National Institute of Neurological Disorders and Stroke Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Access Request (NINDS)

Forms and Documents

Document	Type	Status	Availability
Form 1 FITBIR Informatics System Data Access Request	Form and Instruction	New	Available
Form 1 FITBIR Data Access Request	Form and Instruction	Removed	Available
Attachment D.pdf	Supplementary Document	Uploaded 2016-10-06	Available
FITBIR reinstatement with change SSA FINAL for amendment 10-05-16.doc	Supporting Statement A	Uploaded 2016-10-06	Available
30-day FRN2016-22561.pdf	Supplementary Document	Uploaded 2016-09-19	Available
Attachment C FITBIR Committee.docx	Supplementary Document	Uploaded 2016-09-13	Available
Attachment B PIA.pdf	Supplementary Document	Uploaded 2016-09-13	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
223513	FITBIR Informatics System Data Access Request	Form and Instruction	New
207552	FITBIR Data Access Request	Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0677	ICR Reference No: 201609-0925-001
Status: Historical Active	Previous ICR Reference No: 201306-0925-009
Agency/Subagency: HHS/NIH	Agency Tracking No: 19810
Title: National Institute of Neurological Disorders and Stroke Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Access Request (NINDS)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/21/2016
	Date Received in OIRA: 09/20/2016
Terms of Clearance: Approved consistent with the understanding that any digital or paper instruments associated with this collection will visibly display the approved OMB control number, burden statement, and expiration date.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2019	36 Months From Approved	08/31/2016
Responses	40	0	40
Time Burden (Hours)	63	0	63
Cost Burden (Dollars)	0	0	0

---

Abstract: The primary uses of this information are 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. As data submission and access procedures are maturing, NIH has developed a Data Access Request Form more tailored to the unique needs of FITBIR.

---

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:
	81 FR 44644	07/08/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 64182	09/19/2016
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
FITBIR Informatics System Data Access Request	1	Attachment A

---

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	40	0	0	0	0
Annual Time Burden (Hours)	63	63	0	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: NINDS plans to continue to document, track, monitor and evaluate the use of the FITBIR datasets by collecting information from investigators in the future but the current OMB approval of the NINDS FITBIR Data Access Request (OMB #0925-0677) expired on 08/31/2016 and 60-day comment period extended beyond expiration. Therefore, this is a request to reinstate it for another 3 years, with change to the original request. Additional questions are added to the currently approved form to collect more detailed information about the investigator’s project (e.g., project’s summary/abstract) as well as supplementary information that identifies the investigator’s collaborators on the project, if applicable. We do not think this will significantly increase their burden hours because investigators can simply copy and paste their existing abstracts they have written for grants, scientific meetings or conferences.

---

Annual Cost to Federal Government: $8,407

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: 09/20/2016

---