2014-30057. Submission for OMB Review; 30-Day Comment Request; NIMH Data Repositories Data Submission Request; NIMH Data Repositories Data Access and Use Certification

SUMMARY:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) 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 October 7, 2014, page 60479 and allowed 60-days for public comment. No public 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: 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

NIMH Data Repositories (NDR) Data Submission Request—Revision 0925-0667; the NIMH Data Repositories Data Access and Use Certification—National Institute of Mental Health (NIMH), National Institutes of Health (NIH).

Need and Use of Information Collection: The National Institutes of Mental Health (NIMH) Data Repositories are a group of Federal data repositories based on an informatics platform for human-subjects research domains related to mental health, initially established as the National Database for Autism Research (NDAR) to support autism-related research. In 2013, NIMH received approval from OMB for use of the NIMH Data Access Request and Use Certification (DUC) Form to meet the unique data access needs of all existing NIMH data repositories, which at the time consisted of NDAR, Pediatric MRI (PedsMRI), and the NIMH Clinical Research Datasets (NCRD)—OMB# 0925-0667 (Expiration: 09/30/2016). Now in 2014, two new databases have been added and integrated into the NDAR infrastructure, NDCT and RDoCdb. At this time, NIMH is seeking OMB approval to add an all-purpose NIMH Data Repositories Data Submission Request Form and to revise the all-purpose NIMH Data Repositories Data Access and Use Certification Form. As the data repositories have matured, and with the introduction of the new databases—namely NDCT and RDoCdb—the information being collected for data submission has become more complex, rendering an OMB-approved submission form a new necessity.

OMB approval is requested for three years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 221.

Estimated Annualized Burden Hours

Form	A. Estimates annual burden hours
	Number of respondents	Frequency of response	Average time per response (in hours)	Annual burden hour
NIMH Data Repositories Data Submission Request Form	40	1	95/60	63
NIMH Data Repositories Data Access and Use Certification Form	100	1	95/60	158

Dated: December 15, 2014.

Keisha Shropshire,

NIMH Project Clearance Officer, NIMH, NIH.