[Federal Register Volume 88, Number 99 (Tuesday, May 23, 2023)]
[Notices]
[Pages 33158-33159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 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, [email protected], 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