Federal Register #FDA2026N2431

FDA and HRSA Seek Public Comment on Information Collection for Administrative Practices, Formal Hearings, and Rural Health Programs

This notice involves the Food and Drug Administration (FDA) and Health Resources and Services Administration (HRSA) seeking public comment on proposed information collections related to administrative practices, formal hearings, and rural health care program measures. - Government Buyers: - Department of Health and Human Services - Food and Drug Administration (FDA) - Health Resources and Services Administration (HRSA) - OEMs and Vendors Mentioned: - FDA (regulatory agency, not a commercial OEM) - Immedica Pharma AB (manufacturer of LOARGYS (pegzilarginase-nbln)) - Products/Services Requested: - Information collection for FDA administrative practices and formal hearings - Priority review voucher issuance for LOARGYS (pegzilarginase-nbln) for rare pediatric disease (Arginase 1 Deficiency) - HRSA data collection for Rural Health Care Services Outreach Program - Unique or Notable Requirements: - Public comment is requested on the paperwork and reporting burden for these administrative and regulatory activities - No procurement of goods or services is being solicited; this is an information collection notice - LOARGYS (pegzilarginase-nbln) is specifically referenced as a rare pediatric disease product eligible for a priority review voucher - Locations: - FDA offices in Rockville, North Bethesda, and Silver Spring, MD - HRSA office in Rockville, MD

Description

The Food and Drug Administration (FDA) is seeking public comment on the proposed collection of information related to its administrative practices and procedures, including requests for formal hearings. This collection supports regulations implementing provisions of the Federal Food, Drug, and Cosmetic Act and covers submissions such as petitions, meeting requests, and public participation in guidance development. Comments on this information collection must be submitted by June 8, 2026.

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