Advisory Committee; Obstetrics, Reproductive and Urologic Drugs Advisory; Renewal, 48653-48654 [2024-12528]
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Federal Register / Vol. 89, No. 111 / Friday, June 7, 2024 / Notices
Authority for the Arthritis
Advisory Committee will expire on
April 5, 2026, unless the Commissioner
formally determines that renewal is in
the public interest.
FOR FURTHER INFORMATION CONTACT:
Jessica Seo, Center for Drug Evaluation
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, AAC@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Arthritis 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 concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of arthritis,
rheumatism, and related diseases, and
makes appropriate recommendations to
the Commissioner.
Pursuant to 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 arthritis, rheumatology, orthopedics,
epidemiology or statistics, analgesics,
and related specialties. Members will be
invited to serve for overlapping terms of
up to 4 years. Non-Federal members of
this committee will serve as Special
Government Employees,
representatives, or Ex-Officio members.
Federal members will serve as Regular
Government Employees or Ex-Officios.
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 consumeroriented 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.
The Commissioner or designee shall
have the authority to select members of
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DATES:
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other scientific and technical FDA
advisory committees (normally not to
exceed 10 members) to serve
temporarily as voting members and to
designate consultants to serve
temporarily as voting members when:
(1) expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members) or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a committee charter to specify quorum
requirements.
If functioning as a medical device
panel, an additional non-voting
representative member of consumer
interests and an additional non-voting
representative member of industry
interests will be included in addition to
the voting members.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
human-drug-advisory-committees/
arthritis-advisory-committee 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 notice is issued under the
Federal Advisory Committee Act as
amended (5 U.S.C. 1001 et seq). For
general information related to FDA
advisory committees, please visit us at
https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: June 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–12525 Filed 6–6–24; 8:45 am]
BILLING CODE 4164–01–P
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48653
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0335]
Advisory Committee; Obstetrics,
Reproductive and Urologic Drugs
Advisory; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the renewal of the
Obstetrics, 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 Obstetrics,
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, 2026, expiration
date.
SUMMARY:
Authority for the Obstetrics,
Reproductive and Urologic Drugs
Advisory Committee will expire on
March 23, 2026, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Joyce Frimpong, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–7973, email: ORUDAC@
fda.hhs.gov.
DATES:
Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Obstetrics, 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
obstetrics, gynecology, urology, and
related specialties, and makes
SUPPLEMENTARY INFORMATION:
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07JNN1
ddrumheller on DSK120RN23PROD with NOTICES1
48654
Federal Register / Vol. 89, No. 111 / Friday, June 7, 2024 / Notices
appropriate recommendations to the
Commissioner.
Pursuant to 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 obstetrics, gynecology, urology,
pediatrics, epidemiology, or statistics
and related specialties. Members will be
invited to serve for overlapping terms of
up to 4 years. Non-Federal members of
this committee will serve as Special
Government Employees,
representatives, or Ex-Officio members.
Federal members will serve as Regular
Government Employees or Ex-Officios.
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 consumeroriented 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.
The Commissioner or designee shall
have the authority to select members of
other scientific and technical FDA
advisory committees (normally not to
exceed 10 members) to serve
temporarily as voting members and to
designate consultants to serve
temporarily as voting members when:
(1) expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members), or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a committee charter to specify quorum
requirements.
If functioning as a medical device
panel, an additional non-voting
representative member of consumer
interests and an additional non-voting
representative member of industry
interests will be included in addition to
the voting members.
Further information regarding the
most recent charter and other
information can be found at https://
VerDate Sep<11>2014
17:23 Jun 06, 2024
Jkt 262001
www.fda.gov/advisory-committees/
human-drug-advisory-committees/
obstetrics-reproductive-and-urologicdrugs-advisory-committee-formerlybone-reproductive-and 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 notice is issued under the
Federal Advisory Committee Act as
amended (5 U.S.C. 1001 et seq.). For
general information related to FDA
advisory committees, please visit us at
https://www.fda.gov/Advisory
Committees/default.htm.
Dated: June 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–12528 Filed 6–6–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Privacy Act of 1974; System of
Records
National Institutes of Health
(NIH), Department of Health and Human
Services (HHS).
ACTION: Notice of a new system of
records.
AGENCY:
In accordance with the
requirements of the Privacy Act of 1974,
as amended (Privacy Act, or Act), the
Department of Health and Human
Services (HHS) is establishing a new
System of Records (SOR), 09–25–0224,
‘‘NIH Police Records,’’ to be maintained
by the National Institutes of Health
(NIH). The new system of records will
contain records about individuals who
are the subject of investigations of
crime, civil disturbances, and traffic
accidents occurring on or otherwise
affecting the protection of life and
property on NIH property. Because the
records will constitute law enforcement
investigatory material, elsewhere in the
Federal Register the agency has
published a notice of proposed
rulemaking (NPRM) to exempt this
system of records from certain
requirements of the Privacy Act based
on subsections (j)(2) and (k)(2) of the
Act. The system of records is more fully
described in the system of records
notice (SORN) published in this notice.
