Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee; Renewal, 80116 [2020-27289]
Download as PDF
<![CDATA[
80116
Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices
Pathway; Guidance for Industry and
Food and Drug Administration Staff’’
(document number 19008), ‘‘Orthopedic
Non-Spinal Metallic Bone Screws and
Washers—Performance Criteria for
Safety and Performance Based Pathway;
Guidance for Industry and Food and
Drug Administration Staff’’ (document
number 19009), or ‘‘Magnetic Resonance
(MR) Receive-only Coil—Performance
Criteria for Safety and Performance
Based Pathway; Guidance for Industry
III. Paperwork Reduction Act of 1995
While these guidances contain no
collection of information, they do refer
to previously approved FDA collections
of information. Therefore, clearance by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for these
guidances. The previously approved
collections of information are subject to
review by OMB under the PRA. The
collections of information in the
following FDA regulations and guidance
have been approved by OMB as listed in
the following table:
21 CFR part or guidance
Topic
807, subpart E ..........................................................................................................
‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission
Program and Meetings with Food and Drug Administration Staff‘‘.
Premarket notification ............................
Q-submissions .......................................
Dated: December 7, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–27248 Filed 12–10–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA- 2019–N–4203]
Advisory Committee; Bone,
Reproductive and Urologic Drugs
Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
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 the March 23, 2022, expiration
date.
DATES: Authority for the Bone,
Reproductive and Urologic Drugs
Advisory Committee will expire on
March 23, 2022 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
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
and Food and Drug Administration
Staff’’ (document number 19011) may
send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number and complete
title to identify the guidance you are
requesting.
VerDate Sep<11>2014
23:25 Dec 10, 2020
Jkt 253001
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 is
a discretionary Federal advisory
committee established to provide advice
to the Commissioner.
The Bone, Reproductive and Urologic
Drugs Advisory 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.
Under its Charter, 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
PO 00000
Frm 00127
Fmt 4703
Sfmt 9990
OMB control No.
0910–0120
0910–0756
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 representative member
who is identified with industry
interests. There may also be an alternate
industry representative.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
human-drug-advisory-committees/bonereproductive-and-urologic-drugsadvisory-committee-formerlyreproductive-health-drugs-advisory 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: December 8, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–27289 Filed 12–10–20; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\11DEN1.SGM
11DEN1
]]>Agencies
[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Page 80116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27289]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA- 2019-N-4203]
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 the March 23, 2022, expiration date.
DATES: Authority for the Bone, Reproductive and Urologic Drugs Advisory
Committee will expire on March 23, 2022 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 is a discretionary Federal advisory committee
established to provide advice to the Commissioner.
The Bone, Reproductive and Urologic Drugs Advisory 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.
Under its Charter, 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 representative member
who is identified with industry interests. There may also be an
alternate industry representative.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/human-drug-advisory-committees/bone-reproductive-and-urologic-drugs-advisory-committee-formerly-reproductive-health-drugs-advisory 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: December 8, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27289 Filed 12-10-20; 8:45 am]
BILLING CODE 4164-01-P
