2011-12338. Agency Information Collection Request; 30-Day Public Comment Request

AGENCY:

Office of the Secretary, HHS.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, e-mail your request, including your address, phone number, OMB number, and OS document identifier, to [e-mail], or call the Reports Clearance Office on [phone]. Send written comments and recommendations for the proposed information collections within 30 days of this notice directly to the OS OMB Desk Officer; faxed to OMB at 202-395-5806.

Proposed Project: Research Evaluation and Impact Assessment of ARRA Comparative Effectiveness Research Portfolio—OMB No. 0990-New-Assistant Secretary Planning and Evaluation (ASPE).

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, comparative effectiveness research (CER). The American Reinvestment and Recovery Act of 2009 (ARRA) expanded Federal resources devoted to CER by directing $1.1 billion to the U.S. Department of Health and Human Services (HHS) for such research.

ARRA also called for a report to Congress and the Secretary of HHS on priority CER topics by the Institute of Medicine (IOM). The report presented priority CER topics and recommendations to support a robust and sustainable CER enterprise. In addition, ARRA established the Federal Coordinating Council on Comparative Effectiveness Research (FCCCER) to help coordinate and minimize duplicative efforts of Federally sponsored CER across multiple agencies and to advise the President and Congress on how to allocate Federal CER expenditures.

This project seeks to evaluate and assess the products and outcomes of ARRA-funded CER investments and the impacts of those investments on the priority topics recommended by IOM and on the categories and themes of the FCCCER framework. The primary goals of this evaluation are to (1) conduct an initial assessment of the ARRA CER portfolio, cataloguing how CER funding was invested to achieve the vision of the FCCCER and assessing initial impact from the perspective of various stakeholders; and (2) lay the groundwork for future CER investments by identifying investment opportunities, evidence gaps and lessons learned.

Estimated Annualized Burden Hour Table

Instrument	Type of respondent	Number of respondents	Number of responses per respondent	Average burden (in hours) per response	Total hour burden
Attachment B: Survey (PSLA)	Principal investigators and project directors	730	1	20/60	243
Attachment C: In-depth interviews (PSLA)	Principal investigators and project directors	50	1	1	50
Attachment D: Survey (SSLA)	Key stakeholders: health care providers	600	2	15/60	300
Attachment D: Survey (SSLA)	Key stakeholders: health care organization administrators	600	2	15/60	300
Attachment D: Survey (SSLA)	Key stakeholders: patients/consumers	600	2	15/60	300
Attachment E: Focus group (SSLA)	Members of the general public	60	2	2	240
Attachment F: In-depth interviews (SSLA)	Stakeholders: health care providers	10	1	1	10
Attachment G: In-depth interviews (SSLA)	Stakeholders: health care organization administrators	10	1	1	10
Attachment H: In-depth interviews (SSLA)	Stakeholders: patients/consumers	10	1	1	10
Attachment I: In-Depth interviews (SSLA)	Stakeholders: employers and payers	10	1	1	10
Attachment J: In-Depth interviews (SSLA)	Stakeholders: researchers	10	1	1	10
Attachment K: In-Depth interviews (SSLA)	Stakeholders: developers of health innovations	10	1	1	10
Total		2,700			1,493

Mary Forbes,

Office of the Secretary, Paperwork Reduction Act Clearance Officer.