2011-310. Agency Information Collection Request; 60-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 information collection request 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]. Written comments and recommendations for the proposed information collections must be directed to the OS Paperwork Clearance Officer at the above e-mail address within 60 days.

Proposed Project: Comparative Effectiveness Research Inventory—OMB No. 0990-New-Assistant Secretary for Planning and Evaluation (ASPE).

Abstract: The Office of the Assistance Secretary for Planning and Evaluation (ASPE) is requesting approval by OMB for the collection of information submitted by content users directly to a web-based inventory of comparative effectiveness research (CER). The CER Inventory will categorize and catalogue Federal and non-Federal CER outputs and activities across four main domains: Research, human & scientific capital (e.g., training/education, methods development), data infrastructure, and dissemination & translation. The CER inventory will serve as a valuable tool for researchers, providers, patients, policymakers, and other users.

The CER inventory will draw upon primary data sources, including PubMed, HSRProj, ClinicalTrials.gov, and NIH RePORTER. Working with these four major sources and using the Federal Coordinating Council for CER's definition of CER and strategic framework, selection criteria and tools to select and extract the appropriate subsets of these datasets for inclusion in the CER inventory will be identified. In addition, content owners wishing to submit CER records to the CER inventory will be directed first to submit such records to one of these main primary source databases, as appropriate. This method will not only help to augment these existing databases, it will enable efficient and effective capture of CER information for the CER Inventory via CER search filters, etc., that have been developed for those respective source databases. If candidate CER records under consideration are not suitable for submission to one of these main databases, an alternative method that allows for direct submissions to the CER inventory will be made available to content users. Examples include reports and published articles or projects and programs that focus on areas of CER outside of primary research (e.g., training and education). The pilot inventory tool will provide a web form that may be used by content owners to submit CER records, subject to validation. This process for direct submission will draw from the experience with content owner submissions for such established databases as HSRProj and ClinicalTrials.gov.

Estimated Annualized Burden Table

Form	Type of respondent	Number of respondents	Number of responses per respondent	Total responses	Average burden hours per response	Total burden hours
CER Inventory Direct Submission Form for Reports or Other Publications	Researchers/Research Assistants	400	1	400	25/60	167
CER Inventory Direct Submission Form for Projects	Researchers/Research Assistants	100	1	100	28/60	47
Total						214

Seleda M. Perryman,

Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer.