Proposed Collection; 60-Day Comment Request Inclusion Enrollment Report Form (OD), 21324 [2021-08407]

Download as PDF 21324 Federal Register / Vol. 86, No. 76 / Thursday, April 22, 2021 / Notices 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. 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 SUMMARY: 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 NIHdefined 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. 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 ProjectClearanceBranch@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. 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 SUPPLEMENTARY INFORMATION: ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Information collection forms Number of responses per respondent Average burden per response (in hours) Total annual burden hours Inclusion Enrollment Report Form ................................................................... 5,030 1 3 15,090 Total Annual Burden Hours ...................................................................... ........................ 5,030 ........................ 15,090 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose VerDate Sep<11>2014 19:20 Apr 21, 2021 Jkt 253001 confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: NIGMS Initial Review Group; Training and Workforce Development Subcommittee—A Review of T32 Applications. Date: June 8, 2021. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Natcher Building, 45 Center Drive, Bethesda, MD 20892 (Video Meeting). Contact Person: Isaah S. Vincent, Ph.D., Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, Room 3AN12L, Bethesda, MD 20892, 301–594–2948, isaah.vincent@ nih.gov. PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 Name of Committee: NIGMS Initial Review Group; Training and Workforce Development Subcommittee—C Review of PREP and IMSD Applications. Date: June 21–22, 2021. Time: 8:45 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Natcher Building, 45 Center Drive, Bethesda, MD 20892 (Video Meeting). Contact Person: Lee Warren Slice, Ph.D., Scientific Review Officer, Office of Scientific Review, National Institutes of General Medical Sciences, National Institutes of Health, 45 Center Drive, Room 3AN18A, Bethesda, MD 20814, 301–435–0807, slicelw@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives; 93.859, E:\FR\FM\22APN1.SGM 22APN1

Agencies

[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.

-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
          Information collection forms               Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
Inclusion Enrollment Report Form................           5,030               1               3          15,090
                                                 ---------------------------------------------------------------
    Total Annual Burden Hours...................  ..............           5,030  ..............          15,090
----------------------------------------------------------------------------------------------------------------


    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


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