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The Secretary of Health and Human services proposes to amend the regulations governing the program for family planning services funded under Title X of the Public Health Service Act in order to implement a recent amendment of that Act. The statutory amendment requires family planning projects to encourage family participation in the provision of services by the projects, to the extent practical. The Secretary proposes to implement this amendment by requiring projects to notify the parents of unemancipated minors seeking family planning services when prescription drugs or devices are provided. In addition, where state law requires family planning providers to provide Title X services to unemancipated minors only with notification to or the consent of their parents, projects would be required to comply with that law.
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Today, a substantial reorientation of the Public Health services in the Federal Republic of Germany is broadly seen necessary. Patterns of functional and organisational restructuring of Public Health services on the regional and the communal level are closely linked with concepts of prevention and health promotion. Hence, a number of agencies have already adopted new tasks and functions like comprehensive and transorganizational planning, coordination and evaluation as well as the establishment of new reporting systems. Presently, the transformation process from the bureaucratic mode of administering matters of health to a new Public Health orientation receives new impacts from the international "New Public Management" movement. Comparatively late, with the beginning of the 1990s, a growing number of German municipalities has introduced new concepts of administration. Local government administrations, of which the Public Health services are a part, follow the model of modern service organizations producing services in a more efficient, professionalized and consumer-oriented way. Specific elements of economising modernisation programmes like re-distribution of tasks, de-centralisation, extension of managerial capacities, setting of stimulating working conditions that provide employees with greater independence of action as well as career opportunities, are at the same time prerequisites for innovative strategies of health protection and coordination policies of Public Health services.
This final rule amends the existing regulations governing the National Vaccine Injury Compensation Program (VICP) by adding vaccines against rotavirus to the Table of Injuries, which lists the vaccines covered under the VICP. This action is taken under section 2114(e) of the Public Health Service Act (the Act). The VICP provides a system of no-fault compensation for certain individuals who have been injured by specific childhood vaccines. The two prerequisites for adding vaccines against rotavirus to the VICP have been satisfied. An excise tax of 75 cents per dose was enacted on October 21, 1998, and took effect for sales of the vaccines after October 21, 1998. The Centers for Disease Control and Prevention (CDC) has recommended to the Secretary of HHS that this vaccine be routinely administered to children. Thus, vaccines against rotavirus are now included in the VICP.
The Food and Drug Administration (FDA) is announcing changes to its Orphan Products Development (OPD) grant program for fiscal year (FY) 2000. The previous announcement of this program, which was published in the Federal Register of August 5, 1998 (63 FR 41855), is superseded by this announcement. In the future, a new announcement will be published annually.
The Food and Drug Administration (FDA) is issuing a final rule that amends the diagnostic x-ray systems performance standard for dental panoramic systems and mammography systems. This rule exempts panoramic dental x-ray units from the requirement that they be manufactured with exposure timers that automatically reset to zero upon premature termination of an exposure. Removing the automatic timer reset requirement will not compromise the quality of the radiographic image and will protect patients from being subject to unnecessary radiation due to repeat radiographs. This action also is intended to align the performance standard for mammography systems with the equipment requirements issued under the Mammography Quality Standards Act of 1992 (the MQSA).
The Food and Drug Administration (FDA) is amending its regulations governing mammography. The amendments are intended to incorporate changes required by the Mammography Quality Standards Reauthorization Act (MQSRA). 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 withdraws the direct final rule.
The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. FDA is issuing these amendments directly as a final rule because they are noncontroversial and there is little likelihood that FDA will receive any significant comments opposing the rule. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule under FDA's usual procedures for notice and comment in the event the agency receives any significant adverse comments. If FDA receives any significant adverse comment sufficient to terminate the direct final rule, FDA will consider such comments on the proposed rule in developing the final rule. FDA is issuing this rule as part of the agency's "Blood Initiative" in which FDA is reviewing and revising, when appropriate, its regulations, policies, guidance, and procedures related to blood, blood components, and Source Plasma.
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 silicone inflatable breast prosthesis, a generic type of medical device intended to augment or reconstruct the female breast. This device is made of a silicone shell that is inflated with sterile isotonic saline. Commercial distribution of this device must cease unless a manufacturer or importer has filed with FDA a PMA or PDP for its version of the silicone inflatable breast prosthesis within 90 days of the effective date of this regulation. This regulation reflects FDA's exercise of its discretion to require PMA's or PDP's for preamendments devices and is consistent with FDA's stated priorities and Congress' requirement that class III devices are to be regulated by FDA's premarket review. 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, and the Food and Drug Administration Modernization Act of 1997.
The Food and Drug Administration (FDA) is issuing a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded. FDA is issuing this final rule because many OTC drug products containing colloidal silver ingredients or silver salts are being marketed for numerous serious disease conditions and FDA is not aware of any substantial scientific evidence that supports the use of OTC colloidal silver ingredients or silver salts for these disease conditions.
The Food and Drug Administration (FDA) is amending the regulations for internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter (OTC) use to correct inadvertent errors and to clarify the labeling for over-the-counter drug products written for health professionals.
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The Public Health Service is in a unique position with regard to the access to all socioeconomic groups including those who lack the alertness to make use of our health care system. This highlights it as a key factor in primary prevention. Interventions must focus on the individual situation of the addresses in order to motivate them to healthy behaviour. Health promotion for girls needs more attention, their knowledge and behaviour are decisive for the next generation.