[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outdated or otherwise in need of reform.''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