Document ID: FDA-2019-N-4203-0034
Agency: fda
Document Type: Rule
Title: Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee; Change of Name and Function; Technical Amendment
Posted Date: 2022-03-23T04:00Z

[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 [www.gpo.gov]
[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

0
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.

0
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]
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