2023 Prioritization of Drug, Vaccine, and Dietary Supplement Research Needs for Pregnant, Postpartum, and Lactating Persons |
Overview & Background
OMB # 0925-0766
Expiration Date: 7/2023
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0766). Do not return the completed form to this address.
Expiration Date: 7/2023
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0766). Do not return the completed form to this address.
OVERVIEW
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH), and the U.S. Department of Health and Human Services (HHS) invite all stakeholders to submit 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. For the purpose of this nomination form, the term drug is intended to include small molecule medications as well as biologic therapeutics (e.g., enzyme replacement therapy, monoclonal antibodies, gene therapy vectors, etc.) used for the treatment or prevention of a medical condition.
BACKGROUND
The Task Force for Research Specific to Pregnant and Lactating Women (PRGLAC) 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.
Nominations for the Priority List of Drug, Vaccine, and Dietary Supplement Research Needs for Pregnant, Postpartum, and Lactating Persons are solicited in furtherance of the recommendations outlined in the 2018 PRGLAC Report and 2020 PRGLAC Implementation Plan.