[Federal Register Volume 86, Number 150 (Monday, August 9, 2021)]
[Notices]
[Pages 43558-43559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17037]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; Inclusion 
Enrollment Report Form Conversion to Common Form, Office of the 
Director (OD)

AGENCY: National Institutes of Health, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: In compliance with 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

[[Page 43559]]

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 request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact: Tawanda Abdelmouti, Program Analyst, Office of 
Policy for Extramural Research Administration, 6705 Rockledge Drive, 
Suite 805-C, Bethesda, Maryland 20892, or call a non-toll-free number 
301-435-0978 or Email your request, including your address to 
[email protected]. 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 April 22, 2021, page 
21324 (86 FR 21234) and allowed 60 days for public comment. No public 
comments were received. The purpose of this notice is to allow an 
additional 30 days for public comment. Office of the Director, Office 
of Extramural Research (OER), National Institutes of Health, may not 
conduct or sponsor, and 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 OMB control number.
    In compliance with Section 3507(a)(1)(D) 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.
    Proposed Collection: Inclusion Enrollment 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 194,574.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total annual
          Information  collection forms             respondents   responses  per   response  (in   burden hours
                                                                     respondent       hours)
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Inclusion enrollment form.......................          64,858               1               3         194,574
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    Total.......................................  ..............          64,858  ..............         194,574
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    Dated: July 30, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2021-17037 Filed 8-6-21; 8:45 am]
BILLING CODE 4140-01-P