Department of Health and Human Services July 31, 2017 – Federal Register Recent Federal Regulation Documents
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Developing a Framework for Regulatory Use of Real-World Evidence; Public Workshop
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Developing a Framework for Regulatory Use of Real-World Evidence.'' Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, the purpose of the public workshop is to bring the stakeholder community together to discuss a variety of topics related to the use of real- world data (RWD) and real-world evidence (RWE) in drug development and regulatory decision making. Topics will include an update on FDA's activities to address the use of RWE in regulatory decisions and the development of a framework for tackling challenges related to RWE's regulatory acceptability. In addition, panelists will discuss opportunities to improve data development activities, study designs, and analytical methods used to create robust RWE.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Cardiac Troponin Assays; Public Workshop; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Cardiac Troponin Assays.'' The purpose of the workshop is to discuss the development of innovative troponin assays designed to aid in the diagnosis of myocardial infarction (MI) and additional clinical uses of these assays. The workshop is intended to enhance engagement with stakeholders to facilitate device development and to discuss scientific and regulatory challenges associated with the analytical and clinical validation methods for troponin assay devices. Public input and feedback gained through this workshop may aid in the development of science-based approaches to aid in the efficient development of innovative, safe and effective, troponin diagnostic assays, which may lead to better patient care.
Health Insurance MarketplaceSM
This notice announces the renewal of the charter of the Advisory Panel on Outreach and Education APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace\SM\, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). Additional information about the Panel is available on the Internet at: https://www.cms.gov/Regulations-and- Guidance/Guidance/FACA/APOE.html. Press inquiries are handled through the CMS Press Office at (202) 690-6145.
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