Document ID: FDA-2014-N-0355-0001
Agency: fda
Document Type: Rule
Title: Advisory Committee: Bone, Reproductive and Urologic Drugs
Advisory Committee
Posted Date: 2014-04-11T04:00Z

[Federal Register Volume 79, Number 70 (Friday, April 11, 2014)]
[Rules and Regulations]
[Pages 20094-20095]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08151]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

[Docket No. FDA-2014-N-0355]

Advisory Committee: Bone, Reproductive and Urologic Drugs 
Advisory Committee

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 
function of the Advisory Committee for Reproductive Health Drugs. This 
action is being taken to reflect changes made to the charter for this 
advisory committee.

DATES: This rule is effective April 11, 2014.

FOR FURTHER INFORMATION CONTACT: Teresa Hays, Committee Management 
Officer, Food and Drug Administration, 10903 New Hampshire Ave., Silver 
Spring, MD 20993, 301-796-8220.

SUPPLEMENTARY INFORMATION: FDA is announcing that the name of the 
Advisory Committee for Reproductive Health Drugs, which was established 
on March 23, 1978, has been changed. The Agency decided that the name 
``Bone, 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 osteoporosis and metabolic bone disease, 
obstetrics, gynecology, urology and related specialties, and makes 
appropriate recommendations to the Commissioner of Food and Drugs.
    The Bone, Reproductive and Urologic Drugs Advisory Committee name 
was changed and its functions expanded in the charter renewal dated 
March 23, 2014. 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) 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

[[Page 20095]]

interest because the final rule is merely codifying the new name and 
expanded 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 21 CFR 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 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) Bone, Reproductive and Urologic Drugs Advisory Committee.
    (i) * * *
    (ii) Function: Advises the Commissioner or designee in discharging 
responsibilities as they relate to helping to ensure safe and effective 
drugs for human use and, as required, any other product for which the 
Food and Drug Administration has regulatory responsibility.
* * * * *

    Dated: April 8, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-08151 Filed 4-10-14; 8:45 am]
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