Agency Information Collection Activities; Proposed Collection; Public Comment Request

AGENCY:

Office of the Secretary, HHS.

ACTION:

Notice.

SUMMARY:

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services (HHS), is publishing the following summary of a proposed collection for public comment.

DATES:

Comments on the ICR must be received on or before November 12, 2019.

ADDRESSES:

Submit your comments to Sherette.Funn@hhs.gov or by calling (202) 795-7714.

FOR FURTHER INFORMATION CONTACT:

When submitting comments or requesting information, please include the document identifier 0990-New-60D and project title for reference to Sherrette.funn@hhs.gov, or call the Reports Clearance Officer.

SUPPLEMENTARY INFORMATION:

Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Information Collection Request Title: 0990-XXXX—Subpart C Research Certification Form.

Abstract: Assistant Secretary for Health, Office for Human Research Protections is requesting a new information collection, on the Subpart C Research Certification Form. The purpose of the IRB Registration Form is to provide a simplified, standardized procedure for institutions to submit subpart C research certifications to OHRP in order to obtain authorization to include prisoners in human subjects research as required in 45 CFR 46.305(c).

Likely Respondents: Institutions or Organizations operating IRBs that have enrolled or are planning to enroll prisoners in human subject research conducted or supported by HHS.