2013-19072. Submission for OMB Review; 30-day Comment Request: National Institute of Mental Health Data Access Request and Use Certification

SUMMARY:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Mental Health (NIMH), the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 28, 2013, Volume 78, Number 102, Pages 31947-31948 and allowed 60-days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Mental Health (NIMH), National Institutes of Health, may not conduct or sponsor, and 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 OMB control number.

Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, [e-mail] or by fax to 202-395-6974, Attention: NIH Desk Officer.

DATES:

Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

FOR FURTHER INFORMATION CONTACT:

To obtain a copy of the data collection plans and instruments, 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: [e-mail]. Formal requests for additional plans and instruments must be requested in writing.

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; National Institute of Mental Health (NIMH), National Institutes of Health (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.

Estimated Annualized Burden Hours

Form	Type of respondent	Number of respondents	Frequency of response	Average time per response (in hours)	Annual hour burden
NIMH Data Access Request and Use Certification	Principal Investigators/Research Assistant	240	1	95/60	380

Dated: July 25, 2013.

Sue Murrin,

Executive Officer, NIMH, NIH.