Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license; correction--FDA. Proposed rule; correction

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of July 31, 1998 (63 FR 40858). The document proposed to amend the biologics regulations to eliminate references to establishment licenses and product licenses for all products regulated under the Public Health Services Act. The document published with an incorrect address. This document corrects that error.     

Medical use of byproduct material; public meetings--NRC. Notice of public meetings

The Nuclear Regulatory Commission has developed a proposed rulemaking for a comprehensive revision of its regulations governing the medical use of byproduct material in 10 CFR Part 35, "Medical Use of Byproduct Material," and a proposed revision of its 1979 Medical Use Policy Statement (MPS). Throughout the development of the proposed rule and MPS, the Commission solicited input from the various interests that may be affected by these proposed revisions. The Commission now plans to solicit comments on the proposed rule and MPS through two mechanisms--publishing the documents in the Federal Register for public comment (scheduled for August 1998); and convening three facilitated public meetings, during the public comment period, to discuss the Commission's proposed resolution of the major issues. The public meetings will be held in San Francisco, California, on August 19-20, 1998; in Kansas City, Missouri, on September 16-17, 1998; and in Rockville, Maryland, on October 21-22, 1998. All meetings will be open to the public. Francis X. Cameron, Special Counsel for Public Liaison, in the Commission's Office of the General Counsel, will be the convener and facilitator for the meetings.     

Medical use of byproduct material; proposed revision--NRC. Proposal rule

The Nuclear Regulatory Commission (NRC) is proposing a revision of its regulations governing the medical use of byproduct material. The proposed rule is one component of the Commission's overall program for revising its regulatory framework for medical use. The overall goals of this program are to focus NRC's regulations on those medical procedures that pose the highest risk to workers, patients, and the public, and to structure its regulations to be risk-informed and more performance-based, consistent with the NRC's "Strategic Plan for Fiscal Year 1997-Fiscal Year 2002". A notice in this issue of the Federal Register announcing the Commission's proposed revision of its 1979 "Medical use Policy Statement" for public comment is published elsewhere.     

Medicare program; rural health clinics: amendments to participation requirements and payment provisions; and establishment of a quality assessment and performance improvement program. Final rule

This final rule amends Medicare certification and payment requirements for rural health clinics (RHCs) as required by the Balanced Budget Act of 1997 (BBA). It changes the definition of a qualifying rural shortage area in which a Medicare RHC must be located; establishes criteria for identifying RHCs essential to delivery of primary care services that we can continue to approve as Medicare RHCs in areas no longer designated as medically underserved; and limits waivers of certain nonphysician practitioner staffing requirements. This final rule imposes payment limits on provider-based RHCs and prohibits "commingling" (the use of the space, professional staff, equipment, and other resources) of an RHC with another entity. The rule also requires RHCs to establish a quality assessment and performance improvement program that goes beyond current regulations. Finally, this final rule addresses public comments received on the February 28, 2002 proposed rule and makes other revisions for clarity and uniformity and to improve program administration.     

Medicare program; changes to the hospital outpatient prospective payment system and calendar year 2003 payment rates; and changes to payment suspension for unfiled cost reports. Final rule with comment period

This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In addition, it describes changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2003. This rule also allows the Secretary to suspend Medicare payments "in whole or in part" if a provider fails to file a timely and acceptable cost report. In addition, this rule responds to public comments received on the November 2, 2001 interim final rule with comment period (66 FR 55850) that set forth the criteria the Secretary will use to establish new categories of medical devices eligible for transitional pass-through payment under the Medicare's hospital outpatient prospective payment system. Finally, this rule responds to public comments received on the August 9, 2002 proposed rule for revisions to the hospital outpatient prospective payment system and payment rates (67 FR 52092). CMS finds good cause to waive proposed rulemaking for the assignment of new codes to Ambulatory Payment Classifications and for the payment of influenza and pneumococcal vaccines under reasonable cost; justification for the waiver will follow in a subsequent Federal Register notice.     

Medicare program; changes to the criteria for being classified as an inpatient rehabilitation facility. Final rule

This final rule responds to public comments on the September 9, 2003 proposed rule, and revises the classification criterion, commonly known as the "75 percent rule," used to classify a hospital as an inpatient rehabilitation facility (IRF). This final rule also modifies and expands the medical conditions listed in the regulatory requirements as well as temporarily lowers the percentage of patients required to fall within one of the specified list of medical conditions.     

