[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]



-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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revise those that are outdated or otherwise in need of reform.''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.

<SKIP PAGES = 001>


[[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