Federal Register #FDA2026N9550

FDA and HRSA Request for Information on Botanical Drug Development and Rural Opioid Response Measures

This opportunity involves a request for information from the Food and Drug Administration (FDA) and Health Resources and Services Administration (HRSA), both under the Department of Health and Human Services. - Government Buyer: - Food and Drug Administration (FDA) - Health Resources and Services Administration (HRSA) - Purpose: - FDA is seeking public input to advance the development of botanical drug products (BDPs), including drugs derived from plant materials and fungi. - HRSA is requesting comments on performance measures for the Rural Communities Opioid Response Program (RCORP), which supports substance use disorder prevention and treatment in rural areas. - Products/Services Requested: - No physical products or commercial services are being procured. - FDA requests information and stakeholder perspectives on challenges, research experiences, regulatory issues, and innovative approaches for botanical drug development. - HRSA requests information related to performance measures for RCORP grant initiatives. - OEMs and Vendors: - No specific OEMs or vendors are mentioned. - FDA references previously approved botanical drug products containing sinecatechins, crofelemer, birch triterpenes, and anacaulase-bcdb, as well as botanical active ingredients like psyllium and witch hazel. - Unique/Notable Requirements: - Focus on gathering stakeholder input to inform future regulatory guidance and support for botanical drug development. - Emphasis on innovative approaches and overcoming regulatory challenges in botanical drug product development. - HRSA's request centers on improving performance measurement for rural opioid response programs.

Description

The Food and Drug Administration (FDA) is soliciting public comments to advance the development of botanical drug products (BDPs). This request aims to gather stakeholder perspectives on the current state of BDP development in the U.S., challenges faced, and potential solutions to meet regulatory requirements under the Federal Food, Drug, and Cosmetic Act. The FDA seeks input on research experiences, general challenges, and opportunities to accelerate BDP development while ensuring safety, efficacy, and quality. Comments are due by November 3, 2026.

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