[Federal Register Volume 61, Number 17 (Thursday, January 25, 1996)]
[Proposed Rules]
[Pages 2192-2194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1142]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 2, 10, and 50

[Docket No. 95N-0340]
RIN 0910-AA54


Revocation of Certain Regulations; General

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to revoke 
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.

DATES: Written comments by April 24, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

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outdated or otherwise in need of reform.'' This proposal, which would 
revoke certain obsolete and unnecessary regulations, represents FDA's 
continuing effort to implement the President's plan. In previous issues 
of the Federal Register, FDA proposed revoking or revising other 
regulations, and the agency expects to issue future reinvention 
proposals in upcoming issues.
    The following is a section-by-section analysis of the regulations 
that FDA is proposing to revoke. These regulations are listed 
numerically as they appear in 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 is obsolete. The agency is not aware of its use.

[[Page 2193]]

    (2) Section 1.35 ``Cents-off,'' or other savings representations 
(21 CFR 1.35), is obsolete. The agency is not aware of its use.
    (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 on July 1, 1971 (36 FR 12516). FDA proposed to revoke 
Sec. 2.5 on 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's) determination of imminent hazard. The 1979 
proposed rulemaking was withdrawn 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 were established in 1977 
in the Secretary's decision declaring phenformin hydrochloride an 
imminent hazard. This decision was upheld in Forsham v. Califano, 442 
F.Supp. 203 (D.D.C. 1977). The agency is proposing to revoke Sec. 2.5 
because it is potentially confusing and no longer necessary.
    (4) 21 CFR part 10, subpart C--Electronic Media Coverage of Public 
Administrative Proceedings; Guideline on Policy and Procedures is 
intended to clarify and explain FDA's policy on the presence and 
operation of electronic recording equipment at public proceedings. This 
is a statement of policy and need not be codified. This 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.
    (5) Section 50.21 Effective date (21 CFR 50.21), states 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 proposes to revoke this provision because it is no longer 
necessary. The agency is unaware of any continuing clinical 
investigations that were begun before July 27, 1981, to warrant 
retaining this provision.
    (6) 21 CFR part 50, subpart C--Protections Pertaining to Clinical 
Investigations Involving Prisoners as Subjects describes restrictions 
on clinical investigations involving prisoners, including special 
requirements for institutional review boards reviewing clinical 
investigations involving prisoners. On July 7, 1981 (46 FR 35085), the 
agency stayed the effective date of the subpart C regulations. Because 
the agency has never made the subpart C regulations effective, it now 
proposes to revoke subpart C.

II. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
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 proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The proposed rule, if finalized, would simply 
eliminate certain regulatory provisions that the agency has not used or 
that have become obsolete. Consequently, the proposed rule would not 
impose any additional regulatory burdens on 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.

IV. Request for Comments

    Interested persons may, on or before April 24, 1996, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

-List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 2

    Administrative practice and procedure, Cosmetics, Devices, Drugs, 
Foods.

21 CFR Part 10

    Administrative practice and procedure, News media.

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, it is 
proposed that 21 CFR parts 1, 2, 10, and 50 be 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 2--GENERAL ADMINISTRATIVE RULINGS AND DECISIONS

    -4. The authority citation for 21 CFR part 2 continues to read as 
follows:

    -Authority: Secs. 201, 301, 305, 402, 408, 409, 501, 502, 505, 
507, 512, 601, 701, 702, 704 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321, 331, 335, 342, 346a, 348, 351, 352, 355, 357, 
360b, 361, 371, 372, 374); 15 U.S.C. 402, 409.

Sec.  2.5   [Removed]-

    5. Section 2.5 Imminent hazard to the public health is removed from 
subpart A.

[[Page 2194]]


PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

    -6. The authority citation for 21 CFR part 10 continues to read as 
follows:

    Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321-394); 21 U.S.C. 41-50, 141-149, 467f, 679, 821, 
1034; secs. 2, 351, 354, 361 of the Public Health Service Act (42 
U.S.C. 201, 262, 263b, 264); secs. 2-12 of the Fair Packaging and 
Labeling Act (15 U.S.C. 1451-1461); 5 U.S.C. 551-558, 701-721; 28 
U.S.C. 2112.

Subpart C   [Removed]

    7. Subpart C consisting of Secs. 10.200 through 10.206 is removed.

PART 50--PROTECTION OF HUMAN SUBJECTS

    8. 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]

    9. Section 50.3 Definitions is amended by removing paragraph (j), 
and redesignating paragraphs (k), (l), and (m) as paragraphs (j), (k), 
and (l), respectively.


Sec. 50.21  [Removed]

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


Subpart C  [Removed]

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


    Dated: January 18, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-1142 Filed 1-24-96; 8:45 am]
BILLING CODE 4160-01-F