Revocation of Certain Regulations; General

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1 and 50

[Docket No. 95N-0340]

RIN 0910-AA54

Revocation of Certain Regulations; General

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is revoking certain

regulations that are obsolete or no longer necessary to achieve public

health goals. These regulations have been identified for revocation as

the result of a page-by-page review of the agency's regulations. This

regulatory review is in response to the Administration's ``Reinventing

Government'' initiative which seeks to streamline government to ease

the burden on regulated industry and consumers.

EFFECTIVE DATE: August 22, 1997.

FOR FURTHER INFORMATION CONTACT:

Regarding the regulations mentioned in this document: Philip L.

Chao, Policy Development and Coordination Staff (HF-23), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3380.

Regarding general information on FDA's ``reinventing initiative:''

Lisa M. Helmanis, Regulations Policy Management Staff (HF-26), Food and

Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-

3480.

SUPPLEMENTARY INFORMATION: On March 4, 1995, President Clinton

announced plans for reforming the Federal regulatory system as part of

his ``Reinventing Government'' initiative. In his March 4 directive,

the President ordered all Federal agencies to conduct a page-by-page

review of their regulations and to ``eliminate or revise those that are

outdated or otherwise in need of reform.'' In the Federal Register of

January 25, 1996 (61 FR 2192), FDA issued a proposal to revoke certain

obsolete and unnecessary regulations. The proposal represented FDA's

continuing effort to implement the President's plan and followed other

proposals in previous issues of the Federal Register revoking or

revising other FDA regulations.

The following is a section-by-section analysis of the regulations

that FDA proposed to revoke and any comments or issues associated with

those regulations. These regulations are listed numerically as they

appear in title 21 of the Code of Federal Regulations (CFR).

I. Section-by-Section Analysis

(1) Section 1.31 Package size saving (21 CFR 1.31) addressing

economy size packaging. FDA proposed to revoke this provision because

it is obsolete, and FDA is not aware of its recent use.

FDA received one comment on this provision, and the comment

expressed no objection to revoking this provision. Consequently,

Sec. 1.31 is revoked.

(2) Section 1.35 ``Cents-off,'' or other savings representations

(21 CFR 1.35) prohibiting the placement of any printed matter stating

or representing by implication that a product is offered for sale at a

price that is lower than the ordinary and customary retail price. FDA

proposed to revoke this provision because it is obsolete, and FDA is

not aware of its recent use.

FDA received one comment on this provision, and the comment

expressed no objection to revoking this provision. Consequently, the

agency has revoked Sec. 1.35.

(3) Section 2.5 Imminent hazard to the public health (21 CFR 2.5)

describes the criteria that the Commissioner of Food and Drugs would

use in determining whether an imminent hazard exists. FDA issued this

regulation in the Federal Register of July 1, 1971 (36 FR 12516). FDA

proposed to revoke Sec. 2.5 in the Federal Register of August 21, 1979

(44 FR 48983), in conjunction with broader rulemaking proceedings that

would have established by regulation, among other things, certain

criteria for the Secretary of Health and Human Services' (the

Secretary) determination of an imminent hazard. FDA later withdrew the

1979 proposed rule on January 20, 1994 (59 FR 3042). However, the

principle upon which FDA based its proposed withdrawal of Sec. 2.5 in

1979 is still valid, namely, that it is ``potentially confusing to have

criteria for FDA's recommendations to the Secretary separate from the

criteria for the Secretary's decision'' (44 FR 48983 at 48985). The

criteria used by the Secretary in finding an imminent hazard were

established in 1977 in the Secretary's decision declaring phenformin

hydrochloride to be an imminent hazard. This decision was upheld in

Forsham v. Califano, 442 F.Supp. 203 (D. D.C. 1977). Consequently, FDA

again proposed to revoke Sec. 2.5 because it is potentially confusing

and no longer necessary (61 FR 2192).

The agency did not receive any comments on the proposal to revoke

Sec. 2.5. However, upon further reflection, FDA has decided to retain

Sec. 2.5 because the terms ``imminent hazard'' appear in several

provisions of the Federal Food, Drug, and Cosmetic Act (the act) and

its implementing regulations (see, e.g., section 402(f)(1)(C) of the

act ( 21 U.S.C. 342(f)(1)(C)) (concerning adulteration of dietary

supplements); section 512(e)(1) of the act (21 U.S.C. 360b(e)(1))

concerning withdrawals of approval of animal drugs); section 802(f) of

the act (21 U.S.C. 382(f)) (concerning prohibition of exports); 21 CFR

314.153(a)(1) (suspension of approval of abbreviated new drug

applications); 21 CFR 804.28(b)(3) (medical device reporting for

distributors)). Therefore, to continue providing guidance in

interpreting these and other provisions in the act and FDA regulations,

the agency is retaining Sec. 2.5.

(4) 21 CFR part 10, subpart C, Electronic Media Coverage of Public

Administrative Proceedings; Guideline on Policy and Procedures,

described FDA's policy on the presence and operation of electronic

recording equipment at public proceedings. The preamble to the proposed

rule explained that the subpart ``is a statement of policy and need not

be codified. The information is available to those presiding over such

proceedings through appropriate agency publications (e.g., Policy and

Guidance Handbook for FDA Advisory Committee Members' and from the

staff in FDA's Office of Public Affairs'' (61 FR 2192 and 2193).

