Medical devices; ovarian adnexal mass assessment score test system; labeling; black box restrictions. Final rule

The Food and Drug Administration (FDA) is amending the regulation classifying ovarian adnexal mass assessment score test systems to restrict these devices so that a prescribed warning statement that addresses a risk identified in the special controls guidance document must be in a black box and must appear in all labeling, advertising, and promotional material. The black box warning mitigates the risk to health associated with off-label use as a screening test, stand-alone diagnostic test, or as a test to determine whether or not to proceed with surgery.     

Requiring use of electronic services by certain claimant representatives. Final rules

We are revising our rules to require that claimant representatives use our electronic services as they become available on matters for which the representatives request direct fee payment. In the future, we will publish a notice in the Federal Register when we require representatives who request direct fee payment on a matter to use our available electronic services. We are also adding the requirement to use our available electronic services on matters for which the representative requests direct fee payment as an affirmative duty in our representative conduct rules. These revisions reflect the increased use of technology in representatives' business practices. We expect that the use of electronic services will improve our efficiency by allowing us to manage our workloads more effectively. These rules do not require claimants to use our available electronic services directly; they only require their representatives to use the services on matters for which the representatives request direct fee payment.     

International Conference on Harmonisation; Guidance on E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions.' 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 describes recommendations regarding the context, structure, and format of qualification submissions for clinical and nonclinical genomic biomarkers related to development of drug or biotechnology products, including translational medicine approaches, pharmacokinetics, pharmacodynamics, and efficacy and safety aspects. The guidance is intended to create a harmonized recommended structure for biomarker qualification applications that will foster consistency of applications across regions and facilitate discussions with and among regulatory authorities.     

Medicare program; hospice wage index for fiscal year 2012. Final rule

This final rule will set forth the hospice wage index for fiscal year (FY) 2012 and continue the phase-out of the wage index budget neutrality adjustment factor (BNAF), with an additional 15 percent BNAF reduction, for a total BNAF reduction in FY 2012 of 40 percent. The BNAF phase-out will continue with successive 15 percent reductions from FY 2013 through FY 2016. This final rule will change the hospice aggregate cap calculation methodology. This final rule will also revise the hospice requirement for a face-to-face encounter for recertification of a patient's terminal illness. Finally, this final rule will begin implementation of a hospice quality reporting program.     

Medical devices; neurological devices; classification of repetitive transcranial magnetic stimulation system. Final rule

The Food and Drug Administration (FDA) is classifying the repetitive transcranial magnetic stimulation (rTMS) system into class II (special controls). The Agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.     

Cardiovascular devices; classification of electrocardiograph electrodes. Final rule

The Food and Drug Administration (FDA) is classifying the electrocardiograph electrode, intended to acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram, into class II (special controls). FDA is also exempting this device from the premarket notification requirement.     

突发事件管理中的政府信息公开

应急信息公开是政府的职责,必须坚持依法公开、准确发布、及时传播和适时反馈的原则。在具体操作上,政府必须紧扣事件动态,抢占话语先机;把握事发状态,掌握传播节奏;坦诚公开表态,满足公众期待;抚平公众心态,引导社会舆论;注重公众情态,赢得人民支持;恢复发布常态,消除各方疑虑。     

网络公关异化:现象、原因与监管

网络公关是传统公关与信息技术相结合的产物,其目的是组织通过与公众的双向互动实现良好的组织形象。作为新兴的产业,网络公关在发展过程中出现杜撰口碑、歪曲事实、操纵舆论及暴力营销等异化现象。为促进公关行业有序发展,维持网络市场的竞争秩序,政府与市场要采取纠偏措施,对网络公关主体进行分层监管;同时平等监管公关客体,协调公关客体与主体间的关系;规范网络公关的运作方式,使整个公关行业进入良性发展轨道。     

我国医疗机构分类管理制度探讨

我国的医疗机构分类管理制度已实施10年,在医改背景下对其进行系统分析具有重要意义。本文通过分析医疗机构分类管理制度的构成、内容和实施现状,指出该制度在法律基础、分类方法、配套制度等方面存在的问题,并从法律规范的建设、政府职能的转变、行政管理方式的改变等方面提出了政策建议。     

中国责任政府研究的三个基本问题

责任政府是我国行政体制改革的重要内容,其理论和实践都取得了很大进展。本文对2000年以后国内有关责任政府研究中的三个基本问题进行综述和评价,并结合国外相关研究和实践的前沿,探讨未来研究的方向。