Notice2022-11064
Agency Information Collection Request; 30-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
May 24, 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 100 (Tuesday, May 24, 2022)</title>
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[Federal Register Volume 87, Number 100 (Tuesday, May 24, 2022)]
[Notices]
[Pages 31569-31570]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-11064]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0279]
Agency Information Collection Request; 30-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 June 23, 2022.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, <a href="/cdn-cgi/l/email-protection#96c5fef3e4e4f3e2e2f3b8d0e3f8f8d6fefee5b8f1f9e0"><span class="__cf_email__" data-cfemail="a2f1cac7d0d0c7d6d6c78ce4d7cccce2cacad18cc5cdd4">[email protected]</span></a>
or (202) 795-7714. When submitting comments or requesting information,
please include the document identifier 0990-0279-30D and project title
for reference.
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 Form.
Type of Collection: Reinstatement without change.
OMB No.: 0990-0279.
[[Page 31570]]
Abstract: The Office of the Assistant Secretary for Health, Office
for Human Research Protections is requesting reinstatement of the
Office of Management and Budget (OMB) No. 0990-0279, Department of
Health and Human Services (HHS) Institutional Review Board (IRB)
Registration Form, with no changes, for a three-year period. That form
was previously approved by OMB on February 4, 2019 and expired on
February 28, 2022. The purpose of the IRB Registration Form is to
provide a simplified procedure for: (1) Institutions engaged in
research conducted or supported by HHS to satisfy the HHS regulations
for the protection of human subjects at 45 CFR 46.103(b) and 45 CFR
46.107 as promulgated in 1991 (56 FR 28012, 28022) and amended on June
23, 2005 (70 FR 36325), and 45 CFR 46, subpart E, Registration of
Institutional Review Boards; and, (2) IRBs, in the United States (US),
to satisfy the FDA IRB regulations 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.
Annualized Burden Hour Table
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Number of
IRB registration form Number of responses per Average burden Total burden
respondents respondent per response hours
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Update and Renew Registration................... 5,650 2 30/60 5,650
Initial and Update Registration................. 350 2 45/60 525
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Total....................................... .............. .............. .............. 6,175
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Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2022-11064 Filed 5-23-22; 8:45 am]
BILLING CODE 4150-36-P
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