Notice2024-02649
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 9, 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 28 (Friday, February 9, 2024)</title>
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[Federal Register Volume 89, Number 28 (Friday, February 9, 2024)]
[Notices]
[Page 9163]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-02649]
[[Page 9163]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-new]
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 9, 2024.
ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#d083b8b5a2a2b5a4a4b5fe96a5bebe90b8b8a3feb7bfa6"><span class="__cf_email__" data-cfemail="702318150202150404155e36051e1e301818035e171f06">[email protected]</span></a> or by calling
(202) 264-0041 and <a href="/cdn-cgi/l/email-protection#1c4c4e5d5c54544f325b534a"><span class="__cf_email__" data-cfemail="e5b5b7a4a5adadb6cba2aab3">[email protected]</span></a>.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-New-60D and
project title for reference, to Sherrette A. Funn, email:
<a href="/cdn-cgi/l/email-protection#a8fbc0cddadacddcdccd86eeddc6c6e8c0c0db86cfc7de"><span class="__cf_email__" data-cfemail="eab9828f98988f9e9e8fc4ac9f8484aa828299c48d859c">[email protected]</span></a>, <a href="/cdn-cgi/l/email-protection#7d2d2f3c3d35352e533a322b"><span class="__cf_email__" data-cfemail="cf9f9d8e8f87879ce1888099">[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: Research Misconduct and Noncompliance in
Clinical Trials and Translational Research.
Type of Collection: New.
OMB No.: 0990-XXXX.
Abstract: The Department of Health and Human Services (HHS) Office
of Research Integrity (ORI) has partnered with the Office for Human
Research Protections (OHRP) to launch this data collection effort to
better understand how to serve those who might benefit from additional
education and resources to improve research integrity. ORI and OHRP
have found that researchers, Institutional Review Board (IRB) Chairs,
Research Integrity Officers (RIOs), Human Protections and Compliance
Officers, and Human Protections Administrators, who oversee the conduct
of research involving human research subjects, may struggle with
identifying reportable noncompliance or unanticipated problems,
protocol violations, protocol deficiencies, and falsifications and
fabrications of data and methods in that research. Failure to recognize
these concerns may result in noncompliance, protocol violations and
research misconduct not being adequately addressed; falsified and/or
fabricated methods, data, and results that may be published or used to
obtain federal funding; human research subjects being harmed; and/or
Public Health Service (PHS) funds not being protected.
This data collection is a new request and includes an online survey
instrument used with stakeholders holding positions at institutions
holding a Federalwide Assurance (FWA) and/or operating an IRB, and is
designed to identify barriers in the identification, evaluation, and
reporting of potential research misconduct, protocol violations,
reportable noncompliance, and unanticipated problems in research that
involves human subjects. This data collection is intended to assist ORI
and OHRP in developing approaches to improve how to identify and
distinguish incidents that are reportable to ORI and OHRP from those
that do not require reporting to these offices. This information is
also intended to give RIOs, IRBs, human protections administrators,
compliance officers, and other institutional officials involved with
human subjects' research insight into how they can strengthen their
policies and procedures for identifying, evaluating, and/or
communicating potential research misconduct and reportable
noncompliance and unanticipated problems by identifying gaps, barriers,
and areas in which communication and education may need to be enhanced
within their institution.
Annualized Burden Hour Table
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Number of
Forms (If necessary) Respondents Number of responses per Average burden Total burden
(If necessary) respondents respondents per response hours
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ORI/OHRP Survey.................................................... ............... 1165 1 20/60 388
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Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2024-02649 Filed 2-8-24; 8:45 am]
BILLING CODE 4150-36-P
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