83 FR 15576 - Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 70 (April 11, 2018)

Page Range		15576-15576
FR Document		2018-07437

The Food and Drug Administration (FDA) is announcing the renewal of the Bone, Reproductive and Urologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Bone, Reproductive and Urologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until March 23, 2020.

Federal Register, Volume 83 Issue 70 (Wednesday, April 11, 2018)

[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Page 15576]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-07437]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4561]

Advisory Committee; Bone, Reproductive and Urologic Drugs
Advisory Committee, Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Bone, Reproductive and Urologic Drugs Advisory Committee
by the Commissioner of Food and Drugs (the Commissioner). The
Commissioner has determined that it is in the public interest to renew
the Bone, Reproductive and Urologic Drugs Advisory Committee for an
additional 2 years beyond the charter expiration date. The new charter
will be in effect until March 23, 2020.

DATES: Authority for the Bone, Reproductive and Urologic Drugs Advisory
Committee will expire on March 23, 2020, unless the Commissioner
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, Division of Advisory
Committee and Consultant Management, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, email:
BRUDAC@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Bone, Reproductive and Urologic Drugs Advisory Committee
(the Committee). The Committee is a discretionary Federal advisory
committee established to provide advice to the Commissioner.
The Committee 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 FDA
has regulatory responsibility.
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.
The Committee shall consist of a core of 11 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of osteoporosis and metabolic bone disease, obstetrics,
gynecology, urology, pediatrics, epidemiology, or statistics and
related specialties. Members will be invited to serve for overlapping
terms of up to 4 years. Almost all non-Federal members of this
committee serve as Special Government Employees. The core of voting
members may include one technically qualified member, selected by the
Commissioner or designee, who is identified with consumer interests and
is recommended by either a consortium of consumer-oriented
organizations or other interested persons. In addition to the voting
members, the Committee may include one non-voting member who is
identified with industry interests.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/ucm107572.htm or by contacting
the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT).
In light of the fact that no change has been made to the committee name
or description of duties, no amendment will be made to 21 CFR 14.100.
This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.

Dated: April 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07437 Filed 4-10-18; 8:45 am]
BILLING CODE 4164-01-P

