Federal register
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The Architectural and Transportation Barriers Compliance Board (Access Board) is issuing final accessibility guidelines to serve as the basis for standards to be adopted by the Department of Justice for new construction and alterations of play areas covered by the Americans with Disabilities Act (ADA). The guidelines include scoping and technical provisions for ground level and elevated play components, accessible routes, ramps and transfer systems, ground surfaces, and soft contained play structures. The guidelines will ensure that newly constructed and altered play areas meet the requirements of the ADA and are readily accessible to and usable by individuals with disabilities. The Department of Justice must adopt the guidelines as standards for them to be enforceable under the ADA.
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The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the implanted mechanical/hydraulic urinary continence device, a generic type of medical device intended for the treatment of urinary incontinence. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997.
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This document amends Department of Veterans Affairs (VA) adjudication regulations to reflect changes made by the Veterans Millennium Health Care and Benefits Act. These changes concern payment of dependency and indemnity compensation to the surviving spouses of certain former prisoners of war; the provision of health care, education and home loan benefits to surviving spouses upon termination of their remarriages; and the addition of bronchiolo-alveolar carcinoma to the list of diseases that VA presumes are the result of exposure to radiation during active military service.
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The Food and Drug Administration (FDA) is classifying the nonimplanted, peripheral electrical continence device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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The Food and Drug Administration (FDA) is amending certain references in various medical device regulations. The amendments update the references in those regulations to various standards of the American Society for Testing and Materials (ASTM) to reflect the current standards designations. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedures for notice-and-comment, to provide a procedural framework to finalize the rule in the event that the agency receives any significant adverse comment and withdraws the direct final rule.