Opportunity
Federal Register #FDA-2026-N-10132
FDA Requests Public Comment on Information Collection for Human Subject Protection and IRB Oversight
Buyer
Food and Drug Administration
Posted
September 29, 2026
Respond By
December 01, 2026
Identifier
FDA-2026-N-10132
NAICS
923120
The Food and Drug Administration (FDA), under the Department of Health and Human Services, is seeking public comment on a proposed information collection related to the protection of human subjects and institutional review boards (IRBs). - Government Buyer: - Food and Drug Administration (FDA) - Department of Health and Human Services - Scope of Request: - Proposed collection of information for compliance with 21 CFR parts 50 and 56 - Focuses on protection of human subjects, informed consent, and IRB responsibilities - Includes tracking of medical devices and clinical investigations regulated by FDA - OEMs and Vendors: - No specific OEMs or vendors are mentioned - Products/Services Requested: - No products or services are being procured - Request pertains to reporting, recordkeeping, and third-party disclosure requirements for IRBs and clinical investigators - Unique/Notable Requirements: - Compliance with FDA regulations for human subject protection and IRB oversight - Potential for requesting Certificates of Confidentiality under the 21st Century Cures Act - Invitation for public comment on necessity, accuracy, and burden of information collection, as well as suggestions for minimizing respondent burden
Description
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency related to the protection of human subjects, informed consent, and responsibilities of institutional review boards (IRBs) as set forth in 21 CFR parts 50 and 56. This includes information collection requirements for the tracking of medical devices and clinical investigations regulated by FDA. The notice invites comments on the necessity, accuracy, and burden of the proposed information collection, including ways to minimize the burden on respondents. Comments must be submitted by November 30, 2026.