approval of

applications for investigational device exemptions.

Subpart F, § 5.413–Approval, disapproval, or withdrawal of approval of

applications and entering into agreements for investigational device

exemptions

Subpart B, § 5.60–Required and discretionary postmarket surveillance .. Subpart F, § 5.414–Postmarket surveillance (proposed subject)

31024 Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations

APPENDIX A—PART 5; CORRESPONDING FORMER AND NEW SUBPARTS, SECTION NUMBERS, AND SUBJECTS—Continued

Former CFR Subpart, Section No., and Subject New CFR Subpart, Section No., and Subject

Subpart B, § 5.61–Food standards, food additives, generally recognized

as safe (GRAS) substances, color additives, nutrient content claims,

and health claims.

Subpart E, § 5.300–(same subject)

Subpart B, § 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.

Subpart E, § 5.301–(same subject)

Subpart B, § 5.63–Detention of meat, poultry, eggs, and related

products.

Subpart E, § 5.302–(same subject)

Subpart B, § 5.64–Establishing standards and approving accrediting

bodies under the National Laboratory Accreditation Program.

Subpart E, § 5.303–(same subject)

Subpart B, § 5.66–Approval of schools providing food-processing

instruction.

Subpart E, § 5.304–(same subject)

Subpart B, § 5.67–Issuance of notices of opportunity for a hearing on

proposals for denial of approval of applications for licenses,

suspension of licenses, or revocation of licenses and certain notices

of revocation of licenses.

Subpart D, § 5.202–(same subject)

Subpart B, § 5.68–Issuance and revocation of licenses for the

propagation or manufacture and preparation of biological products.

Subpart D, § 5.203–(same subject)

Subpart B, § 5.69–Notification of release for distribution of biological

products.

Subpart D, § 5.204–(same subject)

Subpart B, § 5.70–Issuance of notices implementing the provisions of

the Drug Amendments of 1962.

Subpart C, § 5.100–(same subject)

Subpart B, § 5.71–Termination of exemptions for new drugs for

investigational use in human beings and in animals (Note: § 5.71(d)

is under animal drugs).

Subpart C, § 5.101–(same subject)

................................................................................................................... Subpart G, § 5.505–(same subject)

Subpart B, § 5.72–Authority to approve and to withdraw approval of a

charge for investigational new drugs.

Subpart C, § 5.102–(same subject)

Subpart B, § 5.75–Removed, effective 5/20/99 ........................................ None

Subpart B, 5.76–Removed, effective 5/20/99 ........................................... None

Subpart B, § 5.78–Removed, effective 5/20/99 ........................................ None

Subpart B, § 5.80–Approval of new drug applications and their

supplements.

Subpart C, § 5.103–(same subject)

Subpart B, § 5.81–Responses to Drug Enforcement Administration

temporary scheduling notices.

Subpart C, § 5.104–(same subject)

Subpart B, § 5.82–Issuance of notices relating to proposals to refuse

approval or to withdraw approval of new drug applications and their

supplements.

Subpart C, § 5.105–(same subject)

Subpart B, § 5.83–Approval of new animal drug applications, medicated

feed mill license applications and their supplements.

Subpart G, § 5.501–(same subject)

Subpart B, § 5.84–Issuance of notices, proposals, and orders relating to

new animal drugs and medicated feed mill license applications.

Subpart G, § 5.502–(same subject)

Subpart B, § 5.85–Authority to ensure that mammography facilities

meet quality standards.

Subpart L, § 5.1000–(same subject)

Subpart B, § 5.86–Variances from performance standards for electronic

products.

Subpart H, § 5.600–(same subject)

Subpart B, § 5.87–Exemption of electronic products from performance

standards and prohibited acts.

Subpart H, § 5.601–(same subject)

Subpart B, § 5.88–Testing programs and methods of certification and

identification for electronic products.

Subpart H, § 5.602–(same subject)

Subpart B, § 5.89–Notification of defects in, and repair or replacement

of, electronic products.

Subpart H, § 5.603–(same subject)

Subpart B, § 5.90–Manufacturers requirement to provide data to

ultimate purchasers of electronic products.

Subpart H, § 5.604–(same subject)

Subpart B, § 5.91–Dealer and distributor direction to provide data to

manufacturers of electronic products.

Subpart H, § 5.605–(same subject)

Subpart B, § 5.92–Acceptance of assistance from State and Local

authorities for enforcement of radiation control legislation and

regulations.

Subpart H, § 5.606–(same subject)

Subpart B, § 5.93–Submission of and effective approval dates for

abbreviated new drug applications and certain new drug applications.

Subpart C, § 5.106–(same subject)

Subpart B, § 5.94–Extensions or stays of effective dates for compliance

wit certain labeling requirements for human prescription drugs.

Subpart C, § 5.107–(same subject)

Subpart B, § 5.95–Submission of and effective approval dates for

abbreviated new animal drug applications and certain new animal

drug applications.

Subpart G, § 5.503–(same subject)

Subpart B, § 5.98–Authority relating to medical device reporting

procedures.

Subpart F, § 5.415–(same subject)

Subpart B, § 5.99–Issuance of notices relating to proposals and orders

for debarment and denial of an application to terminate debarment.

Subpart B, § 5.34–(same subject)

Subpart B, § 5.100–Officials authorized to make certification under 5

U.S.C. 605(b) for any proposed and final rules.

Subpart B, § 5.35–(same subject)

Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules and Regulations 31025

APPENDIX A—PART 5; CORRESPONDING FORMER AND NEW SUBPARTS, SECTION NUMBERS, AND SUBJECTS—Continued

Former CFR Subpart, Section No., and Subject New CFR Subpart, Section No., and Subject

Subpart B, § 5.101–Authority relating to waivers or reductions of

prescription drug user fees.

Subpart C, § 5.108–(same subject)

Subpart C, § 5.200 through § 5.215–Organization ................................... Subpart M, § 5.1100–(same subject)

New–Not previously codified .................................................................... Subpart F, § 5.416–Medical device tracking

New–Not previously codified .................................................................... Subpart F, § 5.400–Issuance of FEDERAL REGISTER documents to

recognize or to withdraw recognition of a standard to meet premarket submission requirements

New–Not previously codified .................................................................... Subpart F, § 5.401–Issuance of FEDERAL REGISTER documents pertaining to exemptions from premarket notification.

New–Not previously codified .................................................................... Subpart F, § 5.408–Determinations concerning the type of valid

scientific evidence submitted in a premarket approval application.

New–Not previously codified .................................................................... Subpart F, § 5.417–Authority pertaining to accreditation functions for

medical devices.

[FR Doc. 01–14294 Filed 6–7–01; 8:45 am]

BILLING CODE 4160–01–S