Medical devices; medical device, user facility, distributor, and manufacturer reporting, certification, and registration--FDA. Tentative final rule

The Food and Drug Administration (FDA) is issuing a tentative final rule to require that device user facilities and distributors, including importers, submit reports to FDA and to the manufacturers, of deaths, serious illnesses and serious injuries related to medical devices. FDA is authorized to issue regulations implementing reporting requirements for user facilities and distributors by certain provisions of the Safe Medical Devices Act of 1990 (the SMDA). This tentative final rule also amends existing reporting requirements for manufacturers to conform them with the proposed reporting requirements for user facilities and distributors, and requires distributors and manufacturers to report certain malfunctions that may cause a death, serious illness or serious injury. The tentative final rule also requires foreign manufacturers to be subject to the same reporting requirements as domestic manufacturers. FDA is designating this document a tentative final rule, although under the Administrative Procedure Act it is a proposed rule. Because of the statutory deadlines discussed below, this "tentative final rule" alerts the public not only to the agency's interest in receiving comments, but also to the need for device user facilities, distributors, and other affected persons to begin preparing for compliance.     

铁路餐饮服务许可管理存在问题探讨

为贯彻落实国家六部委制定的《铁路运营食品安全管理办法》,规范铁路餐饮服务和食品流通许可工作,原铁道部制定了《铁路餐饮服务和食品流通许可管理办法》。但在执行过程中,发现在许可的条件、提交的材料、现场核查与结果判定、撤销许可的情形等方面存在问题,在此提出讨论。     

Medicaid program; elimination of reimbursement under Medicaid for school administration expenditures and costs related to transportation of school-age children between home and school. Final rule

Under the Medicaid program, Federal payment is available for the costs of administrative activities "as found necessary by the Secretary for the proper and efficient administration of the State plan." This final rule eliminates Federal Medicaid payment for the costs of certain school-based administrative and transportation activities because the Secretary has found that these activities are not necessary for the proper and efficient administration of the Medicaid State plan and are not within the definition of the optional transportation benefit. Based on these determinations, under this final rule, Federal Medicaid payments will no longer be available for administrative activities performed by school employees or contractors, or anyone under the control of a public or private educational institution, and for transportation from home to school. In addition, this final rule responds to public comments received on the September 7, 2007 proposed rule.     

Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations to eliminate references to establishment licenses and product licenses for all products regulated under the Public Health Service Act (PHS Act). In lieu of filing an establishment license application (ELA) and product license application (PLA) in order to market a biological product in interstate commerce, a manufacturer would file a single biologics license application (BLA) with the agency. Upon approval of the BLA, a manufacturer would receive a biologics license to market the product in interstate commerce. This action is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiatives and is intended to reduce unnecessary burdens for industry without diminishing public health protection. This action also proposes regulations to implement certain sections of the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Medicare program; payment for respiratory assist devices with bi-level capability and a backup rate. Final rule

This final rule clarifies that respiratory assist devices with bi-level capability and a backup rate must be paid as capped rental items of durable medical equipment (DME) under the Medicare program and not paid as items requiring frequent and substantial servicing (FSS), as defined in section 1834(a)(3) of the Social Security Act. Before 1999, respiratory assist devices with bi-level capability (with or without a backup rate feature) were referred to as "intermittent assist devices with continuous positive airway pressure devices' under the Medicare program and in the Healthcare Common Procedure Coding System (HCPCS). This final rule responds to public comments received on a proposed rule published in the Federal Register on August 22, 2003, and finalizes the policy in that proposed rule. The rule will ensure that respiratory assist devices are consistently and properly paid under Medicare as capped rental items.     

建设法治基础上的公共服务型政府

面对我国政府管理中的问题,许多学者从不同的角度提出了不同的解决方案,这些主张在不同的地方被不同的政府拿来作为政府改革的目标。本文通过对法治政府、有限政府、责任政府和服务型政府的比较分析后,认为法治政府已经涵括了有限政府和责任政府之内容,服务型政府则从管理职能和管理方式上突出了服务之作用,因而,我国应该建立法治基础上的公共服务型政府。     

General administrative rulings and decisions; amendment to the examination and investigation sample requirements; companion document to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations regarding the collection of twice the quantity of food, drug, or cosmetic estimated to be sufficient for analysis. This action increases the dollar amount that FDA will consider to determine whether to routinely collect a reserve sample of a food, drug, or cosmetic product in addition to the quantity sufficient for analysis. Experience has demonstrated that the current dollar amount does not adequately cover the cost of most quantities sufficient for analysis plus reserve samples. This proposed rule is a companion to the direct final rule published elsewhere in this issue of the Federal Register. This action is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiative, and it is intended to reduce the burden of unnecessary regulations on food, drugs, and cosmetics without diminishing the protection of the public health.     

