[Federal Register Volume 62, Number 141 (Wednesday, July 23, 1997)]
[Rules and Regulations]
[Pages 39439-39440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19248]


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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outdated or otherwise in need of reform.''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