NIH Seeks Comments on Brain Cohort Data Form Tweaks
Published Date: 7/31/2026
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 Institute on Drug Abuse (NIDA) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. The purpose of this revision is to update instructions for the Research Data Use Statement and the Progress Report, and to add new instructions for attesting to National Institute of Standards & Technology (NIST) security compliance, and for a Project Close-out at the time of project completion. Burden levels remain unchanged.
Analyzed Economic Effects
4 provisions identified: 0 benefits, 4 costs, 0 mixed.
Signed Data Use Agreement Required
If you want access to NIH Brain Development Cohorts (NBDC) data, you must submit a signed Data Use Certification and a brief description of your research project to the data repository before gaining access. The standard form takes about 1 hour to complete.
Must Attest to NIST Security Compliance
Data recipients must now follow new instructions to attest that they meet National Institute of Standards & Technology (NIST) security compliance as part of the Data Use Certification process. This attestation is added to the instructions for requesting and maintaining access.
Extra Certification for AI/AN Research
If you plan research specifically on American Indian/Alaska Native (AI/AN) populations using NBDC data, you must submit an additional signed Data Use Certification form specifically for AI/AN research. The notice estimates 200 such additional responses annually, each taking about 1 hour.
Time Burden but No Monetary Fees
OMB approval is requested for 3 years and the agency estimates no monetary costs to respondents other than their time. The estimated annualized burden is 2,000 hours total: 1,800 standard individual responses and 200 additional AI/AN responses, each averaging 1 hour.
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