Rule2022-05965
Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee; Change of Name and Function; Technical Amendment
Primary source
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Published
March 23, 2022
Effective
March 23, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is amending the standing advisory committees' regulations to change the name and function of the Bone, Reproductive and Urologic Drugs Advisory Committee. This action is being taken to reflect changes made to the charter for this advisory committee.
Full Text
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<title>Federal Register, Volume 87 Issue 56 (Wednesday, March 23, 2022)</title>
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[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Rules and Regulations]
[Pages 16393-16394]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-05965]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 14
[Docket No. FDA-2019-N-4203]
Advisory Committee; Bone, Reproductive and Urologic Drugs
Advisory Committee; Change of Name and Function; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is amending
the standing advisory committees' regulations to change the name and
function of the Bone, Reproductive and Urologic Drugs Advisory
Committee. This action is being taken to reflect changes made to the
charter for this advisory committee.
DATES: This rule is effective March 23, 2022. The changes are
applicable March 23, 2022.
FOR FURTHER INFORMATION CONTACT: Teresa Hays, Committee Management
Officer, Food and Drug Administration,
[[Page 16394]]
10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-8220.
SUPPLEMENTARY INFORMATION: FDA is announcing that the name of the Bone,
Reproductive and Urologic Drugs Advisory Committee, which was
established on March 23, 1978, has been changed. The Agency decided
that the name ``Obstetrics, Reproductive and Urologic Drugs Advisory
Committee'' more accurately describes the subject areas for which the
committee is responsible. The committee reviews and evaluates data on
the safety and effectiveness of marketed and investigational human drug
products for use in the practice of obstetrics, gynecology, urology and
related specialties, and makes appropriate recommendations to the
Commissioner of Food and Drugs. The mandate of the committee no longer
includes osteoporosis and metabolic bone disease. As osteoporosis and
metabolic bone diseases are topics related to endocrinology and
metabolic disease, these will be discussed by the Endocrinologic and
Metabolic Drugs Advisory Committee.
The Obstetrics, Reproductive and Urologic Drugs Advisory Committee
name was changed, and its functions changed in the charter renewal
dated March 23, 2022. In this final rule, FDA is revising 21 CFR
14.100(c)(9) to reflect these changes.
Publication of this final rule constitutes a final action on this
change under the Administrative Procedure Act. Under 5 U.S.C. 553(b)(B)
and (d)(3) and 21 CFR 10.40(d) and (e)(1), 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 codifying the new name and the function of the advisory
committee to 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
the 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
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1. The authority citation for part 14 continues to read as follows:
Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-
50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155; Pub.
L. 113-54.
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2. Section 14.100 is amended by revising paragraph (c)(8) heading and
paragraph (c)(8)(ii) to read as follows:
Sec. 14.100 List of standing advisory committees.
* * * * *
(c) * * *
(8) Obstetrics, Reproductive and Urologic Drugs Advisory Committee.
* * * * *
(ii) Function: The committee reviews and evaluates data on the
safety and effectiveness of marketed and investigational human drug
products for use in the practice of obstetrics, gynecology, urology and
related specialties, and makes appropriate recommendations to the
Commissioner of Food and Drugs.
* * * * *
Dated: March 16, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation, and International Affairs,
U.S. Food and Drug Administration.
[FR Doc. 2022-05965 Filed 3-22-22; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on March 23, 2022.
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