Change Request Memo

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

National Institutes of Health

National Institute of Mental Health

6001 Executive Boulevard

Bethesda, Maryland 20892

DATE: June 17, 2025

TO: Office of Management and Budget (OMB)

Through: Project Clearance Chief, Mikia Currie, NIH

Project Clearance Liaison, Andrew A. Hooper, NIMH

FROM: Ruben Alvarez

National Institute of Mental Health (NIMH)

SUBJECT: National Institute of Mental Health Data Archive (NDA) (OMB Control #0925-0667, Expiration Date 06/30/2026)

This is a request for OMB to approve non-substantive changes to the NIMH NDA data collection instruments approved on June 23rd, 2023, under the submission entitled, “National Institute of Mental Health Data Archive (NDA)”, OMB Control #0925-0667, Expiration Date 06/30/2026.

Through these instruments, NIMH seeks to collect information from researchers who submit data and request access to shared data in the NIMH Data Archive (NDA). We are requesting approval of minor changes to the Data Use Certificate and Data Submission Agreement instruments, in order to update URLs, simplify language, and include new attestations to indicate awareness and compliance with revised standards of data security. Please note, these updates do not change the respondent time or cost burden estimates. The changes to the form will not meaningfully alter the content, scope, or method of the information collection; and are described in detail below.

Updates to the Data Collection Instruments:

• For the Data Use Certificate, improve explanation of users’ responsibilities for temporary data stewardship

• For the Data Use Certificate, improve description of terms of access violations and instructions for user responses

• For the Data Use Certificate, improve instructions for termination and data destruction

• For the Data Use Certificate, include attestation check boxes for compliance with data security expectation and compliance with NIH security best practices for users of controlled-access data

• For the Data Submission Agreement, improve readability and redirect outdated URLs

Attachments:

1. Revised tracked copy of the NIMH NDA Data Use Certification

2. Revised clean copy of the NIMH NDA Data Use Certification

3. Revised tracked copy of the NIMH NDA Data Submission Agreement

4. Revised clean copy of the NIMH NDA Data Submission Agreement