Federal register
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The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) skin protectant astringent drug products are generally recognized as safe and effective and not misbranded. This action revises some labeling for astringent drug products to be consistent with the final rule for OTC skin protectant drug products (68 FR 33362, June 4, 2003) and adds labeling for certain small packages (styptic pencils). This action is part of FDA's ongoing review of OTC drug products. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule.
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We are revising our regulations that pertain to the processing of initial claims for disability benefits under title II (Social Security Disability Insurance) and title XVI (Supplemental Security Income) of the Social Security Act (the Act). We will be conducting pilot projects wherein we will request photographic identification from individuals filing for title II and title XVI disability and blindness benefits in specified geographic areas covered by the pilot projects. ⋯ We will permit an exception to the photograph requirement when an individual has a sincere religious objection. This process will strengthen the integrity of the disability claims process by helping to ensure that the individual filing the application is the same individual examined by the consultative examination (CE) physician.
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The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M2 eCTD: Electronic Common Technical Document Specification." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance defines the means for industry-to-agency transfer of regulatory information that will facilitate the creation, review, life cycle management, and archiving of the electronic submission. The guidance is intended to assist industry in transferring electronically their marketing applications for human drug and biological products to a regulatory authority.
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This final rule requires hospitals to develop and maintain a quality assessment and performance improvement (QAPI) program. In the December 19, 1997 Federal Register, we published a proposed rule to revise the hospitals conditions of participation (CoPs). The QAPI CoP was one of the conditions included in the proposed rule. ⋯ This typically includes; 1) Identifying and verifying quality-related problems and their underlying cause; 2) Designing and implementing corrective action activities to address deficiencies; 3) Following up to determine the degree of success of an intervention and to detect new problems and opportunities for improvement. Performance improvement activities aim to improve overall performance assuming that there is no permanent threshold for good performance. Under performance improvement framework, hospitals will continuously study and improve the processes of healthcare and delivery of service.
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This final rule with comment period refines the resource-based practice expense relative value units (RVUs) and makes other changes to Medicare Part B payment policy. In addition, as required by statute, we are announcing the physician fee schedule update for CY 2003. The update to the physician fee schedule occurs as a result of a calculation methodology specified by law. ⋯ In addition, we are finalizing the calendar year (CY) 2002 interim RVUs and are issuing interim RVUs for new and revised procedure codes for calendar year (CY) 2003. As required by the statute, we are announcing that the physician fee schedule update for CY 2003 is -4.4 percent, the initial estimate of the sustainable growth rate for CY 2003 is 7.6 percent, and the conversion factor for CY 2003 is $34.5920. This final rule will also allow registered nurses (RNs) to provide emergency care in certain critical access hospitals (CAHs) in frontier areas (an area with fewer than six residents per square mile) or remote locations (locations designated in a State's rural health plan that we have approved.) This policy applies if the State, following consultation with the State Boards of Medicine and Nursing, and in accordance with State law, requests that RNs be included, along with a doctor of medicine or osteopathy, a physician's assistant, or a nurse practitioner with training or experience in emergency care, as personnel authorized to provide emergency services in CAHs in frontier areas or remote locations.