Federal register
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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 hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. The agency also is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.
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The Food and Drug Administration (FDA) is announcing the establishment of a Pediatric Advisory Committee in the Office of the Commissioner. Elsewhere in this issue of the Federal Register, FDA is publishing a document requesting nominations for the membership on this committee. This document adds the Pediatric Advisory Committee to the agency's list of standing advisory committees in 21 CFR 14.100.
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The Food and Drug Administration (FDA) is requiring the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Indwelling blood oxyhemoglobin concentration analyzer, cardiopulmonary bypass pulsatile flow generator, and the ocular plethysmograph. The agency also is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.
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The Food and Drug Administration (FDA) is further delaying, until December 1, 2006, the effective date of certain requirements of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720). In the Federal Register of May 3, 2000 (65 FR 25639), the agency delayed until October 1, 2001, the effective date of certain requirements in the final rule relating to wholesale distribution of prescription drugs by distributors that are not authorized distributors of record, and distribution of blood derivatives by entities that meet the definition of a "health care entity" in the final rule. The agency further delayed the effective date of these requirements in three subsequent Federal Register notices. ⋯ Therefore, it is necessary to delay the effective date of Sec. Sec. 203.3(u) and 203.50 (21 CFR 203.3(u) and 203.50) until December 1, 2007 to allow stakeholders time to continue to move toward this goal. In addition, the further delay of the applicability of Sec. 203.3(q) to wholesale distribution of blood derivatives by health care entities is necessary to give the agency additional time to consider whether regulatory changes are appropriate and, if so, to initiate such changes.
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This interim final rule implements the provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MPDIMA) of 2003, Pub. L. 108-173, which are applicable in 2004 to Medicare payment for covered drugs and physician fee schedule services. These provisions revise the current payment methodology for Part B covered drugs and biologicals that are not paid on a cost or prospective payment basis; make changes to Medicare payment for furnishing or administering drugs and biologicals; revise the geographic practice cost indices and change the physician fee schedule conversion factor. ⋯ The information contained in this final rule related to payment under the physician fee schedule supercedes the information contained in the November 7, 2003, final rule to the extent that the two are inconsistent. All other provisions of the November 7, 2003, final rule are unchanged unless otherwise noted. This rule also extends the "opt-out" provisions of 1802(b)(5)(3) of the Social Security Act to dentists, podiatrists, and optometrists.