Notice2023-10960
Request for Information on the Prioritization of Drug, Vaccine, and Dietary Supplement Research Needs for Pregnant, Postpartum, and Lactating Persons
Primary source
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Published
May 23, 2023
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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, non-profit organizations, patients, providers, advocacy groups, payors, and federal agencies.
Full Text
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<title>Federal Register, Volume 88 Issue 99 (Tuesday, May 23, 2023)</title>
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[Federal Register Volume 88, Number 99 (Tuesday, May 23, 2023)]
[Notices]
[Pages 33158-33159]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-10960]
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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.
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SUMMARY: 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, non-profit organizations, patients,
providers, advocacy groups, payors, and federal agencies.
DATES: 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: <a href="https://www.surveymonkey.com/r/PRGLAC23">https://www.surveymonkey.com/r/PRGLAC23</a>.
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, <a href="/cdn-cgi/l/email-protection#307e797378741d6062777c7173705d51595c1e5e59581e575f46"><span class="__cf_email__" data-cfemail="e4aaada7aca0c9b4b6a3a8a5a7a489858d88ca8a8d8cca838b92">[email protected]</span></a>, 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 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. Evidence-based
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
[[Page 33159]]
health disparity populations. NIH defines health disparity populations
as racial and ethnic minority populations, less privileged
socioeconomic status (SES) populations, underserved rural populations,
sexual and gender minorities (SGM), and any subpopulations that can be
characterized by two or more of these descriptions. For more
information please refer to NIH definition of Health Disparity.
Respondents are asked to address the following topics in the
nomination survey:
(1) Identify the drug, vaccine, or dietary supplement for this
nomination. If applicable, please include generic name of drug or
medication.
(2) Indicate if this nomination is for a:
a. drug,
b. vaccine,
c. dietary supplement.
(3) Indicate the category of condition for the research question
for the nominated drug, vaccine, or dietary supplement. If there are
multiple categories per drug, vaccine, or dietary supplement, please
submit a separate nomination for each one.
a. Pregnancy- or postpartum-specific conditions (e.g., including
but not limited to preterm labor, hyperemesis, labor induction, pre-
eclampsia, postpartum hemorrhage).
b. Lactation-specific conditions (e.g., including but not limited
to low milk supply, mastitis).
c. General medical conditions that may occur in pregnant,
postpartum, and lactating persons (e.g., including but not limited to
asthma, depression, diabetes, cardiac disease, STIs, HIV/AIDS, CMV,
other infectious disease conditions).
(4) Indicate whether the drug, vaccine, or dietary supplement is
used to treat or prevent a condition in:
a. the mother,
b. the fetus,
c. both mother and fetus.
(5) Indicate the therapeutic indication that the drug, vaccine, or
dietary supplement proposed in this nomination is intended to treat or
prevent.
(6) If known, describe the proposed research question and rationale
for urgency of need of the nominated drug, vaccine, dietary supplement,
including existing evidence and feasibility of the proposed research
question.
(7) If known, identify the study design and population that would
be most effective in providing the needed evidence for the proposed
nomination and the impact this evidence will have on clinical care.
(8) If applicable, describe research-related gaps and needs to
enable or facilitate the conduct of proposed studies, such as, but not
limited to, biomarkers or other drug development tools, research
infrastructure or collaborations, or workforce training needs.
(9) Describe any other factors to consider in the process of
prioritizing research needs for drugs, vaccines, and dietary
supplements used by pregnant, postpartum, and lactating persons.
To respond to this RFI, nominations must be made via the nomination
form, which will be made available through September 29, 2023.
Nominations submitted via email will not be considered. All responses
will be compiled into a database that will be reviewed by a committee
of stakeholder representatives, to be identified by the NICHD. The
review will result in a preliminary priority list. An inaugural
stakeholder meeting to review the final priority list and provide
updates to the PRGLAC prioritization process will occur at a future
date.
Responses to this RFI are voluntary and may be submitted
anonymously. Please do not include any personally identifiable
information or any information that you do not wish to make public. You
may voluntarily include your name and contact information with your
response. If you choose to provide NIH with this information, NIH will
not share your name and contact information outside of the Federal
Government unless required by law. Proprietary, classified,
confidential, or sensitive information should not be included in your
response. The Government will use the information submitted in response
to this RFI at its discretion. Other than your name and contact
information, the Government reserves the right to use any submitted
information on public websites, in reports, in summaries of the state
of the science, in any possible resultant solicitation(s), grant(s), or
cooperative agreement(s), or in the development of future funding
opportunity announcements. This RFI is for informational and planning
purposes only and is not a solicitation for applications or an
obligation on the part of the Government to provide support for any
ideas identified in response to it. Please note that the Government
will not pay for the preparation of any information submitted or for
use of that information.
Alison N. Cernich,
Deputy Director, Eunice Kennedy Shriver National Institute of Child
Health and Human Development, National Institutes of Health.
[FR Doc. 2023-10960 Filed 5-22-23; 8:45 am]
BILLING CODE 4140-01-P
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