[Federal Register Volume 87, Number 32 (Wednesday, February 16, 2022)]
[Notices]
[Pages 8853-8854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03239]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Document Identifier: OS-0990-0279]


Agency Information Collection Request; 60-Day 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 April 18, 
2022.

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 0990-0279-60D and 
project title for reference, to Sherrette A. Funn, email: 
[email protected], or call (202) 795-7714 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.
    Title of the Collection: Department of Health and Human Services 
(HHS) Registration of an Institutional Review Board (IRB) Form.
    Type of Collection: Extension.
    OMB No.: 0990-0279.
    Abstract: The Office of the Assistant Secretary for Health, Office 
for Human Research Protections is requesting a three-year extension of 
the Department of Health and Human Services (HHS) Registration of an 
Institutional Review Board (IRB) Form, OMB No. 0990-0279. 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.

[[Page 8854]]



                                          Annualized Burden Hour Table
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                                                                     Number of
              IRB registration form                  Number of     responses per  Average burden   Total burden
                                                    respondents     respondents    per response        hours
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Update and Renew Registration...................           5,800               2             0.5           5,800
Initial and Update Registration.................             400               2           1/0.5             600
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............           6,400
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Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the 
Secretary.
[FR Doc. 2022-03239 Filed 2-15-22; 8:45 am]
BILLING CODE 4150-36-P