Medicare and Medicaid programs; hospital conditions of participation: requirements for history and physical examinations; authentication of verbal orders; securing medications; and postanesthesia evaluations. Final rule

In this rule, we finalize changes to four of the current requirements (or conditions of participation (CoPs)) that hospitals must meet to participate in the Medicare and Medicaid programs. Specifically, this final rule revises and updates our CoP requirements for: Completion of the history and physical examination in the medical staff and the medical record services CoPs; authentication of verbal orders in the nursing service and the medical record services CoPs; securing medications in the pharmaceutical services CoP; and completion of the postanesthesia evaluation in the anesthesia services CoP. We also respond to timely public comments submitted on the proposed rule published in the March 25, 2005 Federal Register (70 FR 15266). The changes specified in this final rule are consistent with current medical practice and will reduce the regulatory burden on hospitals.     

Medicare program; clarifying policies related to the responsibilities of Medicare-participating hospitals in treating individuals with emergency medical conditions. Final rule

This final rule clarifies policies relating to the responsibilities of Medicare-participating hospitals in treating individuals with emergency medical conditions who present to a hospital under the provisions of the Emergency Medical Treatment and Labor Act (EMTALA). The final rule responds to public comments received on a May 9, 2002 proposed rule (67 FR 31404) that both reiterated the agency's interpretations under EMTALA and proposed clarifying changes relating to the implementation of the EMTALA provisions. These reiterations and clarifying changes related to, among other areas, seeking prior authorization from insurers for services, emergency patients presenting at off-campus outpatient clinics that do not routinely provide emergency services, the applicability of the EMTALA provisions to hospital inpatients and outpatients, the circumstances under which physicians must serve on hospital medical staff "on-call" lists, and the responsibilities of hospital-owned ambulances. These reiterations and clarifying changes are needed to ensure uniform and consistent application of policy and to avoid any misunderstanding of EMTALA requirements by individuals, physicians, or hospital employees.     

Public Health Service policies on research misconduct. Final rule

This final rule removes 42 CFR part 50, subpart A, "Responsibilities of Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science," and replaces it with a new, more comprehensive part 93, "Public Health Service Policies on Research Misconduct." The proposed part 93 was published for public comment on April 16, 2004. The final rule reflects both substantive and non-substantive amendments in response to public comments and to correct errors and improve clarity, but the general approach of the NPRM is retained. The purpose of the final rule is to implement legislative and policy changes applicable to research misconduct that occurred over the last several years, including the common Federal policies and procedures on research misconduct issued by the Office of Science and Technology Policy on December 6, 2000.     

行政许可条件研究

许可条件是行政许可设定制度的一个重要内容,也是行政许可制度发挥作用的关键因素。许可条件是申请人能够获得许可的“最高限制性要求”,其设定不仅要做到形式合法,而且还必须兼顾公益与私益的平衡并以必要为限。行政许可设定机关应当遵循上述原则和要求,定期对其设定的行政许可事项及其条件进行评价。     

Immigration and Naturalization Service--nonimmigrant alien (H-1) nurses; state license or examination requirements. Final rule

This final rule requires nonimmigrant nurses to possess a valid state license to practice nursing in the United States or to have successfully passed the screening examination given by the Commission on Graduates of Foreign Nursing Schools in order to qualify for an "H-1" nonimmigrant visa classification. Proof of having met either requirement is necessary before the Service will approve the visa petition. This amendment to the regulations is necessary to ensure that only those nonimmigrant nurses who are fully qualified to perform services of the "exceptional nature" required by section 101(a)(15)(H)(i) of the Act are admitted under this classification.     

对地方行政许可设定权的若干认识

行政许可法关于地方行政许可设定权的立法原则 ,除合法、公开、公平、公正外 ,还包括行政许可权的严格控制与对地方的相对放权的统一 ,注重公正前提下的公正与效率相兼顾。行政许可法对行政许可概念、范围的界定尚待完善。行政许可应限于“附条件的法定权利” ,属于监督性、管制性的行政行为 ,依特定的、明示的申请行为作出“许可”的行为 ,以及行政许可法第 1 2条拟定的事项