Department of Health and Human Services April 11, 2013 – Federal Register Recent Federal Regulation Documents
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Notice of Hearing: Reconsideration of Disapproval of Maine State Plan Amendments (SPA) 12-010
This notice announces an administrative hearing to be held on May 23, 2013, at the CMS Boston Regional Office, JFK Federal Building, 15 N. Sudbury Street, Room 2050, Boston, Massachusetts 02203-0003 to reconsider CMS' decision to disapprove Maine SPA 12-010.
Meeting of the President's Council on Fitness, Sports, and Nutrition
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the President's Council on Fitness, Sports, and Nutrition (PCFSN) will hold a meeting. The meeting will be open to the public.
Expansion Funds for the Support of the Senior Medicare Patrol (SMP) Program
The Administration for Community Living is announcing the availability of expansion funds for the support of the Senior Medicare Patrol (SMP) Program. This additional funding opportunity will be used to expand the reach of the SMP program with the explicit purpose of expanding current program capacity to recruit, train, and support the SMP volunteer network. In addition, this funding opportunity will increase targeted collaborative efforts with the Centers for Medicare and Medicaid Services, Office of Inspector General and other law enforcement entities in identified high fraud states. Funding Opportunity Title/Program Name: Health Care Fraud Prevention Program Expansion and SMP Capacity Building Grants. Announcement Type: Health Care Fraud Prevention Program Expansion Capacity. Funding Opportunity Number: Program Announcement No. HHS-2013-ACL- AoA-SP-0049
National Institute for Occupational Safety and Health Partnership Opportunity on a Research Project To Evaluate the Performance of Isolation Gowns
The NIOSH National Personal Protective Technology Laboratory is initiating a research study in support of American Society for Testing and Materials (ASTM) International standards development to establish minimum performance requirements for isolation gowns for health care workers. NIOSH is seeking to identify currently marketed isolation gown products. All manufacturers are requested to submit samples to NIOSH free of charge for testing. There will be no cost to the manufacturers for testing. Not all submitted products may be tested, depending on the response to this announcement and the results of screening tests. Each manufacturer that submits gowns that are tested will receive the test results from their gowns. Through submission of the gown samples, manufacturers will be making an important contribution to ASTM, International's process to establish an important standard for evaluating the protection provided for health care workers by isolation gowns. Participating manufacturers will be recognized as contributing to the establishment of the performance standard. Manufacturers whose products are tested will also receive the results of all gowns tested in a blinded format. Gown Criteria: Candidate gowns for inclusion in the research program must meet the following criteria: (1) The gowns must be identified (labeled) as ``isolation gowns'' and have full coverage in the back to provide protection for the health care worker and the patient; (2) A minimum of 100 units for each code (model) of disposable (single use) gown submitted; (3) A minimum of 200 ``new'' (unprocessed, unused, unwashed) reusable gowns for each model submitted. Reusable gown submissions must include a labeling recommendation for the maximum number of laundering cycles to be included in this study. Half of the gown samples will be tested after one laundering and drying cycle and half of the gown samples will be tested as laundered for the maximum number of cycles claimed by the manufacturer; and, (4) Samples should be provided in finished package format, with any claims that may not be noted on the packaging or labels provided by the manufacturer. NIOSH will not return any gowns submitted for this testing.
Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Self-Selection Studies for Nonprescription Drug Products.'' This guidance is intended to provide recommendations to industry involved in developing and conducting self-selection studies to support an application for nonprescription drug products. A self-selection study assesses the ability of consumers to apply drug labeling information to their personal health situation to make correct decisions about whether or not it is appropriate for them to use a drug product. This guidance finalizes the draft guidance issued on September 19, 2011.
Medical Device Classification Product Codes; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Medical Device Classification Product Codes.'' This document describes how device product codes are used in a variety of FDA program areas to regulate and track medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).
Prescription Drug User Fee Act Patient-Focused Drug Development; Announcement of Disease Areas for Meetings Conducted in Fiscal Years 2013-2015
The Food and Drug Administration (FDA) is announcing the selection of disease areas to be addressed during the first 3 years of Patient-Focused Drug Development. This 5-year initiative is being conducted to fulfill FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). It provides a more systematic approach for the Agency to obtain patients' input on specific disease areas, including their perspectives on their condition, its impact on daily life, and available therapies. FDA selected these disease areas based on a set of selection criteria, the perspectives of the reviewing divisions at FDA, and the public input received on a preliminary set of disease areas published in the Federal Register on September 24, 2012.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
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