15576 Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices

Dated: March 16, 2018. discharging responsibilities as they DEPARTMENT OF HEALTH AND
Seema Verma, relate to helping to ensure safe and HUMAN SERVICES
Administrator, Centers for Medicare & effective drugs for human use and, as
Medicaid Services. required, any other product for which Food and Drug Administration
Dated: April 5, 2018. FDA has regulatory responsibility. [Docket No. FDA–2018–N–0981]
Alex M. Azar II, The Committee reviews and evaluates
Secretary, Department of Health and Human data on the safety and effectiveness of Preparation for International
Services. marketed and investigational human Cooperation on Cosmetics Regulation
[FR Doc. 2018–07410 Filed 4–10–18; 8:45 am] Twelfth Annual Meeting; Public
drug products for use in the practice of
BILLING CODE 4120–01–P Meeting
osteoporosis and metabolic bone
disease, obstetrics, gynecology, urology, AGENCY: Food and Drug Administration,
and related specialties, and makes HHS.
DEPARTMENT OF HEALTH AND
appropriate recommendations to the ACTION: Notice of public meeting.
HUMAN SERVICES
Commissioner.
SUMMARY: The Food and Drug
Food and Drug Administration The Committee shall consist of a core Administration (FDA or we) is
[Docket No. FDA–2017–N–4561] of 11 voting members including the announcing the following public
Chair. Members and the Chair are meeting entitled ‘‘International
Advisory Committee; Bone, selected by the Commissioner or Cooperation on Cosmetics Regulation
Reproductive and Urologic Drugs designee from among authorities (ICCR)—Preparation for ICCR–12
Advisory Committee, Renewal knowledgeable in the fields of Meeting.’’ The purpose of the public
osteoporosis and metabolic bone meeting is to invite public input on
AGENCY: Food and Drug Administration,
HHS. disease, obstetrics, gynecology, urology, various topics pertaining to the
pediatrics, epidemiology, or statistics regulation of cosmetics. We may use
ACTION: Notice; renewal of advisory
and related specialties. Members will be this input to help us prepare for the
committee.
invited to serve for overlapping terms of ICCR–12 meeting that will be held July
SUMMARY: The Food and Drug up to 4 years. Almost all non-Federal 10 to 12, 2018, in Tokyo, Japan.
Administration (FDA) is announcing the members of this committee serve as DATES: The public meeting will be held
renewal of the Bone, Reproductive and Special Government Employees. The on June 7, 2018, from 2 p.m. to 4 p.m.
Urologic Drugs Advisory Committee by core of voting members may include one See the SUPPLEMENTARY INFORMATION
the Commissioner of Food and Drugs technically qualified member, selected section for registration date and
(the Commissioner). The Commissioner by the Commissioner or designee, who information.
has determined that it is in the public is identified with consumer interests ADDRESSES: The public meeting will be
interest to renew the Bone, and is recommended by either a held at the Food and Drug
Reproductive and Urologic Drugs consortium of consumer-oriented Administration, Center for Food Safety
Advisory Committee for an additional 2 organizations or other interested and Applied Nutrition, 5001 Campus
years beyond the charter expiration persons. In addition to the voting Dr., Wiley Auditorium (first floor),
date. The new charter will be in effect members, the Committee may include College Park, MD 20740.
until March 23, 2020. one non-voting member who is FOR FURTHER INFORMATION CONTACT:
DATES: Authority for the Bone, identified with industry interests. Jonathan Hicks, Office of Cosmetics and
Reproductive and Urologic Drugs Further information regarding the Colors, Food and Drug Administration,
Advisory Committee will expire on 5001 Campus Dr. (HFS–125), College
most recent charter and other
March 23, 2020, unless the Park, MD 20740, jonathan.hicks@
information can be found at https://
Commissioner formally determines that fda.hhs.gov, 240–402–1375.
www.fda.gov/AdvisoryCommittees/
renewal is in the public interest.
CommitteesMeetingMaterials/Drugs/ SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
ReproductiveHealthDrugs I. Background
Kalyani Bhatt, Division of Advisory
AdvisoryCommittee/ucm107572.htm or
Committee and Consultant The intention of the ICCR multilateral
by contacting the Designated Federal
Management, Center for Drug framework is to pave the way for the
Officer (see FOR FURTHER INFORMATION
Evaluation and Research, Food and removal of regulatory obstacles to
CONTACT). In light of the fact that no
Drug Administration, 10903 New international trade while maintaining
Hampshire Ave., Bldg. 31, Rm. 2417, change has been made to the committee
name or description of duties, no global consumer protection. The
Silver Spring, MD 20993–0002, 301– purpose of the meeting is to invite
796–9001, email: BRUDAC@fda.hhs.gov. amendment will be made to 21 CFR public input on various topics
14.100.
SUPPLEMENTARY INFORMATION: Pursuant pertaining to the regulation of
to 41 CFR 102–3.65 and approval by the This document is issued under the cosmetics. We may use this input to
Department of Health and Human Federal Advisory Committee Act (5 help us prepare for the ICCR–12 meeting
Services pursuant to 45 CFR part 11 and U.S.C. app.). For general information that will be held July 10 to 12, 2018, in
by the General Services Administration, related to FDA advisory committees, Tokyo, Japan.
FDA is announcing the renewal of the please check https://www.fda.gov/ ICCR is a voluntary international
amozie on DSK30RV082PROD with NOTICES

Bone, Reproductive and Urologic Drugs AdvisoryCommittees/default.htm. group of cosmetics regulatory
Advisory Committee (the Committee). Dated: April 5, 2018. authorities from Brazil, Canada, the
The Committee is a discretionary European Union, Japan, and the United
Leslie Kux,
Federal advisory committee established States of America. These regulatory
to provide advice to the Commissioner. Associate Commissioner for Policy. authority members will engage in
The Committee advises the [FR Doc. 2018–07437 Filed 4–10–18; 8:45 am] constructive dialogue with their
Commissioner or designee in BILLING CODE 4164–01–P relevant cosmetics industry trade

VerDate Sep<11>2014 17:17 Apr 10, 2018 Jkt 244001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\11APN1.SGM 11APN1

Document Created: 2018-04-10 23:59:13
Document Modified: 2018-04-10 23:59:13

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; renewal of advisory committee.
Dates		Authority for the Bone, Reproductive and Urologic Drugs Advisory Committee will expire on March 23, 2020, unless the Commissioner formally determines that renewal is in the public interest.
Contact		Kalyani Bhatt, Division of Advisory Committee and Consultant Management, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, email: [email protected]
FR Citation		83 FR 15576

83 FR 15576 - Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 70 (April 11, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration