Agency Information Collection Request. 60-Day Public Comment Request, 9163 [2024-02649]
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9163
Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–new]
Agency Information Collection
Request. 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
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
Sherrette.Funn@hhs.gov or by calling
(202) 264–0041 and PRA@HHS.GOV.
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:
Sherrette.Funn@hhs.gov, PRA@
HHS.GOV 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
SUMMARY:
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
Forms
(If necessary)
Respondents
(If necessary)
Number of
respondents
Number of
responses per
respondents
Average
burden per
response
Total
burden
hours
ORI/OHRP Survey ...............................................................
........................
1165
1
20/60
388
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
ddrumheller on DSK120RN23PROD with NOTICES1
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Infectious Disease and
HIV/AIDS Policy, Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
VerDate Sep<11>2014
17:20 Feb 08, 2024
Jkt 262001
The meeting will be held
February 22–23, 2024. The confirmed
meeting times and agenda will be
posted on the NVAC website at https://
www.hhs.gov/nvpo/nvac/meetings/
index.html as soon as they become
available.
DATES:
Meeting of the National Vaccine
Advisory Committee
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) hereby gives notice that
the National Vaccine Advisory
Committee (NVAC) will hold an inperson meeting. The meeting will be
open to the public and public comment
will be heard during the meeting.
SUMMARY:
Instructions regarding
attending this meeting will be posted
ADDRESSES:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
online at: https://www.hhs.gov/nvpo/
nvac/meetings/ at least one
week prior to the meeting. Preregistration is required for those who
wish to attend the meeting in person or
participate in public comment. Please
register at https://www.hhs.gov/nvpo/
nvac/meetings/.
Ann
Aikin, Acting Designated Federal
Officer, Office of Infectious Disease and
HIV/AIDS Policy, U.S. Department of
Health and Human Services, Tower
Building, Room, 1101 Wootton
Parkway, Rockville, MD 20852. Email:
nvac@hhs.gov. Phone: 202–795–7697.
FOR FURTHER INFORMATION CONTACT:
Pursuant
to section 2101 of the Public Health
SUPPLEMENTARY INFORMATION:
E:\FR\FM\09FEN1.SGM
09FEN1
]]>Agencies
[Federal Register Volume 89, Number 28 (Friday, February 9, 2024)]
[Notices]
[Page 9163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.
-----------------------------------------------------------------------
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 [email protected] or by calling
(202) 264-0041 and [email protected].
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:
[email protected], [email protected] 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Forms (If necessary) Respondents Number of responses per Average burden Total burden
(If necessary) respondents respondents per response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
ORI/OHRP Survey.................................................... ............... 1165 1 20/60 388
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
