Agency for Healthcare Research and Quality December 2011 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities: Proposed Collection; Comment Request
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: ``MEPS Cancer Self Administrated Questionnaire.'' 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 November 2nd, 2011 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Request for Measures and Domains To Use in Development of a Standardized Instrument for Use in Public Reporting of Family Experience of Pediatric Inpatient Care
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 soliciting the submission of instruments or domains (for example, key concepts) measuring aspects of families' experience with the quality of inpatient medical and surgical hospital care from all researchers, vendors, hospitals, stakeholders, and other interested parties. The survey development team of Children's Hospital Boston Center of Excellence for Pediatric Quality Measurement (CEPQM), is one of the CHIPRA Pediatric Quality Measures Program (PQMP) Centers of Excellence, which were created pursuant to an interagency agreement between the Centers for Medicare & Medicaid Services (CMS) and AHRQ, and are funded through cooperative agreement awards with AHRQ. AHRQ is interested in instruments and items through which families of pediatric patients assess the care their child receives during the child's inpatient stay. The goal is to develop a standardized instrument for use in the public reporting of family experience of pediatric inpatient care. The team developing this survey intends to submit it to the CAHPS Consortium to request use of the CAHPS trademark. The survey will be developed in accordance with CAHPS Survey Design Principles and will develop implementation instructions based on those for CAHPS instruments (https://www.cahps.AHRQ.gov/About-CAHPS/Principles.aspx.) All CAHPS surveys are available to users free of charge and are published on the AHRQ Web site.
Scientific Information Request on Intravascular Diagnostic and Imaging Medical Devices
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of intravascular diagnostic and imaging medical devices, including: Fractional Flow Reserve (FFR), Coronary Flow Reserve (CFR), Intravascular Ultrasound (IVUS), Intravascular Ultrasound (VH-IVUS) with Virtual Histology, Optical Coherent Tomography (OCT), Near- Infrared Spectroscopy (NIR), Angioscopy, Intravascular Magnetic Resonance Imaging (MRI), Elastrography, and Thermography. Scientific information is being solicited to inform our Comparative Effectiveness Review of Intravascular Diagnostic Procedures and Imaging Techniques versus Angiography Alone, which is currently being conducted by 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.
Scientific Information Request on CYP2C19 Variants and Platelet Reactivity Tests
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of CYP2C19 variants and platelet reactivity tests. Scientific information is being solicited to inform our Comparative Effectiveness Review of Testing of CYP2C19 Variants and Platelet Reactivity for Guiding Antiplatelet Treatment, which is currently being conducted by 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.
Patient Safety Organizations: Voluntary Relinquishment From HealthWatch, Inc.
AHRQ has accepted a notification of voluntary relinquishment from HealthWatch, Inc. of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.
Scientific Information Request on Pressure Ulcer Treatment Medical Devices
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of pressure ulcer treatment medical devices, such as (but not limited to): Ultrasonic wound care systems, negative pressure therapy units, turning & positioning systems, special mattresses, mattress covers, pillows, cushions, etc. Scientific information is being solicited to inform our Pressure Ulcer Treatment Strategies: A Comparative Effectiveness Review, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on these devices 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
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: ``Use of Deliberative Methods to Enhance Public Engagement in the Agency for Healthcare Research and Quality's (AHRQ's) Effective Healthcare (EHC) Program and Comparative Effectiveness Research (CER) Enterprise.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
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