[Federal Register Volume 89, Number 188 (Friday, September 27, 2024)]
[Notices]
[Pages 79300-79301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 www.reginfo.gov/public/do/PRAMain. 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)
----------------------------------------------------------------------------------------------------------------
Inclusion Enrollment Report Form  Grant Applicant/          67,888                1            3         203,664
                                   Recipient.
                                                     -----------------------------------------------------------
    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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