Federal Register #09900490

Public Comment Request: OHRP Research Complaint Form Revision

This notice from the Department of Health and Human Services (HHS), Office of the Secretary, seeks public comment on proposed revisions to the Office for Human Research Protections (OHRP) Research Complaint Form. - Government Buyer: - Department of Health and Human Services (HHS) - Office of the Secretary - Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health - Purpose: - Request for public comment on updates to the OHRP Research Complaint Form (an Information Collection Request, not a procurement) - Key Details: - No OEMs or vendors are involved; this is not a solicitation for products or services - Proposed revisions include: - Updated front matter to align with recent changes to the Federalwide Assurance (FWA) form - Addition of new data collection elements (e.g., prior attempts to resolve issues, past related submissions) - Clearer instructions for complainants - More information about OHRP's communication practices - The form is used to report allegations of noncompliance in HHS-conducted or supported human subject research - Estimated annual respondents: 600 - Estimated total burden: 300 hours - No products, part numbers, or purchase quantities are listed, as this is not a procurement opportunity.

Description

The Department of Health and Human Services Office of the Secretary is requesting public comment on a proposed Information Collection Request (ICR) related to the Office for Human Research Protections Research Complaint Form. The form is used to submit allegations of noncompliance involving human subject research conducted or supported by HHS. The revision includes updates to the form's front matter, addition of new data collection elements, clearer instructions, and details on communication with complainants. Comments must be received by August 31, 2026.

View original listing