National Evaluation of the Clinical and Translational Science Awards (CTSA) Initiative (NCRR)

Forms and Documents

Document Name	Status
Form 4 Mentors Form and Instruction	New
Form 3 Trainees/Scholars Form and Instruction	New
Form 2 Nonusers Form and Instruction	New
Form 1 Users Form and Instruction	New
CTSA OMB stmt B 091710.doc Supporting Statement B	2010-12-20
CTSAEVAL PIA 091710 (2).doc Supplementary Document	2010-12-20
CTSA national evaluation exemption.pdf Supplementary Document	2010-12-20
CTSA OMB stmt A revised 3 31 11 srw.doc Supporting Statement A	2011-04-07

IC Document Collections

IC ID	Document Title	Status
195976	Mentors Form and Instruction	New
195975	Trainees/Scholars Form and Instruction	New
195974	Nonusers Form and Instruction	New
195973	Users Form and Instruction	New

ICR Details

OMB Control No: 0925-0629	ICR Reference No: 201101-0925-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: National Evaluation of the Clinical and Translational Science Awards (CTSA) Initiative (NCRR)
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: 04/08/2011
	Date Received in OIRA: 01/18/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2014	36 Months From Approved
Responses	903	0	0
Time Burden (Hours)	452	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The CTSA Initiative is administered by the Division of Clinical Research Resources (DCRR) within NCRR. The Initiative was designed to spur the transformation of the biomedical research enterprise in the United States so that new treatments can be developed more efficiently and delivered more quickly to patients. The Initiative enables institutions to create an integrated academic home for clinical and translational science that has the resources to train and advance multi- and interdisciplinary investigators and research teams. CTSAs engage basic, translational, and clinical investigators, community clinicians, clinical practices, networks, professional societies, and industry to develop new professional interactions, programs, and research projects. The CTSA Initiative is designed to fundamentally change the organization and operating paradigm of research in major academic medical centers by providing infrastructure resources to support clinical and translational science activities and training for the next generation of scientists.

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Authorizing Statute(s): US Code: 42 USC 242b 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:
	75 FR 62543	10/12/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 81611	12/28/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Users	1	Users Survey
Nonusers	2	Nonusers
Trainees/Scholars	3	Trainees/Scholars Survey
Mentors	4	Mentors Survey

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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	903	0	0	903	0	0
Annual Time Burden (Hours)	452	0	0	452	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.

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Annual Cost to Federal Government: $364,480

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: 01/18/2011

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