Federal register
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This notice describes the methodology we will use to award fiscal year 1989 incentive payments to carriers that successfully increase the number of participating physicians, i.e., physicians who agree to accept Medicare's reasonable charge for all Part B services that they provide to Medicare beneficiaries. It implements provisions of the Omnibus Budget Reconciliation Act of 1986 and the Omnibus Budget Reconciliation Act of 1987 which require us to publish a notice in the Federal Register describing our system for providing payment of a bonus to carriers based on their performance in increasing the number of participating physicians or the proportion of payment for participating physicians' services in their service areas.
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In accordance with the November 9, 1989 order of the United States District Court for the District of Columbia, in American Hospital Association, et al. v. Sullivan, No. 88-2027 (RCL), HCFA is publishing that order and the Joint Stipulation and Order of August 24, 1988.
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The Food and Drug Administration (FDA) is announcing its intent to initiate proceedings to establish the effective dates of the requirement for premarket approval for 31 class III preamendments devices. The devices subject to this notice were distributed commercially before May 28, 1976, or are devices that FDA has determined to be substantially equivalent to such devices. This notice of intent identifies the 31 class III preamendments devices to which FDA has assigned a high priority for the application of premarket approval requirements. FDA is taking this action under the Medical Device Amendments of 1976.
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The Food and Drug Administration (FDA) is proposing to amend (1) its regulations that contain the general standards for any institutional review board (IRB) that reviews clinical investigations regulated by the agency and (2) its regulations that establish general requirements for informed consent of human subjects that participate in such research. The agency intends to conform its regulations to the extent possible to the "Federal Policy for the Protection of Human Research Subjects" (Model Policy) published elsewhere in this issue of the Federal Register. Existing FDA regulations governing protection of human subjects share a common core with the Model Policy and implement the fundamental principles embodied in that policy. The purpose of these proposed amendments is to eliminate certain inconsistencies with the Model Policy.