[Federal Register Volume 61, Number 113 (Tuesday, June 11, 1996)]
[Rules and Regulations]
[Pages 29476-29477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14587]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration-
21 CFR Parts 200, 250, and 310
[Docket No. 95N-0310]
Revocation of Obsolete Regulations
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 are no longer necessary to achieve
public health goals. These regulations were among those identified for
revocation in a page-by-page review conducted 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: July 11, 1996.
FOR FURTHER INFORMATION CONTACT: Christine F. Rogers, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-2041.
SUPPLEMENTARY INFORMATION:
I. Background-
In the Federal Register of October 13, 1995 (60 FR 53480), FDA
published a proposed rule to revoke certain regulations. This was done
in response to the President's order to all Federal agencies to conduct
a page-by-page review of all their regulations and to ``eliminate or
revise those that are outdated or otherwise in need of reform.'' The
proposed rule contained a section-by-section analysis of all the
regulations (21 CFR parts 100, 101, et al.) that FDA intended to
revoke. This final rule pertains only to those regulations (21 CFR
parts 200, 250, and 310) pertaining exclusively to the Center for Drug
Evaluation and Research. No comments were received in response to the
proposal to revoke these regulations.
II. Analysis of Impacts
FDA has examined the impacts of the final 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 final rule, which is the revocation of certain regulations that
are obsolete or are no longer necessary, is consistent with the
regulatory philosophy and principles identified in the Executive Order.
In addition, the final 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. Because this final rule is the revocation of certain
regulations that are obsolete or are no longer necessary, the agency is
not aware of any adverse impact this final rule will have on any small
entities, and the agency certifies that the 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)(9) 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 200
Drugs, Prescription drugs.
21 CFR Part 250
Drugs.
21 CFR Part 310
Administrative practice and procedure, Drugs, Labeling, Medical
devices, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) and under authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 200, 250, and 310 are amended as
follows:
PART 200--GENERAL
1. The authority citation for 21 CFR part 200 continues to read as
follows:
-Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 508,
515, 701, 704, 705 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 358, 360e, 371, 374,
375).
2. Sections 200.100 and 200.101 are removed and the heading for
subpart D is reserved.
PART 250--SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS
3. The authority citation for 21 CFR part 250 continues to read as
follows:
-Authority: Secs. 201, 306, 402, 502, 503, 505, 601(a), 602(a)
and (c), 701, 705(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321, 336, 342, 352, 353, 355, 361(a), 362(a) and (c), 371,
375(b)).
Sec. 250.104 [Removed]
4. Section 250.104 Status of salt substitutes under the Federal
Food, Drug, and Cosmetic Act is removed.
Sec. 250.203 [Removed]
5. Section 250.203 Status of fluoridated water and foods prepared
with fluoridated water is removed.
PART 310--NEW DRUGS
6. The authority citation for 21 CFR part 310 continues to read as
follows:
-Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 512-
516, 520, 601(a), 701, 704, 705, 721 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357,
360b-360f, 360j, 361(a), 371, 374, 375, 379e); secs. 215, 301,
302(a), 351, 354-360F of the Public Health Service Act (42 U.S.C.
216, 241, 242(a), 262, 263b-263n).
Sec. 310.101 [Removed]
7. Section 310.101 FD&C Red No. 4; procedure for discontinuing use
in new drugs for ingestion; statement of policy is removed.
[[Page 29477]]
Sec. 310.304 [Removed]
8. Section 310.304 Drugs that are subjects of approved new drug
applications and that require special studies, records, and reports is
removed.
Dated: June 3, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-14587 Filed 6-10-96; 8:45 am]
BILLING CODE 4160-01-F