Web-Based Assessment of the Clinical Studies Support Center (CSSC)

Forms and Documents

Document Name	Status
Form 4 Board Members Form and Instruction	New
Form 3 Board Chairs Form and Instruction	New
CSSC Assessment Supporting Statement B - V 4.docx Supporting Statement B	2012-05-29
Attachment #7 Certification of Westat IRB Board.pdf Supplementary Document	2012-05-29
Attachment #6 Study Summary CSSC Web-Based Assessment.docx Supplementary Document	2012-05-29
Attachment #2 CSSC Assessment Email to Chairs and Members.docx Supplementary Document	2012-05-29
Attachment #1 CSSC Letter from NHLBI to Board Chairs and Members.docx Supplementary Document	2012-05-29
CSSC Assessment Supporting Statement A - V 5.docx Supporting Statement A	2012-05-29

IC Document Collections

IC ID	Document Title	Status
202520	Board Members Form and Instruction	New
202519	Board Chairs Form and Instruction	New

ICR Details

OMB Control No: 0925-0662	ICR Reference No: 201205-0925-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Web-Based Assessment of the Clinical Studies Support Center (CSSC)
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: 06/27/2012
	Date Received in OIRA: 05/31/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2015	36 Months From Approved
Responses	90	0	0
Time Burden (Hours)	30	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: A Web-based questionnaire will be administered to Chairs and members of monitoring boards to learn their opinions about specific CSSC activities and their satisfaction with the performance of CSSC staff.

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Authorizing Statute(s): None

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:
	77 FR 14531	03/12/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 31027	05/24/2012
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Board Chairs	3, 5a	Chair Questionaire ,   Assessment Screens Chairs
Board Members	4, 5b	Member Questionaire ,   Assessment Screens Members

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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	90	0	0	90	0	0
Annual Time Burden (Hours)	30	0	0	30	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 submission constitutes a new collection of information.

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Annual Cost to Federal Government: $32,000

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]? 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

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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: 05/31/2012

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