National Heart, Lung, and Blood Institute; Amend Notice of Meeting, 33158 [2023-10936]
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33158
Federal Register / Vol. 88, No. 99 / Tuesday, May 23, 2023 / Notices
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
Neuroscience Center, 6001 Executive Blvd.,
Rockville, MD 20892, 305–586–9937,
claudio.ortiz@nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
BRAIN Initiative Advanced Postdoctoral
Career Transition Award to Promote
Diversity (K99/R00).
Date: June 22, 2023.
Time: 11:00 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Emma Perez-Costas, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
Neuroscience Center, 6001 Executive Blvd.,
Rockville, MD 20892, 301–827–9275,
emma.perez-costas@nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: May 17, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–10930 Filed 5–22–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
lotter on DSK11XQN23PROD with NOTICES1
National Heart, Lung, and Blood
Institute; Amend Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Heart, Lung,
and Blood Institute Special Emphasis
Panel, June 6, 2023, 1 p.m. to 5 p.m.,
National Institutes of Health, 6705
Rockledge Drive, Bethesda, MD, 20892
which was published in the Federal
Register on May 15, 2023, FR Document
No. 2023–10224, 88 FRN 30997.
This notice is being amended to
correct the June 6, 2023 meeting title
that was published as ‘‘The National
Heart, Lung, and Blood Institute Special
Emphasis Panel SPECIAL EMPHASIS
PANEL’’. The correct title is ‘‘The
National Heart, Lung, and Blood
Institute Special Emphasis Panel NRSA
Member Conflict Panel’’. The meeting is
closed to the public.
Dated: May 18, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–10936 Filed 5–22–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Information on the
Prioritization of Drug, Vaccine, and
Dietary Supplement Research Needs
for Pregnant, Postpartum, and
Lactating Persons
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Request for information.
The National Institute of
Child Health and Human Development
(NICHD) seeks nominations for drug,
vaccine, and dietary supplement
research needs to be considered in the
development of a Priority List of Drug,
Vaccine, and Dietary Supplement
Research Needs for Pregnant,
Postpartum, and Lactating Persons. The
NICHD is gathering nominations for
drugs prescribed for conditions specific
to or that co-occur during pregnancy
and the postpartum period, including
for lactation; dietary supplements that
may be used in preparation for, during,
or after pregnancy; and vaccines used by
pregnant or lactating persons to prevent
or treat disease. Additionally, the
NICHD is seeking information on factors
and processes it could consider in
prioritizing these nominations.
Nominations are requested from public
and private stakeholders such as, but
not limited to, researchers, academia,
small- and large-scale industries, nonprofit organizations, patients, providers,
advocacy groups, payors, and federal
agencies.
SUMMARY:
The request for information is
open for public comment and will be
accepted through September 29, 2023.
ADDRESSES: Submissions must be
submitted via a survey using the
following link: https://
www.surveymonkey.com/r/PRGLAC23.
FOR FURTHER INFORMATION CONTACT:
Questions about this request for
information should be directed to
Camille Fabiyi, Ph.D., MPH, Eunice
Kennedy Shriver National Institute of
Child Health and Human Development,
National Institutes of Health, 6710B
Rockledge Dr., Bethesda, MD 20892,
NICHD-PRGLAC@mail.nih.gov, 301–
496–3916.
SUPPLEMENTARY INFORMATION: This RFI is
intended to obtain information to help
advance recommendations outlined in
the 2018 Report of the Task Force for
Research Specific to Pregnant and
Lactating Women (PRGLAC) and 2020
PRGLAC Implementation Plan. In 2016,
Congress established PRGLAC through
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the 21st Century Cures Act to advise the
Secretary of Health and Human Services
(HHS) regarding gaps in knowledge and
research on safe and effective therapies
for pregnant and lactating persons. The
PRGLAC task force was charged with
providing advice and guidance to the
HHS Secretary on activities related to
identifying and addressing gaps in
knowledge and research on safe and
effective therapies for pregnant and
lactating persons, including the
development of such therapies and the
collaboration on and coordination of
such activities.
The task force developed 15
recommendations based on information
gleaned during four open meetings and
a request for public comments. The
recommendations were submitted in the
PRGLAC Report to the HHS Secretary
and Congress in September 2018. The
report recommended that pregnant and
lactating persons be included in the
clinical research agenda. The task force
published a PRGLAC Implementation
Plan in August 2020. A comprehensive
review of research conducted for the
task force deliberations clearly showed
the extremely limited information
available on medication use in
pregnancy and lactation. Evidencebased answers are required for pregnant
and lactating persons and their
clinicians to make fully informed
choices based on the risks and benefits
of medicating or not medicating
conditions during pregnancy and
lactation. The provision of clinical data
is essential to increasing the quantity,
quality, and timeliness of research on
safety and efficacy of therapeutic
products used by pregnant, postpartum,
and lactating persons.
Most women use at least one
medication during pregnancy and the
postpartum period. Many women who
become pregnant or are lactating already
have chronic conditions needing
treatment, in addition to conditions that
may arise as a result of pregnancy or
lactation. Consequently, because so few
studies have been conducted, some
prioritization is necessary to determine
which drugs, vaccines, and dietary
supplements should be studied first.
Information Requested
The NICHD seeks information and
actionable recommendations on
research gaps and needs as potential
priorities for drugs, vaccines, and
dietary supplements used by pregnant,
postpartum, or lactating persons.
Comments are strongly encouraged to
address challenges and knowledge gaps
around drugs, vaccines, or dietary
supplements used during pregnancy,
the postpartum period, or lactation on
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[Federal Register Volume 88, Number 99 (Tuesday, May 23, 2023)]
[Notices]
[Page 33158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10936]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute; Amend Notice of
Meeting
Notice is hereby given of a change in the meeting of the National
Heart, Lung, and Blood Institute Special Emphasis Panel, June 6, 2023,
1 p.m. to 5 p.m., National Institutes of Health, 6705 Rockledge Drive,
Bethesda, MD, 20892 which was published in the Federal Register on May
15, 2023, FR Document No. 2023-10224, 88 FRN 30997.
This notice is being amended to correct the June 6, 2023 meeting
title that was published as ``The National Heart, Lung, and Blood
Institute Special Emphasis Panel SPECIAL EMPHASIS PANEL''. The correct
title is ``The National Heart, Lung, and Blood Institute Special
Emphasis Panel NRSA Member Conflict Panel''. The meeting is closed to
the public.
Dated: May 18, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2023-10936 Filed 5-22-23; 8:45 am]
BILLING CODE 4140-01-P
