[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Notices]
[Pages 53883-53884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23282]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-0279]


Agency Information Collection Activities; Proposed Collection; 
Public Comment Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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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 [email protected] or by calling 
(202) 795-7714.

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 [email protected], 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
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                                                                     Number of    Average burden
                    Form name                        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
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IRB Registration Update.........................           5,650               2           30/60           5,650

[[Page 53884]]

 
IRB Registration Initial and Update.............             350               2           45/60             525
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    Total.......................................  ..............  ..............  ..............           6,175
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Terry Clark,
Asst Paperwork Reduction Act Reports Clearance Officer, Office of the 
Secretary.
[FR Doc. 2018-23282 Filed 10-24-18; 8:45 am]
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