National Institutes of Health

SUMMARY:

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Mental Health (NIMH), 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.

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.

To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Keisha Shropshire, NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, or call 301-443-4335 or Email your request, including your address to: kshropsh@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.

Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

Proposed Collection: The National Institute of Mental Health Data Access Request and Use Certification (previously National Database for Autism Research Data Access Request), 0925-0667, Revision, Expiration Date: 01/31/2016; NIMH, NIH.

Need and Use of Information Collection: NIMH recently received OMB approval for use of the National Database for Autism Research (NDAR) Data Use Certification (DUC) Form. NIMH is interested in renaming this form the “NIMH Data Access Request and Use Certification (DUC) Form” and using it to meet the unique data access needs of all NIMH data repositories. The NIMH DUC form is necessary for “Recipient” Principal Investigators and their organization or corporations with approved assurance from the DHHS Office of Human Research Protections to access data or images from NIMH repositories and datasets for research purposes. The primary use of this information is to document, track, monitor, and evaluate the use of the NIMH repositories/datasets, as well as to notify interested recipients of updates, corrections or other changes to the database. There are currently three data repositories/sets positioned to use the NIMH DUC form: NDAR, the NIH Pediatric MRI Data Repository (PedsMRI), and the NIMH Clinical Research Datasets (NCRD).

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 380.