Comparative Effectiveness Research: Portfolio

Forms and Documents

Document Name	Status
0990-CER_Portfolio Part B 6May2011.docx Supporting Statement B	2011-05-12
0990-CER_Portfolio_B - Principal Investigator-Project Director Survey 5-6-11.docx Supplementary Document	2011-05-20
0990-CER_Portfolio_Part A- Attachment A - Legislation.docx Supplementary Document	2011-05-20
0990-CER_Portfolio Part A 6May2011 (2).docx Supporting Statement A	2011-05-12

IC Document Collections

IC ID	Document Title	Status
197792	Stakeholders: developers of health innovations (In-depth interview) Other-survey	New
197791	Stakeholders :Researchers (In-depth interview) Other-survey	New
197790	Stakeholders: employers and payers (In-depth interview) Other-survey	New
197789	Stakeholders: patient/consumer (In-depth interview) Other-survey	New
197788	Stakeholders: healthcare organization administrator (In-depth interview) Other-survey	New
197787	Stakeholders: health care providers (In-depth interviews (SSLA) Other-interview	New
197786	Memeber of the general public -Focus Group (SSLA) Other-focus group	New
197785	Key Stakeholders: Patients/Consumers (Survey SSLA) Other-survey	New
197784	Key Stakeholders: Healthcare organization adminstrators (Survey SSLA) Other-survey	New
197783	Key Stakeholders: Healthcare providers(Survey SSLA) Other-survey	New
197782	Principal Investigators and project directors (In-depth Interviews(PSLA) Other-Interview	New
197781	Principal Investigators and project directors Other-survey	New

ICR Details

OMB Control No: 0990-0381	ICR Reference No: 201105-0990-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Comparative Effectiveness Research: Portfolio
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: 08/25/2011
	Date Received in OIRA: 05/20/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2014	36 Months From Approved
Responses	4,560	0	0
Time Burden (Hours)	1,493	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Researchers and policymakers have emphasized the need for research on effectiveness of health care interventions under real-world conditions in diverse populations and clinical practice settings, that is, CER. The hoped-for impact of ARRA CER initiatives is the development of more and better clinical evidence that will foster fundamental change in how evidence is used in clinical practice and Assessment of American Recovery and Reinvestment Act (ARRA) comparative Effectiveness Research (ACERE)2 promote greater value in the health care system. For this evaluation, ASPE seeks to understand whether initial investments appear to be accomplishing their goals and help policymakers set a course that will achieve these long-term benefits.

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Authorizing Statute(s): PL: Pub.L. 111 - 5 1 Name of Law: American Recovery and Reinvestment Act
   US Code: 8 USC 1 Name of Law: American Recovery and Reinvestment Act
   US Code: 42 USC 301 Name of Law: Public Health Service Act 241
  

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:
	76 FR 6793	02/08/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 28987	05/19/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 12

IC Title	Form No.	Form Name
Key Stakeholders: Healthcare providers(Survey SSLA)
Key Stakeholders: Healthcare organization adminstrators (Survey SSLA)
Principal Investigators and project directors
Principal Investigators and project directors (In-depth Interviews(PSLA)
Key Stakeholders: Patients/Consumers (Survey SSLA)
Memeber of the general public -Focus Group (SSLA)
Stakeholders: health care providers (In-depth interviews (SSLA)
Stakeholders: healthcare organization administrator (In-depth interview)
Stakeholders: patient/consumer (In-depth interview)
Stakeholders: employers and payers (In-depth interview)
Stakeholders :Researchers (In-depth interview)
Stakeholders: developers of health innovations (In-depth interview)

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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	4,560	0	0	4,560	0	0
Annual Time Burden (Hours)	1,493	0	0	1,493	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: New collection

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Annual Cost to Federal Government: $1,389,276

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)? Yes

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: 05/20/2011

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