FDA received one comment arguing against deleting the subpart. The

comment explained that ``policy can

[[Page 39440]]

change more readily than regulations or guidelines'' so that ``the

freedom to electronically cover public meetings is too important to be

changed only as a result of internal Agency deliberation * * * if this

policy is to be modified, it should be done so only in accordance with

standard rule-making procedures, with a public comment period on the

specific changes * * *.''

FDA has decided to retain subpart C even though the agency

continues to maintain that guidelines and policy statements neither

need to be codified in the CFR nor issued through notice and comment

rulemaking. FDA is retaining subpart C in its regulations because, on

rare occasions, the agency has cited provisions in subpart C to address

certain issues, such as whether cameras are allowed at a particular

meeting. The fact that subpart C is a regulation, and therefore more

binding than a guideline, has also made it easier for interested

parties to read and to adhere to FDA's decisions on electronic media at

a public meeting.

Furthermore, FDA fully intends to seek public participation in the

initiation, development, and issuance of guidance documents and is

taking steps to improve its guidance document procedures (see 62 FR

8961, February 27, 1997 (establishing ``good guidance practices'')).

Improved guidance document procedures should address the comment's

principal concern that the public should have the opportunity to

comment on changes to guidance documents.

(5) Section 50.21 Effective date (21 CFR 50.21) stated that the

informed consent requirements in part 50 ``apply to all human subjects

entering a clinical investigation that commences on or after July 27,

1981.'' FDA proposed to revoke this provision because it is no longer

necessary. The preamble to the proposed rule explained that FDA is

unaware of any continuing clinical investigations that were begun

before July 27, 1981, to warrant retaining this provision.

FDA received no comments on this provision and has revoked

Sec. 50.21.

(6) 21 CFR part 50, subpart C, Protections Pertaining to Clinical

Investigations Involving Prisoners as Subjects, described restrictions

on clinical investigations involving prisoners, including special

requirements for institutional review boards reviewing clinical

investigations involving prisoners. In the Federal Register of July 7,

1981 (46 FR 35085), FDA stayed the effective date of the subpart C

regulations and never made them effective. Consequently, the January

25, 1996, proposed rule would revoke the subpart C regulations.

FDA received no comments on this subpart and has revoked subpart C

of part 50 as well as the definition of ``prisoner'' at Sec. 50.3(j)

and renumbered the remaining definitions accordingly.

II. Analysis of Impacts

FDA has examined the impacts of the final rule under Executive

Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).

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). The agency believes that

this final rule is consistent with the regulatory philosophy and

principles set out in the Executive Order. In addition, the rule is not

a significant regulatory action as defined in Executive Order 12866.

Unless the agency certifies that a rule will not have a significant

economic impact on a substantial number of small entities, the

Regulatory Flexibility Act requires the agency to analyze regulatory

options that would minimize any significant impact of a rule on small

entities. This final rule eliminates certain regulatory provisions that

the agency has not used or made effective or that have become obsolete.

Consequently, the agency certifies that this final rule will not have a

significant economic impact on a substantial number of small entities.

Therefore, under the Regulatory Flexibility Act, no further analysis is

required.

III. Environmental Impact

The agency has determined under 21 CFR 25.24(a)(8) that this action

is of a type that does not individually or cumulatively have a

significant effect on the human environment. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

List of Subjects

21 CFR Part 1

Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,

Reporting and recordkeeping requirements.

21 CFR Part 50

Human research subjects, Prisoners, Reporting and recordkeeping

requirements, Safety.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, 21 CFR parts

1 and 50 are amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

1. The authority citation for 21 CFR part 1 continues to read as

follows:

Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act

(15 U.S.C. 1453, 1454, 1455); secs. 201, 403, 502, 505, 512, 602,

701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 343,

352, 355, 360b, 362, 371); sec. 215 of the Public Health Service Act

(42 U.S.C. 216).

Sec. 1.31 [Removed]

2. Section 1.31 Package size savings is removed from subpart B.

Sec. 1.35 [Removed]

3. Section 1.35 ``Cents-off,'' or other savings representations is

removed from subpart B.

PART 50--PROTECTION OF HUMAN SUBJECTS

4. The authority citation for 21 CFR part 50 continues to read as

follows:

Authority: Secs. 201, 406, 408, 409, 502, 503, 505, 506, 507,

510, 513-516, 518-520, 701, 721, 801 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 346, 346a, 348, 352, 353, 355, 356,

357, 360, 360c-360f, 360h-360j, 371, 379e, 381); secs. 215, 301,

351, 354-360F of the Public Health Service Act (42 U.S.C. 216, 241,

262, 263b-263n).

Sec. 50.3 [Amended]

5. Section 50.3 Definitions is amended by removing paragraph (j),

and redesignating paragraphs (k), (l), (m) and (n) as paragraphs (j),

(k), (l) and (m), respectively.

Sec. 50.21 [Removed]

6. Section 50.21 Effective date is removed from subpart B.

Subpart C [Removed]

7. Subpart C consisting of Secs. 50.40 through 50.48 is removed.

Dated: July 14, 1997.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 97-19248 Filed 7-22-97; 8:45 am]

BILLING CODE 4160-01-F