Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee, Renewal, 15576 [2018-07437]
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15576
Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices
amozie on DSK30RV082PROD with NOTICES
Dated: March 16, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: April 5, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
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
[FR Doc. 2018–07410 Filed 4–10–18; 8:45 am]
drug products for use in the practice of
BILLING CODE 4120–01–P
osteoporosis and metabolic bone
disease, obstetrics, gynecology, urology,
and related specialties, and makes
DEPARTMENT OF HEALTH AND
appropriate recommendations to the
HUMAN SERVICES
Commissioner.
Food and Drug Administration
The Committee shall consist of a core
of 11 voting members including the
[Docket No. FDA–2017–N–4561]
Chair. Members and the Chair are
selected by the Commissioner or
Advisory Committee; Bone,
Reproductive and Urologic Drugs
designee from among authorities
Advisory Committee, Renewal
knowledgeable in the fields of
osteoporosis and metabolic bone
AGENCY: Food and Drug Administration,
disease, obstetrics, gynecology, urology,
HHS.
pediatrics, epidemiology, or statistics
ACTION: Notice; renewal of advisory
and related specialties. Members will be
committee.
invited to serve for overlapping terms of
up to 4 years. Almost all non-Federal
SUMMARY: The Food and Drug
Administration (FDA) is announcing the members of this committee serve as
Special Government Employees. The
renewal of the Bone, Reproductive and
core of voting members may include one
Urologic Drugs Advisory Committee by
the Commissioner of Food and Drugs
technically qualified member, selected
(the Commissioner). The Commissioner by the Commissioner or designee, who
has determined that it is in the public
is identified with consumer interests
interest to renew the Bone,
and is recommended by either a
Reproductive and Urologic Drugs
consortium of consumer-oriented
Advisory Committee for an additional 2 organizations or other interested
years beyond the charter expiration
persons. In addition to the voting
date. The new charter will be in effect
members, the Committee may include
until March 23, 2020.
one non-voting member who is
DATES: Authority for the Bone,
identified with industry interests.
Reproductive and Urologic Drugs
Further information regarding the
Advisory Committee will expire on
most recent charter and other
March 23, 2020, unless the
information can be found at https://
Commissioner formally determines that
www.fda.gov/AdvisoryCommittees/
renewal is in the public interest.
CommitteesMeetingMaterials/Drugs/
FOR FURTHER INFORMATION CONTACT:
ReproductiveHealthDrugs
Kalyani Bhatt, Division of Advisory
AdvisoryCommittee/ucm107572.htm or
Committee and Consultant
by contacting the Designated Federal
Management, Center for Drug
Officer (see FOR FURTHER INFORMATION
Evaluation and Research, Food and
CONTACT). In light of the fact that no
Drug Administration, 10903 New
change has been made to the committee
Hampshire Ave., Bldg. 31, Rm. 2417,
name or description of duties, no
Silver Spring, MD 20993–0002, 301–
796–9001, email: BRUDAC@fda.hhs.gov. amendment will be made to 21 CFR
14.100.
SUPPLEMENTARY INFORMATION: Pursuant
This document is issued under the
to 41 CFR 102–3.65 and approval by the
Federal Advisory Committee Act (5
Department of Health and Human
Services pursuant to 45 CFR part 11 and U.S.C. app.). For general information
by the General Services Administration, related to FDA advisory committees,
please check https://www.fda.gov/
FDA is announcing the renewal of the
Bone, Reproductive and Urologic Drugs AdvisoryCommittees/default.htm.
Advisory Committee (the Committee).
Dated: April 5, 2018.
The Committee is a discretionary
Leslie Kux,
Federal advisory committee established
Associate Commissioner for Policy.
to provide advice to the Commissioner.
[FR Doc. 2018–07437 Filed 4–10–18; 8:45 am]
The Committee advises the
Commissioner or designee in
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0981]
Preparation for International
Cooperation on Cosmetics Regulation
Twelfth Annual Meeting; Public
Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public meeting.
The Food and Drug
Administration (FDA or we) is
announcing the following public
meeting entitled ‘‘International
Cooperation on Cosmetics Regulation
(ICCR)—Preparation for ICCR–12
Meeting.’’ The purpose of the public
meeting is to invite public input on
various topics pertaining to the
regulation of cosmetics. We may use
this input to help us prepare for the
ICCR–12 meeting that will be held July
10 to 12, 2018, in Tokyo, Japan.
DATES: The public meeting will be held
on June 7, 2018, from 2 p.m. to 4 p.m.
See the SUPPLEMENTARY INFORMATION
section for registration date and
information.
SUMMARY:
The public meeting will be
held at the Food and Drug
Administration, Center for Food Safety
and Applied Nutrition, 5001 Campus
Dr., Wiley Auditorium (first floor),
College Park, MD 20740.
FOR FURTHER INFORMATION CONTACT:
Jonathan Hicks, Office of Cosmetics and
Colors, Food and Drug Administration,
5001 Campus Dr. (HFS–125), College
Park, MD 20740, jonathan.hicks@
fda.hhs.gov, 240–402–1375.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
The intention of the ICCR multilateral
framework is to pave the way for the
removal of regulatory obstacles to
international trade while maintaining
global consumer protection. The
purpose of the meeting is to invite
public input on various topics
pertaining to the regulation of
cosmetics. We may use this input to
help us prepare for the ICCR–12 meeting
that will be held July 10 to 12, 2018, in
Tokyo, Japan.
ICCR is a voluntary international
group of cosmetics regulatory
authorities from Brazil, Canada, the
European Union, Japan, and the United
States of America. These regulatory
authority members will engage in
constructive dialogue with their
relevant cosmetics industry trade
E:\FR\FM\11APN1.SGM
11APN1
]]>Agencies
[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Page 15576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
[email protected].
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
