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AGENCY:
National Institutes of Health, HHS.
ACTION:
Notice.
SUMMARY:
In compliance with the requirement 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.
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 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 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 ProjectClearanceBranch@mail.nih.gov. 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 July 23, 2024, pages 59746-59747 (89 FR 59746) 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.
The Office of the Director, Office of Extramural Research (OER), National Institutes of Health (NIH), may not conduct or sponsor. 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 Office of Management and Budget (OMB) control number.
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, NIH has submitted to OMB a request for review and approval of the information collection listed below.
Proposed Collection Title: The Inclusion Enrollment Report Form, OMB 0925-0770, Expiration Date 09/30/2024; Extension, 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 without change. 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
| Form name | Type of respondent | Number of respondents | Number of responses per respondent | Average burden per response (in hours) | Total annual burden hours |
|---|---|---|---|---|---|
| Inclusion Enrollment Report Form | Grant Applicant/Recipient | 67,888 | 1 | 3 | 203,664 |
| Total | 67,888 | 203,664 |