DATES: The comment period for this
SORN is co-extensive with the 60-day
comment period provided in the NPRM;
i.e., written comments on the SORN
should be submitted by August 6, 2024.
The new system of records, including
SUMMARY:
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the routine uses and the exemptions,
will become effective when NIH
publishes a Final Rule, which will not
occur until the 60-day comment period
provided in the NPRM has expired and
any comments received on the NPRM
(or on this SORN) have been addressed.
ADDRESSES: The public should address
written comments, identified by the
Privacy Act System of Records (PA
SOR) Number 09–25–0224, by any of
the following methods:
• Federal eRulemaking Portal:
https://regulations.gov. Follow the
instructions for submitting comments.
• Email: privacy@mail.nih.gov and
include PA SOR number 09–25–0224 in
the subject line of the message.
• Phone: (301) 402–6469 (not a tollfree number).
• Fax: (301) 402–0169.
• Mail: NIH Privacy Act Officer,
Office of Management Assessment,
National Institutes of Health, 6705
Rockledge Drive (RK1) 601, Rockville,
MD 20892–7901.
• Hand Delivery/Courier: 6705
Rockledge Drive (RK1) 601, Rockville,
MD 20892–7901.
Comments received will be available
for inspection and copying at this same
address from 9:00 a.m. to 3:00 p.m.,
Monday through Friday, Federal
holidays excepted.
FOR FURTHER INFORMATION CONTACT:
General questions about the system of
records may be submitted to Dustin
Close, NIH Privacy Act Officer, by email
at privacy@mail.nih.gov or mail at the
Office of Management Assessment
(OMA), Office of the Director (OD),
National Institutes of Health (NIH), 6705
Rockledge Drive (RK1) 601, Rockville,
MD 20892–7901. Telephone: 301–402–
6469.
SUPPLEMENTARY INFORMATION: The
Privacy Act (5 U.S.C. 552a) governs the
means by which the United States
Government collects, maintains, and
uses records in a system of records. A
‘‘system of records’’ is a group of any
records under the control of a federal
agency from which information about
individuals is retrieved by name or
other personal identifier. The Privacy
Act requires each agency to publish in
the Federal Register a SORN identifying
and describing each system of records
the agency maintains, including the
purposes for which the agency uses
records in the system of records, the
routine uses for which the agency
discloses, or may disclose, such
information outside the agency without
the subject individual’s prior written
consent, and procedures explaining how
subject individuals can exercise their
rights under the Privacy Act (e.g., to
E:\FR\FM\07JNN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 111 (Friday, June 7, 2024)]
[Notices]
[Pages 48653-48654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12528]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0335]
Advisory Committee; Obstetrics, Reproductive and Urologic Drugs
Advisory; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the renewal of the Obstetrics, 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 Obstetrics, 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,
2026, expiration date.
DATES: Authority for the Obstetrics, Reproductive and Urologic Drugs
Advisory Committee will expire on March 23, 2026, unless the
Commissioner formally determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT: Joyce Frimpong, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-7973, email: [email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Obstetrics,
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 obstetrics, gynecology, urology, and related
specialties, and makes
[[Page 48654]]
appropriate recommendations to the Commissioner.
Pursuant to 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 obstetrics, gynecology, urology,
pediatrics, epidemiology, or statistics and related specialties.
Members will be invited to serve for overlapping terms of up to 4
years. Non-Federal members of this committee will serve as Special
Government Employees, representatives, or Ex-Officio members. Federal
members will serve as Regular Government Employees or Ex-Officios. 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.
The Commissioner or designee shall have the authority to select
members of other scientific and technical FDA advisory committees
(normally not to exceed 10 members) to serve temporarily as voting
members and to designate consultants to serve temporarily as voting
members when: (1) expertise is required that is not available among
current voting standing members of the Committee (when additional
voting members are added to the Committee to provide needed expertise,
a quorum will be based on the combined total of regular and added
members), or (2) to comprise a quorum when, because of unforeseen
circumstances, a quorum is or will be lacking. Because of the size of
the Committee and the variety in the types of issues that it will
consider, FDA may, in connection with a particular committee meeting,
specify a quorum that is less than a majority of the current voting
members. The Agency's regulations (21 CFR 14.22(d)) authorize a
committee charter to specify quorum requirements.
If functioning as a medical device panel, an additional non-voting
representative member of consumer interests and an additional non-
voting representative member of industry interests will be included in
addition to the voting members.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/human-drug-advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee-formerly-bone-reproductive-and 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 notice is issued under the Federal Advisory Committee Act as
amended (5 U.S.C. 1001 et seq.). For general information related to FDA
advisory committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: June 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12528 Filed 6-6-24; 8:45 am]
BILLING CODE 4164-01-P
