Agency for Healthcare Research and Quality April 2013 – Federal Register Recent Federal Regulation Documents

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from medical device manufacturers with products falling within the following UMDNS product codes: Brachytherapy Systems [20-352]; Cyclotrons [15-818]; Radiotherapy Systems, Linear Accelerator [12-364]; Radiotherapy Systems, and Proton Beam [20-546]. Scientific information is being solicited to inform the update of our Comparative Effectiveness Review of Therapies for Clinically Localized Prostate Cancer which is currently being conducted by one of the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.

Section 401(a) of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), Public Law 111-3, amended the Social Security Act (the Act) to enact section 1139A (42 U.S.C. 1320b- 9a). Section 1139A(b) charged the Department of Health and Human Services with improving pediatric health care quality measures. The Agency for Healthcare Research and Quality (AHRQ) is requesting the submission of instruments or domains (for example, key concepts) measuring aspects of the transition from child-focused to adult-focused care in young adults with chronic health conditions from all researchers, vendors, hospitals, stakeholders, and other interested parties. AHRQ is interested in instruments and items through which young adults or parent proxies may assess experiences they have with the health care system, including the transition from pediatric to adult health care. The goal is to develop a standardized instrument for use in assessing the quality of transition from child-focused to adult- focused care in young adults with chronic health conditions.

The Agency for Healthcare Research and Quality (AHRQ) is seeking nominations for both a time-limited workgroup and a standing workgroup to be convened by an AHRQ contractor. The workgroups shall be comprised of individuals with knowledge of the AHRQ Quality Indicators (QIs), their technical specifications, and associated methodological issues. The overarching goals of each group are to provide feedback to AHRQ regarding refinements to the QIs. The time-limited workgroup is more restricted to specific clinical or methodological issues, while the standing workgroup addresses broader issues related to the measurement cycle. Because AHRQ did not get a set of candidates with anticipated breadth of diversity of experience as required in response to our notice (https://www.federalregister.gov/articles/2013/01/28/2013-013 48/ ahrq-standing-workgroup-for-quality-indicator-measure-specifi cation) published on January 28, 2013, Volume 78, No. 18, page numbers: 5810 & 5811, AHRQ resubmits the same notice to give opportunity to those interested in this objective.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluating the Knowledge and Educational Needs of Students of Health Professions on Patient-Centered Outcomes Research.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on January 28th, 2013 and allowed 60 days for public comment. No substantive comments were received. The purpose of this notice is to allow an additional 30 days for public comment.