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Proposed Collection; Comment Request: Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System Data Access Request

---
identifier: "/us/fr/2013-04130"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Proposed Collection; Comment Request: Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System Data Access Request"
title_number: 0
title_name: "Federal Register"
section_number: "2013-04130"
section_name: "Proposed Collection; Comment Request: Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System Data Access Request"
positive_law: false
currency: "2013-02-22"
last_updated: "2013-02-22"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2013-04130"
document_type: "notice"
publication_date: "2013-02-22"
agencies:
  - "Health and Human Services Department"
  - "National Institutes of Health"
fr_citation: "78 FR 12334"
fr_volume: 78
---

#  Proposed Collection; Comment Request: Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System Data Access Request

**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 Neurological Disorders and Stroke (NINDS), the 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 to address 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) The quality, utility, and clarity of the information to be collected; and (4) 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.

**FOR FURTHER INFORMATION CONTACT:**

To request more information on the proposed project, obtain a copy of the data collection plans and instruments, or to submit written comments, 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: *[email protected].*

*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:* Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System Data Access Request.

*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.

*Frequency of Response:* Once per request.

*Affected Public:* Individuals.

*Type of Respondents:* Researchers interested in obtaining access to study data and images from the FITBIR Informatics System for research purposes.

The annual reporting burden is as follows *:*

*Estimated Number of Respondents:* approximately 40.

*Estimated Number of Responses per Respondent:* Once per request.

*Average Burden Hours per Response:* 95/60.

*Estimated Total Annual Burden Hours Requested:* 63.

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. The estimated annual burden hours to complete the data request form are listed below.

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

Dated: February 13, 2013.

Caroline Lewis,

Executive Officer, National Institute of Neurological Disorders and Stroke, National Institutes of Health.