Notice2024-06803
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
April 1, 2024
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 89 Issue 63 (Monday, April 1, 2024)</title>
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[Federal Register Volume 89, Number 63 (Monday, April 1, 2024)]
[Notices]
[Page 22413]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-06803]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0263]
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 May 31, 2024.
ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#8bd8e3eef9f9eeffffeea5cdfee5e5cbe3e3f8a5ece4fd"><span class="__cf_email__" data-cfemail="d083b8b5a2a2b5a4a4b5fe96a5bebe90b8b8a3feb7bfa6">[email protected]</span></a> or by calling
(202) 264-0041 and <a href="/cdn-cgi/l/email-protection#97c7c5d6d7dfdfc4b9d0d8c1"><span class="__cf_email__" data-cfemail="5d0d0f1c1d15150e731a120b">[email protected]</span></a>.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-0263-60D and
project title for reference, to Sherrette A. Funn, email:
<a href="/cdn-cgi/l/email-protection#d685beb3a4a4b3a2a2b3f890a3b8b896bebea5f8b1b9a0"><span class="__cf_email__" data-cfemail="86d5eee3f4f4e3f2f2e3a8c0f3e8e8c6eeeef5a8e1e9f0">[email protected]</span></a>, <a href="/cdn-cgi/l/email-protection#86d6d4c7c6ceced5a8c1c9d0"><span class="__cf_email__" data-cfemail="96c6c4d7d6dedec5b8d1d9c0">[email protected]</span></a> or call (202) 264-0041 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: Protection of Human Subjects: Assurance
Identification/IRB Certification/Declaration of Exemption Form.
Type of Collection: Renewal, three-year extension with non-
substantive changes for the Protection of Human Subjects: Assurance
Identification/IRB Certification/Declaration of Exemption Form OMB No.
0990-0263 Office of the Assistant Secretary for Health, Office for
Human Research Protections.
Abstract: The Office of the Assistant Secretary for Health, Office
for Human Research Protections is requesting is requesting a three-year
extension with non-substantive changes of the Protection of Human
Subjects: Assurance Identification/IRB Certification/Declaration of
Exemption Form, OMB No. 0990-0263.
The information collected on the form is to provide a simplified
method for institutions engaged in research conducted or supported by
the Department of Health and Human Services (HHS) to satisfy the
requirements of HHS regulations for the protection of human subjects at
45 CFR 46.103 for assurance identification and institutional review
board (IRB) certification and declare exemption status. Non-substantive
changes include adding instructions that, if additional assurances
apply, those details can be indicated in the ``Comments'' section and
clarifying that the form element for IRB expiration date does not apply
to all projects.
Likely Respondents: Institutions engaged in research involving
human subjects where the research is supported by HHS. Institutional
use of the form is also relied upon by other Federal departments and
agencies that have codified or follow the Federal Policy for the
Protection of Human Subjects (Common Rule), which is codified for HHS
at 45 CFR part 46, subpart A.
Annualized Burden Hour Table
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Number of
Form name Number of responses per Hours per Response burden
respondents respondent response hours
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Protection of Human Subjects: Assurance 13,000 2 0.5 13,000
Identification/IRB Certification/
Declaration of Exemption...................
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Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2024-06803 Filed 3-29-24; 8:45 am]
BILLING CODE 4150-36-P
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</html>Indexed from Federal Register on April 1, 2024.
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