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Agency Information Collection Activities; Proposed Collection; Public Comment Request

This document has a comment period that ends in 55 days. (11/12/2019) Submit a formal comment

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Office of the Secretary, HHS.




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.


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


Submit your comments to or by calling (202) 795-7714.

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

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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 Start Printed Page 48360(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.

Estimate Annualized Burden in Hours Table

Form nameNumber of respondentsAverage burden per response (in hours)Total burden hours
Subpart C Certification Form80180
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Terry Clark,

Office of the Secretary, Asst Paperwork Reduction Act Reports Clearance Officer.

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[FR Doc. 2019-19857 Filed 9-12-19; 8:45 am]