Federal Register #09900473

HHS Request for Public Comment: Subpart C Certification Form Information Collection Renewal

This opportunity concerns a request for public comment from the Department of Health and Human Services (HHS) regarding the renewal of an information collection process: - Government Buyer: - Department of Health and Human Services (HHS) - Office of the Secretary - Office for Human Research Protections (OHRP), under the Office of the Assistant Secretary for Health (OASH) - Purpose: - Seeking a three-year extension for the HHS Subpart C Certification Form (OMB No. 0990-0473) - The form is used by institutions or organizations operating Institutional Review Boards (IRBs) to certify research involving prisoners in HHS-conducted or supported human subjects research - Products/Services Requested: - Information collection service: Subpart C Certification Form submissions - Estimated forty institutions, each submitting an average of 2.13 responses annually - Total annual burden estimated at eighty-five hours - Unique/Notable Requirements: - The form is designed to simplify and standardize the certification process for research involving prisoners - Aims to reduce staff time and expedite review - This is a request for information collection, not a procurement of products or services - No OEMs or commercial vendors are mentioned, as this is not a product or service acquisition

Description

The Department of Health and Human Services Office of the Secretary is requesting public comments on a proposed Information Collection Request (ICR) as part of the Paperwork Reduction Act process. The ICR involves the HHS Subpart C Certification Form, which institutions use to submit research certifications related to including prisoners in human subjects research. The form aims to simplify and standardize the certification process, reducing staff time and expediting review. Comments on the ICR must be received by August 31, 2026.

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