[Federal Register Volume 86, Number 76 (Thursday, April 22, 2021)]
[Notices]
[Page 21324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08407]



[[Page 21324]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request Inclusion Enrollment 
Report Form (OD)

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 to provide opportunity for public comment on proposed data 
collection projects, the National Institutes of Health (NIH) will 
publish periodic summaries of propose 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 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: Inclusion Enrollment Report Form 
Conversion to Common Form, NEW, 0925-XXXX, Expiration Date XX/XX/XXXX, 
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 converting the Inclusion Enrollment Report form to allow its 
use by the Department of Defense (DoD). The Inclusion Enrollment Report 
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.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 15,090.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
          Information collection forms               Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)     burden hours
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Inclusion Enrollment Report Form................           5,030               1               3          15,090
                                                 ---------------------------------------------------------------
    Total Annual Burden Hours...................  ..............           5,030  ..............          15,090
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    Dated: April 16, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2021-08407 Filed 4-21-21; 8:45 am]
BILLING CODE 4140-01-P