Notice2021-17037
Submission for OMB Review; 30-Day Comment Request; Inclusion Enrollment Report Form Conversion to Common Form, Office of the Director (OD)
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
August 9, 2021
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 150 (Monday, August 9, 2021)</title>
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[Federal Register Volume 86, Number 150 (Monday, August 9, 2021)]
[Notices]
[Pages 43558-43559]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 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
<a href="/cdn-cgi/l/email-protection#7c2c0e1316191f083f10191d0e1d121f193e0e1d121f143c111d151052121514521b130a"><span class="__cf_email__" data-cfemail="663614090c030512250a0307140708050324140708050e260b070f0a48080f0e48010910">[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 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
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