2013-15014. Submission for OMB review; 30-Day Comment Request; Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System Data Access Request

SUMMARY:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act (PRA) of 1995, the National Institute of Neurological Disorders and Stroke (NINDS), 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 February 22, 2013, pages 12334-12335 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 Neurological Disorders and Stroke, 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 request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Rebecca L. Frederick, Office of Science Policy and Planning, OSPP, NINDS, NIH, 31 Center Drive, Building 31, Room 8A03, Bethesda, MD 20892; call 301-496-9271; or Email your request, including your address to: [e-mail]. Formal requests for additional plans and instruments must be requested in writing.

Proposed Collection: Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System Data Access Request. 0925-NEW. National Institute of Neurological Disorders and Stroke.

Need and Use of Information Collection: The FITBIR Informatics System Data Access Request 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 the FITBIR Informatics System for research purposes. The primary use of this information is to document, track, monitor, and evaluate the use of the FITBIR datasets, as well as to notify interested recipients of updates, corrections or other changes to the database.

There are two scenarios for completing the form. The first is where the Principal Investigator (PI) completes the entire FITBIR Informatics System Data Access Request form, and the second where the PI has the Research Assistant begins filling out the form and PI provides the final reviews and signs it.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 63.

Estimated Annual Burden Hours

Form	Number of respondents	Frequency of response	Average time per response (in hours)	Annual hour burden
FITBIR Informatics System Data Access Request	40	1	95/60	63
Total				63

Dated: June 14, 2013.

Caroline Lewis,

Executive Officer, National Institute of Neurological Disorders and Stroke, NIH.