National Institute of Neurological Disorders and Stroke FITBIR Data Access Request

Forms and Documents

Document Name	Status
Form 1 FITBIR Data Access Request Form and Instruction	New
FITBIR_DATA_ACCESS_support_stmt_a_6-14-13.doc Supporting Statement A	2013-06-17

IC Document Collections

IC ID	Document Title	Status
207552	FITBIR Data Access Request Form and Instruction	New

ICR Details

OMB Control No: 0925-0677	ICR Reference No: 201306-0925-009
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No: 19810
Title: National Institute of Neurological Disorders and Stroke FITBIR Data Access Request
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/14/2013
	Date Received in OIRA: 06/26/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2016	36 Months From Approved
Responses	40	0	0
Time Burden (Hours)	63	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: The National Institutes of Health (NIH) created the Federal Interagency Traumatic Brain Injury Research Informatics System, an informatics system and central data repository, housed at the NIH Center for Information Technology, to support and accelerate research on traumatic brain injuries (TBI). FITBIR collects a wide range of data types, including phenotypic and clinical data as well as medical images, derived from individuals who participate in TBI research, regardless of the source of funding. FITBIR provides the infrastructure to store, search across, retrieve, analyze, and share these varied types of data.

---

Authorizing Statute(s): US Code: 42 USC 203 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 4130	02/22/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 37834	06/24/2013
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
FITBIR Data Access Request	1	FITBIR Data Access Request

---

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	40	0	0	40	0	0
Annual Time Burden (Hours)	63	0	0	63	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new ICR.

---

Annual Cost to Federal Government: $8,450

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 06/26/2013

---