Federal Register #FDA-2026-N-3532

FDA Requests Public Comment on Information Collection for Good Laboratory Practice Requirements in Nonclinical Laboratory Studies

This notice from the Food and Drug Administration (FDA) seeks public comment on extending information collection requirements for Good Laboratory Practice (GLP) in nonclinical laboratory studies. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - No OEMs or vendors are mentioned; this is not a procurement opportunity - Products/Services Requested: - No products or services are being procured - The notice pertains to regulatory information collection supporting GLP compliance - Required records include personnel, equipment, protocols, and study results for nonclinical laboratory studies - Unique or Notable Requirements: - Respondents are sponsors of nonclinical laboratory studies supporting FDA applications - Estimated annual reporting and recordkeeping burdens are outlined - Supports quality control and consumer protection in FDA-regulated product safety testing - Place of Performance and Delivery Locations: - FDA offices in Rockville, North Bethesda, and Silver Spring, Maryland

Description

The Food and Drug Administration (FDA) is seeking public comment on the proposed collection of information related to the Good Laboratory Practice Requirements for Nonclinical Laboratory Studies. This collection supports the regulations established to ensure quality control and consumer protection in nonclinical laboratory safety testing. The information collected includes records on personnel, equipment, protocols, and study results necessary for regulatory compliance. Comments on this information collection are invited until June 29, 2026.

View original listing