[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outdated or otherwise in need of reform.''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
