Advisory Committee; Drug Safety and Risk Management Advisory Committee; Renewal, 63435-63436 [2024-17243]
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lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 150 / Monday, August 5, 2024 / Notices
investigational human drug products
including analgesics; e.g., abusedeterrent opioids, novel analgesics, and
issues related to opioid abuse, and those
for use in anesthesiology and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
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 anesthesiology, analgesics (such as:
abuse deterrent opioids, novel
analgesics, and issues related to opioid
abuse) 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 or
representatives. 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
VerDate Sep<11>2014
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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/
anesthetic-and-analgesic-drug-productsadvisory-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 (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: July 31, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–17248 Filed 8–2–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0618]
Advisory Committee; Drug Safety and
Risk Management Advisory
Committee; 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 Drug
Safety and Risk Management 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
Drug Safety and Risk Management
Advisory Committee for an additional 2
years beyond the charter expiration
date. The new charter will be in effect
until the May 31, 2026, expiration date.
DATES: Authority for the Drug Safety
and Risk Management Advisory
Committee will expire on May 31, 2026,
unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Moon Choi, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
SUMMARY:
PO 00000
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63435
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, (240) 743–8319,
DSaRM@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services (HHS) and by the General
Services Administration, FDA is
announcing the renewal of the Drug
Safety and Risk Management 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
information on risk management, risk
communication, and quantitative
evaluation of spontaneous reports for
drugs for human use and for any other
product for which FDA has regulatory
responsibility. The Committee also
advises the Commissioner regarding the
scientific and medical evaluation of all
information gathered by HHS and the
Department of Justice with regard to
safety, efficacy, and abuse potential of
drugs or other substances, and
recommends actions to be taken by HHS
with regard to the marketing,
investigation, and control of such drugs
or other substances.
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 risk communication, risk
management, drug safety, medical,
behavioral, and biological sciences as
they apply to risk management, and
drug abuse. 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 or
representatives. 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.
E:\FR\FM\05AUN1.SGM
05AUN1
63436
Federal Register / Vol. 89, No. 150 / Monday, August 5, 2024 / Notices
lotter on DSK11XQN23PROD with NOTICES1
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/drugsafety-and-risk-management-advisorycommittee 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 (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: July 31, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–17243 Filed 8–2–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Notice of Interest Rate on Overdue
Debts
Section 30.18 of the Department of
Health and Human Services’ claims
collection regulations (45 CFR part 30)
provides that the Secretary shall charge
an annual rate of interest, which is
determined and fixed by the Secretary
of the Treasury after considering private
consumer rates of interest on the date
that the Department of Health and
Human Services becomes entitled to
recovery. The rate cannot be lower than
the Department of Treasury’s current
value of funds rate or the applicable rate
determined from the ‘‘Schedule of
Certified Interest Rates with Range of
Maturities’’ unless the Secretary waives
interest in whole or part, or a different
rate is prescribed by statute, contract, or
repayment agreement. The Secretary of
the Treasury may revise this rate
quarterly. The Department of Health and
Human Services publishes this rate in
the Federal Register.
The current rate of 117⁄8%, as fixed by
the Secretary of the Treasury, is certified
for the quarter ended June 30, 2024.
This rate is based on the Interest Rates
for Specific Legislation, ‘‘National
Health Services Corps Scholarship
Program (42 U.S.C. 254o(b)(1)(A))’’ and
‘‘National Research Service Award
Program (42 U.S.C. 288(c)(4)(B)).’’ This
interest rate will be applied to overdue
debt until the Department of Health and
Human Services publishes a revision.
David C. Horn,
Director, Office of Financial Policy and
Reporting.
[FR Doc. 2024–17139 Filed 8–2–24; 8:45 am]
BILLING CODE 4150–04–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; The Impact of
Clinical Research Training and Medical
Education at the Clinical Center on
Physician Careers in Academia and
Clinical Research
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
SUMMARY:
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18:38 Aug 02, 2024
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and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30 days of the date of this
publication.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Tom Burklow,
MD, Office of Clinical Research Training
and Medical Education, NIH Clinical
Center, National Institutes of Health, 10
Center Drive, Room 1N262, Bethesda,
MD 20892–1158, or call non-toll-free
number 301–435–8015, or Email your
request, including your address to:
tom.burklow@nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on May 13, 2024 (89 FR 41446)
and allowed 60 days for public
comment. No comments were received.
The purpose of this notice is to allow an
additional 30 days for public comment.
The Clinical Center, National Institutes
of Health, may not conduct or sponsor,
and the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: The Impact of
Clinical Research Training and Medical
Education at the Clinical Center on
Physician Careers in Academia and
Clinical Research, OMB #0925–0602
Expiration Date: 6/30/2024, National
Institutes of Health Clinical Center (CC),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The information collected
will allow continued assessment of the
value of the training provided by the
Office of Clinical Research Training and
E:\FR\FM\05AUN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 150 (Monday, August 5, 2024)]
[Notices]
[Pages 63435-63436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17243]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0618]
Advisory Committee; Drug Safety and Risk Management Advisory
Committee; 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 Drug Safety and Risk Management 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 Drug Safety and Risk Management Advisory Committee for an
additional 2 years beyond the charter expiration date. The new charter
will be in effect until the May 31, 2026, expiration date.
DATES: Authority for the Drug Safety and Risk Management Advisory
Committee will expire on May 31, 2026, unless the Commissioner formally
determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Moon Choi, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, (240) 743-8319,
[email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services (HHS) and by the General
Services Administration, FDA is announcing the renewal of the Drug
Safety and Risk Management 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 information on risk management,
risk communication, and quantitative evaluation of spontaneous reports
for drugs for human use and for any other product for which FDA has
regulatory responsibility. The Committee also advises the Commissioner
regarding the scientific and medical evaluation of all information
gathered by HHS and the Department of Justice with regard to safety,
efficacy, and abuse potential of drugs or other substances, and
recommends actions to be taken by HHS with regard to the marketing,
investigation, and control of such drugs or other substances.
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 risk communication, risk management,
drug safety, medical, behavioral, and biological sciences as they apply
to risk management, and drug abuse. 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 or
representatives. 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.
[[Page 63436]]
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/drug-safety-and-risk-management-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 (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: July 31, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17243 Filed 8-2-24; 8:45 am]
BILLING CODE 4164-01-P
