Notice2024-22235
Submission for OMB Review; 30-Day Comment Request; Inclusion Enrollment Form (Office of the Director)
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
September 27, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
In compliance with the requirement of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Full Text
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<title>Federal Register, Volume 89 Issue 188 (Friday, September 27, 2024)</title>
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[Federal Register Volume 89, Number 188 (Friday, September 27, 2024)]
[Notices]
[Pages 79300-79301]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-22235]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Inclusion
Enrollment 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, the National Institutes of Health (NIH) has submitted to
the Office of Management and Budget (OMB) a request for review and
approval of the information collection listed below.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 30-days of the date of
this publication.
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: 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 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#5202203d38373126113e373320333c31371020333c313a123f333b3e7c3c3b3a7c353d24"><span class="__cf_email__" data-cfemail="f1a1839e9b949285b29d949083909f9294b383909f9299b19c90989ddf9f9899df969e87">[email protected]</span></a>.
Formal requests for additional plans and instruments must be requested
in writing.
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on July 23, 2024, pages
59746-59747 (89 FR 59746) and allowed 60 days for public comment. No
public comments were received. The purpose
[[Page 79301]]
of this notice is to allow an additional 30 days for public comment.
The Office of the Director, Office of Extramural Research (OER),
National Institutes of Health (NIH), may not conduct or sponsor. The
respondent is not required to respond to, an information collection
that has been extended, revised, or implemented on or after October 1,
1995, unless it displays a currently valid Office of Management and
Budget (OMB) control number.
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction
Act of 1995, NIH has submitted to OMB a request for review and approval
of the information collection listed below.
Proposed Collection Title: The Inclusion Enrollment Report Form,
OMB 0925-0770, Expiration Date 09/30/2024; Extension, 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 without
change. 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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Average
Number of Number of burden per Total annual
Form name Type of respondent respondents responses per response burden hours
respondent (in hours)
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Inclusion Enrollment Report Form Grant Applicant/ 67,888 1 3 203,664
Recipient.
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Total....................... .................. ............ 67,888 ........... 203,664
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Dated: September 23, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2024-22235 Filed 9-26-24; 8:45 am]
BILLING CODE 4140-01-P
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