Quality of Life Outcomes in Neurological Disorders (NINDS)

Forms and Documents

Document Name	Status
Form 1 Neuro-QOL Form Form and Instruction	New
OMB_application_part B_06-23-8_NIH(revised).doc Supporting Statement B	2008-06-26
Attachment 6 - ENH_ IRB_Approval_Amendment 4.pdf Supplementary Document	2008-06-26
Attachment 5 - ENH IRB Report.pdf Supplementary Document	2008-06-26
Attachment 4 (rev) - IPSOS Privacy Policy.doc Supplementary Document	2008-06-26
Attachment 3 (rev) - IPSOS Invitation.doc Supplementary Document	2008-06-26
Attachment 2 - public comment.doc Supplementary Document	2008-06-26
Attachment 1 Consultants.doc Supplementary Document	2008-06-26
OMB_application_part A_6-23-08_NIH (revised).doc Supporting Statement A	2008-06-26

IC Document Collections

IC ID	Document Title	Status
184026	Neuro-QOL Form Form and Instruction	New

ICR Details

OMB Control No: 0925-0592	ICR Reference No: 200803-0925-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Quality of Life Outcomes in Neurological Disorders (NINDS)
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 with change	Conclusion Date: 07/01/2008
	Date Received in OIRA: 03/04/2008
Terms of Clearance: NIH and OMB agree that this is not a representative sample and will not be used or characterized as such.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2011	36 Months From Approved
Responses	9,000	0	0
Time Burden (Hours)	4,500	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The NINDS Clinical Trials program has been established to support all clinical studies of the neurological disorders and to support development of scientific methodology to advance clinical research in neurology. A key component of the clinical research agenda is conduct of clinical trials to evaluate potential intervention and prevention strategies for neurological disorders.

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Authorizing Statute(s): US Code: 42 USC 285j Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 54269	09/24/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 2925	01/16/2008
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Neuro-QOL Form	1, 2	Survey ,   Survey-Excel

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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	9,000	0	0	9,000	0	0
Annual Time Burden (Hours)	4,500	0	0	4,500	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 information collection request.

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Annual Cost to Federal Government: $163,625

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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: 03/04/2008

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