[Federal Register Volume 89, Number 141 (Tuesday, July 23, 2024)]
[Notices]
[Pages 59746-59747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 [email protected]. 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