[Federal Register Volume 61, Number 108 (Tuesday, June 4, 1996)]
[Rules and Regulations]
[Pages 28047-28048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13978]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 14
Advisory Committee; Change of Name and Function
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the
standing advisory committees' regulations to change the name and the
function of the Fertility and Maternal Health Drugs Advisory Committee.
This action is being taken to more accurately describe this committee.
EFFECTIVE DATE: June 4, 1996.
FOR FURTHER INFORMATION CONTACT: Donna M. Combs, Committee Management
Office (HFA-306), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-443-2765.
SUPPLEMENTARY INFORMATION: FDA is announcing that the name of the
Fertility and Maternal Health Drugs Advisory Committee has been
changed. After reestablishment of this committee, on March 23, 1978,
the agency decided that the name ``Advisory Committee for Reproductive
Health Drugs'' would more accurately describe the subject areas for
which the committee is responsible. The mandate of the committee has
expanded significantly in recent years to include drugs for menopausal
women and drugs used in the practice of andrology. The change is
consistent with the growing use of this term by specialists in the
field of reproductive health, which includes obstetrics, gynecology,
endocrinology,
[[Page 28048]]
andrology, epidemiology, and related specialties. The committee reviews
and evaluates data on the safety and effectiveness of marketed and
investigational human drugs for use in the practice of obstetrics,
gynecology, and related specialties.
The Fertility and Maternal Health Drugs Advisory Committee's name
was changed in the charter renewal dated March 23, 1996. In this
document, FDA is hereby formally changing the name and the function of
the committee by revising 21 CFR 14.100(c)(9).
Publication of this final rule constitutes a final action on this
change under the Administrative Procedure Act. Under 5 U.S.C.
553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), the agency finds good
cause to dispense with notice and public procedure and to proceed to an
immediately effective regulation. Such notice and procedures are
unnecessary and are not in the public interest, because the final rule
is merely a clarifying amendment to existing regulations and when
effective will reflect the current committee charter. -
List of Subjects in 21 CFR Part 14
Administrative practice and procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
14 is amended as follows:
PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
1. The authority citation for 21 CFR part 14 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. App. 2; 28 U.S.C. 2112.
2. Section 14.100 is amended by revising the heading of paragraph
(c)(9) and paragraph (c)(9)(ii) to read as follows:
Sec. 14.100 List of standing advisory committees.
* * * * *
(c) * * *
(9) Advisory Committee for Reproductive Health Drugs.
* * * * *
(ii) Function: Reviews and evaluates data on the safety and
effectiveness of marketed and investigational human drugs for use in
the practice of obstetrics, gynecology, and related specialties.
* * * * *
Dated: May 28, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-13978 Filed 6-3-96; 8:45 am]
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