Proposed Collection; 60-Day Comment Request; Inclusion Enrollment Report Form (Office of the Director)

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed 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 ProjectClearanceBranch@mail.nih.gov. 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: The Inclusion Enrollment Report Form, Revision, OMB 0925-0770, Expiration Date 09/30/2024, 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. 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.