Notice2022-03239
Agency Information Collection Request; 60-Day Public Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 16, 2022
Issuing agencies
Health and Human Services Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 32 (Wednesday, February 16, 2022)</title>
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[Federal Register Volume 87, Number 32 (Wednesday, February 16, 2022)]
[Notices]
[Pages 8853-8854]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="/cdn-cgi/l/email-protection#14477c716666716060713a52617a7a547c7c673a737b62"><span class="__cf_email__" data-cfemail="56053e332424332222337810233838163e3e2578313920">[email protected]</span></a> 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:
<a href="/cdn-cgi/l/email-protection#bbe8d3dec9c9decfcfde95fdced5d5fbd3d3c895dcd4cd"><span class="__cf_email__" data-cfemail="62310a071010071616074c24170c0c220a0a114c050d14">[email protected]</span></a>, 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
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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
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