2018-23282. 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, is publishing the following summary of a proposed collection for public comment.

DATES:

Comments on the ICR must be received on or before November 26, 2018.

ADDRESSES:

Submit your comments to [e-mail] or by calling [phone].

FOR FURTHER INFORMATION CONTACT:

When submitting comments or requesting information, please include the document identifier 0990-0279 New-30D and project title for reference, to [e-mail], or call the Reports Clearance Officer at 202-795-7714.

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: 0990-0279—Extension—Institutional Review Board Registration Form.

Abstract: Assistant Secretary for Health, Office for Human Research Protections is requesting an extension on a currently approved information collection by the Office of Management and Budget, on the Protection of Human Subjects, on the Institutional Review Board (IRB) Form. The purpose of the IRB Registration Form is to provide a simplified procedure for institutions engaged in research conducted or supported by HHS to satisfy the (1) HHS regulations for the protection of human subjects at 45 CFR 46.103((b), 45 CFR 46.107, and 45 CFR 46, subpart E, Registration of Institutional Review Boards; and, the Food and Drug Administration (FDA) regulations for institutional review boards at 21 CFR 56.106.

Likely Respondents: Institutions or organizations operating IRBs that review human subjects research conducted or supported by HHS, or, in the case of FDA's requirements, each IRB in the United States that reviews clinical investigations regulated by FDA under sections 505(i) or 520(g) of the Federal Food, Drug and Cosmetic Act; and each IRB in the United States that reviews clinical investigations that are intended to support applications for research or marketing permits for FDA-regulated products.

Estimate Annualized Burden in Hours Table

Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden hours
IRB Registration Update	5,650	2	30/60	5,650
IRB Registration Initial and Update	350	2	45/60	525
Total				6,175

Terry Clark,

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