Notice2024-16094
Proposed Collection; 60-Day Comment Request; Inclusion Enrollment Report Form (Office of the Director)
Primary source
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Published
July 23, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Full Text
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<title>Federal Register, Volume 89 Issue 141 (Tuesday, July 23, 2024)</title>
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[Federal Register Volume 89, Number 141 (Tuesday, July 23, 2024)]
[Notices]
[Pages 59746-59747]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-16094]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Inclusion Enrollment
Report Form (Office of the Director)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, for opportunity for public comment on proposed data
collection projects, the National Institutes of Health (NIH) will
publish periodic summaries of proposed projects to be submitted to the
Office of Management and Budget (OMB) for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: Ms. Mikia P.
Currie, Program
[[Page 59747]]
Analyst, Office of Policy for Extramural Research Administration, 6705
Rockledge Drive, Suite 350, Bethesda, Maryland 20892, or call a non-
toll-free number 301-435-0941 or email your request, including your
address to <a href="/cdn-cgi/l/email-protection#4010322f2a252334032c252132212e23250232212e2328002d21292c6e2e29286e272f36"><span class="__cf_email__" data-cfemail="7525071a1f1016013619101407141b16103707141b161d3518141c195b1b1c1d5b121a03">[email protected]</span></a>. Formal requests for
additional plans and instruments must be requested in writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written comments and/or suggestions
from the public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) The
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) Ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) Ways to minimize
the burden of the collection of information on those who are to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Proposed Collection Title: The Inclusion Enrollment Report Form,
Revision, OMB 0925-0770, Expiration Date 09/30/2024, Office of the
Director (OD), National Institutes of Health (NIH).
Need and Use of Information Collection: NIH's Office of Extramural
Research (OER) Office of Policy and Extramural Research Administration
(OPERA) is renewing The Inclusion Enrollment Report Form. The Inclusion
Enrollment Report Form is used for all applications involving NIH-
defined clinical research. This form is used to report both planned and
cumulative (or actual) enrollment and describes the sex/gender, race,
and ethnicity of the study participants. Since the last OMB approval,
there has been no change to NIH policies on the inclusion of clinical
research participants.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 203,664.
Estimated Annualized Burden Hours
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Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
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Grant Applicant/Recipient...................... 67,888 1 3 203,664
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Total...................................... 67,888 67,888 203,664
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Dated: July 15, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2024-16094 Filed 7-22-24; 8:45 am]
BILLING CODE 4140-01-P
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